HRSA R&R Two-Tier Application Guide_V2 (Updated April 19, 2024)

U.S. Department of Health and Human Services

R&R

Two-Tier Application Guide

A guide developed and maintained by HRSA for preparing and

submitting two-tier applications through

Grants.gov AND the HRSA Electronic Handbooks (EHBs)

using the SF-424 R&R Workspace Application Package

Updated April 19, 2024

HRSA R&R Two-Tier

Application Guide

Table of Contents

1. INTRODUCTION ........................................................................................................................1

1.1. ABOUT HRSA................................................................................................................... 1

1.2. DOCUMENT PURPOSE AND SCOPE .................................................................................. 1

1.3. DOCUMENT VERSION CONTROL....................................................................................... 2

1.4. SUMMARY OF SIGNIFICANT CHANGES ............................................................................. 2

2. POLICIES, ASSURANCES, DEFINITIONS, AND OTHER INFORMATION ...........................2

2.1. ADMINISTRATIVE AND NATIONAL POLICY REQUIREMENTS .............................................. 2

2.2. COMPLIANCE REQUIREMENTS AT A GLANCE ................................................................... 9

2.3. ASSURANCES AND CERTIFICATIONS ................................................................................ 9

2.4. REFERENCES .................................................................................................................. 10

2.5. DEFINITIONS ................................................................................................................... 10

2.6. ACRONYMS ..................................................................................................................... 10

3. REGISTERING AND APPLYING THROUGH GRANTS.GOV USING WORKSPACE .........12

3.1. ELECTRONIC DELIVERY .................................................................................................. 12

3.2. HOW TO REGISTER TO APPLY THROUGH GRANTS.GOV ................................................ 12

3.3. HOW TO SUB MIT AN APPLICATION TO HRSA VIA GRANTS.GOV ................................... 15

3.4. TIMELY RECEIPT REQUIREMENTS AND PROOF OF TIMELY SUBMISSION ...................... 17

3.5. LATE APPLICATIONS ....................................................................................................... 17

3.6. REQUESTING A WAIVER FROM THE ELECTRONIC SUBMISSION REQUIREMENT ............ 17

4. VALIDATING AND/OR COMPLETING AN APPLICATION IN THE HRSA ELECTRONIC

HANDBOOKS (EHBS) ............................................................................................................19

4.1. REGISTER - PROJECT DIRECTOR AND AUTHORIZING OFFICIAL MUST REGISTER WITH

HRSA EHBS (IF NOT ALREADY REGISTERED)............................................................... 19

4.2. VERIFY STATUS OF APPLICATION................................................................................... 20

4.3. VALIDATE GRANTS.GOV APPLICATION IN THE HRSA EHBS ........................................ 20

4.4. MANAGE ACCESS TO THE APPLICATION ........................................................................ 21

4.5. CHECK VALIDATION ERRORS ......................................................................................... 21

4.6. FIX ERRORS AND COMPLETE APPLICATION ................................................................... 21

4.7. SUBMIT APPLICATION IN HRSA EHBS .......................................................................... 22

5. GENERAL INSTRUCTIONS FOR APPLICATION SUBMISSION .........................................22

5.1. INSTRUCTIONS FOR COMPLETING THE SF-424 R&R FOR TWO-TIER APPLICATIONS.. 23

5.2. NARRATIVE AND ATTACHMENT FORMATTING GUIDELINES............................................ 42

5.3. APPLICATION CONTENT ORDER (TABLE OF CONTENTS)............................................... 44

5.4. APPLICATION PAGE LIMIT ............................................................................................... 47

5.5. SUBMISSION DATES AND TIMES ..................................................................................... 48

5.6. CORRECTING MISTAKES................................................................................................. 48

5.7. TIPS FOR WRITING A STRONG APPLICATION ................................................................. 49

5.8. WITHDRAWING AN APPLICATION .................................................................................... 49

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6. PROCESS OVERVIEW ...........................................................................................................49

6.1. COMPETING APPLICATIONS (PHASES 1 AND 2: SUBMISSION THROUGH GRANTS.GOV

USING WORKSPACE AND THE EHBS) ............................................................................ 49

6.2. APPLICATION PROCESSING ............................................................................................ 50

6.3. OBJECTIVE REVIEW INFORMATION................................................................................. 50

6.4. AWA RD NOTIFICATION .................................................................................................... 51

7. REPORTING REQUIREMENTS..............................................................................................52

8. AGENCY CONTACTS .............................................................................................................54

8.1. WORKING WITH HRSA PROGRAM AND GRANTS MANAGEMENT STAFF ....................... 54

8.2. GRANTS.GOV CUSTOMER SUPPORT .............................................................................. 54

8.3. EHBS PROGRAM-SPECIFIC (BPHC) SUPPORT ............................................................ 54

9. FAQS AND OTHER INFORMATION ......................................................................................55

9.1. SOFTWARE FAQS .......................................................................................................... 55

9.2. APPLICATION RECEIPT FAQS ........................................................................................ 55

9.3. APPLICATION SUBMISSION FAQ .................................................................................... 58

9.4. GRANTS.GOV FAQS ....................................................................................................... 58

9.5. APPLICATION COMPLETENESS CHECKLIST .................................................................... 58

9.6. PROGRAM-SPECIFIC RESOURCES AND TECHNICAL ASSISTANCE................................. 59

10.

TECHNICAL ASSISTANCE RESOURCES

........................................................................59

APPENDIX:

SUPPLEMENTAL INSTRUCTIONS FOR PREPARING THE PROTECTION OF

HUMAN SUBJECTS SECTION OF THE RESEARCH PLAN AND HUMAN SUBJECTS

RESEARCH POLICY ...............................................................................................................60

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1. INTRODUCTION

1.1. About HRSA

Our programs provide equitable health care to people who are geographically isolated

and economically or medically vulnerable. This includes programs that deliver health

services to people with HIV, pregnant people, mothers and their families, those with low

incomes, residents of rural areas, American Indians and Alaska Natives, and those

otherwise unable to access high-quality health care.

Our programs also support health infrastructure, including through training of health

professionals and distributing them to areas where they are needed most, providing

financial support to health care providers, and advancing telehealth.

In addition, we oversee programs for providing discounts on prescription drugs to safety

net providers, facilitating organ, bone marrow, and cord blood transplantation,

compensating individuals injured by vaccination, and maintaining data on health care

malpractice payments.

In Fiscal Year 2021, we provided nearly $54 billion in funding to support our mission.

For more information, visit the HRSA Agency Overview page and explore data and

maps on our health care programs

1.2. Document Purpose and Scope

The purpose of this document is to provide detailed instructions to help you (the

applicant organization/agency) prepare and submit two-tier

competing continuation,

competing supplement, limited competition, and new applications electronically to

HRSA through Grants.gov and the HRSA Electronic Handbooks (EHBs), as specified in

the HRSA notice of funding opportunity (NOFO). This R&R Two-Tier Application Guide

is specific to HRSA NOFOs using the Application for Federal Assistance SF-424

Research and Related (R&R) application package

for research or training awards,

for applicants that are required to submit initial information electronically through

Grants.gov, and subsequent information through the EHBs. This Guide presents

Describes certain HRSA applications where the initial application submission is through Grants.gov (first tier or Phase 1) and the

supplemental information submission is through the EHBs (second tier or Phase 2). Submission of EHBs information is always

completed AFTER Grants.gov submission (refer to FOA for specific guidance and dates).

If you are applying for awards that require the SF-424 Non-Construction application package, you must refer to HRSA’s Application

Guide (where no supplemental EHB information is required) for guidance. If you are applying for awards that require the SF-424

R&R application package (where no supplemental EHBs information is required), you must refer to HRSA’s R&R Application Guide.

HRSA R&R Two-Tier

Application Guide

HRSA general information related to the application preparation and submission

process and will be updated periodically.

Note: To request a subsequent budget period, recipients need only to submit the

streamlined Non-Competing Continuation (NCC) Progress Report for continued funding

of the next budget period. For details and user guides, please visit HRSA Grants

Website.

1.3. Document Version Control

HRSA’s Division of Grants Policy in the Office of Federal Assistance and Acquisition

Management periodically updates and maintains this document.

1.4. Summary of Significant Changes

April 19, 2024

• Added citations regarding the Further Consolidated Appropriations Act, 2024

(P.L. 118-47).

• Added Registering in ID.me for Payment Management System (PMS) Access

guidance for successful applicants who receive an award.

April 1, 2024

• Updated Project Abstract

guidance: removed bulleted list. We no longer require

specific contact details in the Project Abstract Summary form.

January 12, 2024

• Updated Accessibility Provisions and Non-Discrimination Requirements in

Section 2.1. Administrative and National Policy Requirements.

• Updated Executive Level II salary rate limitation amount from $212,100 to

$221,900 to align with OPM's Salary Table No. 2024-EX. Also updated related

salary breakdowns and examples.

2. POLICIES, ASSURANCES, DEFINITIONS, AND OTHER INFORMATION

2.1. Administrative and National Policy Requirements

Successful applicants must comply with 45 CFR part 75 Uniform Administrative

Requirements, Cost Principles, and Audit Requirements for HHS Awards (UAR).

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In addition to the numerous administrative and national policy requirements imposed

by regulation and HHS policies, HRSA stresses the following requirements of every

award:

Standards for Financial Management

Recipients are required to meet the standards and requirements for financial

management systems set forth in 45 CFR part 75. The financial systems must enable

the recipient to maintain records that adequately identify the sources of funds for

federally assisted activities and the purposes for which the award was used, including

authorizations, obligations, unobligated balances, assets, liabilities, outlays or

expenditures, and any program income. The system must also enable the recipient to

compare actual expenditures or outlays with the approved budget for the award.

Internal controls must be in place to ensure that costs charged to HRSA awards are

allowable, allocable to the HRSA award, reasonable, necessary, and documented. For

example, controls must be in place to ensure that only actual time worked on HRSA

projects are charged to HRSA awards, and that the time worked has management

approval from the HRSA award recipient. There also must be internal controls in place

to ensure that costs charged to HRSA awards through subawards are monitored and

evaluated by the HRSA award recipient and that only allowable, allocable, reasonable,

necessary and documented costs are charged to HRSA awards.

HRSA funds must retain their award-specific identity—they may not be commingled

with state funds or other federal funds. [“Commingling funds” typically means

depositing or recording funds in a general account without the ability to identify each

specific source of funds for any expenditure.]

Accessibility Provisions and Non-Discrimination Requirements

If you receive an award, you must follow all applicable nondiscrimination laws. You

agree to this when you register in SAM.gov. You must also submit an Assurance of

Compliance (HHS-690). To learn more, see the

Laws and Regulations Enforced by the

HHS Office for Civil Rights.

Contact the HHS Office for Civil Rights for more information about obligations and

prohibitions under federal civil rights laws or call 1-800-368-1019 or TDD 1-800-537-

7697.

The HRSA Office of Civil Rights, Diversity, and Inclusion (OCRDI) offers

technical assistance, individual consultations, trainings, and plain language

materials to supplement OCR guidance. Visit OCRDI’s website

to learn more

about how federal civil rights laws and accessibility requirements apply to your

programs, or contact OCRDI directly at

HRSACivilRights@hrsa.gov.

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Acknowledgment of Federal Funding

If the NOFO notes that the program is subject to the General Provisions of P.L. 118-47

(or P.L. 117-328), the following statutory mandate applies:

Division H, Title V, Section 505

“When issuing statements, press releases, requests for proposals, bid solicitations and

other documents describing projects or programs funded in whole or in part with federal

money, all grantees receiving federal funds included in this Act, including but not limited

to state and local governments and recipients of federal research grants, shall clearly

state –

(1) the percentage of the total costs of the program or project which will be financed

with federal money;

(2)

the dollar amount of federal funds for the project or program; and

(3) percentage and dollar amount of the total costs of the project or program that will

be financed by non-governmental sources.”

In addition, HRSA requires recipients to use the following acknowledgment and

disclaimer:

“This [project/publication/program/website] [is/was] supported by the Health

Resources and Services Administration (HRSA) of the U.S. Department of Health

and Human Services (HHS) as part of an award totaling $XX with xx percentage

financed with non-governmental sources. The contents are those of the author(s)

and do not necessarily represent the official views of, nor an endorsement, by

HRSA, HHS or the U.S. Government.”

Recipients are required to use this language when issuing statements, press releases,

requests for proposals, bid solicitations, and other HRSA supported publications and

forums describing projects or programs funded in whole or in part with HRSA funding.

Examples of HRSA-supported publications include, but are not limited to, manuals,

toolkits, resource guides, case studies and issues briefs. For more details, see HRSA’s

Communicating and Acknowledging Federal Funding webpage

Conflict of Interest

HRSA has established a

Federal Financial Assistance Conflict of Interest Policy (COI

Policy) pursuant to 45 CFR § 75.112, which requires that awarding agencies establish

conflict of interest policies for federal awards that: 1) Address conditions under which

outside activities, relationships, or financial interests are proper or improper;

2) Provide for advance notification of outside activities, relationships, or financial

interests, and a process of review as appropriate; and 3) Outline how financial

conflicts of interest may be addressed. This policy addresses such conditions;

identifies when and how a non-federal entity (NFE) must provide written notification of

such outside activities, relationships, or financial interests to HRSA or, in the case of

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grant subrecipients, to the pass-through entity, and describes a process of review of

such disclosures; and discusses the means by which financial conflicts of interest may

be addressed.

This COI Policy, except as noted below, applies to all NFEs receiving HRSA financial

assistance, either directly (from HRSA) or indirectly (i.e., through a subaward from a

pass-through entity). Note: For the purposes of this COI Policy, institutions of higher

education that are instrumentalities of a state under applicable state laws are subject

to the requirements applicable to such entities.

Financial Conflict of Interest

HHS requires recipients and investigators to comply with the requirements of 42 CFR

part 50, subpart F, "Responsibility of Applicants for Promoting Objectivity in Research

for which PHS Funding is Sought." A Final Rule amending this PHS regulation (and the

companion regulation at 45 CFR part 94, "Responsible Prospective Contractors,"

imposing similar requirements for research contracts) was published on

August 25,

2011 in the Federal Register. An Institution applying for or receiving PHS funding from a

grant or cooperative agreement that is covered by the rule must be in full compliance

with all of the revised regulatory requirements no later than August 24, 2012, and

immediately upon making its institutional Financial Conflict of Interest (FCOI) policy

publicly accessible as described in the regulation.

Healthy People 2030

Led by HHS, Healthy People 2030 is the nation's 10-year plan for addressing our most

critical public health priorities and challenges. Since 1980, HHS's Office of Disease

Prevention and Health Promotion has set measurable objectives and targets to

improve the health and well-being of the nation.

This decade, Healthy People 2030 features 355 core – or measurable – objectives

with 10-year targets, new objectives related to opioid use disorder and youth e-

cigarette use, and resources for adapting Healthy People 2030 to emerging public

health threats like COVID-19. For the first time, Healthy People 2030 also sets 10-

year targets for objectives related to social determinants of health. More information

about Healthy People 2030 may be found online at https://health.gov/healthypeople

Human Subjects Protection

Federal regulations (45 CFR part 46) require that applications and proposals

involving human subjects must be evaluated with reference to the risks to the

subjects, the adequacy of protection against these risks, the potential benefits of the

research to the subjects and others, and the importance of the knowledge gained or

to be gained. If research involving human subjects is anticipated, recipients must meet

the requirements of the HHS regulations to protect human subjects from research risks

as specified in the Code of Federal Regulations,

Title 45 – Public Welfare, Part 46 –

Protection of Human Subjects (45 CFR part 46), available online.

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NOTE: See the Appendix of this R&R Two-Tier Application Guide for supplemental

instructions for preparing the human subjects section of the research plan.

Mandatory Disclosures

The non-federal entity or applicant for a federal award must disclose, in a timely

manner, in writing to the HHS awarding agency or pass-through entity all violations of

federal criminal law involving fraud, bribery, or gratuity violations potentially affecting

the federal award (45 CFR § 75.113

). Failure to make required disclosures can result

in any of the remedies described in 45 CFR § 75.371, including suspension or

debarment. (See also 2 CFR parts 180 and 376, and 31 U.S.C. 3354).

Submission is required for all applicants and recipients, in writing, to the awarding

agency and to the HHS Office of Inspector General (OIG) all information related to

violations of federal criminal law involving fraud, bribery, or gratuity violations potentially

affecting the federal award. Disclosures must be sent in writing to:

HRSA (The Awarding Agency)

AND

U.S. Department of Health and Human Services

Office of Inspector General

ATTN: Mandatory Grant Disclosures, Intake Coordinator

330 Independence Avenue, SW, Cohen Building

Room 5527

Washington, DC 20201

URL: https://oig.hhs.gov/fraud/report-fraud/index.asp

(Include “Mandatory Grant Disclosures” in subject line)

Fax: (202) 205-0604 (Include “Mandatory Grant Disclosures” in subject line) or

Email: grantdisclosures@oig.hhs.gov

Prohibition on Certain Telecommunications and Video Surveillance Services or

Equipment

(a) As described in 2 CFR § 200.216, recipients and subrecipients are prohibited to

obligate or spend grant funds (to include direct and indirect expenditures as well as

cost share and program) to:

(1) Procure or obtain,

(2) Extend or renew a contract to procure or obtain; or

(3) Enter into contract (or extend or renew contract) to procure or obtain equipment,

services, or systems that use covered telecommunications equipment or services

as a substantial or essential component of any system, or as critical technology

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as part of any system. As described in Pub. L. 115-232, section 889, covered

telecommunications equipment is telecommunications equipment produced by

Huawei Technologies Company or ZTE Corporation (or any subsidiary or affiliate

of such entities).

i. For the purpose of public safety, security of government facilities, physical

security surveillance of critical infrastructure, and other national security

purposes, video surveillance and telecommunications equipment produced

by Hytera Communications Corporation, Hangzhou Hikvision Digital

Technology Company, or Dahua Technology Company (or any subsidiary or

affiliate of such entities).

ii. Telecommunications or video surveillance services provided by such entities

or using such equipment.

iii. Telecommunications or video surveillance equipment or services produced

or provided by an entity that the Secretary of Defense, in consultation with

the Director of the National Intelligence or the Director of the Federal Bureau

of Investigation, reasonably believes to be an entity owned or controlled by,

or otherwise, connected to the government of a covered foreign country.

Research Misconduct

The recipient is responsible for the actions of its employees and other research

collaborators, including third parties, involved in the project. The recipient will inquire

into and, if necessary, investigate and resolve promptly and fairly all instances of

alleged or apparent research misconduct.

42 CFR part 93, “Public Health Service

Policies on Research Misconduct,” specifies recipient responsibilities for dealing with

and reporting possible research misconduct. The regulation is available from the Office

of Research Integrity (ORI) on its home page.

The recipient must carry out its responsibilities with extra care if a research misconduct

inquiry has been initiated as specified in 42 CFR § 93.307 or if the recipient or ORI has

made a finding of research misconduct. The recipient must report promptly to ORI any

incident of alleged or apparent research misconduct that it judges as warranting

investigation and must advise ORI of any decision to initiate an investigation. The

recipient also must notify ORI if it intends to close a case at the inquiry or investigation

stage based on an admission of responsibility, settlement, or for any other reason. The

regulations also require that the recipient submit an annual report.

If a misconduct investigation has been initiated, the recipient must take any necessary

steps, in addition to its normal and ongoing responsibilities under the award, to protect

the scientific integrity of the project, protect human subjects and animals, provide

reports to ORI, and ensure the proper expenditure of funds and continuation of the

project during the investigation, if appropriate. ORI staff members are available to help

recipients with investigating and reporting on research misconduct, and POs are

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available to provide technical assistance and to work with recipients to protect funded

projects from the adverse effects of research misconduct.

If the recipient finds research misconduct by anyone working on an HHS award-

supported project, whether at its organization or at a third-party organization, the

recipient must assess the effect of that finding on the ability to continue that project, as

originally approved, and must promptly request OPDIV prior approval of any intended

change of PI or other key personnel

. In addition, the awarding office may impose

sanctions, such as withdrawal of approval of the PI/PD or other key personnel,

disallowance of costs associated with the invalid or unreliable research, withholding a

non-competing continuation award, suspension or termination, in whole or in part, of the

current award, or debarment.

If research misconduct has affected data validity or reliability, ORI or the OPDIV may

require the recipient and its employee/collaborator authors to submit a correction or

retraction of the data to a journal, publish the corrected data, or both. If the recipient

does not comply with this requirement, the OPDIV may invoke its rights, under 45 CFR

part 74 or 92, to access the data (including copyrightable material developed under the

award), have the data reviewed, and submit the correction.

The recipient must promptly report issues involving potential civil or criminal fraud,

such as false claims or misappropriation of federal funds, to the HHS OIG.

Smoke-Free Workplace

The Public Health Service strongly encourages all award recipients to provide a smoke-

free workplace and to promote the non-use of all tobacco products. Further, Public Law

(P.L.) 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in

some cases, any portion of a facility) in which regular or routine education, library, day

care, health care or early childhood development services are provided to children.

Trafficking in Persons

Awards issued under HRSA NOFOs are subject to the requirements of Section 106(g)

of the Trafficking Victims Protection Act of 2000, as amended (22 U.S.C. 7104). For

the full text of the award term, go to Trafficking Victims Protection

NOTE: The signature of the Authorized Organization Representative (AOR) (by

checking “I agree” in Box 17 of SF-424 R&R) on the application serves as the required

certification of compliance for your organization regarding the administrative and

national policy requirements.

Key Personnel: The Principal Investigator/Project Director (PI/PD) and other individuals who contribute to the programmatic

development or execution of a project or program in a substantive, measurable way, whether or not they receive salaries or

compensation under the award.

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2.2. Compliance Requirements at a Glance

For reference, the chart below provides compliance requirements by recipient and

requirement type.

Recipient Type

Administrative

Requirements

Cost Principles Audit Requirements

State, Local & Tribal

Governments

45 CFR part 75

45 CFR part 75;

subpart E

45 CFR part 75;

subpart F

Colleges &

Universities

45 CFR part 75

45 CFR part 75;

subpart E

45 CFR part 75;

subpart F

Non-Profits 45 CFR part 75

45 CFR part 75;

subpart E

45 CFR part 75;

subpart F

Hospitals 45 CFR part 75

45 CFR part 75,

Appendix IX

45 CFR part 75;

subpart F

For-Profits 45 CFR part 75

48 CFR subpart 31.2

(FAR 31.2)

45 CFR part 75;

subpart F

Foreign 45 CFR part 75

As stated above for

each recipient type

45 CFR part 75

except where the

HHS awarding

agency determines

that the application of

these subparts would

be inconsistent with

the international

obligations of the

United States or the

statutes or

regulations of a

foreign government.

2.3. Assurances and Certifications

The signature of the AOR (by checking “I agree” in Box 17 of SF-424 R&R) on the

application serves as the required certification of compliance for the applicant

organization regarding Lobbying. See Section 5.1.viii of this R&R Two-Tier Application

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Guide for more details. If applicable, complete the Standard Form-LLL Disclosure of

Lobbying Activities Form provided with the application package.

In accordance with the Federal Government’s efforts to reduce reporting burden for

recipients of federal financial assistance, the general certification and representation

requirements contained in the Standard Form 424B (SF-424B) – Assurances – Non-

Construction Programs, and the Standard Form 424D (SF-424D) – Assurances –

Construction Programs, have been standardized federal-wide. Effective January 1,

2020, the forms themselves are no longer required to be part of HRSA’s Application

Package and the updated common certification and representation requirements will

be stored and maintained within the System for Award Management (SAM).

Organizations or individuals applying for federal financial assistance as of January 1,

2020, must validate the federally required common certifications and representations

annually through SAM

2.4. References

About HRSA

How to Apply for a HRSA Grant

System for Award Management (SAM) | SAM.gov Knowledge Base

Grants.gov Online User Guide

Grants.gov Workspace Overview

Tips for Preparing Grant Proposals

2.5. Definitions

Please refer to 45 CFR § 75.2 Definitions

2.6. Acronyms

AL Assistance Listings (formerly the Catalog of Federal Domestic

Assistance (CFDA))

AO Authorizing Official

AOR Authorized Organization Representative

BHW Bureau of Health Workforce

BPHC Bureau of Primary Health Care

CAS Cost Allocation Services

CCR Central Contractor Registration (now defunct)

CFR Code of Federal Regulations

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CGMO Chief Grants Management Officer

DSO Digital Services Operation

DUNS Data Universal Numbering System

EBiz POC E-Business Point of Contact

EHBs Electronic Handbooks

EIN Employer Identification Number

EO Executive Order

FAQ Frequently Asked Questions

FAR Federal Acquisition Regulation

FFATA Federal Funding Accountability and Transparency Act

FORHP Federal Office of Rural Health Policy

FY Fiscal Year

F&A Facilities and Administration

GMO Grants Management Officer

GMS Grants Management Specialist

HAB HIV/AIDS Bureau

HHS Health and Human Services

HRSA Health Resources and Services Administration

HSB Healthcare Systems Bureau

IE Internet Explorer

MCHB Maternal and Child Health Bureau

MPIN Marketing Partner ID Number

MTDC Modified Total Direct Cost

NCC Noncompeting Continuation

NHAS National HIV/AIDS Strategy

NOA Notice of Award

NOFO Notice of Funding Opportunity

OFAM Office of Federal Assistance Management

OMB Office of Management and Budge

ORO Office of Regional Operations

OS Operating System

PC Program Contact

PD Project Director

P.L. Public Law

PO Project Officer / Program Official

POC Point of Contact

R&R Research and Related

SAM System for Award Management

SF Standard Form

TA Technical Assistance

TIN Tax Identification Number

UEI Unique Entity Identifier

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3. REGISTERING AND APPLYING THROUGH GRANTS.GOV USING

WORKSPACE

Grants.gov Application Submission and Receipt Procedures

This section provides the application submission and receipt instructions for HRSA

program applications. Read the following instructions carefully and completely.

Under the two-tier system, HRSA requires you to initially apply electronically.

Information on validating and/or completing an application in the EHBs is provided in

Section 4

of this Guide.

3.1. Electronic Delivery

HRSA is participating in the Grants.gov initiative to provide the grant community with a

single site to find and apply for funding opportunities. HRSA requires you to submit your

applications online.

• NOTE: HRSA highly recommends that you complete the Grants.gov registration process

at least 4 WEEKS before your organization’s first Grants.gov submission.

3.2. How to Register to Apply through Grants.gov

a. Instructions: Read the instructions below about registering to apply for HRSA

funds. You should read the registration instructions carefully and prepare the

information requested before beginning the registration process. Reviewing and

assembling the required information before beginning the registration process will

alleviate last-minute searches for required information.

The registration process can take up to 4 weeks to complete. Therefore,

registration should be done in sufficient time to ensure it does not impact your

ability to meet required application submission deadlines.

If individual applicants are eligible to apply for this funding opportunity, refer to:

Grants.gov: Registration

Organization applicants can find complete instructions here:

Grants.gov: Organization Registration

1) Register with SAM: Th e Unique Entity Identifier (UEI) assigned by the

System for Award Management (SAM), has replaced the Data Universal

Numbering System (DUNS) number. Register in SAM and you will be

assigned a UEI. It takes 1 day (after you enter the EBiz POC name and

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EBiz POC email in SAM) to receive a UEI, which will allow you to register

with Grants.gov and apply for federal funding.

All organizations must register with SAM in order to apply online. Failure to

Grants.gov.

Effective March 3, 2023, individuals assigned a SAM.gov Entity

Administrator role must be an employee, officer, or board member, and

cannot be a non-employee. This change is to ensure entities are in control

of who has permission to control roles within their entity.

Here’s what this means:

• Entity Administrators assigning roles to non-employees will only be able

to assign a Data Entry role or lower.

• Any entities assigning Entity Administrator roles using an Entity

Administrator Role Request Letter (formerly called “notarized letter”) will

no longer be able to assign the Entity Administrator role to a non-

employee.

• Entity Administrator roles assigned to non-employees will be converted

to Data Entry roles. With a Data Entry role, non-employees can still

create and manage entity registration data entry but cannot manage

roles.

If you are an entity using a non-employee or if you are a non-employee

working with an entity to manage registrations, please read (and share)

more about this change on the BUY.GSA.gov blog to know what to expect.

Make sure you “opt-in” for public display of your record within SAM so

HRSA can easily access and review your information. If you see the

question “Is my information available for viewing by the public?” please

answer “Yes.”

For more detailed instructions for registering with SAM, refer to:

Grants.gov: Applicant Registration.

2) Create a Grants.gov Account: The next step in the registration process is to

create an account with Grants.gov. You must know your organization's UEI

number to complete this process. Enter the UEI (SAM) in the data entry

field labeled “UEI” on the Grants.gov SF-424 R&R form. Completing this

process automatically triggers an email request for applicant roles to the

organization's E-Business Point of Contact (EBiz POC) for review. The

HRSA R&R Two-Tier

Application Guide

EBiz POC is a representative from your organization who is the contact

listed for SAM. To apply for awards on behalf of your organization, you will

need the Authorized Organizational Representative (AOR) role.

For more detailed instructions about creating a profile on Grants.gov, refer

to: Grants.gov: Add Profile

3) Authorize Grants.gov Roles: After creating an account on Grants.gov, the

EBiz POC receives an email notifying them of your registration and request

for roles. The EBiz POC will then log in to Grants.gov and authorize the

appropriate roles, which may include the AOR role, thereby giving you

permission to complete and submit applications on behalf of the

organization. You will be able to submit your application online any time

after you have been approved as an AOR.

For more detailed instructions about creating a profile on Grants.gov, refer

to: Grants.gov: Authenticate AOR

4) Track Role Status: To track your role request, refer to:

Grants.gov: Track My Application

b. Electronic Signature: When submitting applications through Grants.gov, insert

the name of your organization's AOR who submits the application into the

signature line of the application, serving as the electronic signature. The EBiz

POC must authorize individuals who are able to make legally binding

commitments on behalf of the organization as an AOR. Applicants often miss this

step and it is crucial for valid and timely submissions.

3.2.1. Find Funding Opportunity

There are three ways to search for HRSA funding opportunities on Grants.gov.

1. Enter keyword or phrase in the Search box at the top of the home page at

Grants.gov.

2. Click on one of the following tabs in the middle of the home page to: Browse

Newest, Browse Categories, Browse Agencies, or Browse Eligibilities.

3. Click the SEARCH GRANTS

tab, enter the funding opportunity number and/or

assistance listings number, and then select the funding opportunity for which you

wish to apply. Refer to the NOFO for eligibility criteria. Otherwise, use the various

filters to help narrow your search.

Search for the funding opportunity under the APPLICANTS tab under How to Apply for

Grants. Enter the NOFO number provided in the field, Funding Opportunity Number.

(Example: HRSA-22-000.)

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Application Guide

3.2.2. Subscribing to a NOFO

HRSA strongly recommends subscribing to NOFOs you are interested in by using the

Subscribe button located next to the Apply button on the Grant Opportunity page. By

subscribing and providing your email address before reviewing or preparing the

workspace application package, you will receive notifications including modifications,

related documents and/or republications of the NOFO on Grants.gov before its closing

date.

3.3. How to Submit an Application to HRSA via Grants.gov

Complete Phase 1

, the Grants.gov portion of the application using both the built-in

instructions and the instructions provided in the NOFO. For assistance with program

guidance related questions, contact the Program Contact (PC) listed in Section VII of

the NOFO. For assistance with budget or other administrative related questions, contact

the Grants Management Specialist (GMS) listed in Section VII of the NOFO.

Grants.gov applicants can apply online using Workspace. Workspace is a shared,

online environment where members of a grant team may simultaneously access and

edit different webforms within an application. For each NOFO, you can create individual

instances of a workspace.

Below is an overview of applying on Grants.gov. For access to complete instructions on

how to apply for opportunities, refer to:

Grants.gov: Apply for Grants

1) Create a Workspace: Creating a workspace allows you to complete your

application online and route it through your organization for review before

submitting.

2) Complete a Workspace: Add participants to the workspace, complete all the

required forms, and check for errors before submission.

a. Adobe Reader: If you decide not to apply by filling out webforms, you

can download individual PDF forms in Workspace so that they will

appear similar to other Standard or HRSA forms. You can download and

save the individual PDF forms to your local device storage, network

drive(s), or external drives, and then access through Adobe Reader.

NOTE: Visit the Adobe Software Compatibility page on Grants.gov to

download the appropriate version of the software at: Grants.gov: Adobe

Software Capability

b. Mandatory Fields in Forms: In the forms, you will note fields marked with

an asterisk and a different background color. You must complete these

mandatory fields to successfully submit your application.

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Application Guide

c. Complete SF-424 Fields First: The forms are designed to fill in common

required fields across other forms, such as the applicant name, address,

and UEI number. To trigger this feature, an applicant must complete the

SF-424 information first. Once it is completed, the information will

transfer to the other forms.

3) Submit a Workspace: You may submit an application through workspace by

clicking the Sign and Submit button on the Manage Workspace page, under the

Forms tab. Note: Your application will not be submitted until you complete this

step. Grants.gov recommends submitting your application package at least 24–48

hours (1–2 calendar days) before the close date to provide you with time to

correct any potential technical issues that may disrupt the application submission.

However, HRSA suggests submitting applications to Grants.gov at least 3

calendar days before the deadline to allow for any unforeseen circumstances.

4) Track a Workspace: After successfully submitting a workspace package, a

Grants.gov Tracking Number (GRANTXXXXXXXX) is automatically assigned to

the package. The number will be listed on the Confirmation page that is generated

after submission.

For additional training resources, including video tutorials, refer to Grants.gov: Applicant

Training.

Applicant Support: Grants.gov provides applicants 24/7 support via the toll-free number

1-800-518-4726 (International callers dial 1-606-545-5035) and email

at support@grants.gov. For questions related to the specific funding opportunity,

contact the number listed in the application package of the award you are applying for.

If you are experiencing difficulties with your submission, it is best to call the Grants.gov

Support Center and get a ticket number. The Support Center ticket number will assist

HRSA with tracking and understanding the issue.

After successful submission in Grants.gov (Phase 1) and subsequent processing by

HRSA, you will be notified by HRSA confirming the successful receipt of your

application and the requirements for the Project Director and Authorizing Official to

review and submit additional information in HRSA EHBs (Phase 2). Your application will

not be considered compliant and complete unless you review and submit the additional

information in HRSA EHBs by the due date.

Notifications from HRSA EHBs are expected to go out within 7 business days from the

date of submission. If you do not receive notification that your application has been

successfully received, please contact the HRSA EHBs Contact Center at 877-GO4-

HRSA (877-464-4772) [TTY: (877) 897-9910] Monday through Friday between 7 a.m.

and 8 p.m. ET or via the web at HRSA Grants and Electronic Handbooks Contact

Center. Please have your Grants.gov tracking number available.

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Application Guide

3.4. Timely Receipt Requirements and Proof of Timely Submission

Online Submission. All applications must be received by 11:59 p.m. ET on the date

listed in Section IV.4. Submission Dates and Times in the NOFO, unless otherwise

noted. Grants.gov automatically records proof of timely submission. An electronic

date/time stamp is generated within the system and sent to the AOR when Grants.gov

successfully receives the application. The applicant AOR will receive an

acknowledgment of receipt and a tracking number (GRANTXXXXXXXX) from

Grants.gov with the successful transmission of their application serving as proof of their

timely submission.

When HRSA successfully retrieves the application from Grants.gov and acknowledges

the download of submissions, Grants.gov will provide an electronic acknowledgment of

receipt of the application to the email address of the applicant with the AOR role. Again,

proof of timely submission shall be the official date and time that Grants.gov receives

your application. Applications received by Grants.gov after the established due date for

the program will be considered late and HRSA will not consider the application for

funding. HRSA strongly suggests that you apply at least 3 calendar days before the

deadline to allow for any unforeseen circumstances. HRSA is under no obligation to

accept applications that are late due to problems with computer systems at your

organization or system-to-system grant submission service, failure to submit by the

deadline, or failure to follow instructions in the Application Guide or instructions in the

NOFO.

If you are using slow internet, such as dial-up connections, be aware that transmission

can take some time before Grants.gov receives your application. Again, Grants.gov will

provide either an error or a successfully received transmission in the form of an email

sent to the applicant with the AOR role. The Grants.gov Support Center reports that

some applicants end the transmission because they think that nothing is occurring

during the transmission process. Please be patient and give the system time to process

the application.

3.5. Late Applications

Applications which do not meet the criteria as outlined in Section IV.4. Submission Dates

and Times of the NOFO will be considered late applications and will not be reviewed.

Refer to HRSA’s Policy on Late Submission of Grant Applications for more information.

3.6. Requesting a Waiver from the Electronic Submission Requirement

HRSA requires you to apply electronically and have the application validated under the

correct funding opportunity number on or before the deadline date and time. The

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Application Guide

registration and application process protects you against fraud and ensures that only

authorized representatives from an organization can submit an application. You are

responsible for maintaining these registrations, which should be completed well in

advance of submitting an application. You must submit your application electronically

by the deadline posted on the NOFO. If you wish to request a waiver from the

submission requirement, you must request an exemption in writing from

ApplicationWaivers@hrsa.gov no later than 5 calendar days after the

opportunity’s closing date. Requests received after 5 calendar may not be

considered. The request should provide details as to why you are technologically unable

to submit electronically through the Grants.gov portal. If requesting a waiver from the

submission requirements, include the following in the email request:

• HRSA funding opportunity number

• Organization’s name

• Address

• Telephone number

• UEI number

• Name, address, and telephone number of the PD

• Grants.gov Tracking Number (GRANTXXXXXXXX) assigned to the

submission along with a copy of the “Rejected with Errors” notification as

received from Grants.gov, if applicable

• If case numbers were given from calling Grants.gov, include those as well

• Any other details regarding the justification

HRSA’s Division of Grants Management (DGMO) in the Office of Federal Assistance

Management is the only office authorized to grant waivers from the electronic

submission requirement.

HRSA is very strict on adhering to application deadlines and submission requirements.

Deadline extensions will not be granted for Grants.gov verification errors, last-minute

registration, or submission errors on your part. DGMO may consider an extension of

published deadlines or allowance of a submission outside of the Grants.gov system,

when justified by circumstances such as natural disasters (e.g., floods or hurricanes),

other disruptions of services (e.g.,such as a prolonged blackout), or in the rare event of

a validated technical issue on the side of the government that prevented you from

applying before the deadline. DGMO will determine the affected geographical area(s) or

other applicant group parameters.

HRSA and its Digital Services Operation (DSO) will only accept paper applications

from applicants that received prior written approval. However, the application must

still be submitted by the deadline.

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Application Guide

4. VALIDATING AND/OR COMPLETING AN APPLICATION IN THE HRSA

ELECTRONIC HANDBOOKS (EHBs)

4.1. Register - Project Director and Authorizing Official Must Register with

HRSA EHBs (if not already registered)

To access a competing application in HRSA EHBs, you must register within the EHBs.

The purpose of the registration process is to collect consistent information from all

applicants and allow for the unique identification of each system user. Applications must

be submitted in the English language and in the terms of U.S. dollars (

45 CFR §

75.111(a))

• Registration within HRSA EHBs is required only once for each applicant.

• HRSA EHBs now allow a single username to be associated with more than

one organization.

Registration within HRSA EHBs is a two-step process. In the first step, individual users

from an organization who participate in the application process must create individual

system accounts. In the second step, the users must associate themselves with the

appropriate grantee organization. To find your organization’s record, use the UEI

number associated with the application submitted in Grants.gov.

To complete the HRSA EHBs registration:

1. Create Individual User Accounts: Identify your role in the grants management

process. HRSA EHBs offer the following three functional roles for individuals from

applicant/recipient organizations:

• Authorizing Official (AO),

• Business Official (BO), and

• Other Employee (for Project Directors, assistant staff, AO designees and others).

For more information on functional responsibilities, refer to the

HRSA EHBs online

help.

2. Associate user with Applicant Organization: Locate the UEI number from the

application SF-424 R&R submitted through Grants.gov. You must use this number to

find your organization during registration. All individuals from the organization

working on the application must use the same UEI number to ensure correct

registration.

Registration with HRSA EHBs is independent of Grants.gov registration.

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Application Guide

For assistance in registering with HRSA EHBs, call the HRSA EHBs Contact Center at

1-877-464-4772 (select option 3) [TTY: 877-897-9910], Monday through Friday (except

federal holidays) from 7 a.m. to 8 p.m. ET or via the web at

HRSA Grants and Electronic

Handbooks Contact Center.

For BPHC funding opportunities, contact Health Center Program Support for assistance

with submitting information in HRSA EHBs, Monday through Friday, 8 a.m. to 8 p.m.

ET, excluding federal holidays, at 877-464-4772 (select option 2) or submit an inquiry

online via the Contact the Bureau of Primary Health Care

form.

• IMPORTANT: You must use your HRSA EHBs Tracking Number or your 10-digit award

number to identify your organization.

4.2. Verify Status of Application

HRSA will send an email to the PD, AO, POC, and the BO (listed on the submitted

application) to confirm that the application was successfully received.

• NOTE: You should check HRSA EHBs within 2–3 business days after submission through

Grants.gov for availability of your application.

4.3. Validate Grants.gov Application in the HRSA EHBs

The HRSA EHBs include a validation process to ensure that only authorized individuals

from an organization are able to access the organization’s competing applications. Th e

first user who seeks access to any competing application will need to provide the

following information:

Data Element

Source

Example

Funding Opportunity

Number

From submitted Grants.gov

application

HRSA-FY-###

Grants.gov Tracking

Number

From submitted Grants.gov

application

GRANTXXXXXXXX

HRSA EHBs

Application Tracking

Number

From email notification sent to

PD, AO, BO, and POC listed on

application.

123456

HRSA R&R Two-Tier

Application Guide

Note that the source of each data element is different and knowledge of the three

numbers together is considered sufficient to provide that individual access to the

application.

To validate the Grants.gov application, log in to the EHBs and click on the View

Applications link and then click on the Add Grants.Gov Application link. (This is only

visible for applications that require supplemental forms.)

You will now need to complete a form using the numbers specified in the table above to

validate your Grants.gov application.

•

NOTE: The first individual who completes this step should use the “Peer Access” feature to

share the application with other individuals from the organization. It is recommended that

the AO complete this step.

4.4. Manage Access to the Application

You must be registered in HRSA EHBs to access the application. To ensure that only

authorized individuals from the organization gain access to the application, you must

follow the process described earlier.

The individual who validated the application must use the “Peer Access” feature to

share this application with other individuals from the organization. This is required if you

wish to allow multiple individuals to work on the application in HRSA EHBs.

Once you have access to the EHBs for your specific application, use the appropriate

link under the deliverables section to access your application.

4.5. Check Validation Errors

HRSA EHBs will validate the application received through Grants.gov. All validation

errors are recorded and displayed. To view the validation errors, use the Grants.gov

Data Validation Comments link on the application status page in HRSA EHBs.

4.6. Fix Errors and Complete Application

You must review the errors in HRSA EHBs and make necessary corrections. You must

also complete the detailed budget and other required forms in HRSA EHBs and assign

an AO who must be a registered user in the HRSA EHBs. HRSA EHBs will show the

status of each form in the application package and the status of all forms must be

“Complete” in the summary page before the HRSA EHBs will allow the application to be

submitted.

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Application Guide

4.7. Submit Application in HRSA EHBs

4.7.1. Competing Applications Submitted Using Both Grants.gov and HRSA EHBs

After the Grants.gov application is pulled into EHBs and validated, the AO verifies the

pending application in HRSA EHBs, and fixes any validation errors. Supplemental

application forms and any required attachments are completed. The AO assigned to the

application within HRSA EHBs must submit the application. (The designee of the AO

can also submit the application.) Submit the completed application to HRSA by the due

dates listed within the NOFO.

• NOTE: You must submit the application by the due date listed within the NOFO. There

are two deadlines within the funding opportunity – one for submission within

Grants.gov and the second for submission within HRSA EHBs. You may not complete the

EHBs portion if you have not met the Grants.gov deadline.

Performance Measures for Competitive Applications - Some HRSA NOFOs include

specific data forms and require performance measure reporting. If the completion of

performance measure information is indicated in the NOFO, successful applicants

receiving award funds will be required, within 30 calendar days of the Notice of Award

(NOA) to register in EHBs and electronically complete the program-specific data forms

that appear in the funding opportunity. This requires the provision of budget breakdowns

in the financial forms based on the award amount, the project abstract and other award

summary data, and objectives for the performance measures.

5. GENERAL INSTRUCTIONS FOR APPLICATION SUBMISSION

HRSA requires you to apply electronically. HRSA encourages you to apply through

Grants.gov

using the Standard Form 424 Research and Related (SF-424 R&R)

application package associated with the NOFO and follow the directions provided at

Grants.gov. If you use an alternative electronic submission, see Grants.gov:

APPLICANT SYSTEM-TO-SYSTEM. Applications must be submitted in the English

language and in the terms of U.S. dollars (45 CFR § 75.111(a)).

The following instructions are applicable to all submissions unless otherwise noted in

the relevant NOFO. Failure to follow the instructions may make your application non-

responsive. HRSA will not consider non-responsive applications and will notify

applicants. It is mandatory to follow the instructions provided to ensure HRSA can

efficiently and consistently print your application for review, if needed.

HRSA R&R Two-Tier

Application Guide

5.1. Instructions for Completing the SF-424 R&R for Two-Tier Applications

i. Application Face Page

Complete Application Form SF-424 R&R provided with the application package.

Prepare according to instructions provided in the form itself.

Important note for applicants:

o Changes to improve award data accuracy have led HHS to require that

applicant street addresses (SF-424 R&R cover page and

Project/Performance Site Location Form) contain a valid 9-digit zip code. Use

the following USPS.com link to find your 9-digit zip code:

https://tools.usps.com/go/ZipLookupAction!input.action?mode=1&refresh=true

Unique Entity Identifier (UEI) Number

Your organization (and subrecipients of HRSA award funds) is required to have a UEI

number in order to apply for a grant or cooperative agreement from the Federal

Government. Include the Organizational UEI number in form SF-424 R&R (item 5 on

the application face page). Applications will not be reviewed without a UEI number.

Note: A missing or incorrect UEI number is the number one reason for applications

being “Rejected for Errors” by Grants.gov. HRSA will not extend the deadline for

applications with a missing or incorrect UEI number. You should take care in entering

the UEI number in the application.

Additionally, your organization (and any subrecipient of HRSA award funds) is

required to register annually with SAM in order to conduct electronic business with

the Federal Government. SAM registration must be maintained with current, accurate

information at all times during which an entity has an active award or an application

or plan under consideration by HRSA. It is extremely important to verify that your

organization’s SAM registration is active and the Marketing Partner ID Number

(MPIN) is current. Organizations will not be able to submit an application or accept an

award if SAM registration is not complete and accurate. Information about registering

with SAM can be found at SAM

.gov.

Assistance Listings Number

The AL number, as listed on the cover of the NOFO, is prepopulated in box 10 of the

form.

ii. Intergovernmental Review (Executive Order (EO) 12372)

If a NOFO is subject to EO 12372, “Intergovernmental Review of federal Programs,” it

will be noted in Section IV.5. Intergovernmental Review of the funding opportunity.

Refer to section 16 on the SF-424 R&R.

If intergovernmental review applies, the following language will appear in the NOFO:

HRSA R&R Two-Tier

Application Guide

Program X is subject to the provisions of Executive Order 12372, as

implemented by 45 CFR part 100.

EO12372 allows states the option of setting up a system for reviewing applications

from within their states for assistance under certain federal programs. Information on

states that have chosen to set up such a review system and corresponding State

Single Points of Contact may be obtained from the following website:

Intergovernmental Review (SPOC List as of April 20, 2020)

All applicants other than federally recognized Native American tribes or tribal

organizations should contact their Single Point of Contact as early as possible to alert

them to the prospective applications and receive any necessary instructions on the

state’s process used under this EO.

iii. Table of Contents

The application should be presented in the order of the Table of Contents provided in

Section 5.3

of this R&R Two-Tier Application Guide. Again, for electronic applications

no table of contents is necessary as it will be generated by the system. (Note: the

Table of Contents will not be counted in the page limit.)

iv. Budget

Note: the directions here may differ from those offered by Grants.gov. Follow

the instructions included in the program-specific NOFO and the instructions

below when completing budget forms.

The Total Project or Program Costs are the total allowable costs (inclusive of direct

and indirect costs) incurred by the recipient to carry out a HRSA-supported project or

activity. Total project or program costs include costs charged to the award and costs

borne by the recipient to satisfy a matching or cost-sharing

requirement, as

applicable.

Classification of Costs:

There is no universal rule for classifying certain costs as either direct or indirect

facilities and administration (F&A) under every accounting system. A cost may be

direct with respect to some specific service or function, but indirect with respect to the

federal award or other final cost objective. Therefore, it is essential that each item of

cost incurred for the same purpose be treated consistently in like circumstances

either as a direct or an indirect F&A cost in order to avoid possible double-charging of

federal awards. Guidelines for determining direct and indirect F&A costs charged to

federal awards are provided in 45 CFR part 75, subpart E

If not a requirement per statute or regulation, voluntary matching or cost sharing is not considered during merit review.

HRSA R&R Two-Tier

Application Guide

Research & Related Budget:

Complete the Research & Related Budget form included with the application package

(Sections A – J and the Cumulative Budget) for each budget period. While up to 5

budget periods are available on the form, refer to the award-specific guidelines for

the maximum number of budget periods allowed in the program for which you are

applying. Following completion of Budget Period 1, click on the “NEXT PERIOD”

button on the final page to allow for completion of Budget Period 2. Repeat this

instruction to complete any remaining Budget Periods.

The Cumulative Budget is automatically generated and provides the total budget

information for the grant request. Errors found in the Cumulative Budget must be

corrected within the incorrect field(s) in all Budget Periods; corrections cannot be

made to the Cumulative Budget itself.

If the NOFO notes that the program is subject to the General Provisions of P.L. 118-

47 (or P.L. 117-328), the following Salary Rate Limitation applies:

Salary Rate Limitation:

The Further Consolidated Appropriations Act, 2024 (P.L. 118-47), Division D, Title II,

§ 202, which supersedes the Consolidated Appropriations Act, 2023 (P.L. 117-328),

Division H, Section 202, provides a salary rate limitation. The law limits the salary

amount that may be awarded and charged to HRSA grants and cooperative

agreements. Award funds may not be used to pay the salary of an individual at a rate

in excess of Executive Level II, which is $221,900 (effective January 2024

). Th is

amount reflects an individual’s base salary exclusive of fringe and any income that

an individual may be permitted to earn outside of the duties to your organization. This

salary rate limitation also applies to subrecipients under a HRSA grant or cooperative

agreement. Note that these or other salary rate limitations will apply in the following

fiscal years, as required by law.

See the breakdown and examples of the limitation below:

Individual’s actual base full-time salary: $255,000

50 percent of time will be devoted to project

Direct salary $127,500

Fringe (25 percent of salary) $ 31,875

Total $159,375

Amount that may be claimed on the application budget due to the statutory salary

rate limitation:

Individual’s base full-time salary adjusted to Executive Level II: $221,900

50 percent of time will be devoted to the project

Direct salary $110,950

Fringe (25 percent of salary) $ 27,737 (rounded down)

Total amount $138,687 (rounded down)

HRSA R&R Two-Tier

Application Guide

Personnel Justification Table

(varied FTE percentages)

Name

Position

Title

% of

FTE

Base Salary

Adjusted Annual

Salary*

Federal Amount

Requested

J. Smith

CEO 50 $255,000 $221,900 $110,950

Green

Dentist 100 $225,000 $221,900 $221,900

Moore

Physician 50 $200,000

No adjustment

needed

$100,000

R. Doe

Nurse

Practitioner

100 $120,000

No adjustment

needed

$120,000

H. Black

Outreach

Director

50 $70,000

No adjustment

needed

$35,000

Jones

Data/AP

Specialist

25 $50,000

No adjustment

needed

$12,500

TOTAL

$920,000

$600,350

*used only when salary is over limitation of $221,900

Finally, remember that in order to be considered as allowable costs on your HRSA

award, you need to ensure that personnel costs are supported by official records that

accurately reflect the work performed and that internal controls provide reasonable

assurance that the personnel costs are accurate, allowable, and allocable to the

HRSA award.

Funding Restrictions (in general)

You may request no more than the funding ceiling amount listed in Section II.2.

Summary of Funding and Section IV.6. Funding Restrictions of the NOFO. Awards to

support projects beyond the first budget year will be contingent upon Congressional

appropriation, satisfactory progress in meeting the project’s objectives, and a

determination that continued funding would be in the best interest of the Federal

Government.

Unallowable Costs

The governing cost principles address selected items of cost. Th e NOFO specifies

unallowable costs that apply to each funding opportunity. The following list of

unallowable costs is not intended to be all-inclusive. Consult the cost principles for

the complete explanation of the allowability or unallowability of costs they address.

For the full list of cost principles refer to Section 2.2 “Compliance Requirements at a

Glance” to see which cost principles apply to your organization and refer to Subpart E

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Application Guide

– Cost Principles at 45 CFR part 75. The allowability of costs under individual HRSA

awards also may be governed by requirements specified in the program statute,

regulations, or the specific terms and conditions of the award, which will take

precedence over the general information provided here and in the regulations that are

referenced.

Also note that a cost is not allowable if it is not reasonable, necessary, allocable to

the award, or adequately documented (45 CFR § 75.403).

Item

Description

Advertising and

Public Relations

Conditionally allowable. See 45 CFR § 75.421 for details.

Advisory Councils

Costs incurred by advisory councils or committees are

unallowable unless authorized by law, the HHS awarding

agency, or as an indirect cost where allocable to federal

awards. See 45 CFR § 75.444, applicable to states, local

governments and Indian tribes.

Alcoholic Beverages

Costs of alcoholic beverages are unallowable.

Bad Debts

Unallowable.

Entertainment Costs Conditionally unallowable. This includes the cost of

amusements, social activities, and related incidental costs.

45 CFR § 75.438 clarifies when entertainment costs may

be charged to a federal award with prior approval.

Fundraising Costs

Unallowable.

Honoraria

Unallowable when the primary intent is to confer distinction

on, or to symbolize respect, esteem, or admiration for, the

recipient of the honorarium. A payment for services

rendered, such as a speaker’s fee under a conference

award, is allowable.

Invention, Patent, or

Licensing Costs

Unallowable as a direct cost unless specifically authorized

in the NOA. May be allowable as indirect costs provided

they are authorized under applicable cost principles and

are included in the negotiation of indirect cost rates. Such

costs include licensing or option fees, attorney’s fees for

preparing or submitting patent applications, and fees paid

to the U.S. Patent and Trademark Office for patent

application, patent maintenance, or recordation of patent-

related information.

Lobbying Generally unallowable, including costs of lobbying

activities to influence the introduction, enactment, or

modification of legislation by the U.S. Congress or a state

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Item

Description

legislature. Under certain circumstances, as provided in

the applicable cost principles, costs associated with

activities that might otherwise be considered “lobbying”

that are directly related to the performance of a grant or

cooperative agreement may be allowable. The recipient

should obtain an advance understanding with the GMS if it

intends to engage in these activities. See

“Restriction on

Lobbying” below and at 45 CFR § 75.450 for additional

descriptions and examples of prohibited activities.

Meals Generally unallowable except for the following:

• Subjects and patients under study.

• Where specifically approved as part of the project or

program activity, e.g., in programs providing

children’s services.

• When an organization customarily provides meals to

employees working beyond the normal workday, as a

part of a formal compensation arrangement.

• As part of a per diem or subsistence allowance

provided in conjunction with allowable travel.

• Under a conference award, when meals are a

necessary and integral part of a conference, provided

that meal costs are not duplicated in participants’ per

diem or subsistence allowances.

Guest meals are not allowable.

Pre-award Costs Costs incurred before the effective date of the sponsored

agreement, whether or not they would have been

allowable thereunder if incurred after such date, are

unallowable unless approved by HRSA or authorized

under expanded authority.

Where authorized by HRSA as an expanded authority, a

recipient may, at its own risk and without HRSA prior

approval, incur obligations and expenditures to cover costs

up to (and including) 90 calendar days before the

beginning date of the initial budget period of a new or

competing continuation award if such costs

• are necessary to conduct the project or program, and

• would be allowable under the grant or cooperative

agreement, if awarded.

However, even if authorized as an expanded authority, if a

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Item

Description

specific expenditure would otherwise require prior

approval, the cost or activity must meet the same tests of

allowability as if incurred after award.

If not authorized as part of expanded authorities, the

applicant/recipient must seek HRSA prior approval before

incurring pre-award costs. HRSA prior approval is required

for any costs to be incurred more than 90 calendar days

before the beginning date of the initial budget period of a

new or competing continuation award.

Promotional Items

(SWAG)

Promotional items and memorabilia (e.g., pencils, cups, t-

shirts, cookbooks, bags), gifts, and souvenirs designed to

promote the recipient’s organization are unallowable as

advertising/public relations costs.

Finally, even if a cost is not included on the above list, if there is not adequate

documentation of particular costs, such as vouchers, invoices, timekeeping records,

etc. with enough detail to determine if the cost is allowable, then the organization’s

annual audit might reflect that the costs cannot be charged to the HRSA award and a

refund will be necessary if the costs remain undocumented.

Funding Restrictions: If the NOFO notes that the program is subject to the General

Provisions of P.L. 118-47 (or P.L. 117-328), the following statutory/legislative

mandates are in effect and organizations should ensure that they have policies and

procedures in place, and effective financial management practices, to avoid

expending any HRSA funds on prohibited activities. Your organization must comply

with all legal requirements and restrictions applicable to the receipt of federal funding

including statutory restrictions on use of funds for lobbying, executive salaries, gun

control, abortion, etc. Like all other applicable award requirements, the effectiveness

of these policies, procedures and controls is subject to audit.

Division B, Title VII

1. Confidentiality Agreements (Section 742)

Division D, Title II

2. Salary Rate Limitation (Section 202)

3. Gun Control (Section 210)

Division D, Title V

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4. Anti-Lobbying (Section 503)

5. Acknowledgment of Federal Funding (Section 505)

6. Restriction on Abortions (Section 506)

7. Exceptions to Restriction on Abortions (Section 507)

8. Ban on Funding Human Embryo Research (Section 508)

9. Limitation on Use of Funds for Promotion of Legalization of Controlled

Substances (Section 509)

10. Restriction of Pornography on Computer Networks (Section 520)

11. Restriction on Purchase of Sterile Needles (Section 526)

Details:

Division B, Title VII

1. Confidentiality Agreements (Section 742)

(a) None of the funds appropriated or otherwise made available by this or any

other Act may be available for a contract, grant, or cooperative agreement with

an entity that requires employees or contractors of such entity seeking to report

fraud, waste, or abuse to sign internal confidentiality agreements or statements

prohibiting or otherwise restricting such employees or contractors from lawfully

reporting such waste, fraud, or abuse to a designated investigative or law

enforcement representative of a federal department or agency authorized to

receive such information.

(b) The limitation in subsection (a) shall not contravene requirements applicable

to Standard Form 312, Form 4414, or any other form issued by a federal

department or agency governing the nondisclosure of classified information.

Division D, Title II

2. Salary Rate Limitation (Section 202)

"None of the funds appropriated in this title shall be used to pay the salary of an

individual, through a grant or other extramural mechanism, at a rate in excess of

Executive Level II."

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Effective January 2024, the Executive Level II salary increased from $212,100 to

$221,900.

This amount reflects an individual’s base salary exclusive of fringe and any

income that an individual may be permitted to earn outside of the duties to the

applicant organization. This salary rate limitation also applies to

subawards/subcontracts under an HRSA grant or cooperative agreement.

3. Gun Control (Section 210)

“None of the funds made available in this title may be used, in whole or in part, to

advocate or promote gun control.”

Division D, Title V

4. Anti-Lobbying (Section 503)

“ (a) No part of any appropriation contained in this Act or transferred pursuant to

section 4002 of Public Law 111–148 shall be used, other than for normal and

recognized executive legislative relationships, for publicity or propaganda

purposes, for the preparation, distribution, or use of any kit, pamphlet, booklet,

publication, electronic communication, radio, television, or video presentation

designed to support or defeat the enactment of legislation before the Congress or

any state or local legislature or legislative body, except in presentation to the

Congress or any state or local legislature itself, or designed to support or defeat

any proposed or pending regulation, administrative action, or order issued by the

executive branch of any state or local government, except in presentation to the

executive branch of any state or local government itself.

(b) No part of any appropriation contained in this Act or transferred pursuant to

section 4002 of Public Law 111–148 shall be used to pay the salary or expenses

of any grant or contract recipient, or agent acting for such recipient, related to

any activity designed to influence the enactment of legislation, appropriations,

regulation, administrative action, or Executive Order proposed or pending before

the Congress or any state government, state legislature or local legislature or

legislative body, other than for normal and recognized executive-legislative

relationships or participation by an agency or officer of a state, local or tribal

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government in policymaking and administrative processes within the executive

branch of that government.

advocate or promote any proposed, pending or future federal, state or local tax

increase, or any proposed, pending, or future requirement or restriction on any

legal consumer product, including its sale or marketing, including but not limited

to the advocacy or promotion of gun control."

5. Acknowledgment of Federal Funding (Section 505)

"When issuing statements, press releases, requests for proposals, bid

solicitations and other documents describing projects or programs funded in

whole or in part with federal money, all grantees receiving federal funds included

in this Act, including but not limited to state and local governments and recipients

of federal research grants, shall clearly state –

(1) the percentage of the total costs of the program or project which will be

financed with federal money;

(2) the dollar amount of federal funds for the project or program; and

(3) percentage and dollar amount of the total costs of the project or program that

will be financed by non-governmental sources."

6. Restriction on Abortions (Section 506)

“(a) None of the funds appropriated in this Act, and none of the funds in any trust

fund to which funds are appropriated in this Act, shall be expended for any

abortion.

(b) None of the funds appropriated in this Act, and none of the funds in any trust

fund to which funds are appropriated in this Act, shall be expended for health

benefits coverage that includes coverage of abortion.

by a managed care provider or organization pursuant to a contract or other

arrangement.”

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7. Exceptions to Restriction on Abortions (Section 507)

“(a) The limitations established in the preceding section shall not apply to an

abortion –

(1) if the pregnancy is the result of an act of rape or incest; or

(2) in the case where a woman suffers from a physical disorder, physical

injury, or physical illness, including a life-endangering physical condition

caused by or arising from the pregnancy itself, that would, as certified by a

physician, place the woman in danger of death unless an abortion is

performed.

(b) Nothing in the preceding section shall be construed as prohibiting the

expenditure by a state, locality, entity, or private person of state, local, or private

funds (other than a state’s or locality’s contribution of Medicaid matching funds).

any managed care provider from offering abortion coverage or the ability of a

state or locality to contract separately with such a provider for such coverage with

state funds (other than a state’s or locality’s contribution of Medicaid matching

funds).

(d)(1) None of the funds made available in this Act may be made available to a

federal agency or program, or to a state or local government, if such agency,

program, or government subjects any institutional or individual health care entity

to discrimination on the basis that the health care entity does not provide, pay for,

provide coverage of, or refer for abortions.

(d)(2) In this subsection, the term ‘‘health care entity’’ includes an individual

physician or other health care professional, a hospital, a provider-sponsored

organization, a health maintenance organization, a health insurance plan, or any

other kind of health care facility, organization, or plan.”

8. Ban on Funding of Human Embryo Research (Section 508)

“(a) None of the funds made available in this Act may be used for –

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(1) the creation of a human embryo or embryos for research purposes; or

(2) research in which a human embryo or embryos are destroyed, discarded,

or knowingly subjected to risk of injury or death greater than that allowed

for research on fetuses in utero under 45 CFR 46.204(b) and section

498(b) of the Public Health Service Act (42 U.S.C. 289g(b)).

(b) For purposes of this section, the term ‘‘human embryo or embryos’’ includes

any organism, not protected as a human subject under 45 CFR 46 as of the date

of the enactment of this Act, that is derived by fertilization, parthenogenesis,

cloning, or any other means from one or more human gametes or human diploid

cells.

9. Limitation on Use of Funds for Promotion of Legalization of Controlled

Substances (Section 509)

"(a) None of the funds made available in this Act may be used for any activity that

promotes the legalization of any drug or other substance included in schedule I of

the schedules of controlled substances established under section 202 of the

Controlled Substances Act except for normal and recognized executive-

congressional communications.

(b)The limitation in subsection (a) shall not apply when there is significant

medical evidence of a therapeutic advantage to the use of such drug or other

substance or that federally sponsored clinical trials are being conducted to

determine therapeutic advantage."

10. Restriction of Pornography on Computer Networks (Section 520)

“(a) None of the funds made available in this Act may be used to maintain or

establish a computer network unless such network blocks the viewing,

downloading, and exchanging of pornography.

(b) Nothing in subsection (a) shall limit the use of funds necessary for any

federal, state, tribal, or local law enforcement agency or any other entity carrying

out criminal investigations, prosecution, or adjudication activities.”

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11. Restriction on Purchase of Sterile Needles (Section 526)

"Notwithstanding any other provision of this Act, no funds appropriated in this Act

shall be used to purchase sterile needles or syringes for the hypodermic injection

of any illegal drug: Provided, That such limitation does not apply to the use of

funds for elements of a program other than making such purchases if the

relevant state or local health department, in consultation with the Centers for

Disease Control and Prevention, determines that the state or local jurisdiction, as

applicable, is experiencing, or is at risk for, a significant increase in hepatitis

infections or an HIV outbreak due to injection drug use, and such program is

operating in accordance with state and local law.”

v. Budget Justification Narrative

Upload the Budget Justification Narrative for the entire period of performance (all

budget periods) in Section K of the Research & Related Budget Form. Provide a

budget narrative that explains the amounts requested for each line of the budget in

Sections A-F. Th e budget narrative should specifically describe how each item will

support the achievement of proposed objectives. Be very careful about showing how

each item in the “other” category is justified. For subsequent budget years, the

narrative should highlight the changes from year 1 or clearly indicate that there are

no substantive budget changes during the period of performance. Do NOT use the

budget narrative to expand the project narrative.

Budget for Multi-Year Award (periods of performance vary, maximum of 5

years)

NOFOs invite applications for periods of performance of 1 to up to 5 years. Generally,

awards, on a competitive basis, will be for a 1-year budget period; although the period

of performance may be up to 5 years. Submission and HRSA approval of the progress

report(s) and any other required submission or reports is the basis for the budget

period renewal and release of subsequent year funds. Funding beyond the 1-year

budget period but within the multi-year period of performance is subject to availability of

funds, satisfactory progress of the recipient, and a determination that continued funding

would be in the best interest of the Federal Government.

In addition to requirements included in the program-specific NOFO, include the

following in the Budget Justification narrative:

Personnel Costs (as listed in Sections A & B on the R&R Budget Form): Explain

personnel costs by listing each staff member who will be supported from funds,

name (if possible), position title, percentage of full-time equivalency, and annual

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salary. If the NOFO notes that the program is subject to the General Provisions

of P.L. 118-47 (or P.L. 117-328), the following applies: Reminder: Award funds

may not be used to pay the salary of an individual at a rate in excess of

Executive Level II of $221,900. An individual's base salary, per se, is NOT

constrained by the statutory provision for a limitation of salary. The rate

limitation simply limits the amount that may be awarded and charged to HRSA

grants and cooperative agreements. Provide an individual’s actual base salary

if it exceeds the cap. See the Personnel Justification Table

in the Budget

section.

Fringe Benefits (as listed in Sections A & B on the R&R Budget Form): List the

components that comprise the fringe benefit rate, for example health insurance,

taxes, unemployment insurance, life insurance, retirement plans, and tuition

reimbursement. The fringe benefits should be directly proportional to that portion

of personnel costs that are allocated for the project. If the NOFO notes that the

program is subject to the General Provisions of P.L. 118-47 (or P.L. 117-328),

the following applies: If an individual’s base salary exceeds the statutory salary

rate limitation (i.e., $221,900), please adjust fringe proportionally.

Equipment (as listed in Section C on the R&R Budget Form): List equipment

costs and provide justification for the need of the equipment to carry out the

project’s goals. Extensive justification and a detailed status of current equipment

must be provided when requesting funds for the purchase of items that meet the

definition of equipment (a unit cost of $5,000 or more and a useful life of 1 or

more years). For example, large items of medical equipment.

Travel (as listed in Section D on the R&R Budget Form): List travel costs

according to local and long distance travel. For local travel, outline the mileage

rate, number of miles, reason for travel and staff member/consumers completing

the travel. The budget should also reflect the travel expenses (e.g., airfare,

lodging, parking, per diem, etc.) for each person and trip associated with

participating in meetings and other proposed trainings or workshops. Name the

traveler(s) if possible, describe the purpose of the travel, provide number of trips

involved, the destinations, and the number of individuals for whom funds are

requested.

Participant/Trainee Support Costs, if applicable (as listed in Section E on the

R&R Budget Form): List tuition/fees/health insurance, stipends, travel,

subsistence, other and the number of participants/trainees.

Other Direct Costs (as listed in Section F on the R&R Budget Form) include the

following, if applicable:

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Materials and Supplies: List the items that the project will use to implement the

proposed project. Separate items into three categories: office supplies (e.g.,

paper, pencils), medical supplies (e.g., syringes, blood tubes, gloves), and

educational supplies (e.g., brochures, videos). Items must be listed separately.

Per 45 CFR § 75.321, property will be classified as supplies if the acquisition cost

is under $5,000. Note that items such as laptops, tablets, and desktop computers

are classified as a supply if the value is under the $5,000 equipment threshold.

Publication Costs: List the total publication funds requested. The proposal budget

may request funds for the costs of documenting, preparing, publishing or

otherwise making available to others the findings and products of the work

conducted under the award. In the budget justification include supporting

information.

Consultant Services: List the total costs for all consultant services. In the budget

justification, identify each consultant, the services he/she will perform, total

number of days, travel costs, and total estimated costs.

ADP/Computer Services: List total funds requested for ADP/Computer Services.

The cost of computer services, including computer-based retrieval of scientific,

technical and education information may be requested. In the budget justification,

include the established computer service rates at the proposing organization if

applicable.

Subawards/Consortium/Contractual Costs: Provide a clear explanation as to the

purpose of each subaward/contract, how the costs were estimated, and the

specific contract deliverables. You should not provide line item details on

proposed contracts, rather you should provide the basis for your cost estimate for

the contract. You are responsible for ensuring that your organization or institution

has in place an established and adequate procurement system with fully

developed written procedures for awarding and monitoring all contracts.

Recipients must notify potential subrecipients that entities receiving subawards

must be registered in SAM and provide the recipient with their UEI number (see

CFR part 25).

For subawards to entities that will help carry out the work of the award, you

should decribe how you will monitor their work to ensure the funds are being

properly used.

Per the Suspension and Debarment rules in the Uniform Administrative

Requirements, as implemented by HRSA under 45 CFR § 75.213, non-federal

entities and contractors are subject to the non-procurement debarment and

suspension regulations implementing Executive Orders 12549 and 12689, 2 CFR

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parts 180 and 376. These regulations restrict awards, subawards and contracts

with certain parties that are debarred, suspended or otherwise excluded from or

ineligible for participation in federal assistance programs or activities.

Equipment or Facility Rental/User Fees: List total funds requested for Equipment

or Facility Rental/Use Fees. In the budget justification, identify each rental user

fee and justify.

Alterations and Renovations: If allowable, list total funds requested for Alterations

& Renovations. In the budget justification, itemize, by category and justify the

costs of alterations and renovations including repairs, painting, removal or

installation of partitions, shielding, or air conditioning. Where applicable, provide

the square footage and costs.

Other: Put all costs that do not fit into any other category and provide an

explanation of each cost in this category (e.g., EHR provider licenses, audit, legal

counsel). In some cases, rent, utilities, and insurance fall under this category if

they are not included in an approved indirect cost rate.

You may include the cost of access accommodations as part of your project’s

budget, including sign interpreters, plain language and health literacy print

materials in alternate formats (including Braille, large print, etc.); and linguistic

competence modifications (e.g., translation or interpretation services.

Data Collection Activities: Funds may be used to support appropriate and

justifiable costs related to meeting evaluation and reporting requirements. Identify

and justify how these funds will be used under the appropriate budget category

(personnel, contractual or other).

Indirect Costs: Indirect costs are those costs incurred for common or joint

objectives which cannot be readily and specifically identified with a particular

project or program but are necessary to the operations of the organization, e.g.,

the cost of operating and maintaining facilities, depreciation, and administrative

salaries. For some institutions, the term “facilities and administration” (F&A) is

used to denote indirect costs. If your organization does not have an indirect cost

rate, you may wish to obtain one through HHS’s Program Support Center (PSC).

Visit PSC’s Indirect Cost Negotiations website

to learn more about rate

agreements, the process for applying for them, and the regional offices which

negotiate them. If indirect costs are included in the budget, attach a copy of the

indirect cost rate agreement. If the indirect cost rate agreement is required per

the NOFO, it will not count toward the page limit. Any non-federal entity that has

never received a negotiated indirect cost rate, (except a governmental

department or agency unit that receives more than $35 million in direct federal

funding) may elect to charge a de minimis rate of 10 percent of modified total

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direct costs (MTDC) which may be used indefinitely. If chosen, this methodology

once elected must be used consistently for all federal awards until such time as a

non-federal entity chooses to negotiate for a rate, which the non-federal entity

may apply to do at any time.

vi. Staffing Plan and Personnel Requirements

You must present a staffing plan and provide a justification for the plan that includes

education and experience qualifications and rationale for the amount of time being

requested for each staff position. Position descriptions that include the roles,

responsibilities, and qualifications of proposed project staff must be included in the

Attachment specified in the NOFO. When applicable, biographical sketches should

include training, language fluency and experience working with the cultural and

linguistically diverse populations that are served by your programs. Th ey should

follow the format described in the NOFO and be uploaded as directed in the NOFO.

Finally, you should describe your method for ensuring that only actual work

performed will be charged to the award and how that method meets federal cost

principle requirements under § 75.430 Compensation—personal services.

vii. Assurances

If research involving human subjects is anticipated, you must meet the requirements

of the HHS regulations to protect human subjects from research risks as specified in

the Code of Federal Regulations,

Title 45 – Public Welfare, Part 46 – Protection of

Human Subjects (45 CFR part 46), available online. See the Appendix of this R&R

Two-Tier Application Guide for supplemental instructions for preparing the human

subjects section of the research plan.

If research involving human subjects is anticipated, you must hold a Federal Wide

Assurance (FWA) of compliance from the

Office of Human Research Protections

(OHRP) before award. You must provide your Human Subject Assurance Number

(from the FWA) in the application; if you do not have an assurance, you must indicate

in the application that you will obtain one from OHRP before award.

viii. Certifications

The signature of the AOR on the application serves as the required certification of

compliance for the applicant organization for the following:

Lobbying

1) No federal appropriated funds have been paid or will be paid, by or on behalf of

the applicant, to any person for influencing or attempting to influence an officer or

employee of an agency, a Member of Congress, an officer or employee of

Congress, or an employee of a Member of Congress in connection with the

awarding of any federal contract, the making of any federal grant, the making of

any federal loan, the entering into of any cooperative agreement, and the

extension, continuation, renewal, amendment, or modification of any federal

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contract, grant, loan, or cooperative agreement.

2) If any funds other than federal appropriated funds have been paid or will be paid

to any person for influencing or attempting to influence an officer or employee of

any agency, a Member of Congress, an officer or employee of Congress, or an

employee of a Member of Congress in connection with this federal contract,

grant, loan, or cooperative agreement, the applicant must complete and submit

Standard Form-LLL, ''Disclosure of Lobbying Activities,'' in accordance with its

instructions.

3) Recipients of HRSA awards shall require that the language of this certification be

included in the award documents for all subawards at all tiers (including

subcontracts, subgrants, and contracts under grants, loans, and cooperative

agreements) and that all subrecipients shall certify and disclose accordingly. This

certification is a material representation of fact upon which reliance was placed

when this transaction was made or entered into. Submission of this certification is

a prerequisite for making or entering into this transaction imposed by section

1352, title 31, U.S. Code. Any person who fails to file the required certification

shall be subject to a civil penalty of not less than $10,000 and not more than

$100,000 for each such failure.

Federal Debt

Any organization or individual that is indebted to the United States, and has a

judgment lien filed against it for a debt to the United States, is ineligible to receive a

federal award. By signing the SF-424 R&R, the applicant is certifying that they are

not delinquent on federal debt in accordance with OMB Circular A-129. (Examples of

relevant debt include delinquent payroll or other taxes, audit disallowances,

guaranteed and direct student loans, benefits that were overpaid, etc.). If an applicant

is delinquent on federal debt, they should attach an explanation that includes proof

that satisfactory arrangements have been made with the Agency to which the debt is

owed. This explanation should be uploaded as an Attachment.

Debarment, Suspension, Ineligibility, and Voluntary Exclusion Certification

By submitting this proposal, the prospective recipient is providing the certification set

out below:

A. This certification in this clause is a material representation of fact. If it is later

determined that the prospective recipient knowingly submitted an erroneous

certification, in addition to other remedies available to the Federal Government,

HHS may pursue available remedies, including but not limited to, suspension

and/or debarment.

B. The prospective recipient shall provide immediate written notice to HRSA if at

any time the recipient learns that its certification was erroneous when submitted,

or had become erroneous due to changed circumstances.

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C. The terms covered transaction, debarred, suspended, ineligible, lower tier

covered transaction, participant, person, primary covered transaction, principal,

proposal, and voluntarily excluded, as used in this certification, are defined in

CFR part 180, as supplemented by 2 CFR part 376.

D. The prospective recipient agrees by submitting this proposal that, should the

proposed covered transaction be entered into, it shall not knowingly enter into

any lower tier covered transaction with a person who is proposed for debarment

under 2 CFR part 180 or 48 CFR part 9, subpart 9.4

, debarred, suspended,

declared ineligible, or voluntarily excluded from participation in this covered

transaction, unless authorized in writing by HRSA.

E. The prospective recipient further agrees by submitting this proposal that it will

include this clause titled ``Certification Regarding Debarment, Suspension,

Ineligibility and Voluntary Exclusion,'' without modification, in all lower tier

covered transactions and in all solicitations for lower tier covered transactions,

and receive a copy of the signed attestation by such lower tier

contractor/subrecipient.

F. A recipient may rely upon a certification of a prospective recipient in a lower tier

covered transaction that neither it nor its principals

, are proposed for debarment

under 2 CFR part 180 or 48 CFR part 9, subpart 9.4, debarred, suspended,

ineligible, or voluntarily excluded from covered transactions, unless it knows that

the certification is erroneous. A participant may decide the method and frequency

by which it determines the eligibility of its principals. HRSA strongly encourages

each participant to check the Excluded Parties database in the

System for Award

Management.

G. Nothing contained in this certification requires establishment of a system of

records in order to provide the certification required by this certification.

H. Except for transactions authorized under paragraph E of this statement, if a

participant in a covered transaction knowingly enters into a lower tier covered

transaction with a person who is proposed for debarment under 2 CFR part 180

or 48 CFR part 9, subpart 9.4, suspended, debarred, ineligible, or voluntarily

excluded from participation in this transaction, in addition to other remedies

Principal:

Per 2 CFR § 180.995,

(a) An officer, director, owner, partner, principal investigator, or other person within a participant with management or supervisory

responsibilities related to a covered transaction; or

(b) A consultant or other person, whether or not employed by the participant or paid with federal funds, who—

(1) Is in a position to handle federal funds; (2) Is in a position to influence or control the use of those funds; or,

(3) Occupies a technical or professional position capable of substantially influencing the development or outcome of an activity

required to perform the covered transaction.

Per 2 CFR § 376.995,

Individuals, in addition to those listed at 2 CFR § 180.995, who participate in HHS covered transactions including:

(a) Providers of federally required audit services; and

(b) Researchers.

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available to the Federal Government, the Department may pursue available

remedies, including, but not limited to, suspension and/or debarment.

ix. Project Abstract

Use the Standard OMB-approved Project Abstract Summary form that is included in

the workspace application package. Do not upload the abstract as an attachment or it

may count toward any applicable page limit.

Provide a summary of the application in the Project Abstract field / box using 4,000

characters or less.

Because the abstract is often distributed to provide information to the public and

Congress, prepare this so that it is clear, accurate, concise, and without reference to

other parts of the application. It must include a brief description of the proposed

project including the needs to be addressed, the proposed services, and the

population group(s) to be served. If the application is funded, your project abstract

information (as submitted) will be made available to public websites and/or databases

including USAspending.gov

. See the NOFO for additional information that may be

required in the project abstract.

x. Project Narrative

This section provides a comprehensive description of all aspects of the proposed

project. It should be succinct, self-explanatory, consistent with forms and

attachments, and well organized so that reviewers can understand the proposed

project. See the NOFO for specific narrative instructions.

xi. Attachments

Provide the attachments as specified in the NOFO. Any hyperlinked attachments will

not be reviewed/opened by HRSA. Unless otherwise noted, attachments count

toward the application page limit specified in the NOFO. You must clearly label

each attachment.

5.2. Narrative and Attachment Formatting Guidelines

5.2.1. Font

Use an easily readable font, such as Times Roman, Arial, Courier, or CG Times. The

text and table portions of the application must be single-spaced and submitted in not

less than a 12-point font. Applications not adhering to 12-point font requirements may

be deemed non-responsive and returned. For charts/graphs, footnotes, and budget

tables, you may use a different pitch or size font but not less than 10-point or size font. It

is vital that the charts/graphs are legible when scanned or reproduced.

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5.2.2. Paper Size and Margins

For duplication and scanning purposes, ensure that the application can be printed on 8

½” x 11” white paper. Margins must be at least one inch at the top, bottom, left and right

of the paper. Left-align text.

5.2.3. Names

Include the name of the applicant and 10-digit award number (if competing continuation

or competing supplement) on each page as a footer.

5.2.4. Section Headings

Put all section headings flush left in bold type.

5.2.5. Page Numbering

Do not number the standard OMB-approved forms. Number each attachment page

sequentially. Reset the numbering for each attachment. (Treat each

attachment/document as a separate section.)

5.2.6. Allowable Attachment or Document Types

Unless otherwise noted in the NOFO, do not submit organizational brochures or other

promotional materials, slides, films, clips, etc.

The HRSA EHBs supports the attachment types listed below. Although Grants.gov

allows you to upload other types of attachments, HRSA only accepts the following

types of attachments. Files with unrecognizable extensions may not be accepted

or may be corrupted, and will not be considered as part of the application. When

HRSA prints the application, documents will print as you have formatted them. If using

Excel or other spreadsheet documents, be aware that reviewers will only see

information that is set in the “Print Area” of the document.

File Attachment Types (acceptable by HRSA)

o .DOC/.DOCX - Microsoft Word

o .RTF - Rich Text Format

o .TXT - Text

o .WPD - Word Perfect Document

o .PDF - Adobe Portable Document Format

o .XLS/.XLSX - Microsoft Excel

o .VSD – Microsoft Visio

File Attachment Names

o Use only the following characters when naming your attachments: A-Z, a-z, 0-9,

underscore (_), hyphen (-), space ( ), period, parenthesis (), curly braces {},

square brackets [], ampersand &, tilde ~, exclamation point !, Comma ,

Semicolon; Apostrophe ‘, At sign @, Number sign #, Dollar Sign $, Percent Sign

%, Plus sign +, Equal sign =.

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o Limit the file attachment name to under 50 characters.

Your application will be rejected by Grants.gov if you use special characters or

attachment names greater than 50 characters.

5.3. Application Content Order (Table of Contents)

HRSA uses an automatic numbering approach to ensure uniformity of all applications

when printed for objective review.

HRSA uses a standard package from Grants.gov (SF-424 R&R) and a standard order of

forms (see the table which follows for Grants.gov submission, the program-specific

NOFO for EHBs submission information). The NOFO also provides you with explicit

instructions where to upload specific Attachments 1 to maximum of 15.

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SF-424 R&R Short Form – Table of Contents

Phase 1: Submission through Grants.Gov

• It is mandatory to follow the instructions provided in this section to ensure that the application can be printed efficiently and

consistently for review.

• In NOFOs with page limits: failure to follow the instructions may make the application non-responsive. Non-responsive applications

will not be considered .

• For electronic submissions, you only have to number the electronic attachment pages sequentially, resetting the numbering for each

attachment, i.e., start at page 1 for each attachment. Do not attempt to number standard OMB-approved form pages.

• For electronic submissions, no Table of Contents is required for the entire application. HRSA will construct an electronic table of

contents in the order specified.

Application Section

Form Type

Instructions

HRSA/Program Guidelines

SF-424 R&R Cover Page

Form

Pages 1 & 2 of the R&R face page.

Required. Not counted in the page limit.

Project/Performance Site

Location(s)

Form

Supports primary and 299 additional sites

in structured form.

Required. Not counted in the page limit.

Project Abstract Summary Form

Form

Ensure the Project Abstract field

succinctly describes the project in plain

language that the public can understand

and use without the full proposal. Use

4,000 characters or less.

Required. Not counted in the page limit.

Refer to Section 5.1.ix of this Guide and

the NOFO for detailed instructions, if

applicable.

Changes to improve grant award data accuracy have led HHS to require that applicant street addresses (SF-424 R&R cover

page and Project/Performance Site Location Form) contain a valid 9-digit zip code. Use the following USPS.com link to find your

9-digit zip code: Look Up a Zip Code

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Application Section

Form Type

Instructions

HRSA/Program Guidelines

Additional Performance Site

Location(s)

Attachment

Can be uploaded in the SF-424 R&R

Performance Site Location(s) form. Single

document with all additional site

locations.

If this attachment is included, it will be

counted in the page limit.

Disclosure of Lobbying Activities

(SF-LLL)

Form

Supports structured data for lobbying

activities.

Not counted in the page limit. Complete if

applicable.

• After successful submission of the Application Forms in Grants.gov (Phase 1), and subsequent processing by HRSA, you will be

notified by HRSA confirming the successful receipt of your application. This notification is expected within 7 business days from the

date of submission in Grants.gov.

• If you do not receive notification within 7 business days after submission in Grants.gov, contact the HRSA EHBs Contact Center at

877-GO4- HRSA (877-464-4772) or via the web at HRSA Grants and Electronic Handbooks Contact Center. Please have your

Grants.gov tracking number at hand.

• Your application will not be considered compliant unless you review and submit the required Attachments in HRSA EHBs (Phase 2)

by the appropriate deadline.

Attachment Number

Attachment Description (Program Guidelines)

Attachments 1–15

Please see instructions in the NOFO.

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After your application has been successfully processed by HRSA you will receive an

email directing you organization to the application in the EHBs, where the required

supplemental information must be submitted. Understand that for your application, only

the forms mentioned in the Table of Contents listed above are submitted through

Grants.gov. All supplemental information will be submitted through the HRSA EHBs.

Refer to the program-specific NOFO for more detailed information.

You are reminded that failure to include all required documents as part of the

application may result in an application being considered as incomplete or non-

responsive.

5.4. Application Page Limit

The total of uploaded attachment pages that count against the page limit shall be no

more than the page limit specified in Section IV. 2. of the NOFO when printed by HRSA.

Forms that DO NOT count in the Page Limit

• Standard OMB-approved forms included in the workspace application package

do not count in the page limit. The abstract is the standard form (SF)

"Project_Abstract Summary.” It does not count in the page limit.

• The Indirect Cost Rate Agreement does not count in the limit.

• The proof of non-profit status (if applicable) does not count in the page limit.

If there are other attachments that do not count against the page limit, this will be clearly

denoted in the NOFO’s Section IV.2.v. or vi. Attachments.

If you use an OMB-approved form that is not included in the workspace application

package for your NOFO, it will count against the page limit. Therefore, we strongly

recommend you use Grants.gov workspace forms associated with your NOFO to avoid

exceeding the page limit.

 HRSA will redact any pages considered over the page limit. The redacted copy of

the application will move forward to the objective review committee.

It is important to ensure your application does not exceed the specified page

limit.

Applications must be complete and validated by Grants.gov under the funding

opportunity number before the deadline.

You must follow the instructions provided in this section. HRSA recommends that you

print all attachments and confirm the number of pages before submission.

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5.5. Submission Dates and Times

Letter of Intent to Apply (ONLY if requested on the cover and in Section IV.7. of

the NOFO)

You are eligible to apply even if no letter of intent is submitted. The letter should identify

your organization and its intent to apply, and briefly describe the proposal. HRSA will

not acknowledge receipt of letters of intent.

This letter should be sent via email by the date listed in the NOFO to:

HRSA Digital Services Operation (DSO)

Use the HRSA opportunity number as email subject (HRSA-##-###)

HRSADSO@hrsa.gov

Application Due Date

The due date for applications in Grants.gov (Phase 1) is 11:59 p.m. ET on the date

listed in Section IV.4 Submission Dates and Times in the NOFO, unless otherwise

noted. The due date to complete all other required information in HRSA EHBs (Phase 2)

is 5 p.m. ET on the date listed in Section IV.4 Submission Dates and Times in the

NOFO, unless otherwise noted. Applications completed online are considered formally

submitted and meeting the deadline if: (1) the application has been successfully

transmitted electronically to the correct funding opportunity number, by the

organization’s AOR through Grants.gov and it has been validated by Grants.gov on or

before the Grants.gov deadline date and time, and (2) the Project Director has entered

the HRSA EHBs to review the application, the Authorizing Official (AO) has submitted

the additional information for the application, and it has been successfully received in

the HRSA EHBs on or before the EHBs deadline and time.

5.6. Correcting Mistakes

HRSA will only accept and review your first validated electronic submission, under the

correct funding opportunity number, in Grants.gov. Applications submitted after the first

submission will be marked as duplicates and considered ineligible for review. If you wish

to change information submitted in a Grants.gov application, you may do so in the

HRSA Electronic Handbooks (HRSA EHBs) application phase.

It is incumbent on you to ensure that the AOR is available to submit the

application to HRSA by the published due date. HRSA will not accept submission

or re-submission of incomplete, rejected, or otherwise delayed applications after

the deadline. Therefore, we urge you to submit your application at least 3 calendar

days before the deadline. If an application is rejected by Grants.gov due to errors, it

must be corrected and resubmitted to Grants.gov before the deadline date and time.

Deadline extensions will not be provided to applicants who do not correct errors and

resubmit before the posted deadline.

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5.7. Tips for Writing a Strong Application

HRSA has designed a TA webpage to assist you in preparing your application.

Resources include help with system registration, finding and applying for funding

opportunities, writing strong applications, understanding the review process, and many

other topics which you will find relevant. The webpage can be accessed online at:

HRSA Apply For A Grant

In addition, you can access a concise resource offering tips for writing proposals for

HHS grants and cooperative agreements at

HRSA Grants and Electronic Handbooks

Contact Center.

5.8. Withdrawing an Application

You may withdraw your application from consideration at any time before an award is

issued. Send notification of this withdrawal via email to ApplicationWaivers@hrsa.gov,

with a copy sent to the Program Contact and Grants Management Specialist listed in

the NOFO.

6. PROCESS OVERVIEW

6.1. Competing Applications (Phases 1 and 2: Submission through Grants.gov

Using Workspace and the EHBs)

The process for submitting a competing application through Grants.gov using

workspace is as follows:

1) HRSA posts all competing NOFOs on Grants.gov

2) In order to apply for a HRSA award, you must complete the Grants.gov registration

process. See Section 3

for more details.

3) Once the NOFO is available, you should search for the funding opportunity in

Grants.gov by clicking the SEARCH GRANTS tab, entering the funding opportunity

number (HRSA-##-###) and then selecting the funding opportunity or clicking the

APPLICANTS tab and then clicking on Apply for Grants.

4) Create a workspace package. Th e NOFO, accessible via the instructions link,

contains critical application instructions. Make note of the funding opportunity

number.

5) Add workspace participants, complete the workspace package, check for errors, and

notify the AOR the application is ready for submission.

6) Submit the application package through Grants.gov.

7) Track the status of your submitted application using Track My Application at

Grants.gov until you receive email notifications that your application has been

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received and validated by Grants.gov and received by HRSA. Be sure the

application has been validated under the correct funding opportunity number.

8) Once Grants.gov validates your application, you may track the status of the

application within HRSA by using the “Track Your Application

” widget, now available

on HRSA’s website. The application tracker will let you know where your application

is at every stage in the process.

After successful submission of the Application Forms in Grants.gov (Phase 1), and

subsequent processing by HRSA, you will be notified by HRSA confirming the

successful receipt of your application.

The following is the process for submitting the supplemental information (Phase 2)

through the EHBs:

1) Refer to the NOFO for specific information. Submit program-specific forms

through the EHBs.

2) Refer to Section 4 of this Guide for more application submission information.

6.2. Application Processing

HRSA staff review each application for eligibility, responsiveness, completeness, and

conformity with the requirements outlined in the relevant NOFO, including

programmatic, budgetary, and grants management compliance. Applications that pass

the initial HRSA completeness and eligibility screening will be reviewed and rated by a

panel based on the program elements and review criteria presented in Section V. 1.

Review Criteria of the relevant NOFO.

All incomplete, ineligible, or otherwise non-compliant applications, and applications

determined to be non-responsive to NOFO requirements will not be reviewed.

You may

withdraw your application from consideration at any time before an award is issued.

For those applications that did not pass the initial screening, HRSA will advise

applicants by email through the EHBs (sent to the individual signing the application on

behalf of the organization) that its application will not be held for further consideration or

be funded. The decision not to make an award, or to make an award at a particular

funding level, is discretionary and is not subject to appeal to any HRSA or HHS official

or board.

6.3. Objective Review Information

The Division of Independent Review is responsible for managing objective reviews

within HRSA. The objective review process provides an objective evaluation of

applications to the individuals responsible for making award decisions. Objective review

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is essential to ensuring selection of applications that best meet the needs of the

program consistent with published evaluation criteria and providing assurance to the

public that the evaluation process is impartial and fair. Applications competing for

federal funds receive an objective and independent review performed by a committee of

experts qualified by training and experience in particular fields or disciplines related to

the program being reviewed. In selecting review committee members, other factors in

addition to training and experience may be considered to improve the balance of the

committee, e.g., geographic distribution. Each reviewer is screened to avoid conflicts of

interest and is responsible for providing an objective, unbiased evaluation based on the

review criteria presented in Section V. 1. Review Criteria of the NOFO.

Applications that pass the initial HRSA completeness and eligibility screening will be

reviewed and rated by a panel based on the program elements and review criteria

presented in the NOFO. The review criteria are designed to enable the review panel to

assess the quality of a proposed project and determine the likelihood of its success. Th e

criteria are closely related to each other and are considered as a whole in judging the

overall quality of an application.

HRSA has procedures for assessing the technical merit of applications to provide for an

objective review and to assist you in understanding the standards against which each

application will be reviewed. HRSA has developed indicators for each review criterion to

assist you in presenting pertinent information related to that criterion and to provide the

reviewer with a standard for evaluation. See the review criteria outlined with specific

detail and scoring points in the NOFOs.

Funding factors may be applied during the objective review process or in the selection

process. Funding factors are addressed in the NOFO, which will specify if you must

make an affirmative request to be considered for a funding factor, what information is

needed to demonstrate eligibility for the funding factor, and whether objective reviewers

or HRSA staff determine if you’ve met the funding factor. The NOFO provides a detailed

explanation of preferences, priorities, or special considerations with an explicit indication

of their effect (e.g., whether they result in additional points being assigned). It is HRSA

policy that funding preferences, priorities, and special considerations must be published

in the NOFO.

You will receive written notification of the outcome of the objective review process,

including a summary of the expert committee’s assessment of the application’s

strengths and weaknesses, and whether the application was selected for funding.

6.4. Award Notification

The Notice of Award (NOA) is the legal document issued to the recipient that indicates

an award has been made and funds may be requested from HRSA. Until an awarding

office has issued an NOA for the initial budget period, any costs you incur for the project

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are incurred at your own risk. HRSA may reimburse pre-award costs only to the extent

that they would otherwise be allowable. The NOA sets forth the amount of funds

granted, the terms and conditions of the award, the effective date of the award, the

budget period for which initial support will be given, the non-federal share to be provided

(if applicable), and the total period of performance for which support is contemplated.

Signed by the Grants Management Officer (GMO), it is sent to the recipient’s AOR, and

reflects the only authorizing document. Any other correspondence announcing that an

application has been selected for award is not an authorization to begin performance.

Generally, HRSA will issue the NOA before the start date of the award as listed in

Section V.4 of the NOFO.

A revised NOA may be issued during a budget period to effect an action resulting in a

change in the period or amount of support or other change in the terms and conditions

of award. An awarding office generally will not issue a revised NOA to reflect a

recipient’s post-award rebudgeting. Applicants who are selected for funding may be

required to respond in a satisfactory manner to conditions placed on their award

document before funding can proceed. Letters of notification do not provide

authorization to begin performance.

Unsuccessful applicants will receive notification from HRSA’s Division of Grants

Management Operations.

Registering in ID.me for Payment Management System (PMS) Access

If you receive an NOA and accept the award, you will need to create an account with

ID.me to access HHS’ PMS system. PMS is the tool used for managing award

payments. This is a new requirement that improves identity assurance since it enables

multi-factor authentication. For more information, visit the PMS website

7. REPORTING REQUIREMENTS

Successful applicants must comply with the following standard reporting and review

activities, unless otherwise noted in the NOFO or NOA. Some programs require

program-specific reporting, so please see Section VI. 3. Reporting in the NOFO:

a. Audit Requirements

Comply with audit requirements of 45 CFR part 75, subpart F. Information on

audits can be found on the Internet at Subpart F - Audit Requirments.

b.Status Reports

1) Federal Financial Report. The Federal Financial Report (SF-425) is

required. The report is an accounting of expenditures under the project that

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year. Financial reports must be submitted electronically. Visit Reporting

Requirements | HRSA. More specific information will be included in the NOA.

2) Progress Report(s). The recipient must submit a progress report to HRSA on

a quarterly, semi-annual, or annual basis (as specified in the NOFO). For

multi-year awards, submission and HRSA approval of recipient progress

report(s) triggers the budget period renewal and release of subsequent year

funds. More information will be provided in the NOA.

3) Final Report. A final report is due within 90 calendar days after the period of

performance ends. The final report collects information relevant to program-

specific goals and progress on strategies; core performance measurement

data; impact of the overall project; the degree to which the recipient achieved

the mission, goal and strategies outlined in the program; recipient objectives

and accomplishments; barriers encountered; and responses to summary

questions regarding the recipient’s overall experiences during the entire

period of performance. Recipients must submit the final report online in the

HRSA EHBs system

4) Tangible Personal Property Report. If applicable, the recipient must submit

the Tangible Personal Property Report (SF-428) and any related forms within

90 calendar days after the period of performance ends. Recipients are

required to report all federally-owned property and acquired equipment with

an acquisition cost of $5,000 or more per unit. Tangible personal property

means property of any kind, except real property, that has physical existence.

It includes equipment and supplies. Property may be provided by HRSA or

acquired by the recipient with award funds. Federally-owned property consists

of items that were furnished by the Federal Government. Tangible personal

property reports must be submitted electronically through HRSA EHBs. More

specific information will be included in the NOA.

5) Any other required reports and/or products specified in the NOFO.

c. Transparency Act Reporting Requirements

New awards (“Type 1”

) issued are subject to the reporting requirements of the

Federal Funding Accountability and Transparency Act (FFATA) of 2006 (P. L.

109–282), as amended by section 6202 of P.L. 110–252, and implemented by 2

CFR part 170. IMPORTANT: The reporting requirements apply for the duration of

the period of performance and so include all subsequent award actions to

Part of a coding system HRSA uses to make distinctions between awards. The award type is the first digit of the “Award No.” as

indicated on the Notice of Award (NOA).

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aforementioned HRSA grants and cooperative agreement awards (e.g.,

competing continuation (“Type 2”), non-competing continuation (“Type 5,”) etc.).

Grant and cooperative agreement recipients must report information for each

first-tier subaward of $25,000 or more in federal funds and executive total

compensation for the recipient’s and subrecipient’s five most highly compensated

executives as outlined in Appendix A to 2 CFR part 170 (FFATA details are

available online at

Requirements for Federal Funding Accountability and

Transparency Act Implementation).

8. AGENCY CONTACTS

8.1. Working with HRSA Program and Grants Management Staff

For assistance with overall program-related questions, contact the PC listed in Section

VII. Agency Contacts of the NOFO. For additional information regarding business,

administrative, or fiscal issues, contact the GMS listed in Section VII. Agency Contacts

of the NOFO. Th e PC and the GMS work as a team in many award-related activities.

Contact Grants.gov Support for technical questions related to Grants.gov.

8.2. Grants.gov Customer Support

Direct all questions regarding Grants.gov to the Grants.gov Call Center at:

1-800-518-4726 (International callers dial 606-545-5035) or via email at

Support@Grants.gov

. Call Center hours of operation are 24 hours a day, 7 days a

week, excluding federal holidays. Be sure to obtain a case number every time you call

so that your issue can be tracked.

For additional support with the Grants.gov website, visit Grants.gov Support

. You can

also visit the Grants.gov Self Service Knowledge Base for answers to commonly asked

questions.

8.3. EHBs Program-Specific (BPHC) Support

For BPHC funding opportunities, direct all questions regarding submitting information in

EHBs to Health Center Program Support. Assistance is available Monday through

Friday, 8 a.m. to 8 p.m. ET, excluding federal holidays, at 877-464-4772 (select option

2) or submit an inquiry online via the Contact the Bureau of Primary Health Care

form.

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9. FAQS AND OTHER INFORMATION

9.1. Software FAQs

9.1.1. What are the software requirements for using Grants.gov?

You will need to download Adobe Reader. For information on Adobe Reader, go to

Adobe Software Compatibility

9.1.2. Can I download Adobe Reader onto my computer?

There are software applications that allow you to successfully navigate the Grants.gov

pages and complete your application. You can find these applications at

Adobe

Software Compatibility. However, depending on your organization’s computer network

and security protocols you may not have the necessary permissions to download

software onto your workstation. Contact your IT department or system administrator to

download the software for you or give you access to this function.

9.1.3. Is Grants.gov Macintosh (Mac) compatible?

Yes

9.2. Application Receipt FAQs

9.2.1. When do I need to submit my application?

Applications must be submitted and validated via Grants.gov (Phase 1) by 11:59 p.m.

ET on the due date unless otherwise specified in the NOFO. You should refer to the

NOFO for exact submission dates and times. An application for HRSA funding must be

both received and validated by Grants.gov by the application deadline. HRSA strongly

suggests submitting applications to Grants.gov at least 3 calendar days before the

deadline to allow for any unforeseen circumstances.

After successful submission in Grants.gov (Phase 1) and subsequent processing by

HRSA, you will be notified by HRSA confirming the successful receipt of your

application and the requirements for the Project Director and Authorizing Official (AO) to

review and submit additional information in HRSA EHBs (Phase 2). Your application will

not be considered compliant and complete unless you review and submit the additional

information in HRSA EHBs by the due date. Both deadlines must be met to be

considered in the competition.

9.2.2. What is the receipt date (the date the application is electronically received

by Grants.gov or the date the data is received by HRSA)?

The submission/receipt date is the date the application is electronically received and

validated by Grants.gov. An application for HRSA funding must be both received and

validated under the correct funding opportunity number by Grants.gov by the application

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deadline. Allow sufficient time to have the application validated, which can take up to 48

hours.

For applications that require verification in HRSA EHBs (refer to the NOFO), the

submission/receipt date will be the date the application is submitted by your

organization’s Authorizing Official (AO) in HRSA EHBs. You will receive an “Application

Successfully Transmitted to HRSA” message in EHBs upon successful final application

submission in HRSA EHBs.

9.2.3 Once my application is submitted, how can I track my application and what

emails can I expect from Grants.gov and HRSA?

You can check the status of your application(s) any time after submission by logging

into Grants.gov and clicking on the Track My Application link

. This link will also be

included in the confirmation email that you receive from Grants.gov.

When you submit your competing application in Grants.gov, it is first received and then

validated by Grants.gov. Typically, this takes a few hours but it may take up to 48 hours

during peak volumes. You will receive four emails from Grants.gov.

The first will confirm receipt of your application by the Grants.gov system (“Received”).

The second will indicate that the application has either been successfully validated

(“Validated”) by the system before transmission to HRSA or has been rejected due to

errors (“Rejected with Errors”). An application for HRSA funding must be both received

and validated under the correct funding opportunity number by Grants.gov by the

application deadline.

Subsequently, HRSA will download the application upon successful validation of your

application by Grants.gov. The status of the application will then change to “Received

by Agency” after successful validation and you will receive a third email from

Grants.gov.

HRSA will process the application to ensure that it has been submitted for the correct

funding opportunity number, along with the correct award number (if applicable) and

recipient/applicant organization. This may take up to 3 business days. HRSA will assign

a unique tracking number to your application which will be posted to Grants.gov. Th e

status of your application will then be changed to “Agency Tracking Number Assigned”

and you will receive a fourth email from Grants.gov.

• NOTE: Refer to FAQ 9.2.5 below for a summary of emails.

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9.2.4. If a resubmission is required due to technological problems encountered

using the Grants.gov or EHBs system and the associated deadline date

has passed, what should I do?

You must contact DGMO at HRSA, within 5 calendar days from the closing date, via

email at ApplicationWaivers@hrsa.gov and provide a detailed explanation. If you

missed the EHBs deadline regarding a BPHC funding opportunity, contact

BPHCEHBWaivers@hrsa.gov. Your email must include the HRSA funding opportunity

number, the name, address, and telephone number of the organization, the

organization’s UEI number, and the name and telephone number of the Project Director,

as well as the Grants.gov Tracking Number (GRANTXXXXXXXX) assigned to your

submission, along with a copy of the “Rejected with Errors” notification you received

from Grants.gov and any BPHC case numbers or Health Center Program Support

communications.

Extensions for competitive funding opportunity deadlines are only granted in the rare

event of a natural disaster or validated technical system problem on the side of the

Government that prevented a timely application submission. An application for HRSA

funding must be both received and validated under the correct funding opportunity

number by the application deadline. Refer to

HRSA’s Policy on Late Submission of

Grant Applications for further information.

9.2.5 Can you summarize the emails received from Grants.gov and identify who

will receive the emails?

Submission Type

Subject

Timeframe

Sent By

Recipient

Competing

Application

“Submission Receipt”

Within 48

hours

Grants.go

AOR

“Submission Validation

Receipt” OR “Rejected

with Errors”

Within 48

hours

Grants.go

AOR

“Grantor Agency

Retrieval Receipt”

Within hours

of second

Grants.go

AOR

“Agency Tracking Number

Assignment”

Within 3

business

days

Grants.go

AOR

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Submission Type

Subject

Timeframe

Sent By

Recipient

Competing

Application

(with verification in

HRSA EHBs)

“Submission Receipt”

Within 48

hours

Grants.go

AOR

“Submission Validation

Receipt” OR “Rejected

with Errors”

Within 48

hours

Grants.go

AOR

“Grantor Agency

Retrieval Receipt”

Within hours

of second

Grants.go

AOR

“Agency Tracking

Number Assignment”

Within 3

business

days

Grants.go

AOR

9.3. Application Submission FAQ

9.3.1 How can I make sure that my electronic application is presented in the

correct order for objective review?

Follow the instructions provided in Section 5

to ensure that your application is presented

in the correct order and is compliant with all the requirements.

9.4. Grants.gov FAQs

For a list of frequently asked questions and answers maintained by Grants.gov, visit

Frequently Asked Questions by Applicants

Grants.gov offers several tools and numerous user guides to assist applicants that are

interested in applying for award funds. To view the many applicant resources available

through Grants.gov, visit Training Resources and Videos for Grants.gov

9.5. Application Completeness Checklist

 Have I read the NOFO and this R&R Two-Tier Application Guide thoroughly?

 Is my organization eligible to apply for the funding opportunity?

 Am I applying to the correct funding opportunity number?

 Is my proposed project responsive to the stated goals and objectives of the

program as specified in the NOFO?

 Have I ensured my application does not exceed the funding ceiling amount

specified in Section III of the NOFO?

 Have I completed all forms and attachments as requested in Section IV of the

NOFO and this Guide?

 Have I ensured my application does not exceed the page limit, if applicable,

specified in the NOFO?

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 Will I apply at least 3 calendar days before the deadline to accommodate any

unforeseen circumstances?

 Have I received confirmation emails from Grants.gov noting validation of

successful submission?

9.6. Program-Specific Resources and Technical Assistance

Refer to Section VIII of the NOFO for additional information/resources (e.g., TA

calls/webinars, related programs, useful website addresses).

10. TECHNICAL ASSISTANCE RESOURCES

HRSA’s Apply for a Grant TA webpage

is a one-stop shop for potential applicants on

how to apply for HRSA funding.

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Application Guide

APPENDIX:

Supplemental Instructions for Preparing the Protection of

Human Subjects Section of the Research Plan and Human Subjects

Research Policy

1. Introduction

A Protection of Human Subjects section of the Research Plan is required for all

applications proposing human subjects research submitted using the SF-424 R&R

instructions and forms. The information provided in the section on Protection of Human

Subjects should be consistent with the information provided on the face page of the

application.

To assist in preparing the section on Protection of Human Subjects, five possible

scenarios are provided in Section 2

below. All research projects will fall into one of

these five scenarios. Determine which scenario the proposed research falls into, then

use the specific instructions applicable to that scenario in

Section 3 of this document.

Where appropriate, Section 3 also provides instructions on addressing the Inclusion of

Sex/Gender and Racial/Ethnic Groups, the Inclusion Enrollment Report(s), and the

Inclusion of Children. See the Glossary for definitions related to human subjects

research. Section 5 includes descriptions of and links to the HHS Human Subjects

Protections regulations that apply to clinical research.

For all scenarios, you must provide sufficient information to allow reviews to determine if

the designation of human subjects involvement is appropriate. The proposed research

must meet all the requirements of applicable HHS policies for the protection of human

subjects from research risks, data and safety monitoring (when applicable), and for the

inclusion of sex/gender and racial/ethnic groups, and children and reporting of

enrollment data for subjects in clinical research (see the Glossary

for definition).

Do not use the human subjects section to circumvent the page limit of the Research

Strategy.

While this information is written primarily for competing applications, guidance here may

also be applicable to interim progress reports.

2. Scenarios

Scenario A. No Human Subjects Research

If no human subjects research is proposed in the application, you will have designated

“No” in response to Human Subjects Research in

Item 1 on the SF-424 RESEARCH &

RELATED Other Project Information form. If your proposed research involves the use of

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human data and/or biological specimens, you must provide a justification for your claim

that no human subjects are involved in the Protection of Human Subjects section of the

Research Plan.

See the instructions for Scenario A

Scenario B. Non-Exempt Human Subjects Research

If research involving human subjects that does not meet the exemption categories is

anticipated to take place under the award, on the SF-424 RESEARCH & RELATED

Other Project Information form you will have designated “Yes” in response to “Are

Human Subjects Involved?” and “No” in response to “Is the Project Exempt from

Federal regulations?” You must provide a complete Protection of Human Subjects

section.

See the instructions for Scenario B

Scenario C. Exempt Human Subjects Research

If all of the proposed human subjects research meets the criteria for one or more of the

exemptions from the requirements in the HHS regulations (45 CFR § 46.101(b)) (see

the Glossary for a detailed description of the exemptions), on the SF-424 RESEARCH &

RELATED Other Project Information form you will have designated “Yes” in response to

“Are Human Subjects Involved?”, “Yes” to “Is the Project Exempt from Federal

regulations?”, and marked the appropriate exemption number. “NA” should be entered

for the Human Subject Assurance Number since no assurance number is required for

exempt research.

If you are not sure whether your proposed research qualifies for an exemption, consult

with the Office for Human Research Protections (OHRP)

, Department of Health and

Human Services by accessing their Web site for guidance and further information.

Please note: if the proposed research involves only the use of human data or biological

specimens, you should first determine whether the research involves human subjects.

The exemptions do not apply if the research does not involve human subjects.

See the instructions for Scenario C.

Scenario D. Delayed-Onset Human Subjects Research

If human subjects research is anticipated within the period of the award but plans for

involvement of human subjects cannot be described in the application as allowed by the

HHS regulations (45 CFR § 46.118), if using the SF-424 RESEARCH & RELATED

Other Project Information form you will have designated “Yes” in response to “Are

Human Subjects Involved?” and, if applicable, “Yes” to “Is the Project Exempt from

Federal regulations?” and marked the appropriate exemption number. Examples of

delayed-onset of human subjects research include:

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• Human subjects research design is dependent upon the completion of animal or

other studies; or

• Human subjects research protocols to be conducted will be determined at a later

time after award (often defined by a NOFO).

See instructions for Scenario D

Scenario E. Human Subjects Research Involving a Clinical Trial

If research involving human subjects is anticipated to take place under the award, and

you intend to conduct a phase I, II, or III clinical trial during the period of performance

that is characterized to include:

a) Prospective assignment of human subjects;

b) One or more interventions, and;

c) Identification of one or more health-related biomedical or behavioral outcomes

If using the SF-424 RESEARCH & RELATED Other Project Information form, you will

have designated “Yes” in response to “Are Human Subjects Involved?”, and “No” to “Is

the Project Exempt from Federal regulations?”

See instructions for Scenario E

3. Instructions for Preparing the Section on Protection of Human

Subjects

Scenario A. No Human Subjects Research Proposed

Criteria

Human Subjects Research No

Exemption Claimed N/A

Clinical Trial N/A

Instructions and Required Information

If proposed studies involve the use of human data or biological specimens, provide an

explanation of why the proposed studies do not constitute research involving human

subjects. In the application narrative (Section H Protection of Human Subjects), include

the following statement below the section heading: “No Human Subjects Research is

proposed in this application” plus any justification as needed.

For studies involving human data or biological specimens, explanation should include: a

description of the source of the data/biospecimens; whether they will be collected

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specifically for this study or were collected for another purpose; what identifiers will be

associated with the human specimens and data and who has access to subject

identities; the role(s) of providers of the data/biological specimens in the proposed

research; and the manner by which the privacy of research participants and

confidentiality of data will be protected.

Research that does not involve intervention or interaction with living individuals, or

identifiable private information, is not human subjects research (see the Glossary

Research involving the use of coded private information or biological specimens may

not constitute human subjects research if the conditions of the OHRP Guidance on

Research Involving Coded Private Information or Biological Specimens have been met

(

Coded Private Information or Specimens Use in Research, Guidance).

Research that only proposes the use of cadaver specimens is not human subjects

research because human subjects are defined as “living individuals.” The use of

cadaver specimens is not regulated by 45 CFR part 46

, but may be governed by other

federal, state or local laws.

Scenario B. Non-Exempt Human Subjects Research

Criteria

Human Subjects Research Yes

Exemption Claimed No

Clinical Trial No

Instructions and Required Information

Although no specific page limit applies to this section of the application, be succinct. In

the application narrative (Section H Protection of Human Subjects), create a

subheading for each required topic.

Follow the instructions that are identified for each of the following topics and provide the

required information:

• Protection of Human Subjects - Section 4.1 - 4.1.4

• Inclusion of Sex/Gender and Racial/Ethnic Groups- Section 4.2

• Inclusion Enrollment Reports(s) - refer to NOFO for details

• Inclusion of Children - Section 4.3

If the research involves more than one protocol or subproject, provide the information

identified above for each unique protocol or project.

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Scenario C: Human Subjects Research Claiming Exemption 1, 2, 3, 4, 5, or 6

Criteria

Human Subjects Research Yes

Exemption Claimed 1, 2, 3, 4, 5, or 6

Clinical Trial No

Instructions and Required Information

Although no specific page limit applies to this section of the application, be succinct. A

detailed description of the exemptions can be found in the Glossary

Although the research may be exempt from the HHS regulatory requirements, the

application must follow the instructions that are identified for each of the following topics

and provide the requested information.

In the application narrative provide the required information for each of the following

topics below:

• Protection of Human Subjects - Include the following statement: “This Human

Subjects Research falls under Exemption(s) …” Clearly identify which

exemption(s) (1, 2, 3, 4*, 5, or 6) you are claiming and justify why the research

meets the criteria for the exemption(s) that you have claimed. This justification

should explain how the proposed research meets the criteria for the exemption

claimed and should not merely repeat the criteria or definitions themselves.

• Inclusion of Sex/Gender and Racial/Ethnic Groups* - Section 4.2

• Inclusion Enrollment Report -refer to NOFO for details

• Inclusion of Children - Section 4.3

*NOTE: If all of the proposed research meets the criteria for Exemption 4, then the

requirements for inclusion of sex/gender and racial/ethnic groups, and inclusion of

children, do not need to be addressed.

Scenario D: Delayed-Onset Human Subjects Research

Criteria

Human Subjects Research Yes

Exemption Yes or No

Clinical Trial Yes or No

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Instructions and Required Information

In rare situations, applications are submitted with the knowledge that human subjects

will be involved during the period of support, but plans are so indefinite that it is not

possible to describe the involvement of human subjects in the application. The kinds of

activities that lack definite plans are often institutional awards where the selection of

specific projects is made by the institution after award, research networks or multi-site

studies where protocols to be conducted are determined after all sites have been

selected, or projects in which the involvement of human subjects depends upon initial

work in the award such as completion of instruments, animal studies, or purification of

compounds.

In the application narrative (Section H Protection of Human Subjects), create a

subheading for each required topic.

Follow the instructions that are identified for each of the following topics and EITHER

provide as much of the information that is requested as possible, OR describe why it is

not possible to provide the information due to delayed-onset of human subjects

research.

• Protection of Human Subjects - Section 4.1 - 4.1.4

• Inclusion of Sex/Gender and Racial/Ethnic Groups - Section 4.2

• Inclusion Enrollment Report(s) - refer to NOFO for details

• Inclusion of Children - Section 4.3

If the research will include a clinical trial, characterized to include (1) prospective

assignment of one or more human subjects; (2) one or more intervention (which can

include placebo or other control), and; (3) evaluation of the effects of the intervention on

one or more health-related biomedical or behavioral outcomes, also include the

following topics.

• Data and Safety Monitoring Plan - Section 4.1.5

• ClinicalTrials.gov Requirements - Section 4.1.6, if applicable

If an award is made, before the involvement of human subjects, the grantee must

submit to the HRSA awarding office for prior approval either (1) detailed information as

required in the Research Plan, Protection of Human Subjects (addressing risks to the

subjects, adequacy of protection against risks, potential benefits of the proposed

research, importance of the knowledge to be gained, and data and safety monitoring

plan, if applicable), Human Subjects Assurance number, and certification of IRB

approval, OR (2) if all of the research meets the criteria for one or more exemptions,

identification of which exemption(s) is/are applicable to the research, and a justification

for the exemption with sufficient information about the involvement of human subjects to

allow a determination that the claimed exemption is appropriate.

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Under no circumstance may human subjects be involved in research until approval is

granted by the awarding entity, and certification of IRB approval (or justification for

exemption) has been accepted by the agency. Inclusion plans and inclusion enrollment

report(s) must also be submitted to the agency before starting human subjects studies.

Scenario E: Clinical Trial

Criteria

Human Subjects Research Yes

Exemption No

Clinical Trial Yes

Instructions and Required Information

In the application narrative (Section H Protection of Human Subjects), include the

following statement below the heading: “This Human Subjects Research meets the

definition of a clinical trial.” (See definition of "clinical trial" in the Glossary

.) Additionally,

create a subheading for each required topic discussed below. Provide the required

information for each of the following topics below:

For each clinical trial proposed, follow the instructions that are identified for each of the

following topics and provide the required information:

• Protection of Human Subjects - Section 4.1 - 4.1.4

• Data and Safety Monitoring – Section 4.1.5

• ClinicalTrials.gov Requirements - Section 4.1.6, if applicable

• Inclusion of Sex/Gender and Racial/Ethnic Groups- Section 4.2

• Inclusion Enrollment Report(s) - refer to NOFO for details

• Inclusion of Children - Section 4.3

If the research involves more than one trial/protocol or subproject, provide the

information identified above for each unique protocol or project.

4. Instructions Pertaining to Non-Exempt Human Subjects Research

This information will be placed in your application narrative (Section H Protection of

Human Subjects). Although no specific page limit applies to this section of the

application, be succinct. Scientific Review Groups will assess each application as being

acceptable or unacceptable with regard to the protection of human subjects. HHS

regulations and policies governing human subjects research are described and

referenced in Section 5

below. Use subheadings to address the issues listed under

items Sections 4.1-4.4 below. If your research includes a clinical trial, include a separate

document entitled "Data and Safety Monitoring Plan" and follow the instructions in

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Section 4.1.5 below. If your research includes a Phase III Clinical Trial, also follow the

additional instructions in Section 4.2.1 below.

4.1 Protection of Human Subjects

4.1.1 Risks to Human Subjects

a) Human Subjects Involvement, Characteristics, and Design

• Describe and justify the proposed involvement of human subjects in the work

outlined in the Research Strategy section.

• Describe the characteristics of the subject population, including their anticipated

number, age range, and health status, if relevant.

• Describe and justify the sampling plan, including retention strategies and the

criteria for inclusion or exclusion of any subpopulation.

• If relevant, explain the rationale for the involvement of special vulnerable

populations, such as fetuses, neonates, pregnant women, children, prisoners,

institutionalized individuals, or others who may be considered vulnerable

populations. Note that 'prisoners' includes all subjects involuntarily incarcerated

(for example, in detention centers) as well as subjects who become incarcerated

after the study begins.

• If relevant to the proposed research, describe procedures for assignment to a

study group. As related to human subjects protection, provide details about all

planned interventions such as dose, frequency, and administration.

• List any collaborating sites where human subjects research will be performed,

and describe the role of those sites and collaborating investigators in performing

the proposed research. Explain how data from the site(s) will be obtained,

managed, and protected.

b) Sources of Materials

• Describe the research material obtained from living individuals in the form of

specimens, records, or data.

• Describe any data that will be collected from human subjects for the project(s)

described in the application.

• Indicate who will have access to individually identifiable private information about

human subjects.

• Provide information about how the specimens, records, and/or data will be

collected, managed, and protected, as well as whether any individually

identifiable private information will be collected specifically for the proposed

research project.

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c) Potential Risks

• Describe all the potential risks to subjects posed by participation in the research

(physical, psychological, financial, legal, or other), and assess their likelihood and

seriousness to the human subjects.

• Where appropriate, describe alternative treatments and procedures, including the

risks and potential benefits of the alternative treatments and procedures, to

participants in the proposed research. When alternative treatments or procedures

are possible, the rationale for the proposed approach should be clear.

4.1.2 Adequacy of Protection Against Risks

a) Recruitment and Informed Consent

• Describe plans for the recruitment of subjects (where appropriate) and the

process for obtaining informed consent. If the proposed studies will include

children, describe the process for meeting requirements for parental permission

and child assent.

• Include a description of the circumstances under which consent will be sought

and obtained, who will seek it, the nature of the information to be provided to

prospective subjects, and the method of documenting consent. When

appropriate, describe how potential adult subjects’ capacity to consent will be

determined and plans for obtaining consent from a legally authorized

representative for adult subjects not able to consent.

• If a waiver of some or all of the elements of informed consent will be sought,

provide justification for the waiver. Informed consent document(s) need not be

submitted to HRSA unless requested.

b) Protections Against Risk

• Describe planned procedures for protecting against or minimizing all potential

risks identified, including risks to privacy of individuals or confidentiality of data,

and assess their likely effectiveness.

• Describe how proposed research involving vulnerable populations meets the

additional regulatory requirements described in the HHS regulations, Subparts B,

C or D. Refer to HHS regulations, and OHRP guidance:

o Additional Protections for Pregnant Women, Human Fetuses and

Neonates:

Subpart B - Additional Protections for Pregnant Women,

Human Fetuses and Neonates Involved in Research

o Additional Protections for Prisoners: Code of Federal Regulations Title 45

Public Welfare DHHS Part 46 Protection of Human Subjects

o OHRP Subpart C Guidance:

Prisoner Involvement in Research

o Additional Protections for Children: Code of Federal Regulations Title 45

Public Welfare DHHS Part 46 Protection of Human Subjects

o OHRP Subpart D Guidance: Subpart D - Additional Protections for

Children Involced as Subjects in Research

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• Where appropriate, discuss plans for ensuring necessary medical or professional

intervention in the event of adverse effects to the subjects. Studies that involve

clinical trials (see definition of “clinical trial” in the Glossary

) must include a

separate attachment describing the plan for data and safety monitoring of the

clinical trials and adverse event reporting to the IRB, the Data and Safety

Monitoring Board (DSMB) (if one has been established for the trial), HRSA and

others, as appropriate, to ensure the safety of subjects (see

Section 4.1.5 below).

• Where appropriate, describe plans for handling incidental findings that may be

uncovered as a result of the research, such as incidental findings from research

imaging, results of screening tests, or misattributed paternity.

NOTE: Test articles (investigational new drugs, devices, or biologics) including test

articles that will be used for purposes or administered by routes that have not been

approved for general use by the Food and Drug Administration (FDA) must be named.

State whether the 30-day interval between submission of applicant certification to the

FDA and its response has elapsed or has been waived and/or whether use of the test

article has been withheld or restricted by the FDA, and/or the status of requests for an

Investigational New Drug (IND) or Investigational Device Exemption (IDE) covering the

proposed use of the test article in the Research Plan.

4.1.3 Potential Benefits of the Proposed Research to Human Subjects and Others

• Discuss the potential benefits of the research to research participants and others.

• Discuss why the risks to subjects are reasonable in relation to the anticipated

benefits to research participants and others.

• Please note that financial compensation of subjects should not be presented as a

benefit of participation in research.

4.1.4 Importance of the Knowledge to be Gained

• Discuss the importance of the knowledge to be gained as a result of the

proposed research.

• Discuss why the risks to subjects are reasonable in relation to the importance of

the knowledge that reasonably may be expected to result.

4.1.5 Data and Safety Monitoring Plan

The PHS Data and Safety Monitoring Policy is described and referenced in Section 5.3

If the proposed research includes a clinical trial, create a heading in Section H

Protection of Human Subjects entitled "Data and Safety Monitoring Plan." Provide a

data and safety monitoring plan (DSMP) that is commensurate with the risks of the trial

and its size and complexity. You must provide a description of the DSMP that you are

proposing to establish for each clinical trial proposed, including:

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• The overall framework for safety monitoring and what information will be

monitored.

• The frequency of monitoring, including any plans for interim analysis and

stopping rules (if applicable).

• The process by which Adverse Events (AEs), including Serious Adverse Events

(SAEs) such as deaths, hospitalizations, and life threatening events, and

Unanticipated Problems (UPs), will be managed and reported as required to the

Institutional Review Board (IRB), the person or group responsible for monitoring,

and HRSA.

• The individual(s) or group that will be responsible for trial monitoring and advising

the appointing entity. Because the monitoring plan will depend on potential risks,

complexity, and the nature of the trial, a number of options for monitoring are

possible. These include, but are not limited to, monitoring by a:

o Project Director (PD)/Principal Investiga

tor (PI): While the PD/PI must

ensure that the trial is conducted according to the protocol, in some cases

(e.g., low risk trials, not blinded), it may be acceptable for the PD/PI to

also be responsible for carrying out the DSMP.

o Independent safety monitor/Designated medical monitor: a physician or

other expert who is independent of the study.

o Independent Monitoring Committee or Safety Monitoring Committee: A

small group of independent investigators and biostatisticians.

o Data and Safety Monitoring Board (DSMB): a formal independent board of

experts including investigators and biostatisticians. As noted in Section

5.3, PHS requires the establishment of DSMBs for multi-site clinical trials

involving interventions that entail potential risk to the participants, and

generally for Phase III clinical trials. Although Phase I and Phase II clinical

trials may also need DSMBs, smaller clinical trials may not require this

oversight format, and alternative monitoring plans may be appropriate.

o If a DSMB is used, please describe the general composition of the Board

without naming specific individuals.

4.1.6 ClinicalTrials.gov Requirements

Public Law 110-85

(also known as the FDA Amendments Act (FDAAA) of 2007)

mandates registration and results reporting of "applicable clinical trials" in

ClinicalTrials.gov. Under the statute these trials generally include: (1) Trials of Drugs

and Biologics: Controlled, clinical investigations, other than Phase 1 investigations, of a

product subject to FDA regulation; and (2) Trials of Devices: Controlled trials with health

outcomes, other than small feasibility studies, and pediatric postmarket surveillance.

Review the statutory definition of applicable clinical trial to identify if registration is

required to comply with the law (See

PL 110-85, Section 801(a), adding new 42 U.S.C.

282(j)(1)(A)).

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PHS encourages registration and results reporting for ALL clinical trials whether or not

registration is required under the FDAAA. On January 28, 2015, NCI published a policy

requiring the reporting of final trial results in a publicly accessible manner within 12

months of the trial’s primary completion date.

When registering clinical trials in the ClinicalTrials.gov Protocol Registration System, if

applicable, enter the HRSA Awar Number associated with the trial in the “Secondary ID”

field (example: R40MC#####).

Registration is accomplished at the

ClinicalTrials.gov Protocol Registration System

Information Web site. A unique identifier called an NCT number, or ClinicalTrials.gov

registry number, will be generated during the registration process. This number should

be included in all Progress Reports and publications.

FDAAA requires:

• the registration of applicable clinical trials in ClinicalTrials.gov no later than 21

days after the first subject is enrolled,

• the reporting of summary results information (including adverse events) no later

than 1 year after the completion date for registered applicable clinical trials

involving drugs that are approved under section 505 of the Food, Drug and

Cosmetic Act (FDCA) or licensed under section 351 of the PHS Act, biologics, or

of devices that are cleared under section 510k of FDCA, and

• if an “applicable clinical trial” is funded in whole or in part by a HRSA grant or

cooperative agreement, grant and progress report forms shall include a

certification that the responsible party has made all required submissions to

ClinicalTrials.gov.

For competing new and renewal applications that include applicable clinical trials which

require registration and results reporting under FDAAA, provide the NCT number/s in

the human subjects section of the Research Plan under a section heading entitled

ClinicalTrials.gov.

The entity responsible for registering the trial is the “responsible party.” The statute

defines the responsible party as:

1) the sponsor of the clinical trial (as defined in 21 CFR § 50.3

) or

2) the principal investigator of such clinical trial if so designated by a sponsor,

grantee, contractor, or recipient (provided that “the principal investigator is

responsible for conducting the trial, has access to and control over the data from

the clinical trial, has the right to publish the results of the trial, and has the ability

to meet all of the requirements” for submitting information under the law). See

110-85, Section 801(a), (adding new 42 U.S.C. 282(j)(1)(A)(ix).

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For the complete statutory definitions of "responsible party" and "applicable clinical trial,"

refer to Elaboration of Definitions of Responsible Party and Applicable Clinical Trial.

The signature on the application of the Authorized Organization Representative assures

compliance with FDAAA.

4.2 Inclusion of Sex/Gender and Racial Ethnic Groups

In Section I Targeted Enrollment of the application narrative, create a section

subheading entitled "Inclusion of Sex/Gender and Racial/Ethnic Groups". Although no

specific page limits apply to this section of the application, be succinct. This section

does not take the place of considering relevant biological variables (such as sex) in the

research strategy. The PHS Policy on the Inclusion of Sex/Gender and Racial/Ethnic

Groups in Clinical Research is described and referenced in Section 5.6

Scientific Review Groups (ie, the Objective Review Committees at HRSA) will assess

each application as being acceptable or unacceptable with regard to the scientifically

justified inclusion (or exclusion) based on sex/gender, race, and ethnicity in clinical

research (see the Glossary

for definition). This section is required for all studies meeting

the definition for clinical research, not just clinical trials. It is important to provide a

detailed plan of who will be included (and/or excluded) and how the distributions of

individuals on the basis of sex/gender, race, and ethnicity are justified in the context of

the scientific goals of the application. Simply stating that certain individuals will not be

excluded or that individuals of any sex/gender or race/ethnicity are eligible is not

sufficient. Details about why the individuals are the appropriate individuals to

accomplish the scientific goals of the study should be provided.

In this section, address, at a minimum, the following four points:

1) Describe the planned distribution of subjects by sex/gender, race, and ethnicity

for each proposed study.

2) Describe the subject selection criteria and rationale for selection of sex/gender,

racial, and ethnic group members in terms of the scientific objectives and

proposed study design. The description may include, but is not limited to,

information on the population characteristics of the disease or condition

understudy.

3) Provide a compelling rationale for proposed sample specifically addressing

exclusion of any sex/gender, racial, or ethnic group that comprises the population

under study.

4) Describe proposed outreach programs for recruiting sex/gender, racial, and

ethnic group members as subjects. This is particularly important if difficulty

recruiting certain groups is anticipated.

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Additional Considerations for justifying inclusion:

There may be reasons why the proposed sample is limited by sex/gender, race, and/or

ethnicity. This should be addressed as part of the four points detailed above.

• Inclusion of certain individuals would be inappropriate with respect to their health;

• The research question addressed is only relevant to certain groups or there is a

gap in the research area;

• Evidence from prior research strongly demonstrates no difference on the basis of

sex/gender, race, and/or ethnicity;

• Sufficient data already exist with regard to the outcome of comparable studies in

the excluded group(s)and duplication is not needed in this study;

• A certain group or groups is excluded or severely limited because the purpose of

the research constrains the applicant's selection of study subjects (e.g., uniquely

valuable stored specimens or existing datasets are limited by sex/gender, race,

and/or ethnicity; very small numbers of subjects are involved; or overriding

factors dictate selection of subjects, such as matching of transplant recipients, or

availability of rare surgical specimens); and/or

• Representation of specimens or existing datasets cannot be accurately

determined (e.g., pooled blood samples, stored specimens, or data-sets with

incomplete sex/gender documentation are used), and this does not compromise

the scientific objectives of the research.

• In general, the cost of recruiting certain groups and/or geographic location alone

are not acceptable reasons for exclusion of particular groups. This should be

considered when developing outreach plans. Establishing collaborations or other

arrangements to recruit may be necessary.

• Additional guidance for research utilizing existing datasets or resources:

o Inclusion must be addressed when conducting clinical research, even if

the samples or data have already been collected as part of a different

study. Details about the sex/gender, race, and ethnicity composition of the

existing dataset/resource should be provided and justified as appropriate

to the scientific goals of the proposed study.

o For the purposes of inclusion policy, an existing dataset may be

constructed of different types of data including but not limited to survey

data, demographic information, health information, genomic information,

etc. Also included would be data to be derived from existing samples of

cells, tissues, or other types of materials that may have been previously

collected for a different purpose or research question but will now be used

to answer a new research question. In general, these will be studies

meeting the definition for clinical research with a prospective plan to

analyze existing data and/or derive data from an existing resource and

where no ongoing or future contact with participants is anticipated.

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4.2.1 Additional Instructions and Requirements When Large Clinical Trials Are

Proposed

If the proposed research includes a large Clinical Trial (ie, a randomized controlled trial

with several hundred or several thousand participants), the section on Inclusion of

Sex/Gender and Racial/Ethnic Groups also MUST address plans for how sex/gender,

race, and ethnicity will be taken into consideration in the design and valid analysis of the

trial. Valid analysis means an unbiased assessment which will, on average, yield the

correct estimate of the difference in outcomes between two groups of subjects. Valid

analysis can and should be conducted for both small and large studies. A valid analysis

does not need to have a high statistical power for detecting a stated effect.

Scientific Review Groups (ie, the Objective Review Committees at HRSA) will assess

each application as being acceptable or unacceptable with regard to the scientifically

justified inclusion plans, including these additional requirements for Phase III clinical

trials.

Applicants should address the following issues for ensuring valid analyses:

• Inclusive eligibility criteria – in general, the cost of recruiting certain groups

and/or geographic location alone are not acceptable reasons for exclusion of

particular groups;

• Allocation of study participants rom different sexes/genders and racial/ethnic

groups to the intervention and control groups by an unbiased process such as

randomization;

• Unbiased evaluation of the outcome(s) of study participants; and

• Use of unbiased statistical analyses and proper methods of inference to estimate

and compare the intervention effects by sex/gender, race, and/or ethnicity,

particularly if prior evidence strongly suggests that differences exist.

Applicants also should address whether they plan to test or not test for differences in

effect among sex/gender, racial, and/or ethnic groups and why that is or is not

appropriate. This may include supporting evidence and/or data derived from animal

studies, clinical observations, metabolic studies, genetic studies, pharmacology studies

as well as observational, natural history, epidemiology and/or other relevant studies.

Additional factors may include planned primary and secondary outcomes and whether

there are previous studies that support or negate the likelihood of differences between

groups.

The plans must include selection and discussion of one of the following analysis plans:

• Plans to conduct analyses to detect significant differences in intervention effect

among sex/gender, racial, and/or ethnic subgroups when prior studies strongly

support these significant differences among one or more subgroups, or

• Plans to include and analyze sex/gender, racial, and/or ethnic subgroups when

prior studies strongly support no significant differences in intervention effect

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between subgroups (representation of sex/gender, racial, and ethnic groups is

not required as subject selection criteria, but inclusion is encouraged), or

• Plans to conduct valid analyses of the intervention effect in sex/gender, racial,

and/or ethnic subgroups (without requiring high statistical power for each

subgroup) when the prior studies neither support nor negate significant

differences in intervention effect among subgroups.

4.3 Inclusion of Children

Create a subsection entitled “Inclusion of Children” and place it immediately following

the subsection on the Inclusion of Sex/Gender and Racial/Ethnic Groups. Although no

specific page limits apply to this section of the application, be succinct. The Policy on

Inclusion of Children is referenced and described in Section 5.8 for inclusion in the

application narrative section. For the purpose of implementing these guidelines, a child

is defined as an individual under the age of 18 years.

Scientific Review Groups (ie, the Objective Review Committees at HRSA) will assess

each application as being acceptable or unacceptable with regard to the age-

appropriate inclusion or exclusion of children in the proposed research project. This

section is required for all studies meeting the definition for clinical research, not just

clinical trials. It is important to provide a detailed plan of who will be included (and/or

excluded) based on age. Details about why the individuals in the given age/age range

are the appropriate individuals to accomplish the scientific goals of the study should be

provided.

Instructions for this item of the Research Plan, including addressing the following

points:

• Describe the age(s) or age range of all individuals to be included in the proposed

study.

• Specifically discuss whether children under the age of 18 (as a whole or a subset

of individuals under 18) will be included or excluded.

• The description of the plan should include a rationale for selecting a specific age

range of children.

• The plan also must include a description of the expertise of the investigative

team for working with children at the ages included, of the appropriateness of the

available facilities to accommodate the children, and the inclusion of a sufficient

number of children to contribute to a meaningful analysis relative to the purpose

of the study.

• When children are involved in research, the Additional Protections for Children

Involved as Subjects in Research (45 CFR part 46 Subpart D

) apply and must be

addressed under the Protections Against Risk subheading (4.1.2.b).

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Justifications for Exclusion of Children

For the purposes of this policy, individuals under 18 are defined as a child; however,

exclusion of any specific age or age range group should be justified in this section. It is

expected that children will be included in all clinical research unless one or more of the

following exclusionary circumstances apply:

• The research topic to be studied is not relevant to children.

• Laws or regulations bar the inclusion of children in the research.

• The knowledge being sought in the research is already available for children or

will be obtained from another ongoing study, and an additional study will be

needlessly redundant. Documentation of other studies justifying the exclusions

should be provided. HRSA program staff can be contacted for guidance on this

issue if the information is not readily available.

• A separate, age-specific study in children is warranted and preferable. Examples

include:

o The condition is relatively rare in children, as compared to adults (in that

extraordinary effort would be needed to include children, although in rare

diseases or disorders where the applicant has made a particular effort to

assemble an adult population, the same effort would be expected to

assemble a similar child population with the rare condition); or

o The number of children is limited because the majority are already accessed

by a nationwide pediatric disease research network; or

o Issues of study design preclude direct applicability of hypotheses and/or

interventions to both adults and children (including different cognitive,

developmental, or disease stages or different age-related metabolic

processes). While this situation may represent a justification for excluding

children in some instances, consideration should be given to taking these

differences into account in the study design and expanding the hypotheses

tested, or the interventions planned, to allow inclusion of children rather than

excluding them.

• Insufficient data are available in adults to judge potential risk in children (in which

case one of the research objectives could be to obtain sufficient adult data to

make this judgment). Although children usually should not be the initial group to

be involved in research studies, in some instances, the nature and seriousness

of the illness may warrant their participation earlier based on careful risk and

benefit analysis.

• Study designs are aimed at collecting additional data on pre-enrolled adult study

subjects (e.g., longitudinal follow-up studies that did not include data on children).

• Other special cases can be justified by the investigator and assessed by the

review group and HRSA to determine if acceptable.

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5. Human Subjects Research Policy

Human Subjects Research Policy includes HHS regulations for the protection of human

subjects and the following PHS policies related to human subjects research.

5.1 Protection of Human Subjects

The Department of Health and Human Services (HHS) regulations for the Protection of

Human Research Subjects, 45 CFR part 46, provide a systematic means, based on

established, internationally recognized ethical principles, to safeguard the rights and

welfare of individuals who participate as subjects in research activities supported or

conducted by the HHS. The regulations stipulate that the recipient organization, whether

domestic or foreign, bears responsibility for safeguarding the rights and welfare of

human subjects in HHS-supported research activities. The regulations require that all

organizations engaged in nonexempt human subjects research supported or conducted

by the HHS hold a Federal-wide Assurance (FWA) with the Office for Human Research

Protections (OHRP), and establish appropriate policies and procedures for the

protection of human subjects. These regulations are available from OHRP, Department

of Health and Human Services, The Tower Building, 1101 Wootton Parkway, Suite 200,

Rockville, MD; telephone: 1-866-447-4777 (toll-free) or (240) 453-6900; email:

ohrp@hhs.gov. In general, OHRP considers organizations that receive direct support

from HHS for the conduct of non-exempt human subjects research to be engaged in

human subjects research. (For more information on whether an institution is engaged in

human subjects research, refer to: Engagement of Institutions in Human Subjects

Research (2008). When a research project is conducted by multiple organizations, each

organization that is engaged in non-exempt human subjects research must hold an

FWA and comply with the regulations at 45 CFR part 46.

Non-exempt research involving human subjects may only be conducted under an HHS

award if the engaged organization(s) is operating in accord with an approved FWA and

provides verification that an Institutional Review Board (IRB) that is registered with

OHRP has reviewed and approved the proposed activity in accordance with the HHS

regulations. Foreign applicant organizations must also comply with the provisions of the

regulations.

Under HHS regulations to protect human subjects, certain research activities are

exempt. With the exception of research projects that meet the criteria for Exemption 4,

studies that are exempt from the human subjects regulatory requirements must still

address the inclusion of sex/gender and racial/ethnic groups, and children in the study

design.

Regulations of the Food and Drug Administration (21 CFR part 50, 21 CFR part 56)

generally apply to biomedical research involving an unapproved drug, device or biologic

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and may apply to certain studies of approved products. Additional information on FDA

regulations is available at CFR - Code of Federal Regulations Title 21. If work falls

under FDA's regulatory requirements, the grantee must follow both HHS and FDA

human subject protection regulations.

Federal requirements to protect human subjects may apply to research on human

specimens (such as cells, blood, and urine), residual diagnostic specimens, and

medical information. Research involving existing data, documents, records, pathological

specimens, diagnostic specimens, or tissues that are individually identifiable is

considered “research involving human subjects.” Research involving the use of coded

private information or biological specimens may not constitute human subjects

research. Refer to the

OHRP Guidance on Research Involving Coded Private

Information or Biological Specimens to clarify when such research is or is not research

involving human subjects.

The HHS regulations require HRSA to evaluate all applications and proposals involving

human subjects (45 CFR § 46.120). This independent evaluation is conducted through

the objective review system and HRSA staff review, and, as required, will take into

consideration the risks to the subjects, the adequacy of protection against these risks,

the potential benefits of the research to the subjects and others, and the importance of

the knowledge gained or to be gained. On the basis of this evaluation, HRSA may

approve or disapprove the application or proposal, or enter into negotiations to develop

an approvable one.

5.1.1 Research Involving the Use of Newborn Blood Spots

Federally funded research using newborn dried blood spots collected on or after March

18, 2015, is considered to be non-exempt human subjects research, and therefore,

must follow the HHS protection of human subjects regulations at 45 CFR part 46

Grant applications submitted to HRSA that will use such materials in research should be

designated as non-exempt human subjects research and include a complete Protection

of Human Subjects section per these instructions including plans for inclusion on the

basis of sex/gender, race, ethnicity, and age.

Such applications that are funded by HRSA must comply with all the relevant federal

regulatory and policy requirements for human subjects research including the

requirement that the recipient institution (and all engaged institutions) have a Federal-

wide Assurance (FWA) from OHRP and certification of IRB approval of the proposed

research.

Parental permission must have been obtained in order to use newborn dried blood

spots collected on or after March 18, 2015, in HRSA-funded research. Waiver of

parental permission for such research is not permitted under this legislation.

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Section 12 of the Newborn Screening Saves Lives Reauthorization Act of 2014 applies

to use of newborn dried blood spots in HHS-funded research. Research funded solely

by state or private entities does not constitute “federally funded research” and is not

subject to Section 12 of the new law. Non-identifiable newborn dried blood spots

collected before March 18, 2015, may continue to be used in NIH-funded research

without parental permission, and this activity would continue to be considered research

that does not involve human subjects under the current human subjects regulations.

5.2 Vulnerable Populations

Investigators who conduct research involving pregnant women, human fetuses and

neonates, prisoners (including subjects who become prisoners after the research has

started), or children, must follow the provisions of the regulations in Subparts B, C, or D

of 45 CFR part 46

, respectively. The subparts describe the additional protections

required for conducting research involving these populations. Relevant information may

be obtained at the OHRP Web site (Regulations and Policy).

Exemptions 1-6 (see Exemptions in the Glossary) do not apply to research involving

prisoners or subjects who become prisoners (see Subpart C). Although Exemptions 1

and 3-6 apply to research involving children (see Subpart D), Exemption 2 can only be

used for research involving educational testing or observations of public behavior when

the investigator(s) do(es) not participate in the activities being observed.

5.3 Data and Safety Monitoring Plans for Clinical Trials

For each proposed clinical trial (See definition of “clinical trial” in the Glossary

), a data

and safety monitoring plan is required that describes oversight and monitoring to ensure

the safety of participants and the validity and integrity of the data. The level of

monitoring should be commensurate with the risks and the size and complexity of the

clinical trial. Before the accrual of human subjects, a detailed data and safety monitoring

plan must be submitted to the applicant’s IRB and to the funding entity for approval.

Adverse Events must be reported to the IRB, HRSA, and other appropriate offices or

agencies. This policy requirement is in addition to any monitoring requirements imposed

45 CFR part 46.

The establishment of a Data and Safety Monitoring Board (DSMB) is specifically

required for multi-site clinical trials involving interventions that entail potential risk to the

participants, and generally for Phase III clinical trials. A DSMB also may be appropriate

for clinical trials if the studies are blinded (masked), employ high-risk interventions, or

involve vulnerable populations.

Summary reports of adverse events must be provided to HRSA, individual IRBs and to

the DSMB (if one has been established for the trial) or other monitoring entity in order

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for them to address reports related to the site for which they have responsibility.

Grantees should address questions on this subject to the HRSA Program Official.

5.4 IRB Approval

HRSA does not require certification of IRB approval of the proposed research before

objective review of an application

Following HRSA objective review, applicants and their institutions will be notified of the

need for review and approval of the proposed research by an IRB that is registered with

OHRP (if it has not already been approved). See

Office for Human Research

Protections to register an IRB. Certification of IRB approval must be sent to the Grants

Management Office identified in the notice requesting documentation.

Because HHS human subject regulations at 45 CFR § 46.103(f) require that each

application for HHS-supported non-exempt human subject research be reviewed and

approved by an IRB (see also IRB review of Applications for HHS Support

) the date of

approval of the application must be submitted to HRSA. However, the IRB must ensure

that any corresponding protocol(s) are consistent with the application, and must

maintain documentation of IRB approval of all corresponding protocols, including those

reviewed by consortium participants. For multi-site research that is not using a single

IRB of record, the primary grantee is expected to collect the certification from each

subrecipient.

Recipients involved in multi-site research may agree to rely on a single IRB of record.

The IRB of record must have an assurance with OHRP. Following OHRP guidance,

HRSA expects that such reliance arrangements will be documented through the signing

of an IRB Authorization Agreement.

Any modifications to the Research Plan in the application, required by either HRSA or

by the IRB, must be submitted with follow-up certification of IRB approval to HRSA

before any research activities involving human subjects are initiated. It is the

responsibility of the PD/PI and the applicant organization to submit the follow-up

documentation.

IRB approval must be dated within the last year to be valid. If more than a year will have

elapsed between the initial IRB review date and the anticipated award date, HRSA shall

require re-review by the IRB before award.

Continuing IRB review of ongoing human subjects research is also required by 45 CFR

§ 46.109(e). A progress report for continuation support should not be submitted until

certification of annual IRB review has been obtained. Th e recipient institution must track

and document IRB approval for all components of an award that involve human

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subjects. Progress reports should report the most recent IRB approval date for any

component which the IRB has approved.

5.5 Required Education in the Protection of Human Research Participants

HRSA requires education on the protection of human research participants for all

individuals identified in applications as senior/key personnel who will be involved in the

design or conduct of human subjects research, before funds are awarded for

applications or contract proposals involving human subjects. For information relating to

this requirement, see the following notices NOTICE: OD-00-039 and

NOTICE: NOT-

OD-01-061, and Frequently Asked Questions ON Requirements for Education. Before

initiating any research activities involving human subjects, institutions will be required to

certify to HRSA that all senior/key personnel involved in the design or conduct of human

subjects research have completed this educational requirement. Although HRSA does

not endorse specific programs, curricula are available to provide guidance and can be

modified to provide training in this area. For information on facilitating education and

developing curricula, see Bioethics Interest Group. Also, NIH has a free tutorial on

human subjects protection that can be used to meet this educational requirement: see

Human Subjects Protections Training.

5.6 Policy on the Inclusion of Sex/Gender and Racial/Ethnic Groups in Clinical

Research

PHS policy requires that all PHS-supported biomedical and behavioral research projects

involving clinical research include diverse sex/gender and racial/ethnic minority

populations unless a clear and compelling rationale and justification establishes to the

satisfaction of the funding agency that inclusion is inappropriate with respect to the

health of the subjects or the purpose of the research. Exclusion under other

circumstances must be designated by the Associate Administrator or Office Director,

upon the recommendation of a HRSA program office based on a compelling rationale

and justification. Cost is not an acceptable reason for exclusion except when the study

would duplicate data from other sources. Women of childbearing potential should not be

routinely excluded from participation in clinical research. This policy applies to research

subjects of all ages.

Representation of diverse racial/ethnic minority populations, as well as sex/gender,

must be addressed in developing a research design appropriate to the scientific

objectives of the study. The Research Plan should describe the composition of the

proposed study population in terms of sex/gender, race, and ethnicity, and provide a

rationale for selection of subjects. It is important to justify the proposed sample on the

basis of sex/gender, race, and ethnicity in the context of the scientific goals of the

proposed study(s) with discussion of the demographics of the population under study

and/or who is at risk for the disease/condition. Such a plan should contain a description

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of the proposed outreach programs for recruiting women and racial/ethnic minorities as

participants.

In addition, as detailed in Section 4.2.1

of these instructions, when conducting a clinical

trial, there are additional requirements and considerations related to valid analysis to

explore differences on the basis of sex/gender, race, and ethnicity.

5.7 PHS Policy on Reporting Race and Ethnicity Data for Subjects in Clinical

Research

The Office of Management and Budget (OMB) defines minimum standards for

maintaining, collecting and presenting data on race and ethnicity for all federal reporting

agencies (including HRSA) in OMB Directive 15:

Race and Ethnic Standards for Federal

Statistics.

The standards were revised in 1997 and include two ethnic categories (Hispanic or

Latino and Not Hispanic or Latino) and five racial categories (American Indian or Alaska

Native, Asian, Black or African American, Native Hawaiian or Other Pacific Islander, and

White). The categories in this classification are social-political constructs and should not

be interpreted as being anthropological in nature. HRSA is required to use these

definitions to allow comparisons to other federal databases, especially the census and

national health databases. Federal agencies will not present data on detailed categories

if doing so would compromise data quality or confidentiality standards.

Collection of this information and use of these categories is required for research that

meets the definition of clinical research. The collection of greater detail is encouraged,

for example on racial or ethnic subpopulations. However, any collection that uses more

detail must be designed in a way that data can be aggregated into these minimally

required OMB categories. Use self-report or self-identification to collect this information

from subjects by asking two separate questions – one on ethnicity and one on race.

Collect ethnicity information first, followed by the question on race and provide

participants with the option to select more than one racial category. Participants also

have the option not to identify. When feasible, HRSA encourages investigators to

include information about individuals who select more than one racial category and

consider that data in their analyses. Participants who self-identify with more than one

racial category should be reported under the “More than one race” category of the

report. The following definitions apply to the minimum standards for the ethnic and racial

categories.

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Ethnic Categories:

• Hispanic or Latino: A person of Cuban, Mexican, Puerto Rican, South or

Central American, or other Spanish culture or origin, regardless of race. The

term, “Spanish origin,” can be used in addition to “Hispanic or Latino.”

• Not Hispanic or Latino

Racial Categories:

• American Indian or Alaska Native: A person having origins in any of the

original peoples of North, Central, or South America, and who maintains tribal

affiliation or community attachment.

• Asian: A person having origins in any of the original peoples of the Far East,

Southeast Asia, or the Indian subcontinent including, for example, Cambodia,

China, India, Japan, Korea, Malaysia, Pakistan, the Philippine Islands, Thailand,

and Vietnam. (Note: Individuals from the Philippine Islands have been recorded

as Pacific Islanders in previous data collection strategies.)

• Black or African American: A person having origins in any of the black racial

groups of Africa. Terms such as “Haitian” or “Negro” can be used in addition to

“Black or African American.”

• Native Hawaiian or Other Pacific Islander: A person having origins in any of

the original peoples of Hawaii, Guam, Samoa, or other Pacific Islands.

• White: A person having origins in any of the original peoples of Europe, the

Middle East, or North Africa.

Ethnic/Racial Subpopulations: In addition to OMB ethnic and racial categories, each

ethnic/racial group contains subpopulations that are delimited by geographic origins,

national origins, and/or cultural differences. It is recognized that there are different ways

of defining and reporting racial and ethnic subpopulation data. The subpopulation to

which an individual is assigned depends on self-reporting of specific origins and/or

cultural heritage. Attention to subpopulations also applies to individuals who self-identify

with more than one race. These ethnic/racial combinations may have biomedical,

behavioral, and/or socio-cultural implications related to the scientific question under

study.

5.8 PHS Policy on Inclusion of Children

PHS policy requires that children (i.e., individuals under the age of 18) must be included

in all clinical research conducted or supported by HRSA unless there are clear and

compelling reasons not to include them. Therefore, applications proposing clinical

research must include a description of plans for including children. If children (or a

subset of children) will be excluded from the research, the application must include an

acceptable justification for the exclusion. For additional details and guidance, please

refer to Section 4.3

of these instructions.

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The involvement of children as subjects in research must be in compliance with all

applicable subparts of 45 CFR part 46

as well as with other pertinent federal laws and

regulations.

IRBs have special review requirements to protect the well-being of children who

participate in research. These requirements relate to risk, benefit, parental/guardian

consent, and assent by children, and to research involving children who are wards of

the state or of another institution. The local IRB approves research that satisfies the

conditions set forth in the regulations.

5.9 Research on Transplantation of Human Fetal Tissue

In signing the application Face Page or checking the “I agree” box on line 17 of the SF-

424 R&R Cover Form, the Authorized Organization Representative of the applicant

organization certifies that if research on the transplantation of human fetal tissue is

conducted, the applicant organization will make available, for audit by the Secretary,

HHS, the physician statements and informed consents required by section 498A (b)(2)

and (c) of the Public Health Service Act, 42 U.S.C. 289g (b)(2) and (c), or ensure HHS

access to those records, if maintained by an entity other than the applicant organization.

5.10 Research Using Human Embryonic Stem Cells

In signing the application Face Page or checking the “I agree” box on line 17 of the SF-

424 R&R Cover Form, the Authorized Organization Representative of the applicant

organization certifies that if research using human embryonic stem cells is proposed,

the applicant organization will identify human embryonic stem cells (hESCs) to be used

from the NIH Registry

or, if a specific cell line cannot be referenced at the time of

application, certify that one from the NIH Registry will be used, in accord with the NIH

Guidelines on Human Stem Cell Research. The Authorized Organization

Representative further certifies that the hESCs will be used in accordance with any

restrictions associated with the line as cited on the Registry (Notice Number: NOT-OD-

10-029 Clarification of Terms and Conditions of Awards using Human Embryonic Stem

Cells). See NIH: Stem Cell Information for additional information on stem cells, federal

policy statements, and guidelines on federally funded stem cell research.

5.11 ClinicalTrials.gov Requirements

In signing the application Face Page or checking the “I agree” box on line 17 of the SF-

424 R&R Cover Form, the Authorized Organization Representative of the applicant

organization certifies that if the research is an applicable clinical trial under Public Law

110-85, the applicant organization will be in compliance with the registration and

reporting requirements of Public Law 110-85 (Section 4.1.6)