Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Funding Opportunity Title
Development of Novel Nonsteroidal Contraceptive Methods (R61/R33 - Clinical Trial Not Allowed)
Activity Code

R61/R33 Exploratory/Developmental Phased Award

Announcement Type
Reissue of RFA-HD-19-015
Related Notices

NOT-OD-23-012 Reminder: FORMS-H Grant Application Forms and Instructions Must be Used for Due Dates On or After January 25, 2023 - New Grant Application Instructions Now Available

NOT-OD-22-195 New NIH "FORMS-H" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2023

NOT-OD-22-189 Implementation Details for the NIH Data Management and Sharing Policy

NOT-OD-22-198 Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023

Funding Opportunity Announcement (FOA) Number
RFA-HD-24-002
Companion Funding Opportunity
None
Assistance Listing Number(s)
93.865
Funding Opportunity Purpose

The purpose of this funding opportunity announcement (FOA) is to support and facilitate multidisciplinary research approaches for the development of novel nonsteroidal contraceptive products for men and women that act prior to fertilization. This FOA aims to position innovative and validated methods for future clinical development.

Key Dates

Posted Date
October 13, 2022
Open Date (Earliest Submission Date)
February 28, 2023
Letter of Intent Due Date(s)

30 days prior to application due date

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
March 29, 2023 Not Applicable Not Applicable July 2023 October 2023 December 2023

All applications are due by 5:00 PM local time of applicant organization. 

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Expiration Date
March 30, 2023
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

The purpose of this funding opportunity announcement (FOA) is to support and facilitate multidisciplinary research approaches for the development of novel nonsteroidal contraceptive products for men and women that act prior to fertilization. This FOA aims to position innovative and validated methods for future clinical development.

Background

Nearly half of all pregnancies in the United States are unintended. There is a critical need for fertility regulation methods that fit the needs of women and men throughout their reproductive lives. This FOA supports the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) in its mission to develop novel, safe and effective contraceptive methods for men and women.

An important component of any early stage product development project is to conduct the necessary research to demonstrate that if the proposed modulation is successful (e.g., inhibition of a specific enzyme), the desired result will be achieved (e.g., infertility). This is commonly referred to as "validation". When a specific and defined molecule is targeted for modulation (e.g., inhibition of a specific enzyme), the specific molecule is referred to as a "target" and the validation process is referred to as "target validation". If more than one specific molecule is targeted (e.g., two related enzymes), the same principles apply for the two molecules (i.e., demonstration that a well characterized modulation of both molecules will achieve the desired result). In addition to supporting contraceptive development research on validated modulations, this FOA encourages innovative ideas and supports early stage, high-risk projects lacking validation by allowing validation during the R61 phase.

Phased Innovation Awards

This funding opportunity will use the R61/R33 phased award mechanism. Support will be provided up to two years for the R61 phase, and up to three years of support may follow for the R33 phase.

Transition from the R61 to the R33 phase

No less than two months before the completion of the R61 phase, awardees may submit the R33 transition package, which includes the R61 progress report describing in detail progress towards the R61 milestones and a description of how research proposed for the R33 phase will be supported by the completion of the R61 phase milestones. These materials will be evaluated by NIH Program staff. R33 funding decisions will be based on transition milestone accomplishment, preparedness of candidate product/technology for further development (if applicable), whether Aims of Phase II (R33 phase) continue to meet programmatic priorities in the context of the FOA objectives, and availability of funds. Grants receiving a positive R33 funding decision will be transitioned to an R33 award without the need to submit a new application. It is anticipated that not all R61 awardees will be transitioned into the R33 phase. Priority may be given to awardees that successfully complete all transition milestones. Applicants must be aware that use of a no-cost extension at the end of the R61 period could jeopardize the award of the R33.

Validation

The purpose of validation is to provide evidence that if the proposed research project is successful in achieving the modulation outlined in the application, the contraceptive method will be effective. Validation, as defined in this FOA, is the demonstration in a mammalian species that the modulation proposed in the application to achieve a contraceptive effect, whether specific (e.g., antagonism of a single specific enzyme) or non-specific (e.g., sperm motility inhibition by exposure to a high molecular weight polymer), results in infertility with a reasonable safety profile.

  • Subfertility is not sufficient to constitute validation. Subfertility as defined in this FOA is the generation of live animals from in vivo mating trials and/or an in vivo or in vitro fertilization rate greater than zero.
  • If the contraceptive target was not validated at the time of initial application, validation must be demonstrated in the transition package for transition to the R33 phase.
  • If the application proposes a modulation to achieve contraceptive effect that is not validated, the milestones in the R61 phase must include a validation plan, including one or more milestones that address the outcome of the validation studies.
  • If validation results solely from inhibition of sperm motility in vitro, it must be demonstrated in both human sperm and sperm from an appropriate model species for pharmaceutical development.
  • For applications proposing the use of protein degradation (e.g., PROTACs, LYTACs, AUTACs), it must be demonstrated in the transition package that ≥80% of the target protein was degraded within the appropriate organ/tissue/cell type compared to controls.
  • Validation is not required for applications focused on the development of devices for the delivery of nonsteroidal contraceptive agents.
  • Reversibility does not need to be demonstrated as part of the validation process.

Examples of research project types and acceptable forms of validation

For applications focused on modulation of defined molecular targets:

Proposed contraception research projects focused on the modulation of specific molecular interaction between an administered molecule (e.g., chemical, antibody) and a defined molecular target(s) (e.g., enzyme, transporter, ion channel) to achieve modulation of the target (e.g., agonism, antagonism) leading to a contraceptive effect (i.e., infertility).

  • Examples include but are not limited to:
    • Targeted deletion of the gene encoding the target to be modulated, resulting in infertility.
    • Development of an antibody that binds specifically to the target and inhibits fertility in a concentration dependent manner in a relevant model (e.g., in vitro fertilization).
    • Specific inhibition of RNA corresponding to target to be modulated leading to inhibition of gametogenesis or loss of gamete function as demonstrated by histology, mating studies or in vitro fertilization.

For high molecular weight polymers:

It is generally accepted that natural or synthetic high molecular weight polymers that interact with cells and inhibit transport (e.g., sperm motility) act via multiple non-specific binding events. Validation of these molecules requires (1) supporting evidence that their action is mediated by non-specific binding, (2) demonstration that the agent can achieve a contraceptive effect, and (3) a demonstrated and reasonable safety profile. See below for a discussion of reasonable safety profile. Program recommends a lack of toxicity at ≥50× the dose for the duration of contact expected to be used to achieve contraceptive effect in a relevant model.

  • Examples include but are not limited to:
    • Use of the agent in a mammalian animal model resulting in infertility.
    • Use of the agent to inhibit sperm motility in vitro to a level consistent with infertility at concentrations consistent with expected in vivo use.
    • Use of the agent to inhibit in vitro fertilization when the product is at concentrations consistent with in vivo use.

For low weight molecules with contraceptive properties that act via unknown molecular interactions:

For low molecular weight molecules (<2000 Daltons) with contraceptive properties that do not have an identified mechanism of action, validation must include demonstration that the compound can achieve (1) a contraceptive effect in a relevant model, and (2) a demonstrated and reasonable safety profile. Program recommends a lack of toxicity at ≥10× the dose for the duration of dosing used to achieve contraceptive effect in a relevant model.

  • Examples include but are not limited to:
    • Mating studies demonstrating a contraceptive effect in all animals at a defined dose/duration, including pharmacokinetic analysis.
    • Toxicological assessment demonstrating a lack of toxicity at ≥5× the dose for the duration resulting in a contraceptive effect.

For projects focused on the development or improvement of vehicles for delivery of nonsteroidal contraceptive agents:

  • Validation is not required for vehicles for the delivery of nonsteroidal contraceptive agents.

Reasonable Safety Profile

To transition to the R33 phase, applicants must demonstrate that their proposed modulation is validated. A component of that validation is a reasonable safety profile. The application should define research to demonstrate in vivo safety parameters consistent with the intended dose/duration used in vitro or in vivo to achieve a contraceptive effect. There must be an appropriate differential between efficacy (e.g., IC50) and safety (e.g., TC50) sufficient to justify supporting further development. These parameters will vary by target, route of administration (e.g., PO, IV) and local versus systemic administration. Applicants should consider addressing toxicity as part of the transition milestones. Applicants who desire further discussion regarding this section are advised to consult the NICHD Scientific/Research contact.

Leveraging Existing Research Resources

If applicable to their project, applicants are encouraged to consult existing research database resources, many of which have been developed with NIH or NICHD involvement. These databases (e.g., Contraceptive Infertility Target DataBase (CITDBase), Mammalian Reproductive Genetics Database V2, Geneshot, NIH Pharos, Open Targets, Calliope) are resources to gather hypothesis-generating information about a target of interest or find additional targets for study.

Research Scope

The purpose of this announcement is to support and facilitate multidisciplinary research approaches to the development of novel nonsteroidal contraceptive methods for men and women that act prior to fertilization, including small molecules, large molecules, biologics and medical devices. This FOA supports research on pre-clinical stages of development from target validation through IND-enabling studies. This FOA also supports the development of multipurpose prevention technologies (MPTs) with both contraceptive and anti-infective properties.

Contraception development research projects appropriate for this FOA include but are not limited to the following:

Male or female contraceptive development based on nonsteroidal action.

Male and/or female pre-coital on-demand contraception based on nonsteroidal action.

Nonsteroidal MPT products based on nonsteroidal action with both contraceptive and anti-infective properties.

Development or improvement of vehicles for delivery of nonsteroidal contraceptive agents including but not limited to vaginal films and microneedles.

Applications focused in the following areas are considered not responsive and will not be reviewed:

  • Applications not focused on the development of a contraceptive product or delivery system
  • Applications focused on molecular targets for which there is no human ortholog
  • Applications based on mechanisms of contraceptive action that may act post-fertilization
  • Applications that focus on the development of methods that may act via the oviduct or uterus
  • Applications based on intrauterine devices/intrauterine systems
  • Application focused on the development of molecules or devices that disrupt/perturb the blood-testis and/or blood-epididymal barriers
  • Applications for the development of molecules for male or female contraception that act via steroid receptors
  • Applications for the development of contraceptive methods that require the administration of one or more exogenous steroidal molecules that act via nuclear steroid receptors
  • Applications focused on male or female condom development
  • Applications focused on target identification, unless they are to identify the target of a low molecular weight molecule with contraceptive properties that acts via an unknown molecular interaction
  • Applications focused on targeted protein degradation (e.g., use of PROTACs, LYTACs, AUTACs) unless application is focused on specific degradation of a known/defined contraceptive target
  • Applications focused on the development of type I-II kinase inhibitors
  • Applications based on the following class of targets:
    • Retinoic acid receptor alpha (RARα), unless the modulation proposed is (1) targeted protein degradation or (2) the research studies after the chemical optimization phase include monitoring immunological response (expression changes in T cells, B cells, granulocytes, macrophages, dendritic cells, and natural killer cells) following chronic compound administration. Immunological monitoring must occur during the R61 phase with results included in the transition package. For applications targeting RARα via targeted protein degradation, immunological monitoring is not required during the R61 phase.
  • Applications for the development of the following molecules and/or their chemical derivatives:
    • Gamendazole
    • H2-Gamendazole
    • Adjudin
    • Gossypol
    • alpha-chlorohydrin

Applications that do not follow the administrative guidelines of this RFA will not be reviewed, including but not limited to:

  • Applications that do not provide a clear path to transition from the R61 to the R33 phase of the award
  • Applications that propose clinical trials
  • Applications proposing only the R61 mechanism or only the R33 mechanism
  • Applications that do not provide milestones for the transition from the R61 to the R33 phase of the award with go/no-go criteria and a Gantt chart (see Section IV.2)

Milestones

All projects must be milestone-driven with clear go/no-go criteria. Milestones are deliverables for each specific aim of the project with quantifiable success metrics and include at minimum annual and/or intermediate quantitative criteria with key success metrics specifically defined. Proposed milestones must be quantitative in nature and unique for each project depending on its position within the development process. Milestones must not be subjective in defining success criteria. Each milestone should have specific and quantifiable measures to evaluate achievement of the milestones. The applicant must explicitly state go/no-go criteria for advancement to the R33 phase in the project.

Prior to funding an application, the NICHD Program Official will contact the applicant to discuss the proposed milestones and any changes recommended by peer review and additional feedback from NICHD staff. The NICHD Program Official and the applicant will negotiate a final set of approved milestones that will be specified in the Notice of Award.

  • The milestones are part of the Research Strategy (and thus subject to the standard page limits) but should be in a separate section titled “Transition Milestones for the R61 Phase.”
  • All applications may include milestones related to intellectual property (e.g., patentability report).
  • All applicants should consider addressing toxicity as part of the transition milestones.

Representative examples of milestones for the research project types discussed in Validation section:

The following are example milestones that correlate to the research project types discussed in the Validation section above. This is not an exhaustive list or prescriptive as the desired values for all applicable projects but are instead examples of the degree of quantitation and specificity expected by Program.

I. Modulation of defined molecular targets that have been validated:

  • Example milestones:
    • High throughput screen of in-house library of 100,000 compounds with Z’≥0.5 and signal to baseline/noise of ≥4.
    • Obtain x-ray crystal structure of target protein with compound of interest at resolution of ≤2.5 Å.
    • Differential scanning fluorimetry-based screen of ≥5,000 compounds resulting in ≥3 compounds with ΔTm>0.5 °C.

II. For high molecular weight polymers:

  • Example milestones:
    • Administration of compound in 3-day mouse mating study resulted in zero pups.
    • Inhibition of sperm penetration through 3 mm of cervical mucus by ≥95%.

III. For low weight molecules with contraceptive properties that act via unknown molecular interactions:

  • Example milestones
    • Solubility ≥10 µM, permeability in MDCK cells ≥1×10-6 cm/s, microsomal stability in rodent and non-rodent species >50% at 60 min, and plasma protein binding <99%.
    • Fertility after administration at 10 mg/kg in mating studies returned to baseline within 2 months.
    • Development of an in vitro phenotypic screen able to distinguish ≥90% decrease in sperm motility.

IV. For projects focused on the development or improvement of vehicles for delivery of nonsteroidal contraceptive agents:

  • Example milestone:
    • Viability of cells treated with compound of interest will be >90% of the control cell population after 7 days and show <10% caspase-1 activity versus control in an inflammasome activity.

Subcontracting of Research Facilities

PDs/PIs may sub-contract portions of their research they are not able to conduct at their facility or institute to outside vendors (e.g., animal studies, protein production, high throughput screening, medicinal chemistry and x-ray crystallography). Applicants interested in subcontracting facilities must obtain agreement in advance, provide for the services in the budget, and include a letter of support in the application (see Section IV.2). Applicants who desire assistance in identifying subcontractors for animal studies or drug development services are advised to consult the NICHD Scientific/Research contact.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed
New

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

Clinical Trial?

Not Allowed: Only accepting applications that do not propose clinical trials.

Funds Available and Anticipated Number of Awards

The NICHD intends to commit $3.0 million in FY 2024 to fund at least seven awards.

Award Budget

For the R61 phase, Direct Costs may not exceed $250,000 per year. For the R33 phase, Direct Costs may not exceed $500,000 per year.

Award Project Period

The scope of the proposed project should determine the project period. The maximum project period of the combined R61 and R33 phases is up to 5 years with up to 2 years for the R61 phase and up to 3 years for the R33 phase. Applications with a project period of less than 5 years are encouraged where feasible.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

  • Public/State Controlled Institutions of Higher Education
  • Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

  • Hispanic-serving Institutions
  • Historically Black Colleges and Universities (HBCUs)
  • Tribally Controlled Colleges and Universities (TCCUs)
  • Alaska Native and Native Hawaiian Serving Institutions
  • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

  • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

  • Small Businesses
  • For-Profit Organizations (Other than Small Businesses)

Local Governments

  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Government

  • Eligible Agencies of the Federal Government
  • U.S. Territory or Possession

Other

  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations
  • Non-domestic (non-U.S.) Entities (Foreign Institutions)
Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed. 

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

  • System for Award Management (SAM)– Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
    • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
    • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
  • eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
  • An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications)

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

  • Descriptive title of proposed activity
  • Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
  • Names of other key personnel
  • Participating institution(s)
  • Number and title of this funding opportunity

The letter of intent should be sent to:

Leigh Allen, PhD
Telephone: 301-594-9151

Email: leigh.allen@nih.gov

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Facilities and Other Resources

If a subcontractor is proposed, provide relevant details on the subcontractor's research environment.

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed.

R&R Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

R&R Subaward Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Specific Aims: The specific aims for both the R61 phase and the R33 phase must be included in the Specific Aims attachment. Include headers indicating the R61 specific aims and the R33 specific aims.

Research Strategy: Applicants must provide an overview of the proposed research, including milestones, feasibility, and timelines for completion of both phases. In preparing the R61/R33 application, investigators must consider that the application will be assigned a single overall impact score. Thus, clarity and completeness of the application regarding specific goals and the feasibility of each phase and the Transition Milestones are critical. Applicants must provide separate sections to describe the R61 and R33 phases. Applicants must not repeat information or details in the R33 section that are described in the R61 section unless they differ substantially.

In the Research Strategy, applicants must include:

  • A description of the validation status of the project at the time of submission.
  • For applications focused on development of a treatment containing two or more identified molecules, a discussion addressing potential compound interactions (i.e., drug:drug interactions).
  • For non-validated projects, a plan to validate the target must be proposed in the R61 phase.
  • A comprehensive Gantt chart for each phase outlining the proposed research and incorporating all proposed milestones and go/no-go criteria.
  • For projects that are in or have completed the chemical optimization phase, a description of potential routes of delivery/administration.
  • For MPT projects, discussion of the anti-infective strategy, the proposed delivery method, and the potential impact on public health.
  • A section titled "Transition Milestones for the R61 Phase." This section must be placed at the end of the R61 section within the Research Strategy. This section must include:
    • Discussion of suitability of the proposed milestones to assess success in the R61 phase.
    • Discussion of the implications of successful completion of these milestones for the proposed R33 phase.
    • Milestones that are specific, quantifiable and scientifically justified; they must not be a simple restatement of the R61 phase specific aims.
    • Go/no-go criteria integrated into the milestone criteria.
    • Sufficiently scientifically rigorous milestones to assess progress in the R61 phase.
    • For non-validated projects, one or more quantitative milestones for completing validation studies.

Letters of Support: Letters of support must be provided for all collaborators and subcontractors.

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages. For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages.

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

  • All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.
Appendix:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form

All instructions in the SF424 (R&R) Application Guide must be followed.

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential fieldof the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by the NICHD, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

 

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.  Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) will not be evaluated at time of review.

For this particular announcement, note the following:

The R61/R33 phased innovation grant supports investigation of novel scientific ideas or new interventions, model systems, tools, or technologies that have the potential for significant impact on biomedical or behavioral and social sciences research. An R61/R33 grant application need not have preliminary data, extensive background material or preliminary information; however, they may be included if available. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Accordingly, reviewers will emphasize the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Reviewers will assign a single impact score for the entire application, which includes both the R61 and R33 phases.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

FOA-specific criteria: For MPT projects, will the anti-infective strategy and proposed delivery method have an important impact on public health?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance, and organizational structure appropriate for the project?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

FOA-specific criteria: Is the proposed project innovative based on the current landscape of contraceptive drug development?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

FOA-specific criteria: Are experimental details and methods to validate the results and alternative strategies, if not successful at first, presented?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment, and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Transition Milestones

Are the proposed Transition Milestones well defined with quantifiable measures that are appropriate for assessing the success of the R61 phase of the awards? Is it clear how the R33 phase of the study will develop and expand once the R61 Transition Milestones are achieved? If the project requires validation, is the validation plan sufficient to address validation and reasonable to perform in time for transition to the R33 phase? Do the Gantt charts appropriately reflect the milestones? Are appropriate go/no-go criteria integrated into the milestone criteria?

Protections for Human Subjects

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not applicable

Renewals

Not applicable

Revisions

Not applicable

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) will not be evaluated at time of review.

Reviewers will comment on whether the Resource Sharing Plan(s) (i.e., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

Authentication of Key Biological and/or Chemical Resources:

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NICHD, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Child Health and Human Development Council (NACHHD). The following will be considered in making funding decisions:

  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities (e.g., branch research priorities; achievement of a balanced product development portfolio, including contraceptive products and medical devices).

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identity, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

Not applicable.

3. Data Management and Sharing

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-637-3015

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Scientific/Research Contact(s)

Leigh Allen, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-594-9151
Email: leigh.allen@nih.gov

Peer Review Contact(s)

Sherry Dupere, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-451-3415
Email: duperes@mail.nih.gov

Financial/Grants Management Contact(s)

Margaret Young
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-642-4552
Email: margaret.young@nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.

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