Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

Office of Research on Women’s Health (ORWH)

National Cancer Institute (NCI)

National Eye Institute (NEI)

National Heart, Lung, and Blood Institute (NHLBI)

National Human Genome Research Institute (NHGRI)

National Institute on Aging (NIA)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

National Institute of Allergy and Infectious Diseases (NIAID)

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

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

National Institute on Deafness and Other Communication Disorders (NIDCD)

National Institute of Dental and Craniofacial Research (NIDCR)

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

National Institute on Drug Abuse (NIDA)

National Institute of Environmental Health Sciences (NIEHS)

National Institute of General Medical Sciences (NIGMS)

National Institute of Mental Health (NIMH)

National Institute of Neurological Disorders and Stroke (NINDS)

National Institute of Nursing Research (NINR)

National Institute on Minority Health and Health Disparities (NIMHD)

National Library of Medicine (NLM)

Fogarty International Center (FIC)

National Center for Complementary and Alternative Medicine (NCCAM)

Division of Program Coordination, Planning and Strategic Initiatives,

Office of Research Infrastructure Programs (ORIP)

National Institute of Biomedical Imaging and Bioengineering (NIBIB)

Funding Opportunity Title

Administrative Supplements for Research on Sex/Gender Differences (Admin Supp)

Activity Code

Administrative Supplement

Additional funds may be awarded as supplements to parent awards using the following Activity Code(s):

Administrative supplement requests must be submitted on paper for the following activity codes:

P01 Research Program Projects

P20 Exploratory Grants

P30 Center Core Grants

P50 Specialized Center

P60 Comprehensive Center

PM1 Program Project or Center with Complex Structure

U10 Cooperative Clinical Research – Cooperative Agreements

U19 Research Program – Cooperative Agreements

U54 Specialized Center- Cooperative Agreements

U56 Exploratory Grants – Cooperative Agreements

UM1 Multi-Component Research Project Cooperative Agreements

Administrative supplement requests may be submitted electronically for the following activity codes:

DP1 NIH Director’s Pioneer Award (NDPA)

DP2 NIH Director’s New Innovator Awards

DP3 Type 1 Diabetes Targeted Research Award

DP4 NIH Director’s Pathfinder Award- Multi-Yr Funding

DP5/UP5 Early Independence Award/Cooperative Agreement

RM1 Research Project with Complex Structure

R01 Research Project Grant

R15 Academic Research Enhancement Award (AREA)

R37 Method to Extend Research in Time (MERIT) Award

U01 Research Project – Cooperative Agreements

Announcement Type

Reissue of PA-14-027

Related Notices

  • December 08, 2014 - See Notice NOT-EB-15-001. Notice of Participation of NIBIB in PA-15-034 “Administrative Supplements for Research on Sex/Gender Differences”

Funding Opportunity Announcement (FOA) Number

PA-15-034

Companion Funding Opportunity

None

Number of Applications

Only one application per parent award is allowed as defined in Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.313; 93.856; 93.361; 93.989; 93.307; 93.173; 93.242; 93.273; 93.172; 93.399; 93.396; 93.395; 93.394; 93.393; 93.213; 93.351;93.879; 93.846; 93.866; 93.853; 93.867; 93.121; 93.113; 93.865; 93.279; 93.847; 93.855; 93.859 ; 93.837; 93.838; 93.839; 93.233, 93.286

Funding Opportunity Purpose

The Office of Research on Women's Health (ORWH) announces the availability of administrative supplements to support research highlighting the impact of sex/gender differences (or similarities) and/or sex and gender factors in human health and illness, including basic, preclinical, clinical and behavioral studies. Of special interest are studies relevant to understanding of the significance of biological sex on cells; comparative studies of male and female tissues, organ systems and physiological systems; sex based comparisons of pathophysiology, biomarkers, gene expression, clinical presentation and prevention and treatment of diseases The proposed research must address at least one objective from Goals 1 through 3 of the NIH Strategic Plan for Women's Health Research.

Key Dates

Posted Date

November 14, 2014

Open Date (Earliest Submission Date)

November 14, 2014

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

January 12, 2015, 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.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

Not Applicable

Advisory Council Review

Not Applicable

Earliest Start Date

June 2015

Expiration Date

January 13, 2015

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Application Guide (SF424 (R&R) Application Guide or PHS 398 Application Guide, as appropriate) except where instructed to do otherwise (in this FOA or in a Notice from the 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.

Table of Contents

Part 1. Overview Information

Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description

Section II. Award Information

Section III. Eligibility Information

Section IV. Application and Submission Information

Section V. Application Review Information

Section VI. Award Administration Information

Section VII. Agency Contacts

Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

The mission of the NIH is to seek fundamental knowledge about the nature and behavior of living systems, and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability. The Office of Research on Women’s Health (ORWH) works in partnership with the NIH institutes, centers and offices to ensure that research on sex and gender factors in health and illness is an integral part of the scientific framework.

This Funding Opportunity Announcement (FOA) requests applications for FY 2015 Administrative Supplements for Research on Sex/Gender Differences. This program is designed to provide supplemental funding to NIH funded researchers to encourage the consideration of sex/gender factors in their ongoing research. The proposed research must address at least one objective from Goals 1 through 3 of the NIH Strategic Plan for Women's Health Research.

Background

Women and men are characterized by both sex and gender, as highlighted in the Institute of Medicine (IOM) report, entitled Exploring the Biological Contributions to Human Health: Does Sex Matter? (2001). In this context, factors that contribute to biological sex differences include chromosomes, reproduction and hormones. Gender refers to socially defined and derived expectations and roles rooted in biology and shaped by the environment and experience. Consideration of these variables and comparisons of males and females may be critical to the accurate interpretation and validation of research findings. Sex and gender variables may also determine how health and disease processes differ among women, or between women and men, and inform the development and testing of preventive and therapeutic interventions in both sexes. Sex based comparisons in research may also ensure that findings are applicable to both women and men.

In a 2014 Nature commentary, NIH leadership called attention to a lack of knowledge about the influence of biological sex in preclinical research. In particular, over-reliance on male animals and cells in basic and preclinical research may obscure key sex differences that could guide clinical studies. Inadequate specification of sex of cells and inadequate inclusion of female animals in experiments and inadequate analysis and reporting of data by sex may also contribute to irreproducibility in preclinical biomedical research.

In 2015 NIH will announce policies that require NIH applications for basic and preclinical research to address biological sex as a consideration in their study design. These policies will be rolled out in phases, with parallel changes in review activities and requirements.

Specific Areas of Research Interest

All applicants must demonstrate that their supplement application addresses at least one objective from Goals 1 -3 of the NIH Strategic Plan for Women's Health Research. Applicants are referred to the Strategic Plan for more information about the goals and specific objectives under each goal. The three goals are as follows:

  • Goal 1: Increase sex differences research in basic science studies.
  • Goal 2: Incorporate findings of sex/gender in the design and development of new technologies, medical devices and therapeutic drugs.
  • Goal 3: Actualize personalized prevention, diagnostics and therapeutics for girls and women.

A broad range of research fitting under these goals and their specific objectives may be appropriate for an administrative supplement application.

Of special interest are studies to understand the influence of biological sex on cells, including primary cell cultures, in vitro cell cultures, explants and transformed cells. For example, the following topics would be considered of interest, but are not limited to those listed below:

  • In vivo methods and techniques to identify fetal sex prior to visualization of gonads
  • Determination of unique properties of in vitro cell cultures at various stages, such as between the time of known genetic sex (XX, XY) and sex differentiation (hormone production and gonad formation), and methods for preventing the loss of sex chromosomes in immortalized cell cultures
  • Development and testing of identifiers of sex specific cells in vitro
  • Biological mechanisms underlying common physiological or pathophysiological processes in male versus female cells in vitro

Other areas of interest include the study of both male and female subjects, and the comparison of their outcomes in the following general areas:

  • Systems biology (e.g. "omics") approaches and outcomes
  • Bioengineering and imaging studies of structural and/or functional differences; medical device development and implementation
  • Computational models of disease progression, transmission and prevention
  • Prenatal and postnatal development, both normal and abnormal
  • Sensitivity and specificity of biomarkers, screening, diagnosis of disease risk, prognosis or benefit of treatment
  • Therapeutic interventions for treatment or prevention; development of drugs/identification of targets; PK/PD profiles

Sex-based Approaches

For purposes of the administrative supplement (and within the scope of the parent application) the following approaches are considered responsive to the intent of the supplement:

  • Add the Opposite Sex: The addition of animal or human subjects, tissues or cells of the sex opposite to those used in the parent grant to allow sex-based comparisons. Applicants should discuss measures to ensure comparability of new data to data already collected under the parent grant.
  • Increase Sample Size: The addition of more animal or human subjects, tissues or cells to a sample which already includes both males and females in order to increase the power of a study to analyze for a sex/gender difference. Applicants should discuss methods used to ensure control of potential cohort differences related to the new data compared to data already collected.
  • Conduct New Comparative Analyses: Sex/gender comparative analyses of existing samples or datasets. Applicants should explain how the proposed analyses expand specific aims already funded under the parent grant.
  • Single Sex Study (with justification): Applicants proposing to use subjects of only one sex may be considered responsive if the administrative supplement request addresses how the data obtained will address and inform the influence of sex on health and disease. These applications must also include a plan to compare data obtained through the supplement to an existing sample, and the appropriate methods applied to address potential cohort differences.

Scope of Support

The funding mechanism being used to support this program, administrative supplements, can be used to cover cost increases that are associated with achieving certain new research objectives as long as they are within the original scope of the project. Any cost increases need to result from making modifications to the project in order to take advantage of opportunities that would increase the value of the project consistent with its originally approved objectives and purposes.

The research proposed under the administrative supplement program must be within the original scope of the parent grant. Applicants should propose research that, if successful, would contribute to a greater understanding of the implications of sex/gender factors affecting human health or disease outcomes.

Applications requesting funds for sex/gender analysis of Phase III clinical trials or studies of conditions affecting only one sex will not be considered under this administrative supplement. The supplement is not appropriate for Phase III clinical trials.

IC-Specific Considerations

Applicants are strongly encouraged to discuss their proposed supplement project with the IC Program Official of the parent grant prior to submission of a supplement application in order to ensure that the supplement content area fits with the scientific priorities of the IC and is within the scope of the parent grant. Applicants should also confirm that the parent grant mechanism is one the IC will support for a supplement. In addition to contact with the IC Program Official for the parent grant, applicants are strongly encouraged to include the Scientific/Research Contact listed in Section VII. Agency Contacts in these communications.

Section II. Award Information

Funding Instrument

The funding instrument will be the same as the parent award.

Application Types Allowed

Non-competing Administrative Supplements

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

ORWH intends to commit up to $7.0M in FY 2015 to fund approximately 70 awards.

Award Budget

Budget requests may be for no more than $100,000 in total costs. Application budgets must reflect the actual needs of the proposed project.

The funding mechanism being used to support this program, administrative supplements, can be used to cover cost increases that are associated with achieving certain new research objectives, as long as the research objectives are within the original scope of the peer reviewed and approved project, or the cost increases are for unanticipated expenses within the original scope of the project. Any cost increases need to result from making modifications to the project that would increase or preserve the overall impact of the project consistent with its originally approved objectives and purposes.

Award Project Period

The project and budget periods must be within the currently approved project period for the existing parent award. All awards are for a one-year period.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

All organizations administering an eligible parent award may apply for a supplement under this announcement.

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)

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)
  • 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

This announcement is for supplements to existing projects. To be eligible, the parent award must be active and the research proposed in the supplement must be accomplished within the competitive segment. The proposed supplement must be to provide for an increase in costs due to unforeseen circumstances. All additional costs must be within the scope of the peer reviewed and approved project.

IMPORTANT: The research proposed by the NIH grantee in the supplement application must be within the original scope of the NIH-supported grant project.

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not 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.

  • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • System for Award Management (SAM) (formerly CCR) – 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.
  • eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. 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 DUNS number and 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)

Individual(s) must hold an active grant or cooperative agreement, and the research proposed in the supplement must be accomplished within the competitive segment of the active award. Individuals are encouraged to work with their organizations to develop applications for support.

For supplements to parent awards that include multiple PDs/PIs, the supplement may be requested by any or all of the PDs/PIs (in accordance with the existing leadership plan) and submitted by the awardee institution of the parent award. Do not use this administrative supplement application to add, delete, or change the PDs/PIs listed on the parent award. Visit the Multiple Program Director/Principal Investigator Policy in the SF424 (R&R) Application Guide for more information.

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 is sufficiently distinct from any other administrative supplement currently under consideration by the awarding NIH Institute or Center. Since applications in response to this announcement will only receive administrative review by the awarding Institute or Center, and will not receive a peer review, the NIH policy on resubmissions will not apply.

Only active awards with at least 18 months remaining at the time of submission will be considered. Awards in no-cost extension periods are not eligible to submit an application in response to this FOA.

Only one application per parent award is allowed. Supplement awards will not be made to individual grants that have been awarded an administrative supplement in the past under PA-13-018 or PA-14-027.

Section IV. Application and Submission Information

1. Requesting an Application Package

For electronic submissions, applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this announcement, or use the eRA Commons streamlined submission process.

2. Content and Form of Application Submission

All forms must be completed for the supplemental activities only and must not reflect funding or activities for the previously awarded parent award.

It is critical that applicants follow the instructions in the Application Guide (SF424 (R&R) Application Guide or PHS 398 Application Guide, as appropriate) including Supplemental Grant Application Instructions 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

Page Limitations

All page limitations described in the Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements: The Research Strategy section of the administrative supplement may not exceed 6 pages.

Application Submission

Electronic submission of request for administrative supplements is only available for single-project activity codes for which competing applications are submitted electronically. Visit the list of single-project Activity Codes Processed Electronically by eRA to determine if the single-project activity code of the parent award has transitioned to electronic submission. Submission of requests for administrative supplements for all other activity codes must use paper.

  • If the administrative supplement may be submitted electronically, then you may either (A) submit using the SF424 (R&R) Application Forms and Grants.gov/Apply, (B) submit using the streamlined submission process of eRA Commons, or (C) submit using the paper-based PHS 398 Application forms and the PHS 398 Application Guide.

Applicants submitting paper applications must use the PHS 398 Application Forms and the PHS 398 Application Guide.

Instructions for Submissions using Grants.gov/Apply for electronic-based submissions

For single project grants with activity codes that have transitioned to electronic submission using the SF424 (R&R) application forms, administrative supplement requests may be submitted electronically as a Revision application type on the R&R Cover Form. Prepare applications using the SF424 (R&R) application forms associated with this announcement. Please note that some forms marked optional in the application package are required for submission of applications for this announcement. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate required and optional forms.

Special Instructions for Streamlined Submissions using the eRA Commons for electronic-based submissions

NIH now offers a streamlined system through the eRA Commons for submitting administrative supplements. Login to the eRA Commons, identify the parent award, and prepare an administrative supplement request. A User’s Guide for submitting through this system is available.

Include the Research Strategy and any other required documentation (described below) as a PDF file using the “Add Other Attachments” function. Budget information should be entered for the grantee institution in the fields provided. There is no template or form available for subaward information; instead, all subaward information should be included as a separate attachment showing the funds requested (by budget period) using the same categories provided for the grantee institution. Also include a budget justification for the subawardee institution in the same file.

Instructions for Submissions using the PHS 398 Application Forms (for paper-based submissions)

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. The grantee institution, on behalf of the PD/PI of the parent award, must submit the request for supplemental funds directly to the awarding component that supports the parent award. Submit a signed, typewritten original of the application, including the checklist, to:

Mary C. Blehar PhD.
Office of Research on Women's Health
Division of Program Coordination, Planning and Strategic Initiatives
National Institutes of Health
6707 Democracy Blvd, Suite 400
Bethesda MD 20892-5484 (use ZIP: 20817 for expedited delivery services)
Telephone: 301-496-9006
Email: ORWHadminsupple@mail.nih.gov

On the face page of the application form, note that your application is in response to a specific program announcement, and enter the title and number of this announcement.

PHS 398 Research Plan (Research Plan)

All instructions in the Application Guide must be followed for all Research Plan sections applicable to the proposed supplement activities. At a minimum, the Research Strategy section should be completed and must include a summary or abstract of the funded parent award or project. Other sections should also be included if they are being changed by the proposed supplement activities.

Research Strategy

  • The first sentence of the Research Strategy section must contain a statement regarding which approach was proposed in the supplemental application. For a list of approaches, see Part 2, Section 1. Sex-based Approaches.
  • The first paragraph of the Research Strategy should indicate which of the strategic goals/objectives from the NIH Strategic Plan for Women's Health Research are addressed by the supplement.
  • Each application should provide sufficient detail to permit evaluation of the supplement's methods and analyses. All applications must include a data analysis plan for sex based comparisons.

Project/Performance Site Locations (Project/Performance Sites)

All instructions in the Application Guide must be followed, with the following additional instructions:

  • Include the primary site where the proposed supplement activities will be performed.
  • If a portion of the proposed supplement activities will be performed at any other site(s), identify the locations in the fields provided.

Senior/Key Personnel Form

All instructions in the Application Guide must be followed, with the following additional instructions:

  • List the PD/PI as the first person (regardless of their role on the supplement activities).
  • List any other Senior/Key Personnel who are being added through this supplement, or for whom additional funds are being requested through this supplement; include a biographical sketch for each.

R&R Detailed Budget Form (for use with electronic submissions)

All budgets should be submitted using the R&R Detailed Budget form, regardless of the form used for the parent award, and should only include funds requested for the additional supplement activities.

Budget for the Entire Proposed Period of Support (for use with paper-based submissions)

A proposed budget should be submitted using the PHS 398 budget forms, in accordance with the PHS 398 Application Guide, and should only include funds requested for the additional supplement activities.

Other Project Information (for use with electronic submissions); Appendix (use with paper-based submissions)

All instructions in the Application Guide must be followed, with the following additional instructions:

IACUC Documentation and IRB Documentation (Uploaded via the Other Attachments Section for electronic submissions)

  • If applicable, include documentation that the proposed research experience was approved by the Institutional Animal Care and Use Committee (IACUC) or human subjects Institutional Review Board (IRB) at the grantee institution. Adherence to the NIH policy for including women and minorities in clinical studies must also be ensured, if additional human subjects’ involvement is planned for the supplement component.

The filename provided for each “Other Attachment” will be the name used for the bookmark in the electronic application in eRA Commons.

Planned Enrollment Report

When conducting clinical research, follow all instructions for completing the Planned Enrollment Report as described in the SF424 (R&R) Application Guide.

PHS 398 Cumulative Inclusion Enrollment Report

When conducting clinical research, follow all instructions for completing the Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 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.

Organizations must submit applications as described above. 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.

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

For electronic application submission, information on the submission process and a definition of on-time submission are provided in the SF424(R&R) Application Guide.

For paper-based application submission, information on the process of receipt and determining if your application is considered on-time is described in detail in the PHS 398 Application Guide.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. 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.

6. Other Submission Requirements and Information

Applications must be submitted using the instructions specified above.

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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues.

Important reminders:

For applications submitted electronically on the SF424 (R&R) Application forms, all PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form of the SF 424(R&R) Application Package. 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.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the (SAM). Additional information may be found in the Application Guide.

See more tips for avoiding common errors.

Post Submission Materials

Not Applicable

Section V. Application Review Information

1. Criteria

Administrative Supplements do not receive peer review. Instead, the administrative criteria described below will be considered in the administrative evaluation process.

The staff of the NIH awarding component will evaluate requests for a supplement to determine its overall merit. The following general criteria will be used:

Budget and Period of Support

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

Overall Impact

NIH staff will consider the ability of the proposed supplement activities to increase or preserve the parent award’s overall impact within the original scope of award:

  • Will the administrative supplement increase or preserve the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved?
  • Will the administrative supplement enhance the understanding and/or knowledge of sex-based basic, preclinical, clinical, or behavioral research related to the science of the parent grant?
  • Has the applicant provided sufficient detail regarding methods and analyses, including a statistical plan for sex-based comparisons? Does the statistical plan propose methods to control for potential cohort variability and/or make comparisons between the data collected via the supplement and those data already existing, when applicable?

In addition, each of the following criteria will be evaluated as applicable for the proposed supplement.

Protections for Human Subjects:

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, NIH staff 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 six categories of research that are exempt under 45 CFR Part 46, NIH staff 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 Children

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 children 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

NIH staff will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

NIH staff 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.

2. Review and Selection Process

Administrative supplement requests will undergo an administrative evaluation by NIH staff, but not a full peer review. Applications submitted for this funding opportunity will be assigned to the awarding component for the parent award and will be administratively evaluated using the criteria shown above.

3. Anticipated Announcement and Award Dates

Not Applicable

Section VI. Award Administration Information

1. Award Notices

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. This may be as an NoA for the supplemental activities only; alternatively, it may be as either a revision to the current year NoA or included as part of a future year NoA. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees 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. When calculating the award for additional funds, NIH will 1) prorate funding if the requested budget period is adjusted at the time of award, and 2) use the institution’s current F&A rate; i.e., the rate in effect when the new funding is provided.

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, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

Any supplements to Cooperative Agreements will be subject to the same Cooperative Agreement terms and conditions as the parent award.

3. Reporting

Reporting requirements will be specified in the terms and conditions of award as applicable to the supplemental activities. In most non-competing continuation applications, the progress report and budget for the supplement must be included with, but clearly delineated from, the progress report and budget for the parent award. The progress report must include information about the activities supported by the supplement even if support for future years is not requested. Continuation of support for the supplement activities in the remaining years of the competitive segment of the grant will depend upon satisfactory review by the NIH awarding component of progress for both the parent award and the supplement project, the research proposed for the next budget period, and the appropriateness of the proposed budget for the proposed effort. This information is submitted with the Research Performance Progress Report (RPPR) and financial statements as required in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees 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.

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 Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: http://grants.nih.gov/support/index.html
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-710-0267
Email: GrantsInfo@nih.gov

Scientific/Research Contact(s)

Mary C. Blehar Ph.D
Office Of Research on Women's Health (ORWH)
Telephone: 240-276-5735
Email: bleharmc@od.nih.gov

Karen Parker, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-5735
Email: klparker@mail.nih.gov

Lisa A. Neuhold, Ph.D.
National Eye Institute (NEI)
Telephone: 301-451-2020
Email: lneuhold@mail.nih.gov

Shari Eason Ludlam, MPH
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301 435-6667
Email: ludlams@nhlbi.nih.gov

Jean E. McEwen, J.D., Ph.D.
National Human Genome Research Institute (NHGRI)
Telephone: 301-402-4997
Email: jean.mcewen@nih.hhs.gov

Chyren Hunter, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-9322
Email: Chyren.Hunter@nih.gov

Judith Arroyo, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-402-0717
Email: jarroyo@mail.nih.gov

Tamara Lewis-Johnson, M.B.A., M.P.H.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2934
Email: lewisjohnsont@niaid.nih.gov

Bernadette Tyree, Ph.D.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-594-5055
Email: tyreeb@mail.nih.gov

Estella Parrott, M.D., M.P.H.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6971
Email: parrotte@mail.nih.gov

Susan Sullivan, Ph.D.
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-451-3841
Email: sullivas@nidcd.nih.gov

Jane Atkinson, D.D.S.
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-435-7908
Email: jatkinso@mail.nih.gov

Chris Mullins, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-451-4902
Email: mullinsc@extra.niddk.nih.gov

Cora Lee Wetherington, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-435-1319
Email: cwetheri@nida.nih.gov

Caroline Dilworth, Ph.D.
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-7727
Email: dilworthch@niehs.nih.gov

Regine Douthard, M.D., MPH
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-435-1759
Email: douthardr@nigms.nih.gov

Catherine Roca, M.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-3945
Email: rocac@mail.nih.gov

Jennifer Alvidrez, Ph.D.
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-9567
Email: Jennifer.alvidrez@nih.gov

Vicky Whittemore, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-1917
Email: whittemorevr@mail.nih.gov

Flora Katz, Ph.D.
Fogarty International Center (FIC)
Telephone: 301-402-9591
Email: katzf@mail.nih.gov

D. Lee Alekel, Ph.D.
National Center for Complementary and Alternative Medicine (NCCAM)
Telephone: 301-443-8374
Email: lee.alekel@nih.gov

Hua-Chuan Sim, M.D.
National Library of Medicine (NLM)
Telephone: 301-594-4882
Email: simh@mail.nih.gov

Miguel Contreras, Ph.D
Officer of Research Infrastructure and Programs (ORIP)
Telephone: 301- 594-9410
Email: miguel.contreras@nih.gov

Lynda Hardy Ph.D. R.N.
National Institute of Nursing Research (NINR)
Telephone: 301-594-5976
Email: Lynda.Hardy@nih.gov

Karen P. Peterson, Ph.D.
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-0707
Email: kpeterso@mail.nih.gov

Peer Review Contact(s)

Not Applicable

Financial/Grants Management Contact(s)

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6279
Email: wolfreyc@mail.nih.gov

William W. Darby
National Eye Institute (NEI)
Telephone: 301-451-2020
Email: wwd@nei.nih.gov

Kimberly O. Stanton
National Heart Lung and Blood Institute (NHLBI)
Telephone: 301-435-0159
Email: stantonk@mail.nih.gov

Monika Christman
National Human Genome Research Institute (NHGRI)
Telephone: 301-435-7860
Email: Monika.Christman@nih.gov

Lesa McQueen
National Institute on Aging (NIA)
Telephone: 301-496-1472
Email: Lesa.McQueen@nih.gov

Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: jfox@mail.nih.gov

Donna Sullivan
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2979
Email: Donna.Sullivan@nih.gov

Andrew Jones
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-435-0610
Email: jonesan@mail.nih.gov

Bryan S. Clark, MBA
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email: clarkb1@mail.nih.gov

Chris Myers
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-402-0909
Email: Myersc@mail.nih.gov

Diana Rutberg
National Institute of Dental and Craniofacial Research (NICDR)
Telephone: 301-594-4798
Email: rutbergd@mail.nih.gov

Diana Ly
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-9249
Email: dianaly@mail.nih.gov

Pamela Fleming
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-6710
Email: pfleming@mail.nih.gov

Lisa Archer Edwards, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-0751
Email: Lisa.Archer@nih.gov

Lisa Moeller
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-3914
Email: moellerl@mail.nih.gov

Tamara Kees
National Institute of Mental Health (NIMH)
Telephone: 301.443.8811
Email: tamara.kees@nih.gov

Priscilla Grant, J.D., C.R.A.
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8412
Email: pg38h@nih.gov

Tijuanna DeCoster MPA
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496 9231
Email: decostert@ninds.nih.gov

Bruce Butrum
Fogarty International Center (FIC)
Telephone: 301-496-1670
Email: butrumb@mail.nih.gov

Ki-Cha Flash
National Center for Advancing Translational Sciences(NCATS)
Telephone: 301-435-0846
Email: Ki-Cha.Flash@nih.gov

George Tucker, MBA
National Center for Complementary and Alternative Medicine (NCCAM)
Telephone: 301-594-8853
Email: gt35v@nih.gov

Mable Nee
National Library of Medicine (NLM)
Telephone: 301-496-4221
Email: mable.nee@nih.gov

Lawrence Haller
National Institute of Nursing Research (NINR)
Telephone: 301-402-1878
Email: Lawrence.Haller@nih.gov

Eunica Haynes
Grants Management Specialist
National Institute of Biomedical Imaging
and Bioengineering, NIH
Telephone: 301-451-4791
Email: haynese@mail.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 Parts 74 and 92.

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