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)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
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 Center for Complementary and Integrative Health (NCCIH)
National Center for Advancing Translational Sciences (NCATS)
Division of Program Coordination, Planning and Strategic Initiatives, Office of Disease Prevention (ODP)
Division of Program Coordination, Planning and Strategic Initiatives, Office of Research Infrastructure Programs (ORIP)

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
P51 Primate Research Center Grants
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
UM2 Program Project or Center with Complex Structure Cooperative Agreement

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 Early Independence Award
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

New

Related Notices

  • January 05, 2016 - Notice of NIAID's Participation in PA-16-066. See Notice NOT-AI-16-017.
  • NOT-OD-16-004 - NIH & AHRQ Announce Upcoming Changes to Policies, Instructions and Forms for 2016 Grant Applications (November 18, 2015)

Funding Opportunity Announcement (FOA) Number

PA-16-066

Companion Funding Opportunity

None

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

93.313; 93.350; 93.286; 93.396; 93.395; 93.394; 93.393; 93.399; 93.839; 93.838; 93.837; 93.233; 93.867; 93.846; 93.859; 93.172; 93.307; 93.273; 93.351; 93.242; 93.279; 93.853; ; 93.847; 93.865; 93.173; 93.213; 93.361; 93.113; 93.121; 93.866; 93.855; 93.856

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

January 5, 2016

Open Date (Earliest Submission Date)

January 15, 2016

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

March 4, 2016, 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 2016

Expiration Date

March 5, 2016

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, eRA Commons Administrative Supplement User 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 2016 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 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 of preclinical biomedical research.

In 2015, NIH announced policies that require applications for research with vertebrate animals and humans to address consideration of sex as a biological variable in study design, analysis, and reporting. This new policy is part of NIH’s efforts to enhance reproducibility by clarifying longstanding expectations about rigor and transparency, and will apply to applications for awards funded in FY17 and beyond. In parent awards, appropriate consideration of sex as a biological variable depends on the context of the research question, existing knowledge about male and female biology and behavior, and other factors. These Administrative Supplements are designed to help bridge existing research with the new policy, and to enhance the ability of currently funded researchers to explore the influence of sex as a primary or focal outcome. For further information on NIH’s expectations about consideration of sex as a biological variable, and NIH’s initiative to improve reproducibility through rigor and transparency, please see the following documents: NOT-15-102, NOT-15-103, NOT-16-011, NOT-16-012.

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)
  • 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.

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

Section II. Award Information
Funding Instrument

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

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

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.

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.

The Office of Research on Women's Health (ORWH) intends to commit $5,000,000 in FY 2016 to fund 50 awards.

Award Budget

Each administrative supplement has a maximum total award of $100,000.  Application budgets are limited to no more than the amount of the current parent award, and 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. The parent grant must have at least 18 months of active grant support remaining from the application deadline date.   

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)
  • 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

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 not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not 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. Since administrative supplements are made against active grants and cooperative agreements, many of these registrations may already be in place. 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. Grants.gov registration is only required if you plan to submit using the 'Electronic Application Submission through Grants.gov' option.

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. Only 1 administrative supplement may be submitted for any specific parent grant.    

Section IV. Application and Submission Information
1. Requesting an Application Package

Applicants must prepare applications using current forms in accordance with the Application Guide.

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 for their submission option (SF424 (R&R) Application Guide, eRA Commons Administrative Supplement User 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 documented requirements 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 applicable to the parent award as described in the Application Guide and the Table of Page Limits must be followed.

Application Submission

Administrative supplement requests for most single-project activity codes can be submitted using either paper or electronic submission processes. Administrative supplement requests for multi-project activity codes must be submitted using the paper submission process. See Activity Code section in Part 1 to determine if electronic submission is an option for your activity code.

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

Instructions for Electronic Application Submission through Grants.gov

Use the “Apply” button(s) in Part I of this announcement to access the application forms package posted at Grants.gov. If presented with more than one form package, use the Competition ID and Competition Titles provided to determine the most appropriate application forms package for your situation.

Prepare applications using the SF424 (R&R) forms associated with the chosen package. 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, with the following additional guidance:

  • R&R Cover form:  Select “Revision” in the “Type of Application” field.
  • Research Plan form: 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.
  • Project/Performance Site Location form: 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.
  • Sr/Key Personnel form: 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.
  • Budget forms (e.g., R&R Budget, PHS 398 Training Budget): Only include funds requested for the additional supplement activities.
  • R&R Other Project Information form: If applicable, attach PDF documents in the “Other Attachments” field indicating 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. Name the documents “IACUC Documentation.pdf” and/or “IRB Documentation.pdf”. 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.

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

NIH 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, with the following additional guidance:

  • Budget information should be entered for the grantee institution in the tabs provided for each selected budget period.
  • Since there is no template or form available for subaward budget information, all subaward information must be included as a PDF attachment in the Subrecipient Budgets section showing the funds requested (by budget period) and using the same categories provided for the grantee institution. The attachment must also include any related budget justification information.
  • Use the “Add Other Attachments” function to include the following PDF documents:
    • Research Strategy including a summary or abstract of the funded parent award or project.
    • If applicable, attach documents indicating 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.

Instructions for Paper-based Submissions using the PHS 398 Application Forms

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application, with the following additional guidance:

  • Checklist: Select “Revision” in the “Type of Application” field.
  • Face Page (Form Page 1): 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.
  • Research Plan: 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.
  • Project/Performance Sites section (Form Page 2): 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.
  • Sr/Key Personnel section (Form Page 2): 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.
  • Budget for Entire Proposed Project Period (Form Page 5): A proposed budget should be submitted using the PHS 398 budget forms and should only include funds requested for the additional supplement activities.
    • If applicable, attach documentation in the Appendix section indicating 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 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:

Dr. Lisa Begg
Office of Research on Women's Health
National Institutes of Health
6707 Democracy Boulevard, Suite 400
Bethesda, MD 20892-5484
Telephone: 301-402-1770
Email: beggl@od.nih.gov

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 electronic 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.

Applicants are responsible for viewing their electronic 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.

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 using the instructions specified above.

Applicants must complete all required registrations prior to submission. 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. For assistance with application submission contact the Application Submission Contacts in Section VII.

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 increase or preserve the likelihood that the fellowship will enhance the candidate's potential for, and commitment to, a productive, independent scientific research career in a health-related field?
  • Will the administrative supplement increase or preserve the likelihood for the candidate to maintain a strong research program?
  • Will the administrative supplement increase or preserve the likelihood for the program to exert a sustained, powerful influence on the research field(s) involved?
  • Will the administrative supplement increase or preserve the potential benefit of the instrument requested for the overall research community and its potential impact on NIH-funded research?

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) 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

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.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency.  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. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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 Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: https://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

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)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-710-0267

Scientific/Research Contact(s)

Lisa Begg, Dr.P.H., RN
Office of Research on Women's Health (ORWH)
Telephone: 301-496-3975 
Email: beggl@od.nih.gov

Genevieve Medley Grimes
National Cancer Institute (NCI)
Telephone: 240-276-5732
Email: genevieve.grimes@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

Katrina Foster, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA) 
Telephone: 301-443-4032
Email: katrina.foster@nih.gov

Jane Lockmuller
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-496-8026
Email: lockj@mail.nih.gov

D. Lee Alekel, Ph.D. 
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) 
Telephone: 301-594-4974
Email: alekeldl@mail.nih.gov

Steven Zullo, Ph.D.
Program Officer
Office of Program Evaluation and Strategic Partnerships
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
6707 Democracy Blvd; Bethesda, MD 20892
Phone: 240-271-9007
steven.zullo@nih.gov

Candace Tingen, Ph.D. 
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6971
Email: tingencm@mail.nih.gov

Alison Cernich, Ph.D. (Rehabilitation research)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-402-2242
Email: alison.cernich@nih.gov

Susan Taymans, Ph.D. (DSD research)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-6517
Email: taymanss@msil.nih.gov

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

Amanda Melillo, Ph.D.
National Institute of Dental and Craniofacial Research (NIDCR) 
Telephone: 301-594-9718
Email: amanda.melillo@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

Lanay Mudd, Ph.D.
National Center for Complementary and Integrative Medicine (NCCIH) 
Telephone: 301-594-9346
Email:  lanay.mudd@nih.gov

Danilo A. Tagle, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-594-8064
Email: danilo.tagle@nih.gov

Amy C. Lossie, Ph.D.
Office of Disease Prevention (ODP)
Telephone: 301-402-9823
Email: amy.lossie@nih.gov

Stephanie J. Murphy, VMD, Ph.D
Office of Research Infrastructure and Programs (ORIP)
Telephone: 301- 451-7818
Email: stephanie.murphy@nih.gov

Rebecca Henry, Ph.D. R.N
National Institute of Nursing Research (NINR)
Telephone: 301-594-5976
Email: Rebecca.henry@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 R. Sullivan
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2979
Email: dsullivan@niaid.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
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 (NIDCR)
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: 301-253-8729
Email: pfleming@mail.nih.gov

Molly Puente
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-1373
Email: puentem@mail.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.
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

Irene Haas
National Center for Advancing Translational Sciences (NCATS) 
Telephone: 301-435-0836
Email:  haasi@mail.nih.gov

Shelley Carow
National Center for Complementary and Integrative Health (NCCIH) 
Telephone: 301-594-3788
Email: carows@mail.nih.gov

Judy Sint
National Institute of Nursing Research (NINR)
Telephone: 301-402-6959
Email: sintj@mail.@nih.gov

Eunica Haynes
Grants Management Specialist
National Institute of Biomedical Imaging
and Bioengineering (NIBIB)
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 Part 75.

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