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Department of Health and Human Services
Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

Office of Dietary Supplements (ODS)
National Cancer Institute (NCI)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of General Medical Sciences (NIGMS)
National Center for Complementary and Integrative Health (NCCIH)
National Institute of Environmental Health Sciences (NIEHS)

Funding Opportunity Title

Administrative Supplements to NIH Awards for Validation Studies of Analytical Methods for Natural Products (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
U10 Cooperative Clinical Research Cooperative Agreements
U19 Research Program Cooperative Agreements
U41 Biotechnology Resource Cooperative Agreements
U54 Specialized Center- Cooperative Agreements
U56 Exploratory Grants Cooperative Agreements
UC3 Biomedical Research, Development, and Growth to Spur the Acceleration of New Technologies (BRDG-SPAN) Cooperative Agreement Program

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<
K01 Research Scientist Development Award - Research & Training
K02 Research Scientist Development Award Research
K05 Research Scientist Award
K06 Research Career Awards
K07 Academic/Teacher Award (ATA)
K08 Clinical Investigator Award (CIA)
K12 Physician Scientist Award (Program) (PSA)
K18 Career Enhancement Award
K22 Career Transition Award
K23 Mentored Patient-Oriented Research Career Development Award
K24 Midcareer Investigator Award in Patient-Oriented Research
K25 Mentored Quantitative Research Career Development Award
K26 Midcareer Investigator Award in Biomedical and Behavioral Research
K99/R00 Career Transition Award/Research Transition Award
R01 Research Project Grant
R03 Small Grant Program
R15 Academic Research Enhancement Award (AREA)
R21 Exploratory/Developmental Research Grant Award
R21/R33 Phased Innovation Award
R24 Resource-Related Research Projects
R37 Method to Extend Research in Time (MERIT) Award
R42 Small Business Technology Transfer (STTR) Grant - Phase II only
R44 Small Business Innovation Research (SBIR) Grant - Phase II only
RM1 Research Project with Complex Structure
U01 Research Project Cooperative Agreements
U24 Resource-Related Research Projects Cooperative Agreements
U44 Small Business Innovation Research (SBIR) Cooperative
UL1 Linked Specialized Center Cooperative Agreement

Announcement Type

Reissue of PA-13-381

Related Notices

  • August 01, 2017 - This PA has been re-issued as PA-17-447.
  • February 19, 2016 - Plan to Move to Updated Forms (FORMS-D) for Administrative Supplement, Successor-In-Interest and Change of Institution Opportunities. See Notice NOT-OD-16-068.
  • January 6, 2016 - Notice of Participation of the National Institute of Environmental Health Sciences (NIEHS) in PA-16-048. See Notice NOT-ES-16-004.
  • 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-16-048

Companion Funding Opportunity

None

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

93.321; 93.213; 93.393; 93.847; 93.859; 93.395; 93.394; 93.113

Funding Opportunity Purpose

The publication of reliable analytical methods for quantitative determination of chemical constituents of natural products and dietary supplements can make critical contributions to the rigor and reproducibility of biomedical research. In order to support formal validation studies and publication of relevant quantitative analytical chemistry methods, Administrative Supplements to certain active awards administered by the participating ICs are available through this FOA. The methods proposed for validation must be used to identify and quantify chemical constituents (active or marker chemical compounds, adulterants, contaminants, or metabolites thereof) in experimental reagents, raw materials, and/or clinical specimens (for example urine or plasma samples). Methods must have been developed or utilized in fulfillment of the active parent grant’s specific aims. Candidate constituents for quantitative method validation studies may include (but are not limited to): phytochemicals; nutrients; and potentially deleterious substances such as pesticides and mycotoxins.

Key Dates
Posted Date

December 4, 2015

Open Date (Earliest Submission Date)

December 15, 2015

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

January 15, 2016; April 15, 2016; October 15, 2016; January 15, 2017; April 15, 2017, 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

March 2016; June 2016; December 2016; March 2017; June 2017

Expiration Date

April 16, 2017

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

There is a strong interest throughout the biomedical research community in improving the reproducibility of research, and the publication of validated analytical methods makes a critical contribution to research reproducibility. The dissemination and broad adoption of reliable quantitative analytical chemistry methods developed in the course of NIH-supported research multiplies the value of that research.

Funds are available through this Funding Opportunity Announcement to support formal validation studies of analytical chemistry methods for the identification and quantification of chemical constituents of natural products or dietary supplements.

Relatively few publicly available and validated analytical methods exist for bioactive constituents in food, dietary supplements, and other orally administered natural products. This makes it difficult to rigorously assess product composition and to conduct reproducible studies assessing mechanism, safety and efficacy. A validated method is a method that has been systematically evaluated for accuracy, precision, and reliability (2013 AOAC International Official Methods of Analysis, Appendix K: Guidelines for Dietary Supplements and Botanicals; http://www.eoma.aoac.org/app_k.pdf, accessed 8/26/2015).

A major goal of The Office of Dietary Supplements (ODS)'s Analytical Methods and Reference Materials (AMRM) Program is to promote development and validation of methods that identify and quantify dietary supplement and natural product constituents, contaminants and adulterants, and their metabolites. This funding opportunity seeks to complement AMRM efforts involving the dietary supplement industry and regulatory authorities by leveraging quantitative analytical methods developed by NIH grantees. These methods may or may not have been previously published and the details of the methods or their documented validation may not be available to the research community.

Experimental approaches to demonstrate the validity of a quantitative analytical method include single-laboratory and multiple-laboratory validation studies. A method that has been developed and used in only one laboratory can be validated within that laboratory, in a single-laboratory validation (SLV). The SLV study is the mechanism for demonstrating method performance prior to subjecting the method to a multi-laboratory study. The multiple-laboratory study provides a higher level of confidence in method performance in that it permits an evaluation of the reproducibility of the method. A successful multi-laboratory study may lead to designation of the method as a final action AOAC Official Method of Analysis.

Purpose

This Administrative Supplement funding opportunity announcement seeks applications for the planning, coordination, management, and conduct of single-laboratory validation studies of analytical methods for quantitative determination of constituents, or their metabolites, from foods, dietary supplements, other orally administered natural products, or their raw source materials.

Methods to be the subject of validation studies must have already been developed and be in use by the grantee at the time of the supplement request. These methods must have been used in the process of achieving the specific aims of the parent NIH awards. While it is understood that further method optimization is often required in the course of a validation study, and funding requests should take this into account, the purpose of this supplement is not to support de novo method development or initial optimization of newly developed methods.

Applications for multiple-laboratory validation studies will not be accepted at this time.

Requirements

Several policies, guidelines, and procedures have been established for the design and conduct of validation studies for quantitative analytical methods. These are described by internationally recognized bodies, for example AOAC International, the International Standardization Organization (ISO), the Nordic Committee on Food Analysis (NMKL). The proposed SLV study must conform to the requirements of AOAC International or other relevant guidelines, where applicable. Applicants are strongly encouraged to review AOAC International's guidelines for the conduct and requirements of a formal SLV study, which can be found in the 2013 AOAC International Official Methods of Analysis, Appendix K: Guidelines for Dietary Supplements and Botanicals (http://www.eoma.aoac.org/app_k.pdf, accessed 8/26/2015).

Critical aspects of a formal SLV study include (but are not limited to):

1. Characterization of a quantitative analytical method s applicability, accuracy, precision, reproducibility, selectivity, and sensitivity.

2. Appropriate use of standard reference materials or certified reference materials for calibration and characterization of method performance.

3. Investigation of each step of the method to determine the extent to which matrix, material, and procedural variables may affect quantitation of the analyte(s).

For studies of quantitative methods for metabolites, applicants are strongly encouraged to consult the U.S. Food and Drug Administration s guidance for full validation of bioanalytical methods for human metabolite studies (http://www.fda.gov/downloads/drugs/GuidanceComplianceRegulatoryInformation/guidances/UCM070107.pdf, accessed 8/25/15). The accuracy, precision, reproducibility, and selectivity of the method for endogenous metabolites and known degradation products should be established for the relevant biological matrix.

The method or methods to be validated must be in use in the parent award to identify and quantify constituents (bioactive and other chemical marker constituents and/or their metabolites, adulterants, or contaminants) in products intended for oral administration in humans, or in biological specimens such as urine, plasma, or tissues. The products under investigation in parent grants may be dietary supplements (including vitamins or other bioactive compounds), foods, and other orally administered natural products or their raw source materials. The investigational products may have been studied in vitro or in vivo under the parent grant.

Examples of quantitative analytical methods which may be supported by this administrative supplement include, but are not limited to, liquid chromatography tandem mass spectroscopy for the identification and quantitation of specific phytochemicals in botanical products, and enzyme-linked immunosorbent assays for the identification and quantitation of specific dietary supplement metabolites in urine. This administrative supplement does not support the development or validation of assays for biological activities affected by dietary supplements or their metabolites, adulterants, or contaminants.

Applicants are expected to provide descriptions of the instrumentation and materials proposed for validation studies. Applicants are also expected to provide details on how they will assure the identity and purity of reference materials and calibrants, whether commercially purchased or produced in-house.

The grantee is expected to publish the validated method and results of the validation study in a peer-reviewed journal, and to cite support by ODS as well as by the IC administering the parent award.

Participating Component Interests

The NCCIH is interested in applications to validate methods which will help to strengthen the reproducibility of future research. As such, NCCIH encourages applicants to justify the need for their proposed method validation by commenting on the number of potential users of the method.

The NCI Nutritional Science Research Group is particularly interested in validation of quantitative analytical methods for vitamins, minerals, amino acids, putative biologically active botanical constituents, and/or their metabolites, in human or animal specimens that may also be useful indicators of bioavailability, or of particular metabolic, epigenetic, or physiological states.

The NCI Cancer Biomarkers Research Group is particularly interested in validation of quantitative analytical methods for dietary supplement metabolites in human or animal specimens that may also be useful indicators of particular metabolic, physiological or pathological states.

The NIDDK is interested in studies that validate quantitative methods for various dietary supplement micronutrients, bioactive compounds and their metabolites that have relevance to metabolic, physiological and pathological conditions of interest to NIDDK.

NIGMS is particularly interested in validating analytical methods for the quantitation and identification of 1) natural products in complex mixtures; and 2) bioactive molecules and/or trace metals in foods, dietary supplements, and other orally administered natural products that may alter the enzymatic activities of drug metabolizing enzymes, drug transporters or energy metabolism.

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.

ODS intends to commit $800,000 in FY 2016 to fund up to eight awards.

Award Budget

Application budgets are limited to no more than 25% of the Council-approved direct costs for the current budget year of the project or $100,000 (direct costs) whichever is less, and must reflect the actual needs of the proposed validation studies. The requested budget may include the cost of validation methods training, consultants, and fees, if any, paid to either AOAC International or a recognized training organization.

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. Supplements may be requested for up to one year. The validation studies proposed for this supplement must be accomplished within the competitive segment of the parent award. Therefore applicants must have at least 18 months of active support remaining on the parent grant as of the application due 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)
  • 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.

Validation studies must be conducted in a laboratory that is a participating component of the parent award. Except in the case of the second laboratory in a two-laboratory validation study, validation studies may not be sub-contracted to a commercial laboratory that was not a participant in the parent award.

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.

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:

Adam J. Kuszak, Ph.D.
Office of Dietary Supplements
National Institutes of Health
6100 Executive Blvd, Rm 3B01, MSC 7517
Bethesda, MD, 20892-7517
(Express/Courier Service - Rockville, MD, 20852)
Telephone: 301.496.1795
Email: [email protected]

Foreign Institutions

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

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

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

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and Times. Applicants are encouraged to submit 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: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Scientific/Research Contact(s)

Thaddeus Schug, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-9469
Email: [email protected]

Adam J. Kuszak, Ph.D.
Office of Dietary Supplements (ODS)
Telephone: 301-496-1795
Email: [email protected]

D. Craig Hopp, Ph.D.
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-496-5825
Email: [email protected]

Nancy J. Emenaker, Ph.D., R.D.
National Cancer Institute (NCI)
Telephone: 240-276-7125
Email: [email protected]

Karl Krueger, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-7026
Email: [email protected]

Padma Maruvada, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8884
Email: [email protected]

Barbara Gerratana, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-3827
Email: [email protected]

Peer Review Contact(s)

Not Applicable

Financial/Grants Management Contact(s)

James Williams
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-1403
Email: [email protected]

Shelley Carow
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-594-3788
Email: [email protected]

Sean Hine
National Cancer Institute (NCI)
Telephone: 240-276-6291
Email: [email protected]

Kevin Reeves
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8861
Email: [email protected]

E.C. Melvin
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-3912
Email: [email protected]

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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