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 Eye Institute (NEI)
National Heart, Lung, and Blood Institute (NHLBI)
National Institute on Aging (NIA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of Environmental Health Sciences (NIEHS)
Fogarty International Center (FIC)
National Center for Complementary and Integrative Health (NCCIH)
National Institute on Deafness and Other Communication Disorders (NIDCD)
Division of Program Coordination, Planning and Strategic Initiatives, Office of Research Infrastructure Programs (ORIP)

Funding Opportunity Title

Administrative Supplements for Research on Dietary Supplements (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
U10 Cooperative Clinical Research – Cooperative Agreements
U19 Research Program – Cooperative Agreements
U41 Biotechnology Resource Cooperative Agreements
U42 Animal (Mammalian and Nonmammalian) Model, and Animal and Biological Materials Resource Cooperative Agreements
U45 Hazardous Waste Worker Health and Safety Training Cooperative Agreements
U54 Specialized Center- Cooperative Agreements
U56 Exploratory Grants – Cooperative Agreements

Administrative supplement requests may be submitted electronically for the following activity codes:
DP1 NIH Director’s Pioneer Award (NDPA)
DP2 NIH Director’s New Innovator Awards
DP4 NIH Director’s Pathfinder Award- Multi-Yr Funding
DP5 Early Independence Award
F05 International Research Fellowships
F30 Individual Predoctoral NRSA for MD/PhD Fellowships
F31 Predoctoral Individual National Research Service Grant Award
F32 Postdoctoral Individual National Research Service 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
R25 Education Projects
U01 Research Project – Cooperative Agreements

Announcement Type

Reissue of PAR-14-201

Related Notices
Funding Opportunity Announcement (FOA) Number

PA-15-258

Companion Funding Opportunity

None

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

93.321, 93.393, 93.273, 93.847, 93.213, 93.856, 93.855, 93.121, 93.989, 93.866, 93.113, 93.837, 93.838, 93.233, 93.867, 93.173, 93.351 

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) announces the availability of administrative supplements to support research in which the supplemental funding would investigate the role of dietary supplements and/or their ingredients in health maintenance and disease prevention. Parent awards need not be focused on dietary supplements; this FOA may provide support to include dietary supplements within the scope of relevant research projects. Research interests of ODS are not limited to specific health conditions, organ systems or population groups. ODS supports all types of research, including pre-clinical, clinical, behavioral, and epidemiological. Additionally, ODS supports research and training programs that build future research capacity for studying the role of dietary supplements in health and disease prevention. Primary consideration for support will be given to applications that stimulate dietary supplement research where it is lacking or lagging, clarify gaps, opportunities and balance between benefits and risks where data are in conflict, target special population groups where additional science on dietary supplements is needed, and focus on the use of dietary supplements in improving or maintaining health and reducing the risk of chronic disease.  

Key Dates
Posted Date

May 14, 2015

Open Date (Earliest Submission Date)

September 15, 2015

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

October 15, 2015; January 15, 2016; or April 15, 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

January 2016; March 2016; July 2016

Expiration Date

April 16, 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 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
Background

The mission of the Office of Dietary Supplements (ODS) is to strengthen knowledge and understanding of dietary supplements by evaluating scientific information, stimulating and supporting research, disseminating research results, and educating the public to foster an enhanced quality of life and health for the U.S. population.

Dietary supplements can have an impact on the prevention of disease and on the maintenance of health. In the US, these ingredients are usually defined as including plant extracts, enzymes, vitamins, minerals, amino acids, and hormonal products that are available without prescription and are consumed in addition to the regular diet. Although vitamin and mineral supplements have been available for decades, their health effects have been the subject of detailed scientific research only within the last 15–20 years. It is important to expand this research to include the health effects of other bioactive factors consumed as dietary supplements to promote health and prevent disease.

Considerable research on the effects of botanical and herbal dietary supplements has been conducted in Asia and Europe where plant products have a long tradition of use. The overwhelming majority of these supplements, however, have not been studied using modern scientific techniques. Nor have they been extensively studied in population groups that may be at risk for chronic diseases.

For many reasons, therefore, it is important to enhance research efforts to determine the benefits and risks of dietary supplements.

Purpose

This FY 2016 Administrative Supplement program is designed to provide supplemental funds to relevant, active, NIH-supported research projects to incorporate dietary supplement research that is within the scope of the parent project. Research interests of ODS are not limited to specific health conditions, organ systems or populations groups. ODS supports all types of research, including pre-clinical, clinical, behavioral, and epidemiological. Additionally, ODS supports research that builds future research capacity for studying the role of dietary supplements in health and disease prevention. Primary consideration for support will be given to applications that stimulate dietary supplement research where it is lacking or lagging, clarify gaps, opportunities and balance between benefits and risks where data are in conflict, target special population groups where additional science on supplements is needed, and focus on the use of dietary supplements in improving or maintaining health and reducing the risk of chronic disease.

Specific Areas of Research Interest

Appropriate topics/studies include, but are not limited to, those listed below:

  • Evidence-based evaluations of the role of dietary supplements, including evaluation of the safety and efficacy of dietary supplement use in the prevention and reduction of risks for chronic diseases.
  • Intervention studies that examine the effects of dietary supplements on maintenance of optimal health or reduction of disease risk where supplement interventions alter physiological endpoints or other health outcomes (e.g., a study that examines the physiologic or mechanistic effects of St. John’s wort on depression or a study assessing the effects of calcium supplements on bone mass density and the reduced risk of osteoporosis).
  • Observational studies that examine the association between intakes of nutrients or other substances from supplementation and disease risk, physiological endpoints or other health outcomes. These would include studies that use food frequency questionnaires, diet recalls, diet records, diet histories, diet surveys and other dietary assessment methods (e.g., a study that uses a food frequency questionnaire to analyze associations between intakes of vitamin E and phytoestrogens and breast cancer risk).  Studies that focus on the beneficial or adverse interactions of dietary supplements with foods, drugs, environmental exposures and other dietary supplements in healthy persons and those with selected conditions where these interactions may affect disease prevention, risk reduction, or the promotion of health and well-being.
  • Studies that collect data, or additional data, on the use of dietary supplements including caffeine-containing energy drinks (CCED), that are expected to affect or modulate parent project outcomes (e.g., BMI, glucose homeostasis, muscle strength, cognitive performance, sleep parameters or reported fatigue).
  • Studies investigating the biological or behavioral effects of common CCED ingredients to obtain data on modulation of those effects by one or more other common CCED ingredients.
  • Studies that investigate isolated bioactive compounds from foods to determine their safety or effect on disease risk, physiological endpoints or other health outcomes, even if they are not currently available as dietary supplements (e.g., a study to investigate bioactive compounds in human milk that are involved in infant growth and development or a study to investigate the safety of phytochemicals from mushrooms or their effects on host immunity or metabolism).
  • Studies that examine the safety, form or bioavailability of dietary supplements (e.g., a rodent study to examine the safety of high intakes of vitamin A, a human study to examine the bioavailability of various forms of folic acid, or a clinical trial to examine the safety and side effects of various doses of saw palmetto). 
  • Studies that delineate how dietary supplements moderate, alter or enhance metabolic, physiological or psychological processes associated with maintenance of optimal health and performance in older animals compared to young and middle-aged adult animals.
  • Studies of single ingredients or complex mixtures that examine the transport, metabolism, mechanism of action, associated enzymes, binding sites, regulatory mechanisms or excretion of dietary supplements in order to elucidate their physiological or biochemical role (e.g., a study to investigate the transport and metabolism of orally administered folic acid or a study to evaluate the mechanism of action of the various components in Panax ginseng).
  • Research to develop, evaluate, optimize or validate analytical methods for verifying ingredient identity and quantifying declared ingredients in raw materials and finished dietary supplement products.
  • Research to develop and/or validate new dietary assessment techniques
  • Studies of iodine nutrition in humans and appropriate animal models, including:  intake of iodine from foods, beverages, supplements, and other dietary sources; development and validation of biomarkers of iodine status in individuals and populations;  laboratory assessment of iodine status; health effects and safety of iodine status and supplementation; and effects of iodine intake and status on maternal health, pregnancy outcomes, and infant and child development, including neurocognitive and neuromuscular development. 

Examples of research projects that typically fall outside the scope of ODS include:

  • Studies on synthetically derived agents (drugs)
  • Studies that administer the supplement intervention with the sole intent to treat a disease process or outcome such as atherosclerosis or depression, without evaluation of the supplement’s effect on the underlying mechanism of action, bioavailability or elucidation of metabolic pathways.
  • Human, animal or laboratory studies that only correlate physiological levels of dietary supplements, their metabolites or marker compounds with disease risk, physiological endpoints or other health outcomes without the administration of a dietary supplement   
    (e.g., a human study correlating serum levels of 25(OH) vitamin D and risk of hip fracture or a human study correlating serum levels of folate and cardiovascular disease).
  • Studies evaluating the effect of whole foods that could be considered “functional foods.” This would include foods such as broccoli and other cruciferous vegetables, garlic, soy and flaxseed. However, if a food ingredient in a defined form is being investigated (e.g., a garlic capsule, a soy or phytoestrogen supplement, EGCG in a green tea supplement, or dried ginger root in a tea bag), then the study would be within the scope of ODS.
  • Studies that involve dietary ingredients used to treat inborn errors of metabolism, such as a study investigating the use of tyrosine to treat phenylketonuria.  However, if the research is focused on the mechanism of action, it could be considered within scope.
  • Studies of compounds that are classified as drugs, such as the hormones estrogen, progesterone, and insulin.
Scope of Support

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

The research proposed under the administrative supplement program must be within the original scope of the parent award.  Applicants should propose research that, if successful, would contribute to a greater understanding of the role of dietary supplements in human health promotion or disease prevention. The following types of applications are considered to fall within the scope of the parent grant.  Applications that propose to add additional animal tissues in order to understand tissue specificity of dietary supplements; applications that propose to increase statistical power of sex/gender differences in response to dietary supplements of human or animal subjects by adding more male or female subjects; and applications that propose new biomarkers or add additional biomarkers of dietary exposure in human or animal studies.

IC-Specific Considerations

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

Section II. Award Information
Funding Instrument

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

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.

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 $3.0 M in FY 2016 to fund 30 awards.

Award Budget

Budget requests may be for no more than $100,000 in total costs. 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. Awards are limited to one year.

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
  • Non-domestic (non-U.S.) Entities (Foreign Institutions)

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 eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant Organizations

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

  • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

Eligible Individuals (Program Director/Principal Investigator)

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

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

2. Cost Sharing

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

3. Additional Information on Eligibility
Number of Applications

Applicant organizations may submit more than one application, provided that each is sufficiently distinct from any other administrative supplement currently under consideration by the awarding NIH Institute or Center.

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

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 in the Application Guide (SF424 (R&R) Application Guide or PHS 398 Application Guide, as appropriate) including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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

Page Limitations

All page limitations described in the Application Guide and the Table of Page Limits must be followed, the research strategy is limited to 12 pages.

Application Submission

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

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

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

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

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

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

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

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

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

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

Cindy Davis
Office of Dietary Supplements
6100 Executive Blvd., Suite 3B01
Rockville, MD 2089s
Telephone: 301-496-0168
Email: davisci@mail.nih.gov

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

PHS 398 Research Plan (Research Plan)

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

Project/Performance Site Locations (Project/Performance Sites)

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

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

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

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

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

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

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

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

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

  • IACUC Documentation and IRB Documentation (Uploaded via the Other Attachments Section for electronic submissions): If applicable, include documentation that the proposed research experience was approved by the Institutional Animal Care and Use Committee (IACUC) or human subjects Institutional Review Board (IRB) at the grantee institution. Adherence to the NIH policy for including women and minorities in clinical studies must also be ensured, if additional human subjects’ involvement is planned for the supplement component.
  • Product Integrity Information (Uploaded via the Other Attachments Section for electronic submissions): To ensure reproducibility of the research, dietary supplements must be rigorously identified, characterized, and documented.  The following information is required for product integrity evaluation (see NCCIH’s Natural Product Integrity Policy for additional information).  

1. For botanicals, the complete taxonomic/scientific name along with the common name and source of the plant material/extract/phytochemical.

2. Identify the manufacturer or distributor (if any) by name and address and contact information along with product brand name, if applicable.

3. State the constituent(s), if any, to which the product is standardized.

4.  For non-botanical ingredients a full description is required.  This should include brand name (if given), chemical purity (and methodology determined), and isomeric purity.  Lot specific or batch specific certificates of analysis from the manufacturer are acceptable.

5. Characterize the supplement composition (ingredient content and quantity), including laboratory analysis to confirm information on the certificate of analysis, if applicable.

6. Provide documentation that demonstrates stability of ingredients for at least the duration of the study and explain how the product will be monitored for stability throughout the project period.

7. Provide documentation that demonstrates reproducibility of product characteristics, especially if more than one batch is used in the study.

8. Assure that the product is free of impurities (accidental or deliberate), e.g., pesticides, drugs, microbes, or metals.

9. If the product is administered via a vehicle other than a tablet/capsule, provide information on the source and composition of the vehicle (diet, etc.) and assure that the ingredient or intervention remain stable and bioavailable (e.g., probiotic added to porridge, EGCG added to rat food) throughout the study.

10. For placebo, verify that the product matches the test agent on sensory characteristics, that the sensory characteristics are stable, and that the product contains no bioactive materials.

Planned Enrollment Report

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

PHS 398 Cumulative Inclusion Enrollment Report

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

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. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications as described above. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

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

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

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

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

6. Other Submission Requirements and Information

Applications must be submitted using the instructions specified above.

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

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues.

Important reminders:
For applications submitted electronically on the SF424 (R&R) Application forms, all PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the awarding Institute or Center, NIH. Applications that are incomplete or non-compliant will not be reviewed

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 stimulate dietary supplement research where it is lacking or lagging, clarify gaps, opportunities and balance between benefits and risks where data are in conflict, target special population groups where additional science on supplements is needed, and/or focus on the use of supplements in improving or maintaining health and reducing the risk of chronic disease?
  • Is adequate product integrity information provided to ensure the reproducibility of the research as described in the submission requirements section?

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

Protections for Human Subjects:

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

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

Inclusion of Women, Minorities, and Children

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

Vertebrate Animals

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

Biohazards

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

2. Review and Selection Process

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

3. Anticipated Announcement and Award Dates

Not Applicable

Section VI. Award Administration Information
1. Award Notices

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

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

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website. When calculating the award for additional funds, NIH will 1) prorate funding if the requested budget period is adjusted at the time of award, and 2) use the institution’s current F&A rate; i.e., the rate in effect when the new funding is provided.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

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

3. Reporting

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

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

Section VII. Agency Contacts

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

Application Submission Contacts

eRA 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)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: http://grants.nih.gov/support/index.html
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-435-0714

Scientific/Research Contact(s)

Cindy Davis
Office of Dietary Supplements (ODS)
Telephone: 301-496-0168
Email: davisci@mail.nih.gov

Kathleen Michels
Fogarty International Center (FIC)
Telephone: 301-435-6031
Email: Kathleen.Michels@nih.gov

Sharon Ross
National Cancer Institute (NCI)
Telephone: 240-276-7124
Email: rosssha@mail.nih.gov

Craig Hopp
National Center for Complementary and Integrative Health (NCCIH formerly NCCAM)
Telephone: 301-496-5825
Email: hoppdc@mail.nih.gov

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

Holly Nicastro
National Heart, Lung and Blood Institute (NHLBI)
Telephone: 301-435-0383
Email: nicastrolhl@nhlbi.nih.gov

Gary Murray
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-9940
Email:  murrayg@mail.nih.gov

Joe Wang
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-451-0747
Email:  wangh4@mail.nih.gov

Nahid Akhyani
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2104
Email: akhyanin@niaid.nih.gov

Judy Hannah
National Institute on Aging (NIA)
Telephone: 301-435-0044
Email: hannahj@nia.nih.gov

Mary Cutting
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-5391 
Email: cuttingma@mail.nih.gov

Padma Maruvada
National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8884
Email:  maruvadp@niddk.nih.gov

Thaddeus Schug
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-9469  
Email: schugt2@niehs.nih.gov

Janet Cyr, Ph.D.
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-402-3458
Email: cyrj@nidcd.nih.gov

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

Peer Review Contact(s)

Not Applicable

Financial/Grants Management Contact(s)

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

Shelley Carow
National Center for Complementary and Integrative Health (NCCIH formerly NCCAM)
Telephone: 301-594-3788
Email: CarowS@MAIL.NIH.GOV

William Darby
National Eye Institute (NEI)
Telephone: 301-451-2020
Email: darbyw@mail.nih.gov

Ann Marie Brasile Mejac
National Health, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0164
Email:  brasilea@nhlbi.nih.gov

John Bladen
National Institute on Aging (NIA)
Telephone: 301-402-7730
Email: bladenj@nia.nih.gov

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

Ann Devine
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2988
Email: ADEVINE@niaid.nih.gov

Diana Rutberg
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-504-4798
Email: rutbergd@mail.nih.gov

Sharon Bourque
National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8846
Email: bourques@extra.niddk.nih.gov

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

Chris Myers
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-435-0713
Email: myersc@mail.nih.gov

Gloria Velez
Office of Research Infrastructure Programs (ORIS)
Telephone: 301-435-0875
Email: gloria.velez@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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