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.

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

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 United States these ingredients are defined as including vitamins, minerals, herbs and other botanicals, amino acids and other dietary substances (as well as their extracts, concentrates, metabolites and constituents) 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 ingredients 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 effectiveness, benefits and risks of dietary supplements.

This FY 2018 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 population 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. ODS is particularly interested in human studies.

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

• 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.
• Assessment of dietary supplement use in cohort studies.
• Addition of biomarkers to randomized controlled trials of dietary supplements.
• 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, 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 that investigate the prospective role of omega-3 polyunsaturated fatty acids (n-3 PUFA) supplementation in metabolic and aging processes including potential anti-inflammatory effects associated with improved cognitive functions, greater gray matter volume and white matter integrity during aging; impact on metabolic function and aging metabolism; influence on skeletal muscle metabolism and its role in the physical decline associated with aging
• Investigations of clinical and/or subclinical vitamin B-12 deficiencies and targeted supplementation in certain demographic groups at risk, including infants, vegans, and the elderly. Evaluation of treatment with vitamin B-12 supplementation of these populations and further investigations to determine to what extent deficiencies are attributable to genetic determinants or acquired impairments of vitamin B12 absorption, distribution, and cellular uptake. Mechanistic studies investigating the associations between vitamin B12 deficiency and neurologic, psychotic and mood symptoms, cognitive impairment and dementia (including Alzheimer's disease and other neurodegenerative disorders), as well as chronic neuro-inflammation and oxidative stress, and their evolution after targeted supplementation

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

• Studies that do not give the supplement by mouth
• 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-hydroxy- 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.

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 this program 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.

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.

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

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.

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.

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.

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.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• 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.

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.

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

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.

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

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

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.

All page limitations applicable to the parent award as described in the Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

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.
• Abstract for the administrative supplement
• Research Plan form: At a minimum, the Research Strategy section should be completed and must include a summary of the funded parent award or project, what new information will be collected in the administrative supplement and how it enhances the parent award. 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.
• 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.

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.
• 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.

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.
• Abstract for the administrative supplement
• Research Plan form: At a minimum, the Research Strategy section should be completed and must include a summary of the funded parent award or project, what new information will be collected in the administrative supplement and how it enhances the parent award. 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.
• Appendix: 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.
• Product Integrity Information. 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.

The grantee institution, on behalf of the PD/PI of the parent award, must submit a signed, typewritten original of the application, including the checklist, to:

Cindy Davis
Office of Dietary Supplement
6100 Executive Blvd., Suite 3B01
Rockville, MD 20892
Telephone: 301-496-0168
Email: davisci@mail.nih.gov

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 stimulate dietary supplement research where it is lacking or lagging, clarify gaps, opportunities and balance between benefits and risk 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) 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.

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

Cooperative Agreement Terms and Conditions of Award

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.

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

Section VII. Agency Contacts

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

Application Submission Contacts

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

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573



Scientific/Research Contact(s)

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

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)
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: nicastrohl@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

Giovanna Zappala
National Institute on Aging (NIA)
Telephone: 301-827-6240
Email: Giovanna.Zappala@nih.gov

Mary Cutting
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-827-4621
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

Daniel J. Raiten, Ph.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301- 435-7568
Email: raitend@mail.nih.gov
Peer Review Contact(s)

Not Applicable

Financial/Grants Management Contact(s)

Leslie Littlejohn
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-435-5278
Email: littlele@mail.nih.gov

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)
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

Karen Brummett
Office of Research Infrastructure Programs (ORIP)
Telephone: 301-594-6268
Email: Karen.Brummett@nih.gov

Bryan S. Clark, MBA
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Email: clark1@mail.nih.gov

Section VIII. Other Information

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

Authority and Regulations

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