ODS Funding of Grants and Administrative Supplements: Frequently Asked Questions (FAQ)

 General Funding Questions

Questions About Administrative Supplements

General Funding Questions

Q. How does ODS fund Grants?
A. Unlike the Institutes and Centers (ICs) at NIH, ODS is not able to directly fund or take primary responsibility for grants. Instead, we co-fund (i.e. contribute to the IC-determined budget) grants that have already been through NIH study section peer-review and will be funded by an NIH IC. In addition to co-funds, we directly fund Administrative Supplements to existing NIH grants.

Q. Will my grant budget increase if ODS co-funds the grant?
A. No. A co-fund is an internal transfer of funds between ODS and the primary IC, and the budget remains the same.

Q. What are the funding priorities for ODS?
A. ODS funds all types of research, including pre-clinical (cellular and animal), clinical, behavioral, and epidemiological, in which the emphasis is on dietary supplements or their ingredients for health promotion and/or disease prevention. The dietary supplement must be administered orally and in physiologically relevant forms and concentrations. ODS funding is not limited to a specific health condition, organ system, or population group. In addition, ODS supports research that builds future research capacity for studying the role of dietary supplements in promoting health and preventing disease.

Q. What type of research is considered outside the scope of ODS?
A. ODS will not entertain grant applications that use dietary supplements to treat a disease unless evidence is provided that the proposed research would also be relevant to disease prevention in healthy individuals.

Q. What are the expectations of ODS-funded investigators?
A. Funded investigators must acknowledge ODS funding in any publications and reports resulting from the award.

Questions About Administrative Supplements

Q. What is an Administrative Supplement?
A. An Administrative Supplement is an award that provides additional funding to a currently funded NIH grant.

Q. What funding opportunities does ODS sponsor for Administrative Supplements?
A. ODS currently has one active funding opportunity announcements:

  1. PA-20-252  “Administrative Supplements for Validation Studies of Analytical Methods for Dietary Supplements and Natural Products”
A recording of the ODS Pre-Application webinar is available for those interested in learning about Administrative Supplements funding through ODS.

Q. What is the purpose of PA-20-252 “Administrative Supplements for Validation Studies of Analytical Methods for Dietary Supplements and Natural Products”?
A. The reproducibility and comparability of research on dietary supplements is enhanced by rigorous analytical characterization of key experimental materials and the publication of validated analytical methods that accurately and precisely characterize and quantify the ingredients in dietary supplements. This opportunity builds on existing NIH awards to support the performance and publication of formal single-laboratory validation studies of relevant quantitative analytical methods. The methods proposed for validation must be used to identify and quantify constituents (i.e., active or marker chemical compounds, adulterants, and contaminants) or their metabolites in experimental reagents, raw materials, and/or clinical specimens (e.g., urine or plasma samples). Methods must have been developed or utilized in fulfillment of the active parent grant’s specific aims. Candidate constituents for quantitative method validation studies may include (but are not limited to) phytochemicals, nutrients, and potentially deleterious substances such as pesticides and mycotoxins.

Q. How does an investigator determine if the proposed Administrative Supplement is within scope of the parent award?
A. Applicants are strongly encouraged to discuss their proposal with the IC Program Official of the parent grant prior to submitting an application. This will ensure that the Administrative Supplement fits within the scientific priorities of the IC and is within the scope of the parent grant.

Q. How does an investigator determine if the proposed Administrative Supplement is within scope of the mission of ODS?
A. Applicants are encouraged to contact Patricia Haggerty at patricia.haggerty@nih.gov for questions related to PA-20-227 or Adam Kuszak at Adam.Kuszak@nih.gov for questions related to PA-20-252.

Q. How much time must be remaining in the parent award to be eligible to apply for an Administrative Supplement?
A. Only active awards with at least 18 months remaining at the time of submission will be considered. Applications for Administrative Supplements in no-cost extension periods are not permitted.

Q. Is there a budget limit to the Administrative Supplements?
A. Yes. Budget requests are limited to $100,000 in direct costs.

Q. What materials should be included in an Administrative Supplement application?
A. A cover form, abstract for the administrative supplement, research plan, project/performance site location form, senior/key personnel form, budget forms, and product integrity information should be included.

Q. Is there a page limit to the research plan section of Administrative Supplement Applications?
A. The research plan is limited to 12 pages.

Q. Who reviews Administrative Supplement applications?
A. Administrative Supplements undergo administrative review by NIH staff for responsiveness, scientific quality, and other factors such as ODS programmatic priorities.

Q. What issues must be considered when submitting an Administrative Supplement application?
A. Consider these four issues:

  1. Reviewers will not have access to the parent grant application, so it is important to include relevant background information, preliminary data, and experimental details.
  2. The application should highlight how the Administrative Supplement would increase the impact of the parent grant and what new information it would provide. 
  3. The research must focus on health promotion or disease prevention rather than disease treatment. If a treatment model is used, evidence must be provided that the proposed research would also be relevant to reducing the risk of developing that disease in healthy individuals. 
  4. The application must include information on the analytical characterization and integrity of dietary supplement and natural-product reagents used (see NCCIH’s Natural Product Integrity Policy). Resources for addressing this issue are described and linked from the ODS Natural Product Characterization and Integrity webpage

Q. What are the ODS review criteria for Administrative Supplement applications?
A. ODS will evaluate the application on these five criteria:

  1. Will the proposed supplemental activities increase or preserve the parent award’s overall impact within the original scope of award?
  2. Has adequate progress been made on the parent award?
  3. Is adequate product integrity information provided to ensure the reproducibility of the research?
  4. Is the proposed budget and the requested period of support fully justified and reasonable?
  5. Will the Administrative Supplement stimulate dietary supplement research where it is lacking or lagging to clarify gaps, address 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?

Q. What is meant by product integrity?
A. Reproducible research on natural products, including dietary supplements, requires the use of replicable, well-characterized interventions. Investigators must demonstrate that their investigative team has the appropriate dietary supplement or natural product and analytical expertise to select the test and placebo agents for study and to ensure product quality, identity, strength and composition as described (https://ods.od.nih.gov/Research/ProductQualityResources.aspx). For example, botanists trained in taxonomy may be required to identify plant materials accurately, or experts in natural products chemistry, microbiology, food science, botany, pharmacognosy, or analytical chemistry may need to be consulted.  

Q. Why does ODS require all Administrative Supplements and grant applications to have their dietary supplement or natural product be evaluated for product integrity
A. Dietary supplements must be rigorously identified and characterized to ensure reproducibility of the research. Documentary evidence of the composition and identity of materials must be provided. 

Q. What information should be included in the product integrity section of an Administrative Supplement application?
A. Information about product integrity can be found at the following website: ODS Natural Product Characterization and Integrity page (https://ods.od.nih.gov/Research/ProductQualityResources.aspx). Applications should contain the following information:

  1. Establish the identity, composition, and purity of the test article (dietary supplement that is being investigated and appropriate controls). Manufacturer provided lot- or batch-specific certificates of analysis (CoAs), with quantitative analytical results, may be acceptable; product specification sheets and safety data sheets are NOT adequate.
    1. Characterize the test article composition, including ingredient content and quantity, and report results of the laboratory analysis to confirm information on the certificate of analysis, if applicable.
    2. For complex test article(s) derived from living organisms, the complete taxonomic/scientific name along with the common name and source of the plant/animal material/extract/phytochemical.
    3. For all test articles, provide documentation demonstrating both chemical and isomeric purity (when appropriate), including the methodology used in purity determination.
    4. State the constituent(s), if any, to which the test article is standardized.
    5. Assure test article(s) is/are free of impurities (accidental or deliberate), e.g., pesticides, drugs, microbes, or metals.
    6. Identify the manufacturer or distributor (if any) by name and address and contact information along with product brand name, if applicable.
  2. Establish stability and reproducibility of the test article preparation.
    1. Provide documentation that demonstrates stability of test article(s) for at least the duration of the study and explain how the test article(s) will be monitored for stability throughout the project period.
    2. Provide documentation that demonstrates reproducibility of test article(s) characteristics, especially if more than one batch is used in the study.
  3. If the test article is administered via a vehicle other than a tablet/capsule, provide information on the source and composition of the vehicle (e.g. diet) and assure that the test article(s) remain stable and bioavailable (e.g., probiotic added to porridge, a botanical added to animal diet) throughout the study.
  4. For placebo, verify that it matches the test article on sensory characteristics, that the sensory characteristics are stable, and that it contains no bioactive materials.