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

Background

There is a growing awareness throughout the biomedical research community of the need to improve the reproducibility of research findings. The performance, and publication, of analytical method validation studies make critical contributions to enhancing experimental design and supporting the authentication and characterization of key experimental reagents. The use of validated methods enhances the reliability and consistency of analytical results, and the dissemination of validated methods developed in the course of NIH-supported research multiplies the value of that research. Funds are available through this Funding Opportunity Announcement (FOA) to support formal validation studies of analytical methods for the accurate, precise, specific, and sensitive quantification of chemical constituents of dietary supplements in experimental formulations or in biological samples.

Relatively few publicly available and validated analytical methods exist for bioactive constituents in food and dietary supplements. This makes it difficult to rigorously assess the composition of experimental materials and to conduct reproducible studies assessing mechanism, efficacy, or safety of dietary supplements. A major goal of The Office of Dietary Supplements (ODS)'s Analytical Methods and Reference Materials (AMRM) Program is to promote development and validation of methods that quantify dietary supplement constituents, contaminants, adulterants, and their metabolites. This funding opportunity seeks to complement AMRM efforts involving the dietary supplement industry and regulatory authorities by leveraging quantitative analytical methods that have been developed by NIH grantees. These methods may or may not have been previously published and the details of the methods or their documented validation may not be available to the broader research community.

A validated method is a method that has been systematically evaluated for performance characteristics including accuracy, precision, and reliability (2013 AOAC International Official Methods of Analysis, Appendix K: Guidelines for Dietary Supplements and Botanicals; http://www.eoma.aoac.org/app_k.pdf, accessed 4/13/2017). Experimental approaches to demonstrate the validity of a quantitative analytical method include single-laboratory and multiple-laboratory validation studies. A method that has been developed and used in a laboratory can be validated for applicability, accuracy, precision, and repeatability within that same laboratory in a single-laboratory validation (SLV) study, which is the mechanism for demonstrating method performance prior to subjecting the method to a multi-laboratory study. A multi-laboratory collaborative study provides a higher level of confidence in method performance in that it permits an evaluation of the method's reproducibility among different laboratories.

Purpose

This Administrative Supplement funding opportunity announcement seeks applications for the conduct of single-laboratory validation (SLV) studies of rigorous analytical methods for the quantification of chemical constituents (e.g., active or marker chemical compounds, adulterants, contaminants), or metabolites thereof, in foods, dietary supplements, their raw source materials, and/or clinical specimens (e.g., urine or plasma).

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

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

Requirements

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

Applicants must have at least 18 months of active support remaining on the parent grant as of the application due date.

Several policies, guidelines, and procedures have been established for the design and conduct of validation studies for quantitative analytical methods. These are described by internationally recognized bodies, e.g. AOAC International, the International Standardization Organization (ISO), and the Nordic Committee on Food Analysis (NMKL). The proposed SLV study must conform to the requirements of AOAC International or other relevant guidelines, where applicable. Applicants are strongly encouraged to review AOAC International's guidelines for the conduct and requirements of a formal SLV study, which can be found in the 2013 AOAC International Official Methods of Analysis, Appendix K: Guidelines for Dietary Supplements and Botanicals (http://www.eoma.aoac.org/app_k.pdf, accessed 4/13/2017).

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

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

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

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

For studies of quantitative methods for metabolites, applicants are strongly encouraged to consult the U.S. Food and Drug Administration’s guidance for full validation of bioanalytical methods for human metabolite studies (http://www.fda.gov/downloads/drugs/GuidanceComplianceRegulatoryInformation/guidances/UCM070107.pdf, accessed 4/13/17). The accuracy, precision, reproducibility, and selectivity of the method for endogenous metabolites and known degradation products should be established for the relevant biological matrix.

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

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

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

Participating Component Interests

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

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

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

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

The NIEHS is particularly interested in validation of quantitative analytical methods for environmental nutrients, such as putative biologically active botanical compounds, and/or their metabolites, in human or animal specimens that may also be useful indicators of bioavailability, or of particular metabolic, epigenetic, or physiological states.

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:

o Hispanic-serving Institutions

o Historically Black Colleges and Universities (HBCUs)

o Tribally Controlled Colleges and Universities (TCCUs)

o Alaska Native and Native Hawaiian Serving Institutions

o Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

This announcement is for supplements to existing projects. To be eligible, the parent award must be active and the research proposed in the supplement must be accomplished within the competitive segment. The proposed supplement must be to provide for an increase in costs due to unforeseen circumstances. All additional costs must be within the scope of the peer reviewed and approved project.

IMPORTANT: The research proposed by the NIH grantee in the supplement application must be within the original scope of the NIH-supported grant project.

Validation studies must be conducted in a laboratory that is a participating component of the active parent award. Validation studies may not be sub-contracted to a commercial laboratory that was not a participant in the parent award.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

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.

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, .

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 proposal.
• Research Plan form: At a minimum, the Research Strategy section should be completed and must include a summary or abstract of the funded parent award or project. Other sections should also be included if they are being changed by the proposed supplement activities.
• Project/Performance Site Location form: Include the primary site where the proposed supplement activities will be performed. If a portion of the proposed supplement activities will be performed at any other site(s), identify the locations in the fields provided.
• Sr/Key Personnel form: List the PD/PI as the first person (regardless of their role on the supplement activities). List any other Senior/Key Personnel who are being added through this supplement, or for whom additional funds are being requested through this supplement; include a biographical sketch for each.
• Budget forms (e.g., R&R Budget, PHS 398 Training Budget): Only include funds requested for the additional supplement activities.
• R&R Other Project Information form: If applicable, attach PDF documents in the Other Attachments field indicating that the proposed research experience was approved by the Institutional Animal Care and Use Committee (IACUC) or human subjects Institutional Review Board (IRB) at the grantee institution. Name the documents IACUC Documentation.pdf and/or IRB Documentation.pdf . Adherence to the NIH policy for including women and minorities in clinical studies must also be ensured, if additional human subjects involvement is planned for the supplement.
• 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).
  • For botanicals, the complete taxonomic/scientific name along with the common name and source of the plant material/extract/phytochemical.
  • Identify the manufacturer or distributor (if any) by name and address and contact information along with product brand name, if applicable.
  • State the constituent(s), if any, to which the product is standardized.
  • 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.
  • Characterize the supplement composition (ingredient content and quantity), including laboratory analysis to confirm information on the certificate of analysis, if applicable.
  • 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.
  • Provide documentation that demonstrates reproducibility of product characteristics, especially if more than one batch is used in the study.
  • Assure that the product is free of impurities (accidental or deliberate), e.g., pesticides, drugs, microbes, or metals.
  • 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.
  • For a 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).

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

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

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

o 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.

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

o 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.

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

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

o 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.

o For a 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 proposal.
• Research Plan: At a minimum, the Research Strategy section should be completed and must include a summary or abstract of the funded parent award or project. Other sections should also be included if they are being changed by the proposed supplement activities.
• Project/Performance Sites section (Form Page 2): Include the primary site where the proposed supplement activities will be performed. If a portion of the proposed supplement activities will be performed at any other site(s), identify the locations in the fields provided.
• Sr/Key Personnel section (Form Page 2): List the PD/PI as the first person (regardless of their role on the supplement activities). List any other Senior/Key Personnel who are being added through this supplement, or for whom additional funds are being requested through this supplement; include a biographical sketch for each.
• Budget for Entire Proposed Project Period (Form Page 5): A proposed budget should be submitted using the PHS 398 budget forms and should only include funds requested for the additional supplement activities.
• If applicable, attach documentation in the Appendix section indicating that the proposed research experience was approved by the Institutional Animal Care and Use Committee (IACUC) or human subjects Institutional Review Board (IRB) at the grantee institution. Adherence to the NIH policy for including women and minorities in clinical studies must also be ensured, if additional human subjects involvement is planned for the supplement component.
• 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).

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

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

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

o 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.

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

o 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.

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

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

o 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.

o For a 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 the request for supplemental funds directly to the awarding component that supports the parent award. Submit a signed, typewritten original of the application, including the checklist, to:

Adam J. Kuszak, Ph.D.
Office of Dietary Supplements
National Institutes of Health
6100 Executive Blvd, Rm 3B01, MSC 7517
Bethesda, MD, 20892-7517
(Express/Courier Service - Rockville, MD, 20852
Telephone: 301-496-1795
Email: kuszakaj@mail.nih.gov

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.

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.

This initiative is not subject to intergovernmental review.

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.

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.

Not Applicable

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 help stimulate dietary supplement research where it is lacking or lagging, or distinguish between benefits and risks where data are in conflict, and/or focus on the use of supplements in improving or maintaining health and reducing the risk of chronic disease?
• Will the administrative supplement increase or preserve the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved?
• Will the administrative supplement increase or preserve the likelihood that the fellowship will enhance the candidate's potential for, and commitment to, a productive, independent scientific research career in a health-related field?
• Will the administrative supplement increase or preserve the likelihood for the candidate to maintain a strong research program?
• Will the administrative supplement increase or preserve the likelihood for the program to exert a sustained, powerful influence on the research field(s) involved?
• Will the administrative supplement increase or preserve the potential benefit of the instrument requested for the overall research community and its potential impact on NIH-funded research?

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

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.

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.

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.

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.

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.

Not Applicable

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.

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.

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.

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

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

Adam J. Kuszak, Ph.D.
Office of Dietary Supplements (ODS)
Telephone: 301-496-1795
Email: kuszakaj@mail.nih.gov

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

Nancy J. Emenaker, Ph.D., R.D.
National Cancer Institute (NCI)
Telephone: 240-276-7125
Email: emenaken@mail.nih.gov

Karl Krueger, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-7026
Email: kruegerk@mail.nih.gov

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

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

Not Applicable

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

Sean Hine
National Cancer Institute (NCI)
Telephone: 240-276-6291
Email: hines@mail.nih.gov

Kevin Reeves
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8861
Email: reeveskm@niddk.nih.gov

Aaron Nicholas
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-7823
Email: nicholaa@niehs.nih.gov

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.

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.