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

National Institutes of Health (NIH)

Components of Participating Organizations

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

Funding Opportunity Title

Validation Studies of Analytical Methods for Dietary Supplement Constituents (Admin Supp - Clinical Trial Not Allowed)

Activity Code

Administrative Supplement

Additional funds may be awarded as supplements to parent awards using the following Activity Code(s):

G12 Research Centers in Minority Institutions Award
P01 Research Program Projects
P20 Exploratory Grants
P30 Center Core Grants

P50 Specialized Center

U19 Research Program – Cooperative Agreements

U41 Biotechnology Resource Cooperative Agreements

U54 Specialized Center- Cooperative Agreements
U56 Exploratory Grants – Cooperative Agreements

UC3 Biomedical Research, Development, and Growth to Spur the Acceleration of New Technologies (BRDG-SPAN) Cooperative Agreement Program

DP1 NIH Director’s Pioneer Award (NDPA)
DP2 NIH Director’s New Innovator Awards
DP3 Type 1 Diabetes Targeted Research Award
DP4 NIH Director’s Pathfinder Award- Multi-Yr Funding
DP5 Early Independence Award

F99/K00 Pre-doc to Post-doc Transition Award/ Post-doctoral Transition Award

K01 Research Scientist Development Award - Research & Training
K02 Research Scientist Development Award – Research
K05 Research Scientist Award
K06 Research Career Awards
K07 Academic/Teacher Award (ATA)
K08 Clinical Investigator Award (CIA)
K12 Physician Scientist Award (Program) (PSA)
K18 Career Enhancement Award
K22 Career Transition Award
K23 Mentored Patient-Oriented Research Career Development Award
K24 Midcareer Investigator Award in Patient-Oriented Research
K25 Mentored Quantitative Research Career Development Award
K26 Midcareer Investigator Award in Biomedical and Behavioral Research
K43 International Research Career Development Award

K76 Emerging Leaders Career Development Award

K99/R00 Career Transition Award/Research Transition Award

R00 Research Transition Award

R01 Research Project Grant
R03 Small Grant Program
R15 Academic Research Enhancement Award (AREA)

R21 Exploratory/Developmental Research Grant Award
R21/R33 Phased Innovation Award
R24 Resource-Related Research Projects

R33 Exploratory/Developmental Grants Phase II
R34 Clinical Trial Planning Grant Program

R37 Method to Extend Research in Time (MERIT) Award
R41 Small Business Technology Transfer (STTR) Grant - Phase I only
R41/R42 Small Business Technology Transfer (STTR) Grant - Phase I, Phase II, and Fast-Track
R41/R42 Small Business Technology Transfer (STTR) Grant - Phase I and Phase II
R42 Small Business Technology Transfer (STTR) Grant - Phase II only
R43 Small Business Innovation Research (SBIR) Grant - Phase I only
R43/R44 Small Business Innovation Research (SBIR) Grant - Phase I, Phase II, and Fast-Track
R43/R44 Small Business Innovation Research (SBIR) Grant - Phase I and Phase II
R44 Small Business Innovation Research (SBIR) Grant - Phase II only

R61/R33 Exploratory/Developmental Phased Award

RC3 Biomedical Research, Development, and Growth to Spur the Acceleration of New Technologies (BRDG-SPAN) Program

RM1 Research Project with Complex Structure
U01 Research Project – Cooperative Agreements

U24 Resource-Related Research Projects – Cooperative Agreements

UG3/UH3 Exploratory/Developmental Phased Award Cooperative Agreement

UH2 Exploratory/Developmental Cooperative Agreement Phase I
UH2/UH3 Phase Innovation Awards Cooperative Agreement
UH3 Exploratory/Developmental Cooperative Agreement Phase II

UM1 Multi-Component Research Project Cooperative Agreements

UP5 Cooperative Agreement

Announcement Type

Reissue of PA-18-818

Related Notices

NOT-OD-20-128 - Notice of Requirement for Electronic Submission of all Administrative Supplements

Funding Opportunity Announcement (FOA) Number

PA-20-252

Companion Funding Opportunity

None

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

93.321; 93.213; 93.393; 93.847; 93.113  

Funding Opportunity Purpose

The rigor and reproducibility of research on dietary supplements are enhanced by rigorous characterization of key experimental resources and biological samples. The dissemination of analytical methods that are validated to accurately and reliably characterize dietary supplements and quantify their constituents and/or metabolites is vital for both basic and clinical research. This FOA builds on existing NIH awards to support the performance and publication of formal single-laboratory validation studies of analytical methods for dietary supplements and other natural products. The method(s) proposed for validation must be used to identify and/or quantify dietary supplement-relevant ingredients or constituents (i.e., active or marker chemical compounds, adulterants, contaminants) or their metabolites in experimental reagents, raw materials, and/or clinical specimens (e.g., urine or plasma samples). The method(s) must already be developed or utilized in fulfillment of the active parent grant's specific aims. Candidate constituents for method validation studies include (but are not limited to): phytochemicals, nutrients, and potentially deleterious substances such as pesticides and mycotoxins. Multi-laboratory validation studies will not be supported through this FOA.

Key Dates
Posted Date

July 30, 2020

Open Date (Earliest Submission Date)

September 15, 2020

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

October 15, 2020, January 15, 2021, April 15, 2021, October 15, 2021, January 17, 2022, and April 15, 2022, by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

Not Applicable

Advisory Council Review

Not Applicable

Earliest Start Date

January 2021; March 2021; July 2021; January 2022; March 2022; July 2022)

Expiration Date

April 16, 2022  

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Application Guide (SF424 (R&R) Application Guide, 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.


There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

    Part 1. Overview Information
    Part 2. Full Text of the Announcement
    Section I. Funding Opportunity Description
    Section II. Award Information
    Section III. Eligibility Information
    Section IV. Application and Submission Information
    Section V. Application Review Information
    Section VI. Award Administration Information
    Section VII. Agency Contacts
    Section VIII. Other Information


    Part 2. Full Text of Announcement
    Section I. Funding Opportunity Description

    Background

    Replicability and reproducibility are essential to the utility and translation of research. It is therefore critical that as new methods are developed their performance be optimized and characterized. Formal validation studies that establish the accuracy, precision, applicability, and sensitivity of analytical methods support the authentication and characterization of key experimental resources and are a powerful approach to improving the rigor and reproducibility of research. The use of validated methods enhances the reliability and consistency of analytical measurements, and the dissemination of validated methods strengthens the value and impact of NIH-supported research outcomes. Funds are available through this Funding Opportunity Announcement (FOA) to support formal validation studies of analytical methods for the determination of dietary supplement ingredients or chemical constituents in experimental formulations or in biological samples.

    A major goal of The Office of Dietary Supplements (ODS) Analytical Methods and Reference Materials (AMRM) Program is to promote the development and validation of methods that can be used to identify and quantify dietary supplement constituents, contaminants, adulterants, and their metabolites in target matrixes. Relatively few publicly available and validated analytical methods exist for constituents in dietary supplements, making it difficult to rigorously and quantitatively assess the composition of experimental materials and to conduct replicable studies to assess the mechanism(s) of action, efficacy, or safety of target analytes. In the course of performing NIH-funded research, grantees often develop or optimize analytical methods for dietary supplements and other natural products. These methods may be employed to quantify concentrations of specific chemical constituent(s) of interest or to qualitatively assess the identity (or quality) of natural product materials to be used as experimental reagents. However, 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. This funding opportunity supports validation studies and dissemination of analytical methods developed by NIH grantees.

    To be validated an analytical method’s performance characteristics are systematically evaluated. Experimental approaches to demonstrate the validity of an 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. With a successful SLV study, a multi-laboratory collaborative study can then permit an evaluation of the method's replicability among different laboratories.

    Purpose

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

    The method(s) to be the subject of validation studies must have already been developed and be in use by the applicant at the time of the funding request. These methods must be 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 multi-laboratory, collaborative validation studies will not be supported 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.

    The method(s) to be validated must be in use in the parent award to identify and/or quantify constituents (bioactive and other 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 related natural 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.

    Budget requests should reflect costs that are necessary and reasonable to complete the work described in the application. Applicants are expected to have readily available the materials necessary to complete the proposed work. For example, applications should carefully consider the amount of dietary ingredient/constituent/metabolite or standard material which would be necessary to conduct the validation study, as applications proposing significant new work to generate these materials will be considered a lower priority for this FOA.

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

    1. Determination of the method's applicability, accuracy, precision, uncertainty, repeatability, limit of detection, limit of quantification, linearity, selectivity, and sensitivity.

    2. When available, standard or certified reference materials should be used 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).

    Critical aspects of a formal SLV study of qualitative methods to identify botanical dietary ingredients include (but are not limited to):

    1. Determination of applicability, inclusivity, exclusivity, probability of identification, robustness, reproducibility, and repeatability.

    2. Careful consideration of sampling plans to establish representative mixtures of the minimum acceptable concentration of target material and maximum concentration of non-target material (inclusivity and exclusivity panels).

    3. Utilization of appropriate statistical approaches to establish the method’s ability to distinguish between target and non-target materials and determine a probability of identification and associated confidence intervals.

    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 requirements and conduct of a formal SLV study of quantitative chemical methods and qualitative identification methods, 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 4/8/2020). Additional relevant information can be found in the U.S. FDA’s 2019 Guidelines for the Validation of Chemical Methods in Food, Feed, Cosmetics, and Veterinary Products, 3d Edition (https://www.fda.gov/media/81810/download, accessed 4/8/2020) and Probability of Identification: A Statistical Model for the Validation of Qualitative Botanical Identification Methods (LaBudde and Harnly, 2012, Journal of AOAC International, 95(1):273).

    For validation 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 4/13/2020). The accuracy, precision, reproducibility, and selectivity of the method for endogenous metabolites and known degradation products should be established for the relevant biological matrix.

    Examples of quantitative analytical methods that 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.

    Various quantitative methods (e.g., chromatographic patterns, spectral patterns, genetic sequences) are commonly employed to generate the underlying data which are subsequently statistically assessed to qualitatively determine the probability of identification for botanical and other natural product experimental reagents.

    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.

    Additional guidance and answers to Frequently Asked Questions for Office of Dietary Supplements grant funding can be found at https://ods.od.nih.gov/Research/Funding.aspx.

    Participating Component Interests

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

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

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

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

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

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

    Section II. Award Information
    Funding Instrument

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

    Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

    Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.

    Application Types Allowed

     

    Non-competing Administrative Supplements

     

    Clinical Trial?

    Not Allowed: Only accepting applications that do not propose clinical trials

    Need help determining whether you are doing a clinical trial?

    Funds Available and Anticipated Number of Awards

    The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

    ODS intends to commit $500,000 in FY 2021 and $500,000 in FY 2022 to fund up to four awards per fiscal year.

    Award Budget

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

    The funding mechanism being used to support this program, administrative supplements, can be used to cover cost increases that are associated with achieving certain new research objectives, as long as the research objectives are within the original scope of the peer reviewed and approved project, or the cost increases are for unanticipated expenses within the original scope of the project. Any cost increases need to result from making modifications to the project that would increase or preserve the overall impact of the project consistent with its originally approved objectives and purposes.

    Award Project Period

    The project and budget periods must be within the currently approved project period for the existing parent award. Supplements may be requested for up to one year. The validation studies proposed for this supplement must be accomplished within the competitive segment of the parent award. Therefore, applicants must have at least 18 months of active support remaining on the parent grant as of the application due date.  

    NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

    Section III. Eligibility Information
    1. Eligible Applicants
    Eligible Organizations

    All organizations administering an eligible parent award may apply for a supplement under this announcement.

    Higher Education Institutions

    • Public/State Controlled Institutions of Higher Education
    • Private Institutions of Higher Education

    The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

    • Hispanic-serving Institutions
    • Historically Black Colleges and Universities (HBCUs)
    • Tribally Controlled Colleges and Universities (TCCUs)
    • Alaska Native and Native Hawaiian Serving Institutions
    • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

    Nonprofits Other Than Institutions of Higher Education

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

    For-Profit Organizations

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

    Governments

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

    Other

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

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

    IMPORTANT: The research proposed by the NIH grantee in the supplement application must be within the original scope of the NIH-supported grant project. Validation studies must be conducted in a laboratory that is a participating component of the active parent award. Validation studies may not be sub-contracted to a commercial laboratory that was not a participant in the parent award.

    Foreign Institutions

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

    Required Registrations

    Applicant Organizations

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

    • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
    • System for Award Management (SAM) – 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.
    • o   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 to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
    • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration. Grants.gov registration is only required if you plan to submit using the 'Electronic Application Submission through Grants.gov' option.

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

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

    Eligible Individuals (Program Director/Principal Investigator)

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

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

    2. Cost Sharing

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

    3. Additional Information on Eligibility
    Number of Applications

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

    Only applications with at least 18 months remaining on the active parent award at the time of the submission due date will be accepted.

     
    Section IV. Application and Submission Information
    1. Requesting an Application Package

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

    The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace 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.

    2. Content and Form of Application Submission

    All forms must be completed for the supplemental activities only and must not reflect funding or activities for the previously awarded parent award.

    It is critical that applicants follow the instructions for their submission option (SF424 (R&R) Application Guide, as appropriate) 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.

    Page Limitations

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

    Application Submission

    Administrative supplement requests must be submitted through Grants.gov using electronic submission processes.

    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:

    • ·    SF424 R&R Cover form:  Select “Revision” in the “Type of Application” field.
    • ·    Research Plan form (e.g., PHS 398 Research Plan form, PHS 398 Career Development Award Supplemental 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. The Research Strategy is 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. Other sections should also be included if they are being changed by the proposed supplement activities.
    • ·    Project/Performance Site Location(s) 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 (Expanded) 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:

    o  Abstract for the Administrative Supplement application.

    o  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).

    o  Establish the identity, composition, and purity of the test article(s) (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.

    § 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.

    § 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.

    § For all test articles, provide documentation demonstrating both chemical and isomeric purity (when appropriate), including the methodology used in purity determination.

    § State the constituent(s), if any, to which the test article is standardized.

    § Assure test article(s) is/are free of impurities (accidental or deliberate), e.g., pesticides, drugs, microbes, or metals.

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

    o  Establish stability and reproducibility of the test article preparation.

    § 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.

    § Provide documentation that demonstrates reproducibility of test article(s) characteristics, especially if more than one batch is used in the study.

    o  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.

    o  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.

    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 How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. 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.

     

    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 help stimulate dietary supplement research where it is lacking or lagging, or help distinguish between benefits and risks where data are in conflict, and/or focus on the use of dietary 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 for the program to exert a sustained, powerful influence on the research field(s) involved?
    • Will the administrative supplement increase or preserve the potential benefit of the instrument requested for the overall research community and its potential impact on NIH-funded research?

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

    Protections for Human Subjects:

    For research that involves human subjects but does not involve one of the 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 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 Individuals Across the Lifespan

    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 individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed.

    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 laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex.  This includes ensuring programs are accessible to persons with limited English proficiency.  The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS.  Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

    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.

    Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.    

    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, application errors and warnings, documenting system problems that threaten submission by the due date, and 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)

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

    Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
    Contact Center Telephone: 800-518-4726
    Email: support@grants.gov

    Scientific/Research Contact(s)

    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: emenaker@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

    Peer Review Contact(s)

    Not Applicable

    Financial/Grants Management Contact(s)

    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
    reeveskm@niddk.nih.gov)


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

    Section VIII. Other Information

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

     

    Authority and Regulations

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

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