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 on Aging (NIA)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Funding Opportunity Title

Administrative Supplements to NIH Awards for Validation Studies of Analytical Methods for Natural Products (Admin Supp)

Activity Code

Administrative Supplement

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

Administrative supplement requests must be submitted on paper for the following activity codes:

P01 Research Program Projects
P20 Exploratory Grants
P30 Center Core Grants
P50 Specialized Center

Administrative supplement requests may be submitted electronically for the following activity codes:

DP1 NIH Director’s Pioneer Award (NDPA)
DP2 NIH Director’s New Innovator Awards
DP3 Type 1 Diabetes Targeted Research Award
DP4 NIH Director’s Pathfinder Award- Multi-Yr Funding
DP5/  Early Independence Award/Cooperative Agreement
K01 Research Scientist Development Award - Research & Training
K02 Research Scientist Development Award – Research
K05 Research Scientist Award
K06 Research Career Awards
K07 Academic/Teacher Award (ATA)
K08 Clinical Investigator Award (CIA)
K12 Physician Scientist Award (Program) (PSA)
K18 Career Enhancement Award
K22 Career Transition Award
K23 Mentored Patient-Oriented Research Career Development Award
K24 Midcareer Investigator Award in Patient-Oriented Research
K25 Mentored Quantitative Research Career Development Award
K26 Midcareer Investigator Award in Biomedical and Behavioral Research
K99/R00 Career Transition Award/Research Transition Award
R01 Research Project Grant
R03 Small Grant Program???
R15 Academic Research Enhancement Award (AREA)
R21 Exploratory/Developmental Research Grant Award
R21/R33 Phased Innovation Award
R24 Resource-Related Research Projects
R37 Method to Extend Research in Time (MERIT) Award
R42 Small Business Technology Transfer (STTR) Grant - Phase II only
R44 Small Business Innovation Research (SBIR) Grant - Phase II only

Announcement Type

Reissue of NOT-OD-11-016

Related Notices

Funding Opportunity Announcement (FOA) Number

PA-13-381

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.213; 93.393; 93.847; 93.866  

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) announces an administrative supplement program to provide funds to NCI- and NIDDK-supported research projects for validation studies of new analytical chemistry methods. These methods must have been developed or be under development by the awardees during the active parent grant. They must be methods used 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 animal tissues. As test agents the products studied may be investigated in vitro or in vivo.  The products under investigation in parent grants may be dietary supplements (including vitamins or other bioactive compounds), foods, and other orally administered natural products or their raw source materials.

Key Dates
Posted Date

October 24, 2013

Open Date (Earliest Submission Date)

January 31, 2014

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

January 31, 2014; June 30, 2014, October 31, 2014; January 31 2015; June 30 2015; October 31, 2015, 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

March 2014

Expiration Date

November 1, 2015

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Application Guide (SF424 (R&R) Application Guide or PHS 398 Application Guide, as appropriate) except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.


A compatible version of Adobe Reader is required for download. For Assistance downloading this or any Grants.gov application package, please contact Grants.gov Customer Support at http://www07.grants.gov/contactus/contactus.jsp.
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

There is a strong interest throughout the biomedical research community in improving the reproducibility of research. The publication of validated analytical methods makes a critical contribution to research reproducibility, and the dissemination and broad adoption of quantitative analytical chemistry methods developed in the course of NIH-supported research multiplies the value of that research, and should enhance confidence in the research literature on the part of the research community and the public.

This Funding Opportunity Announcement (FOA) announces an administrative supplement program to provide funds to NCI- and NIDDK-supported research projects for validation studies of new analytical chemistry methods. These methods must have been developed or be under development by the awardees during the active parent grant. They must be methods used 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 animal tissues. As test agents the products studied may be investigated in vitro or in vivo.  The products under investigation in parent grants may be dietary supplements (including vitamins or other bioactive compounds), foods, and other orally administered natural products or their raw source materials.

Very few publicly available and validated analytical methods exist for bioactive constituents in food, dietary supplements, and other orally administered natural products.  This makes it difficult to confirm product composition and to conduct rigorous clinical studies assessing mechanism, safety and efficacy.  A validated method is a method that has been systematically evaluated for reliability and accuracy.  Experimental approaches to demonstrate the validity of a quantitative analytical method include single-laboratory and multiple-laboratory validation studies.

The analytical methods program is the largest component of ODS's Analytical Methods and Reference Materials (AMRM) Program. The goal of this program is to develop and validate methods that identify and quantify product constituents and their metabolites.

In order to accelerate the progress of the AMRM program this administrative supplement funding opportunity seeks to capture methods developed outside the current program structure which primarily serves regulators and industry. By expanding the validation effort to the larger research community, including NIH grantees, we expect to better serve the research community.

Grantees in the process of investigating the physiologic/biomedical effects of bioactive constituents of foods, dietary supplements, and natural products often develop analytical methods to identify and/or quantify constituents contained in their test agents or their metabolites in animal/human tissue.

These methods may or may not have been formally validated within the laboratory that developed them, and the availability of the methods or their validation may not be available to the research community. Validated methods are critical to advancing rigorous research. 

A method intended to be performed in only one laboratory can be validated within that laboratory.  This would be a single-laboratory validation (SLV). However, the results of a SLV method cannot necessarily be compared to results obtained using a different method or the same SLV method in a different laboratory. The SLV is the mechanism for demonstrating method performance prior to subjecting the method to a multi-laboratory collaborative study. Often a two-laboratory study is an intermediate step before proceeding to a collaborative study. This intermediate step may, in the long run, save time and resources.

The multiple-laboratory collaborative study is the gold standard. Multiple laboratories perform the same test on the same samples. If results from most of the laboratories are the same, the method performance is deemed adequate. AOAC International evaluates the validation study results and publishes the methods in the Journal of AOAC International. A successful collaborative study may lead to listing the method as an AOAC Official Methods of Analysis.

Purpose

The purpose of this Administrative Supplement funding opportunity is to seek applications for the planning, coordination, management, and conduct of single- and two-laboratory validation studies that lead to validation of analytical methods for quantitative determination of constituents in, or metabolites from, a variety of foods, dietary supplements, other orally administered natural products, and their raw source materials. Methods to be validated must be in use by the grantee at the time of the supplement request. 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 studies will not be accepted at this time.

Requirements

The SLV study must conform to the requirements of the AOAC International.  AOAC has prepared a set of guidelines for conducting a SLV study: available in: AOAC International.-Appendix K: Guidelines for Dietary Supplements and Botanicals. In: AOAC official Methods of Analysis, 18th Edition , 2005 (http://eoma.aoac.org.app K.pdf, accessed 4/25/13).  Similarly, the U.S. Food and Drug Administration has published guidance for bioanalytical method validation for human metabolite studies (http://www.fda.gov/downloads/drugs/GuidanceComplianceRegulatoryInformation/guidances/UCM070107.pdf, accessed 4/25/13). 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.

Participating Component Interests

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 develop and 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.

Section II. Award Information
Funding Instrument

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

Application Types Allowed

 

Non-competing Administrative Supplements

Funds Available and Anticipated Number of Awards

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

ODS intends to commit $800,000 in FY 2014 to fund up to eight awards.

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 (total direct costs) whichever is less, and must reflect the actual needs of the proposed project.

If the requested direct costs exceed 25 percent of approved costs or $100,000, the grantee should contact a Scientific/Research Contact listed in this FOA.

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 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. If a performance period of greater than one year is expected, contact a Scientific/Research Contact listed in this FOA.

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

Section III. Eligibility Information


1. Eligible Applicants


Eligible Organizations

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

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

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


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

Foreign Institutions

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

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

All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. 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 invited 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.   

Section IV. Application and Submission Information


1. Requesting an Application Package

Applicants are required to prepare applications according to the current application forms in accordance with the Application Guide.
For electronic submissions, applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this announcement, or use the eRA Commons streamlined submission process.

2. Content and Form of Application Submission

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

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

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

Page Limitations

All page limitations described in the Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements: For all activity codes, the Research Strategy section of the supplement application is limited to 6 pages.

Application Submission

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

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

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

For single project grants with activity codes that have transitioned to electronic submission using the SF424 (R&R) application forms, administrative supplement requests may be submitted electronically as a Revision application type on the R&R Cover Component. Prepare applications using the SF424 (R&R) application forms associated with this announcement. Please note that some components 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 components.

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

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

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

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

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

Nancy J. Emenaker, Ph.D., R.D.
Nutritional Science Research Group
Division of Cancer Prevention
National Cancer Institute (NCI)
9609 Medical Center Drive
5 East, Room 580
Bethesda, MD 20892-7899
Rockville, MD 20850 (Express/Courier Service)
Telephone: 240-276-7125
Email:  emenaken@mail.nih.gov

Karl Krueger, Ph.D.
Cancer Biomarkers Research Group
Division of Cancer Prevention
National Cancer Institute (NCI)
9609 Medical Center Drive, 5 East, Room 132
Bethesda, MD  20892-9790
Telephone: 240- 276- 7026
Email: kruegerk@mail.nih.gov

Padma Maruvada, Ph.D.
Nutrition and Clinical Obesity Program
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Division of Digestive Diseases and Nutrition
6707 Democracy Blvd., Room 663
Bethesda, MD 20892
Telephone: 301- 594- 8884
Email: maruvadp@mail.nih.gov

PHS 398 Research Plan (Research Plan)

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

Project/Performance Site Locations (Project/Performance Sites)

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

Senior/Key Personnel Form

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

R&R Detailed Budget Form (for use with electronic submissions)

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

The requested budget may include the cost of validation methods training, consultants, and fees, if any, paid to AOAC International or a training organization. Contact AOAC International or Program Staff for the availability of SLV training opportunities.

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

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

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

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

IACUC Documentation and IRB Documentation (Uploaded via the Other Attachments Section for electronic submissions)

The filename provided for each “Other Attachment” will be the name used for the bookmark in the electronic application in eRA Commons.

Planned Enrollment Report (for use with electronic submissions)

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

3. Submission Dates and Times

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

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

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

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

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

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

6. Other Submission Requirements and Information

Applications must be submitted using the instructions specified above

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

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

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 Component 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 System for Award Management (SAM). Additional information may be found in the Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and/or responsiveness by the awarding Institute or Center. Applications that are incomplete and/or nonresponsive will not be reviewed.

Post Submission Materials

Not Applicable

Section V. Application Review Information


1. Criteria

Administrative Supplements do not receive peer review. Instead, the administrative criteria described below will be considered in the administrative evaluation process.

The staff of the NIH awarding component will evaluate requests for a supplement to determine its overall merit. The following general criteria will be used:

Budget and Period of Support

NIH Staff will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Overall Impact

NIH staff will consider the ability of the proposed supplement activities to increase or preserve the parent award’s overall impact within the original scope of award:

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

Protections for Human Subjects:

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

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

Inclusion of Women, Minorities, and Children

When the proposed project involves clinical research, NIH staff will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

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

Biohazards

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

2. Review and Selection Process

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

3. Anticipated Announcement and Award Dates

Not Applicable

Section VI. Award Administration Information


1. Award Notices

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

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

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

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

Cooperative Agreement Terms and Conditions of Award

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

3. Reporting

Reporting requirements will be specified in the terms and conditions of award as applicable to the supplemental activities. In most non-competing continuation applications, the progress report and budget for the supplement must be included with, but clearly delineated from, the progress report and budget for the parent award. The progress report must include information about the activities supported by the supplement even if support for future years is not requested. Continuation of support for the supplement activities in the remaining years of the competitive segment of the grant will depend upon satisfactory review by the NIH awarding component of progress for both the parent award and the supplement project, the research proposed for the next budget period, and the appropriateness of the proposed budget for the proposed effort. This information is submitted with the  Non-Competing Grant Progress Report, PHS 2590 or RPPR, and financial statements as required in the NIH Grants Policy Statement.

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

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: commons@od.nih.gov  

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

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-435-0714
TTY: 301-451-5936
Email: GrantsInfo@nih.gov

Scientific/Research Contact(s)

Barbara C. Sorkin, Ph.D.
Office of Dietary Supplements (ODS)
Telephone: 301- 435- 3605
Email: sorkinb@od.nih.gov

Nancy J. Emenaker, Ph.D., R.D.
Nutritional Science Research Group
Division of Cancer Prevention
National Cancer Institute (NCI)
Telephone: 240-276-7125
Email:  emenaken@mail.nih.gov

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

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

Peer Review Contact(s)

Not Applicable

Financial/Grants Management Contact(s)

Sean Hine
Grants Management Branch A
Office of Grants Administration
National Cancer Institute (NCI)
Telephone: 240-276-6291
Email: hines@mail.nih.gov

Sharon Bourque
Grants Management Branch
National Institute of Diabetes and Digestive and Kidney Diseases
Telephone: 301-594-8846
Email: bourques@mail.nih.gov

Section VIII. Other Information

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

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.


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