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 Eye Institute (NEI) National Institute on Aging (NIA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of Environmental Health Sciences (NIEHS)
National Institute of General Medical Sciences (NIGMS)
Fogarty International Center (FIC)
National Center for Complementary and Alternative Medicine (NCCAM)
National Heart, Lung and Blood Institute (NHLBI)

Funding Opportunity Title

Administrative Supplements for Research on Dietary Supplements (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
P60 Comprehensive Center
U10 Cooperative Clinical Research – Cooperative Agreements
U19 Research Program – Cooperative Agreements
U54 Specialized Center- Cooperative Agreements
U56 Exploratory Grants – Cooperative Agreements

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
DP4 NIH Director’s Pathfinder Award- Multi-Yr Funding
DP5/UP5 Early Independence Award/Cooperative Agreement
D43 International Training Grants in Epidemiology
F30 Individual Predoctoral NRSA for MD/PhD Fellowships
F31 Predoctoral Individual National Research Service Grant Award
F32 Postdoctoral Individual National Research Service 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
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
U01 Research Project – Cooperative Agreements

Announcement Type

New

Related Notices

  • June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same.
  • May 20, 2014 - See Notice NOT-EY-14-001. Notice of NEI Participation.
  • May 20, 2014 - See Notice NOT-HL-14-224. Notice of NHLBI Participation.

Funding Opportunity Announcement (FOA) Number

PAR-14-201

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.321, 93.393, 93.273, 93.847, 93.213, 93.856, 93.855, 93.859, 93.121, 93.865, 93.989, 93.866, 93.113, 93.837, 93.838, 93.839, 93.233, 93.867

Funding Opportunity Purpose

The Office of Dietary Supplements (ODS) announces the availability of administrative supplements to support research in which the supplemental funding would investigate the role of dietary supplements and/or their ingredients in health maintenance and disease prevention. Parent awards need not be focused on dietary supplements; this FOA may provide support to include dietary supplements within the scope of relevant research projects. Research interests of ODS are not limited to specific health conditions, organ systems or population groups. ODS supports all types of research, including pre-clinical, clinical, behavioral, and epidemiological. Additionally, ODS supports research and training programs that build future research capacity for studying the role of dietary supplements in health and disease prevention. Primary consideration for support will be given to applications that stimulate dietary supplement research where it is lacking or lagging, clarify gaps, opportunities and balance between benefits and risks where data are in conflict, target special population groups where additional science on dietary supplements is needed, and focus on the use of dietary supplements in improving or maintaining health and reducing the risk of chronic disease.

Key Dates
Posted Date

May 2, 2014

Open Date (Earliest Submission Date)

September 15, 2014

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

October 15, 2014; January 15, 2015; or April 15, 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

January, 2015; March, 2015; July, 2015

Expiration Date

April 16, 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.


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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

The mission of the Office of Dietary Supplements (ODS) is to strengthen knowledge and understanding of dietary supplements by evaluating scientific information, stimulating and supporting research, disseminating research results, and educating the public to foster an enhanced quality of life and health for the U.S. population.

Dietary supplements can have an impact on the prevention of disease and on the maintenance of health. In the US, these ingredients are usually defined as including plant extracts, enzymes, vitamins, minerals, amino acids, and hormonal products that are available without prescription and are consumed in addition to the regular diet. Although vitamin and mineral supplements have been available for decades, their health effects have been the subject of detailed scientific research only within the last 15–20 years. It is important to expand this research to include the health effects of other bioactive factors consumed as dietary supplements to promote health and prevent disease.

Considerable research on the effects of botanical and herbal dietary supplements has been conducted in Asia and Europe where plant products have a long tradition of use. The overwhelming majority of these supplements, however, have not been studied using modern scientific techniques. Nor have they been extensively studied in population groups that may be at risk for chronic diseases.

For many reasons, therefore, it is important to enhance research efforts to determine the benefits and risks of dietary supplements.

Purpose

This FY 2015 Administrative Supplement program is designed to provide supplemental funds to relevant, active, NIH-supported research projects to incorporate dietary supplement research that is within the scope of the parent project. Research interests of ODS are not limited to specific health conditions, organ systems or populations groups. ODS supports all types of research, including pre-clinical, clinical, behavioral, and epidemiological. Additionally, ODS supports research that builds future research capacity for studying the role of dietary supplements in health and disease prevention. Primary consideration for support will be given to applications that stimulate dietary supplement research where it is lacking or lagging, clarify gaps, opportunities and balance between benefits and risks where data are in conflict, target special population groups where additional science on supplements is needed, and focus on the use of dietary supplements in improving or maintaining health and reducing the risk of chronic disease.

Specific Areas of Research Interest

Appropriate topics/studies include, but are not limited to, those listed below. Examples of research projects that typically fall within the scope of ODS include:

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

Scope of Support

The funding mechanism being used to support this program, administrative supplements, can be used to cover cost increases that are associated with achieving certain new research objectives as long as they are within the original scope of the project and are related to dietary supplement investigations. Any cost increases need to result from making modifications to the project in order to take advantage of opportunities that would increase the value of the project consistent with its originally approved objectives and purposes.

The research proposed under the administrative supplement program must be within the original scope of the parent grant.  Applicants should propose research that, if successful, would contribute to a greater understanding of the role of dietary supplements in human health promotion or disease prevention. The following types of applications are considered to fall within the scope of the parent grant.  Applications that propose to add animal subjects or tissues in order to understand tissue specificity of dietary supplements; applications that propose to increase statistical power of sex/gender differences in response to dietary supplements of human or animal subjects by adding more male or female subjects; and applications that propose new biomarkers or add additional biomarkers of dietary exposure in human or animal studies.

IC-Specific Considerations

Applicants are strongly encouraged to discuss their proposed supplement project with the IC Program Official of the parent grant prior to submission of a supplement application in order to ensure that the supplement content area fits within the scientific priorities of the IC and is within the scope of the parent grant, as well as to ensure that the parent grant mechanism is one the IC will support for a supplement.  In addition to contacting with the IC Program Official for the parent grant, applicants are strongly encouraged to include the Scientific/Research Contact listed in Section VII. Agency Contacts in these communications.  

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.

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 up to $3.0M in FY 2015 to fund approximately 30 awards.

Award Budget

Budget requests may be for no more than $100,000 in total costs.  Application budgets are limited to no more than the amount of the current parent award and must reflect the actual needs of the proposed project.

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.

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 eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are  allowed.

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.  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. Since applications in response to this announcement will only receive administrative review by the awarding Institute or Center, the NIH policy on resubmissions will not apply.

Only active awards with at least 18 months remaining at the time of submission will be considered.  Awards in no-cost extension periods are not allowed to submit an application to this FOA.

 Section IV. Application and Submission Information

1. Requesting an Application Package

Applicants must prepare applications using current 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 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 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.

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 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.

Applicants submitting paper applications must use the 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 Form. Prepare applications using the SF424 (R&R) application forms associated with this announcement. 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.

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, to:

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

On the face page of the application form, note that your application is in response to a specific program announcement, and enter the title and number of this announcement.

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.

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.

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)

For electronic submissions, the following information should be submitted in a single PDF in Other Attachments. For paper submissions, the following information should be submitted in the appendix. To ensure reproducibility of the research, dietary supplements must be rigorously identified, characterized, and documented. Applicants are strongly encouraged to consult NCCAM’s Natural Product Integrity Policy (http://nccam.nih.gov/research/policies/naturalproduct.htm) to be aware of the types of information that are required in the application and they are summarized below:

1. For botanicals, the complete taxonomic/scientific name along with the common name  should be provided.

2. For non-botanical ingredients a full description is required.  This should include brand name (if given), chemical purity (and method determined), and isomeric purity.

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

4. State the constituent(s) to which the product is standardized.

5. Characterize the supplement composition (ingredient content and quantity), if applicable.

6. Provide documentation that demonstrates stability of ingredients for at least the duration of the study and explain how the product will be monitored for stability throughout the project period.

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

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

9. If the product is administered via a vehicle other than a tablet/capsule, assure that the characteristics remain stable and bioavailable (e.g., probiotic added to porridge, EGCG added to rat food).

10. For placebo, verify that the product matches the test agent on sensory characteristics, that the sensory characteristics are stable, and that the product contains no bioactives.

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.

PHS 398 Cumulative Inclusion Enrollment Report

When conducting clinical research, follow all instructions for completing the Cumulative Inclusion Enrollment Report 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 form of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the (SAM). Additional information may be found in the Application Guide.

See more tips for avoiding common errors.

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:

Will the administrative supplement stimulate dietary supplement research where it is lacking or lagging, clarify gaps, opportunities and balance between benefits and risks where data are in conflict, target special population groups where additional science on supplements is needed, and/or focus on the use of supplements in improving or maintaining health and reducing the risk of chronic disease?

Is adequate product integrity information provided to ensure the reproducibility of the research as described in the submission requirements section?

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

Protections for Human Subjects:

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

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

Inclusion of Women, Minorities, and Children

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

NIH Staff will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) 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)
Finding Help Online: http://grants.nih.gov/support/index.html
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 Telephone: 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)

Cindy Davis
Office of Dietary Supplements (ODS)
Telephone: 301-496-0168
Email: davisci@mail.nih.gov

Kathleen Michels
Fogarty International Center (FIC)
Telephone: 301-435-6031
Email: Kathleen.Michels@nih.gov

Sharon Ross
National Cancer Institute (NCI)
Telephone: 240-276-7124
Email: rosssha@mail.nih.gov

Carol Pontzer
National Center for Complementary and Alternative Medicine (NCCAM)
Telephone: 240-422-0636
Email: pontzerc@mail.nih.gov

Gary Murray
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-9940
Email:  murrayg@mail.nih.gov

Joe Wang
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-451-0747
Email:  wangh4@mail.nih.gov

Nahid Akhyani
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-443-9339
Email: akhyanin@niaid.nih.gov

Judy Hannah
National Institute on Aging (NIA)
Telephone: 301-435-0044
Email: hannahj@nia.nih.gov

Daniel Raiten
Eunice Kennedy Shriver National Institute
 of Child Health and Human Development (NICHD)
Telephone: 301-435-7568
Email: raitend@mail.nih.gov

Mary Cutting
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-5391 
Email: cuttingma@mail.nih.gov

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

Scott Somers
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-3827
Email: somerss@nigms.nih.gov

Peer Review Contact(s)

Not Applicable

Financial/Grants Management Contact(s)

Elizabeth Whittington
Fogarty International Center (FIC)
Telephone: 301-451-6830
E-mail: elizabeth.cleveland@nih.gov

George Tucker
National Center for Complementary and Alternative Medicine (NCCAM)
Telephone: 301-594-9102
Email: tuckerg@nccam.nih.gov

John Bladen
National Institute on Aging (NIA)
Telephone: 301-402-7730
Email: bladenj@nia.nih.gov

Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: jfox@mail.nih.gov

Ann Devine
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-402-5601
Email: ADEVINE@niaid.nih.gov

Bryan Clark
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email: clarkb1@mail.nih.gov

Diana Rutberg
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-504-4798
Email: rutbergd@mail.nih.gov

Sharon Bourque
National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8846
Email: bourques@extra.niddk.nih.gov

Lisa Moeller
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-3914
Email: moellerl@nigms.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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