Department of Health and Human Services

Part 1. Overview Information

Key Dates

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.

Table of Contents

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

The NIH Institutes and Centers (ICs) named above announce an Administrative Supplement opportunity available to eligible NIH awardees with active R01, P01, and grants. The purpose of this FOA is to generate data to support the implementation of public displays of harmful and potentially harmful constituents (HPHC) information. Investigators with active R01, P01, P50, issued by one of the participating Institute/Centers (ICs) listed in this FOA, may apply for an administrative supplement provided the following conditions are met:

1. The topic of the administrative supplement must be related to the research priorities that are identified in the FOA, conducted under the original NIH award ("parent" award), and related to tobacco products;
2. Efforts proposed and funds requested in the administrative supplement application must expand on the original study design and be relevant to FDA regulation of tobacco products;
3. The parent award must remain active during the entire funding period of this supplement; and
4. The Program Director/Principal Investigator (PD/PI) for the supplement must be the PD/PI of the parent award.

The awards under this FOA will be administered by NIH using designated funds from the Food and Drug Administration (FDA) Center for Tobacco Products (CTP) for tobacco regulatory science mandated by the Family Smoking Prevention and Tobacco Control Act (FSPTCA), Public Law 111-31. The NIH and the FDA have formed an interagency partnership to foster research relevant to tobacco regulations. Within the framework of the Tobacco Control Act, the FDA and NIH share interest in supporting research to aid the development and evaluation of tobacco product regulations. Projects resulting from this FOA are expected to serve the FDA by generating relevant findings and data to inform the regulation of the manufacture, distribution, and marketing of tobacco products to protect public health. Consistent with the FDA CTP mission, this FOA seeks administrative supplements that address the impact of flavors on perceptions and tobacco use behaviors.

Background

Harmful and potentially harmful constituents (HPHCs) are chemicals or chemical compounds in a tobacco product or tobacco smoke that cause, or could cause, harm. Examples of HPHCs include toxicants, carcinogens, and addictive chemicals and chemical compounds, the full list of HPHCs can be found here: http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm297786.htm

The Federal Food, Drug and Cosmetic Act (the Act), as amended by the Family Smoking Prevention and Tobacco Control Act, requires that manufacturers report HPHCs in their products to FDA. Further, section 904(d)(1) of the Act requires FDA to "put on public display a list of HPHCs in tobacco products and tobacco smoke by brand and by quantity in each brand and subbrand in a format that is understandable and not misleading to a lay person". See: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/RiskCommunicationAdvisoryCommittee/UCM364001.pdf.

Previous research conducted by FDA and others have found that consumers have limited knowledge and awareness of chemicals in tobacco products, may be misled by quantitative information insofar as mistakenly believing lower risk to harm from a product that contains lower amounts of specific constituents or fewer overall constituents. FDA’s first phase of research on the public display of HPHC lists was presented to a joint meeting of FDA’s Risk Communication Advisory Committee and Tobacco Products Scientific Advisory Committee in August 2013. Information about the joint meeting, which includes presentations on the legal requirements related to HPHC information and FDA’s research in this area, may be found at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/TobaccoProductsScientificAdvisoryCommittee/ucm346875.htm

Additional information, including Frequently Asked Questions, can be found at https://prevention.nih.gov/tobacco-regulatory-science-program/funding-opportunities

Research Objectives and Scope

This FOA is focused on the following topics related to the public display of HPHC data. Only applications proposing research projects relevant to this topic will be considered for funding:

• Research to define and operationalize what constitutes public display of HPHC information by brand and by quantity in each brand and subbrand in a format that is "understandable and not misleading" to a lay person.
• Design of a format by which to put on public display information by brand and by quantity in each brand and subbrand, based on best practices and scientific evidence, to increase the likelihood that when such information is put on public display is understandable and not misleading to lay persons.

Areas that you may want to consider include:

• The impact of the display of exact values versus ranges for HPHCs
• The effects of numerical display versus pictorial display versus word-based display
• How consumers would use this list
• Positive and negative outcomes of consumers accessing this information
• The different audiences that may access this information
• The channel that is used to publicly display this information

Section II. Award Information

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

• 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)
• Eligible Agencies of the Federal Government
• 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
• Non-domestic (non-U.S.) Entities (Foreign Institutions)

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.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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 one application per parent award is allowed.

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) including Supplemental Grant Application Instructions 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:

Research Strategy not to exceed 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 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:

TOBACCO REGULATORY SCIENCE PROGRAM
6100 EXECUTIVE BLVD., ROOM 3B01
Rockville, MD 20892-7530 (for regular mail)
Rockville, MD 20852 (for express mail, courier service or non-USPS service)
Telephone: 301-451-7464
Email: [email protected]

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:

• 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.

Senior/Key Personnel Form

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

• 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.

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.

Project Summary (for use with paper-based submissions)

A project summary/abstract for the supplement application should be submitted that is distinct from the project summary/abstract for the parent award.

Other Project Information (for use with electronic submissions

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

Project Summary/Abstract: A project summary/abstract for the supplement application should be submitted that is distinct from the project summary/abstract for the parent award.

IACUC Documentation and IRB Documentation (Uploaded via the Other Attachments Section for electronic submissions or Appendix for paper-based submissions)

If applicable, include documentation that the proposed research experience was approved by the Institutional Animal Care and Use Committee (IACUC) or human subjects Institutional Review Board (IRB) at the grantee institution. Adherence to the NIH policy for including women and minorities in clinical studies must also be ensured, if additional human subjects involvement is planned for the supplement component.

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

When conducting clinical research, follow all instructions for completing the Planned Enrollment Report 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.

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the 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.

Awards funded under this FOA are not subject to SNAP authorities and do not have authority for the carryover of unobligated balances from budget period to any subsequent budget period without prior written approval from NIH. Special reporting requirements also apply, as described in Section VI.3. Reporting.

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. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues.

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 compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant 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 increase or preserve the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved?
• How does the administrative supplement address the research priorities identified in the FOA?
• Will the outcomes of the supplement provide new information to further develop the knowledge base that informs the manufacture, distribution and marketing of tobacco products in order to protect the public health?
• Are the strategies, method, and analyses well-reasoned and appropriate to accomplish the specific aims of the supplement?
• What is the likelihood that the work proposed by the supplement will be completed within a 12 month project period?
• Are the PD/PIs, collaborators and other researchers well suited and have the necessary expertise to complete the project?

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 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.

The research findings generated from this FOA may be used to provide scientific evidence informing the regulation of the manufacture, distribution, and marketing of tobacco products to protect public health. If the research data are cited publically in support of regulation, institutions of higher education, hospitals, and other non-profit organizations are subject to the Freedom of Information Act (FOIA) as outlined in Revised Circular A-110 (http://www.whitehouse.gov/omb/circulars_a110/) and section 2.3.11.2.3 of the NIH Grants Policy Statement.

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. An Interim Report will be due six (6) months following the project start date, as well as the annual progress report. Electronic copies should be sent to the Grants Management Specialist listed on the Notice of Grant Award. The scientific summary should be a maximum of two (2) pages.

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
Email: [email protected]

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: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-710-0267
Email: [email protected]

Scientific/Research Contact(s)

Rachel Grana, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-5899
Email: [email protected]

Aaron White, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-9737
Email: [email protected]

Mary A. Kautz, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-3206
Email: [email protected]

Peer Review Contact(s)

Not Applicable

Financial/Grants Management Contact(s)

Amy Knight
National Cancer Institute (NCI)
Telephone: 301-631-3007
Email: [email protected]

Judy S. Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: [email protected]

Amy Bucheimer
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-6710
Email: [email protected]

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 and under the Family Smoking Prevention and Tobacco Control Act (FSPTCA), Public Law 111-31.