Notice of Correction for RFA-OD-17-002 "Center for Coordination of Analytics, Science, Enhancement, and Logistics (CASEL) in Tobacco Regulatory Science (U54)"

Notice Number: NOT-OD-17-054

Key Dates
Release Date: April 10, 2017

Related Announcements
RFA-OD-17-002

Issued by
National Institutes of Health (NIH)
Division of Program Coordination, Planning and Strategic Initiatives, Office of Disease Prevention (ODP)

Purpose

This notice corrects (1) application information in Section IV.2 Content and Form of Application Information, (2) Administrative and National Policy Requirements found in Section VI.2, and (3) reporting requirement information found in Section VI.3 Reporting of RFA-OD-17-002, "Center for Coordination of Analytics, Science, Enhancement, and Logistics (CASEL) in Tobacco Regulatory Science (U54)".

(1) The following section of the RFA is revised accordingly:
Currently reads:
Section IV. Application and Submission Information
2. Content and Form of Application Information

SF424 (R&R) Cover (Center Named Core)
Describe the specific aims of the additional Center-Named Cores that may be a part of the TCORS. Each Center-Named Core must have a separate specific aims page. Complete only the following fields:

  • Applicant Information
  • Type of Applicant (optional)
  • Descriptive Title of Applicant’s Project
  • Proposed Project Start/Ending Dates

Modified to read:
Section IV. Application and Submission Information
2. Content and Form of Application Information

SF424 (R&R) Cover (Center Named Core)
Complete only the following fields:

  • Applicant Information
  • Type of Applicant (optional)
  • Descriptive Title of Applicant’s Project
  • Proposed Project Start/Ending Dates

(2) The following section of the RFA is revised accordingly:

Currently reads:
Section VI. Award Administration Information
2. Administrative and National Policy Requirements

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements.  FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award.  An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS.  The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.”  This provision will apply to all NIH grants and cooperative agreements except fellowships.

Modified to read:
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements.  FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award.  An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS.  The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.”  This provision will apply to all NIH grants and cooperative agreements except fellowships.

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 45 CFR Part 75.322  and NIH Grants Policy Statement Chapter 2.3.11.2.3

(3) The award under this RFA will be administered by the NIH using designated funds from the FDA CTP for tobacco regulatory science mandated by the Family Smoking Prevention and Tobacco Control Act (FSPTCA), Public Law 111-31. All NIH grants using FDA CTP designated funds are required to submit an interim report due at six (6) months following the project start date.

The following section of the RFA is revised accordingly:

Currently reads:
Section VI. Award Administration Information
3. Reporting
When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

Modified to read:
Section VI. Award Administration Information
3. Reporting
When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

An Interim Report will be due at the end of six (6) months following the project start date. Electronic copies should be sent to the Grants Management Specialist listed on the Notice of Grant Award. The Interim Report will use the Non-Competing Continuation Progress Report; PHS 2590 (http://grants.nih.gov/grants/funding/2590/2590.htm). The Interim Progress Report should include: Form Page 1, Form Page 1-Continuation, Project/Performance Site Format Page - use only if additional space is needed; Form Page 5: Progress Report Summary, and Continuation Page as needed. The scientific summary should be a maximum of two (2) pages.

When submitting Interim Progress Reports for CASEL, provide a separate Progress Report Summary (Form Page 5 and continuation page if necessary) for each core in the grant. The Progress Report Summary for each core should not exceed two pages. Tables and figures that summarize key accomplishments are not counted in the two-page limit. Inclusion enrollment reports, detailed budgets, and other PHS 2590 forms not listed above are not required.

A final Research Performance Progress Report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

All other aspects of the FOA remain unchanged.

Inquiries

Please direct all inquiries to:

Tobacco Regulatory Science Program
Office of Disease Prevention
Telephone: 301-451-7464
Email: TRSP@mail.nih.gov