Administrative Supplements to NIH-funded Program Projects/Center Grants: Research Relevant to the Family Smoking Prevention and Tobacco Control Act


Notice Number: NOT-CA-12-007

Key Dates

Release Date:  January 20, 2012
Receipt Date: April 6, 2012
Earliest Anticipated Start Date: September 2012

Issued by

National Cancer Institute (NCI)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Environmental Health Sciences (NIEHS)
National Institute on Drug Abuse (NIDA)
National Heart, Lung, and Blood Institute (NHLBI)
National Institute of Mental Health (NIMH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Purpose

The NIH Institutes and Centers (ICs) named above, announce an Administrative Supplement opportunity available to eligible NIH awardees with active P01, P50, and P60 grants (see details below). Depending on the funding mechanism and the scope of the eligible "parent" award, the supplemental funding may be requested to augment research projects relevant to smoking and tobacco products and/or their constituents.  At least one project must be relevant to the goals of this Administrative Supplement Program.

These administrative supplements will be supported using funds from the Food and Drug Administration (FDA) Center for Tobacco Products (CTP) designated for tobacco regulatory research and mandated by the Family Smoking Prevention and Tobacco Control Act (FSPTCA), Public Law 111-31. Following FSPTCA, the NIH and the FDA have formed an interagency partnership to foster and facilitate research relevant to tobacco regulations. Within the framework of the Tobacco Control Act, the FDA and NIH share interest in supporting research and pilots to aid the development and evaluation of optimal tobacco product regulations.

The administrative supplements program and other FDA-NIH initiatives (for details, see http://cancercontrol.cancer.gov/nih-fda) are intended to provide a rapid mechanism for the FDA to promote research and generate findings needed to inform the development of regulations pertaining to the manufacture, distribution, and marketing of tobacco products. Consistent with the FDA CTP mission, this Notice seeks administrative supplements that expand, enhance, or facilitate research relevant to these issues.

BACKGROUND

Role of FDA in FSPTCA. With the passage of FSPTCA in June 2009, the FDA has authority to regulate the manufacture, marketing, and distribution of tobacco products in order to protect public health. A tobacco product is defined as “any product made or derived from tobacco that is intended for human consumption, including any component, part or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory or a tobacco product).” At present, FDA’s jurisdiction of tobacco products includes all cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco. It is anticipated that FDA will assert jurisdiction over all other tobacco products currently not under its jurisdiction that meet the statutory definition of “tobacco product.” (Regulation Identification Number 0910-AG38Regulation of E-Cigarettes and Other Tobacco Products). The main provisions of FSPTCA defining the role of FDA are as follows.

A full description of the FSPTCA can be found at: http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM237080.pdf

Partnership between FDA and NIH in the Context of FSPTCA. Within the framework of the Tobacco Control Act, the NIH and the FDA have formed an interagency partnership to foster research relevant to tobacco regulations. These activities at the FDA are coordinated by Center for Tobacco Products (CTP). FDA and NIH intend to promote a rapid generation of research data to inform the regulation of the manufacture, distribution, and marketing of tobacco products to protect public health.

Eligibility

Current NIH awardees with active P01, P50, and P60 grants, awarded by any of the participating Institutes/Centers, may apply for an administrative supplement provided the following conditions are met.

The proposed supplement must be within the general scope of the peer-reviewed activities and aims approved within the parent grant.

IMPORTANT: The funding mechanism being used to support this program, administrative supplements, can be used to cover cost increases that are associated with achieving certain research objectives as long as they are within the original scope of the project. 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. Please contact the Program Director assigned to the parent grant as well as the IC Scientific Contact listed in this FOA, for questions related to scientific or programmatic content and to determine if the supplement fits within the approved scope of the project.

Important Note: NOT eligible for this Administrative Supplement Program are awards that:

To be eligible, the parent grant must be active through the entire time period of the supplement, and the research proposed in the supplement must be accomplished within the competitive segment. No-cost extensions cannot be used to accommodate this requirement.

GENERAL SCIENTIFIC PRIORITIES

The focus is on the toxicity and use of new and emerging tobacco products, effective methods to substantially reduce the toxicity of tobacco products and tobacco smoke, effective methods to substantially reduce the overall addictiveness of cigarettes and other tobacco products, and consumer perceptions and behaviors related to tobacco products, claims, and communications regarding tobacco products.

Administrative Supplements to be supported by this program are expected to advance and/or facilitate research in four areas relevant to the Family Smoking Prevention and Tobacco Control Act:  1) the toxicity and use of new and emerging tobacco products; 2) effective methods to substantially reduce the overall addictiveness of cigarettes and other tobacco products; 3) effective methods to substantially reduce the toxicity of tobacco products and smoke (mainstream and/or sidestream); and 4) consumer perceptions and behaviors related to communications regarding tobacco products.

Research questions consistent with this FOA include but are not limited to:

1. New and Emerging Tobacco Products

2. Reducing Addiction to Tobacco Products

3. Reducing Toxicity of Tobacco Products and Smoke

4. Communications about Tobacco Products

Budget and Funding Information

Approximately 20 administrative supplement awards are anticipated in FY 2012, contingent on the receipt of sufficiently meritorious requests. The funding of these Administrative Supplements is expected to commence in August 2012.

A project period of up to 2 years may be proposed (provided the parent grant is active for the entire funding period of the supplement). These administrative supplements are non-renewable.

Only one supplement per eligible "parent" grant may be requested.

Direct costs requested for the supplement must be proportional to the activities proposed and may not exceed 50% of the current annual direct costs for the parent award. In addition, the total cost requested must not exceed $2,000,000 per year and $4,000,000 over the two-year period.

IMPORTANT: This FOA only allows submission of one supplement request per parent grant. 

Preparing an Administrative Supplement Request

Requests should use the PHS398 Application Guide forms, as indicated below. Font size and other formatting rules apply as designated in the instructions. Please note: In any case where instructions provided in the PHS398 Application Guide differ from those provided herein, instructions stated in this Notice shall supersede those in the PHS398 Application Guide. 

Include in the request the following elements:

1. Cover Letter, citing this Notice, signed by the authorized organizational representative/institutional official, and containing the following information:

2. PHS 398 Form Page 1 (Face page) MS Word PDF

3. PHS 398 Form Page 2 MS Word PDF

4. A brief proposal describing the supplemental research activities, including:

A. Introduction (limit 1 page) describing how the proposed supplemental activities relate to the parent award.

B. Specific Aims for the supplement, including a brief statement of expected impact and scientific relevance of the supplemental research to the overall goals of this Administrative Supplements Program (limit 1 page).

C. Research Strategy (limit 6 pages, see details below).

Research Strategy.

Describe the proposed research explaining how it relates to the priority areas defined for this Administrative Supplements Program. Explain also how the proposed supplemental activities will augment research conducted under the parent award. Research Strategy should contain sufficient detail to allow assessment of proposed plans and the appropriateness of the request for supplemental funding in the context of the priorities of this Administrative Supplement Program. 

5. Itemized Budget for the Supplement.

Budgets for Administrative supplement requests may not exceed $2,000,000 in total costs. Direct costs requested for the supplement may not exceed 50% of the current annual direct costs for the parent award. A project period of up to 2 years may be proposed (provided the parent grant remains active). The budget request needs to be broken out over the project period proposed for the supplement. Use the standard PHS 398 Form pages for itemized budget, including justification and Facilities and Administrative costs. 

6. Biographical Sketch for all personnel, including those who are additions on the supplemental project.

7. Human Subjects/Vertebrate Animal documentation (if applicable).

Requests Review and Selection Process

Administrative supplement requests will be reviewed administratively by NIH program experts. Selection factors will include the following:

Submitting Requests

This Notice is a one-time announcement, and formal requests must be received on or before 5 p.m. EST April 6, 2012. The request must be signed by the Authorized Organizational Representative/Signing Official (AOR/SO).

Applicants must submit requests electronically as an e-mail attachment in PDF format. The signature of the AOR must be clearly visible. 

Send the application by e-mail to the IC that holds the parent grant; Application Submission Contacts listed below.  Note that the NIH Center for Scientific Review is NOT involved in receipt of these requests.

IC-Specific Contacts for Scientific Inquiries and Submission of Administrative Supplement Requests

Direct program/scientific-related inquiries to the IC Program Official indicated on the Notice of Award for your parent grant AND the IC Scientific Program Contact identified below.

Submit administrative supplement request to the contact (identified below) for the IC that holds the parent grant. Please make sure to receive an email confirmation of receipt of application from the Application Submission Contact for your parent IC listed above in this notice.

Glen Morgan, Ph.D. (For Scientific Inquiries)
National Cancer Institute
301-496-8585
Glen.morgan@nih.gov

AND

Stacey Vandor, M.P.A. (For Submission of Administrative Supplement Requests)
National Cancer Institute
301-594-6786
Stacey.vandor@nih.gov

Abraham Bautista, Ph.D. (For Scientific Inquiries and Request Submission)
National Institute on Alcohol Abuse and Alcoholism
301-443-9737
bautista@mail.nih.gov

Daniel Shaughnessy, Ph.D. (For Scientific Inquiries and Request Submission)
National Institute of Environmental Health Sciences
919-541-2506
shaughn1@niehs.nih.gov

Kristopher Bough, Ph.D. (For Scientific Inquiries and Request Submission)
National Institute on Drug Abuse
301-443-9800
boughk@mail.nih.gov

William Riley, Ph.D. (For Scientific Inquiries and Request Submission)
National Heart, Lung, and Blood Institute
301-435-0407
wiriley@mail.nih.gov

Denise Juliano-Bult, M.S.W. (For Scientific Inquiries and Request Submission)
National Institute of Mental Health
301-443-1638
djuliano@mail.nih.gov

Caroline Signore (For Scientific Inquiries and Request Submission)
Eunice Kennedy Shriver National Institute of Child  Health and Human Development
301-496-5577
signorec@mail.nih.gov

Grants Management Inquiries

Direct all financial and grants management-related questions to respective contact for your IC from the list below:

Carol A. Perry
National Cancer Institute
301-496-7205
perryc@mail.nih.gov

Judy Fox
National Institute on Alcohol Abuse and Alcoholism
301-443-4704
jfox@mail.nih.gov

Pamela Clark
National Institute of Environmental Health Sciences
919-541-7629
evans3@niehs.nih.gov

Pamela Fleming
National Institute  on Drug Abuse
301-443-6710
pam.fleming@nih.gov

Robert Tarwater
National Heart, Lung, and Blood Institute
301-402-6090
tarwater@nhlbi.nih.gov

Rebecca Claycamp
National Institute of Mental Health
301-443-2811
rc253d@nih.gov

Bryan Clark, MBA
Eunice Kennedy Shriver National Institute of Child Health and Human Development
301-435-6975
clarkb1@mail.nih.gov


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.