Administrative Supplements for Special Research Priority on U.S. Food and Drug Administration (FDA) Tobacco Product Regulation

Notice Number: NOT-CA-10-007

Key Dates
Release Date: January 15, 2010
Request Submission Deadline: February 26, 2010
Earliest Anticipated Start Date for Supplement Awards: May 2010

Issued by
National Cancer Institute (NCI) (http://www.nci.nih.gov)

Purpose

The National Cancer Institute (NCI) is announcing the availability of administrative supplements to NCI-funded cancer control research that is relevant to tobacco products. The enactment of the Family Smoking Prevention and Tobacco Control Act of 2009 (Tobacco Control Act) gave the U.S. Food and Drug Administration (FDA) authority to regulate tobacco products. Although there is a strong scientific base relevant to the regulatory provisions of the Tobacco Control Act, there is a need to expand this science base further to inform more effective regulations.
The purpose of these administrative supplements is to ensure the expansion of knowledge that can be useful for FDA efforts to design and implement tobacco product standards, regulations, and criteria for product-related review.

Eligibility Requirements
Current NCI awardees of R01, P01, P50, U01, and U19 grants/cooperative agreements pertinent to cancer control may apply for an administrative supplement provided the following conditions are met:

1. The topic of the administrative supplement must be related to the focus of research proposed and conducted under the original cancer control award (“parent” award) and must be relevant 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 Principal Investigator (PI) for the supplement must be the PI of the parent award.

Diverse aspects of cancer control are appropriate for supplements related to FDA regulation of tobacco products including cigarettes, all forms of smokeless tobacco, and roll-your-own tobacco products, (e.g., youth tobacco use, consumer perception, post-marketing surveillance, cessation, and health outcomes).  Specific areas of interest to FDA include, but are not limited to:

• Relationship of product ingredient composition to user exposure to substances (especially cigarettes with pyrolytic transformations, but also smokeless products)
• Relationships of product design features (i.e., not ingredient/substances) on user exposures to harmful substances
• Determination of range of variation in manner of use (by individual users) of tobacco products that lead to variation in harmful substance exposures
• Effects of product design features on user and bystander behavior
• Methods of testing products with relevance to user exposures and taking into account, where feasible, individual user variations in manner of use
• Development and qualification of biomarkers, both of short term tissue injury and of long term tobacco-related disease risks (e.g., cancer, inflammation, tumor promotion, co-carcinogenesis, chronic obstructive pulmonary disease, cardiovascular disease)
• Relationships of differences in substance exposure to differences in biomarker measurements and health risks
• Product labeling including health warnings, cessation messages, packaging, and “inserts” and “onserts” 
• Consumer risk perception changes associated with revised product presentation (e.g., warning labels, packaging including new use of color to differentiate subbrands, descriptors not specifically addressed by the Tobacco Control Act  (e.g., “mellow”), “tombstone packaging,” advertising (including restrictions such as black/white text only), and promotion
• Youth tobacco use including:
• impact of tobacco marketing to youth, specifically  impact of descriptors, colors, implied reduced risk,
• preferences of minors for initial experimentation/initiation of tobacco (e.g., dissolvables, smokeless tobacco , low-tar, menthol, particular brands),
• effect of menthol cigarettes on youth smoking,
• effect of reduced nicotine cigarettes on youth smoking,
• effect of ban of flavorings in cigarettes on youth tobacco use including cigarettes, flavored cigars and smokeless tobacco
• marketing and use of dissolvable tobacco products
• Consumer perception of potential modified risk products as related to interest in quitting or interest in trying tobacco products
• Changing marketing practices, including the use of new communication technologies, influence on consumer perceptions and behavior, especially among youth
• Effects of reduced-nicotine tobacco products to on initiation and cessation

The National Cancer Institute is committed to working with FDA to develop research priorities relevant to the new FDA mandate. Projects proposed for supplemental funding should focus on those aspects of cancer control that are reasonably likely to inform policy makers. In particular, applicants should indicate how the project outcomes are expected to expand the science base specifically relevant to provisions of the Tobacco Control Act and, thereby, reasonably likely to play an important role in implementing standards, regulations, and criteria for review under the FDA’s new authority.
Investigators applying for these administrative supplements are strongly encouraged to establish, if appropriate, additional collaborations with experts/researchers/practitioners from related areas, who may, for example, provide economic analysis or marketing research and/or have unique expertise related to menthol-containing tobacco products and their impact on youth tobacco use. It is also recommended that applicants requesting supplemental funding have a plan for how they would disseminate information about their findings with the larger communities of behavioral, psychosocial, and clinical investigators in the context of FDA authority to regulate tobacco products. The inclusion of a timeline that indicates how the tasks will be accomplished during the supplement year is further recommended.

Priority will be given to funding projects that can obtain data directly relevant to implementation of the Tobacco Control Act.  Timeliness of making these data available to FDA is also an important consideration.

Note: Priority in funding will be given to applications that address low income and ethnically diverse populations.

The NCI intends to commit approximately $1,000,000 in FY 2010 to fund five to seven administrative supplements in response to this initiative.

An applicant must request a project period of 1 year only. The budget for total costs is limited to $200,000 per request.

Although the financial plans of the NCI provide support for this program, administrative supplement awards pursuant to this initiative are contingent upon the availability of funds and the receipt of a sufficient number of meritorious requests.

Submission of Requests

Requests for these administrative supplements must be submitted to the NCI Division of Cancer Control and Population Sciences (DCCPS) (see address below). This Notice is a one-time announcement and formal requests must be received on or before February 26, 2010.

Note that the NIH Center for Scientific Review (CSR) IS NOT involved in receipt and processing of these requests.

Requests must be signed by the Authorized Organizational Representative (AOR) at the grantee institution.

Applicants are strongly encouraged to submit requests electronically as an e-mail attachment in pdf format; however, the signature of the AOR must be clearly visible.  The e-mail address for electronic submission is: vandors@mail.nih.gov

Applicants may also submit applications on paper (original and four copies) to:

Stacey Vandor
Division of Cancer Control and Population Sciences
National Cancer Institute
6130 Executive Boulevard, EPN Room 6136
Bethesda, MD 20892 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for non-USPS delivery)

The request should contain sufficient detail (similar to a standard research application) to allow the NCI staff members to assess the scientific merit of the proposed special research priority plans and the appropriateness of the request for supplemental funding.

All requests must include an itemized budget.  Budget requests must not exceed $200,000 in total costs for a funding period not exceeding 12 months.

Requests will be evaluated by NCI program staff (and appropriate consultants) who have expertise in the cancer control research area of youth tobacco, products that may modify risks, marketing, measurement, and consumer perception. Awards will be determined based on scientific merit, program relevance, dissemination research potential, and availability of funds.

Anticipated Award Date

The earliest anticipated supplemental award date for this program will be May 1, 2010.

Inquiries

Before submitting a request, each PI is encouraged to discuss their plans for supplemental research with the NCI Program Director (i.e., Program Official) who is responsible for the particular “parent” R01, P01, P50, U01, or U19 award.

General inquiries concerning the programmatic and review matters should be directed to:

Cathy L. Backinger, PhD, MPH
Tobacco Control Research Branch
Behavioral Research Program
Division of Cancer Control and Population Sciences
National Cancer Institute
6130 Executive Blvd., MSC 7337
Bethesda, MD 20892-7337 (for regular mail)
Rockville, MD 20852 (for express mail and deliveries)
Phone: 301-496-8584
Fax: 301-496-4675
Email: backingc@mail.nih.gov

Inquiries regarding administrative and fiscal matters should be directed to:

Crystal Wolfrey
Office of Grants Administration
National Cancer Institute
6120 Executive Boulevard, EPS Room 243, MSC 7150
Bethesda, MD 20892-7150 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: 301-496-8634
E-mail: crystal.wolfrey@nih.gov

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