View this page "FDA Solicitation for Secondary Analysis of the Effects of Menthol"

[Rick Bevins]

SOLICATION FOR SECONDARY ANALYSIS

On behalf of the Food and Drug Administration’s Center for Tobacco
Products, RTI International is soliciting applications for secondary
analysis to address topics that can inform discussions about the
development of regulatory policy regarding the use of menthol in
cigarettes. Specifically, the analyses supported through this
mechanism will be shared with members of the Tobacco Product
Scientific Advisory Committee to help inform their recommendation
regarding the impact of menthol in cigarettes on public health.

Topics of Interest. Topics of particular interest include the
independent effect of menthol in cigarettes on:

· Initiation of cigarette smoking

· Tobacco dependence

· Tobacco cessation

· Health effects of smoking

Priority will be given to analyses that can identify the effect of
menthol independent of the effect of race and smoking intensity.

Support. Researchers whose plans for secondary analysis are approved
will receive financial support. Support can be provided either as a
consultant agreement or through a subcontract to the researchers’
institution. Up to $10,000 is available per application. Budgets
should reflect a reasonable level of effort given the timeframe.
Primary data collection will not be supported.

Special Requirements:

In order to meet the regulatory schedule, all secondary analyses
supported under this contract must be completed, along with a draft
report of findings, no later than October 20, 2010. Final reports are
due no later than November 10, 2010.

Researchers must also provide documentation of how the data were
collected, analyzed, and interpreted, including relevant statistical
code at the conclusion of analysis.

Researchers may develop independent publications based on these
analyses. However, we alert applicants that FDA plans to prepare and
disseminate a summary report of findings from these secondary
analyses.

For researchers who chose not to apply but who have relevant data sets
of interest, we would appreciate receiving brief descriptions of these
potential data sources.
When submitting proposals, applicants should report the source of
funding for the collection of data being used for secondary
analysis .In addition, applicants must disclose any potential, and
current (within the past 18 months), conflicts of interests, including
any “financial interests and involvements in the issue, affected
products, and/or affected companies or firms. Affected products
include tobacco and menthol. Affected companies or firms include
manufacturers of tobacco products and menthol flavorings/flavorants.”

Streamlined Application Procedures

Researchers interested in conducting secondary analyses can submit a
brief (3 page) application to Ms. Michaela Coglaiti (email
cogl...@rti.org). A description of structure the application
follows. Proposals will be reviewed by RTI and FDA. There is no
strict limit on the number of applications that will be funded under
this mechanism.

Application requests should be submitted by September 7, 2010.

Application Instructions

Applications should be no longer than 3, single-spaced pages, with 1”
margins and 11 point Arial font. Please use the following format:

· State of the problem and relevance to key topics of interest
· Study hypothesis/question
· Description of data source, study population, timeframe, sample
size, etc.
· Primary outcome(s)
· Analytic approach and mock analysis table(s)
· Strengths and weaknesses of data/analysis approach in
addressing key questions (e.g., potential power to detect differences,
racial/ethnic diversity of sample, quality of key variables, etc).
· Timeframe for completing analyses.
· Brief bios of key staff
· Funding source(s) for the collection of data being proposed for
secondary data analysis
· Please list select references for papers that have been
published using the p

Full resume of key staff can be included as an appendix.

Budget. The budget should indicate the full cost of the request
(inclusive of direct and indirect costs), the proposed level of effort
(i.e., hours) for proposed staff, and any other direct costs needed to
complete the analyses.
The mission of the NIH Tobacco and Nicotine Research Interest Group is
to increase collaboration, coordination and communication of tobacco-
and nicotine-related research across NIH Institutes and Centers and
with other DHHS agencies.
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