Full Text CA-94-015

RESEARCH IN INNOVATIVE STRATEGIES TO REDUCE TOBACCO USE

NIH GUIDE, Volume 23, Number 19, May 20, 1994

RFA:  CA-94-015

P.T. 34

Keywords: 
  Smoking Behavior 
  Disease Prevention+ 


National Cancer Institute

Letter of Intent Receipt Date:  June 29, 1994
Application Receipt Date:  September 22, 1994

PURPOSE

The Division of Cancer Prevention and Control (DCPC) of the National
Cancer Institute (NCI) invites research grant applications to study
strategies to develop, implement, and disseminate effective tobacco
control interventions.  Tobacco control interventions are those
interventions that can influence large populations to reduce tobacco
use.  These interventions include, but are not necessarily limited
to, restrictions on sales of tobacco to minors, restrictions on
indoor smoking, increases in tobacco excise taxes, and restrictions
on tobacco advertising.  The goal of this research is to assist
policy makers and public health professionals in the enactment and
enforcement of effective tobacco control policy interventions.

HEALTHY PEOPLE 2000

The Public Health Service (PHS) is committed to achieving the health
promotion objectives of "Healthy People 2000," a PHS-led national
activity for setting priority areas.  This Request for Application
(RFA), Research in Innovative Strategies to Reduce Tobacco Use, is
related to the priority area of tobacco.  Potential applicants may
obtain a copy of "Healthy People 2000" (Full Report:  Stock No.
017-001-00474- 0) or "Healthy People 2000" (Summary Report:  Stock
No. 017-001-00473-1) through the Superintendent of Documents,
Government Printing Office, Washington, DC 20402-9325 (telephone
202-783-3238).

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic and foreign, for-profit and
non-profit organizations, public and private institutions, such as
universities, colleges, hospitals, laboratories, units of State and
local governments, and eligible agencies of the Federal government.
Applications from minority individuals and women are encouraged.

MECHANISM OF SUPPORT

This RFA will use the National Institutes of Health (NIH) individual
research project grant (R01) mechanism.  Responsibility for the
planning, direction, and execution of the proposed project will be
solely that of the applicant.  The total project period for
applications submitted in response to the present RFA may not exceed
four years.  The anticipated award date is March 1, 1995. Because the
nature and scope of the research proposed in response to this RFA may
vary, it is anticipated that the size of an award will also vary.
This RFA is a one-time solicitation.  Future unsolicited competing
continuation applications will compete with investigator-initiated
applications and be reviewed according to the customary NIH peer
review procedures.

FUNDS AVAILABLE

Approximately $4 million in total costs for four years ($1 million
per year for each of four years) will be committed to fund
applications submitted in response to this RFA.  It is anticipated
that three or more new awards will be made, dependent on the receipt
of a sufficient number of applications of high scientific merit.
Although this program is provided for in the financial plans of the
National Cancer Institute, the award of grants pursuant to this RFA
is also contingent upon the availability of funds for this purpose.

RESEARCH OBJECTIVES

Background

Early efforts to reduce the prevalence of cigarette smoking in the
U.S. focused on individualized approaches to help adult smokers to
stop and on educational programs to prevent youth from starting to
smoke.  Later research programs also included the use of mass media
interventions.  In more recent years, interventions have included
efforts at altering the environment of smokers and potential smokers,
through the use of public and private policies on tobacco use.  Such
policies can influence the cost of tobacco products, the prevalence
of mass media messages that encourage tobacco use, the kinds of
places where smoking is allowed, and the ability of youth to purchase
tobacco. Policies are often promulgated by legislative bodies at
local, state, and national levels.  However, regulatory agencies and
private corporations also produce important policies on tobacco use.

Currently, there is widespread agreement among tobacco control
scholars that the most effective intervention programs are
comprehensive in nature, and include policy interventions, mass media
interventions, and more traditional cessation and prevention
services.  Many scholars consider policy interventions as perhaps the
most effective of these interventions.

The impact of increases in cigarette excise taxes has been documented
more thoroughly than most other tobacco control policies.  The rapid,
predictable, and widespread impact of significant increases in excise
taxes makes it one of the most effective of tested tobacco control
interventions.

The impact of clean indoor air policies on cigarette consumption is
less definitive.  Additional studies may provide more complete
information, but there is growing evidence that smoking restrictions
may be causally related to reductions in smoking prevalence.

The effect of cigarette advertising on cigarette consumption,
especially among youth, has recently been examined.  Investigations
have documented reductions in smoking prevalence in association with
restrictions on advertising, bans on smoking, and counter-advertising
campaigns.

A final area of tobacco control policies that appears to reduce
consumption are those policies that effectively restrict the sale of
tobacco to minors.

In spite of the recognition that legislation and other policies can
decrease tobacco use, there remain many questions about the most
effective strategies to develop, implement, enforce, and disseminate
tobacco control policies.  Included among these are questions about
barriers to the passage of effective legislation, especially the role
of tobacco companies in opposing public health legislation.  Only a
small number of studies have documented the large-scale and organized
efforts to stop policy interventions.  Continued documentation of
these efforts is critical to refining future policy initiatives.

Project Description

This program is intended to stimulate innovative behavioral, public
health, and economic research on tobacco control policy
interventions, including the analysis of their feasibility,
effectiveness and consequences of implementation.  The results of
this research should be useful to policy makers and public health
professionals in the enactment and enforcement of effective tobacco
control policies.

A variety of research questions may be addressed.  Investigators are
encouraged to discuss more than one research question in their
applications and to propose research that will address several such
questions.  Below are examples of research questions that could be
addressed.

Tobacco Product Pricing and Taxation

o  What would be the effect on consumption of very large increases in
tobacco product taxes?

o  What are the consequences of earmarking tobacco product tax
revenues for specific programs?

o  What are the most effective strategies for increasing tobacco
excise product taxes?

Restrictions on Indoor Smoking

o  What is the effect of smoking bans in schools on the smoking
behavior of students?

o  What are the most effective strategies for implementing clean
indoor air policies?

o  What strategies facilitate and accelerate compliance with policies
that restrict smoking?

o  What are the economic costs and benefits of ordinances and
policies that restrict smoking?

Tobacco Product Marketing and Promotion

o  What is the role of advertising in: recruiting new smokers/users,
reducing the cessation rate among current users, and increasing the
relapse rate in former smokers/users?

o  What are the consequences of restricting tobacco advertising, for
example, through the removal of billboards near schools or in sports
stadiums, or through bans on sponsorship of sporting events?

o  How are youth, women, and minority populations targeted by tobacco
advertising?

Access to Tobacco Products

o  What are the most effective interventions to reduce tobacco sales
to minors?

o  What effects do restrictions on vending machine sales have on
youth access to tobacco?

o  What strategies can be used to increase enforcement of existing
laws that ban sales to minors?

o  What are the effects of penalties directed at retailers, minors,
or parents?

In selecting topics for this research, applicants must address the
possible study results and how these results will help policy makers
develop and improve future initiatives.

These and other research questions will require a variety of study
designs and outcome measures.  Outcome measures may include, but are
not limited to, measures of smoking prevalence and tobacco
consumption, initiation, cessation, and relapse rates, financial
information, enactment and enforcement of policies, and  changes in
knowledge and attitudes about tobacco use and tobacco control
policies.  While randomized, controlled trials are usually preferred,
the nature of these research questions and the realities of policy
processes may preclude such a design.  In such cases, applicants must
clearly justify the choice of their design.

SPECIAL REQUIREMENTS

It is expected that grantees will participate in a series of
collaborative meetings at NCI.  Although independence and originality
are encouraged in the approaches of the various investigators, they
are expected to share ideas, experiences, and information in
attempting to reach the common goal.  Funds should be budgeted to
permit travel of senior staff to Bethesda, Maryland twice a year over
the course of the grant.  Funds awarded for travel to these meetings
will be restricted for this purpose only. Failure to participate in
these meetings may adversely affect NCI evaluation of the project's
progress when the non-competing continuation application for the
following year is reviewed.

STUDY POPULATIONS

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN
SUBJECTS

It is the policy of the NIH that women and members of minority groups
and their subpopulations must be included in all NIH-supported
biomedical and behavioral research projects involving human subjects,
unless a clear and compelling rationale and justification is provided
that inclusion is inappropriate with respect to the health of the
subjects or the purpose of the research.  This new policy results
from the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43) and supersedes and strengthens the previous policies
(Concerning the Inclusion of Women in Study Populations, and
Concerning the Inclusion of Minorities in Study Populations) which
have been in effect since 1990.  The new policy contains some new
provisions that are substantially different from the 1990 policies.

All investigators proposing research involving human subjects should
read the "NIH Guidelines on the Inclusion of Women and Minorities as
Subjects in Clinical Research," which was reprinted in the Federal
Register of March 28, 1994 (59 FR 14508-14513) to correct typesetting
errors in the earlier publication,and reprinted in the NIH GUIDE FOR
GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11.

Investigators may obtain copies from these sources or from the
program staff or contact person listed below.  Program staff may also
provide additional relevant information concerning the policy.

LETTER OF INTENT

Prospective applicants are asked to submit, by June 29, 1994, a
letter of intent that includes a descriptive title of the proposed
research, the name, address, and telephone number of the Principal
Investigator, and the number and title of the RFA in response to
which the application may be submitted.

Although a letter of intent is not required, is not binding, and does
not enter into the review of subsequent applications, the information
that it contains allows NCI staff to estimate the potential review
workload and to avoid conflict of interest in the review.

The letter of intent is to be sent to Dr. Marc Manley at the address
listed under INQUIRIES.

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 9/91) is to be used
in applying for these grants.  These forms are available at most
institutional offices of sponsored research; from the Office of
Grants Information, Division of Research Grants, National Institutes
of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892,
telephone 301/435-0714; and from the NIH program administrator listed
under INQUIRIES.

The RFA label available in the PHS 398 (rev. 9/91) application form
must be affixed to the bottom of the face page of the application.
Failure to use this label could result in delayed processing of the
application such that it may not reach the review committee in time
for review.  In addition, the RFA title and number must be typed on
line 2a of the face page of the application form and the YES box must
be marked.

Submit a signed, typewritten original of the application, including
the Checklist, and three signed, photocopies, in one package to:

Division of Research Grants
National Institute of Health
Westwood Building, Room 240
Bethesda, MD  20892**

At the time of submission, two additional copies of the application
must also be sent to:

Ms. Toby Friedberg
Referral Office
Division of Extramural Activities
National Cancer Institute
Executive Plaza North, Room 636
Bethesda, MD  20892

Applications must be received by September 22, 1994.  If an
application is received after that date, it will be returned to the
applicant without review.  The Division of Research Grants (DRG) will
not accept any application in response to this announcement that is
essentially the same as one currently pending initial review, unless
the applicant withdraws the pending application.  The DRG will not
accept any application that is essentially the same as one already
reviewed.  This does not preclude the submission of substantial
revisions of applications already reviewed, but such applications
must include an introduction addressing the previous critique.

No addenda or appendix materials will be accepted after the receipt
date unless requested by the Scientific Review Administrator.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by DRG
and responsiveness by the NCI.  Incomplete applications will be
returned to the applicant without further consideration.  If the
application is not responsive to the RFA, NCI staff will contact the
applicant to determine whether to return the application to the
applicant or submit it for review in competition with unsolicited
applications at the next review cycle.

Applications that are complete and responsive to the RFA will be
evaluated for scientific and technical merit by an appropriate peer
review group convened by the NCI in accordance with the review
criteria stated below.  As part of the initial merit review, a
process (triage) may be used by the initial review group in which
applications will be determined to be competitive or non-competitive
based on their scientific merit relative to other applications
received in response to the RFA.  Applications judged to be
competitive will be discussed and be assigned a priority score.
Applications determined to be non-competitive will be withdrawn from
further consideration and the Principal Investigator and the official
signing for the applicant organization will be notified.  The second
level of review will be provided by the National Cancer Advisory
Board.

Review Criteria

o  The extent to which the proposed research will meet the goal of
the RFA.

o  The extent to which the proposed research will meet the project
goal to better understand strategies to develop, implement, and
disseminate effective tobacco control policy interventions.

o  Scientific significance and originality of the proposed research.

o  Appropriateness and adequacy of the methodology proposed to carry
out the research.

o  Availability of resources and facilities to perform the proposed
research.

o  Qualifications and experience of the Principal Investigator and
staff.

o  Documented support for the project from participating agencies and
organizations, if any, including previous relationships and relevant
experience in conducting other collaborative efforts, as well as a
clear delineation of each agency's responsibilities for the project.

o  Appropriateness of the proposed budget and duration in relation to
the proposed research.

AWARD CRITERIA

The anticipated date of award is July 1, 1995.

Awards will be made based on the following criteria:  priority score,
availability of funds, and programmatic priorities.

INQUIRIES

Written and telephone inquiries concerning this RFA are encouraged.
The opportunity to clarify any issues or questions from potential
applicants is welcome.

Direct inquiries regarding programmatic issues and address the letter
of intent to:

Marc Manley, M.D., M.P.H
Division of Cancer Prevention and Control
National Cancer Institute
Executive Plaza North, Room 233
Bethesda, MD  20893
Telephone:  (301) 496-8584
FAX:  (301) 496-8675

Direct inquiries regarding fiscal matters to:

Marci Bollt
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Room 243
Bethesda, MD  20892
Telephone:  (301) 496-7800

AUTHORITIES AND REGULATIONS

This program is described in the Catalog of Federal Domestic
Assistance No. 93.339.  Awards are made under authorization of the
Public Health Service Act, Title IV, Part A (Public Law 78-410, as
amended by Public Law 99-158, 42 USC 241 and 285) and administered
under PHS grants policies and Federal Regulations 42 CFR 52, 45 CFR
Part 74, and 45 CFR Part 92.  This program is not subject to the
intergovernmental review requirements of Executive Order 12372 or
Health Systems Agency review.

The Public Health Service (PHS) strongly encourages all grant
recipients to provide a smoke-free workplace and promote the non-use
of all tobacco products.  This is consistent with the PHS mission to
protect and advance the physical and mental health of the American
people.

.

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