RESEARCH IN STATE AND COMMUNITY TOBACCO CONTROL INTERVENTIONS

Release Date: February 11, 1999

RFA:  CA-99-001

P.T.

National Cancer Institute

Letter of Intent Receipt Date:  June 18, 1999
Application Receipt Date:  July 23, 1999

PURPOSE

The purpose of this Request for Applications (RFA) is to stimulate research on
new or existing tobacco control interventions relevant to state and community 
tobacco control programs.  This will be achieved by supporting research on
innovative tobacco prevention and control interventions at the community, state,
or multi-state level.  The results of this research will guide tobacco control
programs across the Nation,  in order to increase program effectiveness and
produce real reductions in the prevalence of tobacco use.

HEALTHY PEOPLE 2000

The Public Health Service (PHS) is committed to achieving the health promotion
and disease prevention objectives of "Healthy People 2000," a PHS-led national
activity for setting priority areas.  This RFA, Research in State and Community
Tobacco Control Interventions, is related to the priority areas of tobacco and
cancer.  Potential applicants may obtain a copy of "Healthy People 2000" (Full
Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1)
through the Superintendent of Documents, Government Printing Office, Washington,
DC 20402-9325 (telephone 202-512-1800), or at
http://www.crisny.org/health/us/health7.html.

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic and foreign, for-profit and non-profit
organizations, public and private, such as universities, colleges, hospitals,
laboratories, units of State and local governments, and eligible agencies of the
Federal government.  Racial/ethnic minority individuals, women, and persons with
disabilities are encouraged to apply as Principal Investigators.

MECHANISM OF SUPPORT

This RFA will use the National Institutes of Health (NIH) research project grant
(R01) award mechanism.  Responsibility for the planning, direction, and execution
of the proposed project will be solely that of the applicant.  The total project
period for an application submitted in response to this RFA may not exceed 4
years.  Future unsolicited competing continuation applications will compete with
all investigator-initiated applications and be reviewed according to the
customary peer review procedures.  The anticipated award date is April 2000.

FUNDS AVAILABLE

The NCI intends to commit approximately $18,000,000 in FY 2000 to fund 12 to 20
new grants in response to this RFA.  An applicant may request a project period
of up to 4 years and a budget for direct costs of up to $1,000,000 per year,
excluding indirect costs on consortium arrangements.  Because the nature and
scope of the research proposed may vary, it is anticipated that the size of each
award will also vary.  Although the financial plans of the NCI provide support
for this program, awards pursuant to this RFA are contingent upon the
availability of funds and the receipt of a sufficient number of applications of
outstanding scientific and technical merit.  At this time, it is not known if
this RFA will be reissued.

RESEARCH OBJECTIVES

Background

Tobacco use, responsible for nearly one in five deaths, is the leading
preventable killer in the United States.  Cigarettes cause over 420,000 deaths
in the U.S. each year (ref 1) . This includes 120,000 deaths from lung cancer and
more than 31,000 deaths from other cancers (ref 2).  Tobacco use costs the nation
$50 billion annually in direct health care costs (ref 3), and billions more in
lost productivity.  At least 3000 lung cancer deaths occur annually in nonsmokers
because of exposure to the carcinogens contained in environmental tobacco smoke
(ref 4).  Despite the known hazards of tobacco use, 48 million adult Americans
currently smoke cigarettes (ref 5).  Seventy percent of those who smoke want to
quit (ref 6).  Approximately 3000 youth under age 18 become regular smokers every
day (ref 7).  Smoking rates among youth increased 73% between 1988 and 1996 (ref
8).

The field of tobacco control is undergoing fundamental changes.  Tobacco use has
received unprecedented attention as a result of new FDA regulations, state
lawsuits against tobacco companies, and sweeping legislative proposals to reduce
smoking, especially among youth.  Litigation has impelled the release of 
millions of secret documents from tobacco companies, including unpublished
research on nicotine addiction and tobacco marketing.  It has also produced
changes in the way tobacco is advertised and sold in some states.

Several states now invest millions of dollars annually in tobacco control
intervention programs, funded by either dedicated tobacco excise taxes or state
settlements with the tobacco companies.  State-wide programs to reduce tobacco
use have combined multiple approaches, in order to have the greatest impact on
smoking rates.  In these programs, major emphasis has been placed on mass media
campaigns and policy interventions.  These two kinds of strategies have been
studied independently, but in practice are inextricably linked.  Many more states
are now planning similar investments in tobacco control programs.  If these
programs are effective, major reductions in national smoking rates  can be
achieved.

Research on community and state interventions is a top priority for the NCI, as
identified by the Tobacco Research Implementation Group (TRIG) in its recent
report (ref 9). (Available at http://dccps.nci.nih.gov/tcrb/trip/)  Research
programs of community-based policy and  media interventions were specifically
recommended for implementation by the TRIG.

Mass media campaigns have become a highly valued, standard component of  well-
funded tobacco control programs in California, Massachusetts, Florida, Arizona,
and Oregon.  In comprehensive programs, mass media has been used to:  1) Provide
information to the public about facts and issues relating to tobacco use; 2)
Alert citizens and policy makers to information about public policies that
promote or reduce tobacco use; 3) Motivate people to stop or not start using
tobacco; and 4) Recruit tobacco users into treatment programs.  It is clear from
the literature that mass media campaigns can be effective in tobacco control, but
it is also clear that not every campaign is associated with success.

After decades of efforts to help individual smokers, tobacco control research has
begun to investigate the social environment that surrounds smokers and potential
smokers and influences their behavior.  Smoking rates among large populations
appear to be related to certain public and private policies (ref 10).  Policies
can take the form of legislation, such as excise tax increases,  or private
policies, such as workplace or restaurant smoking bans that are implemented
without a public mandate.  Public policies that have been promoted in tobacco
control programs include excise tax increases, restrictions on tobacco marketing,
clean indoor air requirements, and restrictions on youth access to tobacco. 
State tobacco control programs, although limited by restrictions on the use of
public funds, have disseminated information about the impact of tobacco control
policies, frequently through mass media campaigns.  The scientific evidence
supporting some of these policies is quite strong; for others it is more limited. 
Decision-makers frequently must make decisions about the details of these
policies in the absence of strong research.

Because of this paucity of research, fundamental questions  remain concerning
state and community tobacco control programs.  All state governments are now
implementing programs to reduce tobacco use, supported by funding from
litigation, excise taxes, or the Centers for Disease Control  Decisions about the
use of these funds, especially regarding media campaigns and policy
interventions, must be guided by science.  Research has provided limited
information to guide decision-makers in selecting the most effective messages and
media for the general population.  The impact of media and policy interventions
on high-risk groups, such as heavy smokers or multicultural groups must also be
investigated .  Research designs and interventions must be sensitive to the
unique characteristics of different populations.  Research is needed to address
a wide range of multicultural populations and to identify interventions that are
most likely to reduce the disparities in morbidity and mortality that are
attributable to tobacco use.  Questions also remain about the best research
methods to discriminate the impact of individual interventions in the context of
comprehensive programs.  Answers to these questions could dramatically  increase
the impact of state programs, which are the Nation's largest investment in
tobacco control.  Real reductions in tobacco use prevalence could be produced.

Other

Examples of research questions that may be addressed under this RFA include, but
are not limited to:

o  In the context of a state-based program, what is the impact of a large tobacco
control media campaign on: 1)  tobacco use behaviors, 2) readiness to quit,  3)
attitudes toward tobacco advertising and tobacco use, and 4) other predictors of
initiation and cessation?

o  What themes, techniques, and messages of mass media campaigns are most
effective in achieving the goals of the campaign?

o  How should media and policy interventions be tailored to influence high risk
groups, such as heavy smokers, multicultural groups, and youth?  Are tailored
interventions more effective?

o  How can new communications tools, such as the internet, be used to reduce
tobacco use at the community and state levels?

o  What public policies, or combinations of policies, are most strongly
predictive of reductions in tobacco use?

o  In the context of comprehensive tobacco control programs, what are the
relative contribution of media and policy interventions to reductions in tobacco
use rates?

o  How do media interventions interact with private and public tobacco control
policies to influence behavior?

Research teams can choose to test interventions directed at one or more
population groups, at the state or local level.  Investigators must describe in
detail their research design and methods.  Comparisons of different measurement
tools are encouraged.  Investigators may choose to evaluate so-called "natural
experiments" by examining the impact of interventions, policies, or regulations
that are occurring or changing independently.  Large-scale trials, if proposed,
should meet the criteria for such trials, as developed by the NCI Cancer Control
Review Group (ref 11). (Available at http://deainfo.nci.nih.gov/advisory/bsacacntrlmin.htm#4a)

Applicants must describe in detail how the impact of the interventions under
study will be distinguished from the impact of other tobacco control activities. 
For this reason, applicants must demonstrate a detailed understanding of existing
and planned tobacco control activities, and their ability to remain informed of
changes in these activities.  Applicants are strongly encouraged to propose
collaborative studies that include research institutions, state and local health
departments, state and local coalitions, voluntary health organizations, and
other organizations.  All states have tobacco control programs supported by the
state health department.  A contact person for each state health department
tobacco control program is available on the internet at
http://dccps.nci.nih.gov/tcrb/scrfa.html.  An important objective of this
research is to foster the development of cancer control researchers with
experience in community and state level research.

SPECIAL REQUIREMENTS

After awards are made, it is anticipated that collaborative research will be
fostered among the recipients of grants under this RFA.  Awardees that are
testing the impact of similar interventions, using similar media, or focusing on
similar populations will be encouraged to undertake collaborative research
activities.  These may include examining measurement issues, assessing complex
interventions through different designs, or monitoring the responses of the
tobacco industry to new interventions.  At a minimum, investigators will be asked
to consider the collection of common data elements in multiple projects.

Investigators will be convened at the time of award and twice annually throughout
the project in the Washington, D.C. area to consider these issues and how they
might be addressed through collaboration.  Support for travel by the Principal
Investigator and one co-investigator should be included in the proposed budget.

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
policy results from the NIH Revitalization Act of 1993.

All investigators proposing research involving human subjects should read the
"NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical
Research," which was published in the Federal Register of March 28, 1994 (FR 59
14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11,
March 18, 1994, available on the web at:
http://www.nih.gov/grants/guide/1994/94.03.18/notice-nih-guideline008.html.

Investigators also may obtain copies of these policies from the program staff
listed under INQUIRIES.  Program staff may also provide additional relevant
information concerning the policy.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of NIH that children (i.e., individuals under the age of 21)
must be included in all human subjects research, conducted or supported by the
NIH, unless there are scientific and ethical reasons not to include them.  This
policy applies to all initial (Type 1) applications submitted for receipt dates
after October 1, 1998.

All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines" on the Inclusion of Children as Participants in
Research Involving Human Subjects that was published in the NIH Guide for Grants
and Contracts, March 6, 1998, and is available at the following URL address:
http://www.nih.gov/grants/guide/notice-files/not98-024.html.

LETTER OF INTENT

Prospective applicants are asked to submit, by June 18, 1999, a letter of intent
that includes a descriptive title of the proposed research, the name, address,
and telephone number of the Principal Investigator, the identities of other key
personnel and participating institutions, 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 a
subsequent application, the information that it contains allows NCI staff to
estimate the potential review workload and avoid conflict of interest in the
review.

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

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 4/98) is to be used in applying
for these grants.  These forms are available at most institutional offices of
sponsored research and from the Division of Extramural Outreach and Information
Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910,
Bethesda, MD 20892-7910, telephone 301/710-0267, email: [email protected]. 
Applications are also available on the internet at: 
http://www.nih.gov/grants/forms.htm

The RFA label available in the PHS 398 (rev. 4/98) 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 2 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:

CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)

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

Ms. Toby Friedberg
Division of Extramural Activities
National Cancer Institute
6130 Executive Boulevard, Room 636, MSC-7399
Bethesda MD  20892-7399
Rockville,  MD 20850 (for express/courier service)
Telephone:  (301) 496-3428
FAX:  (301) 402-0275
Email: [email protected]

Applications must be received by the application receipt date listed in the
heading of this RFA.  If an application is received after that date, it will be
returned to the applicant without review.  The Center for Scientific Review (CSR)
will not accept any application in response to this RFA that is essentially the
same as one currently pending initial review, unless the applicant withdraws the
pending application.  The CSR 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.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by the CSR and
responsiveness by the NCI.  Incomplete and/or non-responsive applications will
be returned to the applicant without further consideration.  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 will be used by the initial review group in which applications
receive a written critique and undergo a process in which only those applications
deemed to have the highest scientific merit, generally the top half of the
applications under review, will be discussed, assigned a priority score, and
receive a second level review by the National Cancer Advisory Board.

Review Criteria

The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health.  In the
written comments reviewers will be asked to discuss the following aspects of the
application in order to judge the likelihood that the proposed research will have
a substantial impact on the pursuit of these goals.  Each of these criteria will
be addressed and considered in assigning the overall score, weighting them as
appropriate for each application.  Note that the application does not need to be
strong in all categories to be judged likely to have major scientific impact and
thus deserve a high priority score.  For example, an investigator may propose to
carry out important work that by its nature is not innovative but is essential
to move a field forward.

(1) Significance:  Does this study address an important problem? If the aims of
the application are achieved, how will scientific knowledge and public health be
advanced? What will be the effect of these studies on the concepts or methods
that drive this field?

(2) Approach:  Are the conceptual framework, design, methods, and analyses
adequately developed, well-integrated, and appropriate to the aims of the
project? Does the applicant acknowledge potential problem areas and consider
alternative tactics?

(3) Innovation:  Does the project employ novel concepts, approaches or method?
Are the aims original and innovative? Does the project challenge existing
paradigms or develop new methodologies or technologies?

(4) Investigator:  Is the investigator appropriately trained and well suited to
carry out this work? Does the investigator (or the team of investigators) have
experience in community or state-level research or in the field of tobacco
control?  Is the work proposed appropriate to the experience level of the
principal investigator and other researchers (if any)?

(5) Environment:  Does the scientific environment in which the work will be done
contribute to the probability of success?  Do the proposed experiments take
advantage of unique features of the scientific environment or employ useful
collaborative arrangements?  Is there evidence of institutional support?

In addition to the above criteria, in accordance with NIH policy, all
applications will also be reviewed with respect to the following:

The adequacy of plans to include both genders, minorities and their subgroups,
and children as appropriate for the scientific goals of the research.  Plans for
the recruitment and retention of subjects will also be evaluated.

The reasonableness of the proposed budget and duration in relation to the
proposed research.

The adequacy of the proposed protection for humans, animals or the environment,
to the extent they may be adversely affected by the project proposed in the
application.

The initial review group will also examine the provisions for the protection of
human subjects and the safety of the research environment.

SCHEDULE

Letter of Intent Receipt Date:    June 18, 1999
Application Receipt Date:         July 23, 1999
Council Review:                   February 2000
Earliest Anticipated Start Date:  April 2000

AWARD CRITERIA

Award criteria that will be used to make award decisions include: scientific
merit (as determined by peer review), availability of funds, and program balance.

INQUIRIES

Inquiries concerning this RFA are encouraged.  The opportunity to clarify any
issues or questions from potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

Bob Vollinger, M.S.P.H.
National Cancer Institute
6130 Executive Boulevard, Room 241
Rockville, MD  20852-7337
Telephone:  (301) 496-0273
FAX:  (301) 496-8675
Email:  [email protected]

Direct inquiries regarding fiscal matters to:

Brian Albertini
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Room 243
Bethesda, MD  20892
Telephone:  (301) 496-7800, Ext 249
FAX:  (301) 496-8601
Email:  [email protected]

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No.
93.397.  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 and 45 CFR Part 74.  This program is not subject to the intergovernmental
review requirements of Executive Order 12372 or Health Systems Agency review.

The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and promote the non-use of all tobacco products.  In addition, Public
Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain
facilities (or in some cases, any portion of a facility) in which regular or
routine education, library, day care, health care, or early childhood development
services are provided to children.  This is consistent with the PHS mission to
protect and advance the physical and mental health of the American people.

References

1.  American Cancer Society. Cancer Facts & Figures 1996, 24-26, 1996.

2.  Bartecchi CE, MacKenzie TD and Schrier RW. "The Human Costs of Tobacco Use."
New England Journal of Medicine,  330:907-912, 1994.

3.  Bartlett JC, Miller LS, Rice DP et al. Medical-Care Expenditures Attributable
to Cigarette Smoking--United States, 1993. Morbidity. and Mortality Weekly
Report, 43:469-72, 1994.

4.  U.S. Department of Health and Human Services and U.S. Environmental
Protection Agency. Respiratory. Health Effects of Passive Smoking: Lung Cancer
and Other Disorders. The Report of the U.S. Environmental Protection Agency.
National Cancer Institute, Bethesda, Md. 1993. NIH Publication No. 93-3605.

5.  Centers for Disease Control and Prevention. "Cigarette Smoking Among Adults--
United States, 1994." Morbidity. and Mortality. Weekly Report, 45:588-590, 1996.

6.  Thomas RM, Larsen MD. Smoking Prevalence, Beliefs, and Activities by Gender
and Other Demographic Indicators. The Gallup Organization, Inc., Princeton, NJ,
1993.

7.  Pierce JP, Fiore MC, Novotny TE et al. "Trends in Cigarette Smoking in the
United States." Journal of the American Medical Association,  261:61-6, 1989.

8.  Crump C, Packer L, Gfroerer J. "Incidence of Initiation of Cigarette Smoking-
--United States, 1965-1996." Morbidity and Mortality Weekly Report,  47:837-41,
1998.

9.  National Cancer Institute. The National Cancer Institute Tobacco Research
Implementation Group. National Cancer Institute, Bethesda, MD, 1998. (Available
at http://dccps.nci.nih.gov/tcrb/trip/)

10.  National Cancer Institute. Strategies To Control Tobacco Use in the United
States: A Blueprint for Public Health Action in the 1990's.  National Institutes
of Health, 1991. Publication No. 92-3316.

11.  Report of the National Cancer Institute Cancer Control Review Group.
National Cancer Institute, 1997. (Available at
http://deainfo.nci.nih.gov/advisory/bsacacntrlmin.htm#4a)

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