Full Text CA-97-010
 
PREVENTION AND CESSATION OF TOBACCO USE BY CHILDREN AND YOUTH IN THE
U.S.
 
NIH GUIDE, Volume 26, Number 2, January 17, 1997
 
RFA:  CA-97-010
 
P.T.  34, AA

Keywords: 
  Disease Prevention+ 
  Smoking Behavior 

 
National Cancer Institute
National Institute of Child Health and Human Development
National Institute of Nursing Research
 
Letter of Intent Receipt Date:  March 15, 1997
Application Receipt Date:  May 8, 1997
 
PURPOSE
 
The Division of Cancer Prevention and Control (DCPC) of the National
Cancer Institute (NCI), the National Institute of Child Health and
Human Development (NICHD) and the National Institute of Nursing
Research (NINR) seeks proposals for innovative research which has
clear implications for the immediate and significant reduction of
tobacco use by children and youth in the United States.
 
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,
"Prevention and Cessation of Tobacco Use by Children and Youth in the
U.S.", is related to the priority area of cancer. 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,
U.S. Government Printing Office, Washington, DC 20402-9325 (telephone
202-783-3238).
 
ELIGIBILITY REQUIREMENTS
 
Applicants may be domestic for-profit and non-profit organizations,
public and private, such as universities, colleges, hospitals,
laboratories, units of State and local governments, health boards,
public health departments, territorial health departments (including
the District of Columbia), volunteer organizations, clinics,
coalitions, and consortia. Teams of applicants are encouraged. Among
a team of applicants, one must be designated as the lead applicant
and assume responsibility for conduct of the project. Foreign
organizations are not eligible to apply, and applications from
domestic organizations may not include international components.
Women and minority investigators are encouraged to apply.
 
MECHANISM OF SUPPORT
 
This RFA will use the National Institutes of Health (NIH) individual
research project grant (R01).  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 this RFA may not exceed four years.
 
This RFA is a one-time solicitation for FY 97. However, the NCI has
plans to re-issue this RFA for funding in FY 1998.  Future
unsolicited competing continuation applications will compete with all
investigator-initiated applications and be reviewed according to
customary peer review procedures unless additional re-issuances are
required.
 
The total cost for any application in any one-year budget period may
not exceed $500,000.  The anticipated award date for this
solicitation is September 30, 1997.
 
Awards and level of support depend on receipt of a sufficient number
of applications of high scientific merit.  Although this program is
provided for in the financial plans of the NCI and NICHD, the award
of grants pursuant to this RFA is contingent upon the continuing
availability of funds for this purpose.
 
FUNDS AVAILABLE
 
Approximately $4.6 million, per year, in total costs for four years
will be committed to fund applications that are submitted in response
to each of the two solicitations of this RFA.  It is anticipated that
8-12 new individual awards will be made through this solicitation.
 
RESEARCH OBJECTIVES
 
Background
 
Efforts to control tobacco use and tobacco-related morbidity and
mortality in the United States have met with reasonable success, at
least through the early 1990s.  In the thirty-two years since the
publication of the first Surgeon General's Report on Tobacco and
Health, adult smoking rates in the U.S. have been reduced by nearly
34 percent, with reductions among males accounting for much of this
success (1).  Other indices of success, such as changing attitudes
toward tobacco use in public places, widespread perception of tobacco
use as a health hazard, and increasing numbers of laws restricting
tobacco use have also been positive (2).
 
Controlling tobacco use among U.S. youth, however, has not been as
successful. Although there was considerable success in reducing
adolescent tobacco use in the late 1970s and early 1980s, tobacco use
among high school seniors - for whom data with the longest time
trends are available - have remained essentially stable for more than
a decade, with just under 20 percent of seniors reporting daily
smoking (3).  Furthermore, high school dropouts smoke at an
alarmingly high rate. One study in Minnesota found that 77 percent of
both male and female 16-year old dropouts smoked on a daily basis
(4); a similar study in Ontario, Canada, found a nearly 68 percent
smoking rate among high school dropouts (5).
 
When the high school senior tobacco use prevalence rates are
considered in tandem with the dropout smoking rates, the smoking
prevalence rate among U.S. adolescents nearly equals that among
adults, i.e., about 25 percent.  Smokeless tobacco use - spit tobacco
- among youth, especially among males, also continues to rise (6).
If these trends continue, the prospect for further reductions in
national tobacco use prevalence rates, and accompanying
tobacco-related disease rates and economic costs, is unlikely to
change substantially in the foreseeable future.
 
Research Goals
 
While a great deal has been learned about tobacco use by children and
youth - as demonstrated by several recent reviews of this issue
(e.g., 7-10) - there is also a great need to learn more and,
especially, to apply broadly and systematically what has already been
learned.
 
Research alone, however, will certainly not solve this society-wide
and well-entrenched problem, public awareness campaigns, policy
change, revenue restructuring, agricultural reform and other measures
are essential, as well. In fact, there is little doubt that it is the
combination of effort from many channels - public awareness and
commitment, policy change and research, as demonstrated through the
NCI's and American Cancer Society's ASSIST (American Stop Smoking
Intervention Study) program, that will likely have the greatest
effect on reducing tobacco use among children and youth.
 
Therefore, the research arm of this multi-pronged effort, if it has
as its clear purpose the immediate and significant reduction of
tobacco use by children and youth and, particularly, if it is
innovative, extends and does not merely replicate existing research,
and is conducted with the broad application of relevant results as
one of its primary goals, can make an enormous contribution.
Accordingly, among the research issues which should be considered in
response to this solicitation, and as posed by the reviews cited
earlier, especially that conducted by the Institute of Medicine, are
the following:
 
o  What are the characteristics, pharmacological, physiological, and
psychological, of nicotine dependence in its early stages and,
especially, during the transition between experimental and dependent
use?  Are there differences in individual susceptibility to nicotine
dependence among youth? What is the relationship between the
characteristics of different tobacco products and early nicotine
dependence? Are there pharmacological treatments from which nicotine
dependent children and youth will benefit? What are the
characteristics of successful nicotine dependence cessation programs
for youth under age 18? How can these programs be adopted on a large
scale?
 
o  What are the factors influencing the decline in, or relative lack
of involvement in, tobacco use among particular ethnic, social,
religious, or racial groups in the U.S., e.g., African-American
youth?  How can these factors be applied to the larger population of
U.S. youth?  Conversely, is there need for prevention programs aimed
at youth subpopulations at high risk for tobacco use? Can such
programs be successfully developed, evaluated, and adopted on a large
scale?
 
o  What the factors that influence youths' responses to advertising,
promotional, mass media, and warning messages aimed at discouraging
tobacco use? What are factors that influence youth's responses to
advertising, promotional, and mass media messages aimed at
encouraging tobacco use? What are the ethnic, gender, and social
class differences which influence these responses? What are the
characteristics of failed and successful advertising and mass media
campaigns aimed at discouraging tobacco use by children and youth?
 
o  How do tobacco price increases, especially through higher taxes,
affect youth tobacco use in comparison to the effect of prices
increases on adult tobacco use, i.e. are youth more, less, or equally
price-sensitive to tobacco prices than adults?
 
o  What is the optimal age, and circumstances, at which programs
aimed at discouraging tobacco use by children and youth should begin?
Is it better to focus on tobacco use alone in these programs or to
include other youth-relevant health issues such as diet and exercise?
What is the role of the family in discouraging tobacco use among
children and youth? What is the role of the health care community,
ranging from practitioners (e.g., nurses, pediatricians, dentists,
OB-GYNs, family physicians), professional organizations, and
health-care delivery and reimbursement systems?
 
o  What is the optimal way to disseminate and implement successful
youth and children tobacco prevention/cessation programs on a large
scale?
 
Other Requirements
 
Several requirements should be observed in preparing applications in
response to this RFA: (1) The term "Children and Youth" refers to
males and females under the age of 18; (2) The term "Tobacco Use"
includes smoking and smokeless (spitting) tobacco; (3) The term
"Innovative Research" refers to studies that address the problem of
tobacco use by children and youth from a new perspective and that do
not merely add to the scientific literature in areas where
considerable research has already been conducted and where the needs
and challenges are more clearly in the realm of how the programs
developed through previous research can be adopted on a broad scale,
e.g. school-based interventions to prevent tobacco use; (4) Where
scientifically reasonable, possible, and defensible, such
investigative devices as secondary data analysis and meta-analyses
are encouraged in lieu of primary data collection; and (5) All
proposals should include a detailed discussion of (a) why the results
of the research being proposed, if disseminated and adopted on a
large scale, could have an immediate and significant effect on the
reduction of tobacco use by children and youth in the U.S. and (b)
how the results of the research being proposed can, either
immediately or in the near-term, be disseminated and adopted on a
large scale.
 
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
provisions that are substantially different from the 1990 policies.
 
All investigators proposing research involving human subjects should
read the "NIH Guidelines For Inclusion of Women and Minorities as
Subjects in Clinical Research," which have been published in the
Federal Register of March 28, 1994 (FR 59 14508- 14513) and reprinted
in the NIH Guide for Grants and Contracts, Volume 23, Number 11,
March 18, 1994.
 
Investigators also may obtain copies of the policy from the program
staff listed under INQUIRIES.  Program staff may also provide
additional relevant information concerning the policy.
 
LETTER OF INTENT
 
Prospective applicants are asked to submit, by March 15, 1997 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 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:
 
Ms. Veronica Chollette
Division of Cancer Prevention and Control
National Cancer Institute
6130 Executive Boulevard, Room 232 - MSC 7330
Bethesda, MD  20892-7330
Rockville, MD  20852 (for express/courier service)
Telephone:  (301) 496-8520
FAX:  (301) 496-8675 or 480-6637
Email:  [email protected]
 
APPLICATION PROCEDURES
 
Applications are to be submitted on the grant application form PHS
398 (rev. 5/95).  These forms are available at most institutional
offices of sponsored research; 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]; and from the program
administrator listed under INQUIRIES.
 
The RFA label available in the PHS 398 (rev. 5/95) 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 in
Section 2 of the face page of the application form and the YES box
must be marked.
 
All requirements with regard to type, size, page limitations,
appendix material, etc. must be followed or applications will be
returned without review.
 
Submit a signed, typewritten original of the application, including
the Checklist, and three signed, photocopies, in one package to:
 
DIVISION OF RESEARCH GRANTS
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, SUITE 1040 - MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier services)
 
At the time of submission, two additional copies of the application
must also be sent to:
 
Mrs. Toby Friedberg
Division of Extramural Activities
National Cancer Institute
Executive Plaza North, Room 636
6130 Executive Boulevard
Bethesda, MD  20892
Rockville, MD  20852 (for express/courier service)
 
Applications must be received by May 8, 1997.  If an application is
received after the application receipt 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 RFA 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.
 
REVIEW CONSIDERATIONS
 
Upon receipt, applications will be reviewed for completeness by DRG
and responsiveness by the National Cancer Institute.  Incomplete
and/or non-responsive applications will be returned to the applicant
without further consideration.  Those applications judged to be
competitive will undergo further scientific merit review.  Those
applications that are complete and responsive will be evaluated in
accordance with the criteria stated below for scientific/technical
merit by an appropriate peer review group convened by the Division of
Extramural Activities, NCI.
 
As part of the initial review, all applications will 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 applications under review, will be discussed,
assigned a priority score and receive a second level of review by the
National Cancer Advisory Board.
 
Review Criteria include, but are not limited to:
o  scientific, technical, and medical significance of the proposed
research;
 
o  innovative quality of the proposed research, especially as it
avoids merely replicating previous research;
 
o  ability of the research results to be applied on a large scale to
the immediate and significant reduction of tobacco use by children
and youth;
 
o  evidence of familiarity with and understanding of relevant
research literature as it relates to tobacco use prevention and
control and youth;
 
o  appropriateness and adequacy of, in the case of proposals
involving primary data collection, the experimental design and
methodology, including appropriateness of control and comparison
groups, reliability and validity of instruments to assess key
variables, methods to identify and minimize biases and threats to
validity, and specification of statistical power and sample sizes;
and, in the case of proposals involving secondary data analysis or
meta-analysis, clearly stated inclusionary criteria and appropriate
methods of data selection and analysis;
 
o  qualifications and relevant research experience of the Principal
Investigator and collaborating scientists, including the senior
collaborator, particularly in the area of the proposed research;
 
o  availability of the resources necessary to perform the research;
 
o  evidence that appropriate steps have been taken to insure the
protection of human subjects; and
 
o  adequacy of plans to include both genders and minorities and their
subgroups as appropriate for the scientific goals of the research.
Plans for the recruitment and retention of subjects will also be
evaluated.
 
The review group will critically examine the submitted budget and
will recommend an appropriate budget and period of support for each
approved application.
 
AWARD CRITERIA
 
Applications found to have significant and substantial merit will be
considered for funding by the following:
 
o  priority score
o  availability of funds
o  programmatic priorities
 
INQUIRIES
 
Written, telephone and, especially, e-mail 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:
 
Thomas J. Glynn, Ph.D.
Division of Cancer Prevention and Control
National Cancer Institute
6130 Executive Boulevard, Room 243
Bethesda, MD  20892-7330
Rockville, MD  20852 (for express/courier service)
Telephone:  (301) 496-8520
FAX:  (301) 496-8675
Email:  [email protected]
 
Norman Krasnegor, Ph.D.
Centers for Research for Mothers and Children
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 4B05
Rockville, MD  20852
Telephone:  (301) 496-6591
FAX:  (301) 480-7773
Email:  [email protected]
 
June R. Lunney, Ph.D.
Division of Extramural Activities
National Institute of Nursing Research
Building 45, Room 3AN-12
Bethesda, MD  20892-6300
Telephone:  (301) 594-6908
FAX:  (301) 480-8260
Email:  [email protected]
 
Direct inquiries regarding fiscal matters to:
 
Barbara A. Fisher
Grants Administration Branch
National Cancer Institute
6120 Executive Boulevard, Room 243
Bethesda, MD  20892
Telephone: (301) 496-7800, ext. 229
 
Doug Shawver
Grants Management Officer
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A,17-F
Bethesda, MD  20892
Telephone:  (301) 496-1303
Email:  [email protected]
 
Mr. Jeff Carow
Grants Management Office
National Institute of Nursing Research
Building 45, Room 3AN-32
Bethesda, MD  20892-6301
Telephone:  (301) 594-5974
FAX:  (301) 480-8256
Email:  [email protected]
 
AUTHORITY AND REGULATIONS
 
This program is described in the Catalog of Federal Domestic
Assistance No. 93.399, Cancer Control.  Awards are made under
authorization of the Public Health Services 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 and Part 92.  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 and contract 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) Centers for Disease Control and Prevention. Cigarette smoking
among adults - United States, 1993. Morbidity and Mortality Weekly
Report, 1994, 43(50), 925-930.
 
2) U.S. Department of Health and Human Services. Reducing the Health
Consequences of Smoking: 25 Years of Progress. A Report of the
Surgeon General. DHHS Publication No. (CDC) 89-8411, 1989.
Washington, DC: U.S. Government Printing Office, 1989.
 
3) Johnston, L.D., O'Malley, P.M., and Bachman, J.G. National Survey
Results on Drug Use from the Monitoring the Future Study, 1975- 1995.
Rockville, MD: U.S. National Institute on Drug Abuse, 1996.
 
4) Pirie, P.L., Murray, D.M., and Luepker, R.V. Smoking prevalence in
a cohort of adolescents, including absentees, dropouts, and
transfers. American Journal of Public Health, 1988, 78, 176-178.
 
5) Flay, B.R. et al. Six-year followup of the first Waterloo school
smoking prevention trial. American Journal of Public Health, 1989,
79, 1371-1376.
 
6) Boyd, G.M. and Darby, C.A. Smokeless Tobacco Use in the United
States. National Cancer Institute Monograph, 1989, 81, 1-105.
 
7) Glynn, T.J., Greenwald, P., Mills, S.M., and Manley, M.W. Youth
tobacco use in the United States - Problems, progress, goals, and
potential solutions. Preventive Medicine, 1993, 22, 568-575.
 
8) Reid, D.J., McNeill, A.D., and Glynn, T.J. Reducing the prevalence
of smoking in youth in Western countries: An international review.
Tobacco Control, 1995, 4, 266-277.
 
9) U.S. Department of Health and Human Services. Preventing Tobacco
Use Among Young People: A Report of the Surgeon General. Atlanta, GA:
Centers for Disease Control and Prevention, Office on Smoking and
Health, 1994.
 
10) Lynch, B.S. and Bonnie, R.J. (eds) Growing Up Tobacco Free -
Preventing Nicotine Addiction in Children and Youths: A Report of the
Institute of Medicine. Washington, DC:National Academy Press, 1994.
 
.

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