REVIEW AND ANALYSIS OF TOBACCO INDUSTRY DOCUMENTS

Release Date:  June 17, 1999

PA NUMBER:  PAR-99-114

National Cancer Institute

Letter of Intent Receipt Date:  September 17, 1999; May 18, 2000
Application Receipt Date:  October 19, 1999; June 19, 2000

PURPOSE

This Program Announcement (PA) is intended to stimulate research on a wide
variety of scientific, technical, marketing, and tactical undertakings by the
tobacco industry, which were documented in papers, memos, and other records.
The systematic, comprehensive analysis and evaluation of these documents will
greatly contribute to the understanding of what the tobacco industry knew and
will help researchers and the public health community identify effective
strategies to reduce 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 PA, Review and Analysis of Tobacco
Industry Documents, is related to the priority areas of cancer; and tobacco,
alcohol and other drugs.  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 foreign and domestic, 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 PA 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 PA may
not exceed four years.

It is anticipated that applicants will request more than $250,000 direct costs
per year.  Therefore, modular grant application procedures will apply to this
solicitation.

Applicants requesting budgets greater than $500,000 in direct costs are
required to contact program staff in the appropriate NIH institute prior to
submitting their applications (NIH GUIDE, Vol. 25, No. 14, May 3, 1996).
Applicants with budget of more than $500,000 in direct costs that are
submitted without prior communication with NIH program staff will not be
accepted for review.

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. This includes 120,000 deaths from lung cancer and more
than 31,000 deaths from other cancers. Tobacco use costs the nation $50
billion annually in direct health care costs, 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 (ETS).  Despite the known hazards of tobacco use, 48 million adult
Americans currently smoke cigarettes.  Seventy percent of those who smoke want
to quit. Approximately 3000 youth under age 18 become regular smokers every
day. Smoking rates among youth increased 73% between 1988 and 1996.

Landmark tobacco litigation brought by the State Attorneys General and others,
Congressional inquiries, and the Food and Drug Administration's historic
investigation have resulted in the release of millions of previously
inaccessible internal tobacco industry documents. Among other things, the
documents contain information about the health consequences of tobacco use,
cigarette design, tobacco marketing to particular demographic groups
(including youth), the determinates of tobacco use, and how the industry has
worked to undermine public health efforts that effectively reduce tobacco use.

The most comprehensive collection of documents is in Minneapolis, Minnesota,
at the State of Minnesota's Document Depository.  This was established as part
of the settlement reached in May 1998 to resolve the lawsuit brought by the
Minnesota Attorney General and Blue Cross and Blue Shield of Minnesota against
the tobacco companies. The depository contains an estimated 26 million pages
of documents acquired through discovery in the Minnesota litigation and will,
as a condition of the Minnesota settlement, incorporate documents released in
any other smoking and health litigation in this country.  Another 7 million
pages of documents acquired through the litigation are stored in Guildford,
England.

A rapidly increasing portion of the documents in the depository, as well as
other documents, are now available through the Internet, at the following
sites: the House of Representatives Commerce Committee site
(http://www.house.gov/commerce/TobaccoDocs/documents.html); the Smokescreen
site (http://209.8.58.18/); the University of California Library site
(http://galen.library.ucsf.edu/tobacco/); the Tobacco Resolution (tobacco
industry) site (http://www.tobaccoresolution.com/0002.htm); and the Blue
Cross/Blue Shield of Minnesota site
(http://www.mnbluecrosstobacco.com/toblit/trialnews/index.html).  It is
expected that additional sites will become available.

These newly released documents present a unique opportunity to make vast
amounts of previously secret scientific information available in the fields of
nicotine addiction, tobacco, marketing, and tobacco product engineering. The
research findings contained in tobacco industry documents will only be useful
if they undergo systematic analysis, and these analyses are published in the
scientific and lay literature. Six analyses have already been published: five
from Brown and Williamson documents concerning nicotine addiction,
environmental tobacco smoke, and lawyer manipulation of both internal and
external scientific research, (see reference numbers 1-5); and one from
Minnesota tobacco trial documents concerning nicotine addiction, low tar/low
nicotine cigarettes, cigarette design, and nicotine manipulation in cigarette
manufacture, (see reference number 6).

On July 17, 1998, the President issued an Executive Memorandum highlighting
the importance of the tobacco industry documents that have been released as a
result of recent tobacco litigation and congressional subpoenas.  Citing the
potential value of these documents to the public health community, the
Memorandum directed the Secretary of Health and Human Services to do the
following: (1) propose a method for coordinating review of the documents and
making available an easily searchable index and/or digest of the reviewed
documents; (2) propose a plan to disseminate widely the index and/or digest as
well as the documents themselves, including expanded use of the Internet, and
(3) provide a strategy for coordinating a broad public and private review and
analysis of the documents to gain critical public health information.

The Program Announcement is one component of the Department's response to the
President's directive.  The Centers for Disease Control and Prevention (CDC)
is coordinating efforts to increase the availability of the documents through
the Internet.

Specific Aims

Through the analysis of these documents, new information will be obtained
about tobacco industry research, programs, and activities.  Investigators may
review the industry documents in order to assess the scientific validity and
the application of the industry's findings.  Information found in these
documents can be analyzed in conjunction with the analysis of other data sets. 
This new information will help scientists understand tobacco use behavior and
will guide health professionals in the development of new programs to reduce
tobacco use.

The tobacco industry documents should be analyzed to gain scientific and
technical knowledge in a number of areas, including, but not limited to the
following:

nicotine pharmacology
nicotine addiction
health consequences of tobacco use
tobacco product additives
tobacco product design and manufacturing
advertising and promotion
youth initiation
tobacco use cessation
disruption of scientific and public health programs
policy research

Investigators will be faced with unique challenges in obtaining and analyzing
these documents because of their large volume and limited organization. 
Investigators may choose to assess methods for retrieving and analyzing
documents through electronic and other means.

All investigators funded under this program announcement will be asked to make
the tobacco industry documents and indices they use available to scientists
and lay audiences through the Internet.  Investigators will be convened twice
annually to discuss research methods and results of common interest.

SPECIAL REQUIREMENTS

Applications responding to the PAR should include two round trips for two-day
meetings to Bethesda, MD in the budget for each year.

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
(Section 492B of Public Law 103-43).

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 20, 1994
(FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Volume 23,
Number 11, March 18, 1994 available on the web at the following URL address:
http://www.nih.gov/grants/guide/1994/94.03.18/notice-nih-guideline008.html

Investigators also may obtain copies of  the policy from the program staff
listed under INQUIRIES.

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 clear and compelling 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/funding/children/children.htm

LETTER OF INTENT

Prospective applicants are asked to submit 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 PA 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 program staff listed under INQUIRIES
by the letter of intent receipt date listed in the heading of this PA.

APPLICATION PROCEDURES

Applications are to be submitted on the grant application form PHS 398 (rev.
4/98).  Application kits are available at most institutional offices of
sponsored research and may be obtained from the Division of Extramural
Outreach and Information Resources,  National Institutes of Health, 6701
Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, E-
mail: grantsinfo@nih.gov.  The title and number of the program announcement
must be typed in Section 2  on the face page of the application.  The YES box
must be marked.  For those applicants with internet access, the 398 kit may be
found at http://www.nih.gov/grants/funding/phs398/forms_toc.html

The completed original application and three legible copies must be sent or
delivered 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)

REVIEW CONSIDERATIONS

Applications will be reviewed for scientific and technical merit by a peer
review group convened by the Division of Extramural Activities of the National
Cancer Institute, in accordance with the standard NIH peer review procedures. 
As part of the initial merit 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 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.  The
reviewers will comment on the following aspects of the application in their
written critiques 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 by the reviewers 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 a 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 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?  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?

The initial review group will also examine: the appropriateness of proposed
project budget and duration; the adequacy of plans to include both genders,
minorities and their subgroups, and children as appropriate for the scientific
goals of the research and plans for the recruitment and retention of subjects;
the provisions for the protection of human and animal subjects; and the safety
of the research environment.

AWARD CRITERIA

Applications will compete for available funds with all other recommended
applications.  The following will be considered in making funding decisions: 
Quality of the proposed project as determined by peer review, availability of
funds, and program priority.

INQUIRIES

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

Direct inquiries regarding programmatic issues to:

Cathy L. Backinger, M.P.H., Ph.D.
Division of Cancer Control and Population Sciences
National Cancer Institute
Executive Plaza North, Room 241, MSC 7337
Bethesda, MD  20892-7337
Telephone:  (301) 496-8584
FAX:  (301) 496-8675
Email: cb270r@nih.gov

Direct inquiries regarding fiscal matters to:

Brian Albertini
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Room 243, MSC 7150
Bethesda, MD  20892-7150
Telephone:  (301) 496-7800 ext. 249
FAX:  (301) 496-8601
Email:  Albertib@gab.nci.nih.gov

Direct inquiries regarding review issues to:

Ms. Toby Friedberg
Referral Officer
Division of Extramural Activities
National Cancer Institute
Executive Plaza North, Room 636
6130 Executive Blvd., MSC-7399
Rockville, MD 20850 (express courier)
Bethesda MD 20892-7399
Telephone (301) 496-3428
Fax: (301) 402-0275
Email: tf12w@nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No.
93.399, Cancer Cause and Prevention Research.  Awards are made under
authorization of the Sections 301 and 405 of the Public Health Service Act as
amended ( 42 USC 241 and 284) 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 of the
American people.

REFERENCES

1.  Glantz SA, Barnes DE, Bero LA, Hanauer P, Slade J.  Looking through a
keyhole at the tobacco industry: the Brown and Williamson documents.  JAMA. 
1995; 274:219-224.

2.  Slade J, Bero LA, Hanauer P, Barnes ED, Glantz SA.  Nicotine and
addiction: the Brown and Williamson documents.  JAMA.  1995; 274:225-233.

3.  Hanauer P, Slade J, Barnes ED, Bero LA, Glantz SA.  Lawyer control of
internal scientific research to protect against products liability lawsuits: 
the Brown and Williamson documents.  JAMA.  1995; 274:234-240.

4.  Bero LA, Barnes ED, Hanauer P,  Slade J, Glantz SA. Lawyer control of
external scientific research: the Brown and Williamson documents.  JAMA. 
1995; 274:241-247.

5.  Barnes ED, Hanauer P, Slade J, Bero LA, Glantz SA.  Environmental tobacco
smoke:  the Brown and Williamson documents.  JAMA.  1995; 274:248-253.

6.  Hurt RD, Channing RR.  Prying open the door to the cigarette industry's
secrets about nicotine.  JAMA.  1998; 280:1173-1181.


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