REVIEW AND ANALYSIS OF TOBACCO INDUSTRY DOCUMENTS
 
Release Date:  March 7, 2001
 
PA NUMBER:  PAR-01-063
 
National Cancer Institute

Letter of Intent Date:     June 13, 2001;  January 8, 2002
Application Receipt Date:  July 18, 2001;  February 12, 2002

THIS PROGRAM ANNOUNCEMENT (PAR) REPLACES PAR-99-114, WHICH WAS PUBLISHED IN 
NIH GUIDE ON JUNE 17, 1999.
 
THIS PAR USES THE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS.  IT INCLUDES 
DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED 
WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS PAR.

PURPOSE

This Program Announcement (PAR) 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 
enhance understanding of the tobacco industry’s knowledge, strategies and 
tactics, provide a greater understanding of the determinants of tobacco use 
and addiction and help researchers and public health practitioners identify 
effective strategies to prevent and reduce tobacco use.  This PAR will expire 
on February 13, 2002, unless reissued.  NIH Grants policies apply to these 
awards.

RESEARCH OBJECTIVES  

Background

Tobacco use, responsible for nearly one in five deaths, is the nation’s 
leading cause of death.  Cigarettes cause more than 420,000 deaths in the U.S. 
each year, including 120,000 deaths from lung cancer and more than 31,000 
deaths from other cancers. At least 3,000 lung cancer deaths occur annually in 
nonsmokers exposed to environmental tobacco smoke (ETS) carcinogens. In 1993, 
the direct medical costs of tobacco use were $50 billion.  Despite the 
enormous health hazards of tobacco use, 24.1% of adult Americans (47.2 
million) are current smokers.  Approximately 3,000 youth under age 18 become 
regular smokers every day.  

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 tobacco industry internal documents.  Among other things, the 
documents contain important information about the health consequences of 
tobacco use, cigarette design, tobacco marketing to particular demographic 
groups (including youth, women and racial/ethnic minorities), the determinants 
of tobacco use, and how the tobacco industry has worked to block and undermine 
public health efforts that effectively reduce tobacco use.

The most comprehensive collection of tobacco industry 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);  Tobacco  
Documents Online site (http://www.tobaccodocuments.org);  the University of 
California Library site (http://galen.library.ucsf.edu/tobacco);  the Tobacco 
Resolution (tobacco industry) site (http://www.tobaccoresolution.com); and the 
Tobacco Control Resource Center website (http://www.tobacco.neu.edu).  It is expected 
that additional sites will also become available.

These newly released documents present a unique opportunity to make vast 
amounts of previously inaccessible scientific information available to the 
public, in the fields of nicotine addiction, tobacco marketing, and tobacco 
product engineering, among others.  The research findings contained in the 
tobacco industry documents will only be useful if they undergo systematic 
analysis, and these analyses are published in the scientific literature.  
Several 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).
 
Through the analysis of these documents, new information will be obtained 
about tobacco industry research, programs and other 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 scientists and public health practitioners in the development of 
new research and programs to prevent and reduce tobacco use.  

Applications to analyze the tobacco industry documents in areas including, but 
not limited to the following, are encouraged:

-  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 research and public health programs
-  policy research

Investigators face 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.  Other means of disseminating 
documents and research results are encouraged and expected.  Investigators 
will be convened twice annually to discuss research methods and results of 
common interest.  

SPECIAL REQUIREMENTS

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

MECHANISM OF SUPPORT

This PAR 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 PAR may 
not exceed four years.  The earliest anticipated award date is April 1, 2002. 

Applications requesting $250,000 or less in direct costs per year must be in 
modular format.  Applications that request more than $250,000 direct costs per 
year must follow the traditional PHS 398 application instructions.

Specific application instructions have been modified to reflect "MODULAR 
GRANT" and "JUST-IN-TIME" streamlining efforts being examined by the NIH.  
Complete and detailed instructions and information on Modular Grant 
applications can be found at 
http://grants.nih.gov/grants/funding/modular/modular.htm.

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 or 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.

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

Direct inquiries regarding programmatic issues to:
 
Michele Bloch, MD, PhD
Division of Cancer Control and Population Sciences
National Cancer Institute
Executive Plaza North, Room 4032, MSC 7337
Bethesda, MD  20892-7337
Telephone:  (301) 496-8584
FAX:  (301) 496-8675
Email:  blochm@mail.nih.gov
 
Direct inquiries regarding fiscal matters to:
 
Brian Albertini
Grants Administration Branch
National Cancer Institute
6120 Executive Blvd
Suite 243, MSC, 7150
Bethesda, MD 20892
Telephone: (301) 496-7239
FAX:  (301) 496-8601 
Email: Albertib@gab.nci.nih.gov

Direct inquiries regarding review issues to:

Ms. Toby Friedberg
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8109, MSC 8329
Bethesda, MD  20892-8329
Rockville, MD  20852 (for express/courier service)
Telephone (301) 496-3428
Fax: (301) 402-0275
Email:  tf12w@nih.gov

LETTER OF INTENT 

Prospective applicants are asked to submit, by June 13, 2001 and January 8, 
2002, 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 PAR 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 IC staff to estimate the potential 
review workload and plan 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 requesting $250,000 or less in direct costs per year must be in 
modular format.   The modular grant concept establishes specific modules in 
which direct costs may be requested as well as a maximum level for requested 
budgets.  Only limited budgetary information is required under this approach.  
The just-in-time concept allows applicants to submit certain information only 
when there is a possibility for an award.  It is anticipated that these 
changes will reduce the administrative burden for the applicants, reviewers 
and Institute staff.  The research grant application form PHS 398 (rev. 4/98) 
is to be used in applying for these grants, with the modifications noted 
below.  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, 
email: grantsinfo@nih.gov.  The title and number of the PAR must be typed on 
line 2 of the face page of the application form and the YES box must be 
marked.  For those applicants with internet access, the 398 kit may be found 
at: http://grants.nih.gov/grants/funding/phs398/phs398.html   

Applicants planning to submit a grant application requesting $500,000 or more 
in direct costs for any year are required to discuss their eligibility with 
the NCI program staff contact listed under INQUIRIES before submitting the 
application.  Furthermore, the applicant must obtain agreement from the 
program staff that NCI will accept the application for consideration for 
award.  Finally, the applicant must identify, in a cover letter sent with the 
application, the NCI program staff member who agreed to accept assignment of 
the application.  This policy requires an applicant to obtain agreement for 
acceptance of both any such application and any such subsequent amendment. 
Refer to the NIH Guide for Grants and Contracts, March 20, 1998 at 
http://grants.nih.gov/grants/guide/notice-files/not98-030.html

Applicants are strongly encouraged to call the program contacts listed in 
INQUIRIES with any questions regarding the adherence to the guidelines of 
their proposed project to the goals of this PAR.

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS

BUDGET INSTRUCTIONS

Modular Grant applications will request direct costs in $25,000 modules, up to 
a total direct cost request of $250,000 per year.  (Applications that request 
more than $250,000 direct costs in any year must follow the traditional PHS 
398 application instructions.)  The total direct costs must be requested in 
accordance with the program guidelines and the modifications made to the 
standard PHS 398 application instructions described below:

o  FACE PAGE:  Items 7a and 7b should be completed, indicating Direct Costs 
(in $25,000 increments) and Total Costs [Modular Total Direct plus Facilities 
and Administrative (F&A) costs] for the initial budget period.  Items 8a and 
8b should be completed indicating the Direct and Total Costs for the entire 
proposed period of support.

o  DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4 
of the PHS 398.  It is not required and will not be accepted with the 
application.

o  BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the 
categorical budget table on Form Page 5 of the PHS 398.  It is not required 
and will not be accepted with the application.

o  NARRATIVE BUDGET JUSTIFICATION -  Prepare a Modular Grant Budget Narrative 
page (see http://grants.nih.gov/grants/funding/modular/modular.htm for sample 
pages). At the top of the page, enter the total direct costs requested for 
each year.  This is not a form page.

o  Under personnel, list all project personnel, including their names, percent  
of effort, and roles on the project. No individual salary information should 
be provided. However, the applicant should use the NIH appropriation language 
salary cap and the NIH policy for graduate student compensation in developing 
the budget request.

o  For Consortium/Contractual costs, provide an estimate of total costs 
(direct plus facilities and administrative) for each year, each rounded to the 
nearest $1,000. List the individuals/organizations with whom consortium or 
contractual arrangements have been made, the percent effort of all personnel, 
and the role on the project. Indicate whether the collaborating institution is 
domestic or foreign.  The total cost for a consortium/contractual arrangement 
is included in the overall requested modular direct cost amount. Include the 
Letter of Intent to establish a consortium.

o  Provide an additional narrative budget justification if there is a change 
in the number of modules requested from year to year.

o  BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by 
reviewers in the assessment of each individual's qualifications for a specific 
role in the proposed project, as well as to evaluate the overall 
qualifications of the research team.  A biographical sketch is required for 
all key personnel, following the instructions below.  No more than three pages 
may be used for each person.  A sample biographical sketch may be viewed at:  
http://grants.nih.gov/grants/funding/modular/modular.htm.

- Complete the educational block at the top of the form page;- List 
position(s) and any honors; 
- Provide information, including overall goals and responsibilities, on 
research projects ongoing or completed during the last three years;
- List selected peer-reviewed publications, with full citations.

o  CHECKLIST -  This page should be completed and submitted with the 
application. If the F&A rate agreement has been established, indicate the type 
of agreement and the date. All appropriate exclusions must be applied in the 
calculation of the F&A costs for the initial budget period and all future 
budget years.

The applicant should provide the name and phone number of the individual to 
contact concerning fiscal and administrative issues if additional information 
is necessary following the initial review.

Applications not conforming to these guidelines will be considered 
unresponsive to this PAR and will be returned without further review.

Submit a signed, typewritten original of the application, including the 
checklist, and three signed, exact, single-sided photocopies, in one package 
to:
 
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive
Room 1040 - MSC 7710
Bethesda, MD  20892-7710
(20817 for express 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
6116 Executive Boulevard, Room 8109, MSC 8329
Bethesda, MD  20892-8329
Rockville, MD  20852 (for express/courier service)

Applications must be received by July 18, 2001;  February 12, 2002.  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 PAR 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

Applications will be reviewed for completeness by the Center for Scientific 
Review and for adherence to the guidelines to this PAR by the National Cancer 
Institute.  Incomplete applications will be returned to the applicant without 
further consideration.  Applications that are complete and adhere to the 
guidelines of this PAR will be evaluated for scientific and technical merit by 
an appropriate scientific review group convened by the Division of Extramural 
Activities, 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 may 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 five criteria to be used in the evaluation of grant applications are 
listed below.
 
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.
  
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?  

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

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

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)?  

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 adequacy of plans to include 
both genders and 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.

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 sub-populations 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 indicating 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 
UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in 
Clinical Research," published in the NIH Guide for Grants and Contracts on 
August 2, 2000  
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html), 
a complete copy of the updated Guidelines is available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm.  The 
revisions relate to NIH defined Phase III clinical trials and require: a) all 
applications or proposals and/or protocols to provide a description of plans 
to conduct analyses, as appropriate, to address differences by sex/gender 
and/or racial/ethnic groups, including subgroups if applicable; and b) all 
investigators to report accrual, and to conduct and report analyses, as 
appropriate, by sex/gender and/or racial/ethnic group differences.

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://grants.nih.gov/grants/guide/notice-files/not98-024.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.

REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS

All investigators proposing research involving human subjects should read the 
policy that was published in the NIH Guide for Grants and Contracts, June 5, 
2000 (Revised August 25, 2000), available at the following URL address 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

URLS IN NIH GRANT APPLICATIONS OR APPENDICES

All applications and proposals for NIH funding must be self-contained within 
specified page limitations.  Unless otherwise specified in an NIH 
solicitation, internet addresses (URLs) should not be used to provide 
information necessary to the review because reviewers are under no obligation 
to view the Internet sites.  Reviewers are cautioned that their anonymity may 
be compromised when they directly access an Internet site.

HEALTHY PEOPLE 2010

The Public Health Service (PHS) is committed to achieving the health promotion 
and disease prevention objectives of "Healthy People 2010," a PHS led national 
activity for setting priority areas. This PAR, 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 2010" at http://www.health.gov/healthypeople/.

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 Sections 301 and 405 of the Public Health Service Act as 
amended (42 USC 241 and 284) and administered under NIH grants policies and 
Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 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 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. 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 product 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 
internal 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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