ENVIRONMENTAL FACTORS AND BREAST CANCER IN HIGH-RISK AREAS

NIH GUIDE, Volume 22, Number 11, March 19, 1993



RFA AVAILABLE:  CA/ES-93-024



P.T. 34



Keywords:

  Cancer/Carcinogenesis 

  ENVIRONMENT 

  Epidemiology 

  Risk Factors/Analysis 

  Occupational Health and Safety 



National Cancer Institute

National Institute of Environmental Health Sciences



Letter of Intent Receipt Date:  April 16, 1993

Application Receipt Date:  May 20, 1993



THE REQUEST FOR APPLICATIONS (RFA) ANNOUNCED IN THIS NOTICE CONTAINS

ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION.  POTENTIAL

APPLICANTS MAY OBTAIN THE RFA FROM THE CONTACT NAMED IN INQUIRIES,

BELOW.



PURPOSE



The Extramural Programs Branch, Division of Cancer Etiology, National

Cancer Institute (NCI) and the Division of Extramural Research and

Training, National Institute of Environmental Health Sciences (NIEHS)

invites grant applications for innovative epidemiologic studies to

better understand the etiology of breast cancer in high risk areas

including Connecticut, Delaware, Maryland, Massachusetts, New

Hampshire, New Jersey, New York, Rhode Island, Vermont, and Washington,

DC.  These studies are to be designed to take known risk factors into

consideration and must focus on markers or indicators of environmental

exposures that may influence geographic differences in rates and

temporal changes in incidence and mortality.



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,

Environmental Factors and Breast Cancer in High-Risk Areas, is related

to the priority area of cancer.  Potential applicants may obtain a copy

of a "Healthy People 2000" (Full Report:  Stock No. 017-001-00474-0) or

"Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1)

through the Superintendent of Documents, Government Printing Office,

Washington, DC 20402-9325 (telephone 202/783-3238).



ELIGIBILITY REQUIREMENTS



Applications may be submitted by domestic non-profit and for-profit

institutions, public and private, such as colleges, universities,

hospitals, research laboratories, units of State and local governments,

and eligible agencies of the Federal government.  Applications from or

involving minority institutions, individuals, and women are encouraged.



MECHANISM OF SUPPORT



This RFA will be supported through the NIH research project grants

(R01).  Awards will be administered under PHS grants policy as stated

in the PHS Grants Policy Statement, DHHS Publication No. (OASH)

90-50,000, revised October 1, 1990.



Because the nature and scope of the research proposed in response to

this RFA may vary, it is anticipated that the size of an award will

vary also.  It is anticipated that the average award will be

approximately $250,000 total costs.



This RFA is a one-time solicitation.  Responsibility for the planning,

direction, and execution of the proposed project will be solely that of

the applicant.  The total project period for applications submitted in

response to the present RFA may not exceed four years.  Competitive

continuation applications will compete with cited applications and be

reviewed by a Division of Research Grants study section.



If the NCI and the NIEHS determine that there is a sufficient

continuing program need, they may announce a request for renewal

applications.



FUNDS AVAILABLE



Approximately $1.0 million per year in total costs for four years will

be committed by the NCI to specifically fund applications which are

submitted in response to this RFA.  In addition, $250,000 will be

committed by the NIEHS to fund at least one application.  The expected

range of number of awards is three to five.  This funding level is

dependent on the receipt of a sufficient number of applications of high

scientific merit.  Although this program is provided for in the

financial plan of the NCI and the NIEHS, the award of grants pursuant

to this RFA are contingent upon the availability of funds for this

purpose.



RESEARCH OBJECTIVES



This RFA responds to the FY 1993 Senate Appropriations Subcommittee

Report for NIH which specifies that "NCI is directed to conduct a study

with four years of follow-up to determine the factors contributing to

the high breast cancer mortality rates in Connecticut, Delaware,

Maryland, Massachusetts, New Hampshire, New Jersey, New York, Rhode

Island, Vermont, and Washington, DC.  NCI is to develop a plan for

conducting the study and provide it to the House and Senate

Appropriations Committees, the House Committee on Energy and Human

Resources and the Senate Committee on Labor and Human Resources by July

1, 1993.  $1 million is provided to fund this study."



This RFA encourages applications for epidemiologic studies of breast

cancer that include assessment of markers or indicators of

environmental or occupational exposures, and include persons residing

in the high-risk areas of Connecticut, Delaware, Maryland,

Massachusetts, New Hampshire, New Jersey, New York, Rhode Island,

Vermont, and Washington, DC.  These studies are to be designed to take

known risk factors into consideration while focusing on environmental

exposures that may account for geographic differences in rates, as well

as temporal changes in incidence and mortality.Investigators must

include innovative approaches to the quantitation of environmental

and/or occupational exposures and the evaluation of biologic levels in

exposed persons.  Collaborations of multiple disciplines and research

institutions are particularly encouraged.  Whenever possible, research

designs should make use of existing resources, such as specimen

repositories.



Investigators may propose studies for evaluating the mechanisms by

which environmental, nutritional, or occupational exposures could act

in the initiation or promotion of breast cancer, such as through

effects on hormonal or metabolic pathways.  Projects should be proposed

as traditional R01s.  Proposals may build upon ongoing research

projects, utilizing already collected specimens or epidemiologic data.



STUDY POPULATIONS



SPECIAL INSTRUCTIONS FOR INCLUSION OF FEMALES AND MINORITIES IN

CLINICAL RESEARCH STUDIES



For projects involving clinical research, NIH requires applicants to

give special attention to the inclusion of women and minorities in

study populations.  If women or minorities are not included in the

study populations for clinical studies, a specific justification for

this exclusion must be provided.  Applications without such

documentation will not be accepted for review.



LETTER OF INTENT



Prospective applicants are requested to submit by April 16, 1993, a

letter of intent that includes a descriptive title of the proposed

research, the name, address, and telephone number of the Principal

Investigator, the names 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 is helpful in planning for the review of applications.

It allows NCI staff to estimate the potential review workload and to

avoid conflict of interest in review.  The letter of intent is to be

sent to Dr. A.R. Patel at the address listed under INQUIRIES.



APPLICATION PROCEDURES



Applications are to be submitted on form PHS 398 (rev. 9/91) available

at most institutional offices of sponsored research and from the Office

of Grants Inquiries, Division of Research Grants, National Institutes

of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone

301/496-7441.  The format and instructions applicable to regular

research grant applications must be followed.



Applications must be received by May 20, 1993.  If an application is

received after that date, it will be returned without review.  If the

application submitted in response to this RFA is substantially similar

to a research grant application already submitted to the NIH for

review, but has not yet been reviewed, the applicant will be asked to

withdraw either the pending application or the new one.  Simultaneous

submission of identical applications will not be allowed, nor will

essentially identical applications be reviewed by different review

committees.  Therefore, an application cannot be submitted in response

to this RFA that is essentially identical to one that has already been

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



Review criteria for RFAs are the same as those for unsolicited research

grant applications.



AWARD CRITERIA



The earliest anticipated date of award is September 30, 1993.



INQUIRIES



Written and telephone inquiries concerning this RFA are encouraged.

The opportunity to clarify any issues or questions from potential

applicants is welcome.



Direct inquiries regarding programmatic issues, requests for the RFA,

and address the letter of intent to:



A.R. Patel, Ph.D. or Kumiko Iwamoto, M.D.

Division of Cancer Etiology

National Cancer Institute

6130 Executive Boulevard

Executive Plaza North, Suite 535

Rockville, MD  20892

Telephone:  (301) 496-9600



Dr. William A. Suk

Division of Extramural Research and Training

National Institute of Environmental health Sciences

P.O. Box 12233

Research Triangle Park, NC  27709

Telephone:  (919) 541-0797



Direct inquiries regarding fiscal matters to:



Ms. Katherine Schulze

Grants Administration Branch

National Cancer Institute

6120 Executive Boulevard

Executive Plaza South, Suite 243

Rockville, MD  20892

Telephone:  (301) 496-7800, ext. 16



Mr. David L. Mineo

Division of Extramural Research and Training

National Institute of Environmental Health Sciences

P.O. Box 12233

Research Triangle Park, NC  27709

Telephone:  (919) 541-1373



AUTHORITY AND REGULATIONS



This program is described in the Catalog of Federal Domestic Assistance

No. 93.393 and 93.894.  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 Part 52 and 45

CFR Part 74.  This program is not subject to the intergovernmental

review requirements of Executive Order 12372 or Health System Agency

review.



.


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