GENERAL PROVISIONS FOR THE NATIONAL ACTION PLAN ON BREAST CANCEROMNIBUS PUBLIC HEALTH SERVICE (PHS) ADMINISTRATIVE SUPPLEMENTS



NIH GUIDE, Volume 24, Number 14, April 14, 1995



P.T.





Keywords:



National Cancer Institute



PROGRAM GOALS AND SCOPE



The National Action Plan on Breast Cancer (NAPBC) is a public-private

partnership created to eliminate the epidemic of breast cancer.  The

Public Health Service's Office on Women's Health, which coordinates

the implementation of the NAPBC, will offer approximately $2 million

in FY 1995 for supplemental awards of up to $100,000 (direct costs)

for a period of one year.  These administrative supplements are

offered to enable currently federally funded investigators to address

one or more of six high priority areas for breast cancer research and

outreach activities that were derived from the "Proceedings of the

Secretary's Conference to Establish a National Action Plan on Breast

Cancer," held in December 1993.



Any currently funded investigator-initiated PHS research and outreach

grants relevant to breast cancer is eligible for an administrative

supplement under this announcement including those funded by any PHS

entity, NIH Institute, Center or Division (ICD).  Contracts are not

eligible for this supplement program.  Since this announcement

concerns administrative supplements for the National Action Plan on

Breast Cancer, foreign or domestic applications with an international

component are not eligible.



The six priority areas for administrative supplements are:

information dissemination, national biological resource bank,

consumer involvement, breast cancer etiology, clinical trials

accessibility, and breast cancer susceptibility genes issues.



Applicants must address one or more of the six priority areas below.

Within each priority area, examples of issues which may be addressed

are, but not limited to, the following:



INFORMATION DISSEMINATION:  Develop innovative tools, approaches and

strategies to disseminate information to and facilitate communication

between scientists, consumers and practitioners about breast cancer,

breast cancer clinical trials, and breast health using state-of-the-

art information technologies (e.g. computer systems, interactive

videos, CD-ROM, and/or the Information Superhighway).



NATIONAL BIOLOGICAL RESOURCE BANK:  Establish biological resource

banks to ensure a national resource of well characterized and

documented biological materials for multiple areas of breast cancer

research.  Examples of possible topics include, but are not limited

to, a survey of existing tissue banks, the inclusion of other

biological tissues (cell lines, lymphocytes, etc.) in biological

banks, use of new technologies to facilitate the collection of

pertinent background data on samples, and cooperative participation

in the National Biological Resource Bank activities to increase the

availability of samples to investigators across the country.  In

addition, studies to investigate the ethics of using biological

specimens in research are of interest.



CONSUMER INVOLVEMENT:  Ensure consumer involvement at all levels in

the development and implementation of public health and service

delivery programs, research studies, and outreach efforts.  Involve

advocacy groups and women with breast cancer in setting research

priorities and in patient education.



BREAST CANCER ETIOLOGY:  Expand the scope and breadth of biomedical,

epidemiological, and behavioral research activities related to the

etiology of breast cancer.  Priority areas for projects include the

effects of radiation and electromagnetic fields, chemicals and

hormones, lifestyle factors, viruses, and gene-environment

interactions.



CLINICAL TRIALS ACCESSIBILITY:  Make clinical trials more widely

accessible to women with breast cancer and women who are at risk for

breast cancer.  Identify barriers to participation in clinical trials

and develop strategies to overcome these barriers through outreach to

consumers and clinicians, through better understanding of the

decision making process for women and their physicians, through

reduction of economic constraints, etc.



BREAST CANCER SUSCEPTIBILITY GENES ISSUES:  Address the health needs

and ethical, legal, and policy issues of individuals carrying breast

cancer susceptibility genes.  Recommend and test interventions for

consumers, health care providers, and at-risk patient groups, which

will lead to the development of a comprehensive plan for these

groups.



It is especially important to note that all requests for supplements

MUST be within the scope of the parent grant.  The parent grant can

deal with breast cancer, other cancers, other diseases, or any of the

above six priority areas.

Program directors for individual grants must be contacted for

questions on the consistency of the proposed supplemental project's

aims with the parent project.  The parent award must have a minimum

of one year remaining (end date no sooner than September 30, 1996) in

the project from the time the supplement is awarded.  This will

ensure that results of the activities under the administrative

supplement can be incorporated into a competing continuation

application of the parent award at the discretion of the Principal

Investigator.



Direct costs of the supplement can represent no more than 25 percent

of the current year total direct costs, not to exceed $100,000 direct

cost maximum.



APPLICATION PROCEDURES



Principal Investigators requesting supplements (regardless of parent

ICD) should use a standard PHS-398 (rev. 9/91) Face Page and Budget;

no more than five single-spaced pages of text addressing specific

aims, background and significance, research design and methods; and a

list of pertinent references (not included in the five page limit).

In addition, the following material is required:  a copy of the

official initial peer review comments for the parent grant (e.g.

summary statement or the equivalent); the most current Notice of

Grant award; biographical sketches (page FF of PHS-398 or equivalent)

of all relevant project staff.  All requests must be signed by the

appropriate institutional officials as well as the Principal

Investigator.



Budget requests for less than $50,000 direct costs need only indicate

personnel time and effort total dollars requested; budgets in excess

of $50,000 must provide categorical listings as required in PHS Form

398 instructions.

Investigators funded by PHS entities outside of the National Cancer

Institute may be required to provide additional budgetary information

or be subject to additional conditions or limitations consistent with

the general policies and practices of the specific units holding the

parent award.  Individuals will be notified of such issues by their

administrative contact if an award is contemplated.



Submit by the receipt date of June 14, 1995 a signed, typewritten

original of the request and 4 signed, exact copies, in one package

to:



National Action Plan on Breast Cancer

Office on Women's Health, USPHS

Hubert Humphrey Building, Room 730-B

200 Independence Avenue, S.W.

Washington, DC  20201

Telephone:  (202) 690-7650

FAX:        (202) 690-7172



At the same time, an exact copy of the application MUST be submitted

directly to the Program Director of the PHS funding component

responsible for the funding of the parent grant.  The name of the

program director and awarding official should be on the notice of

award for the parent grant that is sent directly to principal

investigators and institutional business offices.  If there is any

question about who or where to send this copy, applicants should call

the agency directly for the information prior to mailing the copy.  A

copy of this announcement should be included with your request for a

supplement.  Failure to do so may exclude the request from the

competition.



In case your program director is not familiar with the NAPBC

competition, they should be referred to one of the individuals listed

below for more information.



EVALUATION AND FUNDING PROCEDURES



Requests for Omnibus Administrative Supplements will be evaluated and

ranked by a process involving representatives of Federal agencies

including DHHS, outside consultants, and the PHS Office of Women's

Health.



The evaluation will be made against the following general criteria:

originality of proposed activity, scientific and technical

significance of the proposed study as related to the six high

priority areas, appropriateness and adequacy of the experimental

approach and methodology to carry out the activity, development of

public and private partnerships, the potential of the project to

develop successful programs during the one year supplement period

(i.e. qualifications of project team, resources, data quality and

management plans), and appropriateness of the proposed budget and

activities to the parent award.



Applicants are encouraged to address the needs of women who may have

been generally underserved in research and outreach projects.

Special consideration will be given to proposed activities that

emphasize the following:



o  Implementing partnerships with public and private sector groups,



o  Including breast cancer consumer/advocacy groups in the design,

conduct and evaluation of clinical/outreach/research strategies,



o  Testing new, innovative designs for ongoing research or outreach

studies,



The information and initial evaluation will be forwarded to

appropriate PHS program directors for review to ensure that the

proposed activities are compatible with and within the scope of the

objectives and aims of the parent project.  Requests will also be

reviewed for the appropriateness of funds requested and for potential

overlap with other current support.



Applications must be submitted by June 14, 1995.  Successful

supplements will be funded no later than September 30, 1995.

Approximately 20-30 supplements will be awarded from this program.



The Public Health Service's Office on Women's Health coordinates the

implementation of the NAPBC.  Funding for the NAPBC is administered

by the National Cancer Institute (NCI).  Approved Administrative

Supplements will be funded directly from the NCI (if the parent grant

is a NCI grant); or through a co-funding or interagency agreement

between NCI and other PHS entities.



INQUIRIES



For additional information about this initiative, interested and

eligible investigators should contact:



Susan J. Blumenthal, M.D., M.P.A.

Deputy Assistant Secretary for Health (Women's Health)

Co-Chair, National Action Plan on Breast Cancer

ATTN:  Suzanne G. Haynes, Ph.D. (etiology; consumer involvement)

Cheryl L. Marks, Ph.D. (clinical trials; information dissemination)

Debbie Saslow, Ph.D. (breast cancer susceptability genes; tissue

bank)

Office on Women's Health, USPHS

Hubert Humphrey Building, Room 730-B

200 Independence Avenue, S.W.

Washington, DC  20201

Telephone:  (202) 401-9587

FAX:        (202) 401-9590



or



Susan M. Sieber, Ph.D.

Deputy Director

Division of Cancer Etiology

National Cancer Institute

Building 31, Room 11A03

Bethesda, MD  20892

Telephone:  (301) 496-5946

FAX:        (301) 496-1297



Direct inquiries regarding fiscal matters to:



William G. Wells

Section Chief

Grants Administration Branch

National Cancer Institute

Executive Plaza South, Suite 243

6120 Executive Boulevard

Bethesda, MD  20892-7150

Telephone:  (301) 496-7800, Extension 250

FAX:  (301) 496-8601



Since program directors in agencies outside of NCI may be unfamiliar

with this program, they are encouraged to contact one of the above

individuals for more information.



.


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