From: kristoff@GENBANK.BIO.NET (Dave Kristofferson)
Newsgroups: bionet.sci-resources
Subject: NIH Guide, vol. 21, no. 32, pt. 1, 4 September 1992
Date: 15 Sep 92 18:52:37 GMT
Distribution: bionet


NOTE: The NIH Guide may be split into more than one mail message to
avoid truncation during e-mail distribution.  The first message always
begins with the RFP/RFA summary sections followed by the appended
texts of the full RFP/RFAs.
----------------------------------------------------------------------

$$XID NIHGUIDE 19920904 V21N32 P1O1 ************************************
X-comment: RFAs described: CA-92-22, CA-92-14

NIH GUIDE - Vol. 21, No. 32 - September 4, 1992

$$INDEX BEGIN *******************************************************
                              NOTICES
$$INDEX N1 **********************************************************

NATIONAL HUMAN SUBJECT PROTECTIONS WORKSHOPS
National Institutes of Health
Food and Drug Administration
INDEX:  NATIONAL INSTITUTES OF HEALTH; FOOD AND DRUG ADMINISTRATION

               NOTICES OF AVAILABILITY (RFPs AND RFAs)
$$INDEX R1 **********************************************************

NIEHS CLINICAL TRIAL PROGRAM (RFP NIH-ES-92-34)
National Institute of Environmental Health Sciences
INDEX:  ENVIRONMENTAL HEALTH SCIENCES

$$INDEX R2 12/08/92 *************************************************

POSSIBLE ROLE OF METALLOTHIONEIN IN CARCINOGENESIS (RFA CA-92-22)
National Cancer Institute
INDEX:  CANCER

$$INDEX R3 01/26/92 *************************************************

BIOMARKERS OF DIETARY FAT IN POST-MENOPAUSAL WOMEN (RFA CA-92-14)
National Cancer Institute
INDEX:  CANCER

                    ONGOING PROGRAM ANNOUNCEMENTS
$$INDEX P1 **********************************************************

RESEARCH ON MENTAL HEALTH SERVICES IN GENERAL HEALTH CARE (PA-92-103)
National Institute of Mental Health
INDEX:  MENTAL HEALTH

This publication is also available electronically to institutions via
BITNET or INTERNET.  Alternative access is through the NIH Grant Line
using a personal computer.  Contact Dr. John James at 301/496-7554 for
details, or send an E-mail message to ZNS@NIHCU.

$$INDEX END *********************************************************

                               NOTICES

$$N1 BEGIN **********************************************************

NATIONAL HUMAN SUBJECT PROTECTIONS WORKSHOPS

NIH GUIDE, Volume 21, Number 32, September 4, 1992

P.T. 42; K.W. 0783005, 1014006

National Institutes of Health
Food and Drug Administration

The Office for Protection from Research Risks (OPRR) of the National
Institutes of Health (NIH) and the Food and Drug Administration (FDA)
are continuing to sponsor a series of workshops on responsibilities of
researchers, Institutional Review Boards (IRBs), and institutional
officials for the protection of human subjects in research. The
workshops are open to everyone with an interest in research involving
human subjects.  The meetings should be of special interest to those
persons currently serving or about to begin serving as a member of an
IRB.  Issues discussed at these workshops are relevant to all other
Public Health Service agencies.  The current schedule includes the
following:

SOUTHWESTERN WORKSHOP

DATES:  November 16 & 17, 1992

LOCATION:
Wyndham Warwick
5701 Main Street
Houston, TX  77005
Telephone:  (713) 526-1991

SPONSORS:
University of Texas Health Science Center at Houston
Prairie View A & M University

REGISTRATION:

Ms. Paula Knudson
Executive Coordinator
Office of Research Support Committee
University of Texas Health Science Center at Houston
P.O. Box 20036
Houston, TX  77225
Telephone:  (713) 792-5048

TITLE:  Geriatric Research as an Ethical Mandate:  Politics, Policy,
and Problems

DESCRIPTION: Expanded life expectancies and expanding technologies are
swelling the ranks of the frail and disabled elderly.  Minimal research
has been carried out to understand the problems this subject group and
their families encounter in finding solutions to their health and
social needs.  The conference will identify key problems that need to
be studied; isolate the risks and benefits associated with behavioral,
clinical, or evaluation research designed to enroll this group as
subjects; and pose solutions that will meet the needs of regulators,
scientists, and the elderly.

The program is designed to be of interest to physicians, nurses,
pharmacists, scientific investigators, other health care professionals,
clergy, lawyers, medical, nursing, social work students, and
psychologists as well as IRB members and administrators.  Attention
will be paid to Federal regulations with special emphasis on the
assessment of risks---medical, legal, and psychosocial.  Opportunities
will be available through workshops, question periods, and informal
discussions for participants to exchange ideas and interests with
faculty and OPRR and FDA representatives.

SOUTHEASTERN WORKSHOP

DATES:  January 14 & 15, 1993

LOCATION:
Sheraton Sand Key Resort
1160 Gulf Boulevard
Clearwater Beach, FL  33515
Telephone:  (813) 595-1611

SPONSORS:
University of South Florida
Florida A & M University

REGISTRATION:
Ms. Eileen Highsmith
Executive Secretary
University of South Florida
4202 E. Fowler Avenue (MP.FAO-126)
Tampa, FL  33620-7900
Telephone:  (813) 974-2897

TITLE:  Barriers to Informed Consent:  Language, Age Factors, Trauma,
and Women/Minority Issues

DESCRIPTION: Today's researchers face numerous barriers to obtaining an
informed consent.  Such issues as age, language, mental capacity, and
sobriety may affect the ability of subjects to give a truly informed
consent.  Many of these barriers oftentimes impact the pool of subjects
which an investigator is willing (or able) to use in a research
project.  In addition, recent legislation from the Congress was
designed to address the issue of inadequate numbers of women and
minorities in research projects.  This conference has been designed to
address three main areas in which barriers to informed consent may
exist:  mental competence, ethnic and gender issues, and research with
children and the elderly.

The conference program is designed to be of value to physicians,
nurses, pharmacists, scientific investigators, and other health care
professionals.  All IRB members, students in health care areas and
administrators will also benefit from the conference.  Attention will
be given to Federal regulations governing research on human subjects,
with special emphasis placed on the assessment of risks---medical,
legal, and psychosocial.  Ample opportunities will be provided to
exchange ideas and interests, through question and answer sessions and
informal discussions.

SOUTHWESTERN WORKSHOP

DATES:  February 12 & 13, 1993

LOCATION:
Sheraton Tempe Mission Palms Hotel
60 East 5th Street
Tempe, AZ  85281
Telephone:  (602) 894-1400

SPONSORS:
Arizona State University
Northern Arizona University

REGISTRATION:
Ms. Carol Jablonski
IRB Coordinator
Office of the Assistant Vice President for Research
Arizona State University
Tempe, AZ  85287-3403
Telephone:  (602) 965-6788

TITLE:  Contemporary Issues in Human Subject Research:  Challenges for
Today's IRBs

DESCRIPTION: This program is designed to be a practical working session
to explore contemporary issues in human subjects protection including
regulations and assurances, categorization of research protocols, uses
of special populations, experimental design and scientific merit, fetal
tissue research, ethical/legal issues in human subjects research, and
conflict of interest.  As appropriate, topics will be discussed from
the perspective of the clinical researcher and the behavioral/social
science researcher. Issues will be discussed in a panel format with
ample time for audience questions.  An outstanding faculty has been
assembled.

This program should be of interest to researchers in clinical medicine
and the behavioral and social sciences. Institutional Review Board
members, university and hospital administrators, lawyers, ethicists,
health care practitioners, students, and other persons with interests
in human subject protection issues.

For further information regarding these workshop or future NIH/FDA
National Human Subject Protections Workshops, please contact:

Ms. Darlene Marie Ross
Executive Assistant for Education
Division of Human Subject Protections
Office for Protection from Research Risks
National Institutes of Health
9000 Rockville Pike
Building 31, Room 5B59
Bethesda, MD  20892
Telephone:  (301) 496-8101

$$N1 END ************************************************************

                NOTICES OF AVAILABILITY (RFPs AND RFAs)

$$R1 BEGIN NIH-ES-92-34 *********************************************

NIEHS CLINICAL TRIAL PROGRAM

NIH GUIDE, Volume 21, Number 32, September 4, 1992

RFP AVAILABLE:  NIH-ES-92-34

P.T. 34; K.W. 0725005, 0755015

National Institute of Environmental Health Sciences

The National Institute of Environmental Health Sciences (NIEHS) seeks
to establish several contracts within 30 minutes' commuting distance of
the NIEHS.  The purpose is to provide clinical support services
including access to patient facilities by NIEHS investigators
performing clinical studies on the effect of environmental agents on
human health.  Examples of efforts to be explored under the contracts
include the study of pulmonary pathobiological effects of
environmentally induced asthma, studies of the role of in utero
exposure of environmental estrogens on bone mineral density, and
studies of the role of environmental estrogens on the onset and
progression of puberty in children.  Specific studies will be
identified by Task Orders.  The requirement for geographic proximity
will allow NIEHS investigators to coordinate their research efforts by
physically working at several sites (NIEHS and contractor facilities)
on a frequent basis.  It is anticipated that several awards will be
made.  The estimated period of performance is 10 years.  Release of the
Request for Proposals (RFP) is anticipated on or about September 2,
1992, with proposals due October 20, 1992.  All responsible sources may
submit a proposal that shall be considered by the agency.

Requests must reference RFP NIH-ES-92-34 and must be forwarded to:

National Institute of Environmental Health Sciences
Contracts and Procurement Management Branch, OM
ATTN:  Thomas M. Hardee, Contracting Officer
79 TW Alexander Drive, Building 4401 Research Commons
P.O. Box 12874
Research Triangle Park, NC  27709
Telephone:  (919) 541-7893
FAX:  (919) 541-2712

$$R1 END ************************************************************

$$R2 BEGIN CA-92-22 FULL-TEXT ***************************************

POSSIBLE ROLE OF METALLOTHIONEIN IN CARCINOGENESIS

NIH GUIDE, Volume 21, Number 32, September 4, 1992

RFA AVAILABLE:  CA-92-22

P.T. 34; K.W. 0715035, 1007009, 1003018, 1002008, 0710030

National Cancer Institute

Letter of Intent Receipt Date:  October 2, 1992
Application Receipt Date:  December 8, 1992

THE REQUEST FOR APPLICATIONS (RFA) ANNOUNCED IN THIS NOTICE CONTAINS
ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION.  POTENTIAL
APPLICANTS MAY OBTAIN THE COMPLETE RFA FROM THE CONTACT NAMED IN
INQUIRIES BELOW.

PURPOSE

The Chemical and Physical Carcinogenesis Branch, Division of Cancer
Etiology, National Cancer Institute (NCI), in collaboration with the
Cancer Biology Branch, Division of Cancer Biology, Diagnosis, and
Centers, NCI, and the Grants and Contracts Operations Branch, Division
of Cancer Treatment, NCI, invites investigator-initiated research grant
applications to elucidate the possible role of metallothionein (MT) in
carcinogenesis.  In addition, the National Institute of Environmental
Sciences (NIEHS) has an interest in the general topic of
metallothionein, but not in the specific emphasis of this RFA, which is
the possible role of metallothionein in carcinogenesis.  New and
experienced investigators may apply for research funds to pursue
multidisciplinary research projects.

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,
Possible Role of Metallothionein in Carcinogenesis, 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
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 and foreign, for-profit and
non-profit, public and private organizations, such as universities,
colleges, hospitals, laboratories, units of State and local
governments, and eligible agencies of the Federal Government.
Applications from women and minority investigators are encouraged.

MECHANISM OF SUPPORT

Support of this program will be through the National Institutes of
Health (NIH) traditional research project grant (R01).  Applicants will
be responsible for the planning, direction, and execution of the
proposed project.  The total project period may not exceed four years.

FUNDS AVAILABLE

Total costs of $1,500,000 per year for four years will be committed to
specifically fund applications submitted in response to this RFA.  It
is anticipated that 9 to 11 awards will be made contingent upon the
availability of funds.  The earliest feasible start date for the
initial awards will be July 1, 1993.

RESEARCH OBJECTIVES

The objectives of this RFA are to encourage research designed to
elucidate the possible role of MT in carcinogenesis.  Specific topic
areas that might be supported by the RFA include, but are not limited
to:

o  Biological and toxicological roles of MT.  Studies such as metal
homeostasis, detoxification, transport, role in cell proliferation
during the perinatal period, and involvement of zinc as a second
messenger in signal transduction, as related to cellular normality.

o  Regulation of MT gene expression.  Studies of metal induction in
various tissues, during development, and organismal specificity in
transgenic and model systems and in normal versus transformed cells.

o  Role of MT in tumor cell pathobiology.  Studies to define the role
of MT in tumor cell progression and metastasis and the types and
staging of tumors that may or may not express excess MT.  Studies
directed at enhancing a rational basis for therapeutic intervention
with metallic anticancer drugs.

o  Role of MT in cancer chemotherapy. Studies on the role of MT in
tumor cell resistance to anticancer drugs, especially metal-based
drugs.  Studies on the use of induction of MT in non-tumor tissue as an
adjunct to reduce toxicity for metallic chemotherapeutics.  Studies
involving mechanisms by which MT synthesis could be specifically
depressed in tumor cells to make them hypersusceptible to metallic
chemotherapeutics.

o  Susceptibility factors in metal carcinogenesis.  Studies assessing
MT gene expression in target tissues of metallic carcinogens in rodents
and molecular epidemiology of MT with special emphasis on target
tissues of metallic carcinogens in humans (e.g. prostate, lung).

o  Molecular interaction of MT with ligands (metals and anticancer
drugs) including binding and exchange, and structural and dynamic
studies.

STUDY POPULATIONS

SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDIES

For projects involving clinical research, the 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

Each prospective applicant is asked to submit, by October 2, 1992, a
letter of intent that includes a descriptive title of the proposed
research, the name, address, telephone and FAX numbers of the PI, the
names of other key personnel, the participating institution(s), and the
number and title of the RFA in response to which an 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, it contains
information that is helpful in planning for the review.  The letter of
intent allows NCI staff to estimate the potential review workload and
helps to avoid conflict of interest in the review.

The letter of intent is to be sent to:

Dr. Yung-Pin Liu
Program Director, Carcinogenesis Mechanisms
Chemical and Physical Carcinogenesis Branch
Division of Cancer Etiology
National Cancer Institute
Executive Plaza North, Suite 700
Bethesda, MD  20892
Telephone:  (301) 496-5471
FAX:  (301) 496-1040

APPLICATION PROCEDURES

Applications must be received by December 8, 1992.  The research grant
application form PHS 398 (rev. 9/91) is to be used in applying for
awards under this RFA.  The application package is available at most
institutional business offices; 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; and
from the NCI Program Director named above.

REVIEW CONSIDERATIONS

Those applications will be evaluated according to the review criteria
stated in the RFA for scientific and technical merit by an appropriate
peer review group convened by the Division of Extramural Activities,
NCI.  The second level of review by the National Cancer Advisory Board
will consider the special needs of the NCI and the priorities of the
National Cancer Program.

INQUIRIES

This Notice of Availability is an abbreviated version of the RFA.
Copies of the complete RFA and written and telephone inquiries
concerning the objectives and scope of the RFA are to be directed to
Dr. Liu at the above address.

Written and telephone inquiries of a budgetary, administrative, and/or
policy nature are to be directed to:

Ms. Jean Cahill
Grants Management Team Leader
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Suite 243
Bethesda, MD  20892
Telephone:  (301) 496-7800, ext. 47
FAX:  (301) 496-8601

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance
No. 93.393, Cancer Cause and Prevention Research.  Awards are made
under the 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 52 and 45 CFR Part 74.  This program is not subject
to the intergovernmental review requirements of Executive Order 12372
or Health Systems Agency review.

$$R2 END ************************************************************

$$R3 BEGIN CA-92-14 FULL-TEXT ***************************************

BIOMARKERS OF DIETARY FAT IN POST-MENOPAUSAL WOMEN

NIH GUIDE, Volume 21, Number 32, September 4, 1992

RFA AVAILABLE:  CA-92-14

P.T. 34; K.W. 0710095, 0760003, 0765025

National Cancer Institute

Letter of Intent Receipt Date:  October 7, 1992
Application Receipt Date:  January 26, 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 Division of Cancer Prevention and Control, National Cancer
Institute (NCI), invites applications for cooperative agreements
directed towards the identification and evaluation of potential
biochemical/biological markers to assess total dietary fat intake in
post-menopausal women and to monitor adherence to dietary interventions
in cancer prevention clinical trials.

The purpose of this RFA is to encourage the submission of applications
from qualified investigators interested in conducting investigations
designed to identify, characterize, and evaluate biochemical/biological
markers to assess dietary intake and adherence.  This research
initiative also seeks to identify and establish a network of
institutions and organizations with scientific expertise, facilities,
and capabilities to conduct controlled feeding studies, metabolic
studies, and field studies.

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,
Biomarkers of Dietary Fat in Post-Menopausal Women, is related to the
priority area of cancer prevention.  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. 017-001-0043-1)
through the Superintendent of Documents, Government Printing Office,
Washington, DC 20402-9325 (telephone 202-783-3238).

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic and foreign 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.
Applications from minority individuals and women are encouraged.

MECHANISM OF SUPPORT

This RFA will support awards through the cooperative agreement, an
assistance mechanism in which substantial NCI programmatic involvement
with the recipient during performance of the planned activity is
anticipated.  The nature of NCI staff involvement is described in the
RFA.  Applicants will be responsible for the planning, direction, and
execution for the proposed project.  In addition to the requirements
stated in this RFA, awards will be administered under PHS grants policy
as stated in Public Health Service Grants Policy Statement, DHHS
Publication No. (OASH) 90-50,000, (rev. 10/90).

This RFA is a one-time solicitation.  Future unsolicited competing
continuation applications will compete with all investigator-initiated
applications and be reviewed by the Division of Research Grants (DRG).
If the NCI determines that there is a sufficient continuing program
need, the NCI may invite all funded recipients to submit competing
continuation applications.

FUNDS AVAILABLE

Approximately $750,000 in total costs per year for three years will be
committed to fund applications submitted in response to this RFA.  It
is anticipated that three to five awards will be made.  This level of
support is dependent on the receipt of a sufficient number of
applications of high scientific merit.  The total project period for
applications submitted in response to the present RFA may not exceed
three years.  Although this program is provided for in the financial
plans of the NCI, the award of grants pursuant to this RFA is also
contingent upon the continuing availability of funds for this purpose.

RESEARCH OBJECTIVES

The specific objectives of this RFA are to encourage research on the
identification and evaluation of biochemical/biological indicators of
total dietary fat intake in post-menopausal women on self-selected low-
and high-fat diets and in controlled feeding and/or metabolic studies.

Background

A major challenge in studying the effects of diet on health and chronic
disease risks is the difficulty of assessing dietary intake.  Current
methods for dietary assessment and adherence monitoring have different
levels of precision and accuracy and all have the inherent limitation
of relying on self-reported data.  The availability of
biochemical/biological markers for assessing dietary fat intake and
adherence in post-menopausal women would greatly facilitate the design,
conduct, and interpretation of cancer prevention clinical trials,
analytical epidemiologic studies, and diet-health survey studies on the
relationship of diet and cancer risk.  Identification of
biochemical/biological indicators of dietary exposure would circumvent
the current dietary assessment methodological shortcomings that limit
the interpretation of data and often prevent the derivation of precise
conclusions about the association of dietary patterns and/or specific
dietary components with the risk of cancer and other chronic diseases.

Specific and sensitive biochemical/biological indicators of dietary
intake, in particular total dietary fat, would greatly facilitate the
design, conduct and interpretation of dietary intervention trials,
epidemiologic studies and diet-health survey studies that attempt to
determine the role of diet in cancer risk and prevention.  In studies
involving dietary modifications, the extent to which the results may be
influenced by varying degrees of adherence is an aspect that is both
important and difficult to evaluate.  Thus, evaluation and validation
of potential biochemical/biological indices of dietary intake will
require controlled human feeding studies using well-defined diets and
precise measures of actual intake.

Studies of Special Interest

Specifically, applications are solicited that will (1) identify and
evaluate potential biochemical/biological indicators of adherence in
post-menopausal women on self-selected low- and high-fat diets, and/or
(2) identify and evaluate biochemical/biological indicators of
adherence to low-fat diets in post-menopausal women in controlled
feeding and/or metabolic studies.  Applicants may propose also to
conduct a series of short-term (6-12 weeks) controlled clinical and/or
metabolic studies and/or field studies.  These studies should be
designed to identify, characterize, and evaluate minimally invasive,
specific and sensitive biochemical/ biological indicators for assessing
total fat intake and/or for monitoring adherence to low-fat diets.
Emphasis should be focused on dietary patterns that are nutritionally
adequate and are characterized by reduced levels of total fat and
saturated fat, increased levels of complex carbohydrates and fiber, and
include a variety of foods typically present in the U.S. diet.  In
addition, the influence of varying the levels of fat intake while
keeping fiber intake constant, weight loss, and energy balance may be
taken into consideration in the study designs.

SPECIAL REQUIREMENTS

The RFA describes the complete terms for this cooperative agreement,
including terms of cooperation, responsibilities of the NCI Program
Director, responsibilities of the awardees, and the arbitration process
to resolve disputes.  Other required applicant information and special
instructions for preparation of cooperative agreement applications are
also included.

STUDY POPULATIONS

SPECIAL INSTRUCTION TO APPLICANTS REGARDING IMPLEMENTATION OF NIH
POLICIES CONCERNING INCLUSION OF MINORITIES IN CLINICAL RESEARCH STUDY
POPULATIONS

For projects involving clinical research, the NIH requires applicants
to give special attention to the inclusion of minorities in study
populations.  If 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 asked to submit by October 7, 1992, a letter
of intent that includes a descriptive title of the proposed research,
the name and address of the PI, the names of other key personnel, the
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, it is requested
in order to provide an indication of the number and scope of
applications to be reviewed.

The letter of intent is to be sent to:

Postal Mail Address:

Carolyn K. Clifford, Ph.D.
Diet and Cancer Branch
Division of Cancer Prevention and Control
National Cancer Institute
Executive Plaza North, Room 212
Bethesda, MD  20892-6130
Telephone:  (301) 496-8573
FAX:  (301) 402-0553

Overnight Delivery Address:

Carolyn K. Clifford, Ph.D.
Diet and Cancer Branch
Division of Cancer Prevention and Control
National Cancer Institute
6130 Executive Boulevard
Executive Plaza North, Room 212
Rockville, MD  20852

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 9/91) is to be used
in applying for these grants.  These forms are available at most
institutional business offices; from the Office of Grants Inquiries,
Division of Research Grants, National Institutes of Health, Room 449,
Westwood Building, 5333 Westbard Avenue, Bethesda, MD 20892; telephone
301/496-7441 and from the NCI Program Director named below.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed by the Division of Research
Grants for completeness.  Incomplete applications will be returned to
the applicant without further consideration.  Evaluation for
responsiveness to the program requirements and criteria stated in the
RFA is an NCI program staff function.  Applications that are judged
non-responsive will be returned to the applicant, but may be submitted
as investigator-initiated research grants.  Questions concerning the
responsiveness of proposed research to the RFA should be directed to
program staff (see INQUIRIES).

If the number of applications is large compared to the number of awards
to be made, the NCI may conduct a preliminary scientific peer review
(triage) to eliminate those applications that are clearly not
competitive.  The NCI will remove from competition those applications
judged to be noncompetitive for award and notify the applicant and
institutional business official.  Those applications judged to be both
competitive and responsive will be further evaluated according to the
review criteria stated in the RFA for scientific and technical merit by
an appropriate peer review group convened by the Division of Extramural
Activities, NCI.  The second level of review by the National Cancer
Advisory Board considers the special needs of the NCI and the
priorities of National Cancer Program.

AWARD CRITERIA

The anticipated date of award is September 30, 1993.  Awards made
pursuant to this RFA are contingent upon the availability of funds for
this purpose and the scientific review.

INQUIRIES

The program staff welcome the opportunity to clarify any issues or
questions from potential applicants.  Written and telephone inquiries
concerning the objectives and scope of this RFA, inquiries about
specific proposed research, and requests for the RFA are encouraged and
should be directed to the Program Director listed below.

Direct inquiries regarding programmatic issues to:

Carolyn K. Clifford, Ph.D.
Chief and Program Director
Diet and Cancer Branch
Division of Cancer Prevention and Control
National Cancer Institute
Executive Plaza North, Room 212
Bethesda, MD  20892-6130
Telephone:  (301) 496-8573
FAX:  (301) 402-0553

Direct inquiries regarding fiscal matters to:

Eileen Natoli
Team Leader, PC Team
Grants Administration Branch
National Cancer Institute
6120 Executive Boulevard
Executive Plaza South, Room 243
Rockville, MD  20852
Telephone:  (301) 496-7800, ext. 56

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance
No. 93.399, Cancer Control.  Awards will be made under the authority of
the Public Health Services Act, Title IV, Section 301 (Public Law
78-410,;42 U.S.C. 241 and Section 412, as amended by Public Law 99-518,
42 U.S.C 258a-1); 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 12732 or Health Systems Agency review.

$$R3 END ************************************************************
                 ONGOING PROGRAM ANNOUNCEMENTS

$$P1 BEGIN PA-92-103 ************************************************

RESEARCH ON MENTAL HEALTH SERVICES IN GENERAL HEALTH CARE

NIH GUIDE, Volume 21, Number 32, September 4, 1992

PA NUMBER:  PA-92-103

P.T. 34; K.W. 0715129, 0730050

National Institute of Mental Health

PURPOSE

The goal of this Program Announcement (PA) is to encourage research on
mental disorders in primary care and other general medical settings,
particularly research that focuses on the nature, recognition,
classification, treatment, and outcomes of people with mental disorders
in these service settings.  This announcement may encourage the
development of needed research that seeks to improve understanding of
how best to assess mental disorders and provide mental health services
in general health care settings.

Among people with current mental disorders who use health services,
about half are not treated in the specialty mental health care sector
and receive health services only in general medical settings.  While
investigator-initiated research in this area has grown substantially,
there is still a tremendous dearth of accurate information on the kinds
of patients with mental disorders in the general health care sector,
the nature and severity of their disorders, and the relationship of
these mental disorders to medical conditions, as well as on the mental
health services--- types, quality, effectiveness---delivered in primary
care and other general health care sectors (e.g., emergency rooms,
nursing homes, general hospital medical and surgical units,
rehabilitation hospitals).

The Primary Care Research Program at the National Institute of Mental
Health (NIMH) was established in response to research findings
indicating the relative gap in use of specialty mental health services
compared to primary care service use by people with mental disorders,
and as an attempt to understand the low recognition rates of mental
disorders in general medical settings and to contribute to health care
policy.  While major research issues at the outset included
epidemiological (prevalence and types of disorders), nosologic
(validity and reliability of diagnoses), clinical practice and
services, systems/organizational, and economic questions, existing
research data are still scant in most of these areas, despite a growth
in the field's scientific inquiries and related activities sponsored by
the program.  Furthermore, this research is called for by the mental
health objectives in the recent report "Healthy People 2000"---two of
which directly address the provision of mental health services by
primary care providers (6.13, 6.14) [footnote 1].  Other recent
activities---the Agency for Health Care Policy and Research of
guidelines for the treatment of depression in primary care (with which
the NIMH has been involved) [footnote 2] active work with new
classification of mental disorders in primary care [footnote 3]---
support this effort.

These and other activities [footnote 4], aligned with scientific data
on the impact of mental health on overall functioning and disability in
people seen in the general health care sector [footnote 5] make a
strong call for more scientific inquiry to inform the gaps between the
mental health needs seen in these general sector settings and the
services provided in these settings.

These gaps are even more evident in special populations seen mainly in
the general health care sector and the special issues of access,
assessment, and utilization that are unique to them:  rural groups,
minority populations, inner city groups, and HIV-infected people.
Attention should also be given to unique issues related to women,
children, adolescents, and the elderly.

Last, research is strongly needed on those people with mental disorders
who may need more services in the general health sector, particularly
the severely mentally ill [footnote 6] and the homeless.

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 effort is
in accordance with specific objectives 6.13 and 6.14.  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) 783-3238.

ELIGIBILITY REQUIREMENTS

Applications may be submitted by foreign and domestic, public and
private, non-profit and for-profit organizations, such as universities,
colleges, hospitals, laboratories, units of State and local
governments, and eligible agencies of the Federal Government.  Women
and minority investigators are encouraged to apply.  Foreign
institutions are only eligible for traditional research grants.

MECHANISMS OF SUPPORT

Research support may be requested through applications for traditional
research grant (RO1), a small grant (R03), and First Independent
Research Support and Transition (FIRST) Award (R29).  Since the latter
programs have special requirements, applicants are advised to refer to
specialized announcements for the small grant and FIRST award programs,
available from:

National Institute of Mental Health
Division of Extramural Activities
Office of Extramural Policy and Analysis
5600 Fishers Lane, Room 9-97
Rockville, MD  20857
Telephone:  (301) 443-4673

Terms and Conditions of Support

Grant funds may be used for expenses clearly related and necessary to
conduct the proposed research, including direct costs and allowable
indirect costs.

Period of Support

Applications for traditional research projects may request support for
up to five years.  Small grants are limited to two years and may not be
renewed.  FIRST awards are made for five years, but are not renewable.
Annual awards will be made, subject to continued availability of funds
and progress achieved.  A competing continuation (renewal) application
for a traditional research award (RO1) may be submitted before the end
of an approved period of support in order to request funds for the
continuation of the project.

RESEARCH OBJECTIVES

The following list of research objectives is meant to be exemplary and
not exhaustive---it serves to identify key topics in which further
rigorous scientific research is needed to delineate mental health needs
and to assess the mental health services provided in the general health
care sector:

(1) Methodological Issues

o  Studies of classification systems for mental disorders and
treatments delivered in the general health care sector, with special
emphasis on validity, comparative diagnostic assessments, and clinical
problems not addressed by available nosologic systems (e.g., childhood
behavioral disorders, subsyndromal disorders like minor depression or
mixed anxiety-depression)

o  Research on the development, applicability, and utility of
instruments or analytic techniques that may be used to assess
multi-dimensional outcomes for people with both mental and medical
disorders seen in the general health care sector.  Such outcomes might
include severity of illness, disability, costs, and community and
family burden

o  Research on the applicability and utility of existing mental health
screening, diagnostic and management instruments in primary care
settings, particularly among patients from different socio-economic,
ethnic, and cultural backgrounds

o  Studies using innovative methodologies (e.g., decision analysis,
meta-analysis) to examine the clinical management of people with mental
disorders in the general health care sector

(2) Recognition and Diagnosis

o  Studies examining the presentation and nature of mental disorders in
primary care and other general health care settings (especially for
children and the elderly), especially duration, remission, and
recurrence of these disorders, with special consideration to the
longitudinal evaluation of treated and untreated subsyndromal
conditions that impair health status

o  Studies of the impact of co-occurring general medical illnesses on
the accurate assessment of mental disorders, and impact on mental
health services delivered in the general health sector for these
populations (e.g., the "accurate" assessment of depression in the
medically ill and service implications)

o  Studies of the relationship between co-occurring alcohol or drug
problems and mental disorders, and the impact of these conditions on
accurate recognition of mental problems by general health care
providers

o  Studies of the barriers to the accurate recognition and diagnosis of
mental disorders, especially in primary care, with special attention to
(a) patient variables such as population specific beliefs (e.g., rural,
cultural) and (b) provider variables, such as knowledge and attitudes
about mental disorders, which may impact on recognition and management
of people with mental disorders

(3) Clinical Services and Practices

o  Research on the types, quality and effectiveness of mental health
services provided by general health care providers, differences of
these services in relation to type of patient (e.g., understudied
groups like the elderly and women in various life cycle stages who seek
general health care), provider (e.g., physician, nurse, social worker)
and setting, and impact on patient outcomes

o  Studies of referral patterns from the general health care sector to
the mental health care sector and barriers to referral (e.g., access,
attitudes, training, reimbursement)---rates, processes, and effect on
patient outcomes, as well as strategies to overcome those barriers

o  Studies addressing improvement of current clinical practice to
ensure adequate mental health services in the general health care
sector---application of clinical trials, analysis of provider-patient
interactions, feasibility of transferring specialist mental health
services to general health care settings, and consultation-liaison
models

o  Studies of innovative educational/teaching models to improve the
recognition and care of patients with mental disorders by their general
health care service providers (e.g., utility of clinical practice
guidelines)

(4) Service System and Financing Issues

o  Studies of the organization, delivery, and cost-effectiveness of
services for mental conditions in primary care settings, with focus on
variations in practice (e.g., managed care systems) and setting (e.g.,
rural, community health centers)

o  Research on the impact of different reimbursement approaches on the
use of general health vs. mental health services (e.g., prepaid health
plans) and implications for services, quality of care, and patient
outcomes

o  Research on existing or innovative models linking or integrating
mental health services with the general health care sector,
particularly for people with severe mental disorders and/or who are
homeless, whose needs crosscut different systems of care (e.g., state
consolidated funding for continuous, coordinated health and social
services)

o  Studies examining the nature and effectiveness of relationships
between the general health care sector and other systems (e.g.,
educational, legal, community) in providing mental health services

STUDY POPULATIONS

Protection of Human Subjects

The Department of Health and Human Services has regulations for the
protection of human subjects and has developed additional regulations
for the protection of children.  A copy of these regulations (45 CFR
46, Protection of Human Subjects) and those pertaining specifically to
children are available from the Office for Protection from Research
Risks, National Institutes of Health, Bethesda, MD 20892, telephone
(301) 496-7041.  Specific questions concerning protection of human
subjects in research may be directed to NIMH staff members listed under
INQUIRIES.

NIH POLICY CONCERNING INCLUSION OF MINORITIES AND WOMEN AS SUBJECTS IN
RESEARCH

Applications for grants and cooperative agreements that involve human
subjects are required to include minorities and both genders in study
populations so that research findings can be of benefit to all persons
at risk of the disease, disorder or condition under study; special
emphasis should be placed on the need for inclusion of minorities and
women in studies of diseases, disorders and conditions which
disproportionately affect them.  This policy applies to all research
involving human subjects and human materials, and applies to males and
females of all ages.  If one gender and/or minorities are excluded or
are inadequately represented in this research, particularly in proposed
population-based studies, a clear compelling rationale for exclusion or
inadequate representation should be provided.  The composition of the
proposed study population must be described in terms of gender and
racial/ethnic group, together with a rationale for its choice.  In
addition, gender and racial/ethnic issues should be addressed in
developing a research design and sample size appropriate for the
scientific objectives of the study.

Applicants are urged to assess carefully the feasibility of including
the broadest possible representation of minority groups.  However, the
NIH recognizes that it may not be feasible or appropriate in all
research projects to include representation of the full array of United
States racial/ethnic minority populations (i.e., American Indians or
Alaskan Natives, Asians or Pacific Islanders, Blacks, Hispanics).
Investigators must provide the rationale for studies on single minority
population groups.

Applications for support of research involving human subjects must
employ a study design with minority and/or gender representation (by
age distribution, risk factors, incidence/prevalence, etc.) appropriate
to the scientific objectives of the research.  It is not an automatic
requirement for the study design to provide statistical power to answer
the questions posed for men and women and racial/ethnic groups
separately; however, whenever there are scientific reasons to
anticipate differences between men and women, and racial/ethnic groups,
with regard to the hypothesis under investigation, applicants should
include an evaluation of these gender and minority group differences in
the proposed study.  If adequate inclusion of one gender and/or
minorities is impossible or inappropriate with respect to the purpose
of the research, because of the health of the subjects, or other
reasons, or if in the only study population available, there is a
disproportionate representation of one gender or minority/majority
group, the rationale for the study population must be well explained
and justified.

The NIH funding components will not make awards of grants and
cooperative agreements that do not comply with this policy.  For
research awards which are covered by this policy, awardees will report
annually on enrollment of women and men, and on the race and ethnicity
of subjects.

APPLICATION PROCEDURES

Applicants are to use the Public Health Service research grant
application form PHS 398 (rev. 9/91).  The number and title of this
announcement, PA-92-103, Research on Mental Health Services in the
General Health Care Sector, must be typed in item number 2a on the face
page of the PHS 398 application form.

Application kits containing the necessary forms may be obtained from
business offices and offices of sponsored research at most
universities, colleges, medical schools, and other major research
facilities.  If such a source is not available, the following office
may be contacted for the necessary application material:

Grants Management Branch
National Institute of Mental Health
5600 Fishers Lane, Room 7C-05
Rockville, MD  20857
Telephone:  (301) 443-4414

The signed original and five legible copies of the completed
application must be sent to:

Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**

REVIEW CONSIDERATIONS

Applications will be reviewed for scientific and technical merit by the
assigned review group in accordance with the standard NIH peer review
procedures.  Following scientific-technical review, the applications
will receive a second-level review by the appropriate national advisory
council.

Review criteria include:

o  Scientific, technical, or medical significance and originality of
the proposed research;

o  Appropriateness and adequacy of the experimental approach and
methodology proposed to carry out the research;

o  Qualifications and research experience of the Principal Investigator
and staff, particularly but not exclusively in the area of the proposed
research;

o  Availability of resources necessary to perform the research, and

o  Appropriateness of the proposed budget and duration in relation to
the proposed research.

Applications will be reviewed in accordance with the following review
schedule:

Receipt Dates    Initial   Advisory Council   Earliest
New/Renewal      Review        Review         Start Date

Feb 1/Mar 1*     May/Jun      Sep/Oct         Dec 1
Jun 1/Jul 1*     Oct/Nov      Jan/Feb         Apr 1
Oct 1/Nov 1*     Feb/Mar      May/Jun         Jul 1

*Competing continuations, supplemental, and revised applications are to
be submitted on these dates.

Applications received after a given receipt date will be held for the
next scheduled receipt date or returned to the applicant, if so
requested by the applicant, without review.

AWARD CRITERIA

Applications will compete for available funds with all other approved
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 balance among research areas
of the announcement.

INQUIRIES

NIMH staff are available for consultation concerning application
development before or during the process of preparing an application.
Potential applicants are advised to contact NIMH staff as early as
possible for information and assistance in initiating the application
process and developing an application.

Direct inquiries regarding programmatic issues to:

Junius J. Gonzales, M.D.
Chief, Primary Care Research Program
Services Research Branch
Division of Applied and Services Research
National Institute of Mental Health
5600 Fishers Lane, Room 18C-14
Rockville, MD  20857
Telephone:  (301) 443-1330

Direct inquiries regarding fiscal matters to:

Stephen J. Hudak
Chief, Grants Management Section
National Institute of Mental Health
5600 Fishers Lane, Room 7C-23
Rockville, MD  20857
Telephone:  (301) 443-4456

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance
No. 93.242.  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 52 and 45 CFR Part 74.
Applications submitted in response to this announcement are not subject
to the intergovernmental review requirements of Executive Order 12372
or Health Systems Agency review.

FOOTNOTES

1.  Healthy People 2000, DHHS Publication No. (PHS) 91- 50212.
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)
783-3238).

2.  AHCPR Panel on Guidelines for the Treatment of Depression in
Primary Care.

3.  NIMH Workshops on the Classification of Mental Disorders in Primary
Care, 1989-90.

4.  Primary Care Research:  Theory and Practice, Conference
Proceedings, Agency for Health Care Policy and Research Publication No.
91-011.

5.  Wells KB et al.  The functioning and well-being of depressed
patients: Results from the medical outcomes study.  Jour. Amer. Med.
Assoc. 262: 914-919, 1989.

6.  Caring for People With Severe Mental Disorders:  A National Plan of
Research to Improve Services, DHHS Publication No. (ADM) 91-1762.

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