From: kristoff@NET.BIO.NET (Dave Kristofferson)
Newsgroups: bionet.sci-resources
Subject: NIH Guide, vol. 21, no. 42, pt. 1, 20 November 1992
Date: 21 Nov 92 04:15:40 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.
----------------------------------------------------------------------

NIH GUIDE - Vol. 21, No. 42 - November 20, 1992

$$INDEX BEGIN *******************************************************

                               NOTICES

$$INDEX N1 **********************************************************

AVAILABILITY OF HUMAN LIVER FOR SCIENTIFIC INVESTIGATION
National Diabetes and Digestive and Kidney Diseases
INDEX:  DIABETES, DIGESTIVE, KIDNEY

$$INDEX N2 **********************************************************

WORKSHOP ON MINIMIZING PAIN AND DISTRESS IN LABORATORY ANIMALS
National Institutes of Health
INDEX:  NATIONAL INSTITUTES OF HEALTH

               NOTICES OF AVAILABILITY (RFPs AND RFAs)

$$INDEX R1 02/09/93 *************************************************

RESEARCH AND DEVELOPMENT PROJECTS IN CHEMOPREVENTION (RFA CA-93-05)
National Cancer Institute
INDEX:  CANCER

$$INDEX R2 03/18/93 *************************************************

VANADIUM SALTS IN THE CLINICAL TREATMENT OF DIABETES MELLITUS (RFA
DK-93-11)
National Institute of Diabetes and Digestive and Kidney Diseases
INDEX:  DIABETES, DIGESTIVE, KIDNEY

$$INDEX R3 04/27/93 *************************************************

EFFECTS OF SEX HORMONES ON CORONARY ARTERY REACTIVITY (RFA HL-93-05-H)
National Heart, Lung, and Blood Institute
INDEX:  HEART, LUNG, BLOOD

                    ONGOING PROGRAM ANNOUNCEMENTS

$$INDEX P1 **********************************************************

DRUG ABUSE TREATMENT OF CRIMINAL JUSTICE-INVOLVED POPULATIONS (PA-
93-21)
National Institute on Drug Abuse
INDEX:  DRUG ABUSE

$$INDEX P2 ***********************************************************

"FAILURE TO THRIVE" SYNDROME AMONG OLDER PERSONS (PA-93-22)
National Institute on Aging
National Institute of Mental Health
INDEX:  AGING; MENTAL HEALTH

$$INDEX P3 **********************************************************

HEMOGLOBIN-BASED OXYGEN CARRIERS:  MECHANISMS OF TOXICITY (PA-93-23)
National Heart, Lung, and Blood Institute
INDEX:  HEART, LUNG, BLOOD

$$INDEX P4 **********************************************************

VULNERABILITY OF THE OLFACTORY SYSTEM TO THE IMPACT OF ENVIRONMENTAL
TOXICANTS AND PATHOGENS (PA-93-24)
National Institute on Aging
National Institute of Allergy and Infectious Diseases
National Institute on Deafness and Other Communication Disorders
National Institute of Environmental Health Sciences
National Institute of Neurological Disorders and Stroke
INDEX:  AGING; ALLERGY, INFECTIOUS DISEASES; DEAFNESS, OTHER
COMMUNICATIONS DISORDERS; ENVIRONMENTAL HEALTH SCIENCES; NEUROLOGICAL
DISORDERS, STROKE

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 **********************************************************

AVAILABILITY OF HUMAN LIVER FOR SCIENTIFIC INVESTIGATION

NIH GUIDE, Volume 21, Number 42, November 20, 1992

P.T. 34; K.W. 0780025, 0765035

National Institute of Diabetes and Digestive and Kidney Diseases

The Liver Tissue Procurement and Distribution System (LTPADS) is a
National Institutes of Health (NIH) service contract to obtain human
liver from regional centers for distribution to scientific
investigators throughout the United States.  These regional centers
have active liver transplant programs with human subjects approval to
provide portions of the resected pathologic liver for which the
transplant is performed.  Human pathologic liver prepared according to
the investigator's specifications provides the opportunity to verify if
animal liver investigations are relevant to human liver
pathophysiology.  The preparation of these livers has been excellent
for the usual molecular biologic techniques.  Therefore, we are
primarily interested in soliciting proposals from investigators
interested in studying pathologic liver specimens.  Examples would
include a particular metabolic disorder or disease entity or the
general process of cirrhosis.  A limited supply of "normal" liver
specimens may also be requested but the turn around time for completion
of large requests for "normal" liver is much longer than for pathologic
liver specimens.

INQUIRIES

Further information and proposal forms for interested investigators can
be obtained from:

Harvey L. Sharp, M.D.
Principal Investigator, Liver Tissue Procurement and Distribution
System
c/o Elizabeth Webster
Box 179 UMHC
University of Minnesota Hospitals
Minneapolis, MD  55455
Telephone:  (612) 624-1133

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

$$N2 BEGIN **********************************************************

WORKSHOP ON MINIMIZING PAIN AND DISTRESS IN LABORATORY ANIMALS

NIH GUIDE, Volume 21, Number 42, November 20, 1992

P.T. 42; K.W. 0201011, 1014003

National Institutes of Health

The National Institutes of Health (NIH), Office for Protection from
Research Risks (OPRR), is continuing to sponsor workshops on
implementing the Public Health Service Policy on Humane Care and Use of
Laboratory Animals.  Each of the workshops scheduled for FY 1993 will
focus on a specific theme.

The workshops are open to institutional administrators, members of
Institutional Animal Care and Use Committees, laboratory animal
veterinarians, investigators and other institutional staff who have
responsibility for high-quality management of sound institutional
animal care and use programs.

Opportunities will be available through workshops, question periods,
and informal discussions for participants to exchange ideas and
interests with faculty and OPRR representatives.

DATE:  DECEMBER 3-4, 1992

TOPIC:  MINIMIZING PAIN AND DISTRESS IN LABORATORY ANIMALS

LOCATION:
Loews Vanderbilt Plaza
2100 West End Avenue
Nashville, TN  37203
Telephone:  (615) 320-1700
FAX:  (615) 320-5019

SPONSORS:
Vanderbilt University
Meharry Medical College

REGISTRATION:
Ms. Marilyn Dasaro
Division of Continuing Medical Education
Vanderbilt University
D-8211 Medical Center North
Nashville, TN  37232-2337
Telephone:  (615) 322-4030
FAX:  (615) 343-0809

$$N2 END ************************************************************

               NOTICES OF AVAILABILITY (RFPs AND RFAs)

$$R1 BEGIN CA-93-05 FULL-TEXT ***************************************

RESEARCH AND DEVELOPMENT PROJECTS IN CHEMOPREVENTION

NIH GUIDE, Volume 21, Number 42, November 20, 1992

RFA AVAILABLE:  CA-93-05

P.T. 34; K.W. 0745003, 0715035

National Cancer Institute

Letter of Intent Receipt Date:  December 9, 1992
Application Receipt Date:  February 9, 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 (DCPC), National Cancer
Institute (NCI), invites applications for cooperative agreements to
encourage coordinated submissions of related projects from
investigators who want to collaborate on studies dedicated to
developmental research in chemoprevention.

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,
Research and Development Projects in Chemoprevention, is related to the
priority area of chemoprevention.  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. 017-001-00473-1)
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 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.

Each application will be considered on its own merit as an individual
research project.  Applicants for Research and Development Projects
(RDPs) in Chemoprevention MAY NOT concurrently submit R01 applications
that represent significant duplication of the efforts described in the
applicant's RDP.

MECHANISM OF SUPPORT

This RFA will use the cooperative agreement (U01) mechanism. The
cooperative agreement is an assistance mechanism in which substantial
NIH programmatic involvement with the recipient during performance of
the planned activity is anticipated.  Responsibility for the planning,
direction, and execution of the proposed project will be solely that of
the applicant/awardee.  Except as otherwise stated in this RFA, 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.

This RFA is a one-time solicitation.  Future unsolicited competitive
continuation applications will compete with all other
investigator-initiated research applications and be peer reviewed by a
study section in the Division of Research Grants (DRG), NIH.  However,
if it is determined that there is a sufficient continuing need, the NCI
will invite recipients of awards made in FY 93 under this RFA to submit
competitive continuing applications for review according to procedures
described below in the APPLICATION PROCEDURES and REVIEW CONSIDERATIONS
sections.

An assistance relationship will exist between NCI and the awardees to
accomplish the purpose of the activity.  The recipients will have
primary responsibility for the development and performance of the
activity.  However, there will be government involvement with regard to
(1) assistance in securing an Investigational New Drug (IND) approval
from the Food and Drug Administration (FDA), (2) coordination and
assistance in obtaining the chemopreventive agent, (3) monitoring of
safety and toxicity and, (4) quality assurance of the clinical
chemistry aspects of the study.  Awards will not be made until all
arrangements for obtaining the IND and the agent are completed.  Final
awards will also consider not only the cost of the clinical trial but
also the cost of the agent and, if necessary, its formulation.

FUNDS AVAILABLE

Approximately $4.0 million in total costs per year for five years will
be committed to specifically fund applications which are submitted in
response to this RFA.  It is anticipated that 9 to 15 awards will be
made annually.  This number of awards 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 should not exceed five years.  The earliest feasible start date for
the initial awards will be December 1993.  Although this program is
provided for in the financial plans of the NCI, awards made pursuant to
this RFA will be contingent upon the continued availability of funds
for this purpose.

RESEARCH OBJECTIVES

This RFA encourages submissions of applications from investigators
wanting to conduct collaborative translational research in cancer
chemoprevention.  Translational research moves the results of basic
research studies in the laboratory or developmental studies to clinical
research in human subjects or populations.  The research objectives of
these projects should be the development of intermediate biomarkers of
cancer risk and the evaluation of the efficacy of individual biological
and/or molecular markers as intermediate endpoints in chemoprevention
trials.

Candidate chemical, biological, molecular, and dietary cancer
chemopreventive agents have been identified from in vivo studies in
animal model systems, and epidemiological studies.  The efficacy of
each of these agents individually or in concert in modulating cancer
risk can best be evaluated through prevention clinical trials.
Limitations of the usefulness of such trials is the long duration and
large sample populations generally needed to achieve statistical
significance.  This limitation could be overcome by identification of
biological or molecular markers suitable for use as intermediate
endpoints in the process of carcinogenesis.  Ideally, such markers
would be expressed in an abnormal form in tumor tissue or washings or
in serum of high-risk individuals, but revert to the normal form when
exposed to the chemopreventive agent.

Our evolving understanding of the molecular biology of carcinogenesis
has identified possible oncogene and suppressor gene candidates and
molecular alterations in these candidates and their interactions with
other cellular components, that could serve as intermediate markers in
cancer chemoprevention trials.  Examples would include sequential
genetic alterations in oncogenes HER-2/neu, C-myc, c-abl; in tumor
suppressors RB, p53 and APC; markers for increased risk for cancer
(Li-Fraumeni-p53, NF-1, APC, and early onset 17q21); and interactions
between oncogenes, suppressor genes and the cyclin P34 complex.  New
developments in the understanding of cellular function and metabolites
have provided information on possible candidate markers for cell
growth, proliferation, differentiation, and neoplastic transformation.
Included among these candidates are abnormal cytology, nuclear
aberrations (micronuclei), ornithine decarboxylase and/or
prostaglandins synthetase, DNA ploidy, and colonic mucosal
proliferation.

Cancer chemoprevention trials responsive to this RFA will examine
modulation of candidate markers in response to administration of
chemopreventive agents.  Additionally, these markers could be used to
identify human populations at high risk for cancer, and therefore
useful as sample populations for these trials.

SPECIAL REQUIREMENTS

This RFA represents a single competition, with a specified deadline,
February 9, 1993, for receipt of applications.  It is expected that
each application will describe plans for a mixture of basic,
developmental and clinical research from an investigator wanting to
focus on a particular study in cancer chemoprevention.  Each
application should have a general focus on study outcomes, and on the
application of basic research and development to human subjects and
populations.

If not contained within the investigator's own research project, plans
should be cited for establishing contacts with investigators with
complementary interests that would fulfill the broader goals of
transitional chemoprevention studies.

All PHS and NIH grant policies will apply to applications received in
response to this announcement.

SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN 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 population 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 December 9, 1992, a
letter of intent that includes a descriptive title of the proposed
research, the name and address of the Principal Investigator, 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, 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 possible conflict of interest in the review.

The letter of intent is to be sent to Dr. Marjorie Perloff at the
address listed under INQUIRIES.

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 9/91) is to be used
in applying for these cooperative agreements.  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,
Maryland 20892, telephone 301/496-7441; and from the NCI Program
Director named below.

Submit a signed, typewritten original of the application, including the
Checklist, and three signed, exact, clear, single-sided photocopies, in
one package to:

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

At time of submission, two additional copies of the application must
also be sent to:

Referral Officer
Division of Extramural Activities
National Cancer Institute
Room 848, Westwood Building
5333 Westbard Avenue
Bethesda, MD  20892

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed (initially) by the DRG for
completeness.  Incomplete applications will be returned to the
applicant without further consideration.  Evaluation for responsiveness
to the RFA is an NCI program staff function.  Applications will be
judged to determine if they meet the goals and objectives of the
program as described in the RFA.  Applications that are judged
non-responsive will be returned to the applicant, but may be submitted
for investigator initiated grant competition at the next receipt date.
Questions concerning the relevance of proposed research to the RFA may
be directed to the NCI Program Director listed under 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 to
identify those which are clearly not competitive for awards.

Those applications judged to be both competitive and responsive will be
further evaluated, using the review criteria shown below, 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 Institute and the priorities of the National
Cancer Program.

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 and requests for the RFA
to:

Marjorie Perloff, M.D.
Chemoprevention Branch
National Cancer Institute
Executive Plaza North, Suite 201
Bethesda, MD  20892-4200
Telephone:  (301) 496-8563
FAX:  (301) 402-0553

Direct inquiries regarding fiscal matters to:

Ms. Eileen Natoli
Division of Cancer Prevention and Control
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Suite 243
Bethesda, MD  20892
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 Service Act, Title IV, Section 301 (Public Law
78-410; 42 U.S.C. 241, and Section 412, as amended by Public Law
99-158, 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 12372 or Health Systems Agency review.

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

$$R2 BEGIN DK-93-11 FULL-TEXT ***************************************

VANADIUM SALTS IN THE CLINICAL TREATMENT OF DIABETES MELLITUS

NIH GUIDE, Volume 21, Number 42, November 20, 1992

RFA AVAILABLE:  DK-93-11

P.T. 34; K.W. 0715075, 0740020, 0755015, 0765020, 1007009

National Institute of Diabetes and Digestive and Kidney Diseases

Letter of Intent Receipt Date:  February 18, 1993
Application Receipt Date:  March 17, 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 INQUIRES,
BELOW.

PURPOSE

The National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK) invites investigator-initiated research grant applications to
study the effects of vanadium salts as potential therapeutic agents for
the treatment of diabetes mellitus.  A significant amount of prior
research in experimental animals, isolated tissues, and cell
preparations has strongly suggested that various forms of vanadium have
a beneficial impact on the abnormal metabolic state associated with
this disease.  This solicitation intends to support preliminary studies
of efficacy, dosimetry and toxicity in human subjects with diabetes.

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,
Vanadium Salts in the Clinical Treatment of Diabetes Mellitus, is
related to the priority area of diabetes and chronic disabling
conditions.  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 or
nonprofit organizations, public and private, such as universities,
colleges, hospitals, laboratories, units of State and local
governments, and eligible agencies of the Federal government.  Minority
individuals and women are encouraged to submit as Principal
Investigators.

MECHANISM OF SUPPORT

This RFA will use the National Institutes of Health (NIH) individual
research grant (R01).  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 two years.  The anticipated award date is
September 30, 1993.

This RFA is a one-time solicitation.  Future unsolicited competing
continuation applications will compete with all investigator-initiated
applications and be reviewed according to the customary peer review
procedures.

In order to adhere to prudent principles of cost-containment, requested
direct costs must not exceed $160,000 for any single application.
Applications exceeding this limit will not be reviewed as part of this
RFA.  With respect to post-award administration, the current policies
and requirements that govern the research grant programs of the NIH
will prevail.

FUNDS AVAILABLE

A total of up to $500,000 for first year expenses and $500,000 for
second year expenses will be committed by the NIDDK to fund
applications submitted in response to this RFA.  The NIDDK plans to
make one to three awards in FY 1993 contingent on the receipt of highly
meritorious applications in response to this solicitation.  The award
of grants pursuant to this RFA is contingent on the availability of
funds for this purpose.

RESEARCH OBJECTIVES

Vanadium, a trace metal for a broad range of organisms including
humans, has been postulated to be a co-factor for a number of enzymatic
processes.  Salts of this element have been known for a decade to
inhibit the action of a number of phosphatases in in vitro situations.
In particular, vanadate has been used frequently in laboratory settings
with isolated tissues and cell cultures as a tool in biochemical
studies of the mechanisms of insulin action and experimental insulin
resistant states.  This ion has shown insulinmimetic properties in
preparations of muscle, liver and adipose tissue as well as whole
animals with various forms of diabetes.  Non-diabetic laboratory
animals appear to show much less response.

Despite the lack of consensus on the precise biochemical mechanism of
action for vanadate, it is clear that a broad array of cellular and
physiologic processes are modified in an insulinmimetic pattern.  The
magnitude and universality (i.e., across tissues, across species,
across diabetes type or model) of these effects are still being debated
in the literature.  In addition, vanadium can exist in a number of
oxidation states (both cationic and anionic), and the state most
relevant to insulin action is not established.

Before embarking on human studies, it will be important to consider the
known and potential toxicities of vanadium.  Clinical studies of any
vanadium compound with regard to diabetes will need to carefully
monitor for incipient toxicity.

The objective of this RFA is to stimulate investigator-initiated
research designed to provide feasibility data on the clinical utility
of vanadium-containing compounds for the treatment of diabetes mellitus
in humans.  Therefore, all applications in response to this RFA must
primarily concern the clinical study of patients with this disease
(NIDDM and/or IDDM) and may include normal (non-diabetic) volunteers as
appropriate to the experimental design.

STUDY POPULATIONS

SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN 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

Potential applicants are strongly encouraged to submit a letter of
intent by February 18, 1993.  The letter of intent is to include:  (1)
names of the Principal Investigator/program director and principal
collaborators, (2) descriptive title of the potential application, (3)
identification of the organization(s) involved, and (4) 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 a subsequent application, the information
that it contains allows NIDDK staff to estimate the potential review
workload and to avoid conflict of interest in the review.

The letter of intent is to be sent to:,

Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 605
Bethesda, MD  20892
Telephone:  (301) 496-7083
FAX:  (301) 402-1277

APPLICATION PROCEDURES

Applications must be received by March 17, 1993.  Additional
information about application procedures and appropriate forms is
provided in the RFA.

REVIEW CONSIDERATIONS

Applications in response to this solicitation will be reviewed using
the usual NIH peer review procedures.  For further details, applicants
are referred to the RFA document.

INQUIRIES

Inquiries regarding programmatic issues related to this announcement
and requests for the RFA may be directed to:

Joan T. Harmon, Ph.D.
Executive Director, Diabetes Research Program
Diabetes Programs Branch, DDEM
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 622
Bethesda, MD  20892
Telephone:  (301) 496-7731
FAX:  (301) 480-0383

Inquiries regarding fiscal matters may be directed to:

Betty Bailey
Grants Management Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 649
Bethesda, MD  20892
Telephone:  (301) 496-7467
FAX:  (301) 496-9721

Schedule:

Letter of Intent:               February 18, 1993
Application Receipt Date:       March 17, 1993
Initial Review:                 June/July 1993
NIDDK Advisory Council Review:  September 1993
Anticipated Award Date:         September 30, 1993

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance
No. 93.847.  Awards are made under the authority 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 Systems Agency review.

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

$$R3 BEGIN HL-93-05 FULL-TEXT ***************************************

EFFECTS OF SEX HORMONES ON CORONARY ARTERY REACTIVITY

NIH GUIDE, Volume 21, Number 42, November 20, 1992

RFA AVAILABLE:  HL-93-05-H

National Heart, Lung, and Blood Institute

P.T. 34; K.W. 0715040, 0760025, 0760085, 1002061, 0765035

Letter of Intent Receipt Date:  February 1, 1993
Application Receipt Date:  April 27, 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 Heart and Vascular Diseases invites grant applications
for up to five years of support for research into the roles of sex
hormones in the physiology and pathophysiology of the coronary
vasculature.  The ultimate goal is to develop insights into therapeutic
approaches for reducing the higher incidence of coronary diseases in
men and post-menopausal women than pre-menopausal women.

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,
Effects of Sex Hormones on Coronary Artery Reactivity, is related to
the priority area of heart disease and stroke. 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 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 use the National Institutes of Health (NIH) individual
research grant (R01).  Responsibility for the planning, direction, and
execution of the proposed project will be solely that of the applicant.
The total project period for each application submitted in response to
the present RFA may not exceed five years.  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.  This RFA is a
one-time solicitation.  Future unsolicited competing continuation
applications will compete with all investigator-initiated applications
and be reviewed according to the customary peer review procedures.

FUNDS AVAILABLE

Approximately $1.5 million in total cost will be provided for the first
year of support for the entire program.  It is anticipated that six new
grants will be awarded under this program.  This level of support 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 National Heart, Lung, and Blood Institute
(NHLBI), awards pursuant to this RFA are contingent upon the
availability of funds for this purpose.  Administrative adjustments in
project period and/or amount of support may be required at the time of
the award.  Since a variety of approaches would represent valid
responses to this announcement, it is anticipated that there will be a
range of costs among individual grants awarded.

RESEARCH OBJECTIVES

Recent studies reveal that temporary ischemia can occur, not only as a
result of organic obstruction of the coronary artery, but also as a
result of vasoconstriction and vasospasm.  Added to this is the fact
that gender is one of the major risk factors for the development of
coronary artery disease.  Involvement of sex hormones in vascular
reactivity has been suggested frequently, but clear evidence for a
mechanism is lacking.  Gender differences in vascular reactivity have
been demonstrated by several research groups, and these studies have
demonstrated that coronary vessels from male animals show greater
vascular reactivity.  However, the degree to which coronary smooth
muscle and the endothelium are sexually differentiated and modulated by
sex hormones remains to be determined.

It has been suggested that one of the protective effects of estrogens
may involve influences on structural elements of the vessel wall.
However, no attempt has been made to see whether or not there is a sex
difference in the distribution and density of steroid binding sites.
Furthermore, a correlation between steroid hormone receptors and
hormonal modulation of cell function in the coronary vasculature still
needs to be determined.  The role of coronary reactivity should be
evaluated in mature and immature animals of both sexes in terms of its
morphological, pharmacological, and biophysiochemical characteristics.

Sex hormones interact with the sympathetic nervous system at the
peripheral level, suggesting that sympathetic control of vascular
reactivity exhibits a dimorphic pattern due to the action of sex
hormones.  Physiological stress such as exercise and hypoxia increases
the sympathetic activity of the heart.  Whether or not the coronary
vascular bed responds to these stimuli in a sexually differentiated
manner is still unclear.  An evaluation of the interaction between the
sympathetic nervous system and sex hormones in this specific vascular
bed will certainly provide important information regarding the
mechanisms underlying coronary vascular disease under normal and
stressful conditions in men and women across all ages.

All applications must be focussed on the role of the sex hormones in
coronary reactivity.  The spectrum of experimental approaches
considered responsive to this RFA includes in vivo and in vitro studies
of coronary vascular reactivity, co-culture techniques to elucidate
cell to cell interaction, cell receptor density, as well as molecular
pharmacological approaches that will enhance our understanding of how
sex hormones regulate coronary vascular cell function.

SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN 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 asked to submit, by February 1, 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 identities 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 NHLBI staff to estimate the potential review workload and to
avoid conflict of interest in the review.

The letter of intent is to be sent to:

Chief, Centers and Special Projects Section, Review Branch
Division of Extramural Affairs
National Heart, Lung and Blood Institute
Westwood Building, Room 553A
Bethesda, MD  20892

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 offices of sponsored research and may be obtained 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.

Send or deliver a signed, typewritten original of the application,
including the checklist, and three signed photocopies to:

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

Send two additional copies of the application to the Chief, Centers and
Special Projects Section, at the address listed under LETTER OF INTENT.

Applicants from institutions that have a General Clinical Research
Center (GCRC) funded by the NIH National Center for Research Resources
may wish to identify the GCRC as a resource for conducting the proposed
research.  In such a case, a letter of agreement from either the GCRC
program director or principal investigator could be included with the
application.

Applications must be received by April 27, 1993.

REVIEW CONSIDERATIONS

Those applications that are complete and responsive will be evaluated
for scientific/technical merit by an appropriate peer review group
convened by the NHLBI.  The second level of review will be provided by
the National Heart, Lung, Blood Advisory Council.

Review criteria for RFAs are generally the same as those for
unsolicited research grant applications. Although multidisciplinary
approaches are encouraged, it is not the intent of this announcement to
solicit applications for large studies that would encompass a variety
of independent projects, i.e., program projects.

AWARD CRITERIA

The most important criterion in selecting awardees will be the
scientific merit as reflected in the priority score.  However, factors
such as program balance and available funds may enter into selection
from among meritorious applications.

The anticipated date of award is December 1, 1993.

INQUIRIES

Inquiries regarding programmatic issues and requests for the RFA
document to:

Dr. Isabella Liang
Division of Heart and Vascular Diseases
National Heart, Lung and Blood Institute
Federal Building, Room 3C06
Bethesda, MD  20892
Telephone:  (301) 496-1081
FAX:  (301) 480-6282

Direct inquiries regarding fiscal and administrative matters to:

Mr. William Darby
Division of Extramural Affairs
National Heart, Lung and Blood Institute
Westwood Building, Room 4A11
Bethesda, MD  20892
Telephone:  (301) 496-7536
FAX:  (301) 402-1200

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance
No. 93.837, Heart and Vascular Diseases.  Awards will be made under the
authority of the Public Health Service Act, Section 301 (42 USC 241)
and administered under PHS grants policies and Federal regulations,
most specifically 42 CFR Part 52 and 45 CFR Part 74.  This program is
not subject to the intergovernmental review requirements of Executive
Order 12372, or to Health Systems Agency Review.

$$R3 END ************************************************************

                    ONGOING PROGRAM ANNOUNCEMENTS

$$P1 BEGIN PA-93-21 FULL-TEXT ***************************************

DRUG ABUSE TREATMENT OF CRIMINAL JUSTICE-INVOLVED POPULATIONS

NIH GUIDE, Volume 21, Number 42, November 20, 1992

PA AVAILABLE:  PA-93-21

P.T. 34; K.W. 0404009, 0404000, 0745070, 0403004

National Institute on Drug Abuse

THE PROGRAM ANNOUNCEMENT ANNOUNCED IN THIS NOTICE CONTAINS ESSENTIAL
INFORMATION FOR THE PREPARATION OF AN APPLICATION.  POTENTIAL
APPLICANTS MAY OBTAIN THE PROGRAM ANNOUNCEMENT FROM THE CONTACTS NAMED
IN INQUIRIES, BELOW.

PURPOSE

The purpose of this announcement is to encourage research on models of
intervention for drug abusers involved with the criminal justice system
(CJS).  Applications may focus on drug abuse treatment linked to the
criminal justice system which is delivered prior to or in lieu of
incarceration, during the period of incarceration, after release, or in
combinations of these.  Applications are also sought for
community-based outreach/intervention behavioral change strategies in
the population of criminal-justice-involved drug users not in
treatment.

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
announcement, Drug Abuse Treatment of Criminal Justice-Involved
Populations, is related to the priority area of health
promotion/alcohol and other drugs.  Some applications under this
announcement may also be related to the priority area of health
promotion/violent and abusive behavior.  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, 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.  Women
and minority investigators are encouraged to apply.  Applications are
especially encouraged from State and municipal governments with
research units and/or State and municipal governments collaborating
with university-based research units.

MECHANISM OF SUPPORT

This Program Announcement will use the National Institutes of Health
(NIH) individual research grant (R01).  Responsibility for the
planning, direction, and execution of the proposed project will be
solely that of the applicant.  Support will be provided for a period of
up to five years (renewable for subsequent periods) subject to
continued availability of funds and progress achieved.  Because of the
nature and scope of the research proposed in response to this program
announcement may vary, it is anticipated that the size of an award will
vary also.

RESEARCH OBJECTIVES

Summary

Carefully controlled research studies are sought to investigate the
effectiveness and cost-effectiveness of drug abuse treatment linked to
criminal justice system involvement and delivered (1) prior to or in
lieu of prosecution or incarceration; (2) in the jail or prison setting
during the period of incarceration; (3) after release or during
transition from incarceration to release; or (4) for combinations of
these.  Research studies to investigate community-based
outreach/intervention behavioral change strategies in the population of
criminal-justice-involved drug users not in treatment will be
supported.  Of particular interest are research projects in geographic
areas having a high or unmet need for drug treatment services in the
criminal justice-involved population.

Program Description

Applicants are advised to review existing information relevant to drug
abuse treatment of CJS-involved populations and to design controlled
clinical studies to determine the impact of providing drug abuse
treatment to CJS-involved clients.  Areas of research interest include
the following:

General

o  Improvement of treatment outcomes for individuals under legal
sanction.

o  Joint effects of criminal justice sanctions and treatment.

o  Strategies to increase retention, improve participation in
treatment, and reduce relapse to drug use and recidivism to criminal
activity.

o  Effectiveness of drug abuse treatment intervention strategies for
the drug-abusing juvenile offender.

Pre-Incarceration

o  Characterization and assessment of criminal justice clients most
likely to benefit from drug abuse treatment.

o  The effectiveness of matching criminal justice clients to
appropriate treatment.

o  Effectiveness of treatment in lieu of prosecution/incarceration in
reducing drug use, reducing criminal behavior, and increasing
productive activities.

o  Effect of legal pressure on client treatment compliance and outcome
variables.  For example, does drug testing increase compliance with
treatment or improve outcomes?

Institution-Based

o  Effectiveness and cost-effectiveness of institution-based treatment
approaches, including effectiveness of treatment beyond the period of
incarceration, and strategies to maintain and increase treatment gains
after return to the community.

o  Increasing the effectiveness of treatment delivered early in an
individual's period of incarceration.

o  Overcoming barriers to implementation of effective treatment within
the institutional setting, and effect of institutional incentives and
disincentives on treatment outcomes.

o  Relationship of inmate characteristics and criminal backgrounds to
treatment compliance and outcomes.

Post-Incarceration

o  Improvement of the effectiveness of drug abuse treatment and
aftercare in halfway houses and similar transitional programs charged
with re-integrating former inmates into the community.

o  Effectiveness of treatment after release compared with non-treatment
alternatives such as intensive supervision and monitoring, parole
supervision, and release without supervision.

o  Treatment program and client factors which predict relapse to
illicit drug use and recidivism to drug-related criminal activity.

Community-Based

o  Community-based outreach/intervention behavior change strategies,
especially in out-of-treatment individuals, to reduce illicit drug use
and drug-related risks such as HIV, TB, STDs, and re-involvement in the
criminal justice system/process.

o  Efficacy of community-based outreach/intervention strategies to
improve health and to reduce drug use and criminal behavior among youth
and adults at different stages of involvement in the criminal justice
system/process.

The importance of a sound research plan and qualified research staff
cannot be over-emphasized.  It is recommended that investigators use
the most rigorous methodology consistent with the purposes of the
research.  Where controlled trials are not feasible, other types of
controls may be used, including case controls, equivalent comparison
groups, regression-discontinuity, or other designs.  While many
treatment or criminal justice agencies have a research department,
those that do not may wish to enter into collaboration with
well-qualified researchers.  All applications are strongly encouraged
to address issues of project feasibility and collaborative
arrangements, study design, sampling procedures, implementation of the
intervention, instrumentation and measurement, data collection, quality
control, tracking of clients, followup, and data analysis, as
appropriate.

Investigators are encouraged to offer HIV testing and counseling in
accordance with current guidelines to subjects identified during the
course of the research as being at risk for HIV acquisition or
transmission.  In high risk populations, investigators are encouraged
to assess the effects of new interventions on the acquisition and
transmission of infectious diseases, including HIV.

STUDY POPULATIONS

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

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.

Human Subjects Protections for Research Involving Prisoners

Activities carried out under this announcement may be governed by DHHS
Regulations for the Protection of Human Research Subjects (45 CFR 46).
These regulations require awardees to establish procedures for the
protection of human subjects involved in any research activities.
Projects involving prisoners require special additional protections in
accordance with Subpart C of the DHHS regulations.

Prior to funding and upon request of the Office for Protection from
Research Risks (OPRR), prospective awardees not holding an
OPRR-approved Multiple Project Assurance must file a Single Project
Assurance with OPRR and establish or identify an Institutional Review
Board (IRB) to review and approve the procedures for carrying out any
human subjects research occurring in conjunction with this award.  A
formal request for the required Assurance will be issued by OPRR at an
appropriate point in the review process, and examples of required
materials will be supplied at that time.  However, applicants may wish
to contact OPRR (301-496-7041) to obtain preliminary guidance on human
subjects issues.  When calling OPRR, applicants should identify
themselves as having questions about research involving prisoners.

APPLICATION PROCEDURES

Applications are to be submitted on the grant application form PHS 398
(rev. 9/91) and will be accepted at the standard application deadlines
as indicated in the application kit.  The receipt dates for
applications for AIDS-related research are found in the PHS 398
instructions.

Application kits are available at most institutional offices of
sponsored research and may be obtained from the Office of Grant
Inquiries, Division of Research Grants, National Institutes of Health,
Westwood Building, Room 240, 5333 Westbard Avenue, Bethesda, Maryland
20892, telephone 301-496-7979.  The title and number of the
announcement must be typed in Section 2a on the face page of the
application.

The completed original and five permanent, legible copies of the PHS
398 form must be submitted to:

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

REVIEW PROCEDURES

The Division of Research Grants, NIH, serves as a central point for
receipt of applications for most discretionary DHHS grant programs.
Applications received under this announcement will be assigned to an
initial review group (IRG) in accordance with established PHS referral
guidelines.  The IRGs, consisting primarily of non-Federal scientific
and technical experts, will review the applications for scientific and
technical merit in accordance with the standard NIH peer review
procedures.  Notification of the review recommendations will be sent to
the applicant after the initial review.  Applications will receive a
second-level review by an appropriate Advisory Council, whose review
may be based on policy considerations as well as scientific merit.
Only applications recommended for further consideration by the Council
may be considered for funding.

AWARD CRITERIA

Applications recommended for further consideration by an appropriate
Advisory Council will be considered for funding on the basis of overall
scientific, clinical and technical merit of the proposal as determined
by peer review, appropriateness of budget estimates, program needs and
balance, policy considerations, adequacy of provisions for the
protection of human subjects, and availability of funds.

INQUIRIES

Written and telephone inquiries are encouraged.  The opportunity to
clarify any issues or questions from potential applicants is welcome.

Direct inquiries regarding programmatic issues related to treatment
research to:

Bennett W. Fletcher, Ph.D.
National Institute on Drug Abuse
5600 Fishers Lane, Room l0A-30
Rockville, MD  20857
Telephone:  (301) 443-4060

Direct inquiries regarding programmatic issues related to
community-based behavioral change research to:

Richard H. Needle, Ph.D., M.P.H.
National Institute on Drug Abuse
5600 Fishers Lane, Room 9A-30
Rockville, MD  20857
Telephone:  (301) 443-6720

Direct inquiries regarding fiscal matters to:

Ms. Shirley Ann Denney
Grants Management Branch
National Institute on Drug Abuse
5600 Fishers Lane, Room 8A-54
Rockville, MD  20857
Telephone:  (301) 443-6710

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance
No. 93.279.  Awards are made under authorization of the Public Health
Service Act, Sections 301 and 405 (42 USC 241 and 284), and
administered under PHS grants policies and Federal Regulations at 42
CFR 52, 45 CFR Part 74 & 92, and 45 CFR Part 46.  42 CFR Part 2 may
also be applicable to these awards.  This program is not subject to the
intergovernmental review requirements of Executive Order 12372 or
Health Systems Agency review.

$$P1 END ************************************************************

$$P2 BEGIN PA-93-22 *************************************************

"FAILURE TO THRIVE" SYNDROME AMONG OLDER PERSONS

NIH GUIDE, Volume 21, Number 42, November 20, 1992

PA:  PA-93-22

P.T. 34; K.W. 0710010, 0710095, 0715072, 0710070, 0765035

National Institute on Aging
National Institute of Mental Health

PURPOSE

Recently, a geriatric syndrome termed "failure to thrive" has been
described, consisting of weight loss, decreased appetite, poor
nutrition, and inactivity, often accompanied by dehydration, depressive
symptoms, impaired immune function, and low serum cholesterol.  Failure
to thrive occurs in both acute and chronic forms, leading to impaired
functional status, morbidity from infection, pressure sores, and
increased mortality.  This syndrome has been identified as an aging
research priority in the Institute of Medicine's report:  Extending
Life, Enhancing Life.  A National Research Agenda on Aging.  (Institute
of Medicine; National Academy Press, Washington, 1991.)  The
relationships between nutritional, metabolic and other pathophysiologic
factors in failure to thrive and their effects on clinical outcomes
remain to be clarified.  While there is evidence that psychiatric
conditions (major and subsyndromal depression and cognitive decline)
are frequently associated with failure to thrive, the nature of this
association needs to be clarified.

"Failure to thrive" in older persons may not be a single process.  It
may be caused by several different pathophysiologic processes.  Thus
there is a strong need for descriptive information on the progression
of failure to thrive in various specific groups of older persons with
different chronic diseases and disabilities, to elucidate potential
differences and commonalities in pathophysiologic mechanisms and
clinical course.

The relationship between nutritional, metabolic and other
pathophysiologic mechanisms in failure to thrive, and their effects on
clinical outcomes, remains to be clarified.  Numerous studies have
documented the extent of protein-calorie malnutrition among nursing
home residents and other specific older populations.  In addition, it
has been suggested that micronutrient deficiencies may play a larger
role in chronic debilitating changes in older persons than is currently
appreciated.  Alterations in endocrine factors affecting metabolism,
inflammatory mediators, and depressive changes in affect have also been
suggested to play a major role in failure to thrive.  The contribution
of specific chronic disease processes and acute conditions to failure
to thrive has yet to be explored fully.  The effectiveness of
interventions against failure to thrive and loss of appetite in older
persons has not been rigorously tested.

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 Program
Announcement (PA), "Failure to Thrive" Syndrome Among Older Persons, is
related to the priority area of aging.  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.
017-00473-1) 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, for-profit and
non-profit organizations, public and private, such as universities,
colleges, hospitals, laboratories, unit of state and local governments,
and eligible agencies of the Federal government.  Applications from
minority individuals and women are encouraged.  Foreign institutions
are not eligible for First Independent Research Support and Transition
(FIRST) awards (R29) or for the Career Awards (K01, K04, K07, K08, K11,
K20, K21).

MECHANISM OF SUPPORT

Awards will be administered under PHS grants policy as stated in the
Public Health Service Grants policy statement, DHHS Publication No.
(OASH) 90-50,000, revised October 1, 1990.  The National Institute on
Aging (NIA) intends to commit $1.8 million in Fiscal Year 1994 for this
research area.  This funding level is dependent on the receipt of a
sufficient number of applications of high scientific merit.
Applications in response to this announcement assigned to the NIA may
not request funding over $175,000 (direct and indirect costs) for the
first year, and may not request more than four percent per year above
$200,000 for subsequent years.  Additionally, the National Institute of
Mental Health (NIMH) anticipates supporting approximately 4-6 awards
under this announcement.  The Principal Investigators will meet
annually with NIA and NIMH staff in Bethesda, Maryland to review the
progress of their studies.  Funds for such travel must be requested in
applications.

The mechanisms for support are:

o  Research Grant (RO1)
o  FIRST award  (R29)
o  Career awards, which include:  Special Emphasis Research Career
Awards (K01) in Nutritional
and Metabolic Factors in Aging, Research Career Development Award
(K04), Clinical Mental Health Academic Award (K07), Clinical
Investigator Award (K08), Physician Scientist Award (K11), Scientist
Development Award for Clinicians (K20), and Scientist Development Award
(K21)

RESEARCH GOALS AND SCOPE

The NIA seeks applications for support of research to clarify
pathophysiological features of the "failure to thrive" syndrome in
older persons and research into its causes, prevention, and treatment.
Topics of interest include:

o  Risk factors, natural history, clinical, and functional features of
failure to thrive in various high-risk older subpopulations.  Though
large scale primary epidemiologic studies are outside the scope of this
PA, ancillary studies to existing population studies are appropriate
and encouraged.

o  Primary endocrine, metabolic, cellular and related pathophysiologic
mechanisms contributing to failure to thrive in older persons.

o  Relationship between nutritional deficiencies, or impairments in
nutrient disposition or metabolism, as causes or results of the various
pathophysiological abnormalities described in "failure to thrive" in
older persons.

o  Interactions and interrelationships among the different components
of failure to thrive, e.g. hypocholesterolemia, specific abnormalities
in immunologic and inflammatory factors, infection, depression.

o  Metabolic responses and alterations in nutritional needs of older
persons associated with acute conditions that may provoke failure to
thrive, e.g., infections, trauma, or surgery.

o  Factors modulating control of appetite as a cause or consequence of
failure to thrive.

o  Pathophysiologic effects of coexisting chronic diseases and/or
comorbid processes of aging contributing to failure to thrive.

o  The role of psychosocial and cultural factors, (e.g., social
supports, social stressors, bereavement, depression, mood and affect,
cultural preferences) in failure to thrive syndrome.

o  Development and use of appropriate animal models for studying
failure to thrive in older persons.

o  Neural interactions with physiological processes underlying failure
to thrive syndrome.

o  Efficacy of interventions in preventing, arresting, or reversing
failure to thrive.  Applicants may choose to study specific populations
and conditions, e.g., post-surgical or trauma patients, infections, or
depression.  Attention to physiologic factors or comorbid conditions
modulating efficacy of interventions in these conditions is
particularly encouraged.

o  Delineation of psychiatric conditions of failure to thrive
(including the range of clinically significant affective symptoms) and
the elucidation of the interrelationship among psychiatric status,
physiological measures, and behavior.

For any of the above topics, attention to the heterogeneity and
frequent multiple morbidity within the geriatric population is
encouraged in the design of research projects.

STUDY POPULATIONS

It is NIH policy that women and minorities must be included in clinical
study populations unless there is a good reason to exclude them.  The
study design must seek to identify any pertinent gender or minority
population differences.

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

NIH policy is that, as appropriate, applicants for NIH grants,
cooperative agreements, and contracts will be required to include
minorities and women in study populations so that research findings can
be of benefit to all persons at risk of the diseases, disorders, or
conditions under study; special emphasis should be placed on the need
for inclusion of minorities and women in studies of diseases,
disorders, and conditions that disproportionately affect them.  This
policy is intended to apply to males as well as females of all ages.
If women or minorities are excluded or inadequately represented in
clinical research, particularly in proposed population-based studies,
a clear compelling rationale for exception to the policy must be
provided.

The composition of the proposed study population must be described in
terms of gender and racial/ethnic groups, 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.  This information should be
included in the form PHS 398 (rev. 9/91) in Sections 1-4 of the
Research Plan AND summarized in Section 5, Human Subjects.

Applicants are urged to assess carefully the feasibility of including
the broadest possible representation of minority groups.  However, 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., Native Americans (including
American Indians or Alaskan Natives, Asian/Pacific Islanders, Blacks,
Hispanics).  The rationale for studies on single minority populations
should be provided.  For the purpose of this policy, clinical research
includes human biomedical and behavioral studies of etiology,
diagnosis, or treatment of diseases, disorders or conditions, including
but not limited to clinical trials.

The usual NIH policies concerning research on human subjects also
apply.  Basic research or clinical studies in which human tissues
cannot be identified or linked to individuals are exempt.  However,
every effort should be made to include human tissues from women and
racial/ethnic minorities when it is important to apply the results of
the study broadly, and this should be addressed by applicants.  For
foreign awards, the policy on inclusion of women applies fully; since
the definition of minority differs in other countries, the applicant
must discuss the relevance of research involving foreign population
groups to the United States' populations, including minorities.

If the required information is not contained within the application,
the application will be returned without review.

Peer reviewers will address specifically whether the research plan in
the application conforms to these policies.  If the representation of
women or minorities in a study is inadequate to answer the scientific
questions(s) addressed and the justification for the selected study
population is inadequate, it will be considered a scientific weakness
or deficiency in the study design and will be reflected in assigning
the priority score to the application.  All applications for clinical
research submitted to NIH are required to address these policies.  NIH
funding components will not award grants or cooperative agreements that
do not comply with these policies.

APPLICATION PROCEDURES

Applications are to be submitted on the application 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, 5333 Westbard Avenue, Room 449,
Bethesda, Maryland 20892, telephone 301/496-7441.  Applications will be
accepted on the standard application receipt dates as indicated in the
application kit.  The program announcement title and number must be
typed on line 2a of the face page.

The completed original application and five legible copies must be sent