From: kristoff@NET.BIO.NET (Dave Kristofferson)
Newsgroups: bionet.sci-resources
Subject: NIH Guide, vol. 21, no. 40, pt. 1, 6 November 1992
Date: 5 Nov 92 18:46:28 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 19921106 V21N40 P1O2 ************************************
X-comment: RFAs described: CA-93-06, HD-93-06, DK-93-12

NIH GUIDE - Vol. 21, No. 40 - November 6, 1992

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

                               NOTICES

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

THE ETHICS OF CLINICAL RESEARCH ON HUMAN SUBJECTS:  FACING THE 21st
CENTURY
National Institutes of Health
INDEX:  NATIONAL INSTITUTES OF HEALTH

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

NATIONAL HUMAN SUBJECT PROTECTIONS WORKSHOPS
National Institutes of Health
INDEX:  NATIONAL INSTITUTES OF HEALTH

$$INDEX N3 **********************************************************

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 01/25/93 *************************************************

DEVELOPMENTAL RESEARCH IN NATIVE PACIFIC POPULATIONS (RFA CA-93-06)
National Cancer Institute
INDEX:  CANCER

$$INDEX R2 04/15/93 *************************************************

NETWORK OF PEDIATRIC PHARMACOLOGY RESEARCH UNITS (RFA HD-93-06)
National Institute of Child Health and Human Development
INDEX:  CHILD HEALTH, HUMAN DEVELOPMENT

$$INDEX R3 05/18/93 *************************************************

RESEARCH USING THE UNITED STATES RENAL DATA SYSTEM (RFA DK-93-12)
National Institute of Diabetes and Digestive and Kidney Diseases
INDEX:  DIABETES, DIGESTIVE, KIDNEY DISEASES

                    ONGOING PROGRAM ANNOUNCEMENTS

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

THE IMMUNOLOGY OF AGING (PA-93-014)
National Institute on Aging
National Institute of Allergy and Infectious Diseases
INDEX:  AGING; ALLERGY, INFECTIOUS DISEASES

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

PHYSIOLOGICAL ROLE OF THE ADRENAL ANDROGEN, DHEA, IN AGING (PA-93-015)
National Institute on Aging
INDEX:  AGING

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

THE ETHICS OF CLINICAL RESEARCH ON HUMAN SUBJECTS:  FACING THE 21st
CENTURY

NIH GUIDE, Volume 21, Number 40, November 6, 1992

P.T. 42; K.W. 0783005

National Institutes of Health

The National Institutes of Health (NIH) Office for Protection from
Research Risks (OPRR) is co-sponsoring with the University of Texas
Medical Branch, Galveston a conference to discuss the ethical issues
associated with clinical research involving human subjects.  This
conference is open to anyone with an interest in research involving
human subjects and may be of special significance for individuals
serving on Institutional Review Boards.

DATES:  February 28 through March 2, 1993

LOCATION:  San Luis Hotel
5222 Seawall Boulevard
Galveston, TX  77551
Telephone:  1-800-392-5937

SPONSORS:  The University of Texas Medical Branch at Galveston
Galveston, Texas
National Institutes of Health, Office for Protection from Research
Risks, Bethesda, MD

REGISTRATION AND INFORMATION:  Ms. Sharon Goodwin
Institute for the Medical Humanities
301 University Boulevard, M-11
The University of Texas Medical Branch
Galveston, TX  77555-1311
Telephone:  (409) 772-2376

This national/international conference will explore the ethics of
clinical research on human subjects.  The goals of this timely meeting
include:

(1) providing a forward-looking analysis of the major ethical issues
now facing biomedical researchers and institutions;

(2) critically examining research ethics as set forth in the Belmont
Report and other position papers of the two National Commissions;

(3) enabling researchers and research-oriented administrators to plan
effectively for future research initiatives; and

(4) providing a forum for discussion and collaboration between IRB
members and ethicists.

INQUIRIES

Ms. Roberta Sonneborn
Office for Protection from Research Risks
National Institutes of Health
Building 31, Room 5B59
Bethesda, MD  20892
Telephone:  (301) 496-7163

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

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

NATIONAL HUMAN SUBJECT PROTECTIONS WORKSHOPS

NIH GUIDE, Volume 21, Number 40, November 6, 1992

P.T. 42; K.W. 0783005

National Institutes of Health
Food and Drug Administration

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 and 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, and other health care
professionals, clergy, lawyers, medical, nursing, social work students,
psychologists, and 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 and 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 and 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.

SOUTHWESTERN WORKSHOP

DATES:  February 28 through March 2, 1993

LOCATION:
San Luis Hotel
5222 Seawall Boulevard
Galveston, TX  77551
Telephone:  (800) 392-5937

SPONSORS:
The University of Texas Medical Branch at Galveston

REGISTRATION:
E. Ray Stinson, Ph.D.
Office of Sponsored Programs-Academic
The University of Texas Medical Branch at Galveston
Galveston, TX  77555-1311
Telephone:  (409)-772-3482

TITLE:  The Ethics of Clinical Research on Human Subjects:  Facing the
21st Century

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

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

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

$$N3 BEGIN **********************************************************

WORKSHOP ON MINIMIZING PAIN AND DISTRESS IN LABORATORY ANIMALS

NIH GUIDE, Volume 21, Number 40, November 6, 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

DATE:  JANUARY 21-22, 1993

TOPIC:  TO BE ANNOUNCED

LOCATION:
Sheraton Grande Torrey Pines
10950 N. Torrey Pines Road
La Jolla, CA  92037
Telephone:  (619) 558-1500
FAX:  (619) 558-1131

SPONSORS:
Scripps Clinic and Research Foundation
Salk Institute

REGISTRATION:
Janie Partridge
Scripps Clinic and Research Foundation/MB
10666 North Torrey Pines Road
La Jolla, CA  92037-000
Telephone:  (619) 554-8048
FAX:  (619) 554-8841

DATE:  June 10-11, 1992

TOPIC:  TO BE ANNOUNCED

LOCATION:
Oklahoma City Marriott
3233 Northwest Expressway
Oklahoma City, OK  73112
Telephone:  (405) 842-6633
FAX:  (405) 842-3152

SPONSOR:
University of Oklahoma Health Sciences Center

REGISTRATION:
Ms. Marilyn Perry, Assistant to Director for Compliance
Division of Animal Resources
BMSB/Room 203
University of Oklahoma Health Sciences Center
Telephone:  (405) 271-5185
FAX:  (405) 271-3032

$$N3 END ************************************************************

               NOTICES OF AVAILABILITY (RFPs AND RFAs)

$$R1 BEGIN CA-93-06 FULL-TEXT ***************************************

DEVELOPMENTAL RESEARCH IN NATIVE PACIFIC POPULATIONS

NIH GUIDE, Volume 21, Number 40, November 6, 1992

RFA AVAILABLE:  CA-93-06

P.T. 34, FB; K.W. 0715035, 0795003, 0745027

National Cancer Institute

Letter of Intent Receipt Date:  December 4, 1992
Application Receipt Date:  January 25, 1993

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

PURPOSE

The National Cancer Program is mandated to address the unique cancer
prevention, early detection, and treatment needs of all populations
within the U.S. and its territories.  Therefore, the Special
Populations Studies Branch (SPSB) of the Division of Cancer Prevention
and Control (DCPC) of the National Cancer Institute (NCI) invites
applications from various organizations for developmental studies that:
(1) assess cancer control need, (2) determine barriers to cancer
control, and/or (3) validate intervention methods and assessment
instruments in native Pacific populations; i.e., American Samoans,
Guamanians (Chamorros), Palauians, and Northern Marianians.  This
initiative will define the cancer prevention and control needs of
native Pacific populations and those of similar ancestry located in the
Pacific as well as the U.S. mainland.

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,
Developmental Research in Native Pacific Populations, 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
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 (including U.S. Territorial
possessions) public and private, for-profit and non-profit
organizations serving native Pacific populations such as universities,
public health departments, voluntary organizations, research centers,
hospitals, consortia of health providers, units of State and local
governments and eligible agencies of the Federal government.  Teams of
applicants are encouraged.  Among a team of applicants, one institution
must be proposed as the lead institution to serve as the applicant and
to assume responsibility for the conduct and administration of the
project.  Note that awards will not be made to foreign institutions and
that applications from domestic organizations may not include
international components.

MECHANISM OF SUPPORT

The mechanism of support for this RFA will be the National Institutes
of Health (NIH) research project grant (R01).  Responsibility for the
planning, direction, and execution of the proposed research will be
solely that of the applicant.  In addition to the requirements stated
in this RFA, 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, 1991.  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.  It
is anticipated that four awards will be made at approximately $300,000
total costs per year.

FUNDS AVAILABLE

Approximately $1.2 million in total costs per year for three years will
be set-aside to specifically fund applications that are submitted in
response to this RFA.  It is anticipated that up to four awards will be
made.  The total project period of these awards may not exceed three
years.  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 plans of the NCI, the
award of a grant pursuant to this RFA is also contingent upon the
availability of funds for this purpose.

RESEARCH OBJECTIVES

Studies conducted under this RFA will seek to define cancer prevention
and control needs/services of the native Pacific population segments
(Phase I).  Studies to test ways in which existing intervention methods
can be used or adapted for the target populations (Phase II); or
studies of new methods designed to be sensitive to the needs of the
target populations (Phase II); or methodologic research on validation
of assessment instruments in target populations (Phase II) are eligible
for consideration under the RFA.  This "developmental cancer control
research" (Phase I and Phase II) is absolutely essential to future
development of cancer prevention and control research for native
Pacific populations.

The following definitions apply for this RFA:

Cancer Control -- Cancer control is defined as the reduction of cancer
incidence, morbidity, and mortality through an orderly sequence from
research on interventions and their impact in defined populations to
the broad, systematic application of the research results.

Phases of Cancer Control -- Cancer control research studies are
classified in the five phases that represent the orderly progression
noted in the above definition:  (I) Hypothesis development; (II)
Intervention methods development and testing; (III) Controlled
intervention trials to establish cause and effect relationships; (IV)
Research in defined human populations; and (V) Demonstration and
implementation studies.

The research of interest in this RFA falls into either Phase I or Phase
II studies.  Hypothesis development (Phase I) studies should focus on
the assessment of cancer prevention and control needs in communities or
organizations within native Pacific populations or studies that
identify barriers to cancer prevention and control within these
indigenous populations.  Methods development and testing studies, Phase
II, should focus on:  (1) validating the use of existing intervention
methods (e.g., dietary modification, health services, tobacco
cessation) applied in the target populations described above; (2)
developing and pilot testing unique methods that are sensitive to the
needs of the target populations described above; or (3) developing and
validating assessment instruments to measure the cancer control related
needs of the target populations or for use in evaluating the
effectiveness of intervention methods in the target populations.

STUDY POPULATIONS

The targeted population of this RFA is the native Pacific populations
and those of similar ancestry located in the Pacific as well as the
U.S. mainland; i.e., American Samoans, Guamanians (Chamorros),
Palauians, and North Marianians.  Applicants responding to this RFA are
expected to successfully access a significant portion of this
population to decrease cancer incidence and mortality, increase cancer
survival, and increase the diagnosis of cancers at earlier stages.

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 December 4, 1992, a
letter of intent that includes a descriptive title of the proposed
research; the name, address, and telephone number of the Principal
Investigator (PI); the identity 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 a subsequent application, 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. George A. Alexander at the address listed under INQUIRIES.

APPLICATION PROCEDURES

Applications are to be submitted on the grant application form PHS 398
(rev. 9/91).  These forms are available at most institutional offices
of sponsored research and the Office of Grants Inquiries, Division of
Research Grants, National Institutes of Health, Westwood Building, 5333
Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301/496-7447.
Applications must be received by January 25, 1993.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed (initially) by the Division
of Research Grants (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.  If an application is judged to be non-responsive, the
applicant will be contacted and given an opportunity to withdraw the
application or to have it considered with other unsolicited
applications received by NIH in the next review cycle. Questions
concerning responsiveness to the RFA may be directed to NCI program
staff identified under INQUIRIES.  Those applications that are complete
and responsive will be initially evaluated in accordance with the
review criteria stated within the RFA for scientific/technical merit by
an ad hoc review committee convened by the Division of Extramural
Activities, NCI.  The second level of review will be provided by the
National Cancer Advisory Board.

INQUIRIES

Written and telephone requests for the RFA and the opportunity to
clarify any issues or questions from potential applicants are welcome.
Direct requests for the RFA and inquiries regarding programmatic issues
to:

George A. Alexander, M.D.
Chief, Special Populations Studies Branch
Cancer Control Science Program
Division of Cancer Prevention and Control
National Cancer Institute
Executive Plaza North, Room 240
Bethesda, MD  20892-4200
Telephone:  (301) 496-8589
FAX:  (301) 496-8675

Direct inquiries regarding fiscal issues to:

Crystal Elliott
Grants Management Specialist
National Cancer Institute
Grants Administration Branch
Executive Plaza South, Room 243
Bethesda, MD  20892
Telephone:  (301) 496-7800  Ext. 19

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance
No. 93.399, Cancer Control Science Program.  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 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.

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

$$R2 BEGIN HD-93-06 FULL-TEXT ***************************************

NETWORK OF PEDIATRIC PHARMACOLOGY RESEARCH UNITS

NIH GUIDE, Volume 21, Number 40, November 6, 1992

RFA AVAILABLE:  HD-93-06

P.T. 34, AA; K.W. 0710100, 0770005, 0403020, 0715006

National Institute of Child Health and Human Development

Letter of Intent Receipt Date:  February 15, 1993
Application Receipt Date:  April 13, 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 BELOW.

PURPOSE

The National Institute of Child Health and Human Development (NICHD)
will support a cooperative network of Pediatric Pharmacology Research
Units (PPRU) to facilitate clinical studies of drug action and
disposition in infants and children.  These studies are to be conducted
by qualified pediatric clinical pharmacologists, either cooperatively
with investigators at other Units in the network, collaboratively with
pharmaceutical companies, or independently with other support.  The
major goal of studies conducted by the PPRU Network is to provide the
clinical data on drugs necessary for U.S. Food and Drug Administration
(FDA) approval for use in children.

HEALTHY PEOPLE 2000

The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention goals of "Healthy People 2000," a
PHS-led national activity for setting priorities.  This RFA, Network of
Pediatric Pharmacology Research Units, is related to the priority areas
of food and drug safety and maternal and infant health.  Copies of
"Healthy People 2000" (Full Report:  Stock No. 017-001-00474-0, or
Summary Report:  Stock No. 017-001-00473-1) are available through the
Superintendent of Documents, Government Printing Office, Washington, DC
20402-9325 (telephone 202-783-3238).

ELIGIBILITY

PPRU cooperative clinical agreement (U10) awards will be made to
children's hospitals or the equivalent, or to educational institutions
with accredited medical schools, within the United States.  The
applicant institution must also meet the standard eligibility
requirements for research grants established in the Public Health
Service Grants Policy Statement #(OASH) 90-50,000, rev. 10/1/90.

There must be at the applicant institution an ongoing program of
excellence in clinical pharmacology, with an emphasis on pediatric
applications.  The quality of this program must be evident from the
receipt by its staff of research support in peer-reviewed competition
or from their consistent record of publication in peer-reviewed
research journals.  In addition, the applicant institution must have
available a sufficient number of eligible research subjects in the
pediatric age groups: newborns, infants, children, pre- adolescents,
and adolescents.

MECHANISM OF SUPPORT

The funding mechanism to be used to assist the scientific community in
undertaking this program of clinical pharmacologic investigation will
be a cooperative clinical agreement (U10) between the participating
units and the NICHD.  The U10 award provides support for laboratory and
administrative resources to assist the research community in carrying
out clinical therapeutic research.  The major difference between a
cooperative agreement and a traditional research grant is the
substantial scientific involvement of NICHD staff beyond the levels
normally required for program stewardship of grants.

FUNDS AVAILABLE

It is expected that up to four applications will be funded, within the
total direct cost limit of $1,000,000 available for the first year.
Therefore, the maximum direct cost request (first year) for individual
applications should not exceed $250,000.  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 plans of the NICHD, awards pursuant to this RFA are
contingent upon the availability of funds for this purpose.

RESEARCH OBJECTIVES

Federal law and the regulations of the FDA require that drugs be tested
for safety and efficacy before they are approved for clinical use.
This testing must take place with all populations with which the drug
will be employed.  Studies must therefore be conducted with infants and
children before a drug can be approved for use with them.

Several practical problems discourage the testing of drugs and medical
devices in children.  These include the unpredictable nature of some of
the clinical responses; the possibility of catastrophic unanticipated
reactions; the threat of adverse effects on growth; the ethical
problems of conducting nontherapeutic research in children; and the
absence of a financial incentive for pharmaceutical companies when
children are a minority of the population for whom the drug might be
prescribed.  The result of these practical problems and the regulatory
requirements is that more than three-quarters of the drugs marketed in
the United States, including many of the most useful agents in modern
therapy, are not approved as safe and effective for use in children.
Since the provision of pediatric care without the use of these agents
would be unacceptable, they are often administered "off-label," meaning
without specific FDA approval.

This dilemma must be resolved if children are to escape the status of
therapeutic orphans and to receive the full benefits of contemporary
therapeutics.  Modern pediatric pharmacology is a sophisticated
clinical discipline capable of carrying out the studies necessary for
the safe and ethical evaluation of drugs in children.  Pursuit of such
studies, however, is limited by the scarcity of available facilities in
which to perform them and the small number of qualified clinical
investigators interested in this problem.

The objective of the PPRU Program is to increase the number and variety
of medications that are FDA-approved for use in children, with the
ultimate goal that all drugs prescribed for children be labeled for
such usage.  This is to be accomplished by providing resources for
pediatric pharmacokinetic and pharmacodynamic research through the
establishment of a network of pediatric pharmacology research units.

Each PPRU will have four specific aims:

(1) To participate with other units in the network and with NICHD staff
assistance in collaborative clinical trials of drugs in children
through protocols determined by consensus;

(2) To provide a locus for the conduct of pre-marketing and
post-marketing clinical trials in children by qualified clinical
pharmacologists working in collaboration with proprietary
pharmaceutical firms;

(3) To conduct independent, investigator-initiated studies on the
pharmacodynamics and pharmacokinetics of drugs in children; and

(4) To provide an environment in which pediatricians and others can
gain supervised experience in pediatric clinical pharmacology.

The PPRU group will be organized through a Network Steering Committee
(NSC), comprising the Principal Investigators (PI) of the funded units,
one NICHD staff member, and appropriate outside advisers.  This
committee will meet at least quarterly to review and select protocols
to be performed collaboratively by the network and to exchange
information on progress.  The NSC will be chaired by a non-NICHD
scientist not affiliated with any of the units.

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 females and minorities in
study populations.  If minorities are not included in the study
populations, a specific justification for this exclusion must be
provided.  Applications without such inclusion or justification will
not be accepted for review.

LETTER OF INTENT

Prospective applicants are asked to submit, by February 15, 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 NICHD 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:

Ephraim Y. Levin, M.D.
Endocrinology, Nutrition and Growth Branch
Center for Research for Mothers and Children
National Institute of Child Health and Human Development
Executive Plaza North, Room 637
Bethesda, MD  20892
Telephone:  (301) 496-5593

APPLICATION PROCEDURES

Applications are to be submitted on form PHS 398, and must be received
by April 13, 1993.  Potential applicants must request the detailed
information included in the complete RFA before preparing an
application.

REVIEW CONSIDERATIONS

Applications will be reviewed by NICHD staff for responsiveness to the
RFA.  A non-responsive application will be returned to the applicants.
Responsive applications may be subjected to a triage by a peer-review
group to determine the scientific merit relative to the other
applications received in response to this RFA.  The NICHD will withdraw
from competition those applications judged to be noncompetitive and
notify the applicants and institutional business officials.

Applications considered responsive to this RFA will be reviewed for
technical merit by an Initial Review Group convened by the scientific
review staff of the NICHD solely to evaluate these applications.
Criteria for the initial review are described in the RFA.  Following
review by the Initial Review Group, applications will be evaluated by
the National Advisory Child Health and Human Development (NACHHD)
Council for program relevance and policy issues before awards are made.

INQUIRIES

Written and telephone requests for the RFA and the opportunity to
clarify any issues or questions from potential applicants are welcome.

Direct requests for the RFA and inquiries regarding programmatic issues
to:

Ephraim Y. Levin, M.D.
Endocrinology, Nutrition and Growth Branch
Center for Research for Mothers and Children
National Institute of Child Health and Human Development
Executive Plaza North, Room 637
Bethesda, MD  20892
Telephone:  (301) 496-5593

Direct inquiries regarding fiscal matters to:

E. Douglas Shawver
Office of Grants and Contracts
National Institute of Child Health and Human Development
Executive Plaza North, Room 505
Bethesda, MD  20892
Telephone:  (301) 496-1303

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance
No. 93.865, Research for Mothers and Children.  Awards are made under
authorization of the Public Health Service Act, Section 301 (42 USC
421), 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 Health Systems
Agency review.

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

$$R3 BEGIN DK-93-12 FULL-TEXT ***************************************

RESEARCH USING THE UNITED STATES RENAL DATA SYSTEM

NIH GUIDE, Volume 21, Number 40, November 6, 1992

RFA AVAILABLE:  DK-93-12

P.T. 34; K.W. 0785095, 0755018

National Institute of Diabetes and Digestive and Kidney Diseases

Letter of Intent Receipt Date:  April 19, 1993
Application Receipt Date:  May 18, 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

This initiative invites grant applications for biomedical research
utilizing the United States Renal Data System (USRDS) database.

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 Using the United States Renal Data System, 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 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 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

Support of this program will be through the investigator initiated
research project grant (R01) mechanism.  Each grant award will not be
more than $50,000 total cost (including direct and indirect costs).
Responsibility for the planning, direction, and execution of the
proposed project will be solely that of the applicant.  Awards will be
administered under PHS grants policy as stated in the PHS Grants Policy
Statement.

This RFA is a one-time solicitation.  Generally, future unsolicited
competing continuation applications will compete with all
investigator-initiated applications and be reviewed according to the
customary peer review procedures.  The total requested project period
for each application submitted in response to this RFA may not exceed
two years.  The earliest possible award date will be January 1994.

FUNDS AVAILABLE

It is anticipated that approximately 10 awards will be made.  However,
this funding level is dependent upon the receipt of a sufficient number
of applications of high scientific merit.  Although this program is
provided for in the financial plans of the National Institute of
Diabetes and Digestive and Kidney Diseases (NIDDK), the award of grants
pursuant to this RFA is also contingent upon the availability of funds
designated for this purpose.

RESEARCH OBJECTIVES

The USRDS database contains information on 420,000 Medicare patients
who have had end-stage renal disease (ESRD) therapy at any time since
1976.  For each patient, the database includes information on basic
demographics, the primary medical diagnosis that led to renal failure,
dialysis records, hospital records, transplant information.  In
addition, the database contains details on the 2,492 institutions that
provide ESRD treatment services.  Limited information is available on
non-Medicare funded ESRD patients who are treated by the Department of
Veterans Affairs (no billing record data or social security
information).  The USRDS database is supplemented by data from the U.S.
Census Bureau.

Specific questions that would be considered responsive to this RFA
include but are not limited to the following examples:  the relative
incidence, prevalence, mortality and survival associated with various
comorbid conditions, causes of ESRD, modes of ESRD treatment, or
subgroups of the treated ESRD population in the United States;
examination of the relative burden of disease in various minority
groups; ecologic analyses which relate prevalence of predisposing
diseases to incidence and prevalence of treated and untreated ESRD in
various subgroups of the population.  Creativity in using the data to
develop descriptive, analytic, and hypothesis generating studies is
encouraged.  Questions primarily of an economic focus would not be
considered responsive to this RFA, although such issues may be included
as secondary aims.

The investigator is encouraged to contact the USRDS Project Officer,
Dr. Lawrence Agodoa, (KUH/NIDDK, Westwood Building, Room 3A-06, 5333
Westbard Avenue, Bethesda, Maryland  20892, telephone 301/496-7571), to
discuss the data request and to request a copy of the USRDS Data
Release Policy and the USRDS Agreement for Data Release Form.  The
USRDS database may be contacted at any time. The USRDS process of
reviewing a written request for data, generating the data, and
releasing the data takes approximately three months.

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 April 19, 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 NIDDK 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:

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

APPLICATION PROCEDURES

Applications are to be submitted using form PHS 398 (rev. 9/91),
available in 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, MD
20892, telephone 301-496- 7441.  The RFA label available in the PHS 398
application form must be affixed to the bottom of the face page.
Detailed instructions on submission procedures are described in the
RFA.

REVIEW CONSIDERATIONS

Applications that are complete and responsive to the RFA will be
evaluated by an appropriate peer review group convened by the NIDDK in
accordance with the usual NIH peer review procedures.  Following
initial review, the applications will be given a secondary review
unless not recommended for further consideration by the initial review
group.  Applications that are incomplete or unresponsive to the RFA
will be returned to the applicant or held until the next regular
receipt date and reviewed by the Division of Research Grants.  Review
criteria are given in the RFA.

INQUIRIES

Written and telephone inquiries concerning this RFA are encouraged.
Inquiries regarding programmatic issues, and requests for the RFA may
be directed to:

Camille A. Jones, M.D., M.P.H.
Director, Epidemiology Program
Division of Kidney, Urologic, and Hematologic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 3A-06
5333 Westbard Avenue
Bethesda, MD  20892
Telephone:  (301) 496-7571

Inquiries regarding fiscal matters may be directed to:

Ms. Trude McCain
Grants Management Specialist
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 649
5333 Westbard Avenue
Bethesda, MD  20892
Telephone:  (301) 496-7467

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance
No. 93.849.  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.  This
program is not subject to the intergovernmental review requirements of
Executive Order 12372 or Health Systems Agency review.

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

                    ONGOING PROGRAM ANNOUNCEMENTS

$$P1 BEGIN PA-93-014 ************************************************

THE IMMUNOLOGY OF AGING

NIH GUIDE, Volume 21, Number 40, November 6, 1992

PA NUMBER:  PA-93-014

P.T. 34; K.W. 0710010, 0710070, 0705040, 0765035

National Institute on Aging
National Institute of Allergy and Infectious Diseases

PURPOSE

It has been well established that overall immune function declines with
advancing age.  However, because the immune system is highly complex,
it is essential to understand the multi-faceted nature of this
age-related loss of immune function and to identify the primary changes
in immune mechanisms leading to this decline in the immune responses.
It has been proposed that the decline and/or dysregulation of the
immune system may be a primary cause of aging or perhaps a pace-setter
of the aging process.  The possibility that changes in the immune
system may be a fundamental predisposing factor in the aging process is
also an appropriate field of scientific inquiry.  Research is also
indicated into the pathological consequences of age-related changes in
the immune system, such as decreased resistance to infection with
pathogens and an increased tendency toward autoimmunity and
immunopathology.

The Biology of Aging Program (BAP) of the National Institute on Aging
(NIA) has responsibility for supporting extramural research and
training in the fundamental studies of immunology as related to aging.
The Geriatrics Program (GP) has responsibility for supporting clinical
studies of the immune competence of aging humans, the transfer of
promising immunological interventions, and the delivery of effective
vaccines to geriatric populations.  The Division of Allergy,
Immunology, and Transplantation (DAIT) of the National Institute of
Allergy and Infectious Diseases (NIAID) is responsible for promoting
research into the basic mechanisms of the immune system and the changes
that occur in the immune system that initiate or contribute to disease.
The two institutes share the goal of achieving a better understanding
of the behavior of the immune system and the specific deficits of
various components of the immune system that occur during aging to
permit intervention and prevent or reverse the immunologic deficits of
aging.

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.
Applications from minority individuals and women are encouraged.
Applicants for K and F awards must be U.S. citizens, non citizen
nationals, or have been lawfully admitted for permanent residence at
the time of award.  Applications related to the health of women and
minorities are particularly encouraged.

MECHANISMS OF SUPPORT

o  Research grant (R01)

o  Program Project grant (P01)

o  First Independent Research Support and Transition (FIRST) award
(R29)

o  Career grants, which include:  Research Career Development Award
(K04); Clinical Investigator Award (K08); Physician Scientist Award
(individual K11)

o  Training grants (T32)

o  Fellowships (F32, F33)

Deadlines for applications are as follows:

F-series and T-series grants:        Jan 10, May 10, Sep 10
New R, K, and P-series:              Feb 1, Jun 1, Oct 1
Competing continuation and revised:  Mar 1, Jul 1, Nov 1

Foreign institutions are not eligible to apply for T32 Awards, Program
Project (P01) Awards, or FIRST Awards (R29).

RESEARCH OBJECTIVES

The NIA and the NIAID invite investigators to submit applications for
research and research training in all areas of immunology that relate
to fundamental processes of aging.  Applications to study the aging of
the immune system in humans, animals, or cell culture systems are
welcome.  Applications that might lead to successful interventions in
the aging of the immune system are particularly encouraged.

The following topics are illustrative of appropriate research areas
covered by this Program Announcement.  However, applications need not
be limited to the issues listed below.

o  Age related changes in the functions of lymphoid organs (thymus,
spleen, lymph nodes, gut-associated lymphoid tissue)

o  The roles of changes in bone marrow cell production and thymic
involution in the aging immune response.  The possible role, source and
mechanism of extrathymic T cell repopulation

o  Age-related changes in the genetic and ontogenic control of T and B
cell production.  Selection and deletion of involved cell types.  The
nature and function of different T and B cell subtypes (naive, memory,
helper, and cytotoxic T cells)

o  Age-related changes in the mechanisms of antigen sequestration,
transport, processing, and presentation, including the accessory cells
involved (Langerhans cells, macrophages, dendritic cells, B cells)

o  Age-related changes in molecules involved in specific antigen
recognition (B-cell and T-cell receptors, MHC-encoded molecules) and in
lymphocyte and macrophage activation

o  Age-related changes in biochemical processes leading to lymphocyte
and macrophage activation

o  Age-related changes in the production of lymphokines and other
cytokines (and their receptors) involved in the immune response

o  The role of hormones and neuroendocrine factors in the regulation of
T and B cell activity and in age-related changes in immune function.

o  Age-related changes in the regulation of the immune response (e.g.,
regulatory cells, immunoglobulin isotypes, the idiotypic network).
Changes in the nature of the antibody repertoire with aging.

o  Immune responses to infectious agents and to vaccines in senescence;
development of vaccine delivery systems.

o  Immunologic tolerance, autoimmunity, and immunopathology in
senescence

o  The interrelationship between disease and immune function in the
aging process

o  The role of nutrition and caloric restriction in the potentiation or
prevention of age-associated deficits in immune function

o  Immune surveillance in aged individuals

o  Generalized immunosuppression due to viral, protozoal, and bacterial
infections in aged individuals

o  Attempts to prevent or reverse the immunologic deficits of aging by
immunotherapy (e.g., development of techniques for immune augmentation,
biological response modifiers, hormonal treatment)

o  Attempts to prevent or reverse the immunologic deficits of aging
through cellular or genetic engineering

o  Effects of drugs on the immune system of older individuals

o  Gender-related differences in any of the above areas of research.

The Geriatrics Program of the NIA also supports research in the
clinical aspects of several of the preceding topics, particularly those
regarding immune responses to infectious agents in senescence and the
development and delivery of effective vaccines.  Inquiries considered
more appropriate for the Geriatrics Program will be referred to them.

STUDY POPULATIONS

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

NIH policy is that applicants for NIH clinical research grants and
cooperative agreements are required to include minorities and women 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 must be placed on the need for inclusion of minorities
and women in studies of diseases, disorders and conditions which
disproportionately affect them.  This policy is intended to apply to
males and 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 must be
provided.

The composition of the proposed study population must be described in
terms of gender and racial/ethnic group.  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 must be included in the form PHS 398 in
Sections 1-4 of the Research Plan AND summarized in Section 3,
Recruitment of Individuals from Underrepresented Racial/Ethnic Groups,
and 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 population groups must be
provided.

For the purpose of this policy, clinical research is defined as human
biomedical and behavioral studies of etiology, epidemiology, prevention
and preventive strategies), 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 excluded.  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 review will be deferred until the information is
provided.

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 design is inadequate to answer the
scientific question(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 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.
National Research Service Award (NRSA) (F32, F33) applications must be
submitted on grant application Form PHS 416 (rev. 10/91).

Application kits 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.  The title and number of the announcement must be typed
in Section 2a on the face page of the application.

Applications 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.

The completed original application and five legible copies must be sent
or delivered to:

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

REVIEW PROCEDURES

Other institutes may also have interest in several of the topics
mentioned here.  All applications in response to this Program
Announcement will be assigned to an Initial Review Group and reviewed
by the usual Public Health Service Peer Review (Study Section)
procedures.  They will also be given appropriate primary and secondary
Institute assignments in accordance with established PHS Referral
Guidelines.  The review criteria are the traditional criteria
appropriate to each mechanism.  In accordance with the standard NIH
peer review procedures, research project grant (R01 and R29)
applications, fellowships  (F32, F33) and research career development
awards (K04) will be reviewed for scientific and technical merit by an
appropriate study section in the Division of Research Grants.  All
other applications will be reviewed by review groups of the appropriate
funding component.  Following the Study Section review, the
applications will receive a second-level review by the appropriate
advisory council.  Funding decisions will be based on the above
evaluations and on the availability of funds.

AWARD CRITERIA

Applications compete for available funds on the basis of scientific
merit.  The following will be considered in making funding decisions:

o  Quality of the proposed project as determined by peer review
o  Availability of funds
o  Program balance among research areas of the announcement

INQUIRIES

Researchers considering an application in response to this announcement
are strongly encouraged to discuss their project, and the range of
grant mechanisms available with NIA and/or NIAID staff.  This can be
done either through a telephone conversation or a brief letter.

Correspondence and inquiries may be directed to:

Dr. David Lavrin, Immunology Program Administrator
Biology of Aging Program
National Institute on Aging
Gateway Building, Room 2C231
7201 Wisconsin Avenue
Bethesda, MD  20892
Telephone:  (301) 496-6402
FAX:  (301) 402-0010

Dr. Joseph Albright
Program Administrator, Division of Allergy, Immunology and
Transplantation
National Institute of Allergy and Infectious Diseases
Solar Building, Room 4A20
Bethesda, MD  20892
Telephone:  (301) 496-7985
FAX:  (301) 402-0175

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance
Nos. 93.866 and 93.855.  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.  This program is not subject to the intergovernmental review
requirements of Executive Order 12372 or Health Systems Agency review.

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

$$P2 BEGIN PA-93-015 ************************************************

PHYSIOLOGICAL ROLE OF THE ADRENAL ANDROGEN, DHEA, IN AGING

NIH GUIDE, Volume 21, Number 40, November 6, 1992

PA NUMBER:  PA-93-015

P.T. 34; K.W. 0710010, 0705030, 0705040, 0760025

National Institute On Aging

PURPOSE

The National Institute on Aging (NIA) has responsibility for extramural
programs of research and training in immunology and endocrinology
related to aging.  This support has resulted in a better understanding
of the behavior of, and specific changes in, various components of the
immune and endocrine systems in aging.

It is well recognized that changes in the immune and endocrine systems
during aging have profound influences on homeostatic mechanisms of the
body.  Some of these changes may be a result of "normal aging;" others
may be due to environmental factors, such as stress and disease.
Steroid, peptide, and eicosenoid hormones secreted from endocrine
tissues are known to influence the immune system.  Conversely, some
cytokines, interferons and interleukins, modulators of immune system
function, have profound regulatory effects on the endocrine system.
Since both the immune and some components of the endocrine systems
decline with advancing age, it is of interest to explore and delineate
regulatory interactions between the immune and endocrine systems in the
aging mammal.

The purpose of this program announcement is to focus on the
physiological role of the adrenal steroidal androgen precursor,
dehydroepiandrosterone (DHEA), in aging.  DHEA, and its sulfated form,
DHEAS, decrease steadily with age in both animals and humans.  This
decline may represent a biomarker of biological aging.  DHEA/DHEAS
levels have also been found to be depressed in a number of disease
states (eg., systemic lupus erythematosis (SLE), AIDS, cancer,
diabetes, cardiovascular disease) and during stress and trauma (e.g.,
burns, surgery).  Administration of DHEA has been shown to inhibit the
development of obesity and to protect against carcinogenesis in mice.
Recent research has demonstrated that the administration of physiologic
doses of DHEA/DHEAS to aged mice may reverse the age-related
immunological anergy by permitting the production of antibody and
cellular responses at levels comparable to those of fully
immunocompetent mature adult mice.  The pattern of the lymphokine
production was also restored to that of normal mature mice.  DHEAS
administration also has been shown to counteract the inflammatory