Subject: NIH GUIDE - V20(43) 11/15/91
From: Dot Baker <[email-masked]>
To: [email-masked]
Date: Fri, 15 Nov 91 08:38 EST

Hi Paul,
   Please post to the NIH Listserver as:
       NIHGUIDE.911115
                      Thanks.    Dottie
 ---------------------------- Text of forwarded message -----------------------
 
$$XID NIHGUIDE 19911115 V20N43 P1O1 ************************************
X-comment: RFAs described: DK-92-13, AR-92-01, DK/HD-92-06, AG-91-17
 
NIH GUIDE - Vol. 20, No. 43 - November 15, 1991
 
$$INDEX BEGIN *******************************************************
 
                                NOTICES
 
$$INDEX N1 **********************************************************
 
NATIONAL WORKSHOPS ON THE PROTECTION OF HUMAN SUBJECTS
National Institutes of Health
Food and Drug Administration
INDEX:  NATIONAL INSTITUTES OF HEALTH, FOOD AND DRUG ADMINISTRATION
 
                          NOTICES OF AVAILABILITY (RFPs AND RFAs)
 
$$INDEX R1 **********************************************************
 
CLOSED LOOP CONTROL OF FUNCTIONAL NEUROMUSCULAR STIMULATION (NIH-NINDS-
92-01)
National Institute of Neurological Disorders and Stroke
INDEX:  NEUROLOGICAL DISORDERS, STROKE
 
$$INDEX R2 **********************************************************
 
DEVELOPMENT AND TESTING OF NEW SPERMICIDES (NICHD-BAA-92-6)
National Institute of Child Health and Human Development
INDEX:  CHILD HEALTH, HUMAN DEVELOPMENT
 
$$INDEX R3 **********************************************************
 
GMP FORMULATION OF PEPTIDE T (SOURCES SOUGHT)
National Institute of Mental Health
INDEX: MENTAL HEALTH
 
$$INDEX R4 02/18/92 *************************************************
 
BASIC RESEARCH ON GROWTH REGULATION IN BENIGN PROSTATIC HYPERPLASIA
(DK-92-13)
National Institute of Diabetes and Digestive and Kidney Diseases
INDEX:  DIABETES, DIGESTIVE, KIDNEY DISEASES
 
$$INDEX R5 04/22/92 *************************************************
 
SKIN DISEASES RESEARCH CORE CENTERS (AR-92-01)
National Institute of Arthritis and Musculoskeletal and Skin Diseases
INDEX:  ARTHRITIS, MUSCULOSKELETAL, SKIN DISEASES
 
$$INDEX R6 03/25/92 *************************************************
 
OBESITY/NUTRITION RESEARCH CENTERS (DK/HD-92-06)
National Institute of Diabetes and Digestive and Kidney Diseases
National Institute of Child Health and Human Development
INDEX:  DIABETES, DIGESTIVE, KIDNEY DISEASES, CHILD HEALTH, HUMAN
DEVELOPMENT
$$INDEX R7 02/19/92 *************************************************
 
DEVELOPMENT OF BIOMARKERS OF AGING (AG-91-17)
National Institute on Aging
INDEX:  AGING
 
$$INDEX END *********************************************************
 
                           NOTICES
 
$$N1 BEGIN **********************************************************
 
NATIONAL WORKSHOPS ON THE PROTECTION OF HUMAN SUBJECTS
 
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 sponsoring a series of workshops on the
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:
 
WEST COAST WORKSHOP
 
DATES:  January 23 and 24, 1992 (REVISED DATES)
 
WORKSHOP SITE:  Los Angeles, CA
 
SPONSORS:
University of Southern California
Los Angeles, CA  90089-4014
 
California State University - Los Angeles
5151 State University Drive
Los Angeles, CA  90032-8202
 
REGISTRATION CONTACT:
Ms. Lily Patterson
Assistant to the Director
Research and Sponsored Programs
California State University - Los Angeles
5151 State University Drive
Los Angeles, CA  90032-8202
Telephone:  (213) 343-3820
 
TOPIC:  Whose Research is it Anyway?  A Workshop on the Protection of
Human Subjects in Research
 
For further information regarding these workshops and future NIH/FDA
National Protection of Human Subjects Workshops, please contact:
 
Ms. Darlene Marie Ross
Executive Assistant for Education
Division of Human Subject Protections
Office for Protection from Research Risks
National Institutes of Health
9000 Rockville Pike
Building 31, Room 5B59
Bethesda, MD  20892
Telephone:  (301) 496-8101
 
$$N1 END ************************************************************
 
                  NOTICES OF AVAILABILITY (RFPs AND RFAs)
 
$$R1 BEGIN NIH-NINDS-92-01 ******************************************
 
CLOSED LOOP CONTROL OF FUNCTIONAL NEUROMUSCULAR STIMULATION
 
RFP AVAILABLE:  NIH-NINDS-92-01
 
P.T. 34; K.W. 0745047, 0740050, 0706040, 0715140
 
National Institute of Neurological Disorders and Stroke
 
The Neural Prosthesis Program of the National Institute of Neurological
Disorders and Stroke (NINDS), NIH, is developing neural prostheses
based on functional neuromuscular stimulation (FNS) for the restoration
of quadriplegic individuals.  The principal goal of the proposed
project is to enhance the utility of FNS systems for hand grasp.
Specific tasks include: developing and evaluating closed-loop FNS
systems for hand grasp utilizing external force and position
integrating FNS wrist stabilization, FNS elbow control and surgical
procedures such as tendon transfer and arthrodesis with an FNS hand
grasp system; developing a biomechanical model of the hand for use in
evaluating advanced FNS systems; and investigating new techniques for
programming of FNS systems and for selection of electrode sites.  A
research team with experience in neural prostheses, spinal cord
rehabilitation, hand surgery, control theory, biomechanics and
physiology will be required to successfully conduct this research.  It
is anticipated that one award will be made for a period of three years
in August 1992.
 
This is not a Request for Proposals (RFP).  To receive a copy of the
RFP, submit a written request to the following address, and supply this
office with two self-addressed mailing labels.  All responsible sources
shall be considered by the agency.  The RFP will be issued on or about
November 15, 1991, with proposals due on January 14, 1992.
 
Contracting Officer
Contracts Management Branch, DEA
National Institute of Neurological Disorders and Stroke
Federal Building, Room 901
7550 Wisconsin Avenue
Bethesda, MD  20892
Attention:  RFP No. NIH-NINDS-92-01
 
$$R1 END ************************************************************
 
$$R2 BEGIN NICHD-BAA-92-6 *******************************************
 
DEVELOPMENT AND TESTING OF NEW SPERMICIDES
 
RFP AVAILABLE:  NICHD-BAA-92-6
 
P.T. 34; K.W. 0750020, 0715182
 
National Institute of Child Health and Human Development
 
The Contraceptive Development Branch of the Center for Population
Research, National Institute of Child Health and Human Development
(NICHD), has a requirement to develop new spermicidal products that
will incorporate either new spermicidal drugs or new formulations of
existing drugs.  The products must be developed as single dose units.
The desired characteristics of the final product should include:  (1)
high contraceptive effectiveness, together with the ability to protect
the user against STDs; (2) employ vehicles for rapid spermicide
delivery; (3) can protect vaginal and cervical epithelia from
irritation; and (4) are long-acting after a single application.  Both
preclinical and clinical studies with new products will be considered.
It is anticipated that three contract awards will be made for a maximum
period of four years each, depending upon the nature and complexity of
the proposed research.
 
This announcement is not a Request for Proposals (RFP).  The RFP will
be issued on or about November 15, 1991.  Proposals will be due
approximately four months thereafter.  Copies of the RFP may be
obtained by sending written requests with a self-addressed label to:
 
Paul J. Duska, Contracting Officer
Contracts Management Branch, OGC
National Institute of Child Health and Human Development
Executive Plaza North, Room 610
9000 Rockville Pike
Bethesda, MD  20892
FAX:  (301) 402-0915
 
$$R2 END ************************************************************
 
$$R3 BEGIN NA-92-01 *************************************************
 
GMP FORMULATION OF PEPTIDE T
 
SOURCES SOUGHT
 
P.T. 34; K.W. 0740021, 0755010
 
National Institute of Mental Health
 
The National Institute of Mental Health (NIMH) is currently involved in
the clinical testing of Peptide T.  The NIMH is seeking a contractor
capable of formulating and producing dosage forms, carrying out quality
control and stability tests, packaging, labeling, storage and shipment
of products, and preparing documentation.  The data prepared must be
adequate to support chemistry requirements of Investigational New Drug
or New Drug Applications submitted by NIMH or NIMH-supported
investigators to the Food & Drug Administration.  The dosage form to be
produced includes intranasal formulations and will involve compounding,
sterilizing, and safety testing bulk pyrogen-free aqueous solutions
according to standardized pharmaceutical formulations and USP methods
and the FDA Good Manufacturing Procedures (GMP).  The NIMH will provide
bulk drug substances, assay methodology, and reference standards.  The
contractor must provide washed and sterilized containers (capable of
administering metered doses of intranasal solution) to be filled with
20 ml of sterilized peptide solution, cap, label, and package according
to specifications provided by the Government, and refrigerate.  The
contractor shall be responsible for sterility and bioburden testing,
HPLC analysis, storage, and shipping of the final product.  The work
requires that the contractor's facility be maintained in accordance
with FDA prescribed Current Good Manufacturing and Laboratory
Practices.  It is anticipated that the NIMH may solicit proposals at a
later date for preparation of approximately 10,000 vials.
 
Interested parties may submit a capability statement that describes the
GMP facilities, technical expertise to
provide the above services, and expected timeframe for completion of
services.  Interested parties are requested to respond within 21 days
of the date of this announcement to:
 
LouEllen M. Rice
Contracting Officer
Contracts Management Branch
National Institute of Mental Health
5600 Fishers Lane, Room 7C-18
Rockville, MD  20857
 
$$R3 END ************************************************************
 
$$R4 BEGIN DK-92-13 FULL-TEXT ***************************************
 
BASIC RESEARCH ON GROWTH REGULATION IN BENIGN PROSTATIC HYPERPLASIA
 
RFA AVAILABLE:  DK-92-13
 
P.T. 34; K.W. 0715105, 0760020, 0765015, 1002004, 1002008
 
National Institute of Diabetes and Digestive and Kidney Diseases
 
Letter of Intent Receipt Date:  November 30, 1991
Application Receipt Date:  February 18, 1992
 
PURPOSE
 
The Division of Kidney, Urologic and Hematologic Diseases (DKUHD) of
the National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK) announces the availability of a Request for Applications (RFA)
from new and experienced investigators for research that will utilize
state-of-the-art cellular, molecular, and genetic techniques to
elucidate the features of prostate growth regulation that are unique to
the development of benign prostatic hyperplasia (BPH).  The purpose of
this RFA is to gain new insights into the factors that initiate and
regulate benign hyperplastic growth in normal prostatic tissues.  The
utilization of transgenic animal models and cell and tissue cultures
that display the features of human BPH is encouraged in this RFA.
 
BACKGROUND
 
BPH is a major cause of morbidity in the adult male.  The diagnosis and
treatment of this disorder contributes significantly to health care
expenditures worldwide.  The spontaneous initiation of the benign
hyperplastic growth of the mature prostate gland is a clinical event
that is unique to primates and a few other animals.  Although it has
been amply demonstrated that normal and abnormal prostate growth is
dependant on the presence of androgens, the factors that initiate and
regulate the benign hyperplastic growth of the mature prostate have not
been adequately elucidated.
 
RESEARCH GOALS AND SCOPE
 
The overall goal of this request is to increase the knowledge of the
initiation and regulation of the growth of the prostate gland as it
applies to the development of BPH.
 
The purpose of this RFA is to fund investigators who use techniques and
models to go beyond the normal endocrine regulatory mechanisms already
demonstrated for prostate growth and look at the role of such factors
as peptide growth factors, interleukins, oncogenes, collagen synthesis,
calmodulin, extracellular matrix, apoptosis, and inflammatory
mediators, in the initiation and regulation of benign hyperplastic
prostate growth. Applications are not limited to the aforementioned
factors but must develop innovative approaches using proven findings
from other spontaneous hyperplastic disorders such as keloids, adrenal
hyperplasia, tissue regeneration, and mesangial cell hyperplasia.
 
A major goal of this initiative is to foster extensive collaboration
between the various disciplines of the basic sciences including
biochemistry, cellular biology, embryology, endocrinology, molecular
genetics, immunology, pharmacology and physiology and research
disciplines in the clinical sciences such as dermatology, nephrology,
and endocrinology, in developing new models for investigating the basic
science aspects of this significant clinical problem.
 
It is not the intent of this initiative to fund projects that will
elucidate solely the structure of steroid hormone receptors in the
prostate cell or further characterize only the role of the sex hormones
in prostate growth.  APPLICATIONS THAT UTILIZE MALIGNANT CELL LINES OR
CANCER TUMOR MODELS TO REPRESENT NORMAL OR BENIGN HYPERPLASTIC GROWTH
WILL NOT BE FUNDED BY THIS RFA.
 
Applications are strongly encouraged that investigate the interaction
of the known promoters and regulators of prostate growth, such as
androgens, with other factors intrinsic and extrinsic to the prostate
gland, such as growth factors and interleukins.
 
ELIGIBILITY REQUIREMENTS
 
Applications may be submitted by domestic and foreign, for-profit and
non-profit, public and private organizations, such as universities,
colleges, hospitals, laboratories, and eligible agencies of the Federal
Government.  Applications from minority individuals and from women are
especially encouraged.
 
MECHANISM OF SUPPORT
 
Support for this program will be through the traditional investigator-
initiated research grant (R01).  The regulations and policies that
govern the research programs of the National Institutes of Health will
prevail.  Support will be provided for up to five years.
 
FUNDS AVAILABLE
 
For FY 1992, $1.25 million in total costs per year will be committed to
fund applications submitted in response to this RFA.  It is anticipated
that five to seven awards will be made.  Applicants must limit the
budget requests to no more than $160,000 in direct costs for the first
year.
 
APPLICATION PROCEDURES
 
Applications must be submitted using Form PHS 398 (rev. 10/88),
available in the business or grants offices of most academic or
research institutions and from the Office of Grants Inquiries, Division
of Research Grants, National Institutes of Health, Room 449, 5333
Westbard Avenue, Bethesda, MD 20892, telephone 301/496-7441.
 
Applications must be received by close of business on February 18,
1992.
 
Detailed instructions on application submission are described in the
RFA.
 
REVIEW PROCEDURES
 
Applications that are not responsive to the research goals and scope of
this RFA will be returned to the investigator.  Acceptable applications
received in response to this RFA will first be reviewed for scientific
and technical merit by an Initial Review Group convened by the Review
Branch, Division of Extramural Program Activities, NIDDK.  A secondary
review for policy and program relevance to the NIDDK mission will be
made by the National Diabetes and Digestive and Kidney Diseases
Advisory Council.
 
INQUIRIES
 
It is IMPERATIVE that the RFA be obtained by all prospective applicants
prior to developing an application.  Requests for the RFA and any other
inquiries regarding it may be addressed to:
 
Leroy M. Nyberg, Jr., Ph.D., M.D.
Director, Urology Program, DKUHD
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 3A-05
Bethesda, MD  20892
Telephone:  (301) 496-7133
FAX:  (301) 496-9721
 
AUTHORITY AND REGULATIONS
 
This program is described in the Catalog of Federal Domestic Assistance
No. 93.849.  Awards will be made under the authority of the Public
Health Service Act, Title III, Section 301 and Section 431 (b) (Public
Law 78-410, as amended:  42 USC 241 and 42 USC 285c-5) and administered
under PHS grants policies and Federal Regulations 42 CFR Part 52 and
CFR Part 74.  This program is not subject to the intergovernmental
review requirements of Executive Order 12372 or Health Systems Agency
review.
 
$$R4 END ************************************************************
 
$$R5 BEGIN AR-92-01 FULL-TEXT ***************************************
 
SKIN DISEASES RESEARCH CORE CENTERS
 
RFA AVAILABLE:  AR-92-01
 
P.T. 04; K.W. 0715185, 0710030
 
National Institute of Arthritis and Musculoskeletal and Skin Diseases
 
Application Receipt Date:  April 22, 1992
 
BACKGROUND
 
The National Institute of Arthritis and Musculoskeletal and Skin
Diseases (NIAMS) announces the availability of a Request for
Applications (RFA) for research core centers in skin diseases.  The
Skin Diseases Research Core Centers (SDRCs) will provide the resources
for a number of established, currently funded investigators, often from
different disciplines, to adopt a multidisciplinary approach to common
research problems in skin diseases and to ensure greater productivity
through interaction among the investigators of individually funded
research projects.  New research directions are encouraged through a
pilot and feasibility component.
 
RESEARCH GOALS AND SCOPE
 
Research in skin diseases is at a stage where broad advances can be
effectively fostered by research core centers.  Examples of advances
include, but are not limited to:
 
o  stratum corneum:  biochemistry, structure, function
o  epidermis:  differentiation, keratinization, cellular constituents
o  dermal-epidermal junction:  structure, functions, diseases
o  skin as an immunological organ
o  autoimmune skin diseases
o  dermis:  structural components, diseases
 
The choice of research problems upon which the SDRC would focus is made
by the Principal Investigator and collaborating currently funded
investigators.
 
ELIGIBILITY
 
Applications may be submitted by domestic, nonprofit, public and
private organizations, such as universities, colleges, hospitals,
laboratories, units of State or local governments, and eligible
agencies of the Federal government.  Applications from minority
individuals and women are encouraged.
 
MECHANISM OF SUPPORT
 
The SDRC (P30) is a mechanism for integrating, coordinating, and
fostering the interdisciplinary cooperation of a group of established
investigators conducting programs of active, high-quality research that
relate to a common theme.  The SDRC provides support for:
 
o  Core resources and facilities to be used by investigators of
individually supported research projects in order to enhance and
coordinate their activities. This support may include personnel,
equipment, supplies, services, and facilities.
 
o  Limited funds for pilot and feasibility studies.
 
o  Program enrichment activities.
 
The NIAMS intends to fund two Skin Disease Research Core Centers in FY
92, subject to the availability of resources and the receipt of
sufficiently meritorious applications, each with a yearly direct cost
budget of up to $400,000.  The funding period is five years.
 
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.
 
APPLICATION GUIDELINES
 
Applicants must contact the NIAMS staff for the detailed guidelines for
the SDRC grant application.  Applications must be submitted on Form PHS
398 (rev. 10/88), which is available in the institution's business
office and from the Office of Grants Inquiries, Division of Research
Grants, National Institutes of Health, Room 449, 5333 Westbard Avenue,
Bethesda, MD 20892, telephone 301/496-7441.
 
All PHS and NIH grant policies governing research project grants apply
to applications received in response to this RFA.
 
DEADLINES
 
Letter of Intent receipt date:  February 17, 1992
Application receipt date:       April 22, 1992
Ad Hoc Study Section review:    June/July 1992
NIAMS Advisory Council Review:  September 1992
Anticipated award date:         September 1992
 
INQUIRIES
 
Further information on the program, including the guidelines for the
Skin Diseases Research Core Centers, may be obtained from:
 
Julia B. Freeman, Ph.D.
Director, Centers Programs
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Westwood Building, Room 403
Bethesda, MD  20892
Telephone:  (301) 496-7495
 
For fiscal and administrative matters, contact:
 
Mary Graham
Grants Management Specialist
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Westwood Building, Room 403
Bethesda, MD  20892
Telephone:  (301) 496-7495
 
AUTHORITY AND REGULATIONS
 
This program is described in the Catalog of Federal Domestic Assistance
No. 93.846.  Grants are awarded 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 at 42 CFR
Part 52 and 45 CFR Part 74. This program is not subject to the
intergovernmental review requirements of Executive Order 12372 or
review by a Health Systems Agency.
 
$$R5 END ************************************************************
 
$$R6 BEGIN DK/HD-92-06 FULL-TEXT ************************************
 
OBESITY/NUTRITION RESEARCH CENTERS
 
RFA AVAILABLE:  DK/HD-92-06
 
P.T. 04; K.W. 0715145, 0765020, 0710095, 0710030
 
National Institute of Diabetes and Digestive and Kidney Diseases
National Institute of Child Health and Human Development
 
Letter of Intent Receipt Date:  January 15, 1992
Application Receipt Date:  March 25, 1992
 
PURPOSE
 
The National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK) and the National Institute of Child Health and Human
Development (NICHD) announce the availability of a Request for
Applications (RFA) entitled "Obesity/Nutrition Research Centers" for
conducting basic and clinical research on obesity and in the related
fields of energy metabolism, body composition, satiety, adipocyte
metabolism, eating disorders, and weight management.  These centers
will be awarded in Fiscal Year 1992.  The award of three
Obesity/Nutrition Research Centers by NIDDK and one Obesity/Nutrition
Research Center by NICHD is anticipated.
 
OBJECTIVE AND SCOPE
 
The objectives of the Core Center are to encourage a multidisciplinary
approach to research in the nutritional sciences and to bring together,
on a cooperative basis, clinical and basic science investigators in a
manner that will enhance and extend the effectiveness of nutritional
research being conducted in the field of obesity, eating disorders, and
energy regulation.  To accomplish the overall goal of these centers,
there must be in existence at the applicant's institution an ongoing
program of excellence in biomedical research related to the study of
obesity.  The research base in the nutritional sciences need not be
exclusively in obesity and can include a focus on eating disorders,
energy metabolism, cell biology, or nutrient metabolism.  It would be
highly desirable that the Principal Investigator, as well as the
applicant institution, have a commitment to the treatment and
prevention of obesity.  The availability of a clinic population with
adequate representation of women and minorities which can be readily
utilized by investigators will play a major role in attracting
investigators to the field of obesity research and to serve as a
resource in the design of pilot and feasibility projects.
 
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.
 
MECHANISM OF SUPPORT
 
Support of this program will be by the Core Center Grant (P30)
mechanism.  An average Center may include about three to five
pilot/feasibility projects and two to four core units.  However, the
actual cost of the Center will vary depending on the needs of the
Center.  In no case shall direct costs requested exceed $600,000 per
year, nor shall the direct costs awarded exceed $500,000 per year per
Center.  The anticipated awards will be for five years and are
contingent upon the availability of appropriated funds.  Currently,
funds totalling approximately $2.0 million (total costs) are available
for support of this announcement.  The award of three new Obesity/
Nutrition Research Centers by NIDDK and one Obesity/Nutrition Research
Center by NICHD is anticipated.
 
METHOD OF APPLYING
 
Letter of Intent
 
Potential applicants are requested to submit a letter of intent by
January 15, 1992.  The letter of intent is non-binding, is not a
necessary requirement for submission of an application, and is not a
precondition for an award. Letters of intent are requested for review
planning purposes.  The NIDDK and NICHD will not specifically respond
to such letters.  Include in the letter of intent the name(s) of the
Principal Investigator and principal collaborators, descriptive titles
of the core facilities and pilot/feasibility projects, and the
institution(s) involved.  Letters of intent are to be sent to:
 
Robert Hammond, Ph.D.
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 406
Bethesda, MD  20892
 
Applications must be submitted using PHS 398 (rev. 10/88).
Applications are available from the business or grants offices of most
academic or research institutions 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.
 
INQUIRIES
 
It is essential that prospective applicants obtain the RFA and the
general description and guidelines for the Obesity Research/Nutrition
Centers from:
 
Van S. Hubbard, M.D., Ph.D.
Director, Nutritional Sciences Branch
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 3A18B
Bethesda, MD  20892
Telephone:  (301) 496-7823
FAX:  (301) 402-1278
 
Gilman Grave, M.D.
Endocrinology, Nutrition and Growth Branch
National Institute of Child Health and Human Development
Executive Plaza North, Room 637A
6130 Executive Boulevard
Rockville, MD  20892
Telephone:  (301) 496-5593
FAX:  (301) 402-2085
 
BUSINESS INFORMATION
 
Nancy Dixon
Supervisory Grants Management Specialist
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 639
Bethesda, MD  20892
Telephone:  (301) 496-7467
 
E. Douglas Shawver
Office of Grants and Contracts
National Institute of Child Health and Human Development
Executive Plaza North, Room 501
6130 Executive Boulevard
Rockville, MD  20892
Telephone:  (301) 496-1303
 
REVIEW PROCEDURES
 
Applications for the Obesity/Nutrition Research Center Grants will be
evaluated for scientific merit by the NIH grant peer review process and
subsequently by either the NIDDK or NICHD Advisory Council for program
relevance and policy issues before awards for meritorious applications
are made.  The special single receipt date for submissions in response
to this announcement is March 25, 1992, with the earliest funding being
September 1992.
 
AUTHORITY AND REGULATIONS
 
This program is described in the Catalog of Federal Domestic Assistance
No. 93. 848.  Awards will be made under the authority of the Public
Health Service Act, Title III, Section 301 and Section 431 (b) (Public
Law 78-410, as amended:  42 USC 241 and 42 USC 285c-5) and administered
under PHS grants policies and Federal Regulations 42 CFR Part 52 and
CFR Part 74.  This program is not subject to the intergovernmental
review requirements of Executive Order 12372 or Health Systems Agency
review.
 
$$R6 END ************************************************************
 
$$R7 BEGIN AG-91-17 FULL-TEXT ***************************************
 
DEVELOPMENT OF BIOMARKERS OF AGING
 
RFA AVAILABLE:  AG-91-17
 
P.T. 34; K.W. 0710010, 0760003, 0755018
 
National Institute on Aging
 
Letter of Intent Receipt Date:  December 16, 1991
Application Receipt Date:  February 19, 1992
 
PURPOSE
 
The Biology of Aging Program (BAP), National Institute on Aging (NIA),
announces the availability of a Request for Applications (RFA) for the
development of biomarkers of aging using rodent animal models supplied
by the NIA.  The major goal of the research to be supported is to
continue the development of a panel of rodent biomarkers of aging
constituted from the biomarkers developed in response to this and a
previously announced RFA (see Development of Biomarkers of Aging, NIH
GUIDE For Grants and Contracts, Vol. 16, No. 19, June 5, 1987).  To
achieve this goal, two separate types of applications are solicited in
this RFA:  one type addresses the assessment of potential biomarkers of
aging, and the other type addresses the statistical analyses of these
potential biomarkers to provide a panel of statistically valid
biomarkers useful for testing future interventions in the aging
process.
 
ELIGIBILITY REQUIREMENTS
 
Applications may be submitted by domestic and foreign, for-profit and
nonprofit, public and private, such as universities, colleges,
hospitals, laboratories, units of State or local governments, and
eligible agencies of the Federal Government.  Applications from
minority individuals and women are encouraged.
 
For the purposes of continuity and to receive the full benefit of 10
years of focus and support in biomarkers of aging research,
applications will be accepted from investigators in either of the
following two categories related to experience with Biomarkers of Aging
Research: investigators currently conducting NIA-funded Biomarkers of
Aging research projects, or investigators who can demonstrate an active
research focus for the previous four or more years on biomarkers of
aging, regardless of the source of research support, using the same
rodent genotypes as are available from the NIA/National Center for
Technological Research biomarker colony described below, are able and
willing to use animals from the NIA/NCTR biomarker colony, and have
suitable facilities for housing these animals.
 
There are no similar experience restrictions on the investigators
applying for the statistical analyses of
biomarkers of aging research.
 
MECHANISM OF SUPPORT
 
This RFA will use the National Institutes of Health (NIH) research
project (R01) grant funding mechanism.  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 Public Health Service Policy Statement,
DHHS Publication No. (OASH) 82-50,000, revised October 1, 1990.
 
FUNDS AVAILABLE
 
A total of $2,000,000 is expected to be available for this program in
FY 1993.  Funds for subsequent years are expected to range from
$1,500,000 to $2,000,000 per year.  It is anticipated that individual
awards will range from $75,000 to $150,000 per year in direct costs.
Collaborative applications or applications to test more than one type
of potential biomarker may request more than $150,000 per year in
direct costs with sufficient justification.  A maximum of 14 awards for
the Biomarker of Aging Research and one award for the Statistical
Analysis of the Biomarkers of Aging Research are anticipated.
 
The award of grants pursuant to this RFA is contingent upon receipt of
appropriated funds for this purpose.  This RFA is a one-time
invitation.  There are no plans for future reissuance.  The duration of
proposed projects may be up to five years.  The start date for funded
projects will be approximately April 1, 1993.
 
RESEARCH OBJECTIVES
 
This RFA is to encourage the continued development of research projects
that utilize the available colony of rodents to conduct biomarker
research.  Two types of applications will be considered:
 
Applications for Biomarkers of Aging Research:  The objective of
applications submitted in response to this request must be the
continued development and testing of one or more biomarkers of aging
using genetically defined mice and/or rats obtained from the NIA/NCTR
biomarker research colony.  In order to allow for the development of a
broadly based panel of biomarkers, applications are solicited from a
wide variety of possible approaches.
 
By the final year of the proposed project, the investigator will be
expected to obtain data for the proposed biomarker using non-invasive
methods, and the proposed biomarker must be applicable to the human
population.
 
The research plan for biomarker development must include evaluation of
each potential biomarker for reproducibility, sensitivity, significance
of rate of change over the lifespan, temporal pattern of changes,
non-lethality, degree of invasiveness required, potential functional
importance to human aging, simplicity, and cost-effectiveness.
 
As one step in a plan to implement testing of potential biomarkers, the
NIA, in collaboration with the NCTR, has available a colony of four
mouse genotypes and three rat genotypes as a resource for rodent
biomarker research.  Mice available in this colony include C57BL/6NNIA,
DBA2/NNIA, B6D2F1 (C56BL/6NNIA X DBA2/NNIA), B6C3F1 (C57BL/6 X C3H)
ranging in age from three to 30 months (approximately 22,000/year).
Available rats include Fischer 344, Brown-Norway, and F344 X BN hybrids
ranging in age from three to 24 months (approximately 6,000/year).
Both male and female rodents are available.  This major animal resource
has provided a suitable test population for 14 investigator-initiated
biomarker research projects over the previous four years.  In order to
allow testing of biomarker sensitivity to interventions that alter
lifespan, and since dietary restriction is the only currently available
intervention that reliably alters lifespan in rodents, ad libitum fed
and dietary restricted animals of each genotype will be available.
Diets used in the NIA/NCTR colony will be made available for shipment
to investigators to assure diet continuity for all animals.
Applications must include funds for diet acquisition and shipment.  All
NIA/NCTR animals are maintained in Specific Pathogen Free barrier
facilities.  Applicants must demonstrate their ability to house animals
received from this colony in similar or equivalent barrier conditions.
This can be achieved either with existing barrier facilities that can
be devoted to this activity, or by the use of laminar flow caging in
non-barrier rooms devoted solely to this project.
 
Collaborative research applications from investigators will be accepted
where biomarker development requires multiple research skills not
available in a single institution, where collaboration enhances the
value of the research conducted at the cooperating institutions or
where multiple use of animals is scientifically feasible and allows
significant research cost economies.
 
The applicant is permitted to propose studies leading to the
elucidation of the physiologic or molecular mechanism(s) by which the
biomarker studied constitutes a biomarker of aging, or the mechanism(s)
by which caloric restriction produces lifespan extension in these
animals.
 
Applications must clearly state the type, number, and use schedule of
all animals needed for the proposed research.  Where multiple or shared
uses of animals are proposed, each relevant application must clearly
show which animals are shared and which are not.  Animals from the
NIA/NCTR biomarker colony will be shipped to investigators by preferred
air freight.  Only costs for investigator-reared animals, if required
by the proposed research design, must be included in the application.
Applications that include the use of investigator-reared animals must
show a clear rationale for using such animals in addition to NIA/NCTR
colony animals.  Applications that do not propose biomarker of aging
research or that do not include the use of NIA/NCTR colony animals will
not be accepted.
 
Applications for the Statistical Analysis of Biomarkers of Aging
Research:  The goal of this segment of the RFA is to bring together the
results of all of the research conducted as a result of this Biomarkers
of Aging Research RFA, using the procedures of mathematical statistics,
to permit a statistically valid assessment of the gerontologic age of
rodents of the genotype specified herein using a panel of applicable
biomarkers of aging.  Applicants may obtain a description of ongoing
research supported by the NIA Biomarkers of Aging program from the
program administrator listed in INQUIRIES of this RFA.  It is
anticipated that a single successful applicant will be able to
accomplish this task, consequently a single award will be made.
 
SPECIAL REQUIREMENTS
 
In order to facilitate the achievement of this goal, the Principal
Investigators of successful applications will be expected to meet
annually to exchange information and to address progress and problems.
Applications in response to this request should include funds for one
trip each year lasting approximately three days to attend this meeting
in addition to any other travel requirements.
 
REVIEW CONSIDERATIONS
 
Applications will be received by the NIH Division of Research Grants
(DRG) and will be assigned to the NIA.  Applications responsive to this
RFA will be evaluated for scientific and technical merit by an initial
review group that will be convened solely to review these applications.
Applications judged by the NIA to be non-responsive (those not directed
at the goals of this RFA) will be returned to the applicant without
review.  Applications may first receive a preliminary review by a
subcommittee of the review panel to establish those applications deemed
to be competitive.  Those applications judged non-competitive will be
so designated, and an abbreviated summary statement noting the major
areas of concern will be sent to the Principal Investigator.
Applications judged to be competitive will be given full review.
Following review by the initial review group, the applications will be
considered by the National Advisory Council on Aging.
 
The factors to be considered in the evaluation of the scientific merit
of each application will be the responsiveness to the intent of this
RFA, and those factors used in the review of traditional
research-project grant applications and the past record of performance
in biomarkers of aging research.  Awards will be made on the basis of
scientific merit and the need to fund applications that provide a broad
spectrum of potential biomarkers.
 
APPLICATION PROCEDURES
 
The research grant application form PHS 398 (rev. 10/88, reprinted
9/89) must be used in applying for these grants.  These forms are
available at most institutional business offices; from the Office of
Grants Inquiries, Division of Research Grants, National Institutes of
Health, 5333 Westbard Avenue, Room 449, Bethesda, MD  20892, telephone
301/496-7441; and from the NIH program administrator named below.
 
The RFA label available in the 10/88-9/89 revision of PHS 398
application form must be affixed to the bottom of the face page.
Failure to use this label could result in delayed processing of the
application such that it may not reach the review committee in time for
review.  In addition, the RFA title, "Development of Biomarkers of
Aging" and number must be typed on line 2 of the face page of the
application form and check the YES box.
 
Submit a signed typewritten original of the application, including the
Checklist, and four signed, exact 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:
 
Chief SRO/OEA
National Institute on Aging
7201 Wisconsin Avenue
Bethesda, MD  20892
 
Applications must be received by February 19, 1992.  If an application
is received after that date, or if it is incomplete, it will be
returned to the applicant.  Additional or revised material will not be
accepted after the receipt date.  Also, the DRG will not accept any
application in response to this announcement that is essentially the
same as one currently pending initial review, unless the applicant
withdraws the pending application.  Nor will the DRG accept any
application that is essentially the same as one already reviewed.  This
does not preclude the submission of substantial revisions of
applications already reviewed, but such applications must include an
introduction addressing the previous critique.
 
LETTER OF INTENT
 
Prospective applicants are encouraged to submit to the program
administrator indicated below a non-binding letter of intent to apply,
post-marked no later than December 16, 1991, 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 this RFA.  The letter of intent is not mandatory and does not
influence the review or funding decisions, but it will enable the NIA
to plan the review.
 
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 to:
 
Richard L. Sprott, Ph.D.
Associate Director, BAP
National Institute on Aging
7201 Wisconsin Avenue
Bethesda, MD  20892
Telephone:  (301) 496-4996
 
Direct inquiries regarding fiscal matters to:
 
Ms. Mary Burton
Grants Management Specialist, GCMO
National Institute on Aging
7201 Wisconsin Avenue
Bethesda, MD  20892
Telephone:  (301) 496-1472
 
AUTHORITY AND REGULATIONS
 
This program is described in the Catalog of Federal Domestic
Assistance, No. 93.866, Aging Research.  Awards are made under
authorization of the Public Health Service Act, Title IV, Part A
(Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and
285) and administered under PHS grants policies and Federal Regulations
42 CFR Part 52 and 45 CFR Part 74.  This program is not subject to the
intergovernmental review requirements of Executive Order 12372 or
Health Systems Agency review.
 
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