Received: from JNET-Daemon by UNCVX1.BITNET; Fri, 15 Nov 91 09:02 EDT
Received: From UNC(MAILER) by UNCVAX1 with Jnet id 0075 for PJONES@UNCVAX1;
 Fri, 15 Nov 91 09:02 EST
Date: Fri, 15 Nov 91 09:02 EST
From: Dot Baker <UNCDOT@UNC.BITNET>
Subject: NIH GUIDE - RFA DK/HD-92-06 - V20(43) 11/15/91
To: pjones@UNCVX1.BITNET

Hi Paul,
   Another to be posted to the NIH Listserver.  Please post as:
       RFADK/HD-92-06.911115
                            Foyyir
 ---------------------------- Text of forwarded message -----------------------
 
$$XID RFA DKHD9206 DK/HD-92-06 P1O1 ************************************
 
OBESITY/NUTRITION RESEARCH CENTERS
 
RFA:  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 National Institute of Child Health and Human Development
(NICHD) invite applications for Obesity/Nutrition Research Centers
(Core Centers: P30) for conducting basic and clinical research on
obesity and 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.
 
BACKGROUND
 
These research centers will combat the serious public health problem of
obesity and capitalize on emerging research opportunities in obesity
and nutrition research.  The Core Center (P30) approach has been shown
to be a unique and effective mechanism to foster and strengthen the
research base related to obesity within a broad nutritional science
context.  An Obesity/Nutrition Research Center will provide an
integrated array of research, shared resources, educational, clinical
and training opportunities that are oriented towards treatment and
prevention of obesity and eating disorders; understanding, control, and
modulation of energy metabolism in obesity; and understanding and
treatment of disorders associated with abnormalities of energy balance
and weight management such as in anorexia nervosa, AIDS and cancer.
The research core center grant is awarded to facilitate coordination
and strengthen the basis of these research activities primarily by
providing funding for core facilities and associated staff that serve
the various projects of the center on a shared basis.
 
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 that 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.
 
Applicants from institutions that have a General Clinical Research
Center (GCRC) funded by the NIH National Center for Research Resources
may wish to identify the GCRC as a resource for conducting the proposed
research.  In such a case, a letter of agreement from either the GCRC
program director or Principal Investigator must be included with the
application.
 
ELIGIBILITY
 
Nonprofit institutions within the United States may apply for the
Obesity/Nutrition Research Centers.  The Obesity/Nutrition Research
Center must be an identifiable unit within a single university or
consortium of cooperating institutions.  There must be in existence at
the applicant's institution an ongoing program of excellence in
biomedical basic and clinical research generally related to the study
of obesity.  The quality of the programs must be evident from the fact
that they have been awarded support through peer reviewed competition.
 
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-lead national activity for setting priorities.  This Request for
Applications (RFA), Obesity/Nutrition Research Centers, is related to
the priority areas of nutrition, physical activity and fitness, heart
disease and stroke, cancer, diabetes, and chronic disabling conditions.
Potential applicants may obtain a copy of "Healthy People 2000" (Full
Report:  Stock No 017-001-00474-0, or Summary Report:  Stock No
017-001-00473-1) through the Superintendent of Documents, Government
Printing Office, Washington, DC  20402-9325 (telephone 202-783-3238).
SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH
POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDY POPULATIONS
 
The NIH policy is that applicants for clinical research grants will be
required to include minorities and women in study populations so that
research findings can be of benefit to all persons at risk of the
disease, disorder, or condition under study.  Special emphasis should
be placed on the need for inclusion of minorities in studies of
diseases that 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 and compelling rationale
should be provided.
 
The composition of the proposed study population must be described in
terms of gender or ethnic group, together with a rationale for its
choice.  In addition, gender and racial or ethnic issues should be
addressed in developing a research design and sample size appropriate
for the scientific objectives of the study.  This information should be
included on grant application form PHS 398 in Sections 2A-D of the
Research Plan AND summarized in Section 2E (Human Subjects).
 
Applicants are urged to carefully assess 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 or 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 should
be provided.
 
For the purpose of this policy, clinical research includes human
biomedical and behavioral studies or 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 addresses by applicants.
 
If the required information is not contained within the application,
the application will be returned.
 
Peer reviewers will specifically address whether the research plan in
the application conforms to these policies.  If the representation of
women and 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 a 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
that do not comply with these policies.
 
MECHANISM OF SUPPORT
 
Support of this program will be by the Core Center Grant (P30)
mechanism.  The underpinning of each core center program must be a
broad base of nutritional sciences research including a critical mass
of obesity research activity.  The Core Center grant is a mechanism
designed to enhance and extend the effectiveness of a group of related
projects and investigators that are already funded through other
mechanisms such as NIH Research Project Grants (R01), First Independent
Research Support and Transition Awards (R29), Research Program Projects
(P0l), Individual Post-doctoral Fellowships (F32), Institutional
Training Grants (T32), and peer reviewed research grants supported by
other Federal or non-Federal sources.  The Core Center grant mechanism
builds upon an established research base that emphasizes common themes
or areas of interest.  The Core Center grant may provide funds for:
 
(1) research cores such as units for body composition analyses, energy
expenditure, cell culture, cell and molecular biology, clinical studies
or nutrient analyses. These cores must be utilized by already funded
projects of two or more center participants;
 
(2) pilot/feasibility projects that encourage new investigators or
established investigators from other fields to pursue new innovative
ideas to a point where they can compete for independent support;
 
(3) temporary salary support to one named, new investigator, usually
for 24 months, in specified areas of research complementary to ongoing
activities of the group and with an approved pilot/feasibility project;
 
(4) program enrichment funds to provide for small conferences or
symposia, advisory committee expenses, and special consultants.
Applicant institutions are encouraged to use the pilot/feasibility
projects and salary support for the new investigator as a resource to
further attract minority investigators to the field. Additionally, as
part of the program enrichment, consideration must be given to topics
pertaining to the concerns of minority populations.  Applicants must
indicate the intent in this regard in the application.
 
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.
 
All applications responsive to this announcement will be considered for
funding by the NIDDK; however, applications that are focused on obesity
in childhood and/or childhood antecedents of adult obesity will be
considered for funding by NICHD.  Joint NIDDK/NICHD support of
applications having a component focused on obesity in childhood and/or
childhood antecedents of adult obesity may be considered in lieu of an
Obesity/Nutrition Research Center dedicated solely to this area of
investigation.
 
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 the 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).  Application
kits are available at most institutional business offices and may be
obtained from the Office of Grants Inquiries, Room 449, Westwood
Building, Division of Research Grants, NIH, telephone 301/496-7441.
Check the "YES" box in line 2 of the application face page and insert
"OBESITY/NUTRITION RESEARCH CENTERS, RFA DK/HD-92-06."  The RFA LABEL
CONTAINED IN THE APPLICATION KIT MUST BE AFFIXED TO THE BOTTOM OF THE
FACE PAGE OF THE ORIGINAL COPY OF THE APPLICATION.  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.
 
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**
 
IMPORTANT:  At the time of submission, two additional copies of the
application must be sent under separate cover 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 received by March 25, 1992.  If an application is
received after that date, it will be returned to the applicant.
 
REVIEW PROCEDURES
 
Applications for Obesity/Nutrition Research Center Grants will be
evaluated by the NIH grant peer review process.  Applications will
initially be reviewed for scientific merit by a special review
committee convened by the NIDDK.  Applications will be reviewed
subsequently by either Institute's 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.  Applications are unlikely to be reviewed by a site
visit team; therefore, the written application must be complete so as
to facilitate review without a site visit.  Extensive additional
material submitted subsequent to the stated receipt date will not be
accepted.
 
RECEIPT AND REVIEW SCHEDULE
 
Letter of Intent Receipt Date (optional):  January 15, 1992
Application Receipt Date:                  March 25, 1992
Initial Review Date:                       June/July 1992
National Digestive Diseases
Advisory Council Review Date:              September 1992
Anticipated Award Date:                    September 1992
 
INQUIRIES
 
The general description and guidelines for the Obesity
Research/Nutrition Centers and additional consultation may be obtained
from:
 
TECHNICAL INFORMATION
 
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
 
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.

