Subject: NIH GUIDE - RFA DK/HD-92-01 - V20(33) 09/06/91
From: Dot Baker <[email-masked]>
To: [email-masked]
Date: Mon, 09 Sep 91 09:26 EST

Hi Paul,
This is #6 of the RFAs for 910906 NIH Guide.
Please post this one as:
RFADKHD-92-01.910906.
More to follow.
            Thanks, M. G. Broaddus
 ---------------------------- Text of forwarded message -----------------------
$$XID RFA DKHD9201 DK/HD-92-01 P1O1 ************************************
 
REQUEST FOR APPLICATIONS
 
RFA:  DK/HD-92-01
 
ENDOCRINOLOGY OF BODY COMPOSITION
 
P.T. 34; K.W. 0785050, 0760025, 0760020, 0715006
 
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:  February 14, 1992
 
PURPOSE
 
The Division of Diabetes, Endocrinology, and Metabolism of the National
Institute od Diabetes and Digestive and Kidney Diseases (NIDDK) and the
Endocrinology, Nutrition and Growth Branch of the National Institute of
Child Health and Human Development (NICHD) encourage
investigator-initiated research grant (R01) applications for support of
basic and clinical studies on the role of both endogenous and
administered hormones in the determination of body composition.
 
DISCIPLINES AND EXPERTISE
 
Interdisciplinary approaches may be needed for the proposed studies.
Specific expertise is required in endocrinology and some of the
following areas:  cell and molecular biology, exercise physiology,
clinical epidemiology, nutrient metabolism, pharmacology, and steroid
biochemistry.
 
BACKGROUND
 
Growth hormone levels are reduced and secretory response to growth
hormone releasing factor is blunted in obese subjects and in some but
not all older subjects.  These findings and a recent report that growth
hormone administration to a selected small group of elderly men
increased bone density and lean body mass, and reduced adiposity, led
some to suggest that growth hormone treatment may have potential
beneficial effects in the elderly.  However, significant questions about
risks and benefits of growth hormone treatment in elderly men remain to
be answered, as do questions about a possible role of growth hormone
administration in older women, growth hormone deficient adults, burn
victims, and other conditions associated with increased catabolism.
 
Many hormones may be involved in the determination of body composition.
Total testosterone levels are inversely correlated with degree of
obesity in obese males.  Excess glucocorticoid secretion is associated
with Cushingoid fat deposition and gonadal steroids may be involved in
male or female pattern obesity.  Caloric intake directly affects serum
triiodothyronine levels, and hypothyroidism is sometimes but not always
associated with obesity.  Thus, there is a clear link between a number
of hormones and body composition, yet the precise roles of these
hormones in the regulation of body composition have yet to be
elucidated.  Much of the work examining the effects of exogenous steroid
or growth hormone administration has been performed in agriculturally
significant animal models.  A precise understanding of the endocrine
regulation of body composition in humans, and of other health outcomes
relating to intervention in this system, is critical to a wide range of
clinically and ethically significant issues.
 
The recent rise in abuse of so called performance enhancing drugs by
athletes and more recently by teenagers wishing to improve their
appearance has focussed attention on the physiologic role of these
hormones in determining body composition, on metabolism, and on athletic
performance.  Variable results have been reported on the effects of
treatment with high dose anabolic steroids and/or growth hormone on
muscle mass and athletic performance.  There is some evidence to suggest
that in combination with a strenuous exercise regimen and high protein
diet, anabolic steroids can improve strength.  Although there are clear
adverse consequences of androgenic steroid and/or growth hormone abuse,
the possibility of increased performance or improved appearance
continues to attract large numbers of young athletes and non-athletes.
A precise understanding of the effects of these hormones on peri- and
post-pubertal growth, metabolism, body composition and performance is a
requisite part of any attempt to stem the abuse of these drugs.
 
The balance between nutrient intake and energy expenditure in normal
individuals is influenced by a number of determinants such as age,
exercise, gender, and nutrient type.  Against this background, the role
and mechanisms of hormones such as growth hormone, thyroid hormone,
anabolic and other steroids, and locally or systemically acting growth
factors in determining body composition require elucidation and are the
subjects of this announcement.
 
OBJECTIVES
 
Applications generated in response to this announcement must be directed
toward an understanding of:  1.) the effects of hormones administered to
athletes and others as performance or image enhancing agents (i.e.,
growth hormone or anabolic steroids), or:  2.) the role of growth
hormone and/or other hormones in the maintenance of normal body
composition, or in the etiology of disorders of body composition, such
as obesity, or:  3.) the effects of exercise and/or diet on the
endocrine system.
 
SCOPE
 
Some examples of research topics that would be considered responsive to
this announcement include the following:
 
o effects of recombinant human growth hormone (rhGH), thyroid hormone,
insulin-like growth factors, anabolic and other steroids or other
hormones on carbohydrate, fat, protein, and mineral metabolism;
 
o relationship between growth hormone levels and loss of lean body mass
with age;
 
o effects of rhGH therapy in specific populations including the elderly,
growth hormone deficient adults, burn victims, and other conditions
associated with increased catabolism;
 
o the effects of drugs used for performance or image enhancement, such
as anabolic steroids or growth hormone, on body mass and composition,
metabolic function, athletic performance, strength and/or growth and
development;
 
o identification of other short- or long-term effects of anabolic
steroids or growth hormone on the endocrine, immune, or reproductive
systems, behavior, neoplasia, or other parameters;
 
o the effects of exercise on growth hormone, androgenic steroid, or
other hormone levels;
 
o the role of hormones in the etiology of obesity or in determining the
obese phenotype (upper or lower body obesity); identification of sites
or mechanisms of neuroendocrine control of lean body mass at the
molecular or cellular level.
 
These areas of interest are not listed in any particular order nor do
they represent a comprehensive inventory of research topics that would
be fostered under this program announcement.  Applicants are encouraged
to propose research in other areas, but must clearly address the broad
program objectives stated above.  Although work proposed may utilize
human or animal models, or cell lines, the goal of the research should
be an understanding of the endocrine processes involved in the
regulation of body composition or metabolism in humans.
 
MECHANISM OF SUPPORT
 
The mechanism of support for this program will be the grant-in-aid
(RO1).  The regulations (Code of Federal Regulation, Title 42, Part 52
and, as applicable to the State and local Governments, Title 45, Part
74) and policies that govern the research grant programs of the National
Institutes of Health will prevail.
 
The NIDDK plans to support approximately five applications and the NICHD
plans to support two to three applications submitted in response to this
solicitation; however, the specific number to be funded will depend upon
the overall merit, the scope of the applications received, and
availability of funds.  Up to $1.4 million for first-year expenses, and
additional expenses for up to five years, will be committed to fund
applications submitted in response to this RFA.  Although this
solicitation is included in the sponsoring Institutes funding plans for
Fiscal Year 1992, support for this solicitation is contingent upon
receipt of appropriated funds for this purpose.  Since a variety of
approaches would represent valid responses to this solicitation, it is
anticipated that there will be a range of costs among individual grants
awarded.  However, prudent principles of cost-containment must be
applied.  With respect to post-award administration, the current
policies and requirements that govern the research grant programs of the
NIH as described in the PHS Grants Policy Statement will prevail.
 
REVIEW PROCEDURES AND CRITERIA
 
Assignment of applications
 
Upon receipt, applications will initially be reviewed by the Division of
Research Grants (DRG) for completeness.  Incomplete applications will be
returned to the applicant without further consideration.  Applications
will be reviewed by program staff for their responsiveness to the
objectives of this RFA.  If an application is considered unresponsive,
the applicant will be contacted and given an opportunity to withdraw the
application or have it considered for the grant program of the NIH.  If
the application submitted in response to this RFA is substantially
similar to a grant application already submitted to the NIH for review,
but has not yet been reviewed, the applicant will be asked to withdraw
either the pending application or the new one.  Simultaneous submission
of identical applications will not be allowed, nor will essentially
identical applications be reviewed by different review committees.
Therefore, an application cannot be submitted in response to this RFA
that is essentially identical to one that has already been 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.
 
Review Procedures
 
Applications in response to this RFA will be reviewed on a nationwide
basis and in accord with the usual NIH peer review procedures.
Applications will first be reviewed for scientific and technical merit
by an Initial Review Group that will be convened by the Review Branch,
Division of Extramural Activities, NIDDK.  This group will be composed
primarily of non-federal scientific consultants.  The applications will
then be reviewed by the National Diabetes and Digestive and Kidney
Disease Advisory Council and the National Advisory Child Health and
Human Development Council.  If the number of applications is large
compared to the number of awards to be made, the NIH may conduct a
preliminary scientific peer review to eliminate those applications that
are clearly not competitive.  The NIH will administratively withdraw
from competition those applications judged to be noncompetitive and
notify the applicant and institutional business official.
 
Review Criteria
 
Review criteria include the extent of relevance and/or contribution of
the proposed research to the overall goals and objectives of the RFA;
the novelty, originality, and feasibility of the approach; the training,
experience, and research competence of the investigator(s); the adequacy
of the experimental design; the suitability of the facilities; and the
appropriateness of the requested budget to the work proposed.
 
METHODS OF APPLYING
 
Letter of Intent
 
Prospective applicants are encouraged to submit an optional letter of
intent, that includes the title of the proposed project and
identification of all participating institutions.  Such letters are
requested only for the purpose of obtaining an indication of the number
and scope of applications to be received.  A letter of intent is not
binding, and it will not enter into the review of the application
subsequently submitted.  This letter is to be received no later than
January 15, 1991, and is to be sent to the program representative listed
under INQUIRIES.
 
Format for Applications
 
Applications must be submitted on form PHS 398 (rev. 10/88) that is
available from an applicant institution's Office of Sponsored Research
and from the Office of Grants Inquiries, Division of Research Grants,
National Institutes of Health, Westwood Building, Room 449, 5333
Westbard Avenue, Bethesda, MD 20892, telephone (301) 496-7441.
Applicants must use the conventional format for research project grant
applications and ensure that the points identified in this announcement
are fulfilled.  To identify the application as a response to this RFA,
check "yes" on item two of page one of the application and enter the
title "Endocrinology of Body Composition" and the RFA Number
DK/HD-92-01.
 
The RFA label included in the PHS 398 application kit 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.
 
As is the case with research project grant applications, applicants are
requested to furnish their own estimates of the time required to achieve
the objectives of the proposed research project.  At the end of the
initial award period, renewal applications may be submitted for further
competitive review through the investigator-initiated research grant
program of the NIH.
 
Application Procedures
 
The original and four copies of the application must be sent or
delivered to:
 
Application Receipt Office
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**
 
Two additional copies of the application must be sent under separate
cover to:
 
Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
National Institutes of Health
Westwood Building, Room 406
Bethesda, MD  20892
 
Timetable
 
A letter of intent is requested by January 15, 1992.  Applications must
be received by February 14, 1992.  Any applications not received by this
date will be considered ineligible for this special solicitation.
 
APPLICATION      INITIAL           COUNCIL       EARLIEST
RECEIPT          REVIEW            REVIEW        START DATE
 
Feb 14, 1992     May, June 1992    Sept 1992     Dec 1, 1992
 
SPECIAL INSTRUCTIONS TO APPLICANTS
 
HEATHY PEOPLE 2000
 
The Public Health Service urges applicants to submit work plans that
address specific objectives of "Heathy People 2000."  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, D.C. 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
 
NIH policy is that applicants for clinical research grants and
cooperative agreements 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 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 should
be provided.
 
The composition of the proposed study population must be described in
terms of gender and racial/ethnic group, together with a rationale for
its choice.  In addition, gender and racial/ethnic issues should be
addressed in developing a research design and sample size appropriate
for the scientific objectives of the study.  This information should be
included in the form PHS 398 in Section 2, A-D of the Research Plan AND
summarized in Section 2, E, Human Subjects.
 
Applicants/offerors 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 should be provided.
 
For the purpose of this policy, clinical research includes 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.
 
INQUIRIES
 
For further information, investigators are encouraged to contact the
following individuals:
 
NIDDK
 
Philip F. Smith, Ph.D.
Director, Endocrinology Research Program
Division of Diabetes, Endocrinology, and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
National Institutes of Health
Westwood Bldg, Room 603
Bethesda, MD  20892
Telephone:  (301) 496-7341
 
Bruce R. Butrum
Grants Management Specialist
Grants Management Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
National Institutes of Health
Westwood Bldg, Room 649
Bethesda, MD  20892
Telephone:  (301) 496-7467
 
NICHD
 
Gilman D. Grave, M.D.
Chief, Endocrinology, Nutrition and Growth Branch
Center for Research for Mothers and Children
National Institute of Child Health and Human Development
National Institutes of Health
Executive Plaza North, Room 637
Bethesda, MD  20892
Telephone:  (301) 496-5593
 
E. Douglas Shawver
Grants Management Branch
Office of Grants and Contracts
National Institute of Child Health and Human Development
National Institutes of Health
Executive Plaza North, Room 505
Bethesda, MD  20892
Telephone:  (301) 496-1303
 
This program is described in the Catalog of Federal Domestic Assistance
93.846; No. 93.847, Diabetes, Endocrinology, and Metabolism; and No.
93.855, Research for Mothers and Children.  Awards will be made under
the authority of the Public Health Service Act, Title III, Section 301
(Public Law 78-410, as amended; 42 USC 241) 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.