Subject: NIH GUIDE - V20(35) 09/20/91 - P2/2
From: Dot Baker <[email-masked]>
To: [email-masked]
Date: Fri, 20 Sep 91 12:12 EST

Hi Paul,
This is part 2 of this week's NIH Guide.  Please post this one
to the NIH Listserver as:
NIHGUIDE2.910920
   Thanks, M. G. Broaddus
 ---------------------------- Text of forwarded message -----------------------
 
$$XID NIHGUIDE 19910920 V20N35 P2O2 ************************************
The Division of Research Grants, NIH, serves as a central point for
receipt of applications for most discretionary PHS grant programs.
Applications received under this announcement will be assigned to an
Initial Review Group (IRG) in accordance with established PHS
Referral Guidelines.  The IRG, consisting primarily of non-Federal
scientific and technical experts, will review the applications for
scientific and technical merit.  Notification of the review
recommendations will be sent to the applicant after the initial
review.  Applications will receive a second-level review by an
appropriate national advisory council whose review may be based on
policy considerations as well as scientific merit.
 
REVIEW CRITERIA
 
Criteria for scientific/technical merit review of applications will
include the following:
 
o  The overall significance and scientific and technical merit of the
proposed research.
 
o  The appropriateness and adequacy of the experimental design,
including the adequacy of the methodology proposed for collection and
analysis of data, including research schematics, detailed analytic
plans, and proposed instrumentation.
 
o  The adequacy of the qualifications (including level of education
and training) and relevant research experience of the Principal
Investigator and key research personnel.
 
o  The availability of adequate facilities, general environment for
the conduct of proposed research, other resources, and collaborative
arrangements necessary for the research.
 
o  The appropriateness of budget estimates for the proposed research
activities.
 
o  Where applicable, the adequacy of procedures to protect or
minimize possible adverse effects on human, animals, or the
environment.
 
o  Conformance of the application to the policy on inclusion of women
and minorities in study populations.
 
AWARD CRITERIA
 
Applications recommended for consideration by the National Advisory
Council on Alcohol Abuse and Alcoholism will be considered for
funding on the basis of overall scientific and technical merit of the
research as determined by peer review, NIAAA program needs and
balance, and availability of funds.
 
TERMS AND CONDITIONS OF SUPPORT
 
Grant funds may be used for expenses clearly related and necessary to
conduct research projects, including both direct costs that can be
specifically identified with the project and allowable indirect costs
of the institution.  Funds may not be used to establish, add a
component to, or operate a treatment, rehabilitation, or prevention
intervention service program.  Support for research-related
treatment, rehabilitation, or prevention services and programs may be
requested only for costs required by the research.  These costs must
be justified in terms of research objectives, methods, and designs
that promise to yield generalizable knowledge and/or make a
significant contribution to theoretical concepts.
 
INQUIRIES
 
Potential applicants are encouraged to seek preapplication
consultation and may contact the individuals listed below for
consultation in preparing an application under this announcement.
Direct inquiries relating to program issues to:
 
Treatment and Treatment Assessment:
 
Joanne Fertig, Ph.D.
Treatment Research Branch
Division of Clinical and Prevention Research
National Institute on Alcohol Abuse and Alcoholism
Parklawn Bldg., Room 14C-20
5600 Fishers Lane
Rockville, MD  20857
Telephone:  (301) 443-0796
 
Basic Etiology:
 
Sam Zakhari, Ph.D. or Walter Hunt, Ph.D.
Division of Basic Research
National Institute on Alcohol Abuse and Alcoholism
Parklawn Bldg., Room 16C-05
5600 Fishers Lane
Rockville, MD  20857
Telephone:  (301) 443-4223
 
Direct inquiries regarding fiscal matters to:
 
Elsie Fleming
Grants Management Branch
Office of Planning and Resource Management
National Institute on Alcohol Abuse and Alcoholism
Parklawn Building, Room 16-86
5600 Fishers Lane
Rockville, MD  20857
Telephone:  (301) 443-4703
 
AUTHORITY AND REGULATIONS
 
This program is described in the Catalog of Federal Domestic
Assistance No. 93.273.  Awards are made under the authority of
Sections 301 and 510 of the Public Health Service Act, as amended (42
USC 241 and 290bb).
 
Federal regulations at 42 CFR Part 52, "Grants for Research
Projects," and Title 45 CFR Parts 74 and 92, generic requirements
concerning the administration of grants, are applicable to these
awards.  This program is not subject to the intergovernmental review
requirements of Executive Order 12372 or Health Systems Agency
review.
 
$$P4 END *************************************************************
 
$$P5 BEGIN PA-91-99 **************************************************
 
STUDIES ON OBESITY
 
PA:  PA-91-99
 
P.T. 34; K.W. 0715145, 0710095, 0765020
 
National Institute of Diabetes and Digestive and Kidney Diseases
National Heart, Lung, and Blood Institute
National Institute of Child Health and Human Development
National Cancer Institute
National Institute on Aging
National Center for Nursing Research
National Institute of Neurological Disorders and Stroke
National Institute of Arthritis and Musculoskeletal and Skin Diseases
National Institute on Deafness and Other Communication Disorders
National Institute of Mental Health
 
BACKGROUND INFORMATION
 
Research on the biomedical and behavioral aspects of obesity is an
important component of the NIH nutrition research program.  Obesity
is widely prevalent in the United States, affecting both children and
adults.  Data on body mass index from the second National Health and
Nutrition Examination Survey (1976-80) indicated that 24 percent of
men and 27 percent of women were overweight (body mass index equal to
or greater than 27.8 for men and 27.3 for women).  The prevalence of
obesity in adults has not declined in the past three decades; some
data suggest that its prevalence in children has increased over this
time.  Obesity is particularly prevalent in minority populations,
especially among minority women.  Obesity is multifactorial in
origin, reflecting inherited, environmental, cultural, and
socioeconomic conditions.
 
Obesity is associated with elevated serum cholesterol levels,
elevated blood pressure, and noninsulin-dependent diabetes, and is an
independent risk factor for coronary heart disease.  It also
increases the risk for gallbladder disease and some types of cancer
and has been implicated in the development of osteoarthritis of the
weight-bearing joints.  Obesity acquired during childhood or
adolescence often persists into adulthood and increases the risk for
some chronic diseases later in life.
 
The great prevalence of obesity and its physical and mental health
consequences make its prevention and treatment a public health
priority.
 
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 program
announcement 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 free
of charge a copy of "Healthy People 2000" (Full Report:  No. 017-001-
474-0, 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).
 
RESEARCH GOALS AND SCOPE
 
The emphasis of this program announcement is the support of research
on the biomedical and behavioral aspects of exogenous obesity.  The
goals of this research, which includes basic, clinical, and
population research, are to establish a clear understanding of the
etiology, prevention, and treatment of this multifaceted condition.
For example, the determinants of obesity during the early stages of
the life cycle need to be identified in order to prevent the onset of
obesity early in life and to identify individuals at high risk of
becoming obese later in life.  Preventive therapies, as well as
successful treatment regimens, need to be designed.  In order to
accomplish these goals, further research is needed on the behavioral
and developmental aspects of obesity in terms of its natural history
and determinants in infancy, childhood, and adolescence; on the
molecular, metabolic, genetic, and neurological aspects of obesity;
on the successful treatment of obesity; and on the effects of obesity
on health and longevity.  A major question with respect to the health
implications of obesity is determining the relative roles of body
composition, body fat, and the regional distribution of body fat in
the morbidity and mortality attributed to obesity.  There is also the
need to learn more about adipose tissue morphology as a determinant
of the pattern of fat distribution and the impaired health and
shortened life span associated with the obese state.  Finally, more
information is needed to support health-based standards of desirable
weight for various age, sex, and ethnic groups.
 
Examples of research areas in obesity of particular interest include,
but are not limited to, the following:
 
Molecular, Metabolic, and Genetic Factors
o  Mechanisms by which obesity contributes to the development of
diseases such as diabetes, coronary heart disease, hypertension, and
cancer, as well as possible differences in such mechanisms among
different ethnic groups.
 
o  The contribution of genetic and metabolic factors to obesity,
including the molecular and genetic basis of energy metabolism and
the nature of genetic aberrations in human obesity.
 
o  Interactions of genetic and environmental factors, as well as
dietary, behavioral, and social factors, in the etiology of obesity
and their effects on the ability to lose weight successfully.
 
o  The contribution of muscle metabolism to energy balance.
 
o  Methods for measuring body fat distribution and determining its
effects on disease.
 
o  Hypometabolism and factors that influence energy expenditure.
 
o  Influence of gestational diabetes on subsequent weight gain of
offspring.
 
o  Role of nutrient composition of the diet in energy balance.
 
Neurological and Endocrine Factors
 
o  The neurophysiology of ingestive behavior, including an
understanding of the mechanisms of anorexia.
 
o  Central nervous system/hypothalamic/autonomic nervous system
(including sympathetic nervous system) control of energy intake and
expenditure, including the neuroanatomical organizations and pathways
that control food intake and the behavioral, hormonal, and metabolic
mechanisms by which such pathways influence satiety mechanisms and
body weight.
 
o  Role of the brain in mediating acquisition, extinction, and
aversion of associations to gustatory, olfactory, and trigeminal
stimulation.
 
o  Neuroanatomical pathways connecting the gastrointestinal system to
the hypothalamus, and the effect of changes in the gastrointestinal
system on the electrophysical activity in the hypothalamus.
 
o  Functional and structural alterations in the brain resulting from
changes in food intake in animals, as well as gustatory, olfactory,
and trigeminal stimulation.
 
o  Neurological mechanisms of taste, smell, and common chemical
reception in a variety of animal models.
Behavioral and Developmental Factors
 
o  Behavioral interventions to prevent and treat obesity at all ages
and in various population groups, including minority populations.
 
o  Behavioral change strategies for weight loss and to prevent
relapse after weight loss.
 
o  Application of the techniques of behavioral neuroscience to the
prevention and treatment of obesity.
 
o  Mechanism of action of reinforcers of food intake and physical
activity.
 
o  Sensory-specific studies of habituation phenomena.
 
o  Genetic/environmental/behavioral interactions.
 
Treatment of Obesity
 
Due to the serious health implications of obesity, research must
continue to find successful measures to treat obesity and to prevent
its recurrence.  Various treatments that need to be examined include
the use of hypocaloric regimens, the effects of exercise alone or in
combination with caloric restriction on metabolism and subsequent
weight loss, and behavioral therapies.  Such treatments need to be
examined across the various stages of the life cycle and in different
risk groups.  Treatment outcomes, including regression of risk
factors and effects on other medical disorders, need to be examined,
including:
 
o  Treatment models and efficacy in various age groups and in
minority populations.
 
o  Influence of duration of obesity on adverse health effects and
response to intervention.
 
o  Effects of weight cycling on cardiovascular risk factors, fat
patterning, and other physiological measures.
 
o  The effect of mild exercise on appetite and the role of exercise
in weight control.
 
o  Mechanism of action and efficacy of pharmacologic agents in energy
balance and weight control.
 
Prevention of Obesity
 
o  Research emphasis on preventing obesity in children, adolescents,
and adults and encouraging healthy active lifestyle at all ages.
 
o  Interventions to reduce sedentary behavior.
 
o  Evaluation of prevention strategies targeted at specific racial,
ethnic, and socioeconomic high-risk groups.
 
SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH
POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDY POPULATIONS
 
National Institutes of Health (NIH) policy is that applicants for NIH
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 and racial 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 addressed by applicants.
 
For foreign awards, the policy on inclusion of women applies fully;
since the definition of minority differs in other countries,
applicants must discuss the relevance of research involving foreign
population groups to the United States' populations, including
minorities.
 
If the required information is not contained within the application,
the application will be returned.
 
Peer reviewers will specifically address 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 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
 
The mechanism of support for this program will be the grant-in-aid
(RO1 and R29).  The regulations (Code of Federal Regulations, Title
42, Part 52 and Title 45, Part 74) and policies that govern the
research grant programs of the Public Health Service will prevail.
The award of grants pursuant to this request for grant applications
is contingent upon ultimate receipt of appropriated funds for this
purpose.
 
The NIH requires applicants for grants to give added attention (where
feasible and appropriate) to the inclusion of minority groups and/or
women in the study populations for research.  For proposed
population-based studies that do not include women and/or minorities,
a clear rationale for not including either or both must be provided.
 
METHOD AND CRITERIA OF REVIEW
 
Assignment of Application:  Applications will be received by the
Division of Research Grants (DRG), NIH, referred to an appropriate
study section for scientific review, and assigned to individual
Institutes for funding consideration. These decisions will be
governed by customary programmatic considerations as specified in the
DRG Referral Guidelines.
 
Review Procedures:  Applications in response to this announcement
will be reviewed in competition with other applications received in
the same review cycle, and in accord with the customary NIH peer
review procedures.  The initial review for scientific and technical
merit will be by a review group composed mostly of non-Federal
scientific consultants (study section).  Following study section
review, the application will be evaluated by the appropriate
Institute Advisory Council or Board with respect to the adequacy of
the technical merit review and the program relevance of the research
proposed.  The review criteria customarily employed by the NIH PHS
for research grant applications will prevail.
 
Deadlines:  Applications will be accepted in accordance with the
usual receipt dates for new applications:  October 1, February 1, and
June 1.

 
METHOD OF APPLYING
 
Applications should be submitted on form PHS 398 (rev. 10/88) that is
available in the business or grants and contracts office at most
academic and research institutions and from the Office of Grants
Inquiries, Division of Research Grants, NIH, Westwood Building, Room
449, Bethesda, MD 20892, telephone (301) 496-7441.  In line 2 on the
face page of the application, the phrase, "Studies on Obesity" must
be inserted.
 
For further information, investigators are encouraged to contact one
or more of the following individuals:
 
Van S. Hubbard, M.D., Ph.D.
Director, Obesity, Eating Disorders and Energy Regulation Program
National Institute of Diabetes and Digestive and Kidney Diseases
National Institutes of Health
Westwood Building, Room 3A18B
Bethesda, MD  20892
Telephone:  (301) 496-7823
 
Eva Obarzanek, Ph.D., M.P.H., R.D.
Prevention and Demonstration Research Branch
Division of Epidemiology and Clinical Applications
National Heart, Lung, and Blood Institute
Federal Building, Room 604
Bethesda, MD  20892
Telephone:  (301) 496-2465
 
Gilman Grave, 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 637A
6130 Executive Boulevard
Rockville, MD  20892
Telephone:  (301) 496-5593
 
Carolyn K. Clifford, Ph.D.
Acting Chief, Diet and Cancer Branch
National Cancer Institute
Executive Plaza North, Room 212
6130 Executive Boulevard
Rockville, MD  20892
Telephone:  (301) 496-8573
 
Ann W. Sorenson, Ph.D.
Director, Nutrition Program
Biology of Aging Program
National Institute on Aging
Building 31, Room 5C21
Bethesda, MD  20892
Telephone:  (301) 496-6402
 
June Lunney, Ph.D., R.N.
Nurse Scientist Administrator
National Center for Nursing Research
Building 31, Room 5B03
Bethesda, MD  20892
Telephone:  (301) 496-0523
 
Kenneth Surrey, Ph.D.
Division of Demyelinating, Atrophic, and Dementing Disorders
National Institute of Neurological Disorders and Stroke
Federal Building, Room 802
Bethesda, MD  20892
Telephone:  (301) 496-1431
 
Joan A. McGowan, Ph.D.
Bone Biology and Bone Diseases Program
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Westwood Building, Room 403
Bethesda, MD  20892
Telephone:  (301) 496-7496
 
Jack Pearl, Ph.D.
Health Scientist Administrator
National Institute on Deafness and Other Communication Disorders
Executive Plaza South, Room 400B-12
6120 Executive Boulevard
Rockville, MD  20892
Telephone:  (301) 496-5061
 
Susan J. Blumenthal, M.D., M.P.A.
Chief, Behavioral Medicine Program
National Institute of Mental Health
Parklawn Building, Room 11C06
5600 Fishers Lane
Rockville, MD  20857
Telephone:  (301) 443-4337
 
Contacts for fiscal and administrative inquiries:
 
Paulette S. Badman
Grants Management Specialist
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 639C
Bethesda, MD  20892
Telephone:  (301) 496-7467
 
Marie Willett
Grants Operations Branch
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
Westwood Building, Room 4A11C
Bethesda, MD  20892
Telephone:  (301) 496-7536
 
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
 
Eileen Natoli
Team Leader, Grants Administration Branch
National Cancer Institute
Executive Plaza South, Room 243
6120 Executive Boulevard
Rockville, MD  20892
Telephone:  (301) 496-7800 ext. 56
 
Carol Combs
Biology of Aging Program
National Institute on Aging
Building 31, Room 5C15
Bethesda, MD  20892
Telephone:  (301) 496-4996
 
Sally A. Nichols
Grants Management Officer
Office of Administrative Management
National Center for Nursing Research
Building 31, Room 5B06
Bethesda, MD  20892
Telephone:  (301) 496-0237
 
Patricia Driscoll
Grants Management Branch
Division of Extramural Activities
National Institute of Neurological Disorders and Stroke
Federal Building, Room 1004
Bethesda, MD  20892
Telephone:  (301) 496-9231
 
Carol Clearfield
Grants Management Specialist
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Westwood Building, Room 403
Bethesda, MD  20892
Telephone:  (301) 496-7495
 
Sharon Hunt
Grants Management Officer
Division of Extramural Activities
National Institute on Deafness and Other Communication Disorders
Executive Plaza South, Room 400-B
6120 Executive Boulevard
Rockville, MD  20892
Telephone:  (301) 402-0909
 
Bruce L. Ringler
Chief, Grants Management Branch
National Institute of Mental Health
5600 Fishers Lane, Room 7C-15
Rockville, MD  20857
Telephone:  (301) 443-3056
 
This program announcement replaces a previous one published in the
NIH Guide for Grants and Contracts, Vol. 13, No. 4, March 30, 1984.
 
AUTHORITY AND REGULATIONS
 
This program is described in the Catalog of Federal Domestic
Assistance Nos. 93.848, 93.847, 93.837, 93.865, 93.393, 93.866,
93.854, 93.173, and 93.242.  Awards are made under the authorization
of the Public Health Service Act, Section 301 (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 74.  This program is not subject to the intergovernmental review
requirements of Executive Order 12372 or Health Systems Agency
review.
 
$$P5 END *************************************************************