Subject: NIH GUIDE January l8, l99l
From: Dot Baker <[email-masked]>
To: [email-masked]
Date: Wed, 16 Jan 91 14:18 EST

Hi Paul,
  This is the first of six items to be posted to the NIH Listserver
this week.
  Please post this as: NIHGUIDE.910118
                                      Dottie
 ---------------------------- Text of forwarded message -----------------------
 
X-comment: NIH Guide (including TOC) contained 11 pages (880 lines)
X-comment: RFAS described:  NS/AG-91-03, NR/AG-91-01, CA-91-06, AG-91-04, AG-
                           91-08

 

 
NIH GUIDE - Vol. 20, No. 3, January 18, 1991

                                   NOTICES

NATIONAL WORKSHOPS ON "PROTECTION OF HUMAN SUBJECTS" ...(84/204)............ 1
National Institutes of Health
Food and Drug Administration
Index:  NATIONAL INSTITUTES OF HEALTH
        FOOD AND DRUG ADMINISTRATION

SMALL GRANTS PROGRAM - REVISED GUIDELINES ..............(207/223)........... 2
National Heart, Lung, and Blood Institute
Index:  HEART, LUNG, BLOOD

                   NOTICES OF AVAILABILITY (RFPs AND RFAs)

ALZHEIMER'S DISEASE AND RELATED CEREBRAL DEGENERATIVE DISORDERS
(RFA NS/AG-91-03) ...............................(244/328, 884/1313)........ 3
National Institute of Neurological Disorders and Stroke
National Institute on Aging
Index:  NEUROLOGICAL DISORDERS, STROKE, AGING

MANAGEMENT OF ALZHEIMER'S DISEASE SYMPTOMS (RFA NR/AG-91-01) ............... 4
National Center for Nursing Research             (331/490, 1316/1802)
National Institute on Aging
Index:  NURSING RESEARCH, AGING

ANALYSES AND PHYSIOLOGY OF ANTICARCINOGENS IN SOYBEANS (RFA CA-91-06) ...... 6
National Cancer Institute                        (493/612, 1805/2213)
Index:  CANCER

SITES TESTING OSTEOPOROSIS PREVENTION/INTERVENTION TREATMENTS
(RFA AG-91-04) ..................................(615/733, 2215/2603)....... 7
National Institute on Aging
Index:  AGING

SITES TESTING OSTEOPOROSIS PREVENTION/INTERVENTION TREATMENTS:
COMPANION STUDIES OF PATHOPHYSIOLOGY AND MECHANISMS (RFA AG-91-08) ......... 9
National Institute on Aging                      (736/840, 2606/2869)
Index:  AGING

 

 

 

 

 

 

 

 
 
                                   NOTICES

NATIONAL WORKSHOPS ON "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 continuing to sponsor 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:
 
I.  WEST COAST WORKSHOP
 
DATES:  February 4-5, 1991
 
WORKSHOP SITE:
Meridien Hotel
50 Third Street
San Francisco, CA  94103
 
SPONSOR:
University of California at San Francisco
Box 0400
San Francisco, CA  94143
 
REGISTRATION CONTACT:
Ms. Phyllis Colbert
Workshop Contact Person
University of California at San Francisco
Box 0400
San Francisco, CA  94143
Telephone:  (415) 476-1881
 
TOPIC:  "The Use of Human Subjects in Research:  AIDS as a Model of
Complexity"
 
II.  MIDEAST WORKSHOP
 
DATES:  March 4-5, 1991
 
WORKSHOP SITE:
Friday Center
Laurel Hill Parkway
Chapel Hill, NC  27599-1020
 
SPONSORS:
University of North Carolina at Chapel Hill
300 Bynum Hall
Chapel Hill, NC  27599-4100
 
Shaw University
118 E. South Street
Raleigh, NC  27611
 
REGISTRATION CONTACT:
Mr. Al Dawson
Director
Friday Center
Laurel Hill Parkway
C. B. 1020
Chapel Hill, NC  27599-1020
Telephone:  (919) 962-1106
 
TOPIC:  "Interpreting the Federal Code for the Protection of Human Subjects"

 

 
            NIH GUIDE - Vol. 20, No. 3, January 18, 1991 - Page 1
III.  MIDWEST WORKSHOP
 
DATES:  April 11-12, 1991
 
WORKSHOP SITE:
Ramada Inn, Lakeshore
4900 South Lake Shore Drive
Chicago, IL  60615
 
SPONSORS:
University of Chicago
970 East 58th Street
Chicago, IL  60637
 
Chicago State University
95th Street at King Drive
Chicago, IL  60628
 
REGISTRATION CONTACT:
Mr. Arnold L. Aronoff
Associate Director
Faculty and Administrative Services
University Research Administration
University of Chicago
970 East 58th Street
Chicago, IL  60637
Telephone:  (312) 702-8669
 
TOPIC:  "Cultural Diversity, Ethics, and Research:  A Workshop on Human
Subject Protection"
 
NIH/FDA have planned national human subject protections workshops in other
parts of the United States.  For further information regarding these workshops
contact:
 
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

SMALL GRANTS PROGRAM - REVISED GUIDELINES
 
P.T. 34; K.W. 1014006
 
National Heart, Lung, and Blood Institute
 
The National Heart, Lung, and Blood Institute (NHLBI) announces the
availability of revised guidelines for the NHLBI Small Grants Program
originally announced in the NIH Guide for Grants and Contracts, Vol. 19, No.
7, February 16, 1990.  Copies are available from:
 
Director
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
Westwood Building, Room 7A17
Bethesda, MD  20892
Telephone:  (301) 496-7416

 

 

 

 

 
 
            NIH GUIDE - Vol. 20, No. 3, January 18, 1991 - Page 2
                   NOTICES OF AVAILABILITY (RFPs AND RFAs)

ALZHEIMER'S DISEASE AND RELATED CEREBRAL DEGENERATIVE DISORDERS
 
RFA AVAILABLE:  NS/AG-91-03
 
P.T. 34; K.W. 0715180, 0705010, 0710010, 1002030, 0755030, 0765033
 
National Institute of Neurological Disorders and Stroke
National Institute on Aging
 
Letter of Intent Receipt Date:  April 1, 1991
Application Receipt Date:  May 6, 1991
 
Background
 
The Division of Demyelinating, Atrophic, and Dementing Disorders of the
National Institute of Neurological Disorders and Stroke (NINDS) and the
Neuroscience and Neuropsychology of Aging Program of the National Institute on
Aging (NIA) jointly announce the availability of a Request for Applications
(RFA) on Alzheimer's Disease and Related Cerebral Degenerative Disorders.  The
NINDS and NIA are interested in enhancing the support of innovative research
projects designed to elucidate the etiology or pathogenesis of cerebral
degenerative disorders such as Alzheimer's disease, to improve diagnosis, and
eventually to provide sound bases for effective therapy.  Topics of interest
include studies in genetics, mechanisms of cell death, nerve growth factors,
animal modeling, neuroimaging, and various aspects of differential diagnosis.
Applications on related topics or other problem areas are also encouraged.
 
Mechanism of Support
 
The support mechanism for this program will be the regular research grant
(R01).  The Institutes expect to make at least 20 awards.
 
Review Procedures
 
All applications should be submitted on form PHS 398 (10/88 revision).
Applications judged by staff to be nonresponsive to the RFA will be
administratively withdrawn and returned to the applicant.  All applications
that are complete and responsive to this RFA will be evaluated by an NINDS
peer review group.  Applications judged competitive for award will be
subsequently reviewed by the National Advisory Neurological Disorders and
Stroke Council and the National Advisory Council on Aging.
 
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.
 
Method of Application
 
Applications must be received by May 6, 1991.  The review for scientific and
technical merit of applications judged responsive to the RFA will take place
in June/July 1991 and Council review will be in September 1991.  Awards will
begin prior to October 1, 1991.
 
Potential applicants may receive the full RFA by E-Guide or on request from:
 
Eugene J. Oliver, Ph.D.
Health Scientist Administrator
Division of Demyelinating, Atrophic, and Dementing Disorders
National Institute of Neurological Disorders and Stroke
National Institutes of Health
Federal Building, Room 806
Bethesda, MD  20892
Telephone:  (301) 496-1431
 
or

 

            NIH GUIDE - Vol. 20, No. 3, January 18, 1991 - Page 3
Carl D. B. Banner, Ph.D.
Program Director, Etiology of Alzheimer's Disease
Dementias of Aging Branch, NNA
National Institute on Aging
National Institutes of Health
Building 31, Room 5C35
Bethesda, MD  20892
Telephone:  (301) 496-9350

MANAGEMENT OF ALZHEIMER'S DISEASE SYMPTOMS
 
RFA AVAILABLE:  NR/AG-91-01
 
P.T. 34; K.W. 0715180, 0785035, 0404000
 
National Center for Nursing Research
National Institute on Aging
 
Letter of Intent Receipt Date:  April 8, 1991
Application Receipt Date:  May 20, 1991
 
The National Center for Nursing Research (NCNR) and the National Institute on
Aging (NIA) invite applications for R01 research proposals for preliminary
investigations that will lead to large-scale clinical studies on the
assessment and nonpharmacological management of secondary symptoms exhibited
by patients with Alzheimer's disease and related disorders (AD).  The
Alzheimer's Association is cooperating with NCNR and NIA in this Request for
Applications (RFA).
 
Estimates indicate that 4 million Americans presently suffer from Alzheimer's
disease or related dementias.  The impact of AD on patients, families, and
society is severe and is anticipated to grow as older persons, the group most
at risk for AD, continue to increase in number.  Although it may not yet be
possible to prevent, treat, or permanently alter the course of the underlying
disease, interventions can be developed and systematically tested that reduce
the patient's secondary symptoms and preserve function.  In addition to
cognitive symptoms, non-cognitive secondary symptoms, which are frequently
seen across the course of Alzheimer's disease and present significant
management problems, are of special concern.  These may include, but are not
limited to, wandering, disturbed sleep, pacing, agitation, feeding and
dressing difficulties, incontinence and toileting difficulties, screaming and
other vocalizations, aggression and violence, and inappropriate sexual
behavior.  These symptoms not only contribute to decisions to institutionalize
affected individuals, but also lead to the use of chemical and physical
restraints.
 
While there exists a great deal of clinical and anecdotal information about
methods that can effectively deal with individual symptoms, little data exist
that have been obtained with the rigor of design and procedures of the
controlled clinical trial.  Therefore, applications are solicited for
preliminary investigations and feasibility studies that will lay the
groundwork for the development of rigorously controlled clinical trials to
test interventions for the management of the secondary symptoms.  Applications
are invited for support of projects to address issues including, but not
limited to:
 
  o  the identification of underlying factors in research subjects that
     result in behavioral symptoms and methods to address these factors.
 
  o  the development of preliminary work and early investigations that
     will lead to the nonpharmacologic management and treatment of the
     secondary symptoms exhibited by patients with Alzheimer's disease
     and related disorders.
 
  o  provision of a rigorous scientific base that will lead to
     controlled clinical trials in institutional or noninstitutional
     settings by delineating approaches for the management of symptoms,
     the duration of change, and the procedures required to maintain the
     change, if possible.
 
  o  development of instruments to assess behavioral problems and
     monitor changes.
 
  o  careful scientific observations of the natural history/ clinical
     course of the behavioral changes that occur during the progression
     of Alzheimer's disease.

            NIH GUIDE - Vol. 20, No. 3, January 18, 1991 - Page 4
MECHANISM OF SUPPORT
 
NCNR and NIA are allocating up to $75,000 in direct costs for each award for
each funding year, not to exceed three years.  The intent is to fund ten to
fifteen R01 grants by September 30, 1991.
 
Following the standard NIH peer review process, Principal Investigators may
submit their applications and summary statements to the Alzheimer's
Association for funding consideration.  The Alzheimer's Association may fund
selected grants at a maximum level of $45,000 total costs each year with a 10
percent ceiling on indirect costs, for a maximum of three years.  The
Alzheimer's Association project start dates for funding may not coincide with
the NCNR or NIA award dates.  Applicants may not receive funding from both NIH
and the Alzheimer's Association for the same application.
 
SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINCAL 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 or represented in the
study populations for clinical studies, a special justification for this
exclusion or inadequate representation must be provided.  Applications without
such documentation will not be accepted for review.
 
REVIEW PROCEDURES AND CRITERIA
 
The individual research grant application form PHS-398 (revised 10/88 or 9/89)
must be used to apply for these grants.  Upon receipt, applications will be
reviewed by NIH staff for completeness and responsiveness.  Incomplete
applications will be returned to the applicant without further consideration.
Applications not responsive to the scientific intent identified in the RFA or
to the timeframe and budget guidelines will be returned to DRG for review with
other unsolicited grant applications during the next available NIH review
cycle.
 
Applications may be subjected to triage by a peer review group to determine
their scientific merit relative to other applications received in response to
this RFA.  The NIH will administratively withdraw those applications judged to
be noncompetitive and notify the applicant and institutional official.  Those
applications judged to be complete, responsive, and competitive will be
evaluated in accordance with the NIH review criteria for scientific/technical
merit by an appropriate peer review group convened by the NCNR and NIA.  The
second level of review will be provided by the NCNR and NIA National Advisory
Councils.
 
Although not a prerequisite for applying, potential applicants are encouraged
to submit a non-binding letter of intent by April 8, 1991, to John C. Chah,
PhD, National Center for Nursing Research, Building 31, Room 5B19, 9000
Rockville Pike, Bethesda, MD 20892.  The letter of intent should include a
descriptive title of the proposed research, the name, address, and telephone
number of the Principal Investigator, the names of other key personnel, and
any other participating institution(s).  Applications must be received by May
20, 1991.
 
Potential applicants are strongly encouraged to obtain the full Request for
Applications (RFA) and to direct inquiries to:
 
Mary D. Lucas, PhD, RN         Teresa S. Radebaugh, Sc.D.
Chief, Acute & Chronic         Chief, Dementias of Aging
    Illness Branch             Neuroscience and
National Center for Nursing      Neuropsychology of Aging
    Research                   National Institute on Aging
Building 31, Room 5B03         Building 31, Room 5C21
Bethesda, MD  20892            Bethesda, MD  20892
Telephone:  (301) 496-0523     Telephone:  (301) 496-9350
 
Other institutes and agencies are also interested in research dealing with
Alzheimer's disease and related disorders, including:
 
The National Institute of Mental Health (NIMH) is interested in research
dealing with the behavioral and emotional consequences of Alzheimer's disease
and related disorders.  The scope of NIMH interest is delineated in the
announcement "Alzheimer's Disease Treatment and Family Stress."  For more
information, contact Enid Light, PhD, NIMH, Room 11C-03, 5600 Fishers Lane,
Rockville, MD 20857, telephone (301) 443-1185.

 
            NIH GUIDE - Vol. 20, No. 3, January 18, 1991 - Page 5
The National Institute of Neurological Disease and Stroke program contact for
Alzheimer's disease related research is Dr. Eugene J. Oliver, NINDS, Federal
Building, Room 806, Bethesda, MD 20892, telephone (301) 496-1431.
 
This RFA is in addition to the ongoing program announcement on "Alzheimer's
Disease and Related Disorders:  Issues in Caregiving," published in the NIH
Guide for Grants and Contracts, Vol. 18, No. 6, February 24, 1989, sponsored
by the National Institute on Aging, National Center for Nursing Research,
National Institute of Mental Health, and the National Center for Health
Services Research (now the Agency for Health Care Policy Research).

ANALYSES AND PHYSIOLOGY OF ANTICARCINOGENS IN SOYBEANS
 
RFA AVAILABLE:  CA-91-06
 
P.T. 34; K.W. 0715035, 1007009, 0745027, 0710095
 
National Cancer Institute
 
Letter of Intent Receipt Date:  March 1, 1991
Application Receipt Date:  April 29, 1991
 
The Division of Cancer Prevention and Control, National Cancer Institute
(NCI), invites applications for grants to quantify levels of total and
individual anticarcinogens in soybeans and soy products and to study their
absorption and metabolism in humans.
 
BACKGROUND
 
Epidemiologic and animal studies suggest soybean-rich diets may reduce cancer
risk.  Populations consuming predominantly plant-based diets, for whom legumes
frequently represent an important protein source, tend to have lower rates of
several cancers than populations who rely heavily on animal products.  One
legume, soybeans, via a variety of soy products (tofu, miso, tempeh, soymilk,
natto), is commonly consumed throughout much of East Asia where breast and
colon cancer rates are low in comparison to Western countries.  Soybeans
contain several classes of compounds in particularly high concentrations with
demonstrated anticancer activity, such as isoflavones, protease inhibitors,
phytosterols, saponins, and inositol hexaphosphate.  Others may also exist.
Basic research on the absorption and metabolism of these compounds in humans
and accurate analytical data on the levels of these compounds in commonly
consumed soy products are needed.  These data will help to determine the
potential impact of soybeans on cancer prevention.
 
The Public Health Service (PHS) is committed to achieving the health promotion
and disease prevention objectives of "Healthy People 2000", a PHS-led national
activity for setting priority areas.  This RFA, "Analyses and Physiology of
Anticarcinogens in Soybeans," is related to the priority area of cancer
prevention.
 
OBJECTIVES AND SCOPE
 
The purpose of this Request for Applications (RFA) is to solicit applications
from qualified investigators to quantify levels of total and individual
anticarcinogens in soybeans and soy products and to study their absorption and
metabolism in humans.  The analytical work should focus only on those
compounds in soybeans and soy products that have demonstrated anticancer
activity and are unique to soybeans and soy products or present at
substantially high levels (relative to other foods).  Total as well as
individual anticarcinogens (e.g., total isoflavones and individual
isoflavones, daidzein, genistein) should be quantified.  All factors
potentially effecting anticarcinogen levels/activity should be considered for
investigation.
 
For the clinical work, studies on the absorption and metabolism of compounds
in soybeans and soy products with demonstrated anticancer activity are to be
conducted.  When feasible, dose-response relationships between soy
product/anticarcinogen intake and anticarcinogen levels in blood and urine,
and/or feces and bile should be conducted.  When available, both commonly
consumed soy products as well as soybean extracts or pure soybean
anticarcinogens should be studied.  Both long-term feeding studies, in which
anticarcinogen levels in subjects consuming soy products/extracts over an
extended period of time, and short-term studies, in which anticarcinogen
levels for a minimal period after the consumption of a single administration
of soy products, extracts, or pure compounds are studied, are appropriate
under this RFA.

            NIH GUIDE - Vol. 20, No. 3, January 18, 1991 - Page 6
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 or adequately
represented in the study populations for clinical studies, a specific
justification for this exclusion or inadequate representation must be
provided.  Applications without such documentation will not be accepted for
review.
 
MECHANISM OF SUPPORT
 
The support mechanism for this program will be the individual research grant
(RO1).  This RFA is a one-time solicitation.  Future unsolicited competing
renewal applications will compete with all investigator-initiated applications
and be reviewed by the Division of Research Grants (DRG).  Approximately
$900,000 in total costs per year for 3 years will be committed to specifically
fund applications that are submitted in response to this RFA.  It is
anticipated that 3 to 4 awards will be made.
 
REVIEW PROCESS
 
All applications submitted in response to this RFA will be evaluated for
scientific and technical merit by an initial review group that will be
convened for this purpose by the Division of Extramural Affairs.  Those
applications judged to be both competitive and responsive will be further
evaluated for scientific and technical merit by an appropriate peer review
group convened by the Division of Extramural Activities, NCI.  The second
level of review by the National Cancer Advisory Board considers the special
needs of the Institute and the priorities of the National Cancer Program.
 
METHOD OF APPLYING
 
Potential applicants are asked to submit a letter of intent and that includes
a descriptive title of the proposed research, the name and address of the
principal investigator, the names of other key personnel, the participating
institutions, and the number and title of the RFA in response to which the
application is being submitted.  This letter should be received no later than
March 1, 1991.  Potential applicants should write or phone the individual
listed below for the full RFA document:
 
Mark J. Messina, Ph.D., Program Director
National Cancer Institute, DCPC
9000 Rockville Pike, EPN 212C
Bethesda, MD  20892
Telephone:  (301) 496-8573
 
The RFA label available in the 10/88 revision of Application Form 398 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.

SITES TESTING OSTEOPOROSIS PREVENTION/INTERVENTION TREATMENTS
 
RFA AVAILABLE:  AG-91-04
 
P.T. 34; K.W. 0705050, 0745027, 0755015, 0710010
 
National Institute on Aging
 
Letter of Intent Receipt Date:  March 15, 1991
Application Receipt Date:  April 29, 1991
 
The National Institute on Aging (NIA) invites applications for cooperative
agreements to develop and test interventions to lessen, prevent, or reverse
loss of bone strength in the hip to reduce risk of hip fractures in older
persons.
 
BACKGROUND, GOALS, SCOPE, AND ELIGIBILITY REQUIREMENTS
 
The enormous public health impact of osteoporosis is concentrated heavily
among persons 65 years old and older.  In particular, the vast majority of hip
fractures occur in this age range.  Several clinical trials of interventions
against osteoporosis have reported promising results, but trials have included
few subjects over age 65, few trials have studied effects on bone density in

            NIH GUIDE - Vol. 20, No. 3, January 18, 1991 - Page 7
the hip, and no trials have adequate statistical power to determine the effect
of interventions on hip fractures in this population.
 
The Request for Applications (RFA) solicits projects which will test the
efficacy of interventions (or combinations of interventions) against
osteoporosis of the hip in persons aged 65 or older.  Proposed studies must
measure effects in the hip but may also include measures of effects at
additional skeletal sites.  Subjects for inclusion in proposed trials must be
age 65 or over.  Studies may also measure effects of osteoporosis treatment on
fractures of the hip and other sites.  A pilot phase for safety and
feasibility testing and protocol refinement of intervention studies may be
proposed.  The Principal Investigators and key staff of STOP/IT (Sites Testing
Osteoporosis Prevention/Intervention Treatments) projects, under the terms of
awards, will meet with the NIA Program Administrator every six months to
review the progress of their studies.  Funds for such travel will be included
in awards.
 
A maximum of $550,000 first year total (direct plus indirect) costs may be
requested per application and a total of no more than $3.1 million may be
requested per application for the entire project duration.  This RFA is a
one-time solicitation.  Up to $2.1 million (total cost) for first-year
expenses and additional approved expenses for up to five years will be
committed in Fiscal Year 1991 to fund applications in response to this RFA.
It is anticipated that up to four awards will be made in FY 1991.  Additional
proposals in response to this RFA may be funded in Fiscal Year 1992 depending
on quality of applications and availability of funds.  Issuance of awards
pursuant to this RFA is contingent on the availability of funds for this
purpose.  The earliest feasible start date for the initial awards will be
September 30, 1991.
 
Applicants responding to this RFA are also encouraged to submit concurrent
companion research project grant applications for studies on the
pathophysiology of osteoporosis in advanced age and the mechanisms affecting
response to treatment in older persons, as described in NIA RFA AG-91-08 in
this issue of the NIH Guide for Grants and Contracts.  No elements of these
proposed companion studies should duplicate any elements of studies proposed
in response to this RFA (AG-91-04).
 
MECHANISM OF SUPPORT
 
Support of this program will be through cooperative agreements (U01) between
each awardee and NIA.  Under the terms of these cooperative agreements, the
awardee defines the design and details of the project under the terms of this
RFA, retains primary responsibility for performance of the research and for
analyzing and publishing results, and agrees to accept assistance from the NIA
Program Administrator in the following:
 
  o  Participation in the monitoring of intervention study issues
     relating to recruitment, treatment, follow-up, quality control, and
     adherence to protocol.
 
  o  Consideration of adjustments of intervention study designs and
     protocols.
 
  o  Assistance in analysis and reporting of intervention study results.
 
REVIEW PROCEDURES AND CRITERIA
 
Applications will be received by the NIH Division of Research Grants and will
be assigned to the NIA.  Responsive applications will be assigned to a special
review group organized by NIA.  Following this review, applications will be
considered by the National Advisory Council on Aging.  Applications will be
evaluated on customary criteria for scientific merit and the adequacy of
applicants' plans for meeting the special program requirements of this RFA.
Applications will be evaluated regarding issues relating to inclusion of women
and minorities.  (Note following special instructions.)
 
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 or adequately
represented in the study populations for clinical studies, a specific
justification for this exclusion or inadequate representation must be
provided.  Applications without such justification will not be accepted for
review.

            NIH GUIDE - Vol. 20, No. 3, January 18, 1991 - Page 8
METHOD OF APPLYING:  Applicants should request the full RFA from the NIA staff
contact listed below.  A letter of intent to submit an application, while not
required, is requested to be sent to the same staff contact by March 15, 1991.
The deadline for receipt of applications is April 29, 1991.  The full RFA may
be obtained from:
 
Stanley L. Slater, M.D.
Geriatrics Program
National Institute on Aging
Building 31, Room 5C27
National Institutes of Health
Bethesda, MD  20892
Telephone:  (301) 496-6761

SITES TESTING OSTEOPOROSIS PREVENTION/INTERVENTION TREATMENTS:  COMPANION
STUDIES OF PATHOPHYSIOLOGY AND MECHANISMS
 
RFA AVAILABLE:  AG-91-08
 
P.T. 34; K.W. 0705050, 0745027, 0710010, 0765035
 
National Institute on Aging
 
Application Receipt Date:  April 29, 1991
 
BACKGROUND:  The National Institute on Aging (NIA) has issued a Request for
Applications (RFA):  SITES TESTING OSTEOPOROSIS PREVENTION/INTERVENTION
TREATMENTS (STOP/IT) (AG-91-04), soliciting projects to test the efficacy of
interventions (or combinations of interventions) against osteoporosis in the
hip, in persons aged 65 or more.  That RFA provides funds for intervention
studies only.  Because evidence is increasing that the disease process may
differ in significant respects in this age range compared to younger ages, and
because much remains to be learned about mechanisms accounting for these
differences, NIA wishes to increase gains in knowledge from these intervention
studies by supporting companion studies to explore mechanisms underlying the
interaction of the disease process with interventions being explored in the
clinical trials funded under AG-91-04.  Therefore, only institutions
responding to AG-91-04 may submit applications in response to this RFA.  Those
not eligible for this RFA who wish support for studies on osteoporosis in
advanced age are encouraged to submit applications at any regularly scheduled
submission deadline, as described in the NIA/NIAMS program announcement:  Type
II Osteoporosis (NIH Guide for Grants and Contracts 17, No. 28, September 2,
1988).
 
RESEARCH GOALS AND SCOPE:  The screening and recruitment of subjects over age
65, as requested in AG-91-04, will provide opportunities for studies on the
pathophysiology of osteoporosis in advanced age, and the mechanisms affecting
response to treatment in older persons.  Studies are encouraged on factors
affecting the progress of the disease in women many years after menopause and
in older men, as well as studies of factors specifically affecting bone loss
in the hip in this age range.  Applicants responding to this RFA are also
invited to explore or verify mechanisms underlying the effects (or lack of
effects) of interventions on bone mass, bone density, and/or bone strength in
older persons.  Because comorbidity and use of multiple medications are
extremely common among persons over age 65, studies of the impact of these
complicating factors on the disease process and responses to interventions are
also appropriate.
 
MECHANISM OF SUPPORT:  Support of this program will be through the Public
Health Service grant-in-aid.  Only the RO1 grant mechanism can be used.
Awards will be administered under PHS grants policy as stated in the Public
Health Service Grants policy statement, DHHS Publication No. (OASH) 82-50,000,
revised October 1, 1990.
 
This RFA is a one-time solicitation.  Up to $1.2 million has been set aside
for total (direct plus indirect) first-year costs and additional approved
expenses for up to five years to fund applications submitted in response to
this RFA.  (NIA and the National Institute of Arthritis, Musculoskeletal and
Skin Diseases will contribute equal shares of this funding.) No single
proposal should request more than $150,000 (direct plus indirect costs) for
first-year expenses.  Future year annual increases will generally be limited
to no more than four percent.  Multiple proposals may be submitted by each
applicant institution.  It is anticipated that approximately 8 awards will be
made in Fiscal Year 1991.  Additional applications submitted in response to
this RFA may be funded in Fiscal Year 1992.  The award of grants pursuant to
this RFA is contingent on receipt of applications of high scientific merit and
the availability of funds for this purpose.
 
            NIH GUIDE - Vol. 20, No. 3, January 18, 1991 - Page 9
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.
 
REVIEW PROCEDURES AND CRITERIA:  Applications will be received by the NIH
Division of Research Grants and will be assigned to NIA.  Responsive
applications will be assigned to a special review group convened by NIA for
review.  Following this review, applications will be considered by the
National Advisory Council on Aging.  Scientific review criteria to be used in
the evaluation of the applications received in response to this RFA are listed
in the full RFA.
 
METHOD OF APPLYING:  Applicants should request the full RFA from the NIA staff
contact listed at the end of this announcement.  A letter of intent to submit
an application, while not required, is requested to be sent to the same staff
contact by March 15, 1991.  Applications should be submitted on the standard
PHS 398 application form (revised October 1988), available at most
institutional business offices and the Division of Research Grants, NIH,
telephone (301) 496-7441.  On item 2 of the face page of the application,
applicants should enter:  NIA (STOP/IT) Companion Studies, AG-91-08.  The RFA
label available in the 10/88 revision of the Application Form 398 must be
affixed to the bottom of the face page.  Failure to use this label could
result in delayed processing of the application and prevent it from reaching
the review committee in time for review.  The deadline for receipt of
applications is April 29, 1991.
 
The full RFA may be obtained from:
 
Stanley L. Slater, M.D.
Geriatrics Program
National Institute on Aging
Room 5C27, Building 31, NIH
Bethesda, MD  20892
Telephone:  (301) 496-6761

 

 

 

 

 

 

 

 

 

 

 

 

 
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