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Herman J. Woltring
03-31-1991, 06:40 AM
Dear Biomch-L readers,

During the first quarter of 1991, the following RFA's (Requests for Applica-
tions) on Osteoporosis were published in the NIH Guide. Following my previous
postings these days, I am posting the complete texts by way of additional ex-
amples; however, future information of this nature may simply provide pointers
to the relevant files and fileservers.

Interested readers should note the deadlines of 15 May (1-2) and 29 April
(3-4), respectively; the letter of intent with (past) deadline of 15 March
is not mandatory, but it might be advisable to inquire whether it would be
advisable to submit one anyhow.

Regards -- Herman J. Woltring, Eindhoven/NL

(1) Basic Research on Osteoporosis (NIAMS, NIDDK)
(2) Clinical and Epidemiology Research in Osteoporosis (NIAMS, NIDDK)
(3) Sites Testing Osteoporosis Prevention/Intervention Treatments (NIA)
(4) Sites Testing Osteoporosis Prevention/Intervention Treatments:
Companion Studies of Pathophysiology and Mechanisms (NIA)

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Date: Wed, 13 Feb 91 11:20:43 EST
Sender: NIH Guide Primary Distribution
From: Q2C@NIHCU.BITNET
Subject: NIH GUIDE - Vol. 20, No. 7, February 15, 1991, Part 1
(extracted from LISTSERV@JHUVM file NIHGDE-L 91-00259)
...

BASIC RESEARCH ON OSTEOPOROSIS

RFA AVAILABLE: AR-91-02

P.T. 34; K.W. 0705050, 0785050, 0760020, 0765030, 0760025, 0760075

National Institute of Arthritis and Musculoskeletal and Skin Diseases
National Institute of Diabetes and Digestive and Kidney Diseases

Application Receipt Date: May 15, 1991

BACKGROUND

Osteoporosis, a condition in which bone mass is low, represents a major public
health problem in the United States, exacting an enormous societal toll
annually in morbidity and mortality. It affects more than 24 million
Americans and is responsible for at least 1.3 million fractures each year.
Moreover, the frequency of osteoporosis and osteoporosis-related fractures is
expected to increase with the expansion of the elderly population in the
upcoming decades.

Bone remodeling is regulated by a complex interplay of bone cells and factors
that modulate the growth and functional activity of the cells. Although there
has been an explosion of information on the nature of the bone forming and
bone resorbing cells and numerous bone-active factors have been identified,
the regulation of bone remodeling by mechanical, endocrine, and local factors,
especially as they relate to osteoporosis, remains poorly understood.

Following a national scientific conference on RESEARCH ADVANCES IN
OSTEOPOROSIS in February 1990, a meeting of leaders in basic and clinical
osteoporosis research met to develop future research directions and
opportunities. These research directions became part of a report that was
requested last year by the Senate Appropriations Committee. The Report on
HHS-wide Research, Education, and Health Promotion Activities in Osteoporosis
also contained information on the status of current research in osteoporosis
throughout the Department of Health and Human Services. A copy of this report
may be requested by contacting Dr. Joan McGowan at the address listed below.
As follow-up to the report to the Senate Appropriations Committee and to be
responsive to current congressional interest and support for osteoporosis
research, a Request for Applications (RFA) has been issued to solicit
applications in the particular areas of basic research in bone biology that
are specifically and directly applicable to osteoporosis.

RESEARCH GOALS AND SCOPE

Some of the basic research areas that were identified as highly promising
research opportunities are: (1) the effect of local and systemic growth
regulators and osteoinductive factors on bone metabolism relevant to
osteoporosis; (2) the development of animal and cell culture models for
osteoporosis; (3) the role of mechanical/gravitational stress in maintaining
bone mass and preventing bone loss; (4) studies of the mechanism of action on
bone of factors with therapeutic potential, such as fluoride, estrogen, and
other hormones, bisphosphonates; (5) the roles of bone architecture and
strength in osteoporotic fractures; and (6) identification, characterization,
and molecular mechanisms of action of receptors for hormones, growth factors,
and cytokines active in bone cells and relevant to the etiology of
osteoporosis. Applications addressing other topics directly and specifically
pertinent to osteoporosis and osteoporosis-induced fractures are encouraged.

MECHANISM OF SUPPORT

The support mechanism for this RFA will be the the traditional,
investigator-initiated research grant (R01). Approximately $2,000,000 in
total costs per year for three to five years will be committed by the National
Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS),
specifically to fund applications that are submitted in response to this RFA.
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
will provide additional funds to support approximately two projects. The
National Institute on Aging may receive secondary assignment on appropriate
applications.

REVIEW PROCEDURES AND CRITERIA

Applications will be reviewed initially by the Division of Research Grants for
completeness and will be assigned to a special NIAMS review group. Evaluation
for responsiveness to the RFA is an NIAMS and NIDDK program staff function.
Applications that are judged non-responsive will be returned to the applicant
but may be submitted as investigator-initiated applications at the next
receipt date. Those applications judged to be both responsive and competitive
will be evaluated for scientific/technical merit by an appropriate initial
review group convened by the NIAMS Review Branch. The second level of review
by the National Advisory Councils of NIAMS, NIDDK and, in some cases, NIA will
make recommendations regarding funding.

METHOD OF APPLYING

The research grant application form PHS 398 (revised 10/88) must be used in
applying for these grants. These forms are available at most institutional
business offices; from the Office of Grants Inquiries, Division of Research
Grants, National Institutes of Health, Room 449, Westwood Building, 5333
Westbard Avenue, Bethesda, Maryland 20892.

Applications must be received by May 15, 1991. If an application is received
after that date, it will be returned to the applicant.

If the application submitted in response to this RFA is substantially similar
to a research 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.

INQUIRIES

Requests for copies of the full RFA may be obtained from:

Dr. Joan A. McGowan
Bone Biology and Bone Diseases Program Director
National Institute of Arthritis and Musculoskeletal and Skin Diseases
5333 Westbard Avenue
Westwood Building, Room 403
Bethesda, MD 20892
Telephone: (301) 496-7495

or

Dr. Ronald Margolis
Director, Endocrinology Research Program
Division of Diabetes, Endocrinology and Metabolic Diseases
NIDDK/NIH
5333 Westbard Avenue
Westwood Building, Room 604
Bethesda, MD 20892
Telephone: (301) 496-7504

--------------

CLINICAL AND EPIDEMIOLOGY RESEARCH ON OSTEOPOROSIS

RFA AVAILABLE: AR-91-03

P.T. 34; K.W. 0705050, 0785055, 0760020, 0760025, 0755030, 0745027

National Institute of Arthritis and Musculoskeletal and Skin Diseases
National Institute of Diabetes and Digestive and Kidney Diseases

Application Receipt Date: May 15, 1991

BACKGROUND

Osteoporosis is a disease characterized by low bone mass, microarchitectural
deterioration of bone tissue, and a consequent increase in fracture risk.
Osteoporosis represents a major public health problem in the United States,
exacting an enormous societal toll annually in morbidity and mortality. It
affects more than 24 million Americans and is responsible for at least 1.3
million fractures each year. Moreover the frequency of osteoporosis and
osteoporosis-related fractures is expected to increase with the expansion of
the elderly population in the upcoming decades.

Following a national scientific conference on RESEARCH ADVANCES IN
OSTEOPOROSIS in February 1990, a meeting of leaders in basic and clinical
osteoporosis research met to develop future research directions and
opportunities. These research directions became part of a report that was
requested last year by the Senate Appropriations Committee. The Report on
HHS-wide Research, Education, and Health Promotion Activities in Osteoporosis
also contained information on the status of current research in osteoporosis
throughout the Department of Health and Human Services. A copy of this report
may be requested by contacting Dr. Joan McGowan at the address listed below.
As follow-up to the report to the Senate Appropriations Committee and to be
responsive to current congressional interest and support for osteoporosis
research, a Request for Applications (RFA) has been issued to solicit
applications in the particular areas of clinical and epidemiologic research
that are specifically and directly applicable to osteoporosis.

RESEARCH GOALS AND SCOPE

This RFA is intended to foster and enhance research specifically directed to
prevention and treatment strategies, as well as epidemiologic studies of
osteoporosis. These areas include: 1) studies on maximizing bone mass in
early life; 2) biochemical markers of bone remodeling; 3) non-invasive
measurement of bone density/mass and structure; 4) further studies of sex
hormone use in osteoporosis; 5) the role of exercise in prevention and
treatment of osteoporosis; 6) development of hormone analogs with specific
therapeutic application in osteoporosis; 7) therapeutic potential for growth
factors; 8) incidence and etiology of osteoporosis in men and blacks; 9)
etiology of juvenile and adult idiopathic osteoporosis; 10) additional
research on risk factors; and 11) research on prevention strategies.

Other clinical and epidemiologic research applications in the field of
osteoporosis are encouraged. In order to be considered responsive to this
RFA, applications must be specifically directed to osteoporosis.

MECHANISM OF SUPPORT

The support mechanism for this RFA will be the the traditional,
investigator-initiated research grant (R01). Approximately $2,000,000 in
total costs per year for three to five years will be committed by the National
Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS),
specifically to fund applications that are submitted in response to this RFA.
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
will provide additional funds to support approximately two projects. The
National Institute on Aging may receive secondary assignment on appropriate
applications.

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 reviewed initially by the Division of Research Grants for
completeness and will be assigned to a special NIAMS review group. Evaluation
for responsiveness to the RFA is an NIAMS and NIDDK program staff function.
Applications that are judged non-responsive will be returned to the applicant
but may be submitted as investigator-initiated applications at the next
receipt date. Those applications judged to be both responsive and competitive
will be evaluated for scientific/technical merit by an appropriate initial
review group convened by the NIAMS Review Branch. The second level of review
by the National Advisory Councils of NIAMS, NIDDK and, in some cases, NIA will
make recommendations regarding funding.

METHOD OF APPLYING

The research grant application form PHS-398 (revised 10/88) must be used in
applying for these grants. These forms are available at most institutional
business offices and from the Office of Grants Inquiries, Division of Research
Grants, National Institutes of Health, Room 449, Westwood Building, 5333
Westbard Avenue, Bethesda, Maryland 20892.

Applications must be received by May 15, 1991. If an application is received
after that date, it will be returned to the applicant. If the application
submitted in response to this RFA is substantially similar to a research 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.

INQUIRIES

Copies of the full RFA may be obtained from:

Dr. Joan A. McGowan
Bone Biology and Bone Diseases Program Director
National Institute of Arthritis and Musculoskeletal and Skin Diseases
5333 Westbard Avenue
Westwood Building, Room 403
Bethesda, MD 20892
Telephone: (301) 496-7495

or

Dr. Ronald Margolis
Director, Endocrinology Research Program
Division of Diabetes, Endocrinology and Metabolic Diseases
NIDDK/NIH
5333 Westbard Avenue
Westwood Building, Room 605
Bethesda, MD 20892
Telephone: (301) 496-7504

...
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Date: Wed, 16 Jan 91 12:07:19 EST
Sender: NIH Guide Primary Distribution
From: Q2C@NIHCU.BITNET
Subject: NIH GUIDE - Vol. 20, No. 3, January 18, 1991
(extracted from LISTSERV@JHUVM file NIHGDE-L 91-00223)
...

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
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.

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.

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