Subject: RFA AR-9l-02 2/l5/9l NIH Guide
From: Dot Baker <[email-masked]>
To: [email-masked]
Date: Wed, 13 Feb 91 12:57 EST

Hi Paul,
  Please post this one to the NIH Listserver as:
      RFAAR-91-02.910215
 ---------------------------- Text of forwarded message -----------------------
 
REQUEST FOR APPLICATIONS
 
RFA NUMBER:  AR-91-02
 
BASIC RESEARCH ON OSTEOPOROSIS
 
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
 
Letter of Intent Receipt Date:  April 1, 1991
Application Receipt Date:  May 15, 1991
 
INTRODUCTION
 
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.  After the age of forty, and particularly after
menopause in women, the balance of bone formation and bone
resorption is disturbed leading to bone loss.  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.
 
BACKGROUND
 
A national scientific conference on RESEARCH ADVANCES IN
OSTEOPOROSIS, sponsored by National Institute of Arthritis and
Musculoskeletal and Skin Diseases (NIAMS), the National Institute
of Diabetes and Digestive and Kidney Diseases (NIDDK), and the
National Institute on Aging, was held in February 1990.
Following the general meeting, the NIAMS convened a meeting of
leaders in basic and clinical osteoporosis research 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) is proposed to solicit applications in the particular areas
of basic 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).  Responsibility for
the planning, direction, and execution of the proposed project
will be solely that of the applicant.  Awards will be
administered under PHS grants policy as stated in the Public
Health Service Grants Policy Statement, DHHS Publication No.
(OASH) 90-50,000, revised October 1, 1990.
 
Approximately $2,000,000 in total costs per year for three to
five years will be committed by the NIAMS, specifically to fund
applications that are submitted in response to this RFA.  The
NIDDK will provide additional funds to support approximately two
projects.  The funding level is dependent on the receipt of a
sufficient number of applications of high scientific merit.  The
total project period for applications submitted in response to
the present RFA should not exceed five (5) years.  The earliest
possible start date for the initial awards will be September 30,
1991.  Although this program is provided for in the financial
plans of the NIAMS and the NIDDK, award of grants pursuant to
this RFA is also contingent upon the availability of funds for
this purpose.  Applications may receive secondary assignment,
when appropriate, to the National Institute on Aging, which may
fund projects in addition to those funded by NIAMS and NIDDK.
Non-profit and for-profit institutions, and foreign as well as
domestic institutions, are eligible to apply.
 
This RFA is a one-time solicitation.  Generally, future
unsolicited competing renewal applications that result from this
current RFA will compete as research project applications with
all other investigator-initiated applications and be reviewed by
a standing Division of Research Grants study section.  However,
should there be sufficient continuing program need, NIAMS and
NIDDK may announce a request for renewal applications.
 
REVIEW PROCEDURES AND CRITERIA
 
REVIEW PROCEDURE
 
Upon receipt, applications will be reviewed initially by the
Division of Research Grants for completeness.  Incomplete
applications will be returned to the applicant without further
consideration.  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 application at the next
receipt date.  Questions concerning the relevance of proposed
research to the RFA should be directed to program staff as
described in INQUIRIES.
 
In cases where the expected number of applications is large
compared to the number of awards to be made, the NIH will conduct
an administrative prereview (triage) to eliminate those that are
clearly not competitive.  The NIH will withdraw from further
competition those applications judged to be noncompetitive and
notify the applicant and institutional business official.
 
Those applications judged to be both responsive and competitive
will be evaluated in accordance with the criteria stated below
for scientific/technical merit by an appropriate initial review
group convened by the NIAMS Review Branch.  The second level of
review by the National Arthritis and Musculoskeletal and Skin
Diseases Advisory Council, the National Institute of Diabetes and
Digestive and Kidney Diseases National Advisory Council and, in
some cases, the National Advisory Council on Aging will make
recommendations regarding funding.
 
REVIEW CRITERIA
 
Proposals responsive to this competitive solicitation will be
reviewed in accordance with the following criteria:
 
1.  Extent of relevance of the proposed research to the aims of
the RFA.
 
2.  Scientific merit of the proposed approach, including the
adequacy and quality of the methodological approach and the
research design.  Familiarity with the proposed techniques should
be demonstrated, e.g., by the presentation of preliminary data.
 
3.  Expertise and qualifications of the Principal Investigator
and proposed staff and/or collaborators to perform the proposed
experiments.
 
4.  Documentation of the adequacy of the facilities and
resources.
 
The review group will critically examine the proposed budget and
recommend an appropriate budget for each approved application.
 
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.
 
The RFA label available in the 10/88 revision of form PHS 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.  In addition, the title of the RFA and the RFA number
must be typed on line 2 of the face page of the application form.
 
Submit a signed, typewritten original of the application,
including the Checklist, and four (4) signed, exact photocopies,
in one package to the Division of Research Grants at the address
below.  The photocopies must be clear and single sided.
 
DIVISION OF RESEARCH GRANTS
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**
 
At the time of submission, two (2) additional copies of the
application must also be sent to:
 
REFERRAL OFFICER
Division of Extramural Activities
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Room 5A-07, Westwood Building
5333 Westbard Avenue
Bethesda, MD  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
 
Written or telephone inquiries concerning the objectives and
scope of this RFA or inquiries about whether or not specific
proposed research would be responsive are encouraged and should
be directed to:
 
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
 
The program directors welcome the opportunity to clarify any
issues or questions from potential applicants.
 
LETTER OF INTENT
 
Prospective applicants are asked to submit by April 1, 1991, a
letter of intent 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.
 
Although a letter of intent is not required, is not binding, and
does not enter into the review of subsequent applications, the
information that it contains is extremely helpful in planning for
the review of applications.  It allows NIAMS staff to estimate
the potential review workload and to avoid possible conflict of
interest in the review.
 
The letter of intent should be sent to Dr Joan McGowan at the
address listed above.
 
This program is described in the Catalog of Federal Domestic
Assistance No. 93.846, Arthritis, Musculoskeletal and Skin
Diseases Research and No. 93.855 Diabetes, Endocrinology and
Metabolism Research.  Awards will be made under authorization of
the Public Health Service Act, Title III, Section 301 (c) (Public
Law 78-410, as amended; 42 USC 241) and administered under PHS
grant 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.