Subject: RFA AR-9l-03 2/l5/9l NIH Guide
From: Dot Baker <[email-masked]>
To: [email-masked]
Date: Thu, 14 Feb 91 14:15 EST

Hi Paul,
   There will be several of these coming to you this afternoon.  Please
notify me when posted.   I'm sure that two of the ones I sent over
yesterday will have to be revised since complete announcements were
not received and I did not notice them until I printed them out today.
    Please post this to the NIH Listserver as:
       RFAAR-91-03.910215
 ---------------------------- Text of forwarded message -----------------------
 
REQUEST FOR APPLICATIONS
 
RFA NUMBER:  AR-91-03
 
CLINICAL AND EPIDEMIOLOGY RESEARCH ON OSTEOPOROSIS
 
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
 
Letter of Intent Receipt Date:  April 1, 1991
Application Receipt Date:  May 15, 1991
 
INTRODUCTION
 
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.
 
Bone mass in the adult skeleton reflects the accumulation and
maintenance of bone tissue during growth and maturation, and the
rate and duration of bone loss thereafter.  Factors that induce a
low peak bone mass and those that underlie excessive
postmenopausal and aging associated bone loss predispose an
individual to osteoporosis.  Although our knowledge is
incomplete, genetic, endocrine and lifestyle factors are
contributory.  The development and testing of strategies for
building and maintaining an adequate bone mass and preventing
bone loss are essential.
 
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 clinical and epidemiologic research that are specifically and
directly applicable to osteoporosis.
 
RESEARCH GOALS
 
This RFA is intended to foster and enhance research specifically
directed to prevention and treatment strategies, as well as
epidemiologic studies of osteoporosis.  Some of these areas,
identified as needing additional research, are listed below:
 
o  Studies on maximizing bone mass in early life
 
o  Biochemical markers of bone remodeling
 
o  Non-invasive measurement of bone density/mass and structure
 
o  Further studies of sex hormone use in osteoporosis
 
o  Role of exercise in prevention and treatment of osteoporosis
 
o  Development of hormone analogs with specific therapeutic application in
osteoporosis
 
o  Therapeutic potential for growth factors
 
o  Incidence and etiology of osteoporosis in men and blacks
 
o  Etiology of juvenile and adult idiopathic osteoporosis
 
o  Additional research on risk factors
 
o  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
 
This RFA will use the traditional National Institutes of Health
(NIH) research project 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 may 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
RFA will compete as research project applications with all other
investigator-initiated applications and be reviewed in a standing
Division of Research Grants study section.  However, should it be
determined that there is a 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 applications 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 examine critically the proposed budget and
recommend an appropriate budget for each approved application.
 
SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF
NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN
CLINICAL RESEARCH STUDY POPULATIONS
 
NIH and ADAHMA policy is that applicants for NIH/ADAHMA clinical
research grants and cooperative agreements will be required to
include minorities and women in study populations so that
research findings can be of benefit to all persons at risk of the
disease, disorder or condition under study; special emphasis
should be placed on the need for inclusion of minorities and
women in studies of diseases, disorders and conditions which
disproportionately affect them.  This policy is intended to apply
to males and females of all ages.  If women or minorities are
excluded or inadequately represented in clinical research,
particularly in proposed population-based studies, a clear
compelling rationale should be provided.
 
The composition of the proposed study group must be described in
terms of gender and racial/ethnic group.  In addition, gender and
racial/ethnic issues should be addressed in developing a research
design and sample size appropriate for the scientific objectives
of the study.  This information should be included in the form
PHS 398 in Section 2, A-D of the Research Plan and summarized in
Section 2, E, Human Subjects.  Applicants are urged to assess
carefully the feasibility of including the broadest possible
representation of minority groups.  However, the NIH recognizes
that it may not be feasible or appropriate in all research
projects to include representation of the full array of United
States racial/ethnic minority populations (i.e., Native
Americans, Asian/Pacific Islanders, Blacks, Hispanics)
 
The rationale for studies on single minority population groups
should be provided.
 
For the purpose of this policy, clinical research includes human
biomedical and behavioral studies of etiology, epidemiology,
prevention (and preventive strategies), diagnosis, or treatment
of diseases, disorders or conditions, including but not limited
to clinical trials.
 
The usual NIH policies concerning research on human subjects also
apply.  Basic research or clinical studies in which human tissues
cannot be identified or linked to individuals are excluded.
However, every effort should be made to include human tissues
form women and racial/ethnic minorities when it is important to
apply the results of the study broadly, and this should be
addressed by applicants.
 
For foreign awards, the policy on inclusion of women applies
fully; since the definition of minority differs in other
countries, the applicant must discuss the relevance of the
research involving foreign population groups to the United
States' populations, including minorities.
 
If the required information is not contained in the application,
the application will be returned.
 
Peer reviewers will address specifically whether the research
plan in the application conforms to these policies.  If the
representation of women or minorities in a study design is
inadequate to the scientific question(s) addressed and the
justification for the selected study population is inadequate, it
will be considered a scientific weakness or deficiency in the
study design and will be reflected in assigning the priority
score to the application.
 
All applications for clinical research submitted to NIH are
required to address these policies.  NIH funding components will
not award grants or cooperative agreements that do not comply
with these policies.
 
METHOD OF APPLYING
 
The 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, Westwood Building, Rm. 449, 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
Westwood Building, Room 5A-07
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 and answer 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.