Full Text AR-94-002

OSTEOPOROSIS/RELATED BONE DISEASES INFORMATION RESOURCE CENTER

NIH GUIDE, Volume 22, Number 34, September 24, 1993

RFA:  AR-94-002

P.T. 16

Keywords: 
  0715031 
  Nutrition/Dietetics 
  Disease Prevention+ 
  Treatment, Medical+ 
  Health and Safety Education 


National Institute of Arthritis and Musculoskeletal and Skin Diseases

Letter of Intent Receipt Date:  November 1, 1993
Application Receipt Date:  December 21, 1993

PURPOSE

The National Institute of Arthritis and Musculoskeletal and Skin
Diseases (NIAMS) invites applications for the purpose of establishing
a resource center for osteoporosis, Paget's disease, and related bone
disorders to facilitate and enhance knowledge and understanding on
the part of health professionals, patients, and the public through
effective dissemination of information.

HEALTHY PEOPLE 2000

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 Request
for Applications (RFA), Osteoporosis/Related Bone Diseases Resource
Center, is related to the priority area of educational and
community-based programs.  Potential applicants may obtain a copy of
"Healthy People 2000" (Full Report:  Stock No. 017-001-00474-0) or
"Healthy People 2000" (Summary Report:  Stock No. 017-001-00473-1)
through the Superintendent of Documents, Government Printing Office,
Washington, DC 20402-9325 (telephone 202-783-3238).

ELIGIBILITY REQUIREMENTS

Applications may be submitted by individuals representing domestic or
foreign non-profit entities involved in activities regarding the
prevention and control of osteoporosis and related bone disorders.
Applications from minority individuals and women are encouraged.

MECHANISM OF SUPPORT

This RFA will use the National Institutes of Health (NIH) Education
Project Grant (R25).  Responsibility for the planning, direction, and
execution of the proposed project will be solely that of the
applicant.  The total project period for applications submitted in
response to the present RFA may not exceed four years.  The
anticipated award date is June 30, 1994.

FUNDS AVAILABLE

The estimated funds (total costs) available for the first year of
support are $500,000 total cost.  The NIAMS expects to make one
award.

RESEARCH OBJECTIVES

Background

Osteoporosis is an important public health problem in which weakened
bones are easily fractured.  More than 1.3 million fractures each
year are attributable to osteoporosis.  Death is a frequent
occurrence in the months immediately following hip fracture.  Fifty
percent of surviving individuals will need help with daily living
activities, and 15 to 25 percent will need to enter a long-term care
institution shortly after the fracture.  In 1986 the annual national
cost of osteoporosis-related fractures was 7 to 10 billion dollars.
Although accurate national cost and personal impact data are less
available for drug-induced osteoporosis, other secondary types of
osteoporosis, Paget's disease, osteogenesis imperfecta, and other
bone diseases these diseases are also important problems.

In the past decade there have been extraordinary advances in the
understanding of basic bone biology leading to very targeted
approaches both in the prevention and effective treatment of several
types of osteoporosis and related bone diseases, but wide application
to clinical care has lagged behind.  Further education of health care
professionals, patients, and the public at large is needed.  In
particular, the teaching of osteoporosis prevention to children and
adolescents and the need to reach all segments of an ethnically,
economically, and geographically diverse American population have
been identified as priorities.

The National Institutes of Health Revitalization Act of 1993 [P.L.
103-43] provided for "the establishment of an information
clearinghouse on osteoporosis and related bone disorders to
facilitate and enhance knowledge and understanding on the part of
health professionals, patients, and the public through the effective
dissemination of information."  The law further requires that such a
clearinghouse be established through "a grant, cooperative agreement,
or contract with a non-profit private entity involved in activities
regarding the prevention and control of osteoporosis and related bone
disorders."

Objective

The objective of this RFA is to establish an information resource
center to reach health professionals, patients and the public with
state-of-the-art information on the prevention and treatment of
osteoporosis and related bone diseases.  This will include evaluation
of the Center's ability to effect beneficial changes in one or more
of the target groups who receive the information.

Bone disease topics addressed by the Center might include, but are
not limited to:  post-menopausal osteoporosis; osteoporosis in men;
osteoporosis in high-risk populations; osteoporosis in hard to reach
populations, including minority, low income, rural, or non-English
speaking populations; corticosteroid-induced osteoporosis; and
similar projects for Paget's disease, osteogenesis imperfecta, and
other bone diseases.

Populations targeted by the Center might be:  health care
professionals, including school nurses or biology teachers, state or
local public health officials, nutrition professionals, physicians,
pharmacists, or others; patient groups, either disease specific or
general, such as retirement groups; the public at large, including
age-specific populations, such as adolescents.  Prevention awareness
initiatives, including hip fracture prevention, are encouraged.

Applicants should describe the methodology by which they will
evaluate the efficacy of their educational activities.

Specific questions that might be addressed include:

o  What are effective ways of making adolescent girls aware of
healthy diets and habits for prevention of future osteoporosis?

o  Which health care providers are the most effective teachers
regarding healthy bone?

o  What methods are effective for changing knowledge in a diverse
population?

These are illustrative only, and are neither exclusive nor
restrictive.  The applicant may select any area(s) of interest that
concerns the prevention, treatment, and dissemination of information
about osteoporosis and/or related bone diseases.

STUDY POPULATIONS

SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH
POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDY POPULATIONS

NIH policy is that applicants for NIH clinical research grants and
cooperative agreements are 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 must 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 must be provided.

The composition of the proposed study population must be described in
terms of gender and racial/ethnic group.  In addition, gender and
racial/ethnic issues must be addressed in developing a research
design and sample size appropriate for the scientific objectives of
the study.  This information must be included in the form PHS 398
(rev. 9/91) in Sections 1-4 of the Research Plan AND summarized in
Section 5, Human Subjects.  Applicants are urged to assess carefully
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/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 is defined as 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 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, the
applicant 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 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 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 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.

LETTER OF INTENT

Prospective applicants are asked to submit, by November 1, 1993, a
letter of intent that includes a descriptive title of the proposed
research, the name, address, and telephone number of the Principal
Investigator, the identities of other key personnel and participating
institutions, and the number and title of the RFA in response to
which the application may be 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 allows NIAMS staff to estimate the potential review
workload and to avoid conflict of interest in the review.

The letter of intent is to be sent to:

Dr. Tommy Broadwater
Review Branch
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Westwood Building, Room 404
Bethesda, MD  20892
Telephone:  (301) 594-9957
FAX:  (301) 594-9673

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 9/91) is to be used
in applying for these grants.  These forms are available at most
institutional offices of sponsored research; from the Office of
Grants Information, Division of Research Grants, National Institutes
of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892,
telephone 301/435-0714; and from the NIH program administrator named
below.

The RFA label available in the PHS 398 (rev. 9/91) application form
must be affixed to the bottom of the face page of the application.
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 RFA title and number must be typed on
line 2a of the face page of the application form and the YES box must
be marked.

Submit a signed, typewritten original of the application, including
the Checklist, and three signed, photocopies, in one package to:

Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**

At the time of submission, two additional copies of the application
must also be sent to:

Dr. Tommy Broadwater
Review Branch
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Westwood Building, Room 403
Bethesda, MD  20892

Applications must be received by December 21, 1993.  If an
application is received after that date, it will be returned to the
applicant without review.  The Division of Research Grants (DRG) will
not accept any application in response to this announcement that is
essentially the same as one currently pending initial review, unless
the applicant withdraws the pending application.  The DRG will not
accept any application that is essentially the same as one already
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.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by DRG
and responsiveness by the NIAMS.  Incomplete applications will be
returned to the applicant without further consideration.  If the
application is not responsive to the RFA, ICD staff will contact the
applicant to determine whether to return the application.

Applications may be triaged by the NIAMS peer review group on the
basis of relative competitiveness.  The NIH will withdraw from
further competition those applications judged to be non-competitive
for award and notify the applicant Principal Investigator and
institutional official.  Those applications judged to be competitive
will undergo further scientific merit review.  Those applications
that are complete and responsive will be evaluated in accordance with
the criteria stated below for scientific/technical merit by an
appropriate peer review group convened by the ICD.  The second level
of review will be provided by the National Arthritis and
Musculoskeletal and Skin Diseases Advisory Council.

Review criteria include:

o  merit and originality of proposed projects;
o  qualifications and experience of the Principal Investigator and
staff;
o  availability of the resources necessary to perform the project;
o  appropriateness of the proposed budget and duration in relation to
the proposed project;
o  ability to reach target populations;
o  ability to evaluate the efficacy of the projects.

AWARD CRITERIA

The anticipated date of award is June 30, 1994.

The award criteria are:

o  priority score
o  availability of funds
o  programmatic priorities

INQUIRIES

Written and telephone inquiries concerning this RFA are encouraged.
The opportunity to clarify any issues or questions from potential
applicants is welcome.

Direct inquiries regarding programmatic issues to:

Dr. Joan McGowan
Bone Biology and Bone Diseases Branch
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Westwood Building, Room 403
Bethesda, MD  20892
Telephone:  (301) 594-9957
FAX:  (301) 594-9673

Direct inquiries regarding fiscal matters to:

Ms. Carol G. Clearfield
Grants Management Branch
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Westwood Building, Room 725B
Bethesda, MD  20892
Telephone:  (301) 594-9973
FAX:  (301) 594-9950

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic
Assistance No. 93.846, Arthritis, Musculoskeletal and Skin Diseases
Research.  Awards will be made under authorization of the Public
Health Service Act, Title III, Section 301 (Public Law 410, 78th
Congress, as amended, 42 USC 241) and administered under PHS grants
policies and Federal Regulations 42 CFR 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.

.

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