Subject: (Copy) NIH GUIDE - Vol. 20, No. 3, January 18, 1991 - RFA AG-9
From: Dot Baker <[email-masked]>
To: [email-masked]
Date: Wed, 16 Jan 91 14:27 EST

Paul,
  I couldnt remember whether or not I had send this to you.  If not,
Please post to the NIH Listserver as:
   RFAAG-91-08.910118
                  Dottie
 ---------------------------- Text of forwarded message -----------------------
 
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
 
I. BACKGROUND
 
The enormous public health impact of osteoporosis continues to grow.
This burden is concentrated heavily among persons over 65 years old.  In
particular, the vast majority of hip fractures occur in this age range,
causing hospitalization and temporary disability for over 215,000
persons per year, and long-term loss of independence for a significant
proportion of these.
 
The National Institute on Aging (NIA) has issued a Request for
Applications (RFA):  SITES TESTING OSTEOPOROSIS PREVENTION/INTERVENTION
TREATMENTS (STOP/IT) (AG-91-04) that solicits 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.
Investigators 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).
 
II.  RESEARCH GOALS AND SCOPE
 
The screening and recruitment of subjects age 65 and older, 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.  All studies should
include subjects (or tissues from subjects) over age 65, and may also
include subjects (or tissues from subjects) of younger ages, as needed.
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.
 
Applications submitted in response to this RFA should fully describe all
resources, personnel, and methods to be used in proposed studies, so
that applications may be reviewed without extensive cross-referencing to
the proposed intervention studies solicited in RFA AG-91-04.
 
III.  ELIGIBILITY AND MECHANISM OF SUPPORT
 
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 to Grants and Contracts 17, No. 28, September 2, 1988).
 
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 5 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 these
funds.) No single proposal may 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 4 percent.  Multiple proposals
may be submitted by each applicant institution.  It is anticipated that
approximately eight 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.
 
Generally, future competing renewal applications will compete with all
investigator-initiated applications and be reviewed by the Division of
Research Grants (DRG).  However, should the NIA determine that there is
a sufficient continuing program need, the RFA may be reissued.  The
earliest feasible start date for the initial awards will be September
30, 1991.
 
SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF
NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN
CLINICAL RESEARCH STUDY POPULATIONS
 
NIH and ADAMHA policy is that applicants for NIH/ADAMHA 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 population 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/offerors 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 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
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 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.
 
IV. 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.  Proposals judged by
the NIA to be non-responsive (those not directed at the goals of this
RFA) will be administratively withdrawn and returned to the applicant
without review.  Proposals may first receive a preliminary review by a
subcommittee of the review panel to establish those applications deemed
to be competitive.  Those proposals judged noncompetitive will be so
designated, and an abbreviated summary statement noting the major areas
of concern will be sent to the Principal Investigator.  Applications
judged to be competitive will be given full review.  Following review by
the initial review group, the applications will be considered by the
National Advisory Council on Aging.
 
Listed below are the major review criteria to be used in the evaluation
of the applications received in response to this RFA:
 
o     scientific merit of the research proposed;
 
o     significance of the research project to the goals of the RFA;
 
o     qualifications, experience, and commitment of the investigators, and
      their ability to devote the required time and effort to the
      project;
 
o     appropriateness of the total budget and budgetary requests; and
 
o     institutional commitment to the requirements of the project.
 
V. Method of Applying
 
A letter of intent to submit an application, while not required, is
requested.  The letter should include a descriptive title, the name and
address of the principal investigator and other key investigators as
well as identifying any other participating institutions.  This letter
must be addressed to the staff contact listed below (see VI below) by
March 15, 1991.  Applications must be submitted on the standard PHS-398
application form (revised October 1988), available at most institutional
business offices or from the Division of Research Grants, NIH, telephone
(301) 496-7441.  Institutions submitting multiple proposals must submit
each on a separate PHS-398 form.  On item 2 of the face page of the
application, applicants must enter:  NIA RFA-- 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 and
placed on the top of the entire package.  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
completed application and four copies must be sent to:
 
Application Receipt Office
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**
 
When the application is submitted to the Division of Research grants,
two copies of the application must be sent to:
 
Chief, Scientific Review Office
National Institute on Aging
Building 31, Room 5C12
9000 Rockville Pike
Bethesda, MD  20892
 
Failure of these copies to be received by the deadline may prevent the
application from being reviewed under this announcement in time to be
considered for an award.
 
VI.  STAFF CONTACT
 
Potential applicants interested in obtaining further information may
write or call:
 
Stanley L. Slater, M.D.
Geriatrics Program
National Institute on Aging
Room 5C27, Building 31
National Institutes of Health
Bethesda, MD  20892
Telephone:  (301) 496-6761
 
This program is described in the Catalog of Federal Domestic Assistance,
Number 93.866.  Grants are awarded under the authority of the Public
Health Service Act (Section 301 42 USC 241) and administered under PHS
grant policies and Federal Regulations, most specifically at 42 CFR Part
52 and 45 CFR Part 74.  This program is not subject to review by a
Health Systems Agency.