Full Text AG-96-003
 
CLAUDE D. PEPPER OLDER AMERICANS INDEPENDENCE CENTERS
 
NIH GUIDE, Volume 25, Number 12, April 19, 1996
 
RFA:  AG-96-003
 
P.T. 04

Keywords: 
  Aging/Gerontology 
  Clinical Medicine, General 
  Disease Prevention+ 
  Treatment, Medical+ 

 
National Institute on Aging
 
Letter of Intent Receipt Date:  July 10, 1996
Application Receipt Date:  September 18, 1996
 
PURPOSE
 
The National Institute on Aging (NIA) invites applications for
support of Claude D. Pepper Older Americans Independence Centers
(OAICs).  These centers are for the purpose of increasing
independence in older Americans. OAICs will provide support for
research to develop and test clinical interventions, and for core
laboratories in the basic sciences.  OAICs also will train
individuals in research approaches to develop and test methods of
maintaining and increasing independence, and to enhance expertise in
aging research through the provision of training in the relevant
fundamental scientific disciplines.  They will conduct demonstration
projects and information dissemination concerning the applications of
such research.  Centers should promote linkages between mechanistic
and outcome research and thereby foster the development by new
investigators of better clinical treatments and preventive
approaches.  It is recognized that the balance between support
devoted to intervention studies and fundamental science will differ
among Centers to take advantage of areas of strength in geriatric and
gerontologic research available at different institutions.  In those
instances where applications request significant core resources to
enhance ongoing projects, the number and quality of externally funded
peer-reviewed studies will be of special importance.  OAICs may
support a broad range of geriatric and aging research.  However,
applications with a predominant focus in neuroscience (with the
exception of stroke rehabilitation in older persons) or the
behavioral and social sciences are more appropriate for other NIA
centers' programs with a primary focus in these disciplines.
 
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), Claude D. Pepper Older Americans Independence
Centers, is related to the priority area of chronic disabling
conditions.  Potential applicants may obtain a copy of "Healthy
People 2000" (Full Report:  Stock No.017-001-00474-0 or Summary
Report:  Stock No.017-001-00473-1) through the Superintendent of
Documents, Government Printing Office, Washington, DC 20402-9325
(telephone 202/512-1800).
 
ELIGIBILITY REQUIREMENTS
 
Only U.S. organizations are eligible to apply.  Applications may be
submitted by domestic for-profit and non-profit organizations, public
and private, such as universities, colleges, hospitals, laboratories,
units of State and local governments, and eligible agencies of the
Federal government.  Racial/ethnic minority individuals, women, and
persons with disabilities are encouraged to apply as Principal
Investigators.
 
MECHANISM OF SUPPORT
 
Older Americans Independence Centers will be supported through the
comprehensive center grant (P60) mechanism. The awarding of funds
pursuant to this RFA is contingent on availability of funds.  All
pertinent DHHS, PHS, and NIH grant regulations, policies and
procedures are applicable.
 
FUNDS AVAILABLE
 
First year budgets may not exceed $1.6 million (direct plus indirect
costs).  Budget increments for subsequent years generally will be
limited to no more than one percent.  Awards are made initially for
no less than five years and may be renewed competitively for
five-year periods.
 
Although it is anticipated that up to $3.2 million will be directed
to the support of competing OAICs in Fiscal Year 1997 and $1.6
million in Fiscal Year 1998, and that two awards will be made in
Fiscal Year 1997 and one award in Fiscal Year 1998 from the
applications received in response to this RFA, issuance of an Older
Americans Independence Center award is contingent upon the receipt of
scientifically meritorious applications and allocation of
appropriated funds for this purpose.
 
RESEARCH OBJECTIVES
 
Millions of older Americans suffer from loss of abilities needed to
live fully independently.  Loss of independence imposes enormous
personal and financial burdens on older persons and their families.
The annual cost to the Nation for care of dependent older persons
totals billions of dollars.
 
Dependence is not inevitable in old age.  It results from disabling
conditions which are potentially, if not currently, preventable or
reversible.  The development and testing of interventions to reduce
disability and increase independence thus offers immense benefits and
potential savings in health care costs.
 
To date efforts to develop such interventions and test their efficacy
in maintaining and increasing independence have been modest, and the
number of researchers with the abilities to conduct such research has
been small.  There is a need for more researchers and research teams
with the ability to:
 
1) Conduct controlled clinical trials of promising interventions
against disabling conditions of older persons.
 
2) Fill gaps in knowledge of the pathophysiology of disabling
conditions, and of the mechanisms affecting their responses to
treatment, and develop and test improved treatments based on this
knowledge.
 
3) Develop and test ways of applying independence-enhancing advances
in treatment within the American health care system.
 
The combination of these three abilities would allow the conduct of
concerted research programs to increase independence for older
Americans.  The Claude D. Pepper OAIC program is designed to expand
this research and the number of researchers capable of conducting it.
 
Specifically, as authorized under amendments to Section 445A of the
Public Health Service Act, each OAIC will conduct:  "research into
the aging processes and into the diagnosis and treatment of diseases,
disorders and complications related to aging, including menopause,
which research includes research on such treatments, and on medical
devices and other medical interventions regarding such diseases,
disorders and complications, that can assist individuals in avoiding
institutionalization and prolonged hospitalization and in otherwise
increasing the independence of the individuals and programs to
develop individuals capable of conducting research in these areas."
As defined by Section 445A of the Public Health Service Act, "the
term independence, with respect to diseases, disorders, and
complications of aging, means the functional ability of individuals
to perform activities of daily living or instrumental activities of
daily living without assistance or supervision."
 
The overall goals of the OAIC program are:
 
1)  To facilitate the development and testing of interventions to
increase or maintain abilities needed for independence of older
persons.
 
2)  To use knowledge gained in these intervention studies in
developing and testing improved interventions.
 
3)  To strengthen core laboratories in the basic sciences as they
relate to aging research and to train researchers in the techniques
of fundamental research relevant to studies in aging and geriatric
medicine.
 
4)  To train researchers capable of leading and conducting research
programs as described in 1), 2), and (3) above.  OAIC research
projects should provide opportunities for the training of such
researchers.
 
5)  To translate OAIC research findings into improvements in health
care practice through demonstration and dissemination projects.
 
The components of OAICs derive from these goals.  OAICs will support:
 
INTERVENTION STUDIES (IS) AND INTERVENTION DEVELOPMENT STUDIES(IDS)
 
At least one Intervention Study or Intervention Development Study
which utilizes human subjects must be eligible for funding following
peer review to qualify as an OAIC.
 
Intervention Studies.  Proposed intervention studies must test the
efficacy of interventions to prevent or ameliorate functional
impairments contributing to loss of independence.  Studies may be of
effects on long-term disability and/or temporary disability following
illness or injury.  In studies of prevention interventions, a focus
on subgroups at high risk for disability is encouraged where
appropriate.
 
All Intervention Studies should measure direct effects on functional
status and have adequate statistical power to determine important
intervention effects on functional abilities.  Central in the
evaluation of these studies will be the adequacy and appropriateness
of the plans for measurements of changes in functional status.
Measures of related medical and physiologic endpoints are encouraged
wherever pertinent.
 
Because older persons with multiple health problems are at especially
high risk for disability, determinations of the efficacy of
interventions in such persons, and analyses of the effects of
different health problems on treatment efficacy, are encouraged where
feasible. Tests of interventions specifically designed against
disabilities resulting from the interaction of two or more comorbid
conditions are also encouraged.
 
Besides measurements of intervention effects on the above outcomes,
each proposed intervention study must also include planned
investigations of:
 
*  Mechanisms underlying the interventions' effects on functional
status, to provide a basis for further improvements in interventions.
Intervention interactions with intermediary response variables such
as underlying disease mechanisms, symptoms, and behavioral factors
should be measured and analyzed as needed for this purpose.
 
*  Factors affecting recruitment into the study and participants'
compliance, to provide data for potential wider applications of the
interventions are considered pertinent and must be included.
 
*  Cost-effectiveness and effects on health care utilization (e.g.,
hospitalizations, nursing home admissions and stays, use of home care
services) of the intervention(s) tested.
 
Applications for intervention studies that do not contain the above
elements will be returned to applicants.
 
Examples of types of interventions for study include:
 
*  Interventions to prevent or reduce frailty and increase physical
performance abilities.  Exercise, nutritional, pharmacologic,
rehabilitative, surgical, and other interventions against disorders
such as osteoarthritis, congestive heart failure, chronic pulmonary
disease, pathologic loss of muscle mass and/or strength,
protein-calorie malnutrition, dizziness, and gait and balance
problems are encouraged.
 
*  Interventions to reduce risk of disabling events such as hip
fractures and strokes, and to reduce impairments following these
events.  Studies of interventions against osteoporosis and to prevent
hip fracture, and studies of techniques to improve functional status
after hip fracture and strokes are encouraged.
 
*  Interventions to prevent or reduce disabling side effects from
medication use.  Examples include drug withdrawal studies and testing
of non-pharmacologic therapeutic alternatives, as well as testing
improved pharmacologic agents or regimens.
 
*  Interventions to prevent, lessen, or shorten temporary disability
from exacerbation or complications of chronic diseases of older
persons.  Examples include transient disability associated with
exacerbations of chronic pulmonary disease, deconditioning during
hospitalization, and acute confusional states.
 
*  Interventions to prevent or reduce disabling sequelae of menopause
and associated estrogen deficiency.  Examples include osteoporotic
fractures and urge incontinence.
 
*  Combined intervention strategies to prevent or ameliorate
disabilities in older persons with multiple impairments.
 
The above list is not exhaustive and its order is not intended to
reflect NIA priorities.  All studies of promising interventions to
enhance independence in older persons are encouraged.  No priority is
placed on having a diversity of intervention topics associated with a
single OAIC.  Applicants may find it advantageous to concentrate on
one or a few topics in which their strengths are greatest.
 
Subjects for these studies may include older persons living at home,
recipients of home care, nursing home residents, hospitalized
patients, and those in other pertinent clinical settings, as
appropriate to each intervention study.  Organizational liaisons
involving one or more medical centers, nursing homes, home care
services, and other care organizations are encouraged wherever
appropriate for the conduct of OAIC activities.
 
All activities to be performed by proposed cores as part of
Intervention Studies should be clearly described in the plans for the
Intervention Study itself.  Examples include functional assessment,
biostatistical support, etc.
 
Intervention Development Studies.  The OAIC center grant may support
other studies to identify, develop, or refine potential interventions
to preserve or increase independence.  Each proposed Intervention
Development Study should present a complete plan for conduct of the
proposed research, analogous in the level of detail to an individual
research project grant proposal.  It should be presented in
sufficient detail to allow for full scientific review.
 
Types of such studies include:
 
*  Tests of therapies on physiologic factors known to affect
functional status.  Both beneficial and adverse effects may be
studied.
 
*  Studies to identify or confirm reversible or preventible risk
factors for disability and/or disabling events.  Examples include
diseases, and previously unidentified pathophysiologic changes
leading to functional impairment and/or disabling events.
Large-scale epidemiologic studies are outside the scope of this RFA.
 
*  Studies of experimental therapeutics directed at the prevention or
treatment of morbid conditions associated with aging.  Research
utilizing animal and/or human subjects is appropriate. (If a study
utilizing animal  subjects is proposed, another study utilizing human
subjects must be included in the IS/IDS section.)
All activities to be performed by proposed cores as part of
Intervention Development Studies should be clearly described in the
plans for the Intervention Development Study itself. Examples include
functional assessment, biostatistical support, etc.
 
RESEARCH RESOURCES CORES (RRC)
 
Applicants may request core resource support to enhance the quality
of OAIC research projects, i.e., Intervention Studies, Intervention
Development Studies and Pilot Research Projects.  RRCs for the
support of laboratories in the fundamental sciences as they relate to
aging research or geriatric medical subspecialties may be requested
as well.  RRCs may also provide support for research projects
relevant to the mission of OAICs whose support is independent of the
OAIC. (e.g., R01, P01, R29, foundation Grant).  Opportunities to
participate in the scientific activities of RRCs should serve to
enhance the development of research skills of new investigators and
where appropriate should encourage linkages between fundamental
science and clinical intervention research.
 
Applicants should not propose a core unless it supports at least two
projects (otherwise the core could simply be included in the one
project it supports).  The justification for proposed cores
(including the merit and number of projects they would support) will
be evaluated by peer reviewers.  Routine patient care costs may not
be requested, but research-related patient care costs are eligible
for support.
 
Examples of possible RRCs include:
 
o  Recruitment/screening/assessment/registry units for subjects for
different OAIC intervention study research protocols.
 
o  Functional assessment units to monitor functional status of
subjects in OAIC studies.
 
o  Diagnostic and pathophysiologic units for studies of mechanisms of
treatment response and interactions with disease.
 
o  Basic science laboratories providing state of the art technologies
and training to center investigators.
 
o  Biostatistical/data management units.
 
o  Cost-effectiveness analysis units.
 
o  Veterinary Units for the support of laboratory animals used in
aging research and the development of animal models of age-associated
diseases.
 
The above list is not intended to describe the full range of
activities to be supported, nor to direct applicants towards these
areas.  Inclusion of research resources cores of any or all these
types in a single proposed OAIC is neither required nor necessarily
advisable.  Innovative organizational approaches are encouraged.
Institutions which are recipients of NIH General Clinical Research
Center awards who wish to apply for an (OAIC) award are encouraged to
use core resources from these Centers for support of OAIC projects
where appropriate.
 
For each Research Resources Core proposed, a core leader should be
named, and plans for the scientific and administrative functioning
must be presented.  The method for prioritizing access to core
resources requested by multiple projects should be described.
 
RESEARCH DEVELOPMENT CORE (RDC)
 
The Research Development Core is a required component of all OAICS.
The RDC will provide salary and other support for junior faculty and
research associates to acquire abilities in research to enhance the
independence of older persons.  This includes all phases of research
to develop interventions to enhance independence, including clinical
trials, studies of mechanisms of treatment response, and
cost-effectiveness/health care utilization studies.  The development
of persons who will have the necessary breadth and depth of
experience needed to lead teams spanning this range of research is of
high priority.  The career development of individuals acquiring
skills in fundamental aging research related to the mission of OAICs
may also be supported here.
 
The research development core should promote linkages between
mechanistic and outcome research.  This will enhance the capacity of
young scientists to develop better clinical treatments and preventive
approaches. This goal may be achieved in a variety of ways including
periodic meetings of center staff and other scientists and most
importantly through the provision of suitable training opportunities.
While the creation of these linkages is an important overall function
of the RDC, it is recognized that this will not in all cases be
feasible.  However, the plan for the educational program of the RDC
as a whole should describe the approach to be followed and the
training plan for at least one (preferably more) of the individuals
receiving support under the RDC should document how training
opportunities will be utilized to achieve the goal of creating these
linkages.
 
The components of the Research Development Core are:
 
Junior Faculty Development Support.  Support may be requested for
salary and fringe benefits for junior faculty participating in OAIC
Intervention Studies and other OAIC research.  The Research
Development Core should present a plan for achieving development of
junior faculty supported under this  component, including a mechanism
for monitoring their scientific progress and development toward
independent research.  Applicants should clearly specify the role of
senior mentors in training and supervising junior faculty and
research associates. A biographical sketch (two pages maximum), a
list of active research support, and a brief description of the
mentor's role in proposed OAIC activities should be provided for all
proposed mentors.
 
Though applicants are not required to identify individual junior
faculty, research associates, and their specific roles in advance,
they are encouraged to do so if possible, since this information is
useful to peer reviewers.  If support is requested for "to-be-named"
junior faculty or research associates, applicants should present
their plans for recruiting, training, and supervising these persons.
 
The Research Development Core may also serve to encourage the
research career development of other junior faculty and research
associates (in addition to those receiving salary support from this
core) by coordinating the participation in OAIC research projects of
other junior faculty and research associates whose salary support may
come from other sources. The overall contribution of the OAIC to the
development of researchers throughout the grantee institution who can
contribute to the development of independence-enhancing interventions
will be considered in the evaluation of OAIC proposals.
 
Didactic Training.  Support may be requested for didactic training in
such topics as clinical trials methodology, biostatistics, pertinent
topics in disease mechanisms and related basic sciences, behavioral
sciences, health services research, etc.  Such support is not
restricted to individuals receiving salary support from the core, but
may be provided to other personnel on OAIC research projects or OAIC
Intervention Development Studies.
 
Pilot and Feasibility Studies.  Pilot and feasibility studies may be
proposed.  New initiatives or pilot and feasibility studies for
biomedical, epidemiological, or behavioral research may be supported
by the RDC funding.  These funds may be used for new investigators,
investigators from other fields willing to bring their research
expertise to geriatrics research, and for investigators whose
proposed research would constitute feasibility testing.  This funding
mechanism is intended  to provide modest support which will allow an
investigator the opportunity to develop preliminary data sufficient
to provide the basis for an application for independent research
support through conventional granting mechanisms.
 
New initiatives, or pilot and feasibility studies, are typically
limited to a one-time nonrenewable award for a maximum of one year of
support.  In very special circumstances, which must be described and
well justified, two years of support may be requested.  Any one
investigator is eligible only once for pilot support, unless the
additional proposed pilot and feasibility study constitutes a real
departure from his or her ongoing research.  Pilot and feasibility
study support is not intended for large undertakings of established
investigators for which it would be appropriate to submit separate
research grant applications.  Pilot and feasibility funds are not
intended to support or supplement ongoing-supported research of an
investigator.
 
The proposals for the pilot or feasibility studies should present a
testable hypothesis and clearly delineate the question being asked,
detail the procedures to be followed, and discuss how the data will
be analyzed.  Each pilot project is limited to no more than $25,000
direct costs.  If the pilot project is requested and justified for
two years, the direct costs are limited to $25,000 per year.  A
maximum of $125,000 (direct costs) may be spent on Pilot and
Feasibility Projects.
 
Research Development Core Leader.  Support may be requested for a
core leader who will be responsible for coordination of the above
activities and must report annually on the progress of all
individuals supported thorough this core, and other core activities.
 
A maximum of $300,000 in total (direct plus indirect) first- year
costs may be requested for the Research Development Core. Budget
increments in future years will generally be limited to one percent.
 
DEMONSTRATION AND INFORMATION DISSEMINATION PROJECTS (DIDP)
 
OAICS must include a DIDP which supports activities to translate
findings from their research into health care practice.  These
activities would normally be expected to be conducted beginning in
the second year of the project, with the first year devoted to
planning. A maximum of $50,000 first-year total (direct plus
indirect) costs and $80,000 annual total (direct plus indirect) costs
for project years two through five may be requested for these
activities. (This sum is a ceiling, not a floor; if less is requested
in this core, more may be requested in other parts of the
application.) Specific projects for demonstration/ information
dissemination activities should be described.  The staffing plan and
a rationale for the organization of this core should be presented.
The methods and techniques to be employed for information
dissemination and the audience targeted and size should be defined.
Attention should be directed to issues of cultural sensitivity with
regard to the target audience. Where appropriate, the information
should be structured so that it can effectively reach minority
populations, including non-English-speaking older people.
 
Examples of projects that may be supported include dissemination of
research results to the public, professionals, and paraprofessionals,
through symposia and in-service training.  Planning and pilot
activities for larger scale demonstration projects to evaluate the
practicability of interventions tested in OAICs within various health
care settings are also appropriate.
 
LEADERSHIP/ADMINISTRATIVE CORE
 
Applicants may include a Leadership/Administrative Core which
requests funds for the OAIC director, OAIC administrator, and support
staff. The OAIC director should be a scientist who can provide
effective administrative and scientific leadership and coordination
with OAIC Intervention Studies.  An OAIC administrator who will
assist the director in managing the Center, addressing issues of
fiscal management and compliance with institutional, PHS, NIH and NIA
policies, should be identified.  A maximum of $120,000 (direct plus
indirect costs) per year for this core, for salary, travel, and other
expenses of the director, administrator and appropriate
administrative staff may be requested.  Future year annual increases
will generally be limited to no more than one percent.
 
OAIC Advisory Panel.  OAIC applications, regardless of whether a
Leadership/Administrative Core is requested, must describe a plan and
budget for the selection of experts from outside the OAIC who will
meet yearly to review the progress of the OAIC and provide a written
report to the OAIC Director.  Potential outside experts should not be
selected or named.  The outside experts' review will be included in
the annual OAIC Progress Report to the NIA.  (A member of the NIA
extramural staff assigned to each Center will routinely attend the
Advisory Panel meetings. It will be the OAIC Director's
responsibility to notify NIA Staff well in advance of the date
scheduled).
 
Coordination Among OAIC's.  OAICs are expected to meet together
yearly to compare research results and to explore possibilities for
collaborative efforts.  Funds should be requested to permit travel of
the OAIC director, administrator and on all OAIC Intervention
Studies, and Intervention Development Studies for meetings with NIA
staff and staff from other OAICs.  Responsibility for organizing
these meetings will rotate among OAIC sites.
 
Required Components of an OAIC.  The minimum required components
which must be determined to be eligible for funding by the peer
reviewers in order to qualify for an OAIC Award are 1) at least one
Intervention Study or Intervention Development Study 2) a Research
Development Core and 3) a Demonstration and Information Dissemination
Project.  All required components must be recommended for the full 5
years in order for the application to be eligible for funding.
 
The total first year budget may not exceed $1,600,000 (direct plus
indirect costs) and the total first year budget for the sum of the
Research Resources Cores, Research Development Core, Demonstration
and Information Dissemination Project and the
Leadership/Administrative Core may not exceed $1,275,000.  Thus, a
center application requesting the full $1,600,000 will have an
Intervention Study/Intervention Development Study first year total
budget request of at least $325,000.
 
INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN
SUBJECTS
 
It is the policy of the NIH that women and members of minority groups
and their subpopulations must be included in all NIH supported
biomedical and behavioral research projects involving human subjects,
unless a clear and compelling rationale and justification is provided
that inclusion is inappropriate with respect to the health of the
subjects or the purpose of the research.  This new policy results
from the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43) and supersedes and strengthens the previous policies
(Concerning the Inclusion of Women in Study Populations, and
Concerning the Inclusion of Minorities in Study Populations), which
have been in effect since 1990.  The new policy contains some
provisions that are substantially different from the 1990 policies.
 
All investigators proposing research involving human subjects should
read the "NIH Guidelines for Inclusion of Women and Minorities as
Subjects in Clinical Research," which have been published in the
Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted
in the NIH Guide for Grants and Contracts, Volume 23, Number 11,
March 18, 1994.
 
LETTER OF INTENT
 
Prospective applicants are asked to submit, by July 10, 1996, 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
NIA staff to estimate the potential review workload and to avoid
possible conflict of interest in the review.
 
The letter of intent is to be sent:
 
Stanley L. Slater, M.D.
Geriatrics Program
National Institute on Aging
Gateway Building, Room 3E-327
Bethesda, MD  20892-9205
Telephone:  (301) 496-6761
 
APPLICATION PROCEDURES
 
The research grant application form PHS 398 (rev. 5/95) is to be used
in applying for these grants.  Applications kits are available at
most institutional offices of sponsored research and may be obtained
from the Grants Information Office, Office of Extramural Outreach and
Information Resources, National Institutes of Health, 6701 Rockledge
Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267,
email:  ASKNIH@odrockm1.od.nih.gov.  The application should be
prepared using the OAIC (P60) Guidelines available from the program
administrator listed under INQUIRIES.
 
The RFA label available in the PHS 398 (rev. 5/95) 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 2 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
6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC, 7710
BETHESDA, MD  20892-7710,
BETHESDA, MD  20817 (for express/courier service)
 
At the time of submission, two additional copies of the application
must be sent to:
 
Michael Oxman, Ph.D., Chief, SRO
National Institute on Aging
Gateway Building - Room 2C212
Bethesda, MD  20892
 
Applications must be received by September 18, 1996.  If an
application is received after that date, it will be returned to the
applicant without review.  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
 
Page Limitation
 
Applications may not exceed a total of twenty-five (25) pages for
parts a-d of the Research Plan for each project and (10) pages for
each core section, with the exception of The Research Development
Core which may include an additional (10) pages for the Research Plan
of each pilot project.
 
Review Schedule
 
Upon receipt, applications will be reviewed for completeness by DRG
and responsiveness by the NIA.  Incomplete applications will be
returned to the applicant without further consideration.  The
applications that are complete and responsive to the RFA will be
evaluated for scientific and technical merit by an appropriate peer
review group convened by the NIA in accordance with the review
criteria stated below.
 
Proposals judged by the NIA Program Staff to be non- responsive
(those that are incomplete, fail to include all required components,
request amounts that exceed allowable limits, or are not directed at
the goals of this RFA) will be returned to the applicant without
review.  Because no site visits will be conducted, each application
must be thorough and complete enough to stand on its own.  Additional
materials or revisions will not be accepted after the receipt date.
It is strongly recommended that Institutional Review Board and, if
appropriate, Institutional Animal Care and Use Committee approval be
secured before the application is submitted. Otherwise, it is the
applicant's responsibility to ensure these certifications are sent to
the Scientific Review Office, NIA, within 60 days of the receipt
date, unless an earlier date is set by the Scientific Review
Administrator.  Applications failing to comply with this requirement
well be returned without review.  There will be no further
notifications on this issue.  Applications may first receive a
preliminary review by the review panel to establish those
applications deemed to be competitive. Applications considered to be
"non-competitive for funding" will be so designated, and an
abbreviated summary report noting the major weaknesses will be sent
to the principal investigator.  The remaining applications will be
given full review.  The full committee may designate additional
applications as "Not Recommended for Further Consideration."  Further
review will be by the National Advisory Council on Aging.  The
earliest start date will be July 1, 1997.
 
REVIEW CRITERIA
 
The primary criterion for review by the NIA review committee in
evaluating each OAIC grant application will be the effectiveness of
the proposed program in contributing to increasing independence for
older Americans through the conduct of research, demonstration, and
dissemination projects; and development of academic leaders in
geriatrics with effective research, teaching and clinical
capabilities.
Specific criteria related to this standard include:
 
1.  Scientific merit of research and its expected impact on the
maintenance of independent functioning of older persons.  For
competitive renewal applications, this will include an assessment of
achievements during the prior award period.
 
2.  Contribution of Research Resources Cores, where included, to
enhancement of research, training and pilot projects.  Where major
resources are requested for the RRCs, the number and quality of
externally-funded peer-reviewed studies will of considerable
importance.
 
3.  Role of the Research Development Core in providing educational
and other career development opportunities for fellows, junior
faculty and other professional and paraprofessional personnel
associated with the Center. The quality of the plans to promote
linkages between mechanistic and applied research are an important
aspect in the evaluation of the RDC.
 
Other review criteria include:
 
1.  Leadership ability and scientific stature of the program director
and his/her ability to meet the program's demands of time and effort.
 
2.  Qualifications, experience, and commitment of the investigators
responsible for core units and their ability to devote the required
time and effort to the program.
 
3.  Presence of an administrative and organizational structure
conducive to attaining the objectives of the proposed program.
 
4.  Arrangements for internal quality control of ongoing research,
the allocation of funds, day-to-day management, contractual
agreements, the internal communication and cooperation among
investigators in the program.
 
5.  Quality of proposed external review process.
 
6.  Appropriateness of the total budget and budgetary requests for
the individual components.
 
7.  Academic and physical environment as it bears on patients, space
and equipment and on the potential for interaction among scientists
within the center and with scientists from other departments,
institutions and Claude D.  Pepper Centers.
 
8.  Institutional commitment to the requirements of the program.
 
9.  The adequacy of the means for protecting against risks to human
subjects, animals and the environment.
 
10.  adequacy of plans to include both genders and minorities and
their subgroups as appropriate for the scientific goals of the
research.  Plans for the recruitment and retention of subjects will
also be evaluated.
 
AWARD CRITERIA
 
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:
 
Stanley L.  Slater, M.D.
Geriatrics Program
National Institute on Aging
Gateway Building, 3E-327
Bethesda, MD  20892-9205
Telephone:  (301) 496-6761
FAX:  (301) 402-1784
Email:  Slaters@GW.NIA.NIH.GOV
 
Direct inquiries regarding fiscal matters to:
 
David Reiter
Grants Management Office
National Institute on Aging
Gateway Building, Room 2N-212
Bethesda, MD  20892-9205
Telephone:  (301) 496-1472
Email:  ReiterD@GW.NIA.NIH.GOV
 
AUTHORITY AND REGULATIONS
 
This program is described in the Catalog of Federal Domestic
Assistance No.  93.866.  Awards are made under authorization of the
Public Health Service Act, Title IV, Part A (Public Law 78-410), as
amended by Public Law 99-158, 42 USC 241 and 285) 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.
 
The PHS strongly encourages all grant and contract recipients to
provide a smoke-free workplace and promote the non-use of all tobacco
products.  In addition, Public Law 103-227, the Pro-Children Act of
1994, prohibits smoking in certain facilities (or in some cases, any
portion of a facility) in which regular or routine education,
library, day care, health care or early childhood development
services are provided to children.  This is consistent with the PHS
mission to protect and advance the physical and mental health of the
American people.
 
.

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	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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