Full Text AG-95-004

ALZHEIMER'S DISEASE CORE CENTER GRANTS

NIH GUIDE, Volume 24, Number 14, April 14, 1995

RFA:  AG-95-004

P.T. 04

Keywords: 
  Senile Dementia 
  Biomedical Research, Multidiscipl 
  Etiology 
  Pathogenesis 
  Diagnosis, Medical 
  Treatment, Medical+ 


National Institute on Aging

Letter of Intent Receipt Date:  August 1, 1995
Application Receipt Date:  September 15, 1995

PURPOSE

The National Institute on Aging (NIA) invites applications from
qualified institutions for support of Alzheimer's Disease Core
Centers (ADCC) that are designed to serve as shared research
resources to facilitate research in Alzheimer's disease (AD).  The
NIA Alzheimer's Disease Centers program is authorized by the Public
Health Service Act, Section 445, and includes fourteen Alzheimer's
Disease Research Centers (ADRC) and fourteen ADCCs. ADCCs expand the
capacity of the applicant institution to conduct basic and clinical
research in AD by increasing the available research resources.  ADCCs
are expected to provide core resources that will enhance ongoing
research by bringing together biomedical, behavioral, and clinical
science investigators in a manner that will enrich the effectiveness
of research on the etiology, pathogenesis, diagnosis, treatment, and
prevention of AD, and ultimately improve health care delivery.  The
ADCC will also foster the development of new lines of research and
provide a suitable environment for fellows and junior faculty to
acquire research skills and experience in Alzheimer's disease
research. An ADCC is required to include administrative, clinical,
neuropathological, and information transfer cores.  Other cores can
be proposed.  Each ADCC will fund at least two pilot research
projects per year.  The ADCCs will provide well-characterized
patients, patient and family information, and tissue and other
biological samples for use in research projects.  Research activities
that use ADCC core resources will be supported through the usual NIH
and other federal agency mechanisms for the funding of
investigator-initiated applications in addition to non-federal
funding sources.

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), Alzheimer's Disease Core Center Grants, 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 202-783-3238).

ELIGIBILITY REQUIREMENTS

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.  No foreign or
international components will be considered in this RFA.
Applications from racial/ethnic minority individuals, women, and
persons with disabilities are encouraged.  At the time of award, the
applicant institution cannot have another Alzheimer's Disease Center
funded by the NIA.

Institutions eligible for Core Center Grants (P30s) are those at
which there are (1) at least five principal investigators with any
PHS agency research grant or comparable peer reviewed research
project (including those funded by State governments or private
foundations) related to neurodegenerative diseases, each with at
least two years of committed support remaining at the time of
application or (2) one or more program project (P01) grants related
to neurodegenerative diseases, which also have at least two years of
committed support remaining. If P01 grant(s) exist there should be no
overlap of the P01 cores with the P30 cores.

MECHANISM OF SUPPORT

The support mechanism for this program will be the NIH Core Center
Grant (P30).  Responsibility for the planning, direction, and
execution of the proposed center will be solely that of the
applicant.  Investigators may request up to five years of support.
The anticipated award date is July 1, 1996.

FUNDS AVAILABLE

The award of grants pursuant to this RFA is contingent upon the
availability of funds for this purpose.  The intent is to fund up to
eight new and/or competing renewal ADCC grants in Fiscal Year 1996.
The specific number will depend upon the merit of the applications
received and the funds available.  These applications do not compete
for funding within the general pool of dollars available for
investigator-initiated research proposals.  Only applications of
sufficiently high merit will be funded.  The direct costs requested
for new applications for each ADCC may not exceed $600,000 for the
first year.  Competing renewal applications may not request more than
a ten per cent increase of direct costs over the final year of
funding in the current award or $600,000, whichever is higher.
Direct cost requests for subsequent years may increase above the
prior year direct cost award no more than 4%. Awards made in response
to this RFA are renewable through the submission of a competing
continuation application.

RESEARCH OBJECTIVES

Background

Alzheimer's disease (AD) may presently affect up to 4 million older
people in the United States.  Although it is occasionally identified
in patients in their forties and fifties, it is most frequently
associated with advancing age.  It doubles in prevalence with every
five years past the age of 60; thus, extending life by ten years
quadruples the probability of the disease.  Alzheimer's disease is
the most frequent cause of institutionalization for long-term care,
and it destroys the active, productive life of its victims and
devastates their families financially and emotionally.  In 1993, it
was estimated that the United States spent as much as 100 billion
dollars/year for the direct and indirect costs of care for patients
with Alzheimer's disease.

Both the Executive and Legislative Branches of the Federal Government
have expressed concern about the enormity of the problem posed by
this disease.  Congressional concern about Alzheimer's disease has
focused on funding for research on the causes and treatment of the
disease, and on the cost of care. Congress directed the National
Institutes of Health (NIH), and in particular the National Institute
on Aging (NIA), to foster further research related to Alzheimer's
disease.

The long-range development plans for AD research have included
several strategies.  One of the most prominent was the development of
a cadre of Alzheimer's Disease Research Centers (ADRCs)  in major
university medical centers.  The ADRC program was designed to support
a multi-faceted approach to AD including clinical and other core
services, basic and clinical research, and other professional and
public information and education activities.

Alzheimer's Disease Core Center (ADCC) grants complement the ADRCs.
ADCCs provide core support to their respective research communities
upon which meritorious research programs can be constructed or
expanded.  The research will be supported through the usual NIH and
other investigator initiated funding mechanisms. The ADCCs provide to
the university investigators and research groups well characterized
patients, patient and family information, and tissue and biological
specimens for use in research projects.

While each ADCC will develop in accordance with local talents,
interests, and resources, each should be responsive to national needs
related to Alzheimer's disease.  ADCCs should be willing to work with
other Federal agency-supported Alzheimer's disease programs in
furthering mutual goals.  Potential applicants are encouraged to
utilize the strengths of their particular institutions in preparing a
plan that will cover the spectrum of required activities.  While
types of activities that should be included are indicated in these
guidelines, specific approaches for their accomplishment are left to
the applicant.

SPECIAL REQUIREMENTS

An Alzheimer's Disease Core Center will be an identifiable
organizational unit formed by a single institution or a consortium of
cooperating institutions.  Such a center will involve the interaction
of broad and diverse elements.  Therefore, lines of authority and
sanction by the appropriate institutional officials must be clearly
specified.

Each applicant institution will name an ADCC Director who will be the
key figure in the administration and management of the ADCC grant.
The Director will be responsible for the organization and operation
of the ADCC.  The Director should be experienced and respected and
must be able to coordinate, integrate, and provide guidance in the
establishment of new programs in Alzheimer's disease research and
allied areas.  A significant time commitment must be made by the
Director.  The Director must be demonstrably capable of providing
leadership in the coordination of the ADCC. An Associate Director may
be named who will be involved in the administrative and scientific
efforts of the Center.

The required elements of an ADCC for which funding is available
through the P30 mechanism are the administrative, clinical,
neuropathological, education and information transfer cores, and
pilot projects.  Additional cores may be proposed and justified as
required to advance the local research effort.

Cores

A core is a shared central laboratory or clinical research facility,
service, or resource.  Each core is directed by an investigator with
substantial expertise related to the core, usually a faculty-level
individual.  Core facilities may be proposed that will enhance
productivity or in other ways benefit a group of investigators to
accomplish the stated goals.  Two important and related
considerations are the degree to which currently funded investigators
will use and will benefit from core resources and, the degree to
which the resources will promote new and/or expanded AD research
efforts.  Applicants should document and describe briefly the
projects, both existing and planned, which will depend upon resources
provided by the cores (clinical and neuropathology cores, in
particular).

The ADCC cores support resources that allow or provide for the
following: the acquisition of subjects for research; the evaluation
and treatment of patients; the design and support of research
protocols; the neuropathological diagnosis of the disease;
documentation of the cognitive, behavioral and social consequences of
Alzheimer's disease; data collection and analysis; and training and
outreach programs related to Alzheimer's disease.  Consequently, each
application should  demonstrate the presence of, or propose methods
to achieve, the above capabilities.

Required Cores

Administrative Core

While the final administrative structure of the ADCC will, for the
most part, be left to the discretion of the applicant institution,
NIA's experience has demonstrated that the effective development of
Center programs requires interaction among the Director, the
principal investigators of the cores, the principal investigators of
research projects using the cores, appropriate institutional
administrative personnel, the staff of the awarding agency, and the
members of the community in which the Center is located.

The success of the ADCC is dependent upon the involvement of
scientific and professional personnel representing a variety of
disciplines and subspecialities who must be willing to relate to each
other in order to facilitate the development of new knowledge.  An
executive committee should be established to assist the Director in
making the scientific and administrative decisions relating to the
Center.  In addition to coordination of the ADCC, the Director, with
his or her executive committee, will be responsible for allocation
and monitoring of ADCC funds and the identification and selection of
key personnel.  It is essential that there be appropriate plans for
removing core support from projects that are no longer related to the
objectives of the ADCC.  The executive committee should be encouraged
to seek outside advice and consultation in its review of the
scientific content of the program.

In addition to the executive committee, it will be necessary to
establish an ad hoc review committee advisory to the ADCC Director.
The committee should be composed of scientists from outside the ADCC
with expertise relevant to the programs and interest of the ADCC. The
responsibility of this group will be to review the applications for
pilot studies.

An external advisory committee should also be established of
scientists from outside of the institution.  Unless already
appointed, members should not be recruited until the NIH grant review
is complete.  This committee will be used to evaluate the programs of
the ADCC, the effectiveness of communications within the ADCC, and
any other activities in which problems arise for which outside
expertise is required or desirable.  The committee should meet at
least once annually.  However, the nature of its responsibilities may
require occasional ad hoc meetings or teleconferences.  A member of
the NIA extramural program staff is to be invited to attend each
meeting as an observer.  The administrative requirements of the ADCC
will necessitate the assistance of an administrator with business
management expertise. It is important that such an official be
identified and directly involved with the fiscal and administrative
aspects of the ADCC application and grant.  The administrator should
be a member of the executive committee.  While budget formulation and
planning will undoubtedly begin with the Director in collaboration
with the scientific staff, the administrator must be involved in the
process and provide consultation in matters of fiscal administration
and evaluate such things as equipment on hand versus that requested
for the core facilities.  The administrator should attend the annual
ADCC Director's meeting and funds may be requested for this purpose.

It is expected that the ADCC administrative structure will facilitate
the following:

o  coordination and integration of ADCC components and activities;

o  review of utilization of funds, including funds for pilot studies;

o  support and advice for the ADCC Director in his/her efforts to
oversee the activities of the Center;

o  interaction with the scientific and lay communities to develop
relevant goals for the ADCC within the immediate environment of the
Center.

To facilitate communication between the ADCC and NIA, the NIA will
designate one member of its extramural program staff to work closely
with and act as a resource for the ADCC.  This individual will be in
a position to advise the director and/or administrator on policy
issues.  The ADCC application should include funds for travel of
director to at least one of the semiannual meetings of all Center
Directors, to provide an opportunity for coordination and exchange of
information.

Clinical Core

The clinical core serves the functions of patient registry, patient
coordination and follow-up, evaluation, clinical and laboratory data
gathering, and data coordination.  A clinical core may perform a
limited amount of developmental work, but may not engage in research
per se.  The developmental work allowable in a clinical core must be
directly related to the function of the core.  It may be directed
toward improving and expanding the core functions, e.g., improvement
of existing, or development of additional, methodologies, techniques
or services.  Proposed developmental work should be described as
completely as possible in the application.  Planning for patient
recruitment should include sensitivity to research design including
population-based epidemiological research.  Efforts to recruit
diverse population subgroups should be outlined.  Also include a
description of the types (with specific examples) of research
projects that will use the core and what benefits will obtain to
other research activities from the existence of the clinical core.

Neuropathology Core

This core will provide post mortem diagnosis on cases enrolled in the
clinical core and from other well documented Alzheimer cases.
Procedures and facilities should be described related to criteria for
diagnosis, and the collection, storage, and distribution of brain
tissue and other biological samples.  The procedure for prioritizing
the use of tissues and other biological samples should be discussed
along with a description of the research projects that will use
material from this core.  Data gathering and storage activities
should be well coordinated with those of the clinical core.

Education and Information Transfer Core

This core will support both the development of professional staff to
improve clinical and research skills related to Alzheimer's disease
and outreach programs that will publicize the ADCC and educate
families and other caregivers.  The methods and techniques to be
employed for information dissemination and the audience targeted
should be defined.  Attention should be directed to issues of
cultural sensitivity and, where appropriate, the information should
be structured so that it can effectively reach minority populations,
including non-English-speaking people. Clearly stated objectives and
a systematic plan as to how these objectives will be met are
required. Specific assessment methodology is also required.

Other Cores

The NIA, through the ADCC, will support additional cores that seem
likely to result in scientific accomplishments beyond those
attainable solely through support of the mandatory cores.  It is
important to note that support is not allowed for cores that only
replace or centralize resources supported on individual project
grants.  In a Core Center Grant application, it is not sufficient for
the principal investigator merely to identify such centralized
resources.  Rather, it must be demonstrated exactly how each core
would augment or enhance the present capabilities of the
investigators and make possible new activities.  There should be a
thorough discussion of the projects that will use core resources.

Pilot Studies

A plan to support pilot studies for biomedical, epidemiological, or
behavioral research should be included and budgeted in the
application.  The description of the plan to solicit, review and
administer pilot grants should be included in the Administrative Core
but a separate budget including the total request for pilots should
be submitted.  These funds may be used for new investigators,
investigators from other fields willing to bring their research
expertise to Alzheimer's disease, and investigators whose proposed
research would constitute feasibility testing. This funding mechanism
is intended to provide modest support that 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.

Pilot 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 study constitutes a
real departure from his or her ongoing research.  Pilot study support
is not intended for large undertakings of established investigators
for which it would be appropriate to submit separate research grant
applications.  Pilot funds are not intended to support or supplement
ongoing-supported research of an investigator.

Since eligibility for pilot studies is difficult to define, some
examples may be helpful:

o  A study proposed by an established investigator who has experience
in areas other than clinical research, and who wants to work in the
Alzheimer's disease research field; or study by an established
clinical investigator who wants to try a new hypothesis, method, or
approach that is not an extension of ongoing research.

o  A study proposed by a new investigator, with an interest in
research in Alzheimer's disease, before the study has developed to
the point of being suitable to apply for individual grant support.

o  A study to determine the availability of sufficient subjects with
specific characteristics, needed for a study of importance in
Alzheimer's disease research, for which conventional funding would be
sought if the study is deemed to be feasible.

Each pilot project is limited to no more than $20,000 direct costs.
If the pilot project is requested and justified for two years, the
direct costs are limited to $20,000 per year.

No pilot applications should be submitted with the ADCC application
but, instead, the number requested for each year (2 minimum) and the
plans for soliciting pilot proposals should be described.  A plan
must also be presented within the administrative core for peer review
of the pilot studies including the structure and composition of the
review panel.

Budget Considerations

All ADCC applications should request and provide justification for
five years of support.

The direct costs requested for new applications for each ADCC may not
exceed $600,000  for the first year. Competing renewal applications
may not request more than a ten per cent increase of direct costs
over the final year of funding in the current award or $600,000,
whichever is higher.  Direct cost requests for subsequent years may
increase above the prior year direct cost award no more than four
percent.

The total direct costs are to be distributed approximately as
follows: (This proposed distribution is intended only as a general
guideline and proportions may vary if needed and justified.   If
additional cores are proposed based on local needs, the distribution
may be adjusted accordingly.)

o   Administrative Core (including salary support)  ..........15
percent

o   Pilot Studies ............................................10
percent

o   Clinical Core ............................................50
percent

o   Neuropathology Core ......................................15
percent

o   Education and Information Transfer Core ..................10
percent

Support for secretarial and administrative staff may be provided to
the extent that their activities relate to administrative management
of the ADCC activities, providing these costs have not been included
in the institution's indirect cost pool.

Where large items of equipment are requested, the application must
document what is already available and provide clear justification in
terms of use by core staff and how they relate to research projects
dependent on the core.  General purpose equipment needs should be
included and justified only after surveying the availability of such
items within the institution.  Expenditures for major equipment are
not discouraged when well justified.

Research patient care costs (both inpatient and outpatient expenses)
will be considered in the context of other existing institutional
clinical resources.  Attempts should be made by the applicant
institution to utilize existing clinical facilities, such as General
Clinical Research Centers and individually supported beds.  Costs
relating to the clinical efforts of the ADCC may be funded through
the ADCC, provided there is no overlap of funding.  Only those
research patient costs directly related to ADCC activities may be
charged to the ADCC.

Domestic and foreign travel of project personnel directly related to
the core activities of the ADCC is allowable.  Plans should be
included for travel and lodging for at least one annual meeting of
the Center Directors and administrators.

Cost for consultant services (consultant fees, per diem, travel) may
be included when the services are required for the ADCC. Costs
associated with consultation for technical assistance or for
evaluation of ADCC activities, including costs for external
reviewers, are allowable.  Evidence must be presented that the
services are essential, are directly applicable to the objectives of
the ADCC, and cannot be provided by persons otherwise compensated
under the ADCC.

Costs directly related to the activities of the cores and their
administration may be requested and should be justified by the
particular circumstances of the applicant group.  However, such items
as telephone charges, postage, photocopying costs, memberships,
computer time, shop charges, and secretarial or administrative
services will undergo careful scrutiny.

Requests and commitments for pilots in competing applications (new
and renewal) will be budgeted, as a separate line in the "composite"
budget at $20,000 per pilot per year (without escalation).  They
should not be included in the Administrative Core or elsewhere in the
application.  A brief description of the pilot research and detailed
pilot budgets for the first year of funding will be due shortly
before the award of competing applications.  Indirect costs will be
provided in accordance with these budgets.

Pilot grants are allowed for consortium arrangements but direct cost
should not exceed $20,000 with total consortium cost budgeted not to
exceed $25,000 for each pilot.  No indirect costs will be provided to
the grantee for pilot projects conducted by consortia.

If consortium arrangements are contemplated, the following
information should be provided in the application:

o   A list of all proposed performance sites both at the applicant
institution and at the collaborating institutions.

o   A separate, detailed budget for the initial and future  years for
each institution and, where appropriate, for each unit of activity at
each institution.

o   A composite budget for all units of activity at each institution
for each year, as well as a composite budget for the total proposed
budget for each year.

o   An explanation of the programmatic, fiscal, and administrative
arrangements made between the grantee institution and the
collaborating institutions.

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.

Investigators also may obtain copies of the policy from the program
staff listed under INQUIRIES.  Program staff may also provide
additional relevant information concerning the policy.

LETTER OF INTENT

Prospective applicants are asked to submit, by August 1, 1995, a
letter of intent that includes a descriptive title of the proposed
research, the name, address, and phone number of the Principal
Investigator, the identities of other key personnel including
leadership of the cores, and the number and title of this RFA.  A
letter of intent is not an absolute requirement, is not binding, and
does not enter into the review of subsequent applications. The
information that it contains is helpful in planning for the review of
the applications.  It allows NIA staff to estimate the potential
review workload and to avoid conflicts of interest in the selection
of reviewers.  The letter of intent is to be sent to Dr. Creighton
Phelps at the address listed under INQUIRIES.

APPLICATION PROCEDURES

The application should be prepared using instructions in this RFA and
those in supplementary instructions for preparation of
multi-component applications available from the program staff listed
under  INQUIRIES.  Prior to submission of the formal application,
consultation with NIA program staff concerning the technical aspects
of preparing the application is strongly encouraged.

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 and from the Office of
Grants Information, Division of Research Grants, National Institutes
of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone
(301) 710-0267.  To identify these applications as being in response
to the RFA, check "YES" on item 2a of page 1 of the application and
enter the title:  "ALZHEIMER'S DISEASE CORE CENTER GRANT" and the RFA
number.  In item 2b enter P30.  The RFA label available the
application 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.  Submit a signed, original of the application,
including the Checklist, and three signed, exact 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 courier service)

The entire address should appear in UPPER CASE letters without
punctuation to allow optical scanners to read and sort mail.

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

Michael Oxman, Ph.D.
National Institute on Aging
Gateway Building, Room 2C212
7201 Wisconsin Avenue  MSC 9205
Bethesda, MD  20892-9205

Applications must be received by September 15, 1995.  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 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.

Page Limitation: Applications may not exceed a total of twenty-five
(25) pages for parts 1-4 of  each core.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by DRG
and responsiveness by NIA.  Incomplete applications will be returned
to the applicant without further consideration.  If NIA staff find
that the application is not responsive (those that fail to include
all required components, request amounts that exceed allowable
limits, or are not directed to the goals of this RFA) it will be
returned without further consideration.

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.  As part of this merit review, a
triage process may be used in which applications will be determined
to be competitive or non-competitive based on their scientific merit
relative to other applications received in response to the RFA.
Applications judged to be competitive will be reviewed in detail by
an initial  peer review group and also receive a second level of
review by the National Advisory Council on Aging.  Applications
determined 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 and the application withdrawn.
The factors to be considered in the evaluation of the merit of each
application will be those used in the review of the cores in standard
multi-project research grant applications.  Applicants should clearly
demonstrate the ways in which the ADCC will build the local research
program, will support on-going projects and will attract both senior
and new investigators to AD research.  Each application must be
thorough and complete enough to stand on its own and should be
prepared as if no site visit will occur. Additional materials or
revisions will not be accepted after the receipt date.  It is
strongly recommended that Institutional Review Board (IRB) and, if
appropriate, Institutional Animal Care and Use Committee (IACUC)
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. Applications failing to comply with this requirement
will be returned without review.  There will be no further
notifications on this issue.

Review Criteria

Listed below are the major review criteria to be used in the
evaluation of the ADCC applications; these criteria will be applied
to competing continuations by evaluating progress and to new
applications by evaluating preliminary work and plans for
implementation of the new program.

Research

o  The overall purpose of an ADCC is to increase the quantity and
quality of research in Alzheimer's disease within an applicant
institution.  The expected effect of the ADCC on the capacity of the
institution to conduct AD research and to secure extramural funding
will be a factor in review.

o  A base of ongoing high quality research dependent on core
resources and the potential to launch additional appropriate research
activities is a prerequisite for the establishment or continuation of
an ADCC and is an important component of the review.

o  The merit of the pilot grant program proposed in new applications
and the quality of pilots funded in the previous award period for
competing continuations will be the main criteria for evaluating the
pilot programs .

Administration

o  The scientific and administrative leadership  ability of the ADCC
Director and his/her staff, and their commitment and ability to
devote adequate time to the  management of the ADCC program.

o  The proposed administrative organization.

o  Coordination of ongoing research and its use of the ADCC. This
includes various mechanisms for internal monitoring.

o  Procedures for internal communication and cooperation among the
investigators involved in the ADCC.

o  Procedures for allocating the resources of the ADCCs in response
to requests made by investigators.

o  Mechanisms for selecting or replacing professional or technical
personnel within the ADCC.

o  Mechanisms for reviewing the use of, and administering funds for,
pilot projects.

o  Management capabilities that include fiscal administration,
procurement, property and personnel management, planning, budgeting,
etc.

o  For competing continuation applications, composition of the
advisory board.  Is it appropriate?  Will it have regularly scheduled
meetings?  Are its responsibilities defined?

o  The appropriateness of the ADCC budgets for the core resources.

Institutional Commitment

o  The institutional commitment to the program, including the lines
of reporting for the ADCC, and the institution's contribution to the
management capabilities of the ADCC.

o  The academic environment and resources in which the activities
will be conducted, including the availability of space, equipment and
facilities, and the potential for interaction with scientists from
other departments and components.

o  The institutional commitment to provision of adequate staffing.

o  The institutional commitment to helping recruit individuals
responsible for conducting essential ADCC functions.

Investigators

o  What are the qualifications of the participants? What are their
academic credentials and their research records?

o  What evidence is there of collaboration among the participants in
the ADCC?

o  Does the group have stability?

Facilities

o  Are available facilities adequate?  Are they reasonably contiguous
or physically separated?

o  If funds for renovation are requested, do these seem appropriate
in terms of available resources, including space and its utilization?

o  Will requested changes in facilities fit in satisfactorily with
available ones?

Cores

o  How does each proposed core fit into the overall research program?
Will it enhance collaborative and/or interdisciplinary research?

o  How many NIH-funded investigators will be using  each core, for
what purpose, and to what extent?  What is the anticipated future
use?

o  Would the proposed core(s) duplicate existing resources or
services?  If so, are the requested new resources justified?  Do
other grant funds already provide any of the requested capabilities?

AWARD CRITERIA

The anticipated date of award will be July 1996. Funding criteria
will be scientific merit (based on the review criteria listed above),
availability of funds, and programmatic priorities.

INQUIRIES

Inquiries are encouraged.  The opportunity to clarify any issues or
questions from potential applicants is welcome.  Inquiries regarding
programmatic issues, letters of intent, and requests for
supplementary guidelines may be directed to:

Dr. Creighton H. Phelps
Dementias of Aging Branch
National Institute on Aging
Gateway Building, Suite 3C307
7201 Wisconsin Avenue MSC 9205
Bethesda, MD  20892-9205
Telephone:  (301) 496-9350
FAX:  (301) 496-1494
Email:  phelps%nihniagw.bitnet@cu.nih.gov

Direct inquiries regarding fiscal matters to:

Linda Whipp
Grants Management Office
National Institute on Aging
Gateway Building, Room 2N-212
Bethesda, MD  20892-9205
Telephone:  (301) 496-1472
FAX:  (301) 402-3672
Email:  whipp%nihniagw.bitnet@cu.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 routing 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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