ALZHEIMER'S DISEASE DATA COORDINATING CENTER

Release Date:  February 5, 1998

RFA:  AG-98-004

P.T.

National Institute on Aging

Letter of Intent Receipt Date:  May 15, 1998
Application Receipt Date:  August 12 ,1998

PURPOSE

The National Institute on Aging (NIA) invites cooperative agreement
applications from qualified institutions for support of an
Alzheimer's Disease Data Coordinating Center (ADDCC) which is
designed to serve as a shared research resource to facilitate
research in Alzheimer's disease (AD).  The NIA Alzheimer's Disease
Centers (ADC) program is authorized by the Public Health Service
Act, Section 445, and includes fourteen Alzheimer's Disease
Research Centers (ADRC) and thirteen Alzheimer's Disease Core
Centers (ADCC).

Alzheimer's disease research would benefit from analysis of
combined data collected systematically from all of the existing
ADCs and, eventually, from other sources where longitudinal data
are collected.  Such data on demented patients and unaffected, age-
matched controls would support 1) clinical, molecular and
pathological research on disease natural history, heterogeneity,
diagnosis and clinical-pathological correlations; 2) demographic
information important for policy research and 3) epidemiological
research related to the identification of risk factors.  At the
present time, information is being collected and stored separately
at the 27 Alzheimer's Disease Centers.  This planned initiative
will help systematize data collection and analysis across centers
and create a central data coordinating center where data from all
ADCs can be combined, coordinated, and made available to
researchers from the ADCs and to the wider research community.  The
data coordinating center will assemble, maintain, analyze and
disseminate data; catalog brain tissue and other  biological
samples stored at the ADCs; serve as a study design and statistical
consulting resource for ADCs utilizing the database; and coordinate
semi-annual meetings of the ADCs  to discuss progress and planning
for shared initiatives. The primary objectives will be to : 1)
establish and maintain a data base of clinical, pathological and
biochemical information collected at the ADCs from persons with
Alzheimer's disease and related disorders and from unaffected age-
matched controls; 2) provide assistance to investigators in
planning and conducting research studies using the database; and 3)
make available data and a catalog of tissues and other biological
samples collected from AD patients and controls for use in
epidemiological, clinical, molecular and pathological studies by
qualified investigators.  With the establishment of this data
coordinating center, important and novel research issues can be
addressed which would not be possible with the resources available
at any one center.  Research activities that use  ADDCC resources
may be supported through the usual National Institutes of Health
(NIH) and other federal and non-federal sources for the funding of
investigator-initiated applications.

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
Data Coordinating Center, 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

Applications may be submitted by domestic 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. The applicant organization should have experience in
functioning as a data coordinating center for clinical studies of
a medical and/or behavioral nature, or in other large-scale data
management and analysis projects and have knowledge about the
unique characteristics of Alzheimer's disease and related
dementias, the NIA Alzheimer's Disease Centers Program, and the
status of current AD research, including important unanswered
questions that could be addressed using the larger data sets.

MECHANISM OF SUPPORT

The administrative and funding instrument to be used for this
program will be a cooperative agreement (U01) , an þassistanceþ
mechanism in which a substantial involvement between NIA program
staff and the awardee is anticipated during performance of the
activity. Under the cooperative agreement, the NIA's purpose is to
support and/or stimulate the recipient's activity by involvement in
and otherwise working jointly with the award recipient in a
partnership role, but it is not to assume direction, prime
responsibility, or a dominant role in the activity.  Details of the
responsibilities, relationships and governance of the study to be
funded under this cooperative agreement are discussed later in this
document under the section þTerms and Conditions of Awardþ.

The total project period for applications submitted in response to
this RFA may not exceed five years.  The anticipated award date is
July 1, 1999.  The ADDCC will be recompeted every five years,
depending upon available funds.

FUNDS AVAILABLE

It is anticipated that one award for a Data Coordinating Center
will be made, with an estimated total cost of $3,000,000 (including
direct and indirect costs) in the first year. The award of the
Cooperative Agreement pursuant to this RFA is contingent on the
availability of funds for this purpose.

RESEARCH OBJECTIVES

A.  Background

Alzheimer's disease may presently affect up to 4 million older
people in the United States.  Although it is occasionally
identified in persons in their forties and fifties,  it is most
frequently found in persons over the age of 65.  It doubles in
prevalence with every five years past the age of 65; 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;  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 and, with the growth of the elderly
population, the prospect of an even greater problem in the future. 
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, and in particular the National Institute on Aging, 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 Centers to support a
multi-faceted approach to AD including clinical and other core
services, research on basic mechanisms and clinical course of the
disease, and professional and public information and education
activities.  The ADCs provide to university investigators and
research groups well characterized patients and controls,
information about patients and families, and tissue and biological
specimens for use in research projects.  Collection of data from
these resources in a central data center will provide opportunities
for new and larger scale collaborative studies on Alzheimer's
disease than were possible in the individual ADCs.

B.  Research Goals and Scope

Applications should present a plan for a data coordinating center
which includes approaches to the following activities and any
others that would complement the functions outlined here:

1)  Data Coordination

a. assume responsibility for the minimum common database (tracking
approximately 50 variables) currently in existence to which all
ADCs contribute basic demographic, clinical and pathological
information about patients in a standard format; to gradually
expand this database and plan links to ADC databases which will
include information of greater depth and breadth about the
clinical, pathological, genetic and demographic status of the
patients and controls.  Expansion will entail surveying all
existing ADC database structures and proposing ways to integrate
common variables and index non-conforming variables in a central
database. This will include setting up the central database and
collecting, editing, verifying, reformatting and assisting in the
analysis of the data.  The ADDCC will assure quality control and
provide appropriate detailed data reports to the steering committee
and the NIA at regular intervals;

b. propose a plan for orderly transfer of the data from the Interim
Data Center, currently in operation, to the new Coordinating Center
and to the NIA or another Data Coordinating Center at the end of
the funding period, if necessary;

c. propose a time frame for complete data migration from all ADCs
to the ADDCC;

d. facilitate ADC participation in further data sharing efforts and
studies using the databases;

e. develop protocols for data collection, formatting and
transmission to and from individual ADCs and the ADDCC

f. propose a mechanism to protect the rights of individual Centers
to conduct studies on patients recruited to that Center while still
contributing clinical and pathological core data to the
Coordinating Center;

g.  prepare a catalog of all tissues, biological specimens, cell
lines, reagents and molecular probes available from each of the
ADCs and distribute the catalog to investigators both within and
outside of the ADCs;

h.  develop and maintain a comprehensive set of procedures to
assure data quality and also procedures to assure confidentiality
of subjects

i.  develop training programs to educate ADDCC staff and ADC staff
about operating procedures with the goal of maximizing efficiency
of data operations;

j.  develop procedures to publicize the kind of data available in
the ADDCC and the procedures for getting access to it.

2)  Consultation on study design and statistical analysis

a. provide statistical advice and consultation on study design to
investigators involved in studies approved by the Steering
Committee and to encourage maximum use of the data;
 collected by the data center

b. provide  assistance in planning for recruitment of individuals
for prospective epidemiological, genetic and clinical studies;

3) Coordination of meetings and reports

a. establish a steering committee to oversee ADDCC operations made
up of representatives from the ADCs, specialized consultants, the
Principal Investigator of the ADDCC and NIA staff; The steering
committee must be kept informed and approve of any changes in
policy;

b. organize at least two meetings each year of the ADDCC Steering
Committee and also organize regular teleconferences to allow the
steering committee to monitor operations and approve changes in
procedures; provide administrative support to semi-annual meetings
of the ADC Directors and annual meetings of the ADC Administrators,
Education and Neuropathology Core leaders;

c. prepare regular reports as defined by the steering committee and
the NIA and special reports when requested;

d. develop a Manual of Operations in conjunction with the Steering
Committee;

4.) Pilot studies

a. provide funding for pilot or feasibility studies involving joint
efforts between one or more of the ADCs and the ADDCC, and using
data from or specimens cataloged by the ADDCC;

C.  Minimum Requirements for the Staff of the Data Coordinating
Center

1)  Staff must be prepared to cooperate in all data coordination
activities with the NIA and the ADCs.

2)  The key staff must demonstrate prior experience in complex
large-scale collaborative studies
and have experience arranging logistical services for complex
studies.

3) The Principal Investigator and/or other key staff must present
evidence in the form of publications or descriptions of previous
experience that demonstrates their knowledge of Alzheimer's disease
and related dementias research and familiarity with the AD research
literature including genetics, epidemiology, molecular pathogenesis
and clinical course of the disease.

4) The PI and /or key staff must demonstrate familiarity with the
structure and operations of NIA Alzheimer's Disease Centers.

5) The Principal Investigator must be willing to commit at least
25% effort to this Coordinating Center.

6) The Principal Investigator and other staff must have appropriate
expertise and capability in biostatistics, data management, data
analysis, and project management.

7) The Center staff must have the ability to assist in designing
protocols, study manuals and data collection systems, including
distributed data entry and plans for data analysis.

8) The Center staff must have experience in developing and
maintaining data quality control systems.

9) The Center staff should have the ability to generate regular
reports for studies approved by the Steering Committee, for use of
the NIA, or other special reports as needed.

10) The Center staff must demonstrate successful experience in
assisting clinical investigators prepare manuscripts for
publication that utilize data gathered from collaborative research.

11) The Center staff must provide evidence of their prior
management capability for the following: a) to estimate appropriate
and reasonable resources needed for individual projects in its role
as a Data Coordinating Center; b) to manage resources efficiently
during the research; c) to adjust assigned resources to changing
demands as the research work progresses; d) to keep NIA informed of
changes of resource allocations; and e) to subcontract with
affiliated ADCs or other outside organizations.

SPECIAL REQUIREMENTS

Terms and Conditions of Award

The Alzheimer's Disease Data Coordinating 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.

The administrative and funding instrument used for the ADDCC is the
cooperative agreement  (U01),  an "assistance" mechanism  (rather
than an "acquisition" mechanism), in which substantial NIH
scientific and/or programmatic involvement with the awardee is
anticipated during the performance of the activity.  Under the
cooperative agreement, the NIH purpose is to support and/or
stimulate the recipient's activity by involvement in and otherwise
working jointly with the award recipient in a partner role, but it
is not to assume direction, prime responsibility, or a dominant
role in the activity. Consistent with the cooperative agreement
concept, the dominant role and prime responsibility for the planned
activity resides with the awardee for the project as a whole,
although specific tasks and activities in carrying out the activity
will be shared between the awardee and the NIA Program Official.

The following terms and conditions will be incorporated into the
award statement and provided to the Principal Investigator as well
as to the institutional officials at the time of the award.  These
terms are in addition to, not in lieu of, otherwise applicable
Office of Management and Budget (OMB) administrative guidelines, 
HHS Grant Administration Regulations at 45 CFR Part 74 and 92, and
other HHS, PHS,  and NIH Grants Administration policy statements.

A.  Awardee Rights and Responsibilities

The awardee will have substantial and lead responsibilities in all
tasks and activities.  These include data collection, quality
control, final data analysis, and assistance with preparation of
publications. The awardee agrees to work cooperatively with the
ADCs and agrees to accept guidance from the ADDCC Steering
Committee and to follow the Manual of Operations approved by the
Steering Committee.

B.  NIA Staff Responsibilities

The NIA will name a Program Official from within the Dementias of
Aging Branch of the Neuroscience and Neuropsychology of Aging
Program whose function will be to assist the Principal Investigator
and the Steering Committee in oversight of the Coordinating Center. 
The Program Official will be a non-voting member of the steering
committee and all key study group subcommittees.  The Program
Official will have substantial scientific-programmatic involvement
including participation in database development, budget monitoring,
identification of relevant research questions, selection of pilot
studies, modification of protocols, quality control, data analysis
and interpretation, preparation of publications, and coordination
and performance monitoring.  The prime responsibility for these
activities resides with the awardee although specific tasks and
activities in overseeing the studies will be shared between the
awardee and the NIA Program Official.

The NIA reserves the right to terminate or curtail the award in the
event of a lapse in data reporting, quality control, or other major
breach of the protocol.

C.  Collaborative Responsibilities

The ADDCC Steering Committee will include the ADDCC Principal
Investigator, the NIA Program Official,  the three members of the
ADC Directors' Executive Committee and three additional ADC
Directors elected from the ADC Directors group. Two other outside
members with data center expertise shall be appointed by the
Steering Committee.  A Chairperson will be elected from the
membership of the Steering Committee.  The Principal Investigator
of the ADDCC and the NIA Program Official are ineligible to serve
as chair. A staff member from the NIA Grants and Contracts
Management Office will serve in an advisory capacity to the
committee.  The functions of the Steering Committee are to oversee
the expansion of the minimum database and the setting up of the
data center; approve operating procedures and changes in operating
procedures; identify, prioritize, and review study topics; consider
the relevant research questions and available resources; review
proposals for feasibility studies submitted for funding by the
ADDCC; consult with and advise the leadership of the ADDCC and the
NIA and monitor the data center's progress in meeting goals; help
the ADDCC analyze and interpret data from studies associated with
the ADDCC; and approve the composition of a publications committee.
The Steering Committee can act as the Publications Committee or it
may select a Publications Committee, composed of representatives
from the ADCs, that will make decisions about publication policies
including authorship and will review all manuscripts before
publication.  The awardee will be required to accept and implement
the procedures approved by the Steering Committee.

D.  Arbitration

Any disagreement that may arise on scientific/programmatic matters
(within the scope of the award) between recipient and the NIA may
be brought to arbitration.  An arbitration panel will be composed
of three independent members - one selected by the Steering
Committee, a second member selected by NIA,  and the third member
selected by the two prior selected members.  This special
arbitration procedure in no way affects the awardee's right to
appeal an adverse action that is otherwise appealable in accordance
with the PHS regulations, 42 CFR Part 50, Subpart D and HHS
regulation, 45 CFR Part 16.

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 policy results from the NIH Revitalization Act of
1993 (Section 492B of Public Law 103-43).

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, No. 11, March 18, 1994.

LETTER OF INTENT

Prospective applicants are asked to submit, by May 15 , 1998, a
letter of intent that includes a descriptive title of the proposed
ADDCC, the name, address, and phone number of the Principal
Investigator, the identities of other key personnel, 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. 
Prior to submission of the formal application, consultation with
NIA program staff concerning the technical aspects of preparing the
application is strongly encouraged. A page limit of 75 pages for
the research plan in applications responding to this RFA should not
be exceeded.

The current version of the research grant application form PHS 398
is to be used in applying for these grants. These forms are
available at most institutional offices of sponsored research, from
the World Wide Web at
http://grants.nih.gov/grants/funding/funding.htm, and from the
Division of Extramural Outreach and Information Resources, National
Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892-
7910, telephone (301) 435-0714, Email: ASKNIH@od.nih.gov.

To identify these applications as being in response to the RFA, the
RFA label available in the Application Form 398 must be affixed to
the bottom of the face page.  Failure to use this label could
result in delayed processing of the application such that it may
not reach the review committee in time for review. In addition the
RFA title: "ALZHEIMER'S DISEASE DATA COORDINATING CENTER" and the
RFA number must be typed on line 2 of the face page of the
application.

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

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040-MSC 9205
Bethesda, MD 20892-7710
Bethesda, MD 20817-7710 (for courier/overnight service)

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

Dr. Mary Nekola
Chief, Scientific Review Office
National Institute on Aging
Gateway Building - Room 2C212
7201 Wisconsin Avenue  MSC 9205
Bethesda, MD 20892-9205
ATTN: Alzheimer Data Coordinating Center

Applications must be received by August 12, 1998.  If an
application is received after that date, it will be returned to the
applicant without review.

CONTENT OF APPLICATION

The application should have 1) an introduction  2) a description of
capabilities and experience of the key personnel,  3) a research
plan for the first five years of the data center, and  4) a budget
with justification of all expenses.  The description and research
plan must incorporate the following minimum requirements.

A. Description of Capabilities and Experience

1.  Describe the applicant organization's facilities, resources,
and how the staff's strengths in biostatistics, data management,
data analysis, and project management skills have been used in
previous, successful large-scale collaborative research.

2.  Describe the extent of involvement of the Principal
Investigator in previous large-scale, collaborative research.

3.  Describe the knowledge and experience of the Principal
Investigator and/or other staff in research on Alzheimer's disease
and related dementias and knowledge of the structure and operations
of the NIA Alzheimer's Disease Centers.

4.  Describe the experience of the key personnel in assisting
protocol design, data entry procedures and manual preparation, and
in data collection for previous large-scale, complex research
projects.

5.  Describe the experience of the applicants in data quality
control in previous large-scale, collaborative research.

6.  Present the applicant's record in generating reports on data
collection and performance in previous large-scale collaborative
projects.

7.  Summarize the applicant's contributions in preparing
manuscripts from previous large-scale, collaborative research.

8.  Describe how logistical services and organizational support
have been developed and utilized in managing resources and
monitoring performance in previous large-scale, collaborative
research.

B.  Research Plan

1.  Describe the applicant's conception of the role of the Data
Coordinating Center in furthering Alzheimer's disease research
using large data sets.

2.  Describe in detail examples of studies on Alzheimer's disease
etiology, pathogenesis and clinical course that would be feasible
using an expanded data set, including any new  data that would need
to be collected  for the studies.  Include appropriate citations
from the scientific literature.  Describe the statistical methods
to be used, the unique analytic challenges these studies may face,
and strategies for dealing with these challenges

3.  Provide a statement of intent to collaborate with all of the
ADCs and the NIA consistent with the terms of the award.

4.  Describe, in detail, plans for rapidly migrating data from the
existing interim data center (information about the structure and
function of the interim data center is available upon request) to
the new data coordinating center, expansion of these data-sets, and
plans for orderly transfer of the data to another center or the NIA
at the end of the funding period, if necessary.

5.  Describe the platform for the database, stages of development,
and procedures for maintaining data integrity and assuring
confidentiality.

6.  Describe the nature of additional data, over the minimum data
set, to be collected and a timetable for implementation of further
data collection.

7.  Propose an idealized staffing pattern for providing data
coordinating functions from protocol design through analysis,
reporting and dissemination.

8.  Propose an operational structure for providing and coordinating
the data functions for several research protocols simultaneously.

9.  Propose an administrative and management structure that would
support and enhance the operational structure.

10.  Propose a plan to provide logistical support for the
semiannual meetings of the Steering Committee of the ADDCC and the
ADC directors in addition to annual meetings of the ADC
administrators, and the Education and Neuropathology Core Leaders.

11.  Propose methods to be used to assure effective communication
among the ADDCC, the participating ADCs and the NIA using the
capabilities of the Internet and World Wide Web while preserving
confidentiality of data.

12.  Describe a method for reimbursing individual ADC costs for
collecting, preparing, and submitting data to the central data
coordinating center.

13.  Outline a process for soliciting, reviewing, and funding small
feasibility studies which would involve collaboration among the
ADCs using data coordinated by the ADDCC.

14.  Propose a process for initial cataloging of all brain and
other biological specimens and reagents banked by the ADCs and for
preparing a biannual inventory of specimens from the ADCs.

15.  Describe a proposed operating arrangement with the ADCs to
determine how permission will be granted to access, use and publish
data available in the data center.

16.  Propose a charter for the Steering Committee, using
information about its functions described in this RFA, which can
then be modified and adopted by the Steering Committee once it is
established.

C.  Budget Considerations

All ADDCC proposals should request and provide justification for
five years of support.

The total costs (direct plus indirect) requested for  applications
for the ADDCC may not exceed $3,000,000  for the first year. 
Direct cost requests for subsequent years should reflect any
projected growth and  inflationary increases limited to no more
than 3% per year.

In addition to personnel, equipment, and supplies, budgeting should
include funds for:

- Feasibility studies -  for ADCs and/or groups of ADCs to conduct
cooperative pilot studies ($30,000 -$50,000/study ) using data
collected by the ADCs (approximately 10% of budget)

- Subcontracts to the ADCs for local cost recovery for expanded
data collection,  beyond the minimum data set, including formatting
and preparation of data for transmission to the data center
(approximately 50% of budget)

- Costs for logistical arrangements (e.g., meeting room rental,
audio video expenses, speaker expenses, etc.) of two meetings each
year for the ADDCC Steering Committee and the  ADC Directors, and
one meeting each year for the ADC Administrators, Education Core
and Neuropathology Core leaders.  Travel funds for the Steering
Committee Meeting (but not ADC meetings) should be budgeted as well
as funds for regular teleconferences for the Steering Committee.

- Costs for training ADC and ADDCC staff

D.  For consortium arrangements, the following information should
be provided in the application:

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

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

3.  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.

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

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by the
Center for Scientific Review (CSR) 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
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 are listed below 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 ADDCC applications:

1.  The organizational and administrative structure of the proposed
program including evidence of the degree of commitment and support
of the organization/institution for the proposed  program and the
relative positions of the proposed project staff within the
applicant's organizational structure.

2.  The scientific merit of the proposed approach to data
collection, management and coordination, as outlined in the RFA. 
Documentation of the specific competence and previous experience of
professional, technical, and administrative staff pertinent to the
data center. Prior experience should be demonstrated in similar
studies, for the collection of data from multiple locations,  as
well as experience in monitoring the quality and timeliness of such
data.

3.  Documentation of the specific competence and previous
experience of professional staff with the unique features of
Alzheimer's disease and related dementias research and the NIA
Alzheimer's Disease Centers Program.  The extent to which uses for
data collected in the Center demonstrate an understanding of this
complex disease process and logical approaches to answering
questions fundamental to the disease.

4.  Demonstrable knowledge of the potential problems associated
with the conduct of this project and possible solutions.

5.  Suitability of proposed data management and data analysis
plans, the adequacy of the proposed facility  and technical
hardware and appropriateness of the budget for the work proposed.

6.  The approach to, and likelihood of, soliciting cooperation from
the ADCs while exercising appropriate leadership in matters of
study design, protocol revisions, data acquisition, management, and
analysis.  Specific plans for ensuring quality control of data
collection and confidentiality across all study sites are required.

7.  Suitability of a plan to assume management of data already
collected by the Interim Data Center, for a rapid and orderly
transition from the current system to a new system, and for
transferring data to a new grantee at the end of the award period
or to the NIA, if necessary.

8.  Suitability of plans to manage a pilot studies program
including solicitation , review and funding of pilot or feasibility
studies.

9.  Suitability of plans for managing meetings of the steering
committee and the ADC meetings.

AWARD CRITERIA

Applications recommended by the National Advisory Council on Aging
will be considered for award based upon (1) scientific and
technical merit; (2) program balance, including in this instance
sufficient compatibility of features to make a successful
collaborative program a reasonable likelihood; and (3) availability
of funds.

INQUIRIES

Letters of intent and inquiries regarding programmatic issues
should be directed to:

Dr. Creighton H. Phelps
Dementias of Aging Branch
National Institute on Aging
7201 Wisconsin Avenue, Suite 3C307 - MSC 9205
Bethesda, MD  20892-9205
Telephone:  (301) 496-9350
FAX:  (301) 496-1494
Email: phelpsc@exmur.nia.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:  whippl@exmur.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 Public Health Service (PHS) strongly encourages all grant
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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