Full Text RR-95-002

NATIONAL GENE VECTOR LABORATORIES

NIH GUIDE, Volume 23, Number 40, November 18, 1994

RFA:  RR-95-002

P.T. 34

Keywords: 
  Genetics 
  Gene Therapy+ 


National Center for Research Resources
National Cancer Institute
National Heart, Lung, and Blood Institute
National Institute of Diabetes and Digestive and Kidney Diseases

Letter of Intent Receipt Date:  December 15, 1994
Application Receipt Date:  February 21, 1995

PURPOSE

The National Center for Research Resources (NCRR), together with the
National Cancer Institute (NCI), the National Heart, Lung, and Blood
Institute (NHLBI), and the National Institute of Diabetes and
Digestive and Kidney Diseases (NIDDK) as cosponsors, invite
applications to establish National Gene Vector Laboratories to
enhance research leading to successful gene therapy of single- and
multiple-gene disorders.  For purposes of this solicitation, the term
"vector" is used in the broadest sense to refer to any vehicle
designed to deliver genetic material into human somatic cells.  The
National Gene Vector Laboratories will provide shared resources to
facilitate optimal vector production of clinical grade vectors for
human gene therapy research.  The overall goals are to provide
vectors for the prevention, treatment, and cure of a wide variety of
medical conditions through gene therapy.

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), National Gene Vector Laboratories, is related
to many of the priority areas discussed in this publication.
Potential applicants may obtain a copy of "Healthy People 2000" (Full
Report:  Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary
Report:  Stock No. 017-001-00473-1) through the Superintendent of
Documents, Government Printing Office, Washington, DC 20402-9325
(telephone 202 783-3238).

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic, but not foreign, 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 Program Directors.

MECHANISM OF SUPPORT

The administrative and funding instrument to be used for this program
will be the NIH Animal (Mammalian and Nonmammalian) Model, and Animal
and Biological Materials Resource Cooperative Agreement (U42), an
"assistance" mechanism (rather than an "acquisition" mechanism), in
which substantial NIH scientific and/or programmatic involvement with
the awardee is anticipated during 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. Details of the responsibilities, relationships, and
governance of the projects to be funded under cooperative
agreement(s) are discussed later in this document under the section
"Terms and Conditions of Award."

The total project period for applications submitted in response to
the present RFA may not exceed five years.  The anticipated award
date is August 1, 1995.  Because the nature and scope of the activity
proposed in response to this RFA may vary, it is anticipated that the
size of an award will vary also.

Awards and level of support depend on receipt of a sufficient number
of applications of high scientific merit.  Although this program is
provided for in the financial plans of the NCRR and cosponsoring
Institutes, awards pursuant to this RFA are contingent upon the
availability of funds for this purpose.

This RFA is currently anticipated to be a one-time solicitation.
However, if it is determined that there is a sufficient continuing
need, the NCRR will invite new applicants and recipients of awards
under this RFA to submit competitive new and/or competitive
continuation cooperative agreement applications for review according
to the procedures described in REVIEW CONSIDERATIONS.

FUNDS AVAILABLE

Approximately $3.5 million in total costs will be available in Fiscal
Year 1995 for the first year of support of meritorious applications
submitted in response to this RFA .  It is anticipated that between
one and three awards will be made.

RESEARCH OBJECTIVES

Background

Recent understanding of molecular biology, combined with
breakthroughs in virology and gene transfer techniques, have led to
new approaches to the treatment of both inherited and acquired
diseases.  Diseases thought to be amenable to gene therapy include,
but are not limited to, single gene disorders such as cystic
fibrosis, Gaucher disease, adenosine deaminase deficiency, immune
deficiencies, hemoglobinopathies, hemophilias, hyperlipidemias, and
multifactorial disorders such as cancer, hypertension, diabetes,
heart disease, and pulmonary diseases.  In addition, diseases such as
acquired immunodeficiency syndrome (AIDS) and malignancies require
suitable vector development, production, and distribution to enhance
research leading to effective treatment.  Gene therapy for such
diseases requires the development of suitable vectors to transfer new
genetic material to target cells.  Somatic cells such as lung,
muscle, liver, neuronal, and bone marrow stem cells, as well as tumor
cells, are important targets for gene therapy.  An array of viral
vectors are under investigation for use in such treatments.  In
addition, liposome formulations have been approved as vehicles for
the delivery of DNA.  The technical requirements and the expense of
vector development, production, and safety testing have limited the
capacity of clinical investigators to proceed with implementation of
gene therapy.  Just as collaborative efforts have facilitated the
testing of gene therapy for cystic fibrosis, optimal progress in
treatment of other diseases would be enhanced by national cooperation
for the production and distribution of vectors for gene therapy.  In
addition, centralizing such facilities will reduce the cost barrier
for the production of vectors and therefore, enhance development of
vectors for rare disorders where commercialization is not cost
effective.

Objectives and Scope

The objective of this RFA is to solicit applications for cooperative
agreements to support national laboratories for vector production,
maintenance, and distribution for use in gene therapy.  The rapid
advancements in the field of molecular genetics have led to the
identification and characterization of many genes and their products.
In addition, investigators are ready to initiate clinical trials for
promising gene therapies and patients are anticipating being
participants in these studies.  There is difficulty in bringing these
scientific breakthroughs to clinically applicable therapies.  Failure
to accommodate the urgent need for vector production and distribution
constitutes a barrier to progress in the field of gene therapy.
Through this cooperative agreement initiative, national laboratories
will be supported to develop plans and methods to produce and
distribute gene therapy vectors for protocols that have received FDA
approval and/or have either been determined not to require or have
been recommended for approval by the Recombinant DNA Advisory
Committee (RAC) and received approval from the Director of the NIH.
Highest priority for use of the facilities will be given to projects
that have received peer-reviewed grant support.  These vectors would
have been developed and had preclinical testing supported by NIH
funding.  Facilities must demonstrate expertise in production of gene
therapy vectors that meet FDA criteria for human use.  Facilities
must address which of the currently approved vectors including
retroviral, adenoviral, adeno-associated viral, and/or cationic
liposomes will be produced at the facility, and must address how they
will incorporate new technologies in the future.  Facilities must
have the capability to produce several vectors simultaneously and
provide information regarding maximal capabilities.

SPECIAL REQUIREMENTS

These cooperative agreements (U42s) will require cooperation among
the NCRR scientific coordinator, the participating Institute and
Center (IC) program administrators, and the Program Directors of each
vector production facility in order to assure smooth interactions
among awardee organizations.

To promote the development of a collaborative program among the award
recipients, a number of issues need to be addressed in their
applications as discussed below.

The following terms and conditions will be incorporated into the
award statement and provided to the Program Director as well as the
institutional official at the time of award.

Terms and Conditions of Award

These special Terms of Award are in addition to, and not in lieu of,
otherwise applicable OMB administrative guidelines, HHS Grant
Administration Regulations at 45 CFR Parts 74 and 92, and other HHS,
PHS, and NIH Grant Administration policy statements.

The administrative and funding instrument used for this program is a
cooperative agreement (U42), an "assistance" mechanism (rather than
an "acquisition" mechanism), in which substantial NIH scientific
and/or programmatic involvement with the awardee is anticipated
during 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 this concept, the dominant role and prime responsibility for the
activity resides with the awardee(s) for the project as a whole,
although specific tasks and activities in carrying out the project(s)
will be shared among the awardees and the IC participants.

1.  Awardee Rights and Responsibilities

The Program Directors and an associate from each institution will
plan and design the details of the project including appropriate
methods for defining and operating the vector laboratories.  They
will retain primary responsibility for the performance of the
activity.  Program Directors and associates must form and agree to
participate as members of the National Gene Vector Laboratories
Steering Committee.  Program Directors will appoint outside experts
to balance the composition and size of the Steering Committee so that
the total percentage of NIH representatives does not exceed 40
percent of the membership.  Each member of the Steering Committee,
including the outside experts, will have one vote.

The Program Directors, in cooperation with the other Steering
Committee members, are responsible for developing the details of the
operating policies of the National Gene Vector Laboratories,
including definition of objectives and approaches, planning,
implementation, and interaction with other Program Directors, and
assurance of scientific integrity.

The Steering Committee will elect a Chairperson from among the
participating Program Directors.  Rules governing the selection and
tenure of the Chairperson and outside experts will also be
established by the Steering Committee.  The facility represented by
the elected chairperson will then be designated as the Coordinating
Facility for purposes of submitting applications for use of all
facilities.  That facility will also be responsible for the paperwork
involved in Steering Committee meetings including preparing meeting
agendas, chairing meetings, writing and distributing minutes, and
notifying successful and unsuccessful applicants for use of the
resource of decisions made and providing the written rationale for
such.

The Chairperson of the Steering Committee must present an update of
activities at each meeting.  In order to accomplish this obligation,
each Program Director is responsible for timely preparation and
submission of his or her individual update to the Chairperson of the
Steering Committee who will prepare a summary for presentation at the
time of each Steering Committee meeting for incorporation into the
minutes.

2.  I/C Staff Responsibilities

One representative from the NCRR will be designated to serve as the
NIH Scientific Coordinator to the cooperative agreement.  The NIH
Scientific Coordinator and one program administrator from each
cosponsoring Institute will serve on the Steering Committee in order
to bring that individual's unique perspective on a given categoric
disease for which the individual oversees basic genetic research.  In
consultation with awardees, these individuals may convene workshops
or sponsor seminars within existing meetings to update the Program
Directors on advances in gene therapy accomplished through NIH
support.  While each of the four participating IC representatives
will attend and have a vote on the Steering Committee, according to
the organization of the Committee, their cumulative votes will never
exceed 40 percent.  As members of the Steering Committee, the NIH
Scientific Coordinator and the other IC program administrators attend
and participate in all meetings and assist in developing operating
policies, quality control procedures, and consistent policies for
dealing with recurring situations that require cooperative action.
The NIH Scientific Coordinator will assist in coordinating the
activities of the awardees and in facilitating exchange of
information.  The role of the NIH Scientific Coordinator and
Institute program administrators, as detailed throughout these terms
of cooperation, is to assist and facilitate, but not to direct
activities of the National Gene Vector Laboratories.  The NIH
Scientific Coordinator and the Institute program administrators act
as liaisons to the NIH and as information resources about research
activities in gene identification and gene therapy.  The NIH
representatives may also act as "catalysts," bringing together groups
with characterized vectors and groups with the requisite resources
and expertise to implement high quality clinical research.  The
Steering Committee coordinates and facilitates the activities
supported by these cooperative agreements.

3.  Collaborative Responsibilities

Steering Committee

The members of the Steering Committee will establish the functions of
the Steering Committee, its method of operation, quality control
assurance, cooperation among Program Directors, the NIH, and users of
the facilities.  The Steering Committee will also make provisions for
an arbitration panel as described below.  Criteria for accession and
discontinuance of use of the facility will also be delineated.  The
Committee will then reach a consensus on these issues and generate
three documents:  one outlining its functions, handling of quality
control issues, mode of cooperation of among awardees, the NIH, and
the users of the facilities, conflict of interest, and mode of
operation; a second enumerating criteria and procedures for accession
and discontinuance of use of the facility for a given vector; and a
third which will serve as an application form for investigators
wishing to use the facility.

The Steering Committee will meet three times during the first year of
the awards and twice annually, thereafter.  Program Directors are
also responsible for formulating consistent policies for dealing with
recurring situations that require coordinated action through
participation by the Program Directors and any other designated
representatives at Steering Committee meetings.  Steering Committee
meetings should be scheduled in close sequence with RAC meetings in
order to avoid unnecessary delays in setting priorities and approving
vectors.

4.  Arbitration

Any disagreement that may arise on scientific/programmatic matters
within the scope of the award, between award recipients and the NIH
may be brought to arbitration.  An arbitration panel of external
consultants will be created, and convened as needed, to resolve any
irreconcilable differences of opinion related to
scientific/programmatic matters among awardees and the NIH with
respect to implementation of a proposed operating policy or other
problems that may arise.  The panel will include one member selected
by the Program Directors, one member selected by the NIH
representatives, and a third member chosen by the other two members
of the arbitration panel.  These special arbitration procedures in no
way affect the awardee's right to appeal an adverse determination in
accordance with PHS regulations at 42 CFR part 50, subpart D and HHS
regulations at 45 CFR part 16.  Applicants should anticipate probable
areas of conflict and put forward an arbitration plan in their
applications.

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 new
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 of March 18, 1994, Volume
23, Number 11.

Investigators 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 December 15, 1994, a
letter of intent that includes a descriptive title of the proposed
project, the name, address and telephone number of the Program
Director, 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 a subsequent application, the information is helpful in planning
for the review of applications.  It allows IC staff to estimate the
potential review workload and avoid conflict of interest in the
review.

The letter of intent is to be sent to:

Dorothy D. Sogn, M.D.
General Clinical Research Centers Program
National Center for Research Resources
Westwood Building, Room 10A-07
5333 Westbard Avenue
Bethesda, MD 20892-4500**
Telephone:  (301) 594-7945
FAX:  (301) 594-7929

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 9/91) is to be used
in applying for these cooperative agreements.  These forms are
available at most institutional offices of sponsored research; from
the Office of Grants Information, Division of Research Grants,
National Institutes of Health, 5333 Westbard Avenue, Room 449,
Bethesda, MD 20892-4500, telephone 301/710-0267; and from the program
administrators listed under INQUIRIES.

The general instructions for format, budget issues, etc., in the
application packet should be followed except for the following.  The
Research Plan (Sections A-D) may not exceed 150 pages, and must
address the issues 1. through 4. listed below as well as points
discussed in the Review Criteria section of this RFA.  The budget
pages of the application must address points raised under item 6.
below.

Special Application Requirements

1.  Resources

a.  A detailed description of the facility and its compliance with
current Good Manufacturing Practices as put forth by the Food and
Drug Administration should be included.  Access to animal and
virology facilities as well as any necessary computer facilities
should be documented.

For current FDA guidance related to facilities for gene therapy,
contact:

Division of Establishment Licensing
1401 Rockville Pike, HFM-205
Rockville, MD  20852-1448
Telephone:  (301) 594-2049

For information about Good Manufacturing Practices refer to Title 21
of the Code of Federal Regulations (CFR), sections 210-211 and 610.
For information about Good Laboratory Practices refer to the CFR
Title 21, section 58.

Pertinent portions of the CFR can be ordered from:

The Government Printing Office
Superintendent of Documents
Washington, DC  20402
Telephone:  (202) 783-3238

b.  Documentation must be provided of the maximum number of vectors
that may be produced and maintained simultaneously and per year.

2.  Scientific Expertise and Experience in Vector Production

a.  Documentation of experience in vector production and expertise in
virology and molecular genetics should be provided.  An understanding
of important trends in gene therapy research and incorporation of new
technologies in the future should also be documented.

b.  Documentation should be provided regarding which of the current
vector technologies (retroviral, adenoviral, adeno-associated viral,
and/or liposome components) will be performed at the facility.  A
detailed description of vector production methodology should also be
provided and should include plans to establish and maintain a master
cell bank of a producer cell line.

c.  Knowledge of, and ability to adhere to, FDA guidelines for
quality control and safety testing for microbial contamination,
endogenous and recombinant replication-competent retroviruses, and
other viral contaminants of vectors at all stages of development and
maintenance (including post distribution monitoring) should be
outlined.

d.  Methods of certification of supernatants and final products
should be described and outside sources of safety testing should be
identified.

Human somatic cell gene therapy involves the administration to
patients of materials considered biological products, and thus
subject to regulation by the Center for Biologics Evaluation and
Research (CBER), FDA.  Investigational New Drug (IND) applications
are filed concerning clinical use of such products.  Investigators
planning clinical studies in these areas or preclinical and animal
studies in support of future applications should inform themselves
concerning the types of preclinical studies that are appropriate for
such biological products.

CBER has prepared a document entitled, "Points to Consider in Human
Somatic Cell Therapy (1991)," which provides guidance in this area.
Other relevant Points to Consider documents should also be consulted.
These may include:

"Points to Consider in the Production and Testing of New Drugs and
Biological Produced by Recombinant DNA technology (1985);" "Points to
Consider in the Characterization of Cell Lines Used to Produce
Biologicals (1987);" "Points to Consider in the Manufacture and
Testing of Monoclonal Antibody Products for Human Use (1987);" and
"Points to Consider in the Collection, Processing, and Testing of Ex-
Vivo Activated Mononuclear Leukocytes for Administration to Humans
(1989)."

Copies of Points to Consider documents are available from:

The Division of Congressional and Public Affairs
CBER
HFM-12
1401 Rockville Pike, Suite 200 N
Rockville, MD  20852-1448
Telephone:  (301) 594-0830

CBER staff are also available for questions about which types of
therapies are covered, for consultation, or for arrangement of pre-
IND meetings at (301) 594-0830.

3.  Collaborative Abilities

a.  Applicants should propose detailed plans for how to organize the
cooperative resource.  The function of the Steering Committee,
including its mode of operation and methods of handling quality
control and conflicts of interest, should be described.  Suggested
requirements for access to, and termination of use of, the facilities
should be elaborated.  Include proposed methods to be used to apply
for access to the resources, both to have a vector developed from a
gene sequence and to petition to use a vector for clinical studies.
Issues of intellectual property and authorship of and plans for
publications should be addressed.

b.  Methods should be proposed for establishing an inventory of
vectors and their respective stages of development, as well as
procedures for maintaining and distributing products and tracking the
status of clinical studies.

c.  Rules for access to the laboratory should be proposed and the
relationship between users and investigators proposing studies
defined.

d.  A description should be provided concerning how the availability
of the resource will be made known to the scientific community (e.g.,
notices of availability in scientific journals, displays at national
meetings, etc.).  If necessary, costs for these activities should be
included in the budget.

e.  Outside experts will be added to the Steering Committee to
balance its composition.  Applicants should describe the types of
expertise, but not individuals, needed to balance the composition of
the Steering Committee.

4.  Adherence to Terms of Cooperation

a.  Because the Terms of Cooperation discussed above will be included
in all awards issued as a result of the RFA, it is critical that each
applicant include specific plans for responding to these terms.

b.  Plans should describe clearly how applicants plan to interact
with the other awardees involved in the cooperative agreement and
describe how they will comply with the involvement of the NIH
representatives.

c.  The expertise required for an effective Steering Committee should
be proposed as well as how the Steering Committee would function to
identify priorities for accessing the resources.

d.  Plans should describe the role of the Steering Committee in
coordinating activities of the cooperative laboratories, establishing
policies and priorities, and reviewing progress.

5. Budget

a.  Minimal and maximal staffing patterns and budgets for operation
must be outlined; the cost of producing, maintaining, and
distributing a representative vector being budgeted separately.

b.  The Program Director of each funded application will be a member
of a Steering Committee that will meet three times in the first year
and twice in each subsequent year.  Travel funds for Steering
Committee meetings should be set aside as a budget line item.  For
planning purposes, either three trips to Washington DC or one East
Coast, one West Coast and one Central U.S. trip in the first year may
be proposed.

c.  In addition to travel funds for institutional personnel, funds
should be included to support travel by one outside expert (per
applicant) to the Steering Committee meeting twice per year,
anticipated travel expenses for workshop/seminar participants, plus
any additional travel anticipated for Steering Committee members.

d.  One awardee institution will be designated as the Coordinating
Facility and will have responsibility for certain tasks outlined
under Responsibilities of Awardees.  Each applicant should provide a
budget for these tasks, in the event of being designated the
Coordinating Facility.

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

Submit a signed typewritten original of the application, including
the checklist, and three signed exact, clear, single-sided
photocopies, in one package to:

Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892-4500**

At the time of submission, send two additional copies of the
application to:

Dr. Mary Ann Sestili
Director, Office of Review
National Center for Research Resources
Westwood Building, Room 10A-11
Bethesda, Md  20892

Applications must be received by February 21, 1995.  Applications
received after this date will be returned.  The Division of Research
Grants (DRG) will not accept any application in response to this RFA
that is the same as one currently pending initial review, unless the
applicant withdraws the pending application.  The DRG will not accept
any application that is essentially the same as one already reviewed.
This does not preclude the submission of substantial revisions of
applications already reviewed, but such applications must include an
introduction addressing the previous critique.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by DRG
and responsiveness by NCRR.  Applications that are incomplete or
unresponsive will be returned to the applicant without further
consideration.  Applications must adhere to the page limitations and
Special Application Requirements noted under the section APPLICATION
PROCEDURES above to be considered responsive.  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 Office of Review, NCRR, in accordance with the review criteria
stated below.  Following scientific-technical review, the
applications will receive a second-level review by the appropriate
national advisory councils/boards.

As part of the initial merit review, a process (triage) may be used
by the initial review group 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 discussed and be
assigned a priority score.  Applications determined to be non-
competitive will be withdrawn from further consideration and the
Program Director and the official signing for the applicant
organization will be notified.

Review Criteria

Reviewers will be asked to review the grant applications by
considering the following criteria:

1.  Scientific and technical merit of the proposed activities and
organizational plans for implementing the proposed National Gene
Vector Laboratories and the extent to which they address the overall
goals and objectives of the RFA.

2.  Availability and quality of facilities and resources required for
this project.

3.  Qualifications, experience, and proposed responsibilities of the
Program Director and other key personnel.

4.  Plans for effective cooperation and coordination among
participating awardees and the NIH.

5.  Plans for protection of the rights of human subjects and for
inclusion of women and minorities and their subgroups as appropriate
to the scientific goals of the activity.

Reviewers will also judge the appropriateness of the proposed budget
and duration for each meritorious application.

AWARD CRITERIA

The earliest anticipated date of award is August 1, 1995.  Awards
will be based primarily on the scientific merit, diversity of vector
production capability, and programmatic priorities.  Some
consideration may also be given to geographic diversity.

INQUIRIES

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:

Dorothy D. Sogn, M.D.
General Clinical Research Centers Program
National Center for Research Resources
Westwood Building, Room 10A-07
Bethesda, MD  20892-4500
Telephone:  (301) 594-7945
FAX:  (301) 594-7929
Email:  DorothyS@EP.NCRR.NIH.GOV

Inese Z. Beitins, M.D.
General Clinical Research Centers Program
National Center for Research Resources
Westwood Building, Room 10A-03
Bethesda, MD  20892-4500
Telephone:  (301) 594-7945
FAX:  (301) 594-7929
Email:  IneseB@EP.NCRR.NIH.GOV

Direct inquiries regarding fiscal matters to:

Ms. Mary V. Niemiec
Office of Grants and Contracts Management
National Center for Research Resources
Westwood Building, Room 849
Bethesda, MD  20892-4500
Telephone:  (301) 594-7955
FAX:  (301) 594-7910
Email:  MaryN@EP.NCRR.NIH.GOV

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic
Assistance No. 93.922.  Awards are made under authorization of the
Public Health Service Act, Title III, Part A (Public Law 78-410 as
amended by public law 99-158, 42 USC 241) and administered under PHS
grants policies and Federal Regulations 42 CFR Part 52, 45 CFR Part
74 and 45 CFR 92.  This program may be subject to the
intergovernmental review requirements of Executive Order 12372 or
Health Systems Agency review.

The Public Health Service strongly encourages all grant recipients to
provide a smoke-free workplace and promote the non-use of all tobacco
products.  This is consistent with the PHS mission to protect and
advance the physical and mental health of the American people.

.

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