OPPORTUNITIES FOR RESEARCH AT REGIONAL PRIMATE RESEARCH CENTERS

Release Date:  March 6, 1998

PA NUMBER:  PA-98-036

P.T.

National Center for Research Resources

PURPOSE

It is recognized that nonhuman primate research resources may not be readily
accessible to all investigators who wish to use them in research.  The purpose
of this Program Announcement (PA) is to offer mechanisms through which these
resources can be more readily accessible to researchers.  The National Center for
Research Resources (NCRR) thereby invites investigator-initiated research project
grants (R01, R21) applications for research that utilizes nonhuman primates and
other research resources at the seven Regional Primate Research Centers (RPRCs). 
The National Institute of Allergy and Infectious Diseases (NIAID) is a co-sponsor
of this solicitation.  Applications that are within the mission of NIAID will
receive funding consideration from that Institute.  The overall objectives of
this initiative are to: (1) promote cutting edge scientific research, (2) enhance
utilization of nonhuman primates and other resources within the RPRCs, and (3)
promote coordinated research efforts with Center staff scientists who are located
at the seven RPRCs.

HEALTHY PEOPLE 2000

The Public Health Service (PHS) is committed to achieving the health promotion
and disease prevention objectives of þHealthy People 2000,þ a PHS-led national
activity for setting priority areas.  This PA, Opportunities for Research at
RPRCs, is related to the priority areas of infectious diseases particularly AIDS-
related.  Potential applicants may obtain a copy of þHealthy 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 foreign and domestic, for-profit and non-profit
organizations, public and private, such as universities, colleges, hospitals,
laboratories, units of state and local governments and eligible agencies of the
federal government.  Racial/ethnic minority individuals, women and persons with
disabilities are encouraged to apply as Principal Investigators.

The proposed research must be conducted at one of the seven Regional Primate
Research Centers (RPRCs)and in collaboration with one or more RPRC staff
scientists.  To be eligible, the Principal Investigator must not currently be a
center/core staff member receiving support (salary and/or other research support)
from the NCRR-supported RPRC grant and may not be located at a RPRC.  If the
Principal Investigator"s grantee institution is different from the grantee
institution of the RPRC, a consortium or contractual agreement must be
established with the RPRC.  A consortium or contractual agreement is an agreement
whereby a research project is carried out by the grantee and one or more other
organizations that are separate legal entities, i.e., an agreement between two
institutions.  (See page 24 in the booklet for "Application for a Public Health
Service Grant, Form 398").

MECHANISM OF SUPPORT

Research support may be obtained through applications for an investigator-
initiated research project grant (R01) or exploratory/development grant (R21). 
Total costs for R21 applications are limited to $100,000 direct costs per year. 
R21 grants are also limited to a two year period.  The R21 is to be used for the
support of innovative, exploratory/developmental research projects.

Investigators with innovative ideas for research using the nonhuman primate model
have previously had difficulty identifying potential funding sources.  The R21
mechanism will provide investigators at all career levels with a defined level
of funding adequate for the initial feasibility testing of high risk/high impact
concepts and, if the concepts are viable, for the generation of experimental
preliminary data.  This would render the investigators competitive for funding
through the research project grant (R01) award mechanism, thus potentially
leading to the establishment of new research programs in areas that might have
previously remained unexplored.

Although NCRR desires to stimulate research in several areas, the specific amount
of funding available for each research area will depend on the level of annual
appropriated funds, quality of research applications and program priorities at
the time of the award.  It is estimated that approximately $4.0 million (2.5
million AIDS related) will be available for this activity in 1998.

RESEARCH OBJECTIVES

Nonhuman primate species have played a key role in advancing our knowledge base
in understanding diseases processes and it is important that research efforts
utilizing these models be expanded.  Although much progress has been made in the
development of nonhuman primate animal model systems, particularly for AIDS-
related research, cures for many diseases and effective preventive measures are
lacking.  It is clear that further studies are needed to identify the basic
mechanisms of disease processes in order to develop methods for prevention and/or
control.

The major objective of this program announcement is to encourage the
establishment of  well-integrated and coordinated research programs by active
investigators which will effectively utilize nonhuman primate resources at the
RPRCs through the research project grant (R01, R21) mechanisms.  This will be
accomplished by:

1) Encouraging mechanistic studies on addressing human disease using the nonhuman
primate model to improve our understanding of the basic etiology and pathogenesis
of a particular disease and , at the same time, develop effective therapies to
control and/or prevent the disease.

2) Providing support for maintenance and further development of nonhuman primate
models at the relevant RPRCs.

3) Providing support for scientists to utilize RPRC facilities, animals and the
nonhuman primate expertise of staff at the RPRCs to facilitate the research
efforts.

The following are examples of human health problems for which the nonhuman
primate may be the most appropriate animal model.  These are representative of
potential areas for research and are not meant to be all-inclusive:

o  AIDS and AIDS-related research, especially vaccine developing and testing

o  Development and utilization of gene vector therapeutic methods for combating
disease

o  New and re-emerging infectious diseases such as hepatitis, malaria, etc.

o  Pathogenesis as well as potential therapies for neurological diseases such as
Parkinson"s Disease, Alzheimer"s and other Dementias

o  Developmental research on cryopreservation technologies for preserving sperm,
ova, embryos and somatic cell lines

o  Development of non-human primate models to facilitate basic research and pre-
clinical trials of tolerance induction for solid organ and bone marrow
transplantation.

o  Development of non-human primate models of autoimmune diseases to facilitate
basic research and pre-clinical studies of autoimmune diseases.

o  Studies of twinning and cloning to facilitate studies using any non-human
primate models of disease specially developed for research

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 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.

APPLICATION PROCEDURES

Applications are to be submitted on the grant application form PHS 398 (rev.
5/95) and will be accepted at the standard application deadlines as indicated in
the application kit.  Please note that all AIDS-related applications have a
special receipt date and review and award schedule.  Application kits are
available at most institutional offices of sponsored research and may be obtained
from the Division of Extramural Outreach and Information Resources, National
Institutes of Health, 6701 Rockledge Drive, MSC 7910, bethesda, MD 20892-7910,
telephone 301/435-0714, email:  ASKNIH@od.nih.gov.

The title and number of the program announcement must be typed in section 2 on
the face page of the application.

Prior to applicant submission, an applicant is expected to confirm the
availability of resources at one of the RPRCs, and the application must contain
a letter from the relevant RPRC director confirming the availability of the
center resources.  The research application must spell out any collaborative
research arrangement with RPRC-based investigators.  In addition to a description
of the proposed relationship with the RPRC, the application must also include
appropriate budget expenses for utilization of the RPRC, including animal per
diem costs.  Detailed procedures for accessing a RPRC are published in the NIH
Guide to Grants and Contracts, Volume 25, January 17, 1997.  A RPRC Director (See
list below) may be contacted directly or contact the NCRR Program Director listed
below regarding accessing RPRCs.  The applicant must also acquire protocol
approval from the RPRC Institutional Animal Care and Use Committee.

The completed original application and four legible copies must be sent or
delivered to:

CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817-7710 (for express/courier service)

At the time of submission one additional must also be sent to:

Jerry A. Robinson, Ph.D.
Comparative Medicine
National Center for Research Resources
6705 Rockledge Drive, Suite 6030
Bethesda, MD  20892
Telephone:  (301) 435-0744
FAX:  (301) 435-3819
Email:  jerryR@ep.ncrr.nih.gov

REVIEW CONSIDERATIONS

Applications that are complete will be evaluated for scientific and technical
merit by a Center for Scientific Review initial review group convened in
accordance with the standard NIH peer review procedures.  As part of the initial
merit review, all applications will receive a written critique and undergo a
process in which only those applications deemed to have the highest scientific
merit, generally the top half of the applications under review, will be
discussed, assigned a priority score, and receive a second level review by the
appropriate National Advisory Council.

Review Criteria

The five criteria to be used in the evaluation of grant applications are listed
below.  To put those criteria in context, the following information is contained
in instructions to the peer reviewers.

The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health.  The
reviewers will comment on the following aspects of the application in their
written critiques in order to judge the likelihood that the proposed research
will have a substantial impact on the pursuit of these goals.  Each of these
criteria will be addressed and considered by the reviewers in assigning the
overall score weighting them as appropriate for each application.  Note that the
application does not need to be strong in all categories to be judged likely to
have a major scientific impact and thus deserve a high priority score.  For
example, an investigator may propose to carry out important work that by its
nature is not innovative but is essential to move a field forward.

1. Significance.  Does this study address an important problem?  If the aims of
the application are achieved, how will scientific knowledge be advanced?  What
will be the effect of these studies on the concepts or methods that drive this
field?

2. Approach.  Are the conceptual framework, design, methods, and analyses
adequately developed, well-integrated, and appropriate to the aims of the
project?  Does the applicant acknowledge potential problem areas and consider
alternative tactics?

3. Innovation.  Does this project employ novel concepts, approaches or methods? 
Are the aims original and innovative?  Does the project challenge existing
paradigms or develop new methodologies or technologies?

4. Investigator.  Is the investigator appropriately trained and well suited to
carry out this work?  Is the work proposed appropriate to the experience level
of the principle investigator and other researchers (if any)?

5. Environment.  Does the scientific environment in which the work will be done
contribute to the probability of success?  Do the proposed experiments take
advantage of unique features of the scientific environment or employ useful
collaborative arrangements?  Is there evidence for institutional support?

6. Potential.  Do these novel and innovative approaches clearly require
additional preliminary data for their value to be established?  What is the
prospects of the preliminary findings leading to a full hypothesis-driven, R01
application?

AWARD CRITERIA

Applications will compete for available funds with all other approved
applications.  The following will be considered in making funding decisions: 
quality of the proposed project as determined by peer review, availability of
funds, and program priority.

INQUIRIES

Inquiries are encouraged.  The opportunity to clarify any issues for NCRR or
questions from potential applicants is welcome.

Direct inquires regarding basic research programmatic issues and the Regional
Primate Research Center Program to:

Jerry A. Robinson, Ph.D.
Comparative Medicine
National Center for Research Resources
6705 Rockledge Drive, Suite 6030
Bethesda, MD  20892
Telephone:  (301) 435-0744
FAX:  (301) 435-3819
Email:  jerryR@ep.ncrr.nih.gov

Direct inquiries regarding NIAID research program issues to:

Stephen M. Rose, Ph.D.
Division of Allergy, Immunology and Transplantation
National Institute of Allergy and Infectious Diseases
6003 Executive Boulevard, Room 4A14
Bethesda, MD  20892-7640
Telephone:  (301) 496-5598
FAX:  (301) 402-2571
Email:  Steve_Rose@nih.gov

Direct inquiries regarding fiscal matters to:

Paul Karadbil
Office of Grants Management
National Center for Research Resources
6705 Rockledge Drive, Suite 6210
Bethesda, MD  20892
Telephone:  (301) 435-0836
FAX:  (301) 480-6210

Direct inquiries regarding a respective Regional Primate Research Center to:

Andrew G. Hendrickx, Ph.D., Director
California Regional Primate Research Center
University of California, Davis
Davis, CA  95616
Telephone:  (916) 752-0420
FAX:  (916) 752-8201
URL: http://www.crprc.ucdavis.edu

Ronald D. Hunt, D.V.M., Director
New England Regional Primate Research Center
One Pine Hill Drive
Southborough, MA  01772
Telephone:  (508) 624-8002
FAX:  (508) 460-0612

M. Susan Smith, Ph.D., Director
Oregon Regional Primate Research Center
505 N.W. 185th Avenue
Beaverton, OR  97006
Telephone:  (503) 645-1141
FAX:  (503) 690-5532
URL:  http://www.teleport.com/~orprc

Peter J. Gerone, Sc.D., Director
Tulane Regional Primate Research Center
18703 Three Rivers Road
Covington, LA  70433
Telephone:  (504) 892-2040
FAX:  (504) 893-1352
URL:  http://www.tpc.tulane.edu

William R. Morton, V.M.D., Director
Washington Regional Primate Research Center
P.O. Box 357330
University of Washington
Seattle, WA  98195-7330
Telephone:  (206) 543-0440
FAX:  (206) 685-0305

Joseph W. Kemnitz, Ph.D., Interim Director
Wisconsin Regional Primate Research Center
University of Wisconsin - Madison
1220 Capitol Court
Madison, WI  53715-1299
Telephone:  (608) 263-3500
FAX:  (608) 263-4031
URL:  http://www.primate.wisc.edu

Thomas R. Insel, M.D., Director
Yerkes Regional Primate Research Center
Emory University
954 Gatewood Road, N.E.
Atlanta, GA  30329
Telephone:  (404) 727-7707 or 727-7721
FAX:  (404) 727-0623
URL:  http://www.emory.edu/YERKES/

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic No.
Awards are made under authorization of the Public Health Service Act, Sections
301 and 464H, and administered under PHS policies and Federal Regulations at
Title 42 CFR 52, "Grants for Research Projects," Title 45 CFR Parts 74 and 92,
"Administration of Grants," and 45 CFR Part 48 "Protections of Human Subjects." 
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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