DATABASE MANAGEMENT OF NIH-SUPPORTED CHIMPANZEES

Release Date:  May 25, 1999

RFA:  RR-99-006

Update: The following update relating to this announcement has been issued:

August 3, 2010 - This RFA has been reissued as (RFA-RR-10-008).

National Center for Research Resources

Letter of Intent Receipt Date:  June 18, 1999
Application Receipt Date:  July 21, 1999

PURPOSE

The Comparative Medicine Area of the National Center for Research Resources is
issuing this Request for Applications (RFA) to encourage the submission of
applications to create, develop and maintain a chimpanzee database for
biomedical research purposes.  In 1986, NIH established five chimpanzee
breeding colonies in order to have an adequate supply of these animals
available for biomedical research purposes.  Based on the recommendations in a
report from the National Academy of Sciences, NCRR has created a NIH
Chimpanzee Management Program (ChiMP).  One of the key elements of the NIH
ChiMP is the accumulation of individual animal histories into a single,
accessible database.  The database will contain the genealogy, clinical, and
experimental information as well as other relevant statistics on every animal
within the NIH-supported facilities.

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 RFA, Database Management of NIH-
Supported Chimpanzees, is related to several priority areas, including AIDS,
other infectious diseases, cancer heart disease and stroke, diabetes and
chronic disability conditions, maternal and infant health, and others. 
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 for-profit and non-profit
organizations, public and private, such as universities, colleges, hospitals,
laboratories, units of State and local governments, and eligible agencies of
the Federal Government.  Racial/ethnic minority individuals, women, and
persons with disabilities are encouraged to apply as Principal Investigators.

MECHANISM OF SUPPORT

The administrative and funding instrument to be used for this program will be
a cooperative agreement (U24), 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. 
The total project period for an application submitted in response to this RFA
may not exceed five years.  The anticipated award date is March 2000.  This
RFA is a one-time solicitation.

FUNDS AVAILABLE

The estimated funds (total costs) available for the first year of support for
the entire program is $750,000.  It is anticipated that there will be one
cooperative agreement awarded.

PROGRAM GOALS AND SCOPE

The NIH recognizes the need to ensure a continued resource of chimpanzees for
use in biomedical and behavioral research.  It is important that an adequate
supply of chimpanzees be maintained to develop and test preventive and
therapeutic strategies for hepatitis, malaria and AIDS, including candidate
vaccines and drug treatments, and for other critical health issues.  The
overall objective of this program is to provide specialized research resources
(physical facilities, technology, professional and technical expertise) for
investigators who require chimpanzees for research examining human health
problems.  In conjunction with maintaining a research population, the NIH
recognizes the value of developing and maintaining a database for the NIH-
supported animals.  The database will contain information on every animal"s
history and will serve as a resource to the biomedical research community.

The major features of this database are as follows:

o  First and foremost, the database must be accessible to and interactive with
prospective investigators proposing to utilize chimpanzees in approved
experimental protocols.

o  The database must be also interactive and contain the records for each NIH-
supported chimpanzee at the designated Chimpanzee Biomedical Research Colonies
(CBRCs).

The database should contain the genealogy of each chimpanzee at the CBRC
facilities.

o  Summaries of general clinical histories should be maintained as part of the
animal records.  Routine clinical observations (raw data) will be maintained
only at the CBRC.

o  Involvement in experimentation must be documented.  Specific experimental
protocols will not be part of the database.  However, documentation of
exposures to infectious diseases, etc., and organ, tissue manipulation
(splenectomy, etc.) must be part of the animals" records.

o  The application should describe who is responsible for the input of the
various types of data, and who is responsible for the validity of the data
entered.

SPECIAL REQUIREMENTS

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 part 74 and 92, and other HHS, PHS, and NIH Grant Administration
policy statements.

The administrative and funding instrument used for this program is the
Cooperative Agreement (U24), 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 this concept, the dominant role and prime responsibility for
the activity resides with the awardee for the project as a whole, although
specific tasks and activities in carrying out these activities will be shared
between the awardee, the CBRC Directors, and the NIH ChiMP Office Directors.

1.  Awardee Rights and Responsibilities

Awardee will have primary and lead responsibilities for the project as a
whole, including data collection, quality control, final data analysis and
interpretation, preparation of reports.  The database will contain the
genealogy, clinical, and experimental information as well as other relevant
statistics on every animal within the NIH-supported facilities. In addition,
the database must be accessible to and interactive with prospective
investigators proposing to utilize chimpanzees in approved experimental
protocols.  Collaboration with the Directors of the NCRR-supported Chimpanzee
Biomedical Research Colonies, and interactions with the Director, ChiMP
Office/NCRR, is required.  Applicants will collaborate and share data freely
with the chimpanzee colony grantees, and the Director of the NCRR ChiMP
Office, as well as to be able and willing to share data and communicate with
the NCRR in an internet environment.  However, awardees will retain custody of
and have primary rights to the data developed under these awards, subject to
Government rights of access consistent with current HHS, PHS, and NIH.

2.  NIH Chimpanzee Management Program (ChiMP).

The Director of the NIH ChiMP Office will serve as the ChiMP Coordinator.  The
ChiMP Coordinator will have substantial scientific/programmatic involvement
during the conduct of this activity through technical assistance, advice and
coordination above and beyond normal program stewardship for grants.  The
ChiMP Coordinator will be involved in the selection process of appropriate
animals for research, ensure that there is collection of pertinent clinical
information on the animals in experimental protocols, and monitor the data
input into the database.  The ChiMP Coordinator will also ensure that all
protocols have been reviewed and approved by the Interagency Animal Models
Committee prior to experimentation.

3.  Advisory Panel

Based on the information obtained, a working group of nongovernment experts
from the National Advisory Research Resources Council (NARRC) will make
recommendations to the ChiMP Coordinator and advise on long-term plans for
research use, breeding colony size, demographics, genetics, and genetic
management as well as long-term care.

4.  Arbitration

Any disagreement that may arise on scientific/programmatic matters (within the
scope of the award), between award recipient and NCRR may be brought to
arbitration.  An arbitration panel will be composed of three members -- one
selected by the Advisory Panel (with the NCRR member not voting) or by the
individual awardee in the event of an individual disagreement, a second member
selected by NCRR, 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 at 42 CFR Part 50, Subpart D and HHS regulation at 45
CFR Part 16.

LETTER OF INTENT

Prospective applicants are asked to submit, by June 18, 1999, a letter of
intent that includes a descriptive title of the proposed research, the name,
address, and telephone number of the Principal Investigator, the identities of
other key personnel, collaborators and their activities, 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 that it contains allow NCRR staff to estimate the potential
review workload and avoid conflict of interest in the review.

The letter of intent is to be sent to:

John Strandberg, D.V.M., Ph.D.
Comparative Medicine
National Center for Research Resources
6705 Rockledge Drive, Room 6030
Bethesda, MD 20892
Telephone: (301)435-0744
FAX: (301)480-3819
Email: [email protected]

APPLICATION PROCEDURES

To promote the development of a collaborative program among the award
recipient and the chimpanzee colony grantees, a number of issues need to be
addressed in the application.  Applicants must include their specific plans
for responding to the "Terms and Conditions of Award" section.  Applicants
should detail the specialized or unique facilities, fundamental
infrastructure, and core resources and services that are available to support
and manage the database, and should propose any additional equipment,
specialized programming, and personnel requirements needed to participate in
the cooperative group.  If facilities at more than one institution are
required, applicants should thoroughly describe them.  Applicants should
describe the personnel and the computer hardware and software available, and
should propose additional needs related to the proposed cooperative group
activities.  The roles and expertise of all key personnel, collaborators, and
consultants who are associated with the application should be well documented.

Each applicant should describe his/her plans for interfacing with the NIH
ChiMP Office and the Chimpanzee Colony grantees and should propose his/her
views on how the NIH ChiMP Office and chimpanzee colony grantees activities
should be carried out in the context of the Awardee Rights and
Responsibilities described above.  Applicants should state their willingness
to collaborate and share data freely with the chimpanzee colony grantees, and
the Director of the NCRR ChiMP Office, as well as to be able and willing to
share data and communicate with the NCRR in an internet environment. 
Applicants should also describe how they will comply with the decisions of the
Advisory Panel to the ChiMP Office, and how they will fulfill the
responsibility to work together cooperatively.  Applicants should submit
budget requests that include travel to required grantee meetings and/or
telephone conferences.  The awardee will meet with the NIH ChiMP Office
Director and the Chimpanzee Colony Directors at least once yearly and should
include travel funds in budget requests.

The research grant application form PHS 398 (rev. 4/98) is to be used in
applying for this award.  These forms are available at most institutional
offices of sponsored research, from the Division of Extramural Outreach and
Information Resources, National Institutes of Health, 6701 Rockledge Drive,
MSC 7910, Bethesda, MD 20892-7910, telephone 301/453-0714, e-mail:
[email protected], and from the program administrator listed under INQUIRIES.

The RFA label available in the PHS 398 (rev. 4/98) application form must be
affixed to the bottom of the face page of the application.  Failure to use
this label could result in delayed processing of the application such that it
may not reach the review committee in time for review.  In addition, the RFA
title and number must be typed on line 2a of the face page of the application
form and the YES box must be marked.

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

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

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

John Strandberg, D.V.M., Ph.D.
Comparative Medicine
National Center for Research Resources
6705 Rockledge Drive, Room 6030
Bethesda, MD 20892
Telephone: (301) 435-0744
FAX: (301) 480-3819
Email: [email protected]

Applications must be received by July 21, 1999.  If an application is received
after that date, it will be returned to the applicant without review.  The
Center for Scientific Review (CSR) will not accept any application in response
to this RFA that is essentially the same as one currently pending initial
review, unless the applicant withdraws the pending application.  The CSR 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 CSR and
responsiveness by NCRR staff.  Incomplete and/or non-responsive applications
will be returned to the applicant 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 NCRR in
accordance with the review criteria stated below.

As part of the initial merit review, a streamlining process may be used in
which applications receive a written critique and under 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 by the National Advisory Research
Resources Council.

REVIEW CRITERIA

Applicants are encouraged to submit and describe their own ideas about how
best to meet the goals of the cooperative study and are expected to address
issues identified under SPECIAL REQUIREMENTS of the RFA.

The review group will assess the technical merits of the proposal and other
related factors including:

o  scientific, technical, or medical significance and originality of proposed
database facilities,

o  interactive capability of the proposed database, such as data input from
chimpanzee colonies, search capabilities for investigators, and reporting
analyses from NIH ChiMP Office,

o  appropriateness and adequacy of the procedures and methods proposed for
inputting, maintaining and accessing the animal records,

o  qualifications and experience of the Principal Investigator and staff,

o  availability of the database and protocol procedures for accessibility in
order to identify specific information necessary to utilize chimpanzees for
research purposes,

o  database compatibility with year 2000 issues,

o  provisions for the protection of human and animal subjects data and the
safety of the working environment,

o  demonstrated willingness to work as part of ChiMP and collaborate with the
NCRR Director of the NIH ChiMP Office,

AWARD CRITERIA

Applications recommended by the National Advisory Research Resources Council
will be considered for award based upon (a) scientific and technical merit,
(b) program balance, and (c) availability of funds.

Letter of Intent Receipt Date:  June 18, 1999
Application Receipt Date:       July 21, 1999
Review by NARRC:                January 2000
Anticipated Award Date:         March 2000

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:

John Strandberg, D.V.M., Ph.D.
Comparative Medicine
National Center for Research Resources
6705 Rockledge Drive, Room 6030
Bethesda, MD 20892-7965
Telephone: (301)435-0744
FAX: (301)480-3819
Email: [email protected]

Direct inquiries regarding fiscal matters to:

Ms. Joellen Harper
Office of Grants Management
National Center for Research Resources
6705 Rockledge Drive, Room 6086
Bethesda, MD 20892-7965
Telephone: (301)435-0844
Email: [email protected]

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No.
93.306.  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 NIH grants policies and Federal
Regulations 42 CFR 52 and 45 CFR Part 74 and 92.  This program is not subject
to the intergovernmental review requirements of Executive Order 12372 or
Health Systems Agency review.

The PHS strongly encourages all grant and contract recipients to provide a
smoke-free workplace and promote the non-use of all tobacco products.  In
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking
in certain facilities (or in some cases, any portion of a facility) in which
regular or routine education, library, day care, health care or early
childhood development services are provided to children.  This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.

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National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892