CENTERS OF CLINICAL RESEARCH EXCELLENCE AT RCMI ELIGIBLE INSTITUTIONS WITH
MEDICAL SCHOOLS

Release Date:  January 20, 1999

RFA: RR-99-005 (see NOT-RR-04-003)

P.T.

National Center for Research Resources

Application Receipt Date:  March 11, 1999

PURPOSE

The National Center for Research Resources (NCRR) invites applications for the
establishment of Centers of Clinical Research Excellence (CCRE) at NCRR-supported
Research Centers in Minority Institutions (RCMI) with affiliated medical schools. 
The purpose of this Request for Applications (RFA) is to augment and strengthen
the institutional clinical research capabilities.  This will be done by providing
support to recruit senior basic or clinical research investigators, who are
established investigators with independent research support.  They can serve as
mentors to more junior investigators and for those in junior career development
in clinical research.  These new faculty will receive support to establish their
research laboratories, acquire specialized equipment, and support postdoctoral
fellows and technical assistants.  It is anticipated that they will serve as
magnet investigators for the recruitment of other research faculty who will
compliment the specific research area.  Ideally, this research area will focus
on one or more of the diseases that disproportionately affect the indigenous
populations served by the RCMI institution.  Long-range, it is anticipated that
this will facilitate the development of the institution's clinical research
capacity.  It is also anticipated that the CCRE will compliment the RCMI Clinical
Research Infrastructure Initiative (RCRII) that began with the first awards in
FY 1995.

The National Institutes of Health (NIH) recognizes that minority institutions are
an integral component of our national biomedical research agenda.  Therefore, the
NIH is offering programmatic assistance for the development of the technology and
resources that are necessary to conduct state-of-the-art clinical research at
these institutions.  Long-range, it is anticipated that this will facilitate the
participation of these institutions in preparing the next generation of clinical 
investigators.  This RFA is one way that the NIH identifies and supports clinical
investigators at eligible institutions to conduct and report the meritorious,
preliminary research that will foster successful competition for traditional
research project grants (e.g., R-series and P-series) during the performance
period of the award.  Beyond this, as is the case for the RCRII, the penultimate
objectives of this initiative are:  (1) assist the participating institutions to
conduct clinical research which will improve the health of the Nation's citizens,
especially racial and ethnic minorities; (2) enhance the clinical research
capacity of the eligible institutions; and (3) position these medical schools to
compete successfully for clinical research support.

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.  Potential applicants may obtain a copy of
"Healthy People 2000" at http://www.crisny.org/health/us/health7.html.

ELIGIBILITY REQUIREMENTS

Applications will only be accepted from domestic, public or private, non-profit,
academic institutions that award the M.D. degree, at which more than 50 percent
of the students enrolled are from cultural or racial minority groups.  Each
applicant institution MUST identify a collaborating institution.  All
collaborating institutions must be domestic Federal or non-Federal, public or
private, non-profit organizations. This will facilitate additional mentoring and
research collaboration.

The principal investigator, who serves as CCRE Program Director, must be a U.S.
citizen, permanent resident, or non-citizen national.  An award pursuant to this
RFA will not be made until and unless the institution has appointed a Program
Director who is an established clinical investigator with an active research
program that is supported by extramural investigator-initiated clinical research
support and who has the professional skills needed to direct the Program.

Participating applicant investigators who are already resident at the applicant
institution must have completed two or more years of postdoctoral clinical
research and must be full-time employees of the applicant institution.  Any
collaborating investigator must be an NIH grantee currently supported by R-series
and/or P-series.

MECHANISM OF SUPPORT

The Cooperative Agreement (U-series) award is the administrative mechanism for
supporting activities in which the NIH collaborates substantially in scientific
and/or programmatic matters with the awardee institution(s).  The Specialized
Center-Cooperative Agreement (U54) mechanism will be used to support the CCRE
award.  It is anticipated that collaborating scientists will benefit from a
broader range of research resources and interdisciplinary research approaches
than are available at any one institution.  A CCRE award will support research
and research development activities within the scope of the program priorities
identified by the NCRR.

The NIH will support and stimulate the activities of the awardee(s) by working
as a partner.  The NIH will not assume direction, take primary responsibility,
or in any other way dominate the activity.  The section TERMS AND CONDITIONS
contains detailed descriptions of the responsibilities, relationships, and
governance of the activities supported by the cooperative agreements for the
Centers for Clinical Research Excellence.

FUNDS AVAILABLE

The NCRR plans to make up to three awards in Fiscal Year 1999.  An applicant may
request support for up to five years and a direct cost budget of up to $1 million
per year, excluding indirect costs on consortium arrangements.  Because the
nature and scope of the research proposed may vary, it is anticipated that the
size of each award will also vary.  Although the NCRR financial plans provide
support for this program, awards pursuant to this RFA are contingent upon the
availability of funds and the receipt of applications of outstanding scientific
and technical merit.  At this time, it is not known if competing renewal
applications will be accepted and/or if this RFA will be reissued.

Applicants planning to respond to this RFA by submitting an application for the
CCRE that requests $500,000 or more in direct costs for any year are advised that
he or she must contact the Director, Research Infrastructure (DRI), NCRR before
submitting the application, i.e., as plans for the study are being developed. 
Furthermore, the applicant must obtain agreement from the DRI that the
application will be accepted for consideration for award.  Finally, the applicant
must identify, in a cover letter sent with the application, the staff member in
the Center who agreed to accept assignment of the application.

RESEARCH OBJECTIVES

Background

The NCRR intends to foster an improved health status of and eliminate the health
care disparity experienced by racial and ethnic minority Americans.  Focused
research and research career development programs such as the CCRE are used to
achieve this objective.  Secondly, the NIH recognizes that the contributions that
minority academic health centers can make to fulfilling the promise of the NIH
research agenda are unique and essential.  Therefore, the NIH has the
responsibility to the Nation to ensure that these institutions can develop the
technology and other resources needed to conduct state-of-the-art clinical
research.  Thirdly, the NIH, by means of the CCRE and other programs, can foster
the collaborative research affiliations needed to address clinical research
problems relevant to the communities and regions served by the CCRE grantee. 

The CCRE's objectives will be accomplished by providing support to recruit magnet
clinical investigators and providing support for developmental clinical research
projects.  With respect to the former, the magnet investigator(s) will increase
the institution's clinical research milieu and will also serve as mentors for
more junior investigators at the institution.  The developmental projects will
allow clinical research faculty at the institution to use their research skills
and abilities to obtain preliminary data and publications that can help ensure
successful competition for traditional research project grants during the
performance period of the award.

Research Areas

In FY 1985, the legislation which authorized the RCMI Program called attention
to the disparity in the health status of minorities as compared to white
Americans.  More recently, President Clinton called these disparities to the
Nation's attention in his FY1999 budget proposal for the Department of Health and
Human Services.  He called for initiatives to eliminate gaps between the health
of non-Latino whites and minorities by the year 2010.  The President declared
that such disparities, as seen for a variety of cancers (breast, prostate and
colon/rectal), diabetes, infant mortality, cerebrovascular and cardiovascular
disease, and AIDS "are unacceptable in a country that values equality and equal
opportunity."  The CCRE initiative is consistent with and in response to this
mandate.

The research plan of an application for a CCRE award must contain the description
of up to three multi disciplinary, collaborative, developmental research projects
that will be mutually beneficial to participating investigators through
coordinated, cooperative interactions.  The research excellence of these projects
will be enhanced by effectively using the scientific and technical strengths of
collaborating investigators.  These projects must add to the body of clinical
research that is the overall focus of the CCRE.

SPECIAL REQUIREMENTS

The awardee will work to establish research priorities within the approved
research scope of each CCRE award through discussions with the DRI.  The NCRR
reserves the right to include outside consultants/experts in these discussions. 
After the awardee and the DRI have set the priorities, the awardee will be
responsible for conducting the research activities.  The awardee and the DRI will
interact in a cooperative manner throughout the duration of the award to
facilitate progress and resolve any problems that may arise.  Other NIH program
staff may participate in establishing research priorities throughout the
performance period of the CCRE award.

TERMS AND CONDITIONS

The following Terms of Award are in addition to, and not instead of, otherwise
applicable OMB administrative guidelines, DHHS Grant Administration Regulations
at 45 CFR Part 74 and 92, and other DHHS, PHS, and NIH grant administration
policies.  Cooperative Agreements are subject to the administrative requirements
outlined in pertinent OMB, DHHS, PHS, and NIH guidelines, with particular
emphasis on DHHS regulations at 42 CFR Part 52 and 45 CFR Part 74.  Indirect
costs are calculated and awarded for cooperative agreement awards the same as for
grants.

1.  The Awardee Rights and Responsibilities

o  The awardee has primary authority and responsibility to define the scientific
objectives and approaches, and to plan, conduct, analyze, and publish results,
interpretations, and conclusions of the studies;

o  The awardee has the primary responsibility for establishing effective and
substantial research collaborations with NIH grantees.  The scope and nature of
research on common protocols must be adequately documented and must ensure
participation, collaboration, and sharing of methods and data among collaborating
organizations;

o  The awardee has the primary responsibility for establishing an internal
advisory committee of the collaborating clinical scientists.  The committee will
have the responsibility for directing and monitoring the progress of the research
projects.  Beyond this, the committee must develop opportunities for information
exchange, seminar presentations, and research training opportunities for students
and fellows;

o  The awardee has the primary responsibility for establishing an external
advisory committee of distinguished senior clinical scientists.  Annually, the
committee will assess the productivity of the CCRE, make recommendations for the
future direction of the CCRE initiative, and provide advice and guidance about
personnel matters and the allocation of resources to individual projects and
investigators;

o  The awardee will retain custody of and primary rights to the data and
intellectual property developed under the award, subject to current government
policies regarding rights of access as consistent with current DHHS, PHS, and NIH
policies.  The NCRR reserves the right to negotiate additional awardee terms and
conditions based on recommendations from the Initial Review Group and the
National Advisory Research Resources Council.

2.  NCRR-DRI Staff Responsibilities

The NCRR-DRI will have substantial scientific/programmatic involvement during the
award performance period by contributing to planning and assessment activities,
providing technical assistance, advice and coordination beyond normal program
stewardship for grants. (See INQUIRIES, below.)

o  The NCRR-DRI will have primary responsibility for stewardship of the award and
overall responsibility for monitoring the conduct, progress, and fiscal
management of the research program.  The NCRR-DRI will provide advice and
guidance as appropriate;

o  The NCRR-DRI will help shape a comprehensive framework for the development of
the CCRE and provide technical advice and expertise regarding scientific
direction and program management.  The NCRR-DRI will provide advice and guidance
as appropriate;

o  The NCRR-DRI will help the applicant institution and CCRE Director establish
reasonable time lines to achieve the developmental goals of the CCRE.  The NCRR-
DRI will facilitate interactions between the awardee and collaborating
investigators.  The NCRR-DRI will use programmatic authority within the Research
Centers in Minority Institutions (RCMI) Program to assist in the sharing of
research resources and infrastructure for CCRE awards at RCMI-supported
institutions;

o  The NCRR-DRI will reserve the authority to recommend reductions in budget,
withhold support, or suspend and/or terminate the award if technical performance
falls below acceptable standards for quality and timeliness;

o  The NCRR-DRI will actively participate as a non-voting member in all meetings
of the external advisory committee during the performance period of the award;

o  The NCRR-DRI will have the authority to recommend additional research
endeavors within the approved research and negotiated budgets;

o  The NCRR-DRI reserves the right to include selected extramural and intramural
staff as consultants/experts on scientific issues during the performance period
of the award.

3.  Arbitration

Any disagreements about scientific/programmatic matters (within the scope of the
award) between the awardee and NCRR may be brought to an arbitration panel
convened by the Director, NCRR.  The arbitration panel will be composed of three
members, one person selected by the awardee, one person selected by the NCRR, and
a third person selected by these two members.  The decision of the arbitration
panel, by majority vote, will be binding.  The process to resolve programmatic
differences described above in no way affects the rights of a recipient of a
cooperative agreement assistance grant to appeal an adverse determination in
accordance with PHS regulations at 42 CFR Part 50, Subpart D, and DHHS
regulations at 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.  Adequate
plans to include both genders and minorities and their subgroups as appropriate
for the scientific goals of the research must be included.  Plans for recruitment
and retention of subjects will be evaluated.  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 was 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.  This information is available on the Internet at
https://grants.nih.gov/grants/guide/notice-files/not94-105.html.

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.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of NIH that children (i.e., individuals under the age of 21)
must be included in all human subjects research, conducted or supported by the
NIH, unless there are scientific and ethical reasons not to include them.  This
applies to all initial (Type 1) applications submitted for receipt dates after
October 1, 1998.

All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines on the Inclusion of Children as Participants in
Research Involving Human Subjects" that was published in the NIH Guide for Grants
and Contracts, March 6, 1998, and is available at the following URL address:
https://grants.nih.gov/grants/guide/notice-files/not98-024.html

APPLICATION PROCEDURES 

The research grant application form PHS 398 (rev. 4/98) is to be used in applying
for these grants.  These forms 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) 710-0267; Email:
GrantsInfo@nih.gov; and from the NIH program administrator listed under
INQUIRIES. 

An application for a CCRE award must include the following:

o  A research plan for up to five years that includes the proposed organization
and component functions of the CCRE.  The plan should demonstrate the applicant's
knowledge, ingenuity and commitment to developing productive, competitive
clinical research;

o  A description of and justification for the proposed individual research
projects (15 page limitation for the Research Plan Section for each project). 
Applicants are required to propose up to three meritorious research projects. 
Competitive applications will develop new and/or strengthen existing
collaborative projects with NIH/PHS grantees from research-intensive
institutions.  Applicants must clearly define the nature and extent of the
research collaboration, such that the necessary fiscal and scientific aspects are
fully explained in the application;

o  A description of the research and research training goals and capabilities of
the proposed CCRE.  The Program Director and the DRI must establish a time line
for supported applicant investigators to prepare and submit proposals for
traditional research grant review during the performance period of the CCRE
award; and,

o  A description of the infrastructure for conducting studies aimed a developing
a competitive clinical research program.

The CCRE application must address the following key elements:

1.  Administration

o  Define the chain of responsibility for decision making and administration,
beginning at the level of the institution's President and including all key staff
(e.g., Sponsored Programs Administrator, Department Chair, and Dean).  Describe
the plans for day-to-day administration of the CCRE, including program
coordination, planning, and evaluation.  Describe the proposed relationship of
the CCRE to the RCRII or other clinical research activities and, in detail, how
the CCRE initiative will augment and strengthen the existing clinical research
infrastructure;

o  The applicant must identify and outline plans for support staff (e.g., grants
management, administrative, and technical) to ensure the timely ordering of
research supplies, equipment, and other resources essential to the scientific
productivity of the research award.  If these resources are provided via an
existing RCRII award, they must not be requested in this application.

2.  Program Direction/Advisory Committee

o  Selection and appointment of a CCRE Program Director who has had experience
with clinical research funding and research training;

o  Appointment of an Advisory Committee whose composition consists of clinical
investigators whose research experience and expertise compliments the research
focus of the CCRE;

o  A research plan for up to five years that includes the proposed organization
and component functions of the CCRE.  The plan should demonstrate the applicant's
knowledge, ingenuity, practicality, and commitment to developing a significant,
productive, research program, and describe how the proposed activities will
enhance the scientific capabilities of faculty and fellows involved in clinical
research;
 
o  Establishment of a time-line by the Program Director for developmental project
investigators to prepare and submit proposals for traditional research grant
review during the performance period of the CCRE award.

3.  Institutional Commitment/Supporting Infrastructure

o  Evidence that the senior leadership at the applicant institution has addressed
issues such as tenure, promotion, research release-time, and other personnel
matters pertaining to the scientific success of the CCRE;

o  A research plan for up to five years that includes the proposed organization
and component functions of the CCRE.  The plan should demonstrate the
institution's commitment to developing a significant, productive, research
program;

o  Documentation/evidence of institutional commitment and the availability of
technical resources and facilities for the long-term support of the CCRE. 
Features of the institutional environment that are relevant to effective
accomplishment of the CCRE overall goals must be briefly described;

o  As appropriate, availability of existing resources (e.g., clinical and
laboratory facilities, patient populations, geographic distributions of space and
personnel) and collaborative resources should be described;

o  A letter of support from a senior institution official (e.g., President or
Dean) should outline the commitment for resources and facilities to sustain and
support the CCRE throughout the period of funding and beyond the performance
period of this award;

o  The applicant institution must show evidence of an existing research
infrastructure that can support clinical research.  Previous (past five years)
and current research support used for clinical research should be described.  The
existing research infrastructure and needed enhancements must be delineated.

4)  Collaboration

o  Competitive applications may include no more than three developmental clinical
research projects.  Each project must have a PHS-supported grantee at a near-by
research-intensive institution as a collaborator.  Investigators must clearly
define the nature and extent of the research collaboration, such that they fully
explain the necessary administrative, fiscal, and scientific aspects in the
application;

o  The nature and scope of the collaborative research projects must be
documented.  Collaborating investigators must devote a minimum of 20 percent
research effort to the respective projects.  These costs may be paid via a
subcontract.

5)  Developmental Projects

o  A description of and justification for the developmental research projects and
core service facilities.  Applicants are required to propose up to three
meritorious research projects, and must describe the nature and scope of any
scientific research collaborations;

o  Selection of up to three highly qualified investigators from the applicant
organization to propose and direct meritorious research projects suited to their
research expertise.  These projects should focus on one of the diseases that
disproportionately affect the health status of minority populations (see above). 
These investigators are required to devote a minimum of 50 percent research
effort to their respective projects;

o  Each project must be presented in the format of an R01 application.  The
research plan should be limited to 15 pages for Research Plan Section (a-d in the
PHS 398).  The maximum allowable direct cost is $200,000 per year/project.  These
projects must involve clinical investigators at nearby institutions as
collaborators.

The RFA label, available in the PHS 398 application kit, 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 number and title must
be typed on line 2 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 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:

Dr. Grace S. Ault
Office of Review
National Center for Research Resources
6705 Rockledge Drive, Room 6018 - MSC 7965
Bethesda, MD  20892-7965
Bethesda, MD  20817 (for express/courier service)
Telephone: (301) 435-0811
FAX:  (301) 480-3660
Email:  GraceA@ncrr.nih.gov

Schedule

Application Receipt Date:  March 11, 1999
Council Review:            September 7-8, 1999
Earliest Award Date:       September 30, 1999

Applications must be received by March 11, 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 an application in response to this
RFA that is essentially the same as one currently pending initial review, unless
the applicant withdraws the pending application.  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.  Applications that are incomplete, non-responsive
to this RFA, and/or exceed the maximum first year total direct cost limit of $1
million, excluding indirect costs for consortium budgets, will be returned to the
applicant without further consideration.  The applications will be reviewed by
an NCRR Special Emphasis Panel.  The NCRR will withdraw from further competition
those applications judged by the review committee to be noncompetitive for an
award and notify the applicant Principal Investigator and applicant organization.

The review of a CCRE application will be based on the feasibility and potential
for the proposed Center to create an environment for clinical investigation, the
recruitment of magnet clinical investigators conducting clinical research on
diseases that have disproportionate effect on minority populations, the proposed
Program Director, the institutional support and infrastructure, the quality of
the clinical research projects and collaborations, and the potential of young
clinical investigators to gain scientific independence.

REVIEW CRITERIA

The review will be organized according to the following considerations:

1.  Administration

o  The chain of command in the administration of the grant and the Center;

o  The day-to-day administration of the Center, coordination of research
activities, planning and evaluation;

o  The plans for the establishment and utilization of support structure (grants
management, administrative, technical) to provide resources essential to carry
out the scientific projects;

o  The relationship of the proposed program to the already existing RCRII, if
applicable.

2.  Program Direction/Advisory Committee

o  The qualifications and track record of the proposed CCRE Program Director;
his/her experience, publication record in clinical research as a funded clinical
investigator; previous experience as mentor of young investigators and serving
as role model; and the administrative qualifications to direct the Center;

o  Selection and appointment of members of the Advisory Committee; the proposed
oversight role of the Advisory Committee in the functioning of the Center;

o  The Program Director's knowledge, commitment and ingenuity to develop a
productive research program as reflected in the five-year research plan.

3.  Institutional Commitment/Supporting Infrastructure

o  Documentation of institutional endorsement of the proposed five-year plan,
including a letter of support from a senior institutional official; features of
the institutional environment that are relevant or unique in assuring the success
of the program;

o  Existing research infrastructure (laboratory space, equipment, clinical
facilities, animal housing, computer resources) and its commitment to the
proposed CCRE program that would facilitate and support the proposed clinical
research;

o  Justification for the proposed needed infrastructure enhancement;

o  Availability of patient population and patient recruitment.

4.  Overall Program Quality

o  Past and current clinical research support, including institutional grant
support for clinical research;

o  Recruitment of senior clinical investigators that would allow the development
of clinical research on diseases that have disproportionate affect on minority
populations;

o  The potential for enriching the academic and intellectual milieu for doing
clinical research and the feasibility and potential for junior investigators to
gain scientific independence under the mentorship of senior clinical
investigators;

o  The proposed five year plan and the establishment of the developmental project
for young investigators and fellows; plans to prepare young investigators to
write their own grant proposal and become independent investigators.

5.  Collaboration

o  The strength of the relationship of the applicant investigators and
collaborating researchers, if any, particularly the academic qualifications,
research experience, expertise and research productivity, as well as
administrative and fiscal relationships;

o  The importance and relevance of each collaborative project to the achievement
of CCRE program objectives.

6.  Developmental Projects

Each of the Developmental Projects will be evaluated for its scientific merits
using the standard NIH R01 review criteria:

(1) Significance:  Does this protocol 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
protocol?  Does the applicant acknowledge potential problem areas and consider
alternative tactics?

(3) Innovation:  Does the protocol 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 protocol?  Is the work proposed appropriate to the experience
level of the Principal Investigator and other researchers (if any)?

(5) Environment:  Does the scientific environment in which the protocol will be
performed 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 of institutional support?

A protocol 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.

In addition to the above criteria, in accordance with NIH policy, all
applications will also be reviewed with respect to the following:

o  The adequacy of plans to include both genders, minorities and their subgroups,
and children as appropriate for the scientific goals of the research.  Plans for
the recruitment and retention of subjects will also be evaluated;

o  The adequacy of the proposed protection for humans (including biohazards
safety in the research environment), animals, or the environment, to the extent
that they may be adversely affected by the project(s) proposed in the
application;

o  The reasonableness and appropriateness of the proposed budget and duration,
including the justification for requested personnel, equipment and other items,
in relation to the aims and methods of the proposed research studies.

AWARD CRITERIA

Funding decisions will be based on scientific and technical merit as determined
by a Special Emphasis Panel and the National Advisory Research Resources Council,
program balance, and the availability of funds.

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:

Dr. Sidney A. McNairy, Jr.
Research Infrastructure
National Center for Research Resources
6705 Rockledge Drive - MSC 7965
Bethesda, MD  20892-7965
Telephone:  (301) 435-0788
FAX:  (301) 480-3770
Email: SidneyM@ncrr.nih.gov

For information on budget and fiscal matters, contact:

Mr. Paul Karadbil
Office of Grants Management
National Center for Research Resources
6705 Rockledge Drive - MSC 7965
Bethesda, MD  20892-7965
Telephone:  (301) 435-0844
FAX: (301) 480-7777
Email: PaulK@ncrr.nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No.
93.389 (Research Infrastructure).  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 Regulation 42 CFR 52 and 45 CFR Part 74. This program is not subject
to the intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review.

The PHS strongly encourages all grant and contract recipients to provide a
smoke-free workplace and promote the non-use of all tobacco products.  In
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in
certain facilities (or in some cases, any portion of a facility) in which regular
or 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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	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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