Full Text HD-95-003

SPECIALIZED RESEARCH CENTER PROGRAMS OR CENTER CORE GRANTS TO SUPPORT
RESEARCH IN REPRODUCTION

NIH GUIDE, Volume 23, Number 33, September 16, 1994

RFA AVAILABLE:  HD-95-003

P.T. 04

Keywords: 
  Human Reproduction/Fertility 
  Reproductive Endocrinology 
  Reproductive Physiology 
  Biomedical Research, Multidiscipl 


National Institute of Child Health and Human Development

Letter of Intent Receipt Date:  January 3, 1995
Application Receipt Date:  May 18, 1995

PURPOSE

The National Institute of Child Health and Human Development (NICHD)
provides funding for a limited number of research centers in the
reproductive sciences.  These centers are broadly based investigative
endeavors encompassing research of a biomedical nature.  They are
supported through either Center Core Grants (P30) or Specialized
Research Center Grants (P50).

These centers form a national network that fosters communication,
innovation, and high quality research.  Reproductive Sciences Research
Centers provide a stimulating, multidisciplinary environment that
attracts and nurtures both established and promising young
investigators.  Each Center works closely with the NICHD staff in
participating in a Center Network and in carrying out its objectives in
a manner consistent with the goals and mission of the NICHD.

Background

The Reproductive Sciences Branch (RSB) of the Center for Population
Research (CPR) of the NICHD supports basic and clinical research on
reproduction that relies on a variety of approaches in biomedical
sciences.  Among the grant mechanisms used to provide research support,
the RSB uses:

(1) Specialized Research Center Grants (P50s), which support integrated
groups of research projects and supporting core service facilities.
The research activities included in such project grants must comprise,
by definition, a multidisciplinary approach to biomedical problems
addressing the research objectives announced in this RFA.  These
research programs may have more than one theme, focus, or emphasis, but
all of the subprojects involved must be responsive to one or more of
the specific research areas of reproduction supported by the RSB.

(2) Center Core Grants (P30s), which support Center Core facilities
designed to enhance existing federally supported research projects
within the purview of the RSB, CPR, NICHD.  Such center awards require
a critical mass of individual awards for which coordinated technical
support would be cost-effective to the NIH.  Core Grants provide no
funds for the direct support of research projects other than for new
program development; however, by making cost-effective resources and
facilities available, they enhance the productivity of existing
projects that are either integrated in a specialized research area or
organized within a central theme of research that addresses the
research objectives announced in this RFA.

At present, the RSB supports a fixed number of centers with a
commitment of five years of support that is competitively renewable for
additional five-year periods.  Committed support for three P50 Centers
and three P30 Centers ends in FY 1996, and it is anticipated that these
Centers will submit renewal applications.  New groups of investigators,
in addition to the current awardees, are invited to compete for up to
six awards in FY 1996.

HEALTHY PEOPLE 2000

The Public Health Service 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), Specialized Research Center Programs or Center
Core Grants to Support Research in Reproduction, is related to the area
of family planning.  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

Domestic institutions are eligible to apply for these centers.
Applications prepared for this competition may not propose
multi-institutional consortium arrangements.  In order to receive
funding, an individual domestic institution's application for a
specialized reproductive research center (P50) must have three or more
related, integrated, and high quality research subprojects that provide
a multidisciplinary, yet thematic, approach to the problems to be
investigated.  These research subprojects may be accompanied by an
appropriate number and type of core facilities, as described below, for
providing them cost-effective technical support.

MECHANISM OF SUPPORT

The support mechanisms for these programs are the P50 Specialized
Reproductive Sciences Research Center Grant and the P30 Reproductive
Sciences Research Center Core Grant.  The applications should be
prepared in a manner consistent with the policy and instructional
details of this RFA and the general guidelines presented in the
publications entitled either P50 SPECIALIZED RESEARCH CENTER GRANT
GUIDELINES or P30 CENTER CORE GRANT GUIDELINES that are available from
the NICHD offices listed below.  The current policies and requirements
that govern the research grant programs of NIH will prevail (Code of
Federal Regulations, Title 42, Part 52 and Title 45, Part 75).  The
total project period for applications  submitted to this RFA is five
years.  The anticipated award date will be April 1, 1996.

The concurrent submission of an R01 or R29 research project application
to do essentially the same research as that proposed in a subproject of
a P50 Center application is permissible within the context of extant
NIH policy.  As a general policy, preference in selection for funding
by NICHD will be given to the subprojects of the P50 Center in order to
maintain the integrity of the program and the validity of its merit
assessment.  The coincident R01 or R29 application(s) will usually be
expected to be withdrawn or relinquished.  P50 subprojects must address
one or more of the biomedical topics announced in this RFA to be
eligible for funding.

A domestic institution's application for a reproductive sciences
research Center Core facility (P30) must be predicated on the existence
of a comprehensive research base in the reproductive sciences comprised
of a substantial number of  relevant, eligible, and funded research
grants which will be active on April 1, 1996.  Such grant projects must
directly address one or more of the biomedical topics announced in this
RFA to be eligible for inclusion in the center.  A majority of these
grants must be supported by the NICHD.  In addition, the eligibility
for funding a core in a P30 Center is determined by the demonstrated
need of a minimal number of three relevant NIH (or other federally
reviewed and funded) research grants from the research base in the
application.  P30 Center grant funds support only active users of the
core facilities and services from the research base (projects) proposed
in the Center grant application and only serve programs of scientific
research relevant to the mission of the RSB, CPR.

Core facilities eligible for support under this RFA are organized
activities directly providing reagents, assays, sophisticated technical
services and technical expertise in areas required by multiple projects
of a center.  Such Core facilities neither directly conduct project
type research nor serve as a funding source for non-Center technical
services available elsewhere at the institution.  It is expected that
such Core facilities will be organized to provide training only for
eligible users and only to the extent necessary to  utilize the Core
effectively.  The general guideline request for information
demonstrating research training program history and availability
pertains to discussing the overall richness of the environment of the
Center's setting and should not be confused with Core service needs per
se.

If a New Program Development (NPD) component is requested, it must be
a single investigator's subproject description with a research plan
formatted in the usual NIH research project style.  Sufficient detail
should be provided to allow a full peer-review evaluation of its
merits.

New Specialized Research Center Grant (P50) applications may not
request more than $600,000 in direct costs for the first year.  New
Center Core Grant (P30) applications may not request more than $500,000
in direct costs for the first year.  Renewal applications from existing
P30 or P50 Centers may not request initial year direct costs exceeding
120 percent of the Council recommended direct costs for the final year
of the preceding project period.  Unless prior written approval of the
NICHD has been obtained, applications with requests exceeding these
guidelines will be administratively withdrawn by the NICHD and returned
to the applicant.

FUNDS AVAILABLE

Although this solicitation is included in the fiscal plans for FY 1996,
support for these center grants is contingent upon the receipt of funds
for these purposes.  The number of grants to be awarded is also
contingent upon a sufficient number of applications receiving high
enough levels of merit to be considered for an award.  It is expected
that up to six awards will be made as a result of this announcement
within the expected total costs limit of $4,100,000 available for the
first year.

RESEARCH OBJECTIVES

The ultimate goals of biomedical research in the reproductive sciences
are to develop new knowledge leading to clinical applications that will
enable men and women to control their fertility with methods that are
safe, effective, inexpensive, reversible, and acceptable to various
population groups, and to overcome problems of infertility and
reproductive disorders.  Domestic U.S. Reproductive Sciences centers
designated as "Specialized Reproductive Sciences Research Centers"
(P50s) and as "Reproductive Sciences Research Centers" (P30s) are
awarded funds for the support of comprehensive reproductive research
programs of high quality that focus on topics deemed to be of high
priority and significance because of their critically important
relationship to the mission of the RSB, CPR.

This RFA is specifically designed to stimulate the reproductive
sciences research community to organize or to maintain reproductive
sciences research centers of outstanding quality that, serving as
national research resources, form a network that fosters communication,
innovation, and high quality research.  Applications are encouraged for
the biomedical topics listed below:

1.  Reproductive medicine:  Fertility and infertility aspects
2.  Mechanism(s) of follicular selection, atresia and ovulation
3.  Neuroendocrinology of reproduction:  Clarification of the
regulatory mechanisms of the hypothalamo-pituitary-gonadal axis related
to fertility
4.  Regulatory mechanism(s) of gametogenesis

5.  Mechanism of action of reproductive hormones, particularly at the
cellular and genetic level; modification of action by growth factors
6.  Mechanisms regulating gonadal or genital tract functions
7.  Studies on fertilization, preimplantation embryo development, or
blastocyst implantation
8.  Immunological mechanisms regulating fertility

SPECIAL REQUIREMENTS

Applicants may request travel funds to attend an annual meeting of the
directors of P50s and P30s.

STUDY POPULATIONS

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is 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 rational 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 Population, 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 from these sources or from the program
staff or contact person listed below.  Program staff may also provide
additional relevant information concerning the policy.

LETTER OF INTENT

Interested applicants may contact the RSB staff for an advisory
consultation regarding reproductive sciences center grants (P50s and
P30s).  Prospective applicants are asked to submit, by January 3, 1995,
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 and participating
institutions, and the number and title of the RFA in response to which
the application may be submitted.  Although a letter intent is not
required, is not binding, and does not enter into the review of
subsequent applications, the information that it contains allows NICHD
staff to estimate the potential review workload and to avoid conflict
of interest in the review.  The letter of intent is to be sent to Julia
Lobotsky at the address listed under INQUIRIES.

APPLICATION PROCEDURES

The grant application form PHS 398 (rev. 09/91) is to be used to
prepare these applications.  The form PHS 398 is available from most
offices of sponsored research and from the Office of Grants
Information, Division of Research Grants, National Institutes of
Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone
301/435-0714.  The RFA number HD-95-003 and the type of center grant
request (P50 or P30) must be indicated on the face page of the
application in item 2a.  The RFA label available in the form PHS 398
must be affixed to the bottom of the face page.  Failure to use this
label could result in delayed processing of the application such that
it may not reach the review committee in time for review.

It is especially important that applicants obtain and follow the
supplemental NICHD guidelines for preparing the application.  These
guidelines address special organizational aspects that require certain
tabulations in addition to the usual instructions.  Applications must
be submitted by May 18, 1995.  Send or deliver the original, completed,
signed application and three, signed complete copies to:

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

In addition to those applications mailed to the Division of Research
Grants, two copies of the application must be sent under separate cover
directly to:

Susan Streufert, Ph.D.
Division of Scientific Review
National Institute of Child Health and Human Development
Building 6100, Room 5E03
Bethesda, MD  20892-7510

Late applications will not be accepted and will be returned to the
applicants.

REVIEW CONSIDERATIONS

Upon receipt, the applications will be reviewed for completeness by DRG
and responsiveness by NICHD.  Incomplete applications will be returned
to the applicant without further consideration.  If NICHD staff find
that the application is not responsive to the RFA, it will be returned
without further consideration.

Applications that are complete and responsive to the RFA will be
evaluated for scientific and technical merit by an appropriate peer
review group convened by the NICHD in accordance with the review
criteria stated below.  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 noncompetitive 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, and will also receive a second level of
review by the National Advisory Child Health and Human Development
Council.  Applications determined to be noncompetitive will be
withdrawn from further consideration and the principal
investigator/program director and the official signing for the
applicant organization will be promptly notified.

Those applications judged to be competitive will be further evaluated
by peer review for scientific/technical merit.  The Scientific Review
Administrator (SRA) of the Population Research Committee (PRC), NICHD,
may forward the application to selected members of the PRC for their
evaluation to determine if a site visit is needed.  A site visit,
however, is not a prerequisite for consideration of an application by
the PRC.  If a site visit is required, the SRA will communicate with
the applicant for the visit arrangements as described in the
guidelines.  The initial review for scientific merit will be carried
out by the PRC in November 1995.  The second-level review will be made
by the National Advisory Child Health and Human Development Council in
January 1996.  The earliest possible funding date is April 1, 1996.
Review procedures and criteria are detailed in the P50 SPECIALIZED
RESEARCH CENTER GUIDELINES and P30 CENTER CORE GRANT GUIDELINES
(available from the NICHD offices listed below).

AWARD CRITERIA

The anticipated date of award is April 1, 1996.  Funding decisions will
be based on the IRG and NACHHD Council recommendations, program
relevance, and the availability of funds.

INQUIRIES

Written and telephone inquiries concerning this RFA are encouraged.
The opportunity to clarify any issues or questions from potential
applicants is welcome.  For further information regarding programmatic
issues, contact:

Julia Lobotsky, M.S.
Center for Population Research
National Institute of Child Health and Human Development
Building 6100, Room 8B01
Bethesda, MD  20892-7510
Telephone:  (301) 496-6515

For information on budget and fiscal matters, contact:

Melinda Nelson
Office of Grants and Contracts
National Institute of Child Health and Human Development
Building 6100, Room 8A17K
Bethesda, MD  20892-7510
Telephone:  (301) 496-5481

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance
No. 93.864, Population Research.  Awards will be made under the
authority of the Public Health Service Act 301 (42 USC 241) and 441
(USC 289d) and administered under PHS grants policies and Federal
Regulations 42 CFR Part 52 and 45 CFR Part 74.  This program is not
subject to A-95 or Health Systems Agency review.  The Public Health
Service (PHS) strongly encourages all grant recipients to provide a
smoke-free workplace and promote the non-use of all tobacco products.
This is consistent with the PHS mission to protect and advance the
physical and mental health of the American people.

.

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