Full Text HD-94-01

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

NIH GUIDE, Volume 21, Number 36, October 9, 1992

RFA:  HD-94-01

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 2, 1993
Application Receipt Date:  May 18, 1993

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 in reproduction.  These research programs may
have more than one theme, focus, or emphasis but all of the projects
involved must be responsive to one or more specific research areas of
reproduction promulgated 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.

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 one P50
Center and three P30 Centers ends in FY 1994, and it is anticipated
that these Centers will submit renewal applications.  While there are
no additional Center positions available at this time, new groups of
investigators, in addition to the current awardees, are invited to
compete for the existing four positions in FY 1994.

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 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 projects that
provide a multidisciplinary, yet thematic, approach to the problems
to be investigated.  These research projects may be accompanied by an
appropriate number and type of core facilities, as described below,
providing cost-effective technical support.

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 projects must address one or more of the announced
biomedical topics 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, 1994.  Such
grant projects must directly address one or more of the announced
biomedical topics 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 announcement 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 project 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.

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,
1994.

FUNDS AVAILABLE

Although this solicitation is included in the fiscal plans for FY
1994, 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 four awards will be made as a result of this
announcement within the expected total costs limit of $3,600,000
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 Request for Applications (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 must request travel funds to attend an annual meeting of
the directors of P50s and P30s.

STUDY POPULATIONS

SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH
POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDY POPULATIONS

NIH policy is that applicants for NIH clinical research grants and
cooperative agreements will be required to include minorities and
women in study populations so that research findings can be of
benefit to all persons at risk of the disease, disorder or condition
under study; special emphasis should be placed on the need for
inclusion of minorities and women in studies of diseases, disorders
and conditions which disproportionately affect them.  This policy is
intended to apply to males and females of all ages.  If women or
minorities are excluded or inadequately represented in clinical
research, particularly in proposed population-based studies, a clear
compelling rationale should be provided.

The composition of the proposed study population must be described in
terms of gender and racial/ethnic group.  In addition, gender and
racial/ethnic issues should be addressed in developing a research
design and sample size appropriate for the scientific objectives of
the study.  This information should be included in the form PHS 398
(rev. 9/91) in Sections 1-4 of the Research Plan AND summarized in
Section 5, Human Subjects.  Applicants are urged to assess carefully
the feasibility of including the broadest possible representation of
minority groups.  However, NIH recognizes that it may not be feasible
or appropriate in all research projects to include representation of
the full array of United States racial/ethnic minority populations
(i.e., Native Americans (including American Indians or Alaskan
Natives), Asian/Pacific Islanders, Blacks, Hispanics).

The rationale for studies on single minority population groups should
be provided.  For the purpose of this policy, clinical research
includes human biomedical and behavioral studies of etiology,
epidemiology, prevention (and preventive strategies), diagnosis, or
treatment of diseases, disorders or conditions, including but not
limited to clinical trials.

The usual NIH policies concerning research on human subjects also
apply.  Basic research or clinical studies in which human tissues
cannot be identified or linked to individuals are excluded. However,
every effort should be made to include human tissues from women and
racial/ethnic minorities when it is important to apply the results of
the study broadly, and this should be addressed by applicants.

For foreign awards, the policy on inclusion of women applies fully;
since the definition of minority differs in other countries, the
applicant must discuss the relevance of research involving foreign
population groups to the United States populations, including
minorities.

If the required information is not contained within the application,
the application will be returned.

Peer reviewers will address specifically whether the research plan in
the application conforms to these policies.  If the representation of
women or minorities in a study design is inadequate to answer the
scientific question(s) addressed AND the justification for the
selected study population is inadequate, it will be considered a
scientific weakness or deficiency in the study design and will be
reflected in assigning the priority score to the application.

All applications for clinical research submitted to NIH are required
to address these policies.  NIH funding components will not award
grants or cooperative agreements that do not comply with these
policies.

LETTER OF INTENT

Interested applicants should contact the RSB staff for an advisory
consultation regarding reproductive sciences center grants (P50s and
P30s).  If an applicant intends to apply, it is strongly recommended,
but not mandatory, that the applicant send a letter of intent to the
RSB staff at the address listed below by January 2, 1994.  This
letter is to include a list of the titles of relevant research
projects to be associated with the center, and the names of relevant
key investigators.  The letter of intent should be received by the
RSB no later than January 2, 1993, but applicants are encouraged to
send it as soon as they decide to apply for the grant so that the RSB
staff can be of maximum assistance in the application process.  The
letter of intent is to be sent to the RSB staff contact listed at the
end of this RFA.

APPLICATION PROCEDURES

The grant application form PHS 398 (rev. 09/91) is to be used to
prepare these applications.  The RFA number (HD-94-01) 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
PHS form 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.  The PHS 398 form is available from most business offices
or grant/contract offices at most institutions and can also be
obtained from NIH by calling 301/496-7441.

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, 1993.  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:

Laurance Johnston, Ph.D.
Division of Scientific Review
National Institute of Child Health and Human Development
Building 6100, Room 5E01
Bethesda, MD  20892

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

REVIEW CONSIDERATIONS

An administrative review of the application will be performed by the
Review, Program, and Grants Management staff for conformance to NIH
policy and NICHD guidelines, as well as for relevance to the program
purview of the RSB.  Applications that fail to comply with NIH policy
and/or NICHD guidelines will be formally returned to the applicant.
Applications may be subjected to a triage by a peer review group to
determine their potential competitiveness relative to other
applications submitted.  The Institute will withdraw from competition
those applications judged by the triage procedure to be
noncompetitive and notify the applicants and institutional business
officials.

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 1993.  The second-level
review will be made by the National Advisory Child Health and Human
Development Council in January 1994.  The earliest possible funding
date is April 1, 1994.  Review procedures and criteria are detailed
in the P50 SPECIALIZED RESEARCH CENTER GRANT GUIDELINES and P30
CENTER CORE GRANT GUIDELINES (available from the NICHD offices listed
below).

AWARD CRITERIA

The anticipated date of award is April 1, 1994.  Funding decisions
will be based on the IRG and NACHHD Council recommendations, program
relevance, and the availability of funds.

INQUIRIES

For further information regarding programmatic issues, contact:

Julia Lobotsky, M.S.
Reproductive Sciences Branch
Center for Population Research
National Institute of Child Health and Human Development
Building 6100, Room 8B01
Bethesda, MD  20892
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
Bethesda, MD  20892
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.

.

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