Full Text HD-95-017

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

NIH GUIDE, Volume 24, Number 30, August 18, 1995

RFA:  HD-95-017

P.T. 04

Keywords: 
  Human Reproduction/Fertility 
  Biomedical Research, Multidiscipl 


National Institute of Child Health and Human Development

Letter of Intent Receipt Date:  January 10, 1996
Application Receipt Date:  May 15, 1996

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 Center Core Grants (P30) and 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
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 Request for Applications (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.  An annual competition is held to
guide the NICHD's award decisions for funding new or renewal Center
Grant applications in the next fiscal year.  In fiscal year 1997,
awards to one P50 Center and three P30 Centers end, and it is
expected that up to four new or renewal competing awards will be
made.  It is anticipated that the existing Centers will submit
renewal applications.  New groups of investigators interested in
submitting a P50 Center application, in addition to the current
awardees, are invited to compete for the awards available in FY 1997.
Applications for new P30 Center Core Grants will not be considered
for this round of competition.

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, 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 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

Domestic for-profit and non-profit organizations, public and private,
such as universities, colleges, hospitals, laboratories, and units of
State or local governments are eligible to apply for these centers.
Applications prepared for this competition may not propose multi-
institutional consortium arrangements.  Racial/ethnic minority
individuals, women and persons with disabilities are encouraged to
apply as Principal Investigators.  Applications eligible for award
consideration include those for a new P50 Center or a renewal of a
P30 or P50 Center.  Applications for a new P30 Center are not
eligible for award consideration and, if received, will be returned
to the applicant unreviewed.

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.

FUNDS AVAILABLE

Although this solicitation is included in the fiscal plans for FY
1997, 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 RFA
within the expected total costs limit of $3.8M available for the
first year.

SPECIAL REQUIREMENTS

Specialized Research Center Grants (P50)

In order to receive funding, an individual domestic institution's
application for a P50 Center Grant 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 cost-effective technical support.  For new P50 Center
applications, at least one of the subprojects must be a clinical
research program.  Furthermore, it is strongly encouraged that at
least one basic science subproject be in a similar scientific area as
a clinical subproject in order to provide a setting for translation
of basic science knowledge to the clinic.  The inclusion of basic and
clinical research in a P50 Center should also enhance the interaction
between basic and clinical scientists, thereby enriching the research
environment in the Center.  Although existing P50 Centers will not be
required to propose a clinical research subproject in the
applications for competing renewals, they are strongly encouraged to
do so.

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 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) usually will 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.

Center Core Grants (P30)

A domestic institution's application for a reproductive sciences
research Center Core Grant (P30) must be predicated on the existence
of a comprehensive research base in the reproductive sciences.  This
research base must be comprised of a minimum of ten specifically
relevant NIH-funded projects of which at least five are administered
by RSB, CPR.  Regardless of funding source, all projects must
directly address one or more of the biomedical topics announced in
this RFA to be eligible for inclusion in the center, and all must be
active on April 1, 1997.

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 peer-reviewed and funded) research grants from the
research base in the application.  At least two of the user projects
justifying the proposed Core must be NICHD-funded grants.  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.

In addition to requesting funds for the core facilities, a P30 Center
application can also request funds for a New Program Development
(NPD) component.  To be considered for funding, the principal
investigator of an NPD should be either a new investigator or an
early career stage investigator seeking to conduct research in a new
area which is significantly different from their past research focus.
If an NPD is requested, it must be a 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.

Budget

New Specialized Research Center Grant (P50) applications may not
request more than $600,000 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.  Budgets of new and renewal applications will be stringently
reviewed within these guidelines.  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.

Applicants must request travel funds for the Principal Investigator
to attend an annual meeting of the directors of P50s and P30s.

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 reproductive research.
Applications are encouraged for the biomedical topics listed below:

1.  Reproductive medicine:  Fertility and infertility aspects,
including assisted reproductive technologies

2.  Regulatory mechanisms governing gametogenesis, including
intracellular processes controlling mitosis and meiosis and germ
cell-somatic cell interactions which support gametogenesis

3.  Ovarian follicular development, especially intraovarian
mechanisms regulating follicular selection and atresia

4.  Reproductive neuroendocrinology, particularly molecular and
cellular control of hypothalamic and pituitary hormone secretion and
pulsatility

5.  Mechanisms of action of reproductive hormones, particularly at
the cellular and molecular level, and how cytokines and growth
factors affect reproductive hormone actions

6.  Studies on fertilization, preimplantation embryo genetics and
development or implantation

7.  Mechanisms regulating fertility- or infertility-related genital
tract functions

8.  Immunological mechanisms regulating fertility

Applications submitted in response to this RFA may not request
subprojects in P50 Centers or Core facilities access in P30 Centers
for projects whose main research focus is in the area of reproductive
oncology, reproductive toxicology or reproductive epidemiology.
These topic areas are outside the purview of research areas supported
by RSB, CPR, and, therefore, will be deemed nonresponsive to this
RFA.  Since elimination of such subprojects (P50) or grants (P30)
from a center application can jeopardize the funding status of the
center application, prospective applicants preparing either a new or
competing center grant application are encouraged to discuss such
programmatic issues with the program staff cited under INQUIRIES in
this RFA.

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 rationale 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 consult with the RSB staff contact
regarding reproductive sciences center grants (P50s and P30s).
Prospective applicants are asked to submit, by January 10, 1996, a
letter of intent that includes a descriptive title of the proposed
research, the names of relevant key investigators, 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 allows NICHD staff to
estimate the potential review workload and avoid conflict of interest
in the review.

The letter of intent is to be sent to Dr. Louis V. DePaolo at the
address listed under INQUIRIES.

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 5/95) is to be used
in applying for these grants.  These forms are available at most
institutional offices of sponsored research; from the Office of
Grants Information, Division of Research Grants, National Institutes
of Health, 6701 Rockledge Drive, Room 3032, MSC 7762, Bethesda, MD
20892-7762, telephone 301/710-0267 and from the program administrator
listed under INQUIRIES.

It is especially important that applicants obtain and follow the
supplemental NICHD guidelines for preparing the application.  These
guidelines address special organizational aspects that benefit from
certain tabulations in addition to the usual instructions.

The RFA label available in the PHS 398 (rev. 5/95) 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 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:

Division of Research Grants
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:

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

Applications must be received by May 15, 1996.  If an application is
received after that date, it will be returned to the applicant
without review.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by DRG
and responsiveness by NICHD.  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 the NICHD in accordance
with the review criteria detailed in the P50 SPECIALIZED RESEARCH
CENTER GUIDELINES AND P30 CENTER CORE GRANT GUIDELINES (available
from the NICHD program staff listed under INQUIRIES).

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

Applications submitted in response to this RFA may receive a site
visit as part of the review process.  However, applicants should
assure that their applications are complete and can stand on their
own.

AWARD CRITERIA

The anticipated date of award is April 1, 1997.  Funding decisions
will be based on the recommendations of the peer review group and the
NACHHD, program relevance, 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:

Louis V. DePaolo, Ph.D.
Center for Population Research
National Institute of Child Health and Human Development
Building 6100, Room 8B01
Bethesda, MD  20892-7510
Telephone:  (301) 496-6515
FAX:  (301) 496-0962
Email:  [email protected]

For information on budget and fiscal matters, contact:

Ms. 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
FAX:  (301) 402-0915
Email:  [email protected]

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic
Assistance No. 93.864, Population Research.  Awards are made under
authorization of the PHS 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 Regulations 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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