Subject: NIH GUIDE - RFA HD-92-01 - V20(33) 09/06/91
From: Dot Baker <[email-masked]>
To: [email-masked]
Date: Fri, 06 Sep 91 15:36 EST

Hi Paul,
This is the third RFA.  Please post to NIH listserver as
RFAHD-92-01.
    Thanks, M. G. Broaddus
 ---------------------------- Text of forwarded message -----------------------
 
$$XID RFA HD9201 HD-92-01 P1O1 *****************************************
 
REQUEST FOR APPLICATIONS
 
SPECIALIZED RESEARCH CENTER PROGRAMS AND CENTER CORE GRANTS TO SUPPORT
RESEARCH IN REPRODUCTION
 
RFA:  HD-92-01
 
P.T. 04; K.W. 0413002, 0710110, 0710115, 0710030
 
National Institute of Child Health and Human Development
 
Letter of Intent Receipt Date:  January 2, 1992
Application Receipt Date:  May 15, 1992
 
The National Institute of Child Health and Human Development (NICHD)
provides funding for a limited number of research centers in the area of
reproductive sciences research.  These centers are broadly based
investigative endeavors encompassing research of a biomedical nature.
They are supported through either 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 new 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 National Institute of Child Health and Human
Development (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) that 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) that 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 two P30
Centers ends in FY 1993, and it is anticipated that these Centers will
submit renewal applications.  Although there are no additional Center
awards available at this time, new groups of investigators are invited
to compete with current awardees for the existing three awards in FY
1993.
 
RESEARCH GOALS AND SCOPE
 
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
 
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 development
    of embryos, or blastocyst implantation
 
8.  Immunological mechanisms regulating fertility
 
SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH
POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDY POPULATIONS
 
NIH and ADAMHA policy is that applicants for NIH/ADAMHA 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 in Section 2,
A-D of the Research Plan AND summarized in Section 2, E, Human Subjects.
Applicants/offerors 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.
 
ELIGIBILITY
 
In order to receive funding, a domestic institution's application for a
specialized reproductive research center (P50) must have three (3) 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 providing cost-effective
technical support.
 
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 that will be active on April 1, 1993.  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 (3) relevant NIH (or other federally reviewed
and funded) research grants from the research base in the application.
P30 Center grants only support 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.
 
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.  Although this solicitation is
included in the plans for FY 1993, 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 three awards will be made as a
result of this announcement.  The applications must be prepared in a
manner consistent with the instructional details of this RFA and the
general guidelines presented in the publications entitled P50
SPECIALIZED RESEARCH CENTER GRANT GUIDELINES and 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).  Applications prepared for the
competition may not propose multi-institutional consortiums.
Applications for grants involving clinical studies must include members
of minority groups and women in the study populations.  Otherwise, a
clear rationale for their exclusion must be provided in the application.
Special instructions regarding implementation of this policy are
available for PHS 398 users.
 
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.
 
REVIEW PROCEDURES AND CRITERIA
 
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,
NICHD guidelines, and/or are not responsive to this RFA and the program
interests of RSB will be 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
NICHD will withdraw from competition those applications judged by the
triage procedure to be noncompetitive and will 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 1992.  The second-level review will be made by the National
Advisory Child Health and Human Development Council in January 1993.
The earliest possible funding date is April 1, 1993.  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).
 
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 (or a P01 Program Project) 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 (or P01 Program Project) 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.
 
METHOD OF APPLYING
 
Interested applicants may 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 applicants send a letter of intent to the RSB
staff at the address listed below by January 2, 1992.  This letter is to
include a list of the titles of relevant research projects to be
associated with it, and the names of relevant key investigators and
other participating institutions.  The letter of intent is to be
received by the RSB no later than January 2, 1992, 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 standard grant application form PHS 398 (rev. 10/88) is used to
prepare these applications.  The RFA number, HD-92-01 and the type of
center grant request (P50 or P30) must be indicated on the face page of
the application in item #2.  The RFA label available in the 10/88
version of 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.  The PHS 398 form is available from most business offices or
grant/contract offices at most institutions and from NIH by calling
telephone (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 15, 1992.  Send or deliver the original, completed,
signed application and four complete copies to:
 
Application Receipt Office
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.
Scientific Review Program
National Institute of Child Health and Human Development
National Institutes of Health
Executive Plaza North, Suite 520
Bethesda, MD  20892
 
Late applications will not be accepted and will be returned to the
applicants.
 
For further information contact:
 
Julia Lobotsky, M.S.
Reproductive Sciences Branch
Center for Population Research
National Institute of Child Health and Human Development
National Institutes of Health
Executive Plaza North, Suite 603
Bethesda, MD  20892
Telephone:  (301) 496-6515
 
For information on budget and fiscal matters, contact:
 
Melinda Nelson
National Institute of Child Health and Human Development
Executive Plaza North, Room 505
Bethesda, MD  20892
Telephone:  (301) 496-5481
 
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.