Full Text HD-95-008

COOPERATIVE SPECIALIZED INFERTILITY RESEARCH CENTER PROGRAM

NIH GUIDE, Volume 24, Number 10, March 17, 1995

RFA:  HD-95-008

P.T. 04

Keywords: 
  Human Reproduction/Fertility 
  Biomedical Research, Multidiscipl 
  Clinical Medicine, General 


National Institute of Child Health and Human Development

Letter of Intent Receipt Date:  May 15, 1995
Application Receipt Date:  October 11, 1995

PURPOSE

The National Institute of Child Health and Human Development (NICHD)
invites applications from investigators willing to participate with
the NICHD under a cooperative agreement in a multicenter cooperative
research program termed the National Cooperative Program for
Infertility Research (NCPIR).  The objective of this Program is to
expedite the development of new approaches for the diagnosis and
treatment of human male or female infertility.  Recognizing that the
complexity of infertility research severely limits the progress that
can be achieved by individual investigators working alone, the NICHD
will support at least two Centers comprised of biomedical research
projects and technical service core facilities that are interactively
organized to conduct accelerated preclinical and clinical research
and development studies on promising new leads in human infertility
research.  The Centers will also serve as national resources for the
career development of young scientists electing to pursue research in
high priority areas of infertility research.  The benefit of this
activity will be to the infertile couples, their health-care
providers, and the public.

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 Request
for Applications (RFA), Cooperative Specialized Infertility Research
Center Program, is related to the priority 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 202-783-3238).

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic for-profit and non-profit
organizations, public and private, that meet the requirements stated
in this RFA.  Minority individuals, persons with disabilities, and
women are encouraged to apply as Principal Investigators.  The need
for continuous and active communications and interactions among the
awarded sites dictates that only institutions in the United States
will be eligible for these Center grant awards.

MECHANISM OF SUPPORT

The funding mechanism to be used to assist the scientific community
in undertaking this Program of applied human biology research will be
the National Institutes of Health (NIH) cooperative specialized
center (U54) mechanism.  Funding will be provided by means of
cooperative agreements established between the participating Centers
and the NICHD.  A cooperative agreement is not an "acquisition"
mechanism.  It is an "assistance" mechanism in which substantial NIH
scientific and/or programmatic involvement with the awardee is
anticipated during the performance of the activities conducted by the
awardee.  Under a cooperative agreement, the NIH purpose is to
support, stimulate, and expedite the recipient's activities by
jointly being involved with them.  NIH staff work cooperatively with
the award recipients in a partner role and do not assume direction,
prime responsibility, or a dominant role in the activity.  Details of
the responsibilities, relationships, and governance of the activities
to be funded under the cooperative agreements awarded for this
Program are discussed later in this document under the section "Terms
and Conditions."

The total project period for an application submitted in response to
this RFA may not exceed five years.  The anticipated award date is
September 1, 1996.  Because the nature and scope of the research
proposed in response to this RFA may vary, it is anticipated that the
size of the awards will also vary.

Awards and levels of support depend on the receipt of a sufficient
number of applications of high scientific merit.  Although the
Program is provided for in the financial plans of the NICHD, awards
pursuant to the RFA are contingent upon the availability of funds for
this purpose.

This RFA is a one-time only solicitation for the purpose of the
present competition.  At this time, the NICHD has not determined
whether or how this Program will be continued beyond the present
solicitation.  Any future NICHD determination in this regard will be
publicly announced.

FUNDS AVAILABLE

It is anticipated that an estimated total of $3,040,000 (including
indirect and direct costs) will be available for the entire program
for the first year of the Program.  It is planned that these funds
will support at least two Center awards.  In addition to new
applications received in response to this solicitation, up to two
competing continuation (renewal) applications are expected to compete
for these two Center awards.

RESEARCH OBJECTIVES

Background

It has been estimated that infertility affects between 35 and 70
million married couples, who would like to have children, around the
world (World Health Organization, 1988 data).  In U.S. studies
described nearly 50 years ago, it was stated that 10 percent of
married couples were "sterile," while the remaining 90 percent
possessed varying degrees of fertility.  More recent studies
(National Center for Health Statistics, 1988 and 1990 data) in the
U.S. have conservatively indicated that there are 2.3 million
infertile couples, about nine percent of the domestic married couple
population base with wives aged 15 to 44.  In addition, it has been
observed that about 4.9 million U.S. women in this age range had an
impaired ability to have children. While analyses of the U.S.
population base has not found alarming increases in either the number
of infertile couples or the overall incidence of infertility,
physician office visits reflecting societal life style requirements
for infertility services have markedly increased from 1968 (600,000)
to 1988 (1,350,000) with a projected peak in 1995 approaching
1,800,000.  Of the infertile couples seeking medical treatment for
infertility, it has been estimated that up to one-half will be
unsuccessful in achieving their desired outcome.

Human infertility is generally accorded to female factors (40
percent), male factors (40 percent), male and female factors (10
percent) or unexplained infertility factors (10 percent). Current
therapy results for male factor infertility have been discouraging.
One earlier British study reported only a 20 percent chance of a
successful pregnancy within two years and no significant improvement
of this chance with the use of therapeutic insemination, husband
(TIH).  Potential applications of assisted reproductive technology
aimed at male infertility alleviation, such as Intracytoplasmic Sperm
Injection have not been well researched yet.  Varicocele is a
progressive disorder affecting 15 percent of pubertal boys.  While
evidence suggests many, but not all, of the men affected by this
disorder experience infertility, the underlying pathophysiology and
effective treatment approaches are not well understood.

Ovulation failure has been reported to be the underlying cause for at
least 25 percent of female factor infertility.  A specific cause for
anovulation is usually not able to be determined.  Chronic
anovulation predisposes the female to infertility and compromises
fecundity if not detected and treated early.  Recent findings also
indicate that current ovulation inducing fertility drug treatments
may carry, in certain circumstances, underappreciated risks to the
female (hyperstimulation, ovarian cancer) and the child (multiple
gestation, low birth weight prematurity consequences) associated with
medically assisted conception procedures.  In reproductive aged
females, it has been estimated that the general incidence of
endometriosis is 5 to 15 percent.  For women being surgically treated
for infertility, the incidence is 30 to 50 percent.  Among infertile
females with no other known cause of their infertility, the incidence
has been reported at 40 to 70 percent.  The causative role of
endometriosis in infertility is poorly understood at present and
optimal diagnosis and treatment of endometriosis has yet to be
attained.  The role of dysfunctional uterine bleeding, either in the
presence or absence of uterine myomata, is not well understood with
respect to infertility.  Uterine myomata occur in nearly 20 percent
of all reproductive aged women, are the single most common diagnosis
from gynecological hospital admissions, may be the only clinical
abnormality observed in an infertile couple, and represent the most
common medical indication for an often unwanted hysterectomy that
prematurely ends a females reproductive option.

Objectives

It is the primary objective of the cooperative research program
described in this RFA to meet the nationally identified need for a
coordinated infertility research program that will accelerate the
translation of promising new preclinical or clinical leads into new
clinical methods available to the public.  The need for accelerated
basic and clinical research on the diagnostic and therapeutic aspects
of infertility alleviation or cure has been extensively considered in
a number of relevant reports ("Infertility: Medical and Social
Choices," Office of Technology Assessment of the Congress of the
United States, Publication OTA-BA-358, May 1988; "Infertility in
America:  Why is the Government Ignoring a Major Health Problem?,"
Report of the House Committee on Government Operations, December
1989; and "Medically Assisted Conception: An Agenda for Research,"
Report of the Institute of Medicine of the National Research Council,
1989.)  Legislative directives included in the deliberations of the
101st U.S. Congress stressed the need to enhance support for research
on the diagnostic and therapeutic aspects of infertility alleviation
(Resolution HJ 173, Bill HR 2956).  Such directives were restated in
the respective appropriation committee reports issued by the 102nd
U.S. Congress.  The NIH Reauthorization Act of 1993 issued from the
103rd U.S. Congress and enacted on June 10, 1993, as PL 103-43 (Title
X., Subtitle A., Section 1001) authorized the Director, NICHD, to
make grants or contracts for the operation of two Centers to conduct
activities for the purpose of improving methods of diagnosis and
treatment of infertility and to provide for the coordination of the
Centers assisted under this section.  The terms of PL 103-43
acknowledge that infertility research and development problems are so
complex that they can not be solved by individual investigators
working alone and that "without specialized centers, promising new
leads may never be translated into new methods or ever made available
to the public."  The operational requirements to be met by such
Centers are further detailed in the subsequent section of this RFA.

Research Scope

The scope of the research projects expected to be pursued by a
proposed Center's research plan should address studies organized with
an orientation to either female factor or male factor infertility
research.  Although it is anticipated that the overall NCPIR
cooperative research program may be expanded by one or more Centers
in the future, to accommodate a broadened range of studies, the two
Centers to be awarded from this RFA are expected to be oriented
toward either research on the early diagnosis and/or therapy of those
female factors that most contribute to infertility (endometriosis,
ovulatory dysfunction, uterine dysfunction) or those male factors
associated with ineffective sperm production (quality or quantity) or
function.  Research proposals for projects or cores directly
involving human in vitro fertilization and/or embryo transfer must be
in compliance with NIH policies for such research and should not,
therefore, include efforts or activities that create human embryos
solely for research purposes.  As a cardinal principle, the current
Center organization should consist of multidisciplinary projects
and/or cores capable of interacting in a coordinated, cooperative
fashion.  Each Center should organize its overall research plan to
include a mix of primary clinical and closely adjunctive preclinical
research activities.  Applicants should note that it is not the
intent of this cooperative research program to fund a collection of
diverse, noninteractive projects.  Awards will not be made for
applications with research activities focused exclusively on basic
research or clinical research.  It is not intended for the Centers to
conduct epidemiological research or large clinical trials.
Applicants should particularly note that the NICHD currently supports
a separately established cooperative research program, called the
Reproductive Medicine Clinical Trial Network (RMN) for conducting
national clinical research trials of experimental protocols and it is
not the intent of the present NCPIR cooperative research program to
support additional large-scale, long-term clinical trials.  It is
anticipated, however, that progress achieved by the NCPIR Centers may
lead to collaborating interactions with the existing RMN group.

The scope of the Centers requested in the present RFA is expected to
include a program of applied human biology involving clinical
research projects and requisitely adjunctive preclinical projects
and/or cores that may prove translational in moving research progress
from the bench into the clinic.  Within the requirement for a minimum
of three funded projects to constitute a Center award, an applicant's
research plan might, for example, include a set of clinical research
projects and related animal model projects to study
infertility-related aspects of endometriosis.

Alternately, an applicant's research design strategy may include
projects involving clinical and preclinical animal investigations of
several different types of infertility-associated ovulation failure.
Another orientation might be toward male spermatogenesis failure.
Yet another orientation of scope might encompass comparative clinical
and preclinical experimental evaluations of in vitro fertilization
and embryo transfer protocols.  Research proposals for projects or
cores directly involving human in vitro fertilization and/or embryo
transfer must be in compliance with NIH policies for such research
and should not, therefore, include efforts or activities that create
human embryos solely for research purposes.  These examples are only
indicative of general strategy designs and should not be taken as an
inclusive or exclusive preference of the NICHD.

Guidance and Management Structures

The National Cooperative Program for Infertility Research (NCPIR)
will include two Centers supporting an aggregate of up to ten to
twelve research projects and two or more technical service cores. At
least one clinical project and an administrative core will reside in
the sponsoring department of the grantee institution awarded a Center
grant.  As the Centers may be consortium-based, other research
projects may be resident at domestic U.S. institutions other than the
grantee institution.  A Steering Committee consisting of the
investigators responsible for each project, the Principal
Investigator of each Center, an NICHD staff Research Coordinator, and
a nongovernment chairperson designated by the Steering Committee will
assist and guide the conduct of the research performed by the
Centers.  A nonvoting member of the NICHD grants management staff
will serve as an advisor to the Committee.  The Steering Committee
will employ a consensus decision process to assist the Centers in
evaluating the progress of Center projects, proposed new research
initiatives, the need for extra-Center collaborations and the need to
redirect certain Center efforts due to either sufficient data
acquisition to permit conclusion, the acquisition of data supporting
an alternative study initiative or experience proving that proposed
research is no longer feasible.  Further details of the guidance and
management structures and processes may be found in the Terms and
Conditions section below.

Description of a Center

The minimal requirements for the Centers described in this RFA are as
follows (see also Review Criteria and Procedures below):

o  Competent and experienced principal investigator who is committed
to and directly involved in human infertility research;

o  Availability of competent and experienced scientific experts to
direct individual research projects or cores associated with the
proposed Center;

o  Availability of the technical resources and facilities necessary
for the conduct of the experiments;

o  Access to properly managed animal facilities for projects
conducting animal studies;

o  Access to inpatient and outpatient reproductive health care units
providing adequate numbers of patients for clinical research projects
(Applicants from institutions which have a General Clinical Research
Center (GCRC) funded by the NIH National Center for Research
Resources may wish to identify the GCRC as a resource for conducting
the proposed research.  In such a case, a letter of agreement from
either the GCRC program director or principal investigator should be
included with the application);

o  A research environment conducive to the training of new
investigators in infertility research;

o  Willingness to cooperate in a coordinated cooperative research
program involving two or more Centers with multiple interacting
research projects, and if required, service cores;

o  Substantive evidence of departmental and institutional support for
and commitment to the proposed Center.

SPECIAL REQUIREMENTS

Contents of Applications

A response to this RFA should consist of a proposal that includes:

o  A description of a National Center for Infertility Research (NCIR)
consisting of multiple individual research projects and, as
justified, one or more core service facilities.  For suggested
formatting instructions see the document, "Suggested Format for NICHD
U54 Grant Applications," available from the program staff listed
under INQUIRIES.

o  A description of the capabilities of the Center to meet or exceed
the minimal requirements stated earlier (see DESCRIPTION OF A CENTER
above).

o  A proposed five-year research plan that presents the applicant's
perception of the Center's organization and component functions.
This plan should demonstrate the applicant's knowledge, ingenuity,
practicality, and commitment in organizing a multiproject research
infrastructure for conducting studies aimed at developing new
approaches to the diagnosis and/or therapy of human infertility.  The
research plan for the Center and all component projects must address
the "Research Scope" described earlier.  For the 02 through 05 years
of the overall Center research plan, the plan should include (for
peer review evaluation) at least one and no more than two "New
Program Development" (NPD) research projects directly related to the
overall research emphasis of the Center, which will provide up to
$75,000 total cost per annum to new investigators who have not been
the Principal Investigator of a funded NIH (or comparable) research
project grant award.  The initial NPD project(s) should be presented
as a two-year research project by a named new  investigator.  NPD
project investigators may be resident at either the grantee or a
participating consortium institution.  For each successfully competed
NPD project, the NICHD will include a full four years of budgeting
support to permit renewal of a continuing project or replacement by a
new NPD project in accord with the consensus decision process of the
NCPIR Steering Committee.

Optimal components of the Center organization include the mix of
local and external projects or cores to be included in the Center as
follows:

o  Principal investigators may consider organizing the Center to
attack a problem from different disciplines using collaborations
between institutions via consortium subcontract arrangements for
projects at other institutions.  Centers may thus seek to maximize
their scientific expertise and research capabilities by including in
the application new projects or technical service cores to be
supported at other institutions through subcontracted consortium
arrangements.

o  The Principal Investigator may choose to organize the Center using
collaborations of projects within the same institution.

o  The Principal Investigator of the Center may wish to incorporate
into the application a highly relevant individual NIH research
project, which is currently ongoing and deemed appropriate for
transfer into the Center.  Such a project may be fully presented in
the Center application as a renewal project and, contingent upon the
review outcome, become eligible for funding through the Center upon
relinquishment of the prior awarded project.

Irrespective of the organizational mix selected by the Principal
Investigator, each research project or core proposed for inclusion in
the Center must be described independently using the PHS 398
application format as described in Appendix A of this RFA.  For the
individual projects or cores, the page limits stated in the PHS 398
instructions must be followed.  The overall Center application must
also use the PHS 398 format to provide at the beginning of the
application an overall summary of the Center's organization and
cumulative aggregate budgeting for the various budgetary categories.
In both instances, all essential information for the evaluation of
the application must appear in the body of the application rather
than in an appendix.

Terms and Conditions of Award

The following terms and conditions of the award, and details of the
arbitration procedures pertaining to the scope and nature of the
interaction between the NICHD and the participating Centers will be
incorporated into the Notice of Grant Award and provided to the
Principal Investigator as well as the institutional official at the
time of award.  These procedures will be in addition to the customary
programmatic and financial negotiations which occur in the
administration of grants.

1.  The purpose of these cooperative agreements is to establish new
methods for the diagnosis or therapy of human infertility.

2.  Planning and implementation of the studies will be done by a
Steering Committee consisting of the Principal and Project
Investigators from each of the participating Centers, one NICHD staff
member from the Reproductive Sciences Branch, CPR, NICHD, who will be
the Research Coordinator and Collaborator, and a nongovernment
Chairperson, who will be a nonvoting member, as designated by the
Steering Committee.  A member of the NICHD grants management staff
will serve as a nonvoting advisor to the Committee.  The Steering
Committee meetings will be convened at least twice yearly.  The
purpose of these meetings is to share scientific information, assess
scientific progress, identify new research opportunities, establish
priorities that will accelerate the translation of preclinical
findings into clinical applications, and conduct the business of the
cooperative research program.

3.  The primary authorities and responsibilities of the awardees are
to participate cooperatively with the Steering Committee in the
following activities:

o  Determine objectives and experimental approaches;
o  Design protocols;
o  Conduct experiments and collect the resulting data;
o  Analyze results and interpret the results;
o  Present results and plans to the Steering Committee;
o  Publish results, conclusions, and interpretation of the studies;
and
o  Modify, delete, or add protocols within the Program

Awardees will retain custody of and primary rights to their data
developed under the award subject to current government policies
regarding rights of access as consistent with current HHS, PHS, and
NIH policies.

The awardees agree to accept the coordinating role of the Steering
Committee and the cooperative nature of the group process.

4.  The degree of programmatic involvement of the Research
Coordinator is as follows:

o  Participation in the group process setting research priorities,
deciding optimal research approaches and protocol designs, and
contributing to the adjustment of research protocols or approaches as
warranted.  The Research Coordinator will assist and facilitate the
group process and not direct it.

o  Providing, as a member of the Steering Committee, assistance by
reviewing and commenting on all transitional phases of the Centers'
activities prior to implementation to assure consistency with
required program goals and compliance with research protocol
priorities.  This includes efforts to improve and strengthen inter-
and intra-Center cooperation amongst the research projects of the
Centers as well as interactions with industry.  The Research
Coordinator will, as required, help redirect program efforts,
including options of modifications or terminations by mutual consent
between the Program and NICHD.  In the event of disagreements among
the Program participants, the Research Coordinator will assist in
forming an arbitration panel as discussed below;

o  Retaining the option to recommend the withholding of support from
a Center project or core materially failing to meet the technical
performance requirements established by the Program. This includes
identifying jointly with participants the need to add additional
research projects or service cores to Centers or to phase out a
Center project or core when performance standards have not been met;
and

o  Participating in data analyses, interpretations, and where
warranted, co-authorship of the publication of results of studies
conducted by a Center to the research community and health care
recipients.

5.  Arbitration

When agreement between an awardee and NICHD staff cannot be reached
on scientific/programmatic issues that may arise after the award, an
arbitration panel will be formed.  The panel will consist of one
person selected by the Principal Investigators, one person selected
by NICHD staff, and a third person selected by these two members.
The decision of the arbitration panel, by majority vote, will be
binding.  This special arbitration procedure in no way affects the
right of an awardee to appeal an adverse action in accordance with
PHS regulations at 42 CFR Part 50, Subpart D, and HHS regulations at
45 CFR Part 16.

6.  Cooperative agreements are assistance mechanisms and are subject
to the same administrative requirements as grants.  The above special
Terms of Award are in addition to, and not in lieu of, otherwise
applicable OMB administrative guidelines, HHS, PHS, and NIH grant
regulations, policies and procedures, with particular emphasis on HHS
regulations at 45 CFR Part 74 and 92. Business management aspects of
these awards will be administered by the NICHD Grants Management
section in accordance with HHS, PHS, and NIH grant administration
requirements.

7.  The level of support recommended for future years is subject to
negotiation and the availability of funds.

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 subject,
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 Populations, and
Concerning the Inclusion of Minorities in Study Populations), which
have been in effect since 1990.  The new policy contains some
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, Volume 23, Number 11,
March 18, 1994.

Investigators also may obtain copies of the policy from the program
staff listed under INQUIRIES.  Program staff may also provide further
discussion concerning the policy.

LETTER OF INTENT

Prospective applicants are asked to submit, by May 15, 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 of 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 Dr. Michael E. McClure at the
address listed under INQUIRIES.

APPLICATION PROCEDURES

All applicants must document their ability to meet or exceed the
minimum requirements as set out in the DESCRIPTION OF A CENTER
section and meet or exceed those in the SPECIAL REQUIREMENTS section
as detailed above.  This specifically includes understanding of and
commitment to the cooperative nature of this Program.

Any competing renewal application should include in the progress
report section a description of how the Center has met the special
cooperative agreement terms and conditions of the award, including
its interaction with other NCPIR Center projects and the NICHD
Research Coordinator.

Applications from institutions that have a General Clinical Research
Center (GCRC) funded by the NIH National Center for Research
Resources may wish to identify the GCRC as a resource for conducting
the proposed research, if appropriate.  If so, a letter of agreement
from either the GCRC program director or principal investigator could
be included with the application.

The research grant application form PHS 398 (rev. 9/91) is to be used
in applying for these awards.  These forms are available at most
institutional offices of sponsored research and from the Office of
Grants Information, Division of Research Grants, National Institutes
of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892,
telephone 301/435-0714.

Additional suggestions for formatting the application into a Center
grant application are provided in the document "Suggested Format for
NICHD U54 Grant Applications," which is available from the program
staff listed under INQUIRIES.

The RFA label available in the PHS 398 (rev. 9/91) 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, COOPERATIVE SPECIALIZED
INFERTILITY RESEARCH CENTER GRANT, and number, RFA HD-95-008, must be
typed on line 2a of the face page of the application form and the YES
box must be checked.  On line 2b, type U54.

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 mail or 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 61E, Room 5E03
Bethesda, MD  20892

Applications must be received by October 11, 1995.  If an application
is received after that date, it will be returned to the applicant
without review.  The Division of Research Grants (DRG) will not
accept any application in response to this RFA that is essentially
the same as one currently pending initial review, unless the
applicant withdraws the pending application.  The DRG will not accept
any application that is essentially the same as one already reviewed.
This does not preclude the submission of substantial revisions of
applications already reviewed, but such applications must include an
introduction addressing the previous critique.

Schedule

Letter of Intent Receipt Date:     May 15, 1995
Application Receipt Date:          October 11, 1995
Initial Review Group Peer Review:  February/March 1996
NACHHD Council Review:             June 4, 1996
Earliest Award Date:               September 1, 1996

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by DRG
and responsiveness by NICHD staff.  Incomplete applications will be
returned to the applicant without further consideration.  Any
application that does not meet the minimum requirements in the
DESCRIPTION OF A CENTER and SPECIAL REQUIREMENTS sections of this RFA
will be considered unresponsive to the RFA and returned to the
applicant.

Applications that are complete and responsive to the Request for
Applications 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, all applications will receive a written critique and may
undergo a process in which only those applications deemed to have the
highest scientific merit will be discussed, assigned a priority
score, and receive a second level review by the National Advisory
Child Health and Human Development Council.

Review Criteria

Evaluation of the applications will be based upon the following:

1.  Qualifications, experience, and commitment of key personnel,
particularly, but not exclusively, in the area of the proposed
research

o  Scientific, clinical, and administrative abilities of the
Principal Investigator and other key participants;

o  Knowledge and experience of the Principal Investigator and other
key investigators in areas relevant to the conduct of the experiments
proposed;

o  Documented commitment time for the proposed studies and the
specifically stated and described willingness of the Principal
Investigator and the key investigators to work and collaborate with
other Centers and with NICHD assistance in the manner summarized in
this RFA;

2.  Protocols and Procedures

o  Scientific merit of the application and its component projects and
cores, including ethical issues relating to human subjects

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

o  Responsiveness of the application to the research objectives of
the Program outlined in this RFA;

o  Willingness to work and cooperate with other Centers and the NICHD
in the manner summarized in this RFA.

3.  Facilities and Management

o  Adequacy of administrative, clinical, and technical capabilities
to conduct the research proposed;

o  Adequacy of animal facilities and appropriateness of animal care
management where animal work is proposed;

o  Adequacy of clinical facilities and appropriateness of patient
care management where clinical work is proposed; and

o  Institutional assurance to provide support to the Center in such
areas as fiscal administration, personnel management, space
allocation, procurement, planning, and budgeting.

4.  Budgeting

Appropriateness of the proposed budget and duration in relation to
the proposed research.

AWARD CRITERIA

The anticipated date of award is September 1, 1996.  Applications
approved by the NACHHD Council will be considered for award based on
scientific and technical merit; compatibility of features to make a
successful collaborative program a reasonable likelihood; program
balance; and availability of funds.  In order to be eligible for an
award, an application must have at least three fundable projects, at
least two of which are entirely or predominately clinical research
projects.  If the consortium option described in this RFA is
employed, at least one clinical research project and the
administrative core must reside at the institution submitting the
application.  Awards will not be made for applications with research
activities focused exclusively on clinical research or exclusively on
basic research or for applications proposing epidemiological or large
scale clinical trial research.

INQUIRIES

Written and telephone inquiries concerning this RFA are encouraged.
The opportunity to clarify any issues or questions from potential
applicants is welcome.

Direct inquiries regarding programmatic issues and address the letter
of intent to:

Michael E. McClure, Ph.D.
Center for Population Research
National Institute of Child Health and Human Development
Building 61E, Room 8B01
Bethesda, MD  20892
Telephone:  (301) 496-6515
FAX:  (301) 496-0962
Email:  MCCLUREM@HD01.NICHD.NIH.GOV

Direct inquiries regarding fiscal matters to:

Ms. Melinda Nelson
Office of Grants and Contracts
National Institute of Child Health and Human Development
Building 61E, Room 8A17
Bethesda, MD  20892
Telephone:  (301) 496-5481
FAX:  (301) 402-0915
Email:  NELSONM@HD01.NICHD.NIH.GOV

AUTHORITY AND REGULATIONS

This Program is described in the Catalog of Federal Domestic
Assistance number 13.864, Population Research.  Awards will be made
under the authority of the Public Health Service Act, Title X,
Section 1004 (Public Law 92-572, as amended; 42 USC 241) and Title
III, Section 301 (Public Law 78-410, as amended; 42 USC 241).  These
special Terms of Award are in addition to, and not in lieu of,
otherwise applicable OMB administrative guidelines, HHS grant
administration regulations at 45 CFR Part 74, and other HHS, PHS, and
NIH grant administration policies.  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 routing 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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