COOPERATIVE SPECIALIZED INFERTILITY RESEARCH CENTERS

Release Date:  November 7, 2000

RFA:  HD-01-001

National Institute of Child Health and Human Development
 (http://www.nichd.nih.gov) 

Letter of Intent Receipt Date:  February 15, 2001
Application Receipt Date:       July 10, 2001
 

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 comprising biomedical research projects and technical 
service core facilities, 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 efforts of the NCPIR centers will 
be enhanced by interaction within and among them, as well as with other NICHD-
supported cooperative research programs such as the Specialized Cooperative 
Centers Program in Reproduction Research and the National Cooperative 
Reproductive Medicine Network.  The benefit of this activity will be to the 
infertile couples, their health-care providers, and the public.

HEALTHY PEOPLE 2010

The Public Health Service (PHS) is committed to achieving the health promotion 
and disease prevention objectives of “Healthy People 2010,” a PHS-led national 
activity for setting priority areas.  This Request for Applications (RFA) is 
related to one or more priority areas.  Potential applicants may obtain 
“Healthy People 2010" at http://www.health.gov/healthypeople/. 

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic for-profit and non-profit 
organizations, public and private, such as universities, colleges, hospitals, 
laboratories, units of State and local governments, and eligible agencies of 
the Federal government.  The need for continuous and active communication 
among sites dictates that only institutions in the United States are eligible 
to apply.  Racial/ethnic minority individuals, women, and persons with 
disabilities are encouraged to apply as Principal Investigators.

MECHANISM OF SUPPORT

This RFA will use the National Institutes of Health (NIH) specialized 
cooperative research center (U54) award mechanism, an “assistance” mechanism 
(rather than an “acquisition” mechanism) in which substantial NIH scientific 
and/or programmatic involvement with the awardee is anticipated during 
performance of the activity.  Under the cooperative agreement, the NIH purpose 
is to support and stimulate the recipients’ activity by involvement in the 
activity and otherwise working jointly with the award recipients in a partner 
role, but it is not to assume direction, prime responsibility, or a dominant 
role in the activity.  Details of the responsibilities, relationships and 
governance of the studies to be funded under cooperative agreements are 
discussed below under Terms and Conditions of Award.  Potential applicants may 
obtain the NICHD U54 Specialized Cooperative Research Center Grant Guidelines 
at http://www.nichd.nih.gov/funding/mechanism/u54_guide.cfm. 

FUNDS AVAILABLE

NICHD intends to commit $3.0 million in total costs [Direct plus Facilities 
and Administrative (F & A) costs] in FY 2002 to fund up to two new and/or 
competing continuation grants in response to this RFA.   An applicant for a 
new center may request a project period of up to five years and a budget for 
direct costs of up to $1.0 million for the first year, excluding F & A costs 
on consortium arrangements, with incremental increases not exceeding three 
percent in each subsequent year.  An applicant for a competing continuation 
grant may request a project period of up to five years and a budget for direct 
costs of up to120 percent of the direct costs awarded for the final 
competitive segment of the preceding project period as stated in the Notice of 
Grant Award.  Applications exceeding the budgetary limits specified above will 
be returned to the applicant without peer review.  Because the nature and 
scope of the research proposed may vary, it is anticipated that the size of 
awards also will vary.  Although the financial plans of NICHD provide support 
for this program, awards pursuant to this RFA are contingent upon the 
availability of funds and the receipt of a sufficient number of meritorious 
applications.  The anticipated award date is April 2, 2002.  

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.  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

Infertility is a major public health problem, affecting 7.1 percent, or 2.1 
million married couples in the United States, according to the latest 
available data of the National Center for Health Statistics.  The same data 
show that 6.2 million women aged 15-44 have some degree of impaired fecundity, 
of whom 2.7 million have sought medical help. 

Categorizing human infertility is not an exact science, but it is generally 
attributed to female factors (40 percent), male factors (40 percent), combined 
male and female factors (10 percent) or so-called “unexplained” infertility 
(10 percent).  For couples in whom a definitive diagnosis can be made, such as 
ovulation dysfunction or tubal disease, treatment may be chosen accordingly.  
In many cases, however, treatment is empirical.  In recent years, assisted 
reproductive technologies (ART) have rapidly expanded the possibilities of 
infertility treatment, but many questions remain, not the least of which is 
the inherent potential to transmit chromosomal aberrations that in themselves 
may have been responsible for fertility failure.  The NICHD is considering 
these issues in a number of ways.  A workshop was held in April 2000 on 
“Outcomes of Children Born as a Result of Intracytoplasmic Sperm Injection 
(ICSI).”  As part of the “NICHD Strategic Plan 2000: From Cells to Selves,” 
developed with the help of outside experts and the public, the NICHD 
identified as a scientific goal:  “Pursue Research Leading to Improved 
Outcomes in Assisted Reproductive Technologies” as part of the section, 
“Reproductive Health for the 21st Century” 
(http://www.nichd.nih.gov/strategicplan/cells/). 

Infertility and its treatment, however, involve much more than the pragmatic, 
and often invasive, approaches of ART.  Anywhere along the chain of events 
that result in the birth of a healthy child, abnormalities can occur that 
impair fertility.  The hypothalamic-pituitary-gonadal axis, germ cell 
production and maturation, steroid hormone production and function, the 
reproductive tract, fertilization, implantation and early development -- all 
are vulnerable steps.  Reducing the use of hysterectomy in treating 
reproductive-aged women with gynecologic diseases preserves their fertility 
potential.  Safety, acceptability, and economics also figure in the 
development of improved treatment.  For example, prevention of high-order 
multiple gestation, with its attendant morbidity and cost, has become an issue 
in infertility treatment.  There remains a need for better understanding of 
the basic and applied human biology that forms the foundation for 
understanding, diagnosing, and treating infertility.  

Objectives of the Program

The cooperative research program described in this RFA is designed to meet the 
nationally identified need for coordinated infertility research to expedite 
the translation of promising preclinical or clinical leads into new or 
improved practice available to the public.  The need for accelerated basic, 
translational, and clinical research on the diagnosis, prevention, and 
treatment of infertility, as documented in a number of relevant reports, 
provided the original impetus for the NCPIR (“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; “Medically Assisted Conception: An 
Agenda for Research,” Report of the Institute of Medicine of the National 
Research Council, 1989).   Much has been learned since the inception of the 
NCPIR, but the NICHD continues to emphasize infertility research as an ongoing 
need.  The Research Agenda for the Reproductive Sciences Branch of the NICHD 
devoted major sections to research progress and unmet needs in male and female 
infertility.  In addition, the document entitled “NICHD Special Emphasis Areas 
for Discretionary Funding” lists, among its 14 key topic areas, four directly 
relating to infertility 
(http://grants.nih.gov/grants/guide/notice-files/not98-073.html).
 
The NCPIR originated when legislative directives included in the deliberations 
of the 101st 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 Congress.  The NIH 
Reauthorization Act of 1993, issued from the 103rd 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 
cannot 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 FY 2001 Senate 
Appropriations Committee Report language relating to infertility and 
contraceptive research encourages NICHD to continue aggressive activities in 
this area, specifically including support of the Centers.  

Research Scope

The scope of the research projects proposed in a Center’s research plan should 
address infertility as a result of female factor, male factor, or both.  
Although 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 include projects that 
will lead to 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 (http://stemcells.nih.gov/index.asp).  As a 
cardinal principle, each Center organization should consist of a 
multidisciplinary set of projects and/or cores capable of interacting in a 
coordinated, cooperative fashion.  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 on 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 National Cooperative Reproductive Medicine Network, for 
conducting national clinical trials, including male and female infertility 
treatment, 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 findings from NCPIR Centers may form the basis for 
protocols to be developed and conducted by the Reproductive Medicine Network, 
with collaboration from the NCPIR.

Each Center should organize its overall research plan to include a mix of 
patient-oriented research, clinical research in the broader sense of involving 
human material, and closely related basic research activities.  Within the 
NICHD requirement for a minimum of three funded projects to constitute a 
Center award, there are various options for a Center’s organization of its 
projects.  An applicant’s research plan might, for example, include a set of 
clinical research projects and related basic or animal model projects to study 
infertility-related aspects of a specific disease or disorder, e.g., 
endometriosis.  Alternately, an applicant’s research design strategy may 
include projects involving clinical and preclinical investigations integrating 
management of more than one infertility factor.  Yet another orientation of 
scope might encompass comparative clinical and preclinical experimental 
evaluations of ART protocols.  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 research projects and, when 
appropriate, technical service cores.  At least one patient-oriented research 
project and an administrative core will reside in the sponsoring department of 
the grantee institution awarded a Center grant.  Centers may include one 
consortium-based, research project (excluding developmental projects) located 
at a domestic U.S. institution other than the grantee institution.  A Steering 
Committee consisting of the investigators responsible for each project 
(excluding developmental project investigators), the Principal Investigator of 
each Center, and an NICHD staff Research Coordinator, 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 the proposed research is no longer 
feasible.  An NICHD Program Official (not the Research Coordinator) will 
provide administrative oversight and monitor progress of the NCPIR.  Further 
details of the guidance and management structures and processes may be found 
under Terms and Conditions of Award, below.

SPECIAL REQUIREMENTS

Description of a Center

The minimal requirements for a Center described in this RFA are as follows 
(see sections on REVIEW PROCEDURES and Award Criteria below):

o  An administrative core unit that provides oversight to the Center, located 
at the applicant institution and accessed only by budgeted Center subprojects 
and cores.

o  A research plan that is responsive to the objectives of the Centers Program 
set forth in this RFA (see RESEARCH OBJECTIVES).

o  At least three research projects (not including developmental projects) 
that thematically address one or more research areas listed under Research 
Scope.  It is required that at least one project involve patient-oriented 
research.

o  At least one developmental research project directly related to the overall 
research emphasis of the Center, the budget of which cannot exceed 10 percent 
of the center grant’s first-year direct cost budget, inclusive of the portion 
budgeted for developmental projects, or $100,000 per year, whichever amount is 
smaller.  The Principal Investigator (PI) of a developmental project must be a 
new investigator, i.e., an investigator who has not been the PI of a funded 
NIH or comparable research project other than a small grant (R03), an Academic 
Research Enhancement Award (R15), an exploratory/developmental grant (R21), or 
certain research career awards directed principally to clinicians at the 
beginning of their research career (K01, K08, K22, and K23).  The PI can 
reside at either the grantee institution or a participating consortium 
institution.  A minimum of 50 percent effort must be expended on the project 
by the new investigator.  Support for a developmental project is limited to a 
two-year period which can be extended by one year with NICHD approval.  If a 
developmental project is favorably recommended, funds will be included each 
year for the full duration of support of the parent grant.  Funds in the 
outyears will be contingent upon review and approval of additional 
developmental projects by the Steering Committee and NICHD.  A developmental 
project should be an opportunity for its PI to progress toward research 
independence.  As such, the project proposal should explicitly include plans 
for mentoring by one or more established Center investigators.

o  Funds to support a collaborative project with another Cooperative 
Specialized Infertility Research Center or Specialized Cooperative Center in 
Reproduction Research.  These funds, not to exceed $50,000 in direct costs, 
will be requested as part of the Administrative Core budget, and will be 
restricted for use to support collaborative projects pending an external peer 
review of the project and approval by the NCPIR Steering Committee, by the 
Steering Committee of the Specialized Cooperative Centers Program in 
Reproduction Research, if appropriate, and by NICHD.            

o  A 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 research.

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 that require 
patient participation.  [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.  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 other Cooperative Specialized Infertility Research Centers, as well 
as other cooperative programs administered by the NICHD such as the 
Specialized Cooperative Centers Program in Reproduction Research and the 
National Cooperative Reproductive Medicine Network.

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

Optional components of the Center organization include the mix of projects and 
cores to be included in the Center:

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

Centers may seek to maximize their scientific expertise and research 
capabilities by including in the application a project to be supported at 
another institution through subcontracted consortium arrangements.  No more 
than one consortium project (excluding a developmental project) will be 
permissible in each center, however, portions of other projects may be 
subcontracted.

The Principal Investigator of the Center may wish to incorporate into the 
application a highly relevant individual NIH research project that 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 peer review outcome, may become eligible for funding 
through the Center upon relinquishment of the prior awarded project grant.

The Principal Investigator may choose one of two center structure options 
regarding access to technical service core facilities:

o  Closed Access Structure - In this center structure, administrative and all 
technical service cores will be utilized by budgeted center subprojects only.  
Consistent with NICHD guidelines for establishment of core facilities, 
utilization by three subprojects is required to justify a core technical 
service facility.  Percent utilization by any one of the three subprojects 
justifying the core may not exceed 50 percent or be less than five percent.  
The percent utilization of additional subprojects requiring core services may 
be less than five percent.  Costs necessary to use a particular core facility 
may be incorporated into the budget of the core unit, and not in the budgets 
of the research subprojects per se.  No internal charge-back system would be 
required.

o  Open Access Structure - In this center structure, budgeted center 
subprojects as well as research projects external to the Center (e.g., R01, 
R03, P01 subproject) may have access to technical service cores.  However, 
special consideration must be given to justification of a technical service 
core facility and the formal establishment of an effective charge-back system 
for all technical service cores.  For each core service facility, at least one 
of the three projects used to justify a core must be a budgeted center 
subproject, while the remaining project(s) used in justifying the core must be 
externally funded NICHD projects administered by the Reproductive Sciences 
Branch (RSB).  Percent utilization by any internally budgeted center 
subproject or externally-funded RSB project used to justify a particular core 
facility may not exceed 50 percent or be less than five percent.  An 
additional seven federally-funded, peer-reviewed external research projects 
addressing program-relevant research areas of the RSB may access the core up 
to 100 percent of its service capacity.  The 50/5 percent utilization 
requirement applies to this group of external projects.  Centers must 
establish an internal management policy for evaluating the acceptability of 
proposed RSB program relevant external projects to access the core facilities.  
Approval of requests for core access privileges for external projects that 
would replace those described above must be made to RSB Program Staff who then 
will evaluate the extent to which the project is relevant to RSB mission 
research areas (see Research Scope), and render a decision accordingly.

If centers choose to operate in an open access format, costs necessary to 
utilize a particular core facility by budgeted center subprojects must be 
incorporated into the budget of the subproject and not the core budget in 
order to accommodate participation in the required charge-back system.  Core 
budgets will be justified and evaluated based on access by budgeted center 
subprojects and external, program-relevant research projects as described 
above.  Above and beyond this arrangement, technology-based core units may 
offer services to additional external projects addressing any area of research 
regardless of funding source only on a full payback (fee-for-service or in-
kind) basis.  However, additional funds necessary to provide services to these 
external projects (e.g., technical support, supplies, etc.) must come from 
sources other than the center funding, such as the supply budgets of the 
external projects wishing to access the core facilities.  In choosing to 
configure a center in an open-access center structure, the Principal 
Investigator must have in place, and adequately describe in the application, 
management policies that ensure that budgeted center subprojects are given 
highest priority in receiving services provided by the core.

Centers choosing to configure in an open-access center format may propose one 
or more technical service cores that will be utilized exclusively by budgeted 
center subprojects.  These centers may, therefore, have a mix of open and 
restricted access technical service cores.  On the other hand, administrative 
cores in open center structures may be accessed only by budgeted center 
subprojects.

Once an award is made, centers configured as a closed-access center structure 
may, at a later time, choose to convert to an open access center structure by 
requesting such conversion in writing to the NICHD.

Travel to Meetings

Principal Investigators should request travel funds to support their 
participation in the annual Directors’ Meeting and two Steering Committee 
Meetings per year.  Key Investigators of budgeted center projects and 
Directors of technical service cores should request travel funds to support 
participation at two Steering Committee Meetings per year.

Terms and Conditions of Award

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

The purpose of these cooperative agreements is to support a coordinated 
research program of specialized centers that seek to establish new methods for 
the diagnosis, treatment and amelioration of human infertility.

1.  Awardee Rights and Responsibilities

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, interpret, and present results and plans to the Steering Committee 
for approved activities;
o  Publish results, conclusions, and interpretation of the studies.

The Awardees will agree to:  (1) accept the coordinating role of the Steering 
Committee which includes evaluating objectives and research goals of the 
Centers Program, and recommending modification, deletion or addition of 
protocols within the Centers Program; and (2) follow any common protocols in 
which they participate for multicenter projects that are approved by the 
Steering Committee.

Awardees will agree, when appropriate, to work cooperatively with other NICHD-
supported cooperative programs, particularly those administered by the RSB 
such as the Specialized Cooperative Centers Program in Reproduction Research 
and the National Cooperative Reproductive Medicine Network.  Examples of 
interaction with these programs may include providing reagents and access to 
research resources, and participation in research focus groups.  Findings from 
NCPIR Centers may form the basis for protocols to be developed and conducted 
by the Reproductive Medicine Network, with collaboration from the NCPIR.

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.

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

o  Participating in the overall coordination of the Centers Program with the 
Steering Committee.  This includes 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 overall coordination of the 
Program, 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.  The Research Coordinator will also assist 
the research efforts of the Centers Program by facilitating access to fiscal 
and intellectual resources provided by industry, private foundations, and NIH 
intramural scientists.  The Research Coordinator will, as required, help 
reprogram research efforts, including options to modify or terminate them, by 
mutual consent between the Centers 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  Interacting with each individual center awardee to evaluate objectives and 
research goals of that particular center, 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 this process and not direct it.  The Research Coordinator will also 
provide assistance in reviewing and commenting on all major transitional 
changes of an individual center’s activities prior to implementation to assure 
consistency with required goals of the Centers Program.

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, where warranted, in data analyses, interpretations, and the 
dissemination of study findings to the research community and health care 
recipients including co-authorship of the publication of results of studies 
conducted by the Centers.

3.  Collaborative Responsibilities

Overall coordination of the Program consistent with the stated intent of the 
RFA will be done by a Steering Committee consisting of the Principal and 
Project Investigators from each of the participating Centers (excluding 
developmental project investigators), and one NICHD staff member from the RSB, 
CPR, NICHD, who will be the Research Coordinator.  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.

4.  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 Investigator, 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.

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 sub-populations must be included in all NIH-supported biomedical and 
behavioral research projects involving human subjects, unless a clear and 
compelling rationale and justification are provided indicating that inclusion 
is inappropriate with respect to the health of the subjects or the purpose of 
the research.  This policy results from the NIH Revitalization Act of 1993 
(Section 492B of Public Law 103-43). 

All investigators proposing research involving human subjects should read the 
UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in 
Clinical Research," published in the NIH Guide for Grants and Contracts on 
August 2, 2000 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); 
a complete copy of the updated Guidelines is available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm.  The 
revisions relate to NIH-defined Phase III clinical trials and require:  a) all 
applications or proposals and/or protocols to provide a description of plans 
to conduct analyses, as appropriate, to address differences by sex/gender 
and/or racial/ethnic groups, including subgroups if applicable; and b) all 
investigators to report accrual, and to conduct and report analyses, as 
appropriate, by sex/gender and/or racial/ethnic group differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of NIH that children (i.e., individuals under the age of 21) 
must be included in all human subjects research, conducted or supported by the 
NIH, unless there are scientific and ethical reasons not to include them.  
This policy applies to all initial (Type 1) applications submitted for receipt 
dates after October 1, 1998.

All investigators proposing research involving human subjects should read the 
"NIH Policy and Guidelines on the Inclusion of Children as Participants in 
Research Involving Human Subjects,”  published in the NIH Guide for Grants and 
Contracts, March 6, 1998, and available on the Internet at:  
http://grants.nih.gov/grants/guide/notice-files/not98-024.html. 

Investigators also may obtain copies of these policies from the program staff 
listed under INQUIRIES.  Program staff may also provide additional relevant 
information concerning the policy.

URLS IN NIH GRANT APPLICATIONS OR APPENDICES

All applications and proposals for NIH funding must be self-contained within 
specified page limitations.  Unless otherwise specified in an NIH 
solicitation, Internet addresses (URLs) should not be used to provide 
information necessary to the review because reviewers are under no obligation 
to view the Internet sites.  Reviewers are cautioned that their anonymity may 
be compromised when they directly access an Internet site.

LETTER OF INTENT

Prospective applicants are asked to submit 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 this RFA.  
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 plan 
the review.

The letter of intent is to be sent to Dr. Louis De Paolo at the address listed 
under INQUIRIES, below, by February 15, 2001.

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 4/98) is to be used in 
applying for these grants.  These forms are available at most institutional 
offices of sponsored research, on the Internet at 
http://grants.nih.gov/grants/funding/phs398/phs398.html, and from the Division 
of Extramural Outreach and Information Resources, National Institutes of 
Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 
301-435-0714, E-mail: Grantsinfo@nih.gov. 

Application Instructions

Applications for the U54 grant are to be prepared in a manner consistent with 
the information presented in the NICHD U54 Cooperative Specialized Research 
Center Grant Guidelines, available from the contacts listed under INQUIRIES, 
below, and at: http://www.nichd.nih.gov/funding/mechanism/u54_guide.cfm. 

At minimum, an application in response to this RFA should include:

o  A description of a Cooperative Specialized Infertility Research Center 
consisting of multiple individual research subprojects, an Administrative 
Core, and, if applicable, one or more technology-based core service 
facilities. 

o  A description of the capabilities of the Center to meet or exceed the 
minimal requirements for a Center stated in this RFA (see Description of a 
Center).

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 multi-project 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 subprojects 
must address the Research Scope described above.

o  A statement describing the willingness of the Principal Investigator to 
cooperate in a coordinated cooperative centers program with the objective of 
developing research project and/or service core interactions between other 
Cooperative Specialized Infertility Centers, as well as with other NICHD-
supported cooperative programs.

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

o   For competing renewal applications, evidence of having met the Terms and 
Conditions of the award during the previous funding period.

All applicants must document their ability to meet or exceed the minimum 
requirements as set forth in this RFA.  This specifically includes 
understanding of and commitment to the cooperative nature of this program, and 
willingness to meet the Terms and Conditions of Award.

Submission Procedures

The RFA label available in the PHS 398 (rev. 4/98) application form must be 
stapled to the bottom of the face page of the application and must display the 
RFA number HD-01-001.  A sample RFA label is available at 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.  Please note this is 
in the pdf format.  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:

CENTER FOR SCIENTIFIC REVIEW
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 should be 
sent to:

L.R. Stanford, Ph.D.
Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5E03, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service)

Applications must be received by July 10, 2001.  If an application is received 
after that date, it will be returned to the applicant without review.

The Center for Scientific Review (CSR) 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 
CSR 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.  

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by CSR and for 
responsiveness to the RFA by NICHD staff.  Incomplete and/or non-responsive 
applications will be returned to the applicant without further consideration.  
Any application that does not meet the minimum application requirements as set 
forth under SPECIAL REQUIREMENTS will be considered unresponsive to the RFA.  
Responsiveness includes, but is not limited to, the program relevance of the 
proposed research subprojects and external projects being proposed to access 
core facilities, as determined by NICHD.

Applications that are complete and responsive to the RFA will be evaluated for 
scientific and technical merit by an appropriate peer review group convened by 
the NICHD in accordance with the review criteria stated below.  As part of the 
initial merit review, 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 (NACHHD) Council.

A site visit is not a required part of the review process.  Applicants should 
ensure that their applications are complete as written and can stand on their 
own.

Review Criteria

The scientific and technical merit peer review focuses on three areas:  (1) 
review of the component research subprojects; (2) review of the core units, 
and (3) review of the overall center as an integrated effort.  Applications 
submitted in response to this RFA will be evaluated according to the review 
criteria described in the NICHD U54 Cooperative Specialized Research Center 
Grant Guidelines, available from the contacts listed under INQUIRIES, below, 
and at http://www.nichd.nih.gov/funding/mechanism/u54_guide.cfm. 

SCHEDULE

Letter of Intent Receipt Date:    February 15, 2001
Application Receipt Date:         July 10, 2001
Peer Review:                      October/November 2001
Council Review:                   January 2002
Earliest Anticipated Award Date:  April 2, 2002

AWARD CRITERIA

Applications recommended by the NACHHD Council will be considered for award 
based on scientific and technical merit as determined by peer review; program 
balance; and availability of funds.    

INQUIRIES

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

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

Louis V. DePaolo, Ph.D.
Reproductive Sciences Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8B01, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 435-6970
FAX:  (301) 496-0962
E-mail:  ld38p@nih.gov   

Direct inquiries regarding fiscal matters to:

Ms. Mary Ellen Colvin
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A17M, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 496-1304
FAX:  (301) 402-0915
E-mail:  mc113b@nih.gov

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 Sections 
301 and 405 of the Public Health Service Act, as amended (42 USC 241 and 284) 
and administered under NIH grants policies and Federal Regulations 42 CFR 52 
and 45 CFR Parts 74 and 92.  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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NIH Funding Opportunities and Notices


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