COOPERATIVE REPRODUCTIVE SCIENCE RESEARCH CENTERS AT MINORITY INSTITUTIONS

Release Date:  November 20, 2000

RFA:  HD-00-019

National Institute of Child Health and Human Development 
     (http://www.nichd.nih.gov) 
Office of Research on Minority Health 
     (http://ncmhd.nih.gov/)
Office of Research on Women’s Health 
     (http://www4.od.nih.gov/orwh/)

Letter of Intent Receipt Date:  February 16, 2001
Application Receipt Date:  March 29, 2001

PURPOSE

The National Institute of Child Health and Human Development (NICHD), in 
collaboration with the NIH Office of Research on Minority Health (ORMH) and 
the Office of Research on Women’s Health (ORWH), invites new and established 
basic science, translational, and clinical investigators to submit grant 
applications for Cooperative Reproductive Science Research Centers at 
Minority Institutions.  Applications for these centers are sought from 
investigators willing to participate with the NICHD under a Cooperative 
Agreement (U54) mechanism in a multicenter cooperative research program.  
Center investigators will be expected to work with NICHD staff in 
facilitating research collaborations and interactions within and between 
centers.  

The purpose of this new initiative is to form a cooperative program that will 
augment and strengthen the research infrastructure and research capabilities 
of faculty, students, and fellows at minority institutions by supporting the 
development of new, and/or the enhancement of ongoing, basic science, 
translational, and clinical research that focuses on topics deemed to be of 
high priority and significance because of their critical importance to 
reproductive health.  Applications are encouraged that address priority areas 
in reproductive science that include, but are not limited to, the following 
broad topics:  (1) reproductive biology, physiology, and genetics; (2) 
reproductive endocrinology; and (3) reproductive medicine encompassing 
infertility, gynecology, and andrology.  

The overall focus of the initiative is intended to stimulate the development 
of a competitive research environment in reproductive science at minority 
institutions.  Reproductive scientists at minority institutions are invited 
to establish a collaborative partnership with NICHD-designated reproductive 
science research institutional programs, thereby benefiting from a broader 
range of resources, experienced leadership, and exposure to ongoing research 
projects.  Such centers would bring together strong teams of experienced and 
new investigators, around a reproductive science theme, to share essential 
facilities, services, knowledge, and other resources.  Long-term 
comprehensive affiliation can be expected to lead to the development of a 
stable relationship between the minority institution and the NICHD 
reproductive science program that can build and foster independent and 
competitive research capabilities at the minority institution.  It is 
envisioned that each center will ultimately become a training and mentoring 
resource for developing and strengthening the research capacity of the nation 
by expanding opportunities for minority scientists, particularly those 
underrepresented within the scientific workforce.  

This solicitation embraces the NICHD Research Agenda for identifying and 
characterizing the factors and potential avenues of treatment related to 
priority areas of reproductive science, represents an extension of ongoing 
efforts, and demonstrates the Institute’s emphasis on expanding research 
support for reproductive sciences.  Finally, a major hallmark of the 
initiative is its inclusiveness in addressing research across the 
reproductive life span among diverse populations of women and men, thereby 
improving the health of all citizens.

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 of the priority areas.  
Potential applicants may obtain “Healthy People 2010” at 
http://www.health.gov/healthypeople/.

ELIGIBILITY REQUIREMENTS

Applications may be submitted by minority, for-profit and non-profit 
organizations, public and private, such as universities, colleges, and 
academic institutions that offer Ph.D., M.D., and/or equivalent health 
professional degrees, at which 50 percent or more of the students enrolled 
are from racial/ethnic minority groups and a significant proportion of 
minority students are underrepresented in the biomedical sciences (e.g., 
African Americans, Hispanics, Native Americans, Alaskan Natives, Native 
Hawaiians, and Pacific Islanders).  To be responsive to this RFA, each 
applicant institution must identify a collaborative affiliation with an 
NICHD-designated reproductive science research institutional program.  The 
collaboration should be for the purpose of facilitating and addressing the 
scientific objectives of the proposed center.  A list of the designated NICHD 
programs may be obtained at http://www.nichd.nih.gov/RFA/HD-00-019/HD-00-
019.htm and from the program staff listed under INQUIRIES, below.

The Principal Investigator from the minority institution, who serves as the 
Center Director, must be an experienced researcher and be able to provide 
both administrative and scientific leadership.  The Co-director, from the 
collaborating institution, must be an established investigator from an NICHD-
supported reproductive science program.  Participating collaborating 
investigators must be designated NICHD grantees (supported by grant 
mechanisms such as the U-series, R01, P01, or K12). 

The need for continuous and active communication among sites dictates that 
only minority institutions in the United States, its possessions or its 
territories are eligible to apply.  Ideally, the collaborating institutions 
should be in close proximity to one another.  However, if this is not 
possible, applicants should describe procedures and/or processes that will be 
used to overcome any potential problems associated with the geographical 
separation.  Racial/ethnic minority individuals, women, and persons with 
disabilities are encouraged to apply as Principal Investigators.

Only one application will be accepted per eligible minority institution and 
each NICHD-designated reproductive science research institutional program may 
participate in no more than one application in response to this RFA.

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 the 
performance of the research development activities.  Under the cooperative 
agreement, the NIH staff support and stimulate the recipients’ activities by 
involvement in the activity and otherwise working jointly in a partner role, 
but 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 below under “Terms and Conditions of Award.”  

The total project period for applications submitted in response to this RFA 
is five years.  The anticipated award date is September 30, 2001.  

FUNDS AVAILABLE

The NICHD, ORWH, and ORMH intend to commit approximately $3 million in total 
costs (Direct plus Facilities and Administrative [F & A] costs) in FY 2001 to 
fund up to three new centers in response to this RFA.  An applicant may 
request a project period of up to five years and a budget for direct costs of 
up to $1 million per year, including F & A costs on consortium arrangements.  
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 the NICHD, ORWH, and ORMH 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.  

RESEARCH OBJECTIVES

Background

There has been increased focus on addressing health disparities and improving 
the health status of all Americans.  The increasing ethnic and racial 
diversity of the U.S. population heightens the need to understand the impact 
of health disparities over the reproductive life span of the American public.  
The ultimate goal of reproductive science research supported by the NICHD is 
to strengthen the science base and develop new knowledge leading to clinical 
applications that will foster improved reproductive health.  One way to 
support this effort is to increase the cadre of new and experienced minority 
investigators in ongoing and emerging areas of reproductive science. 

Research in reproductive science remains relatively unexplored at minority 
institutions.  Some minority institutions have had difficulties developing 
and sustaining independent programs in biomedical research, and there is a 
dearth of minority scientists who are pursuing successful biomedical research 
careers.  The low level of involvement of minority institutions in 
reproductive science and the lack of sufficient training opportunities for 
minority scientists represent two major obstacles to developing an effective 
research effort aimed at addressing significant health disparities.  This 
initiative will support the development of an enhanced research 
infrastructure in reproductive science at these institutions.  Creating 
collaborations among minority institutions and other ongoing NICHD 
reproductive science research programs would integrate and take advantage of 
their respective expertise and experience.  The Cooperative Reproductive 
Science Research Centers at Minority Institutions would bring together strong 
teams of experienced and new investigators, around a reproductive science 
theme, to share essential facilities, services, knowledge, and other 
resources.

It is not the intent of this RFA to focus only on studying disease processes 
and disorders that disproportionately affect the reproductive health of 
minority groups, but to encourage and foster the development of an 
infrastructure at minority institutions needed to support the NIH research 
agenda.  State-of-the-art reproductive science research centers at minority 
institutions would accomplish the following objectives:  (1) create 
professional opportunities for minority investigators; (2) cultivate an 
academic and research milieu that would stimulate interest among students and 
fellows to pursue research careers in reproductive science; and (3) 
contribute to providing an environment in research excellence that would 
increase the competitiveness of minority institutions and investigators for 
traditional research project grants.  It is envisioned that increasing the 
diversity among investigators and institutions would strengthen the 
scientific research conducted at these institutions, and participating in 
research supported by this initiative would enhance the experience, training, 
and career development of minority students and investigators associated with 
these institutions.  

NICHD’s strategic framework, “From Cells to Selves” 
(http://www.nichd.nih.gov/strategicplan/cells/), highlights selected 
scientific themes for future exploration and development that emphasize the 
importance of fostering training opportunities for basic science, 
translational, and clinical investigators, supporting the research 
infrastructure of institutions, and translating science to meet the needs of 
special populations and eliminate health disparities.  The framework 
acknowledges that for innovative and creative scientific projects to succeed, 
the appropriate infrastructure, resources, and technologies need to exist.  
The Cooperative Reproductive Science Research Centers at Minority 
Institutions initiative represents an expansion of research opportunities at 
minority institutions by creating strong reproductive science programs, 
stimulating partnerships with research-intensive institutions, enhancing the 
careers of underrepresented minority scientists, exposing graduate and 
undergraduate students to meritorious research, and stimulating long-term 
interest in reproductive science research careers among qualified 
underrepresented minority students. 

The Institute has demonstrated a long-term commitment to support reproductive 
science institutional programs that have the framework to stimulate 
multidisciplinary and interdisciplinary interactions among basic science, 
translational, and clinical investigators interested in establishing quality 
research projects in reproductive science.  This RFA is specifically designed 
to encourage the reproductive science research community to form partnerships 
and support research-based centers at minority institutions, and to form a 
cooperative network with NICHD that fosters communication, innovation, and 
excellence.  Thus, the major goals of this initiative are to support 
specialized reproductive science programs of distinction and to facilitate 
the development of a competitive research environment at minority 
institutions.

Research Scope 

The Cooperative Reproductive Science Research Centers at Minority 
Institutions Program is composed of research-based center grants designed to 
support interactive groups of research projects and supporting administrative 
core units.  The research activities included in these center grants must 
comprise, by definition, a multidisciplinary approach to the specific 
research topic areas announced in this RFA.  These centers may have more than 
one theme, focus or emphasis, but all of the projects involved must be 
responsive to one or more of the designated reproductive science research 
areas supported by NICHD.

There are a number of relevant research themes that would lend themselves to 
a cooperative center approach and are considered important for the potential 
development of new leads in reproductive science.  Examples of the scope of 
research deemed responsive to this RFA include, but are not limited to, the 
following topics:

(1)  Reproductive Biology, Physiology, and Genetics  

o  Biology of male or female gonads and reproductive tract, including 
genetic, cellular, molecular, physiologic, hormonal, developmental, and 
immunologic aspects of production and function of sperm and oocytes, and 
their union to form an embryo. 

o  Gametogenesis, gamete maturation, gonadotropin regulation, role of gonadal 
somatic cells, ovulation, gamete transport, acquisition of fertilization 
potential, and function of corpus luteum. 

o  Fertilization:  in vitro and in vivo, abnormal and normal. 

o  Blastocyst-uterus interaction in normal and abnormal implantation, pre- 
and peri-implantation embryo development. 

o  Genetics of susceptibility to reproductive diseases and disorders.

(2)  Reproductive Endocrinology 

o  Mechanisms of action of male or female steroid, protein, and peptide 
hormones and other compounds important for reproduction, including target 
cells of the hypothalamic–pituitary-genital tract.  

o  Studies on the biosynthesis, secretion, and metabolism of hormones and 
other compounds involved in reproductive processes. 

o  Modulation, signal transduction, and intermediary action of reproductive 
hormones by secondary messengers, receptor modulators (e.g., selective 
estrogen receptor modulators/SERMs and selective androgen receptor 
modulators/SARMs), and co-activators/co-repressors. 

o  Establishment of cell lines and bioassays as models of reproductive 
endocrine activity.  

o  Targeted genetic animal models of reproductive function and dysfunction. 

o  Reproductive neuroendocrinology, including positive and negative feedback 
systems that influence reproductive processes, defining signal pathways. 

o  Interactions among the nervous, immune, and endocrine systems in 
regulating reproductive processes. 

(3)  Reproductive Medicine 

o  Etiology, pathophysiology, prevention, diagnosis, and treatment aspects of 
male or female infertility and reproductive diseases and disorders. 

o  Clinical studies and clinical trials. 

o  Efficacy and safety of assisted reproductive technologies and other drugs, 
devices, and surgical treatments for infertility. 

o  Andrology, including endocrine disorders, sperm production, maturation, 
transport, and function.  

o  Endocrine dysfunction, including central, hypothalamic, pituitary, and 
target organ abnormalities of reproductive hormone production and action. 

o  Benign gynecological conditions such as endometriosis, leiomyomata uteri, 
disorders (and normal function) of the pelvic floor and external genitalia. 

o  Follicular maturation, ovulation and corpus luteum formation, egg quality, 
and uterine markers. 

o  Mechanisms underlying hypothalamic, pituitary, and reproductive tract 
dysfunction in such conditions as gonadotropin deficiency, amenorrhea, 
polycystic ovary syndrome, and premature ovarian failure. 

o  Female sexual function and dysfunction. 

o  Nutrition, body weight, and exercise as determinants affecting 
reproductive function and fertility. 

(4)  Risk Factors for Reproductive Disorders 

o  Determination of the influence and role of risk factors such as race, 
ethnicity, culture, and co-morbid medical conditions or previous surgery 
associated with the occurrence of male or female reproductive disorders 
(including pathophysiology, etiology, diagnosis, treatment outcomes, and 
complications).

Research proposals 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.  

Prospective applicants are encouraged to consider relevant topics other than 
those listed here and to discuss their ideas with the program staff listed 
under INQUIRIES, below.

Guidance and Management Structures 

The Principal Investigator/Center Director affiliated with the applicant 
institution and the Co-director associated with the NICHD-supported 
reproductive science collaborating institution will be responsible for the 
scientific and administrative leadership of each center.  The management of 
the Centers Program includes two committees (the Steering Committee and 
Scientific Advisory Board) as described below in “Terms and Conditions of 
Award.” 

o  Each Center Director and Co-director will participate as members of a 
Steering Committee that will assist in the coordination of all centers.  A 
Chairperson will be chosen by a majority of the Committee members.  The NICHD 
Project Coordinator will participate as a voting member and a member of the 
NICHD grants management staff will serve as a nonvoting advisor to the 
Committee.  The Steering Committee will employ a consensus decision process 
to guide the centers in evaluating the progress of member center programs, 
their proposed new research initiatives within the general scope of the 
approved programs, and the need for collaboration either within or outside 
the center.  The Steering Committee will meet at least once a year.

o  An independent Scientific Advisory Board will advise the Steering 
Committee in identifying and prioritizing research topics appropriate for 
study.  The Scientific Advisory Board, chosen by the NICHD with the advice of 
the Steering Committee, will consist of consultants with appropriate research 
expertise.  A Chairperson will be chosen by a majority of the Board members.  
The Board will (1) review the broad goals and accomplishments of the centers, 
including any mentoring, career development, and training activities; (2) 
assess interim progress of all scientific projects and their relevance to the 
broad objectives of this initiative; and (3) assist in identifying, 
prioritizing, and reviewing proposed research projects that emerge during the 
course of the grant.  The NICHD program staff will serve as ex officio 
member(s) of the Board.  The Scientific Advisory Board will meet annually and 
must submit a written report to the NICHD that summarizes its evaluation and 
recommendations.

SPECIAL REQUIREMENTS 

Center Characteristics

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

1.  Center Description.  The applicant institution must offer Ph.D., M.D., 
and/or equivalent health professional degrees, 50 percent or more of the 
students enrolled must be from racial/ethnic minority groups, and a 
significant proportion of the minority students must be underrepresented in 
the biomedical sciences (e.g., African Americans, Hispanics, Native 
Americans, Alaskan Natives, Native Hawaiians, and Pacific Islanders).  Each 
center consists of the applicant minority institution and the collaborating 
NICHD-designated reproductive science research institutional program.  The 
Center Director is from the minority institution and is the Principal 
Investigator.  The Co-director is from the collaborating reproductive science 
program.  Joint research projects may be in basic science, translational or 
clinical research specifically addressing targeted areas in reproductive 
science.

o  Each center will represent a consortium consisting of the grantee 
institution and the required collaborative partnership with one of the NICHD-
designated reproductive science institutional programs (as defined in this 
solicitation) that should have the flexibility to identify new opportunities 
through formalized planning, evaluation, and priority-setting activities.  
The applicant institution will be expected to support research activities and 
should have evidence of an existing research infrastructure.

o  The application should include letters of commitment from leadership 
within the minority institution and the identified collaborating institution 
that are fully supportive of this activity and that commit the additional 
resources necessary to ensure that these partnerships will have the maximum 
chance of success.  Institutions comprising each consortium should be 
selected to facilitate attainment of the scientific objectives of the center.  
Each application must justify the specific pattern of collaboration in light 
of the scientific aims of the center and the resources that the participating 
institutions have to contribute, and should outline the mutual benefits to be 
gained as a result of the affiliation.  Research partnerships are also 
encouraged between departments, divisions, and schools within a single 
institution to facilitate attainment of the scientific goals of the center.

2.  Center Administration.  The Principal Investigator/Center Director 
affiliated with the applicant institution and a Co-director affiliated with 
the NICHD reproductive science collaborating institution will be responsible 
for the scientific and administrative leadership of the center.  

o  Each center partnership should develop a planning and evaluation component 
to assure the progress of the collaboration, and procedures should be in 
place for reviewing internal research proposals, enhancing infrastructure, 
and recruiting new investigators on the basis of their merit and potential to 
contribute effectively in achieving stated goals and objectives.

o Each Center Director and Co-director will participate as members of a 
Steering Committee that will assist in the coordination of all centers.  A 
Chairperson will be chosen by a majority of the Committee members.  The NICHD 
Project Coordinator will participate as a voting member, and a member of the 
NICHD grants management staff will serve as a nonvoting advisor to the 
Committee.  The Steering Committee will employ a consensus decision process 
to guide the centers in evaluating the progress of member center programs, 
their proposed new research initiatives within the general scope of the 
approved programs, and the need for collaboration either within or outside 
the center.  The Steering Committee will meet at least once a year.

o  An independent Scientific Advisory Board will advise the Steering 
Committee in identifying and prioritizing research topics appropriate for 
study.  The Scientific Advisory Board, chosen by the NICHD with the advice of 
the Steering Committee, will consist of consultants with appropriate research 
expertise.  A Chairperson will be chosen by a majority of the Board members.  
The Board will (1) review the broad goals and accomplishments of the center, 
including any mentoring, career development, and training activities; (2) 
assess interim progress of all scientific projects and their relevance to the 
broad objectives of this initiative; and (3) assist in identifying, 
prioritizing, and reviewing proposed research projects that emerge during the 
course of the grant.  The NICHD program staff will serve as ex officio 
member(s) of the Board.  The Scientific Advisory Board will meet annually and 
must submit a written report to the NICHD that summarizes its evaluation and 
recommendations.

3.  Research Development Core.  The function of the core is to strengthen, 
stabilize and consolidate interaction and cooperation between the minority 
institution and the affiliated NICHD reproductive science program.  All 
research projects will be part of the Research Development Core.  Each center 
will consist of at least three research projects that thematically address 
one or more research areas listed under Research Scope, above.  All of the 
research projects must be of sufficient scientific merit to warrant 
independent support and must be an integral part of the center.  It is 
required that at least three research projects be maintained at all times for 
the duration of the award.

o  Applicants are required to propose at least three meritorious reproductive 
science research projects and must describe the nature and scope of the 
proposed scientific research collaborations.  Qualified investigators from 
the applicant minority institution or the collaborating institution should be 
selected to propose and lead research projects suited to their respective 
reproductive science expertise.  A co-investigator from the other institution 
must be involved in the project. 

o  Each of the proposed projects should effectively use the scientific and 
technical strengths of collaborating investigators, and investigators must 
clearly define the nature and extent of the research collaboration, 
addressing administrative, fiscal, and scientific matters in the application.  
All projects must include experienced investigators at identified NICHD 
reproductive science programs as collaborators.

o  At least two of the projects must be traditional R01-type research 
projects.  Each project will involve participation by accomplished co-
investigators from the collaborating institutions.  Each R01-type research 
project may not exceed $250,000 in direct costs per year.

o  Each center may include, in addition to the two traditional research 
projects, one or more short-term research pilot projects.  The total project 
period may not exceed two years, and each pilot project may not exceed 
$100,000 direct costs per year.  The purpose of the short-term project(s) is 
to support pilot or feasibility studies that can lead to a traditional 
research project(s) funded as part of the center grant.  Each project will 
involve participation by accomplished co-investigators from the collaborating 
institutions.  The expectation is that successful pilot projects will become 
traditional R01-type research projects.

4.  Administrative Core.  Core resources supporting center development 
activities, educational activities, administrative services, salaries of key 
personnel, biostatistical and computer services, a planning and evaluation 
component, and shared equipment should be included.  The function of the core 
is to strengthen, stabilize, and consolidate interaction and cooperation 
between the minority institution and the affiliated NICHD reproductive 
science program.  The level of support for core resources must be 
commensurate with the level of research proposed and funded.  The 
administrative core should include support for meetings (workshops and 
seminars) or other activities to explore new and expanded collaborative 
research, research training, and career development activities.  Travel for 
the Center Director and key investigators to an annual meeting of NICHD 
Center Directors must be budgeted in the administrative core.  This budget 
must also include travel for the Center Director and Co-director to the 
Steering Committee meetings.  

Allowable Costs 

Items fundable under an NICHD U54 grant include:

a.  Direct support of individual research projects.
b.  Research Development Core (research projects) and Administrative Core 
activities used by these research projects.
c.  Salaries and support for a limited number of administrative and clerical 
personnel, such as the Center Director, Co-director, Center Administrator, 
secretaries, and clerical support staff.  The criteria defined under revised 
OMB Circular A-21 will be used by NICHD staff to determine if funding of 
administrative and clerical support staff is allowable.
d.  Administrative support services, including supplies, duplication, 
telephone, and maintenance contracts for equipment when not covered by 
institutional Facilities and Administrative (F&A) charges.
e.  At the discretion of the NICHD Centers Program, and as described in the 
RFA, travel to meetings to confer with other NICHD Center Directors and 
Administrators or to visit other center facilities pursuant to the 
administration of the center.
f.  Travel of Center Director, Co-director, and other investigators to 
scientific meetings.
g.  Travel of technical staff for training that would enhance the quality of 
the research projects supported by the U54 grant.
h.  Seminars or meetings designed to promote interdisciplinary interaction, 
education, or center cohesiveness.
i.  Consultants providing specific scientific and/or technical support to 
center projects or cores. 
j.  Costs related to Steering Committee and NICHD Center Directors’ meetings.

Research Career Development and Training Opportunities 

While formal research training cannot be supported by this solicitation, it 
is understood that participation in research supported by this initiative can 
have significant impact on the career development of underrepresented 
minorities in the scientific workforce.  Successful applicants are encouraged 
to use existing research training and/or career development programs to 
encourage qualified and interested underrepresented minorities to participate 
in research funded under this RFA.

Terms and Conditions of Award 

The following Terms and Conditions of Award are in addition to, and not 
instead of, otherwise applicable OMB administrative guidelines, HHS Grant 
Administration Regulations at 45 CFR Part 74 and 92, and other HHS, PHS, and 
NIH grant administration policies.  Cooperative Agreements are subject to the 
administrative requirements outlined in pertinent OMB, HHS, PHS, and NIH 
guidelines, with particular emphasis on HHS regulations at 42 CFR Part 52 and 
45 CFR Part 74.  Indirect costs are calculated and awarded for cooperative 
agreement awards the same as for grants.

The purpose of these cooperative agreements is to support a coordinated 
research program of centers pursuing high quality reproductive science 
research at minority institutions.  Consistent with the cooperative agreement 
mechanism, the dominant role and prime responsibilities reside with the 
awardees for the project as a whole, although specific tasks and activities 
in carrying out the studies will be shared among the awardees and the NICHD 
program staff, as described in this announcement.

1.  Awardee Rights and Responsibilities

The responsibilities and authorities of the awardees will be as follows:

o  Primary authority and responsibility remain with the awardee:  to define 
the scientific objectives and pursue research approaches; to plan and conduct 
experiments; to collect and analyze resulting data; and to publish results, 
interpretations, and conclusions of the studies.  The nature and scope of 
research on common protocols must be adequately documented and must ensure 
participation, sharing of methods and data among collaborating organizations.

o  The awardee will agree to (1) participate cooperatively and accept the 
coordinating role of the Steering Committee, which includes evaluating 
objectives and research goals of the centers and recommending modification, 
deletion or addition of protocols within the centers; (2) follow any common 
protocols in which they participate and any multicenter projects that are 
approved by the Steering Committee; (3) accept the advisory role of the 
Scientific Advisory Board, which includes providing guidance and 
recommendations; and (4) support the cooperative nature of the group process.

o  Each collaborating partnership should plan regular communications to 
discuss the progress and direction of its activities and to confirm that 
necessary interactions within the center are taking place.

o  The awardee will retain custody of and primary rights to the data and 
intellectual property developed under the award, subject to current 
Government policies regarding rights of access consistent with current HHS, 
PHS, and NIH policies.  

2.  NICHD Program Staff Involvement

The role of the NICHD program staff will be to assist the awardees, the 
Steering Committee, and the Scientific Advisory Board in the following ways: 

o  Participate in the overall coordination of the program with the Steering 
Committee.  This includes efforts to improve and strengthen inter- and intra-
center cooperation among the research projects of the centers; facilitate 
interactions between the awardee and collaborating investigators; and retain 
scientific/programmatic involvement during the award performance period by 
contributing to planning and assessment activities, providing technical 
assistance, advice and coordination beyond typical program stewardship for 
grants.  

o  Provide technical advice and expertise regarding scientific direction and 
program management to help shape a comprehensive framework for the 
development of the center; interact with each individual center grant awardee 
evaluating objectives and research goals of the particular center, deciding 
optimal research approaches and protocol designs, and contributing to the 
adjustment of research protocols or approaches, as warranted.  The Project 
Coordinator will assist and facilitate this process and not direct it. 

o  Assist research efforts by facilitating access to fiscal and intellectual 
resources; recommend additional research endeavors within the approved 
research and negotiated budgets; participate, where warranted, in data 
analysis, interpretation, and dissemination of study findings; and assist 
through review, comment, analysis and, where appropriate, co-authorship, in 
reporting results to investigators and health care recipients. 

o  Reserve the authority to recommend reductions in budget, withhold support, 
suspend and/or terminate the award if technical performance falls below 
acceptable standards for quality and timeliness.  The program staff will, as 
required, help reprogram research efforts, including options to modify or 
terminate them, by mutual consent between the center and NICHD.  This 
includes identifying jointly with participants of the Steering Committee and 
Scientific Advisory Board the need to add additional research projects to 
centers or to phase out a center project or core when performance standards 
are not met. 

o  Serve as an ex officio member of the Scientific Advisory Board.  
Participate as a voting member of the Steering Committee and all active 
subcommittees.

o  The Program Official will, as required, maintain primary responsibility 
for stewardship of the award and overall responsibility for monitoring the 
conduct, progress, and fiscal management of the research program; 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 program; and reserve the right to 
include selected NIH extramural and intramural staff as consultants/experts 
on scientific issues during the performance periods of the award.  

The NICHD reserves the right to negotiate additional awardee terms and 
conditions based on recommendations from the Scientific Review Group and the 
National Advisory Child Health and Human Development Council.

3. Collaborative Responsibilities

Overall coordination of the program, consistent with the stated intent of the 
RFA, will be managed by a Steering Committee, Scientific Advisory Board, and 
the NICHD program staff.  

o  The center partnership must have a planning and evaluation component in 
place for reviewing internal proposals for pilot and traditional research 
projects based on their merit and potential to contribute effectively to 
achieving high priority goals and objectives.  The center partnership will 
have responsibility for directing the research projects and flexibility to 
discontinue and start new projects based on the regular evaluation of 
progress and identification of new opportunities through formalized and 
priority setting activities.  Beyond this, the center should develop 
opportunities for information exchange, seminar presentation, and research 
training opportunities for students and fellows.

o  An independent Scientific Advisory Board will advise the Steering 
Committee in identifying and prioritizing research topics appropriate for 
study.  The Scientific Advisory Board, chosen by the NICHD with the advice of 
the Steering Committee, will consist of consultants with appropriate research 
expertise.  A Chairperson will be chosen by a majority vote of Board members.  
The Board will (1) review the broad goals and accomplishments of the center, 
and identify areas of new opportunity based on continuing evaluation; (2) 
assess interim progress of all scientific projects and their relevance to the 
broad objectives of this initiative; and (3) assist in identifying, 
prioritizing, and reviewing proposed research projects that emerge during the 
course of the grant period.  The NICHD program  staff will serve as ex 
officio member(s) of the Board.  The Scientific Advisory Board will meet 
annually and must submit a written report to the NICHD that summarizes its 
evaluation and recommendations for improvement.

o  The Steering Committee will be composed of the Center Directors and Co-
directors from the collaborating institutions, and the NICHD Project 
Coordinator.  A Chairperson will be chosen by a majority vote of the 
Committee members.  The purpose of these meetings is to share scientific 
information, assess scientific progress, identify new research opportunities 
and potential avenues of collaboration, establish priorities, reallocate 
resources, and conduct the business of the cooperative research program.  The 
Committee will have the responsibility for monitoring the progress of the 
research projects.  The NICHD Project Coordinator will participate as a 
voting member of the Committee and any subcommittees.  A member of the NICHD 
grants management staff will serve as a nonvoting advisor on the committee.  
The Steering Committee will meet at least once a year.

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, and a 
third person selected by these two members.  The decision of the arbitration 
panel, by majority vote, will be binding.  The process to resolve 
programmatic differences described above in no way affects the rights of a 
recipient of a cooperative agreement assistance grant to appeal an adverse 
determination 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 subject 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 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.

PREAPPLICATION WORKSHOP

An information/technical assistance preapplication workshop addressing the 
scientific and administrative issues associated with this initiative will be 
held during the Fall 2000.  The purpose of the workshop is to (1) familiarize 
the potential applicant with established NIH guidelines and criteria for 
review, (2) discuss the areas of NICHD programmatic emphasis, and (3) respond 
to potential applicants’ technical questions about application format, 
procedures, etc.  Logistic information, including date, time and location, 
will be posted at http://www.nichd.nih.gov/RFA/HD-00-019/HD-00-019.htm and 
may be obtained from program staff listed under INQUIRIES, below.  For those 
who cannot attend the workshop, a written summary will be posted at that 
website. 

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. Estella Parrott, by February 16, 
2001, at the address listed under INQUIRIES.

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

General Format:  

o  All essential information for the evaluation of the center application 
must appear in the body of the application rather than in an appendix.  The 
instructions accompanying form PHS 398 must be followed as completely as 
possible, but some modification, outlined below, will be necessary.  For 
example, in lieu of the preprinted Table of Contents outline on Form Page 3 
of PHS 398, a Table of Contents should be prepared listing all of the major 
sections described below and paginated to enable reviewers to find specific 
information readily.  Pagination must be consecutive throughout the 
application.  The Abstract should consist of a description of the composite 
research program, indicate the emphasis of the component research projects, 
and identify the purpose of the proposed core units.

o  The Table of Contents should contain the types of information suggested 
below:
Section I - General Information, Section II - Research Plan, and Section III 
– Appendix, if applicable.  The following guidelines will provide directions 
and descriptions for preparing each section.  Major areas to be listed and 
paginated in the Table of Contents are underlined.
 
Section I - General Information

A. Face Page 

o  Complete all items on the application's face page.  This is Form Page 1 of 
the application; number succeeding pages consecutively.

o  On line 2, enter the RFA number (HD-00-019) and title (“Cooperative 
Reproductive Science Research Centers at Minority Institutions”), and mark 
the YES box.

B. Description and Personnel 

o  On Form Page 2, describe briefly the overall research program, indicate 
the emphasis of the component research projects, and identify the purpose of 
the proposed core units.

o  List scientific and technical personnel participating in the Cooperative 
Research Center.  Use continuation pages as necessary, numbering 
consecutively.

C. Table of Contents 

o  Prepare the Table of Contents as noted above.  The major areas to be 
listed are enumerated in these instructions.

D. Budget Estimates 

o  Prepare a series of composite Budget Tables for the Cooperative Research 
Center Grant as requested below.  A separate detailed budget is required for 
each research project and for each core unit.

1. Composite Budget 

a. Use Form Page 4, "DETAILED BUDGET FOR INITIAL BUDGET PERIOD," of the PHS 
398 to present the total direct cost budget for all requested support for 
the first year. For each category, such as "PERSONNEL," "EQUIPMENT," etc., 
list the amount requested for each research project and for each core 
unit.

If consortium arrangements have been made involving other institutions or 
organizations, include total costs (direct and F&A) associated with such 
third party participation in the "CONSORTIUM/CONTRACTUAL COSTS" category.  
Costs for purchased services should be itemized under "OTHER EXPENSES."

b. Use Form Page 5, "BUDGET FOR ENTIRE PROPOSED PROJECT PERIOD," of the PHS 
398 to prepare a budget, by category, that provides direct cost totals for 
each year of requested support.

2. Individual Project and Core Budgets 

a. First year (use Form Page 4 of PHS 398 for each) 

b. Total project period (use Form Page 5 of PHS 398 for each) 

o  Consortium Budgets (if applicable) should be presented as described in 
Item 1 (Composite Budget), including a budget for the entire proposed project 
period. Total Direct and F & A costs of sub-awardees are to be shown under 
"CONSORTIUM/CONTRACTUAL COSTS" on individual research project or core budgets 
and a detailed consortium budget is to be inserted following the appropriate 
research project or core budgets.

o  Budget Justifications:  Describe the specific functions of key scientific 
and technical personnel, consultants, collaborators, and support staff.  For 
all years, explain and justify any unusual items such as major equipment or 
alterations and renovations. For future years of support requested, justify 
any significant increases in any category over the first 12-month budget 
period.  Identify such significant increases with asterisks against the 
appropriate amounts.  If a recurring annual increase in "PERSONNEL" or "OTHER 
EXPENSES" is anticipated, give the percentage.   

E. Biographical Sketch 

o  Biographical sketches are required for all key scientific and technical 
personnel participating in the research projects and core units as listed on 
Form Page 2.

o  Beginning with the Principal Investigator/Center Director, and following 
in alphabetical order, submit biographical sketches as described in the 
"Instructions for Form PHS-398," using Form Page 6.   Do not exceed two pages 
for each person.

F. Summary of Other Support 

o  To aid in the review of your application, information on all current and 
pending research support of key personnel may be presented in tabular form.  
Please indicate by an asterisk research support that overlaps with projects 
proposed in this application.  For all key personnel named on Form Page 2 
(except consultants), beginning with Principal Investigator and in 
alphabetical order thereafter.  Identify other support in the following 
categories:

1. Current Active Support; and 

2. Applications Pending Review or Funding.

G. Resources 

o  Complete the "RESOURCES" section on Form Page 8 of the PHS 398 for the 
overall center.  Briefly describe the features of the institutional 
environment that are or would be relevant to the effective implementation of 
the proposed program.  As appropriate, describe available resources, such as 
clinical and laboratory facilities, participating and affiliated units, 
patient populations, geographical distribution of space and personnel, and 
consultative resources.  Use continuation pages as needed.

Section II - Research Plan

o  A proposed five-year research plan that is responsive to the objectives 
set forth in this RFA and presents the organization and component functions 
of the center must be included.  The research plan must contain the 
description of at least three collaborative research projects that will be 
mutually beneficial to participating investigators through coordinated, 
cooperative interactions.  The plan should demonstrate the applicant’s 
knowledge, ingenuity, and commitment to developing productive, competitive 
reproductive science research.

o  Include a detailed Table of Contents with pagination (numeric only) at the 
beginning of Section II.  Identify each research project or core unit by 
title, and assign each research project a number (I, II, III) and each core 
unit a capital letter (A,B,C) that reflects the order in which the research 
projects and core units are presented in the application research plan.  For 
each research project and core unit, provide the names of the Principal 
Investigator/Co-Principal Investigator or Core Director/Co-director, and 
biographical sketches for personnel not identified previously.

A. Introductory Overview 

o  Although there is no page limitation for this section, applicants are 
encouraged to present a concise and succinct overview.  Discuss the 
objectives of the center and general plans for the proposed grant period.

1. Center Description/Management

o  A description of and justification for the proposed research development 
core, which consists of the individual research projects, and the 
administrative core unit should be included.  This should include the 
capabilities to meet or exceed the minimal requirements for a center, as 
stated in this RFA.  List by title and investigator the component research 
projects and core units, showing the interrelationship between the research 
projects, the core units, and their relationship to the central theme.  
Applicants must also provide a detailed description of the process involved 
in selecting projects included in the center grant application as well as the 
process that will be used in evaluating their outcomes, and in selecting a 
new set of projects based on their merit and potential for meeting the 
objectives of the partnership.

o  Discuss the general rationale for the partnership and mutual benefits that 
the minority institution and collaborating institution expect to derive from 
the affiliation.  Include a discussion of potential opportunities that the 
partnership may consider as the relationship and affiliation evolves.

o  The goals of the center must be described and background and significance 
of the topics being addressed discussed.  In addition, each research project 
and core unit must be fully explained in light of how they contribute to 
achieving these goals.  The organizational and administrative structure, the 
responsibilities of the Center Director, the Co-director, and the individual 
investigators, and the proposed mechanism for monitoring scientific progress 
must be addressed.  Describe the organizational framework and provide an 
organizational chart.

o  A description of the qualifications and experience of the Center Director 
and Co-director in terms of their ability to provide scientific and 
administrative leadership, and how they plan to promote the collaboration and 
cooperation needed to achieve the center objectives.  

o  The center must be prepared to participate in a cooperative manner.  
Document institutional and departmental commitment to support this 
cooperative study and staff dedicated to this program.  

o  Clearly outline the chain of responsibility for decision making and 
administration, beginning at the level of the institution’s President or 
other senior official and including all key staff (e.g., Sponsored Program 
Administrator, Department Chair, and Dean).  Describe the plans for day-to-
day administration of the center, including program coordination, planning, 
and evaluation.  Describe the proposed relationship of the center to existing 
research activities and, in detail, how the center will augment and 
strengthen the existing research infrastructure.

o  Include information on the use of the steering and advisory committees, 
and the method of determining core access and space assignment.

o  The applicant must identify and outline plans for support staff (e.g., 
grants management, administrative, and technical) to ensure the timely 
ordering of research supplies, equipment, and other resources essential to 
the scientific productivity of the research award.

o  Describe the availability of existing resources (e.g., clinical and 
laboratory facilities, patient populations, geographic distributions of space 
and personnel) and collaborative resources that can support a research 
program.

o  Briefly describe how the proposed activities will enhance the scientific 
capabilities of faculty, students, and fellows in reproductive science and 
strengthen the reproductive science curriculum. 

2. Institutional Commitment/Supporting Infrastructure

o  A letter of commitment from a senior official (e.g., President or Dean) at 
the applicant institution should outline the commitment for resources and 
facilities to sustain and support the center throughout the period of funding 
and beyond the performance of this award; document institutional and 
department commitment and the availability of technical resources and 
facilities for the long-term support of the center; delineate features of the 
institutional environment that are relevant to the overall success of the 
reproductive science program; provide evidence that senior leadership has 
addressed issues such as tenure, promotion, research release time, and other 
personnel matters pertaining to the scientific success of the center.  

o  A letter of commitment from a senior official (e.g., President or Dean) at 
the collaborating NICHD reproductive science institutional program should 
outline the commitment for resources and facilities to sustain and support 
the center throughout the period of funding; document institutional and 
department commitment and the availability of technical resources and 
facilities; and delineate features of the institutional environment that are 
relevant to the scientific success of the center.

3. Assurances and Collaborative Agreements.  

o  Any arrangements for collaborative and cooperative endeavors or 
subcontracting should be highlighted.  Letters of Intent to Collaborate and 
Letters of Agreement from consultants should be referenced here and included 
at the end of the appropriate research project or core unit.  (This is 
usually covered under each research project and core.)

B. Research Development Core Description 

o  It is required that at least three research projects be maintained at all 
times for the duration of the award. These research projects must 
thematically address one or more research areas listed under Research Scope. 

o  At least two of the research projects must be in the format of an R01-type 
application.  One or more research project may be a short-term pilot project.  
The maximum direct costs for each R01-type project is $250,000 per year and 
for each pilot project is $100,000 per year.

o  Selection of qualified investigators from the applicant minority 
institution or collaborating institution to propose and lead meritorious 
research projects suited to their reproductive science expertise must be 
identified.  A co-investigator from the other institution must be involved in 
the project.  Each of the proposed projects should effectively use the 
scientific and technical strengths of collaborating investigators, and 
investigators must clearly define the nature and extent of the research 
collaboration, such that they fully explain the necessary administrative, 
fiscal, and scientific focus in the application.  These projects must involve 
established investigators at affiliated NICHD-designated institutions as 
collaborators.

o  Each of the research projects and the core units proposed for inclusion in 
the center should be described using the PHS 398 application format.  
However, additional face pages are NOT necessary for each research project.  
Each research project description should include an abstract depicting the 
purpose and objectives of the research.  Another paragraph should include a 
description explaining how the project relates to the overall priorities and 
objectives as described in the application. 

o  Identify each project by a Roman numeral (I, II, III…) and a title.

o  For each component research project, a full description is to be provided 
following the format presented in Form PHS 398.  A 25-page limitation will 
apply for each of the R01-type projects and a 10-page limitation will apply 
for the short-term pilot project(s).  Unless stated otherwise in this RFA, 
the page limitations for each section provided in the PHS 398 instructions 
are to be used.  Begin the presentation of each component research project on 
a separate page.  For each project, include the following information:

1. Introductory Information 

a.  Indicate: 

o  Project Title

o  Project Principal Investigator, title, location

o  Other investigators, consultants, and collaborators, titles (Associate 
Professor, Postdoctoral Fellow, student).

a.  Abstract of Research Plan (use Form Page 2 of PHS 398)

2. Research Project Information: 

Discuss the purpose and nature of the project and its relevance to the 
application's overall theme.  Address the following:

a.  Specific Aims 

b.  Significance 

c.  Preliminary Studies.  Describe the research project's use of core unit 
services, including need for the services, and the advantages and cost 
effectiveness of core unit usage for the project. 

d.  Research Design and Methods.  For research involving human subjects, this 
section must address the inclusion of women, minorities and their subgroups, 
and children as research subjects, following relevant policy announcements. 

e.  Human Subjects 

f.  Vertebrate Animals 

g.  Consultants 

h.  Collaborative arrangements, including pertinent letters of assurance and 
intent. 

i.  Literature Cited

C.  Administrative Core Description 

o  A full description is to be provided following the format presented below.  
Unless stated otherwise in this RFA, the page limitations for each section 
provided in the PHS 398 instructions are to be used.  

o  Briefly summarize the overall objectives of core unit; present the 
organizational framework or chart; highlight the decision-making process for 
use of core unit services described.

o  Explain the core facility in light of how it will contribute to achieving 
the goals of the center, and the ability to provide administrative oversight 
and coordination.  Provide a description of key personnel, space, physical 
resources and projected use.  Describe specific functions of the 
administrative core, such as the daily oversight, travel and logistic 
services needed to support the center.  This should include organizing 
meetings, workshops, and seminars, documenting the results of activities, 
providing critical secretarial services, biostatistical and computer 
services, etc.  Describe the planning and evaluation component and procedures 
for internal review of research proposals.

o  Include the following information: 

a.  Objective(s) 

b.  Staffing:  Description of key professional and support staff functions 

c.  Resources:  Description of space and physical resources

d.  Services Provided:  Describe projected services to other core units and 
research projects, and the center as a whole

D.  Checklist - As required in Form PHS 398

Section III – Appendix, if applicable

o  Include materials as appropriate (see PHS 398)

Submission Instructions

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-00-019.  A sample RFA label is available at 
http://www.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.
Director, 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)
Lstanfor@mail.nih.gov 

Applications must be received by March 29, 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 the CSR and 
for responsiveness to the RFA by NICHD.  Incomplete and/or non-responsive 
applications will be returned to the applicant without further consideration.  
Applications that are complete and responsive to the RFA will be evaluated 
for scientific and technical merit by an appropriate peer review group 
convened by NICHD in accordance with the review criteria stated below.  Site 
visits will not be conducted in the review of these applications.  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

The scientific and technical merit peer review focuses on three areas:  (1) 
review of the overall center as an integrated effort; (2) review of the 
administrative core, and (3) review of the component research projects that 
make up the research development core. 

1.  Overall Center Evaluation Criteria

o  Strengths of the center in terms of the combined focus of the research 
projects and core units, and the significance of the application to the 
objectives of the program, as outlined in this RFA.  The importance and 
relevance of each collaborative project to the achievement of the center 
program objectives.  Feasibility of achieving the priorities and objectives 
of this collaboration within the five-year period.

o  Qualifications and experience of the Principal Investigator/Center 
Director and Co-director to provide scientific and administrative leadership, 
and the ability to meet the center’s demands of time and effort.  
Specifically stated and described willingness of the Principal 
Investigator/Center Director and Co-director to work and cooperate with other 
centers and with the NICHD in the manner summarized in this RFA.  For key 
personnel from both collaborating institutions:  the adequacy of the 
qualifications and experience to successfully plan for and achieve the 
objectives of center.

o  Appropriateness of the minority institution and NICHD-designated 
reproductive science research program collaboration with respect to the 
scientific aims of the center, including the use of partnerships to access 
scientific expertise from inter- and intra-institutional affiliations.  
Multidisciplinary scope of the center; its cohesiveness, coordination, and 
synergistic potential among the center and its projects. 

o  The strength of the relationship of the applicant, key investigators and 
the collaborating researchers, particularly the academic qualifications, 
research experience, expertise and research productivity, as well as 
administrative and fiscal relationship.

o  Appropriateness of the structure and plans for the administration of the 
grant and center.  An appropriate organizational and administrative structure 
for effective attainment of center objectives that considers arrangements for 
internal quality control of ongoing research, the solicitation of funds, day-
to-day management, contractual agreements, and internal communication among 
center investigators.

o  Demonstrated institutional commitment to the center and its objectives in 
terms of providing research facilities and management support.  The plans for 
the establishment and utilization of support structure (grants management, 
administrative, technical) to provide resources essential to carry out the 
scientific projects.

o  Documentation of institutional endorsement of the proposed five-year plan, 
including letters of commitment from senior institutional officials from both 
collaborating institutions.  The degree to which the letters of commitment 
fully address and support the priorities and objectives of the center.

o  The institutional environment in which the research will be conducted, 
including the availability of space, equipment, and subjects, if proposed; 
adequacy of administrative, clinical and technical capabilities to conduct 
the research proposed; and the physical proximity of investigators or, if 
geographically separated, the plans to ensure a successful collaborative 
effort.  Features of the institutional environment that are relevant or 
unique in assuring the success of the program.

o  Existing research infrastructure (laboratory space, equipment, clinical 
facilities, animal housing, and computer resources) and its commitment to the 
center that would facilitate and support the reproductive science research 
program.  The relationship of the proposed program to already existing 
reproductive science programs, if applicable.

o  The degree to which this center, if fully successful, would enrich the 
academic and intellectual milieu for reproductive science research at the 
minority institution, and the feasibility and potential for underrepresented 
minority investigators to gain research experience and independence.

2.  Administrative Core Evaluation Criteria

o  Quality and availability of core resources, and the appropriateness of the 
use of the administrative core services.  The adequacy of the structure and 
organization for effective attainment of center priorities and objectives.  
Evidence that the core will provide the necessary administrative support, 
such as oversight and management, biostatistical and computer services, 
planning and evaluation component, contractual agreements, support, travel, 
and logistic services, and internal communications among investigators 
required for the successful completion of the research projects.  

o  Qualifications, experience and commitment of co-Investigators and key 
personnel designated to support the administrative core.

3.  Research Development Core:  Research Project Evaluation Criteria 

Each research project (as defined in this solicitation) will be individually 
evaluated for its scientific and technical merit using the standard NIH 
review criteria.  

o  Significance:  Does this study address an important problem?  If the aims 
of the application are achieved, how will scientific knowledge be advanced?  
What will be the effect of these studies on the concepts or methods that 
drive this field?  

o  Approach:  Are the conceptual framework, design, methods, and analyses 
adequately developed, well integrated, and appropriate to the aims of the 
project?  Does the applicant acknowledge potential problem areas and consider 
alternative tactics?

o  Innovation:  Does the project employ novel concepts, approaches or 
methods?  Are the aims original and innovative?  Does the project challenge 
existing paradigms or develop new methodologies or technologies? 

o  Investigators:  Are the key investigators and collaborative investigators 
appropriately trained and well suited to carry out this work?  Is the work 
proposed appropriate to the experience level of the key investigators and 
other collaborative researchers?  Are the key investigators and collaborative 
investigators committed to devote the required time and effort to the 
research project and the center?  Are the key investigators and collaborative 
investigators willing to cooperate, as appropriate, with NICHD assistance in 
the manner summarized in this RFA. 

o  Environment:  Does the scientific environment in which the work will be 
done contribute to the probability of success?  Do the proposed experiments 
take advantage of unique features of the scientific environment or employ 
useful collaborative arrangements?  Is there evidence of institutional 
support?

In addition to the above criteria, in accordance with NIH policy, all 
applications also will be reviewed with respect to the following:

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

o  The reasonableness of the proposed budget and duration in relation to the 
proposed research.

o  The adequacy of the proposed protection for humans, animals or the 
environment, to the extent they may be adversely affected by the project  
proposed in the application.

SCHEDULE

Letter of Intent Receipt Date:     February 16, 2001
Application Receipt Date:          March 29, 2001
Peer Review Date:                  June/July 2001
Council Review:                    September 2001
Earliest Anticipated Start Date:   September 30, 2001

AWARD CRITERIA

Criteria that will be used to make award decisions include:

o  scientific merit (as determined by peer review)
o  availability of funds
o  programmatic priorities.

INQUIRIES

Inquiries concerning this RFA are encouraged.  The opportunity to clarify any 
issues or questions from potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

Estella Parrott, M.D., M.P.H.
Center for Population Research
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8B01, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 496-6515
FAX:  (301) 496-0962
E-mail:  ep61h@nih.gov

Direct inquiries regarding fiscal matters to:

Diane Watson
Chief, Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A17, MSC 7510 
Bethesda, MD  20892-7510
Telephone: 301) 496-5001
FAX:  (301) 402-0915
E-mail:  dw40j@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 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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy


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