WOMEN'S REPRODUCTIVE HEALTH RESEARCH CAREER CENTERS

Release Date:  November 12, 1998

RFA:  HD-99-001

P.T.

National Institute of Child Health and Human Development
Office of Research on Women's Health

Letter of Intent Receipt Date:  December 11, 1998
Application Receipt Date:  January 22, 1999

THIS RFA IS A REISSUANCE OF HD-98-004.

PURPOSE

The National Institute of Child Health and Human Development (NICHD) and the
Office of Research on Women's Health (ORWH) invite institutional career award
applications for Women's Reproductive Health Research Career Development Centers,
hereafter termed "Centers."  This is a reissuance of RFA HD-98-004 which
initiated this new Centers program in 1998. Centers will support research career
development of  obstetrician-gynecologists, to be known as Women's Reproductive
Health Research (WRHR) Scholars, who have recently completed postgraduate
clinical training, and who are commencing basic, translational and/or clinical
research relevant to women's health. The goal of this initiative is to promote
the performance of research and transfer of findings that will benefit the health
of women. The Centers will accomplish this by bridging clinical training with
research independence,  increasing the number and skills of obstetrician-
gynecologist investigators at awardee institutions through a mentored research
experience leading to an independent scientific career addressing women's health
concerns.

HEALTHY PEOPLE 2000

The Public Health Service (PHS) is committed to achieving the health promotion
and disease prevention objectives of "Healthy People 2000," a PHS-led national
activity for setting priority areas.  This Request for Applications (RFA),
Women's Reproductive Health Research Career Development Centers, is related to
the priority area of human resource development.  Potential applicants may obtain
a copy of "Healthy People 2000" at http://www.crisny.org/health/us/health7.html.

ELIGIBILITY REQUIREMENTS

Applications may be submitted on behalf of departments of Obstetrics and
Gynecology, as defined below, by domestic for-profit and non-profit non-Federal
organizations, public or private, such as hospitals, medical schools or other
institutions of higher education.  Foreign institutions are not eligible for this
institutional career award.  An eligible institution will have  a department of
Obstetrics and Gynecology (here understood to include a department providing
obstetrical and/or gynecologic care as its primary function, regardless of title)
that has as a primary teaching site either a hospital for women or an
obstetrics-gynecology program with an identifiable organizational structure
within a larger medical institution in the United States of America.  Applicant
institutions must have the clinical specialties and subspecialties and the
clinical and research facilities sufficient to meet the purposes of the Center
program, namely, to bridge clinical training with a career in basic,
translational and/or clinical research relevant to women's reproductive health.
Racial/ethnic minority individuals, persons with disabilities, and women are
encouraged to apply as Principal Investigators.

MECHANISM OF SUPPORT

This RFA will use the K12 Mentored Clinical Scientist Development Program Award.
The K12 awards will be for a period of five years.  Because the nature and scope
of the research proposed in response to this RFA may vary, it is anticipated that
the size of an award will also vary.  K12 awards will be for up to $400,000 total
(direct plus indirect) costs per year, and will support a minimum of three WRHR
Scholars.  The number of awards will be influenced by the amount of funds
available to NICHD, by the overall merit of the applications, and by their
relevance to program goals stated in this RFA. The anticipated award date is July
1, 1999.

Planning, direction, and execution of each component of the research and career
development program will be the responsibility of the WRHR Scholar with the
guidance of his or her mentor.  

This RFA is a one-time solicitation.  NICHD has not yet determined whether or how
this program will be continued beyond the commitments expressed in the present
RFA. 

FUNDS AVAILABLE

NICHD and ORWH intend to commit will be approximately $3 million (total costs)
for the first year of support of the entire program.  It is anticipated that up
to eight awards will be made. Although the financial plans of NICHD and ORWH
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 applications
of outstanding scientific and technical merit.

RESEARCH OBJECTIVES

A need for expanded support for bridging clinical training with an independent
career in  research addressing women's health concerns has been identified in a
number of sources.  These include the 1992 Institute of Medicine Report,
"Strengthening Research in Academic OB/Gyn Departments," the 1997 NICHD
Extramural Program 5-Year Plan Report: "A Research Agenda for the Reproductive
Sciences Branch," and report language in the Fiscal Year 1998 House
Appropriations Report (No. 105-205; July 25, 1997.)  Center grant awards from
this RFA will meet the specified need by providing departments of Obstetrics and
Gynecology, both developing and established, an opportunity to build national
capacity for junior investigators in women's health research.  Investigators with
established research programs covering a broad range of  basic and applied
biomedical and biobehavioral science in the Obstetrics-Gynecology together with
collaborating departments form an intellectual and technical research base for
mentoring WRHR Scholars.  Although mentors from collaborating departments may
provide needed expertise and resources, the emphasis of WRHR Scholars' projects
should be on research ultimately relevant to obstetrics/gynecology and/or its
subspecialties: maternal-fetal medicine, gynecologic oncology, and reproductive
endocrinology; and relevant emerging fields such as adolescent gynecology,
urogynecology and the reproductive health of women with disabilities. Projects
may be basic, translational, and/or clinical research, but must be within the
biomedical and biobehavioral purview of NIH. Research with a primary focus on
health care delivery, health services, or health policy is outside the scope of
this RFA.  Research focused on somatic health, for example, breast,
cardiovascular, or musculoskeletal systems, should similarly not be proposed.

SPECIAL REQUIREMENTS

A.  Institutional Environment: Applicant institutions should show commitment to
the Center's goals, and provide assurances that the institution intends the
Center and the supported WRHR Scholars to be an integral part of its research
program, including various forms of cost-sharing (c.f. Environment, under "Review
Considerations").  Research facilities and training opportunities (see B, below)
will be a critical part of the environment.  Applicant institutions should
provide a guarantee of 75% protected time for the WRHR Scholars for research.

B.  Center Composition: Applicants must describe or propose a multidisciplinary
career development program that will maximize the use of relevant research and
educational resources.  The Center must have a strong research base, comprising
the investigations of established scientists who will provide expertise,
resources, and mentoring to the WRHR Scholars.  The research base must be broad
and relevant to current areas of research interest and need in women's
reproductive health. The environment should be one which will stimulate and
increase the interactions between basic scientists and clinical investigators. 
There should be an adequate pool of junior  investigators likely to benefit from
mentored research career development.  Of major importance, the Center must have
a scientifically sound and equitable procedure for selecting which WRHR Scholars
and projects are to be supported.  There must be documented evidence of an
institutional commitment to support the Center's human and tangible resources and
its goal of developing and retaining productive, independent investigators in
areas of women's reproductive health concerns.

C.  Principal Investigator:  The Principal Investigator of a Center must be the
Chair of the Department of Obstetrics and Gynecology, or equivalent.  He/she
should possess the scientific expertise, leadership and administrative
capabilities required to coordinate and supervise a multidisciplinary research
and development program of this scope.  As an option, the application may request
a coinvestigator to serve as Program Director, with responsibility for some or
all of the day-to-day operations of the Center. There are no specific
requirements for the Program Director, but if one is included, he/she should have
experience and qualifications complementing those of the Principal Investigator.

D.  Advisory Committee: The Advisory Committee will be a group of scientists from
the department of Obstetrics and Gynecology, and other departments or
institutions as appropriate, with interests relevant to the Center's research
programs.  It may include mentors.  The two major functions of the committee are
to evaluate 1) applications from WRHR Scholar candidates, and 2) the overall
conduct of the Center.  Specifically, the committee  makes recommendations to the
Principal Investigator as to WRHR Scholar appointments, evaluates ongoing
research activities annually, makes recommendations regarding their continuation,
and makes recommendations to the Principal Investigator regarding priorities for
use of the Core laboratory, if applicable.  The committee may use institutional
or outside consultants if needed.  Plans to include members or consultants from
outside institutions may be described, but such individuals should not be named.
The committee is a formal part of the structure of the Center.  It should meet
regularly, and keep written minutes which may be reviewed as part of a competing
or noncompeting application.

E.  Mentors:  Each WRHR Scholar appointed under the K12 award must have a primary
sponsor who is recognized as an independent investigator and who is actively
involved in basic, translational and/or clinical research relevant to this
initiative, and who has a successful record of providing research training of a
type expected in this Center.  An assigned mentor will provide guidance for the
development of each WRHR Scholar assigned to the program.  The mentor must be
committed to continue this involvement throughout the WRHR Scholar's total period
of development under the award.

F.  Career Development Program:  The K12 award provides five years of funding for
the Center.  The Center will support WRHR Scholars for periods of two to five
years consisting of consecutive 12 month appointments.  The program may be
divided into two distinct phases if appropriate -- a basic and/or clinical
science training component and an intensive research experience under the general
guidance of a qualified mentor.  WRHR Scholars appointed under this program
should, as needed, receive formal didactic coursework to support their career
development, which may include, for example, biostatistics, epidemiology, and
clinical trials.  At least 75% of the WRHR Scholar's full-time professional
effort must be devoted to the K12 program per se.  The remainder of the recipient
WRHR Scholar's time may be devoted to developing other clinical pursuits
consonant with the objectives of the award. 

G.  WRHR Scholars: The Scholar position is a junior faculty appointment, not a
fellowship.  Candidates for support as WRHR Scholars must have an M.D. degree or
its equivalent, must have completed postgraduate residency in
obstetrics-gynecology, must identify a mentor with extensive research experience,
and must be willing to spend a minimum of 75% of full-time professional effort
conducting research and research career development.  Completion of clinical
subspecialty training is not required of candidates practicing general obstetrics
and gynecology; however, those who choose to subspecialize must have completed
their fellowship.  In order to accommodate the needs of those interested in
participating in this program who may have had a career hiatus because of family
responsibilities, uniformed service, etc., there is no limit on time elapsed
since completion of clinical training.  Support is in the form of a minimum of
two consecutive 12-month appointments, renewable in annual increments for up to
five years total, and is contingent upon satisfactory progress as reported to the
Advisory Committee and to NICHD in the annual progress report of the Center. 
Centers are encouraged to recruit members of underrepresented minorities, women,
and candidates with disabilities. Candidates must be U.S. citizens or noncitizen
nationals, or must have been lawfully admitted for permanent residence and
possess an Alien Registration Receipt Card (I-151 or I-551) or some other
verification of legal admission as a permanent resident.  Noncitizen nationals,
although not U.S.  citizens, owe permanent allegiance to the U.S.  They are
usually born in lands that are not states but are under U.S. sovereignty,
jurisdiction, or administration.  Individuals on temporary or student visas are
not eligible.

At the time support begins, WRHR Scholars may not have served as the principal
investigator or equivalent on an NIH research project (R01), Mentored Clinical
Scientist Development Award or its equivalent (K08), a subproject of a program
project (P01) or center grant (P50), or equivalent PHS research grant awards. 
WRHR Scholars may not accept or hold any other PHS award that duplicates the
provisions of this career award.

During the period of this award, WRHR Scholars are encouraged to apply for, and
may accept and hold, independent research grant support.

H.  Core laboratory: With strong justification, a scientific Core laboratory may
be requested as part of the Center, within the total budget.  Such a Core would
provide skilled technical services to complement and extend the capabilities of
the mentors to promote the career development of the WRHR Scholars.  Such a Core
might provide scientific services such as, but not limited to, assays, molecular
biology or cell culture.  Requests for a Core must be justified in terms of cost-
effective enhancement of the research resources that will serve at least three
WRHR Scholars' projects. The Core, if any, must be a new entity, not an extension
or enhancement of an existing facility. The award may support professional
direction of the Core lab, up to 50% effort, as well as technical assistance,
supplies, equipment, and appropriate costs of operation.  Institutional
commitment to the Core lab must be demonstrated, and may take the form of
providing or renovating space, purchase of required equipment, and/or support of
personnel.  

I.  Allowable Costs:

1.  The Center structure may have these elements:

a)  Administration: Salary and fringe benefits for the Program Director, if any,
up to 10% effort, as well as a part-time secretary, may be requested.  No
compensation may be requested for the Principal Investigator.  Travel to an
annual Center Directors' meeting for the Principal Investigator or the Program
Director must be requested.

b) Core Laboratory: Budgets may include salaries and fringe benefits for a Core
Director (up to 50%), other technical staff, supplies, animals, equipment
purchase and maintenance.  The sum of the budgets for Administration and a Core
laboratory may not exceed $100,000.

c) Indirect costs: Indirect costs will be reimbursed at 8% of modified total
direct costs, or at the actual indirect cost rate, whichever is less.

2.  As part of the Center budget, an application must request a minimum of three
WRHR Scholar positions.  Support for each WRHR Scholar position may not exceed
$100,000 total costs per year.

a) Salary:  The NIH will provide salary and fringe benefits for the WRHR Scholar,
within the NIH cap of $125,000 annual salary.  The institution may supplement the
NIH salary contribution up to a level that is consistent with the institution's
salary scale; however, supplementation may not be from Federal funds unless
specifically authorized by the Federal program from which such funds are derived. 
In no case may PHS funds be used for salary supplementation.  Institutional
supplementation of salary must not require extra duties or responsibilities that
would interfere with the purpose of the Center.  Under expanded authorities,
however, institutions may rebudget funds within the total costs awarded to cover
salaries consistent with the institution's salary scale.

The total salary requested for each WRHR Scholar must be based on a full-time,
12-month staff appointment.  It must be consistent both with the established
salary structure at the institution and with salaries actually provided by the
institution from its own funds to other staff members of equivalent
qualifications, rank, and responsibilities in the department concerned.  If
full-time, 12-month salaries are not currently paid to comparable staff members,
the salary proposed must be appropriately related to the existing salary
structure.

b) Research Development Support: Within each WRHR Scholar's total award, grant
funds may be used toward the following expenses:  (1) salary as above; (2)
tuition, fees, and books related to career development; (3) research expenses,
such as supplies, equipment and technical personnel; (4) travel to one training
or scientific meeting per year; (5) statistical services including personnel and
computer time.

Grant funds may not be requested for the following: compensation for the
Principal Investigator or mentors, direct support of the mentors' laboratories;
compensation of administrative personnel normally paid from institutional
overhead charges; administrative activities such as public relations, or health
or educational services; travel of the Principal Investigator, Program Director
or mentors to scientific meetings; costs of clinical care; and alterations and
renovations. 

In accord with directives derived from H.R. 2264 and S. 1061 and (Sec. 513) and
included in the Labor, HHS, and Education Fiscal Year 1998 Appropriations Bill
enacted into law (Public Law 105-78) on November 13, 1997, funds provided for the
awards made from this RFA must only be used in compliance with the following
directive: 

"Sec. 513.  (a) None of the funds made available in this Act may be used for--
     (1) the creation of a human embryo or embryos for research purposes; or
     (2) research in which a human embryo or embryos are destroyed, discarded,
or knowingly subjected to risk of injury or death greater than that allowed for
research on fetuses in utero under 45 CFR 46.208(a)(2) and section 498 (b) of the
Public Health Service Act (42 U.S.C. 289g (b)).
            (b) For purposes of this section, the term "human embryo or embryos"
includes any organism, not protected as a human subject under 45 CFR 46 as of the
date of the enactment of this Act, that is derived by fertilization,
parthenogenesis, cloning, or any other means from one or more human gametes or
human diploid cells."

Per NIH policy, publications resulting from work supported by the award must cite
the grant number in a footnote.  The citation must include a disclaimer that no
federal funds were used for the performance of in vitro fertilization - embryo
transfer, if any such activities may have been reported in the publication. 

J. Evaluation:  In carrying out its stewardship of human resource related
programs, the NIH may begin requesting information essential to an assessment of
the effectiveness of this program.  Accordingly, awardee institutions are hereby
notified that WRHR Scholars may be contacted after the completion of their career
development experiences for periodic updates on various aspects of their
employment history, publications, support from research grants or contracts,
honors and awards, professional activities, and other information helpful in
evaluating the impact of the program.

K.  Other Income: Fees resulting from clinical practice, professional
consultation, or other comparable activities required by the research and
research-related activities of this award may not be retained by the candidate. 
Such fees must be assigned to the grantee institution for disposition by any of
the following methods:

The funds may be expended by the grantee institution in accordance with the NIH
policy on supplementation of career award salaries and to provide fringe benefits
in proportion to such supplementation.  Such salary supplementation and fringe
benefit payments must be within the established policies of the grantee
institution. 

The funds may be used for health-related research purposes.

The funds may be paid to miscellaneous receipts of the U.S. Treasury.  Checks
should be made payable to the Department of Health and Human Services, NIH, and
forwarded to the Director, Division of Financial Management, NIH, Bethesda,
Maryland 20892.  Checks must identify the relevant award account and reason for
the payment.

Center personnel supported by the K12 award may retain royalties and fees for
activities such as scholarly writing, service on advisory groups, or honoraria
from other institutions for lectures or seminars, provided these activities
remain incidental and provided that the retention of such pay is consistent with
the policies and practices of the grantee institution.

Usually, funds budgeted in an NIH institute-supported research or training grant
for the salaries or fringe benefits of individuals, but freed as a result of a
career award, may not be rebudgeted.  An institute will give consideration to
approval for use of released funds only under unusual circumstances.  Any
proposed retention of funds released as a result of an NIH career award must
receive prior written approval of the institute awarding component.

L.  Special Leave: Candidates appointed to this program career award may engage
in research experiences at another institution, including a foreign laboratory,
if directly related to the purpose of the award.  Only local, institutional
approval is required if such leave does not exceed three months.  For longer
periods, prior written approval of the NIH awarding institute is required.  To
obtain prior approval, the Principal Investigator must submit a letter describing
the plan, countersigned by the appropriate institutional official, to the NICHD. 
A copy of a letter or other evidence from the performing institution where the
leave is to be taken must be submitted to assure that satisfactory arrangements
have been made.  Support from the career award will continue during such leave.

Leave without award support may not exceed 12 months.  Such leave requires the
prior written approval of the NIH funding component and will be granted only in
an unusual situation.  Support from other sources is permissible during the
period of leave.  Such leave does not reduce the total number of months of
program support for which an individual is eligible.  Parental leave will be
granted consistent with the policies of the NIH and the grantee institution.

M.  Termination:  The Director of the NIH may discontinue a Center award upon
determination that the purpose or terms of the award are not being fulfilled. 
In the event an award is terminated, the Director of the NIH shall notify the
grantee institution in writing of this determination, the reasons therefor, the
effective date, and the right to appeal the decision.

A final progress report, invention statement, and Financial Status Report are
required upon termination or relinquishment of an award.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the NIH that women and members of minority groups and their
subpopulations must be included in all NIH supported biomedical and behavioral
research projects involving human subjects, unless a clear and compelling
rationale and justification is provided that inclusion is inappropriate with
respect to the health of the subjects or the purpose of the research. This 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
"NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical
Research," which was published in the Federal Register of March 28, 1994 (FR 59
14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11,
March 18, 1994, available on the web at:
http://grants.nih.gov/grants/guide/notice-files/not94-105.html. 

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 that was published in the NIH Guide for Grants
and Contracts, March 6, 1998, and is available at the following URL address:
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.

LETTER OF INTENT

Prospective applicants are asked to submit, by December 11, 1998, a letter of
intent that includes a descriptive title of the proposed research, the name,
address, and telephone number of the Principal Investigator, the identities of
other key personnel and participating institutions, and the number and title of
the RFA in response to which the application may be submitted.  Although a letter
of intent is not required, is not binding, and does not enter into the review of
a subsequent application, the information that it contains allows NICHD staff to
estimate the potential review workload and avoid conflict of interest in the
review.

The letter of intent is to be sent to Dr. Donna L. Vogel at the address listed
under INQUIRIES.

APPLICATION PROCEDURES

Prospective applicants are strongly encouraged to contact program staff at the
address listed under INQUIRIES early in the planning phase, to ensure that
applications are responsive to the goals of this initiative.

The research grant application form PHS 398 (rev. 5/95), "Research Career Award"
section, is to be used in applying for these grants.  These forms are available
at most institutional offices of sponsored research 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,
email: GrantsInfo@nih.gov.

The RFA label available in the PHS 398 application form must be affixed to the
bottom of the face page of the application.  Failure to use this label could
result in delayed processing of the application such that it may not reach the
review committee in time for review.  In addition, the RFA title, "WRHR Career
Development," and number must be typed on line 2 of the face page of the
application form and the YES box must be marked.  Human subjects and vertebrate
animals may be checked "no" with an explanation in the research plan that
appropriate assurances will be provided when the actual projects are known.

The application must address the following issues under the headings for the
Research Career Award table of contents:

Include all information requested under "Section I: Basic Administrative Data." 
Budget requests must be provided according to the instructions in form PHS 398. 
A composite page DD for the entire Center budget request should be followed by
one page for the Scholars' costs and one for Administration and Core laboratory
(if applicable).  Provide page EE for the composite only. The requests for
tuition and fees, books, travel, research development expenses, etc., must be
justified and specified by category.

"Section II: Specialized Information" should be modified as follows:

The section may begin with an overview of the proposed Center.  

(1) The Candidate:  Describe in general terms the pool of potential candidates
including information about the types of prior clinical and research training.
Do not name prospective Scholars. Describe the criteria to be used for candidate
evaluation for selection as WRHR Scholars.  Describe plans to recruit candidates,
including those from racial or ethnic groups that are currently underrepresented
in biomedical, behavioral, or clinical sciences.

(2) Statement by Sponsor: Summarize the immediate and long-term career objectives
of the Center, explaining how the Center will contribute to their attainment. 

 Describe the career development plans for prospective candidates.  Considering
the Center goals and the likely goals of prospective candidates, describe a plan
to provide the necessary research background and experiences, considering the
expected range of prior research training in the applicant pool.  For example,
candidates with little previous research experience may require a phased
developmental period in which the first phase of support under this program award
is comprised largely of didactic training in basic and/or clinical research
sciences.  For these candidates, a second phase would be an intensive, supervised
research experience to complete a longer developmental program.  More experienced
candidates may benefit from entering immediately into a mentored research
experience of at least two years supported by this Center award.  The application
should contain a description of how the career development plan will be tailored
to the needs of the prospective candidates, and should distinguish the plan from
fellowship training.

Describe the composition of the Advisory committee, identifying by name and role
the internal members, and the desired expertise (but not the name or affiliation)
of external members, if any. 

(3) Environment and Institutional Commitment to Candidate: Provide information
establishing the commitment of the applicant institution, the Principal
Investigator, and Program Director, if any, and the faculty mentors to providing
developmental experiences that lead to independence in biomedical, behavioral,
and/or clinical research relevant to women's health. Include the specifics of
cost-sharing. There is no dollar requirement, but significant input will be
considered a strength. Letters of commitment from faculty mentors are not
required unless they are collaborators from other institutions.

(4) Research Plan:  For each faculty member proposed as a potential mentor,
provide a paragraph on his or her research relevant to the goals expressed in
this RFA, that may be the foundation of a WRHR Scholar's research experience in
the Center.  The research experiences may include basic, translational, and/or
clinical science approaches to biomedical or behavioral problems in women's
reproductive health.  Lengthy, detailed protocols or plans for specific
experiments should not be included. No limits are specified for the number of
proposed mentors; however, fewer than six may not provide sufficient choice of
projects, while more than twenty-five may dilute the focus on women's
reproductive health.  List up to five current or former students or fellows the
faculty member has trained.

Applications must include plans for instruction in the responsible conduct of
research, including the rationale, subject matter, appropriateness, format,
frequency and duration of instruction; and the amount and nature of faculty
participation.  No award will be made if an application lacks this component.

Note:  Page limitations on research project grant applications, as stated in the
guidelines and instructions for PHS Form 398, do not apply to Center
applications, although applicants are encouraged to be concise.  Applicants
should ensure that all materials directly applicable to the above review criteria
are included in the body of the application, not in an appendix.

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, MSC 7910
BETHESDA MD  20892-7910
(BETHESDA MD  20817 for express/courier delivery)

At the time of submission, two additional copies of the application must also be
sent to:

Scott F. Andres, Ph.D.
Division of Scientific Review
National Institute of Child Health and Human Development 
6100 Executive Blvd. Room 5E01 MSC 7510
BETHESDA MD  20892-7510
(ROCKVILLE MD 20852 for express/courier delivery)

Applications must be received by January 22, 1999.  If an application is received
after that date, it will be returned to the applicant without review.  

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by the CSR and
responsiveness by the NICHD.  Incomplete and/or non-responsive applications will
be returned to the applicant without further consideration.  Applications that
are complete and responsive to the RFA will be evaluated for scientific and
technical merit by an appropriate peer review group convened by the NICHD in
accordance with the review criteria stated below.  As part of the initial merit
review, a process will be used by the initial review group in which applications
receive a written critique and undergo a process in which only those applications
deemed to have the highest scientific merit, generally the top half of the
applications under review, will be discussed, assigned a priority score, and
receive a second level review by the National Advisory Child Health and Human
Development Council.

Review Criteria

Program overall:  The probable impact of the Center award on enhancing the
capacity of the grantee institution to develop well-qualified new obstetrician-
gynecologist investigators, thus enhancing women's reproductive health research
locally and nationally.  This includes the experience of the Principal
Investigator/Program Director in preparing physician investigators for
independent research careers.

Candidates:

o  Availability of an adequate pool of potential candidates,

o  Plans to identify, recruit, and select candidates (including minorities and
women), with a commitment to research relevant to women's reproductive health,
and the potential to develop as independent researchers.

Career Development Plan:

o  Likelihood that the career development plan will contribute significantly to
the scientific development of the candidates;

o  Appropriateness of the content, the phasing, and the proposed duration of the
career development plan for achieving scientific independence for the prospective
candidates;

o  Consistency of the career development plan with prospective candidates' career
goals; and

o  Quality of the training in the responsible conduct of research. 

Research Plan:

o  Usefulness of the research plan as a vehicle for developing the research
skills as described in the career development plan;

o  Appropriateness of plans to comply with NIH policy on inclusion of women,
minorities and children.

Mentors:

o  Appropriateness of the faculty mentors' qualifications in the areas of
research relevant to this RFA; 

o  Quality and extent of the mentors' proposed roles in providing guidance and
advice to candidates; and

o  Previous experience of the mentors in fostering the development of
researchers.

Core laboratory, if applicable:

o  Nature and quality of the optional Core laboratory: technical merit,
scientific justification, evidence of cost-effectiveness, procedures for quality
control, allocation of resources among multiple users, qualifications of the Core
laboratory director and technical staff, and probable utility to the research
projects of the WRHR Scholars.

Environment 

o  Applicant institution's commitment to the Center's scientific development of
the WRHR Scholars, and assurances that the institution intends the program and
the supported WRHR Scholars to be an integral part of its research program,
including various forms of cost-sharing;

o  Adequacy of research facilities including availability of a General Clinical
Research Center, if applicable, and training opportunities, including
demonstration of the research base;

o  Quality of the environment for scientific and professional development,
including opportunities for faculty positions that emphasize research; and

o  Applicant institution's commitment to the appropriate balance of research and
clinical responsibilities, including guarantee of 75% protected time for
research.

Budget:

o  Justification of budget requests in relation to Center career development
goals and research aims.

AWARD CRITERIA

The anticipated date of award is July 1, 1999.  Second level review by the NACHHD
Council will be in June 1999.  Funding decisions will be made based on the merit
score assigned by the initial review group, the need for research personnel in
specific program areas, and the availability of funds.

INQUIRIES

Written, e-mail, 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:

Donna L. Vogel, M.D., Ph.D.
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
Email: dv1h@nih.gov

Direct inquiries regarding fiscal matters to:

Ms. Melinda Nelson
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A17 - MSC 7150
BETHESDA MD 20892-7510
Telephone: (301) 496-5481
Fax: (301) 402-0915
Email:  mn23z@nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No.
93.121.  Mentored Clinical Scientist Development Program Awards are made under
authorization of Title III, Section 301 of the Public Health Service Act (Public
Law 78-410, as amended by Public Law 99-158, 42 USC 241).  The Code of Federal
Regulations, Title 42 Part 52, and Title 45 part 74, are applicable to this
program.  This program is described in the Catalog of Federal Domestic Assistance
No. 93.121.  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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