Full Text HD-95-009


NIH GUIDE, Volume 23, Number 45, December 23, 1994

RFA:  HD-95-009

P.T. 04

  Prenatal Factors 

National Institute of Child Health and Human Development

Letter of Intent Receipt Date:  January 13, 1995
Application Receipt Date:  March 22, 1995


The National Institute of Child Health and Human Development (NICHD)
invites applications from investigators to develop multidisciplinary
research efforts that will advance knowledge about diseases and
disorders of pregnancy and infancy with the aim of reducing infant
morbidity and mortality in rural populations.  The resulting grant
will be part of the Perinatal Emphasis Research Centers (PERC)
program.  These centers are intended for the support of hypothesis-
testing research efforts; they are not intended to support service or
demonstration projects.  PERCs are organized around problem/need
themes and are established where research can be coordinated with
existing programs of health care to ensure the rapid assimilation of
new scientific knowledge into health care delivery.  Active PERCs are
addressing issues in high-risk pregnancies (diabetes, hypertension),
prevention of prematurity, fetal hypoxia, intrauterine growth
retardation, and infant sleep physiology.  A PERC works closely with
NICHD in participating in the center network and in carrying out its
objectives in a manner consistent with NICHD goals and missions.


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), Perinatal Emphasis Research Centers, is
related to the priority area of maternal and infant health.
Potential applicants may obtain a copy of "Healthy People 2000" (Full
Report:  Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary
Report:  Stock No. 017-001-00473-1) through the Superintendent of
Documents, Government Printing Office, Washington, DC 20402-9325
(telephone 202-783-3238).


The need for continuous and active communication among centers
mandates that only institutions in the United States will be eligible
for participation.  Domestic, non-profit organizations and
institutions are eligible to apply.  Racial/ethnic minority
individuals, women, and persons with disabilities are encouraged to
apply as Principal Investigators.  As stated in the NICHD Center
Guidelines, the NICHD will not support more than one NICHD center
grant (P50) in a given department or specialty unit.


Grants will be awarded using the National Institutes of Health (NIH)
specialized research center grant (P50) mechanism.  Review of
applications and management of grants will be subject to applicable
policies for NIH research center (P50) grants.  The P50 is an
institutional award, made in the name of a principal investigator,
and awarded competitively.  It provides support for both research
projects and the core services used by those projects.


The estimated funds available for the first year of support will not
exceed $500,000 for direct costs and $750,000 total costs.  The
initial award will be made for a period of five years.  Budget
increments for subsequent years generally will be limited to
increases not to exceed four percent.  Budgets of applications will
be stringently reviewed within these guidelines.  It is expected that
one award will be made in response to this RFA in the area of rural
maternal/infant health.



A major goal of the Pregnancy and Perinatology (PP) Branch of the
Center for Research for Mothers and Children (CRMC) of the NICHD is
the prevention of diseases and disorders during pregnancy and
infancy.  Too many infants are born too soon, too small for their
gestational age, or with an abnormality in development initiated
prior to birth or shortly thereafter that causes immediate or delayed
abnormality in structure or function.  If all newborns were free of
defects and were mature enough to cope during the first month of
life, much of this nation's infant mortality and morbidity could be

This RFA invites applications for a research center to develop new
knowledge about diseases and disorders of pregnancy and infancy with
the aim of reducing infant morbidity and mortality in rural

Areas of Research Interest

By issuing this RFA, the CRMC is indicating its wish to encourage
investigator interest in developing multidisciplinary research
efforts that will advance knowledge in areas important to its mission
and specifically as it relates to health of mothers and infants in
rural areas.

A PERC grant is used to promote and support multidisciplinary
research efforts in areas where (a) knowledge gaps are not being
sufficiently addressed by ongoing research, or (b) there are needs to
stimulate and intensify efforts in promising research areas.
Research areas for PERC grants have been and will continue to be
identified by CRMC and PP in consultation with outside advisors.
Through the PERC programs for mothers and infants, NICHD has
undertaken concerted biomedical and behavioral research efforts
directed toward improving pregnancy outcome and ensuring infant
survival and well-being.  PERCs are located throughout the United
States and presently are addressing the issues listed in the PURPOSE
paragraph above.

In addition to the areas addressed in the current PERCs, which
continue to be of interest, it is recognized that other medical
problems need to be approached in the same multidisciplinary fashion.
Clinical studies may include etiologic mechanisms, improvement of
diagnostic techniques, and various aspects of prevention and
management.  All investigative approaches can be used from molecular
biology to cellular, organ or whole organism physiology, epidemiology
as well as clinical evaluations.  The PERC in rural health may
address, among other problems, distance to available medical
facilities and the effect on rates of preventable illnesses and
disease.  Supported research may be carried out in experimental
animals.  A minimum of one subproject must address issues in

Research interests include, but are not necessarily limited to, the

1.  High-Risk Pregnancies (e.g., diabetes, hypertension, drug abuse)
- Effects upon pregnancy, fetal development, and neonatal adaptation.

2.  Intrauterine Growth - All aspects that may contribute to the
regulation of fetal growth such as role of growth factors, hypoxia,
nutrients, hormones, infections; placental function; regulation of
maternal blood volume and uterine and umbilical blood flow;
methodology to assess fetal health and development.

3.  Initiation of Labor - Normal and abnormal mechanisms and outcomes
in term, preterm, and/or postterm births.

4.  Neonatal Disorders - Adaptation, response to external stimuli,
unique nutritional requirements, response to acute and chronic injury
(including asphyxia, ROP, BPD, NEC), remodeling and repair, immune
function and development.

5.  Perinatal epidemiology and clinical research addressing the
special needs of rural populations.  Overall goals are similar to the
ones stated above; developing and testing interventions to reduce
infant mortality, low birth weight, intrauterine growth retardation,
and preterm delivery as they apply to stable and statewide rural


The PERC program holds an annual meeting of the Principal
Investigators to assess progress.  A budget request must be included
in the application for this purpose.


It is the policy of 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 are provided that
inclusion is inappropriate with respect to the health of the subjects
or the purpose of the research.  This new policy results from the NIH
Revitalization Act of 1993 (Section 492B of Public Law 103-43) and
supersedes and strengthens the previous policies (Concerning the
Inclusion of Women in Study Populations, and Concerning the Inclusion
of Minorities in Study Populations), which have been in effect since
1990.  These new policy contains some provisions that are
substantially different from the 1990 policies.

All investigators proposing research involving human subjects should
read the "NIH Guidelines For Inclusion of Women and Minorities as
subjects in Clinical Research," which have been published in the
Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted
in the NIH Guide for Grants and Contracts, Volume 23, Number 11,
March 18, 1994.

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


Prospective applicants are asked to submit, by January 13, 1995, a
letter of intent that includes a descriptive title of the proposed
research; the name, address, and telephone number of the Principal
Investigator; the identities of other key personnel and participating
institutions; and the number and title of the RFA in response to
which the application may be submitted.  Although a letter of intent
is not required, is not binding, and does not enter into the review
of subsequent applications, the information that it contains allows
NICHD staff to estimate the potential review workload and to avoid
conflict of interest in the review.

The letter of intent is to be sent to Dr. Charlotte Catz at the
address listed under INQUIRIES.


The research grant application form PHS 398 (rev. 9/91) is to be used
in applying for these grants.  These forms are available at most
institutional offices of sponsored research; from the Office of
Grants Information, Division of Research Grants, National Institutes
of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892,
telephone 301-710-0267; and from the program administrator listed

Detailed guidelines are found in "NICHD Research Center Programs" P50
Specialized Research Center guidelines (hereafter called NICHD Center
Guidelines).  The guidelines include the following restrictions:  (1)
a five-year total program funding period, (2) at least three projects
at all times, and (3) each core serving as a resource for at least
three projects at all times.  The NICHD Center Guidelines may be
obtained from Dr. Charlotte Catz at the address listed under

The RFA label available in the PHS 398 (rev. 9/91) application form
must be affixed to the bottom of the face page of the application.
Failure to use this label could result in delayed processing of the
application such that it may not reach the review committee in time
for review.  In addition, the RFA title and number must be typed on
line 2a 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:

Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**

At the time of submission, two additional copies of the application
and any appendix material must be sent to:

Susan Streufert, Ph.D.
Division of Scientific Review
National Institute of Child Health and Human Development
Executive Building, Room 5E03F
6100 Executive Boulevard, MSC 7510
Rockville, MD  20852-7510
Telephone:  (301) 496-1485
Email:  StreufeS@HD01.NICHD.NIH.GOV

Applications must be received by March 22, 1995.  If an application
is received after that date, it will be returned to the applicant
without review.  The Division of Research Grants (DRG) will not
accept any application in response to this RFA that is essentially
the same as one currently pending initial review, unless the
applicant withdraws the pending application.  The DRG will not accept
any application that is essentially the same as one already reviewed.
This does not preclude the submission of substantial revisions of
applications already reviewed, but such applications must include an
introduction addressing the previous critique.


Upon receipt, applications will be reviewed for completeness by DRG
and responsiveness by the NICHD.  Incomplete or nonresponsive
applications will be returned to the applicant without further

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 (triage) may be used by the initial review group in which
applications will be determined to be competitive or noncompetitive
based on their scientific merit relative to other applications
received in response to the RFA. Applications judged to be
competitive will be discussed and be assigned a priority score.
Applications judged to be noncompetitive will be withdrawn from
further consideration and the Principal Investigator and the official
signing for the applicant organization will be notified.  Review
procedures and criteria are detailed in the P50 Specialized Research
Center Grant Guidelines.  Applications will be reviewed under the
criteria indicated below:

1.  Significance of the proposed research program to the CRMC
perinatal research mission.

2.  Scope and breadth of the center's program, the component research
projects, and core units.

3.  Suitability of the program's central theme for a cooperative
research effort.

4.  Multidisciplinary scope of the program and provisions for
coordinating the research projects and core units.

5.  Leadership and scientific stature of the program director and
his/her ability to meet the program's demands of time and effort.

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

7.  Academic and physical environment as it bears on patients, space,
and equipment, and on the potential for interaction with scientists
from other departments and institutions.

8.  Arrangements for internal quality control of ongoing research,
the allocation of funds, day-to-day management, contractual
agreements, and internal communication and cooperation among the
investigators in the program.

9.  Presence of an administrative and organizational structure
conducive to attaining the objectives of the proposed program.  The
existence of an external advisory board and a description of its
function are necessary.

The review of the projects and core units will consider:

1.  Scientific merit of each project and the relation of the project
to the central theme of the overall program (a simple compilation of
several R01-type projects loosely related will not be acceptable).

2.  Technical merit, cost effectiveness, and quality control of each
core unit (each core must be used by at least three research

3.  The appropriateness of the research projects' use of core

4.  Qualifications, experience, and commitment of the investigators
responsible for the research projects or core units and their ability
to devote the required time and effort to the program.

5.  Appropriateness of budgetary requests.

6.  The adequacy of the means proposed for protecting against risks
to human subjects, animals, and/or environment.

7.  Participation of a suitable number of responsible, experienced

8.  Institutional commitment to the requirements of the program.


Applications will be considered for award on the basis of their
scientific and technical merit, as determined by peer review, and
upon allocation of appropriated funds for this purpose.  Furthermore,
the NICHD will not support more than one NICHD center grant (P50) in
a given department or specialty unit. The anticipated award date is
September 1995.


Inquiries regarding this RFA are encouraged.  The staff welcomes the
opportunity to clarify any issues or questions from potential

Direct inquiries regarding programmatic issues, requests for the
program guidelines, and address the letter of intent to:

Dr. Charlotte Catz
Center for Research for Mothers and Children
National Institute of Child Health and Human Development
Executive Building, Room 4B03
6100 Executive Boulevard, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 496-5575
Email:  CatzC@HD01.NICHD.NIH.GOV

Direct inquiries regarding budgetary issues to:

Mr. Douglas Shawver
Office of Grants and Contracts
National Institute of Child Health and Human Development
Executive Building, Room 8A17F
6100 Executive Boulevard MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 496-1303
Email:  ShawverD@HD.NICHD.NIH.GOV


This program is described in the catalog of Federal Domestic
Assistance No. 93.865, Research for Mothers and Children.  Awards
will be made under the authority of the Public Health Service Act,
Sections 1004, 301 and 444, and administered under PHS grant policies
and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74.  This
program is not subject to the intergovernmental review requirements
of Executive Order 12372 or Health Systems Agency review.

The Public Health Service (PHS) strongly encourages all grant
recipients to provide a smoke free workplace and promote the non use
of all tobacco products.  This is consistent with the PHS mission to
protect in advance the physical and mental health of the American


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