Full Text HD-95-007

COOPERATIVE MULTICENTER MATERNAL-FETAL MEDICINE UNITS NETWORK

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

RFA:  HD-95-007

P.T. 34

Keywords: 
  Obstetrics - Gynecology 
  Pregnancy 
  Prenatal Factors 


National Institute of Child Health and Human Development

Letter of Intent Receipt Date:  April 1, 1995
Application Receipt Date:  June 16, 1995

PURPOSE

The National Institute of Child Health and Human Development (NICHD)
invites applications from investigators willing to participate with
the NICHD under a Cooperative Agreement (U10) in an ongoing
multicenter clinical program designed to investigate problems in
clinical obstetrics, particularly those related to prevention of low
birth weight.  The objective of this program is to facilitate
resolution of these problems by establishing a network of academic
centers that, by rigorous patient evaluation using common protocols,
can study the required numbers of patients and can provide answers
more rapidly than individual centers acting alone.

The NICHD program staff will assist the principal investigators of
the MFMUs and the Advisory Board in identifying research topics of
high priority, and in designing and implementing protocols
appropriate to the evaluation of optimum management in these areas.

It is anticipated that approximately 12 or 13 clinical centers will
be involved in the program.

HEALTHY PEOPLE 2000

The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2000,"
a PHS-led national activity for setting priority areas.  This Request
for Applications (RFA), Cooperative Multicenter Maternal-Fetal
Medicine Units Network, is related to the priority area of low birth
weight. Potential applicants may obtain a copy of "Healthy People
2000" (Full Report:  Stock No. 017-001-00474-0 or Summary Report:
Stock No. 017-001-00473-1) through the Superintendent of Documents,
Government Printing Office, Washington, DC 20402-9325 (telephone
202-783-3238).

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic non-profit organizations,
public and private.  Organizations should have academically-oriented
divisions of maternal-fetal medicine.  The need for continuous and
active communication among sites dictates that only institutions in
the United States are eligible to apply.  Racial/ethnic minority
individuals, women, and persons with disabilities are encouraged to
apply as principal investigators.

MECHANISM OF SUPPORT

The administrative and funding instrument to be used for this program
will be a cooperative agreement (U10), an "assistance" mechanism
(rather than an "acquisition" mechanism), in which substantial NIH
scientific and/or programmatic involvement with the awardee is
anticipated during performance of the activity.  Under the
cooperative agreement, the NIH purpose is to support and stimulate
the recipients' activity by involvement in the activity and otherwise
working jointly with the award recipients in a partner role, but it
is not to assume direction, prime responsibility, or a dominant role
in the activity.  Details of the responsibilities, relationships and
governance of the study to be funded under cooperative agreements are
discussed later in this document under the section "Terms of
Agreement."

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

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

At this time, the NICHD has not determined whether or how this
solicitation will be continued beyond the present RFA.

FUNDS AVAILABLE

It is anticipated that 12 or 13 awards for Clinical Sites will be
made, with an estimated total cost of $3,500,000 (including direct
and indirect costs) for the entire program in the first year.  Up to
nine competing continuation awards and at least three new awards are
expected.

RESEARCH OBJECTIVES

A.  Background

Modern obstetrical management, especially the management of high-risk
pregnancies, has in some instances adopted principles of care, and at
times employed pharmaceuticals and methodologies without rigorous use
of the controlled observation necessary for their objective
evaluation.  Often the development of this medical specialty (and
others as well) has been marked by the enthusiastic adoption of
concepts and procedures followed by their modification or
replacement, sometimes decades later, after extensive experience has
failed to support their usefulness or shown unexpected consequences.
Costs involved in instrument purchase and employment have often been
large, and uncertainties embedded in such obstetrical practices have
contributed at least partly to the rising incidence of cesarean
delivery.  Regional differences in practice have complicated the
field.

In an attempt to respond to the need for well-designed clinical
trials in maternal-fetal medicine, NICHD established a Network of
Maternal-Fetal Medicine Units in 1986.  Seven university units were
selected among respondents to an RFA.  The Network Steering
Committee, which consists of representatives from each clinical
center, NICHD staff, and data coordinating center staff, evaluated
several controversial issues for study.  It then selected certain
priority areas on which to develop protocols for randomized clinical
trials.  Trials were done on question of postterm pregnancy,
management of preterm labor, and prevention of preeclampsia.  A Data
Monitoring and Safety Committee also advises NICHD on research design
issues, data quality and analysis, and ethical and human subject
protection aspects of protocols.

During the second grant period of the MFMU Network (1991-1996),
clinical trials were initiated on preterm premature rupture of
membranes, prevention of preeclampsia in high-risk patients,
predictors of preterm birth, obstetric predictors of neonatal
survival, varicella in pregnancy, asthma in pregnancy, and bacterial
vaginosis in pregnancy.

The NICHD expects that ongoing clinical trials dealing with preterm
labor, asthma and bacterial vaginosis will probably continue into the
continuation grant period for existing centers.  Centers that might
join the Network in the next award period (beginning April 1, 1996)
may participate in the protocols ongoing at that time.

The NICHD intends to enable the Network to initiate new protocols
within the first year of the next award period.  The topics of these
protocols will be decided cooperatively by the Steering Committee
with advice from the Advisory Board.  Areas of interest include:
gestational diabetes mellitus, and techniques to reduce the risk of
preterm labor and birth.

B.  Objectives and Scope

There are a number of controversial issues in maternal-fetal medicine
that might be clarified by multicenter collaborative research.
Funded principal investigators will cooperate with the NICHD program
officer in identifying research topics of high priority and in
designing protocols appropriate to the evaluation of superior, or
even optimal management in these areas.  The participating
maternal-fetal medicine units (MFMUs) will be designated as "clinical
centers", and will recruit, assess and treat the subjects in the
clinical research of the Network, with each MFMU being supervised by
its respective principal investigator.  The data center will have
primary responsibility for data management and analysis for Network
research in collaboration with the Steering Committee.

C.  Guidance and Management Structures

The management of the MFMU Network includes three committees whose
functions are as follows:

1.  A Steering Committee will be responsible for protocol
development, assisted by the Advisory Board and the Data Safety and
Monitoring Committee.  The Steering Committee will have primary
responsibility for the conduct of protocols and the preparation of
publications.  The Steering Committee will be composed of all
principal investigators, one representative from the data center, and
three NICHD staff.  NICHD staff will comprise the Director of the
Center for Research for Mothers and Children (CRMC), an obstetrician
from the Pregnancy and Perinatology Branch (MFMU program officer),
and a representative from the Epidemiology and Biometry Research
Program.  The MFMU program officer will be the only voting NICHD
staff member of the Steering Committee.  An outside chairperson, who
is not participating as a principal investigator, will be selected by
the NICHD.

2.  An Advisory Board will advise the Steering Committee in the
identification and prioritization of topics for network research.
The Advisory Board, chosen by the NICHD with the advice of the
Steering Committee, will be composed of individuals with expertise in
clinical trials, biostatistics, epidemiology, perinatology, and
neonatology; the Chairperson of the Steering Committee; the Director
of the CRMC; and the MFMU program officer.  Additional members will
participate based on the need for specific expertise.

3.  A Data Safety and Monitoring Committee will monitor the safety of
ongoing clinical trials and advise on their conduct.  It will be
established by NICHD and will represent expertise in ethics, clinical
trial design, perinatology, neonatology, and basic science.

In addition, the Network has established Policies and Procedures that
govern its operations, including publications.  These documents are
under periodic review, and may be amended and supplemented at the
discretion of the Steering Committee.

SPECIAL REQUIREMENTS

The NICHD invites applications both from current members of the MFMU
Network (competing renewal applications) and from prospective members
(new applications).  Minimum requirements for applicants are as
follows (see also Review Criteria and Procedures, below):

A.  Requirements for Applicants

1.  Academic Productivity

Provide evidence of recent research productivity by the applicant
Clinical Center in previous or present clinical trials, especially of
a cooperative, multicenter nature.  Specifically, contributions in
key areas such as protocol design, patient recruitment, data analysis
and interpretation, and publication are important.

Applicants who are current MFMU Network members should describe their
participation in Network research during the current competitive
segment.

New applicants should describe their recent participation in one
randomized clinical trial, preferably of a multicenter nature.

2.  Maternal-Fetal Staffing

Physician staffing of the MFMU should include at least three
maternal-fetal medicine subspecialists, each of whom would be
available to take primary responsibility for one or more of the
Network protocols at the unit.  Provide complete descriptions of
their training and qualifications in both clinical care and research,
and their previous and current involvement in clinical research.
Specifically, the academic status and academic career development
pathways should be described.  The approximate percentage time
protected for research by the academic department should be
specified.

3.  Research Nurse Staffing

A research nurse must be designated for the full-time nurse
coordinator position.  Also, additional research nursing staff should
be available.  Provide descriptions of these individuals' training,
experience, and involvement in clinical research.

4.  Available Population

Applicant units must have at least 2,700 births per year currently in
the unit, with a minimum of 30 percent documented to be high risk
pregnancies.

Applicants that have numbers of births near the minimum or which have
experienced a decline in annual births in recent years, should
document efforts to maintain access to an adequate number of
obstetric patients for research purposes.

A large majority of patients with obstetric complications who deliver
in the MFMU must also receive prenatal care at the institution.

The patient population served by the MFMU must  be characterized by
demographics, obstetric parameters, and payment status.  Indications
be given of the proportions of various subgroups, including
minorities, that have been eligible, and have actually been
randomized, in previous or current clinical trials (see also section
on Inclusion of Women and Minorities).

5.  Strengths of the MFMU

A detailed description of the clinical attributes of the MFMU must be
provided.  This should include antenatal fetal testing, intrapartum
diagnosis, laboratory testing, and perinatal pathology.

Other institutional components related to the MFMU must also be
described.  In particular, the ambulatory facilities for prenatal and
postpartum care must be presented, including the established policies
and procedures for conducting clinical research in these facilities,
in both low risk and complicated pregnancies.  Also, the availability
of an institutional pharmacy capable of supporting clinical research
must be documented.

Describe whether, and how, MFMU policies and procedures may have been
modified, if necessary, to support clinical research in the past.

6.  Perinatal Data System

The MFMU unit must have an established perinatal data system,
preferably computerized, to collect and tabulate perinatal
statistics.  Applicants must provide a detailed description of the
variables collected, and the data quality and management activities.
The applicant must also illustrate how the system has been used
recently to plan and perform clinical research.

7.  Neonatal Intensive Care Unit

One or more neonatologists active in clinical research at the
institution must be designated.  Such individual(s) must commit to
serve as a consultant and possible collaborator in Network research.
The academic status and career development pathways of these
individuals must be described.

Describe the organization and service load of the NICU at the
institution, including the existing newborn follow-up program and its
research activities.

8.  Proposed Protocol Concept (new applicants only)

To provide peer reviewers and NICHD an idea of the capabilities of
investigators, only new applicants must submit a "concept", briefly
(2-3 pages) summarizing a protocol that the applicant might submit to
the Network for possible implementation at all Network centers.  The
proposed "concept" will serve as an indicator of the applicant's
ability to participate in the development and design of cooperative
protocols in the Network.  The "concept" or another design on the
same topic, may or may not actually be performed by the Network.  It
is anticipated that funded MFMU centers will be invited to submit the
"concepts" included in their applications to the Network Steering
Committee.

For purposes of this RFA only, the protocol "concept" must address
ONE of the following topics:

a.  Tocolytics to prevent preterm birth after initial successful
suppression of preterm labor.

b.  Morbidity associated with gestational diabetes mellitus.

c.  Antenatal steroids for preterm premature rupture of membranes
(PROM).

The "concept" should also demonstrate use of the applicant's
perinatal data system to estimate numbers of available patients
eligible for the protocol at the institution.  The "concept" should
also address relevant ethical issues and the appropriate inclusion of
minorities as subjects.

9.  Intent to Participate

There must be a clearly expressed intent to participate in a
cooperative manner with other MFMU units, the NICHD, and the data
center, in all aspects of Network research, as outlined in this RFA.

10.  Departmental and Institutional Commitments

The departmental and institutional commitments to collaborative
maternal-fetal research should be clearly documented by letters to
the Principal Investigator, and by citing evidence of past support.

11.  Acceptance of Budgetary Mechanism

Assurance of cooperation with the policy of capitation of research
costs for each individual protocol, in addition to a base budget,
should be provided from the department and from the institutional
office of sponsored research programs.

B.  Optional:  Special Strengths Available to The MFMU Unit

All applicants, both competing renewals and new, are also invited to
describe briefly any special research strengths of the MFMU that may
be relevant to Network research.  Such strengths would represent
state-of-the-art scientific capabilities that might be shared or made
available to the Network, to expand the scientific productivity of
the research, over what it might be otherwise.  For example,
capabilities in areas such as genetics, placental function, or
clinical pharmacology, are examples of relevant strengths that could
be included.

Special administrative strengths may also be described.  For example,
both competing and new applications may also present the availability
of potentially collaborating maternal-fetal medicine units in medical
centers with which affiliations have been developed by the applicant
institution for the purpose of clinical research.  The same
requirements (above) must be met by such affiliated institutions.
Another example of an administrative strength would be linkage with
ongoing, specialized registries.

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

C.  Budget Preparation

The instructions for budget requests provided with the research grant
application form (PHS 398) should be followed.  Indirect costs will
be awarded in the same manner as for research project grants (RO1).
Budgets will be reviewed on the basis of appropriateness for the work
proposed.  Allowable costs and policies governing the research grants
programs of the NIH will prevail.  In planning the budget section of
the application each applicant should submit budget estimates for all
years.

The first-year budget at the time of application will be limited to a
BASE BUDGET with maximum allowances as follows:

Principal Investigator 10% effort
Research Nurse Coordinator 100% effort
Data Entry Clerk 50% effort
Supplies and Small Equipment (itemized and justified) NTE $4,500
Travel (a total of 10 trips to Bethesda per Network team) as
appropriate
Other costs (itemized and individually justified) NTE $2,500

When an application has been favorably recommended and is being
considered for funding, the applicant will be required to complete
protocol budgets for those studies underway within the network.
These budgets will consist of specific protocol-related allowances
and will be capitated on the anticipated number of subjects to be
enrolled in the study at the applicant MFMU.

Ongoing annual budgets of MFMU Network members will be based on
individual protocols that will be funded through a capitation system.
Each MFMU Network member will be given base costs (listed above), in
addition to a flat fee per patient successfully enrolled and
completed.  The individual members will be required to project
patient enrollment for a specific protocol during a specified time
frame; continuation and level of funding will be based on actual
recruitment.

Future years' budgets should be limited to base budget costs, with an
annual increment not to exceed four percent.

Terms of Agreement

The funding mechanism to be used to assist the scientific community
in undertaking this system of clinical investigation will be a
Cooperative Agreement between the participating units and NICHD.  The
major difference between a Cooperative Agreement and a research grant
is that there will be substantial programmatic involvement of NICHD
staff above and beyond the levels required for traditional program
management of grants.  Specifically, the role of the NICHD
Maternal-Fetal Research network program officer will be to aid the
awardees and the Steering Committee in the following ways:

o  Assistance in the identification of important areas of study.

o  Assistance in the development of study protocols.

o  Assistance in the development and review of capitation-based
budgets, including the identification of study costs and special
institutional needs.

o  Assistance in the review and evaluation of each stage of the
program before subsequent stages are started, in conjunction with the
Steering Committee, and the Advisory Board.

o  Assistance in reporting results in the community of investigators
and health care recipients.

Programmatic responsibility for scientific review and oversight of
these Cooperative Agreements will reside with the MFMU Network
program official. This role will include the following:

o  Assurance of the scientific merit of the trials.  The NICHD
reserves the right to terminate support of a participating center if
technical performance requirements such as protocol compliance,
enrollment targets, or randomization of subjects are not met; if a
study reaches a major endpoint substantially before schedule; or, if
an ethical issue dictates premature termination.

o  Assistance in the efficient conduct of the trials, including
ongoing review of progress; possible redirection of activities to
improve performance and cooperation; and frequent communication with
other members of the Steering Committee.

o  Initiation of a decision to modify or terminate a study based on
the advice of the data center, Data Safety and Monitoring Committee,
and Advisory Committee with the mutual consent of the Steering
Committee.

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

o  Identification of priority issues for research.

o  Development and implementation of protocols.

o  Collection and transmission of accurate data in a timely manner.

o  Analysis of data and publication of results of the MFMU trials.

All parties will agree to accept the coordinating role of the group
and the participatory and cooperative nature of the group process.

The specific terms, conditions, and details of arbitration procedures
pertaining to the scope and nature of the interaction between NICHD
and the participating MFMUs will be incorporated into the Notice of
Grant Award.  These procedures will be in addition to the customary
programmatic and financial negotiations that occur in the
administration of grants; they will be invoked only when agreement
cannot be reached between the awardee and the MFMU program officer on
issues that may arise after the award.  In that event, an arbitration
panel will be formed consisting of one person selected by the
principal investigators, one person selected by the Chief of the
Pregnancy and Perinatology Branch, and a third person selected by
these two members.  The decision of the arbitration panel will be
binding.

Terms of Award of Cooperative Agreement are in addition to, and not
in lieu of, otherwise applicable OMB administrative guidelines, DHHS
grant administration regulations at 45 CFR Part 74 and other DHHS,
PHS, and NIH grant administration policies.  The NICHD review
procedure in no way affects the right of a recipient of a cooperative
agreement to appeal an adverse determination under the terms of PHS
regulations at 42 CFR Part 50, Subpart D, and DHHS regulations at 45
CFR Part 16.  Business management aspects of these awards will be
administered by the NICHD Office of Grants and Contracts in
accordance with DHHS, PHS, and NIH grant administration requirements.

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 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.  The new policy contains some
provisions that are substantially different from the 1990 policies.

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

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

LETTER OF INTENT

Prospective applicants are asked to submit, by April 1, 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 a subsequent application, the informtation that it contains allows
the 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. Donald McNellis at the
address listed under INQUIRIES.

APPLICATION PROCEDURES

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 and from the Office of
Grants Information, Division of Research Grants, National Institutes
of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892,
telephone 301-710-0267.

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, COOPERATIVE
MULTICENTER NETWORK OF MATERNAL-FETAL MEDICINE UNITS (MFMUs) HD-
95-007, 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 Institute of Health
6701 Rockledge Drive, Room 1040 - MSC 7710
Bethesda, MD  20893-7710
Bethesda, MD  20817 (for express mail)

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

Susan Streufert, Ph.D.
Division of Scientific Review
National Institute of Child Health and Human Development
Executive Building, Room 5E03F
6100 Executive Boulevard, MSC 7510
Bethesda, MD  20892-7510

Applications must be received by June 16, 1995.  If an application is
received after that date, it will be returned to the applicant
without review.  The Division of Research Grants (DRG) will not
accept any application in response to this RFA that is essentially
the same as one currently pending initial review, unless the
applicant withdraws the pending application.  The DRG will not accept
any application that is essentially the same as one already reviewed.
This does not preclude the submission of substantial revisions of
applications already reviewed, but such applications must include an
introduction addressing the previous critique.

Schedule

Letter of Intent Receipt Date:  April 1, 1995
Application Receipt Date:       June 15, 1995
NICHD Council Review:           January 1996
Earliest Award Date:            April 1, 1996

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by DRG
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 Division of Scientific
Review, 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 determined to be
non-competitive will be withdrawn from further consideration and the
Principal Investigator and the official signing for the applicant
organization will be notified.

Review Criteria

a.  Qualifications, Experience, and Commitment of Key Personnel.

o  Scientific, clinical, and administrative abilities and academic
productivity of the principal investigator and other team members;

o  Knowledge and experience in areas relevant to the conduct of
collaborative clinical research, especially randomized clinical
trials, in maternal-fetal medicine.  This should include specific
experience in research design;

o  Commitment of staff time for the satisfactory conduct of the
study;

o  Experience and qualifications of team members who would be
responsible for data quality and management activities.

b.  Protocols and Procedures

o  Quality of the unit's participation in either (1) (new applicants)
a randomized, clinical trial in the recent past, or (2) (current
Network members) Network protocols during the current grant period;

o  Willingness to work and cooperate with other MFMUs and the NICHD
in the manner summarized in this RFA;

o  Quality of the proposed "concept" protocol designed to be
undertaken by the Network (new applicants only);

o  Optional research strengths, as presented.

c.  Facilities and Management

o  Adequacy of administrative, clinical, and data organizational
management facilities as described in the minimum requirements;

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

o  optional administrative strengths, such as affiliations with other
research units.

d.  Budget - Appropriateness of the Proposed Budget

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

The initial review group will also examine the provisions for the
protection of human and animal subjects and the safety of the
research environment.

AWARD CRITERIA

Applications recommended by the NACHHD Council will be considered for
award based primarily on scientific and technical merit.  Program
balance, that is, the scope and variety of research strengths to
enable a successful collaborative program, will be considered.  Final
selection of Clinical Centers for funding may be partly based on the
need for diversity in the study population.  Availability of funds
may also determine the awards made.

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:

Donald McNellis, M.D.
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
FAX:  (301) 496-3790
Email:  mcnellid@hd01.nichd.nih.gov

Direct inquiries regarding fiscal matters to:

Ms. Mary Ellen Colvin
Office of Grants and Contracts
National Institute of Child Health and Human Development
Executive Building, Room 8A17G
6100 Executive Boulevard MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 496-1303
FAX:  (3010 402-0915
Email:  colvinm@hd01.nichd.nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic
Assistance No. 93.3, 93.865.  Awards are made under authorization of
the Public Health Service Act, Title IV, Part A (Public Law 78-410,
as amended by Public Law 99-158, 42 USC 241 and 285) and administered
under PHS grants policies and Federal Regulations 42 CFR 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 PHS strongly encourages all grant and contract recipients to
provide a smoke-free workplace and promote the non-use of all tobacco
products.  In addition, Public Law 103-227, the Pro-Children Act of
1994, prohibits smoking in certain facilities (or in some cases, any
portion of a facility) in which regular or routing education,
library, day care, health care or early childhood development
services are provided to children.  This is consistent with the phs
mission to protect and advance the physical and mental health of the
american people.

.

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