Full Text HD-95-006

COOPERATIVE MULTICENTER NEONATAL RESEARCH NETWORK

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

RFA:  HD-95-006

P.T. 34

Keywords: 
  0775013 
  Infants 
  Health Services Delivery 
  Clinical Medicine, General 


National Institute of Child Health and Human Development

Letter of Intent Receipt Date:  April 1, 1995
Application Receipt Date:  June 15, 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 the safety and
efficacy of treatment and management strategies to care for newborn
infants, particularly those related to management of low birth weight
infants.  The objective of this program is to facilitate evaluation
of these strategies 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 Neonatal Research Network and the Advisory Board in identifying
research topics of high priority, and in designing and implementing
protocols appropriate to the evaluation of optimal 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 Neonatal Research
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 neonatal 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 and
Conditions."

The total project period for an application 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
size of awards will vary also.

The number of 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
ten competing continuation awards and at least three new awards are
expected.

RESEARCH OBJECTIVES

A.  Background

Modern neonatology medicine has introduced a number of principles of
management and innovative methodologies without rigorous use of the
controlled observation necessary for their objective evaluation.  A
major problem has been the balance between assuring prompt
implementation of new technologies, procedures, treatments and drugs,
and adequate evaluation of their safety and efficacy.  Indeed,
because of the urgent demands of sick infants, care is often based on
limited knowledge of new modalities not subjected to critical studies
prior to introduction and use.  In a critically ill infant, an
innovative idea may be tried which, if the infant's condition
improves, may rapidly set a new trend, and become the standard of
care.  Therefore, the incorporation into the arsenal of therapies
frequently is based on limited experience, and their efficacy and/or
safety have not been evaluated scientifically.

In an attempt to respond to the need for well-designed clinical
trials in neonatal medicine, NICHD established a Neonatal Research
Network 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 center staff, evaluated several controversial issues for
study.  It then selected certain priority areas in which to develop
protocols for randomized clinical trials.  Protocols on the
prevention of sepsis, intraventricular hemorrhage, pulmonary
hypertension, surfactant administration, and outcome and resource
requirements for very low birthweight (VLBW) infants were initiated.
In addition, the Network established a generic data base of infants
less than 1500 grams at birth.  A Data Monitoring and Safety
Committee 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 Neonatal Research Network
(1991-1996), clinical trials were initiated on the prevention or
treatment of chronic lung disease, intraventricular hemorrhage,
retinopathy of prematurity, and persistent pulmonary hypertension.
Studies of VLBW maturity and postnatal growth, the sequelae of the
fetal drug exposure, and a standardized follow-up program were also
initiated.

The NICHD expects that the ongoing clinical trials dealing with the
prevention of intraventricular hemorrhage and retinopathy of
prematurity, the treatment of persistent pulmonary hypertension, and
the follow-up study will continue into the new grant period in
existing centers.  New protocols may be developed before the Network
is refunded.  Centers that 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 all
major areas of newborn pathophysiology: cerebral function, pulmonary
physiology, gastrointestinal function and nutrition, immunology, etc.
Also of interest are the evaluation of drugs in the newborn, the
rapid transfer of new technologies to neonatal medicine, strategies
to reduce the cost and preserve the quality of neonatal care, and
long-term outcome.

B.  Objectives and Scope

There are a number of controversial issues in neonatology 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 Neonatal Research
Network members will be designated as "Clinical Centers" which will
recruit, assess and treat subjects under the supervision of the
respective Clinical Center 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 Neonatal Research 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
two NICHD staff.  NICHD staff will comprise the Director of the
Center for Research for Mothers and Children (CRMC) and a
neonatologist from the Pregnancy and Perinatology Branch (Neonatal
Research Network program officer).  The Neonatal Research Network
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; and the
Director of the CRMC and the Neonatal Research Network 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 clinical trial
design and conduct, perinatology, neonatology, basic science, and
ethics.

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
Neonatal Research 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 Neonatal Research Network members should
describe their participation in Network research during the current
competitive segment in detail, i.e., studies in which they
participated, subcommittee memberships and chairman, percentage of
patients eligible for each study, and percentage of eligible patients
who were recruited for each study.

New applicants should describe their recent participation in at least
one randomized clinical trial and one observational study, preferably
of a multicenter nature, providing similar information to that
requested from current Network members.

2.  Neonatology Staffing

Participants must be based in a level III neonatal intensive care
unit that admits both inborn and outborn patients.  Physician
staffing of the Clinical Center should include at least four
full-time board-certified neonatologists. 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.  Available Population

Applicant Clinical Centers must have at least 500 admissions per year
currently in the unit.  No more than 30 percent of admissions should
be outborn.  Large perinatal centers will be given preference over
combined services composed of a small inborn unit and a
transfer/tertiary care service.

Applicants that have numbers of births near the minimum or have
experienced a recent decline in annual admissions, should describe
this decline and document efforts to maintain access to an adequate
number of neonatal patients for research purposes.

The patient population served by the Clinical Center should be
characterized by demographics, obstetric parameters, and payment
status.  Indications should 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).

4.  Maternal Fetal Medicine Unit

The Clinical Center should be located in an institution with a
perinatal program that delivers high-risk pregnancies and has one or
more perinatologists active in clinical research on staff.  A history
of cooperation between neonatology and obstetrics towards excellence
in clinical care, maintenance of a data base, and research
productivity should be documented.  An obstetrician at the
institution who has interest and experience in clinical research and
is willing to participate in the Neonatal Research Network should 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 such individual(s) must be
described.

The organization and service load of the Maternal Fetal Medicine
Units at the institution, including its research activities, must be
included.

5.  Facilities and Clinical Capabilities

The applicant Clinical Center should have a full range of pediatric
subspecialists, state-of-the-art facilities and clinical
capabilities, and excellent support staff.  The applicant Clinical
Center should include a detailed description of facilities,
equipment, and clinical capabilities; pediatric subspecialists and
support staff; specialty clinics; laboratory facilities; and imaging
capabilities.  The availability of an institutional pharmacy and
respiratory therapy program capable of supporting clinical research
should also be documented.

An established neonatal follow-up program with experience in
following patients and a designated facility must be in place.  The
professional staff should include a developmental pediatrician or
neonatologist with similar expertise.  Specialists available to
consult should include pediatric neurology, ophthalmology,
orthopedics, surgery; physical and/or occupational therapy; and
social services.  A system of ongoing follow-up data collection must
be documented, as well as established policies and procedures for
conducting clinical research in these facilities.

All applicants, both new and competing renewals, are also invited to
describe briefly any special research strengths 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.  For
example, an ongoing specialized registry or capabilities in areas
such as PET scanning, prenatal diagnosis, molecular biology, and
clinical pharmacology constitute some of the relevant strengths that
could be included.

Special administrative strengths may also be described.  For example,
both competing and new applications may present the availability of
potentially collaborating neonatal units in medical centers with
which affiliations have been developed by the applicant institution
for clinical research.  The same requirements (above) must be met by
such affiliated institutions.

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 should be included
with the application.

A description of whether, and how, policies and procedures may have
been modified to support neonatal clinical research in the past must
be provided.

6.  Perinatal Data System

The Clinical Center must have an established neonatal/perinatal data
system, preferably computerized, to collect and tabulate statistics.
Applicants must provide a detailed description of the variables
collected and the data quality and management activities.  The
applicant should also illustrate how the system has been used
recently to plan and perform clinical research.  All successful
applicants must be willing to provide complete, accurate, and timely
data to the Neonatal Research Network generic data base.

7.  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.

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" proposal,
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" may not actually
be performed by the Network, although it is anticipated that funded
Neonatal Research Network 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" should address
ONE of the following topics:

a.  Strategies to improve the neurologic outcome of VLBW infants
(including diagnosis and treatment of acute perinatal asphyxia).

b.  Treatments to reduce the risk of chronic lung disease.

c.  Strategies to reduce the cost while preserving the quality of
neonatal care.

The "concept" should also demonstrate use of the applicant's
perinatal data system to estimate numbers of available patients
eligible for the protocol at their 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 Neonatal Research Network Clinical
Centers, 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
neonatal/perinatal 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.  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 costs and
will be capitated on the anticipated number of subjects to be
enrolled in the study at the applicant Clinical Center.

Ongoing annual budgets of Neonatal Research Network members will be
based on individual protocols, which will be funded through a
capitation system.  Each Clinical Center will be given base costs
(listed above), in addition to a flat fee per patient successfully
enrolled and completed.  The principal investigator 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 Neonatal
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 review and oversight of these
Cooperative Agreements will reside with the Neonatal Research Network
program officer.  This role will include the following:

o  Assurance of the scientific merit of the trials, including the
option to withhold support of a participating center if technical
performance requirements such as protocol compliance, enrollment
targets, or randomization of subjects are not met.

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 common protocols.

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

o  Analysis of data and publication of results of the Neonatal
Research Network studies.

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 Neonatal Research Network units 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 on issues that may
arise after the award between the awardee and the Neonatal Research
Network program officer.  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 information 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. Linda L. Wright 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 301-435-0714.

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 NEONATAL RESEARCH NETWORK HD-95-006, 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 or courier service)

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 15, 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.

Criteria for Review of Applications:

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

o  Willingness to work and cooperate with other Neonatal Research
Network units 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

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

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.

AWARD CRITERIA

Applications recommended by the National Advisory Child Health and
Human Development 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 in 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:

Linda L. Wright, M.D.
Center for Research for Mothers and Children
National Institute of Child Health and Human Development
Executive Building, Room 4B03F
6100 Executive Boulevard, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 496-5575
FAX:  (301) 496-3790
Email:  WrightL@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:  (301) 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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