COOPERATIVE MULTICENTER MATERNAL-FETAL MEDICINE UNITS NETWORK

Release Date:  April 3, 2000

RFA:  HD-00-009 (This RFA has been reissued, see RFA-HD-04-023)

National Institute of Child Health and Human Development

Letter of Intent Receipt Date:  April 21, 2000
Application Receipt Date:       July 11, 2000

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, prematurity, and medical problems 
of pregnancy.  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 
Maternal-Fetal Medicine network Units (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 13 to 15 clinical centers will be 
involved in the program.

HEALTHY PEOPLE 2010

The Public Health Service (PHS) is committed to achieving the health promotion 
and disease prevention objectives of  Healthy People 2010,  a PHS-led national 
activity for setting priority areas.  This Request for Applications (RFA), 
Cooperative Multicenter Maternal-Fetal Medicine Units Network, is related to 
the priority area of low birth weight.  Potential applicants may obtain 
 Healthy People 2010  at:  http://www.health.gov/healthypeople/.   

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

This RFA will use the National Institutes of Health (NIH) cooperative 
agreement (U10) award mechanism, an  assistance  mechanism (rather than an 
 acquisition  mechanism), in which substantial NIH scientific and/or 
programmatic involvement with the awardee is anticipated during 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 below under 
 Terms and Conditions of Award. 

FUNDS AVAILABLE

NICHD intends to commit approximately $6.4 million in total costs [Direct plus 
Facilities and Administrative (F&A) costs] in FY 2001 to fund 13 to 15 new 
and/or competing continuation grants in response to this RFA.  An applicant 
may request a project period of up to five years and a budget for direct costs 
of up to $325,000 per year, excluding F&A costs on consortium arrangements.  
Because the nature and scope of the research proposed may vary, it is 
anticipated that the size of the awards also will vary.  Although the 
financial plans of NICHD provide support for this program, awards pursuant to 
this RFA are contingent upon the availability of funds and the receipt of a 
sufficient number of meritorious applications.

RESEARCH OBJECTIVES

Background

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 has 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 from 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 in which to develop protocols for randomized 
clinical trials.  Trials were carried out on questions 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.

In the second grant period of the MFMU Network (1991-1996), clinical trials on 
stuck twins and varicella were performed.  During the third funding period 
(1996-2001), clinical trials were initiated on fetal fibronectin as a 
predictor for premature delivery, cervical ultrasound during pregnancy, 
antenatal magnesium, asthma during pregnancy, maternal and neonatal outcomes 
after cesarean section, and progesterone for the prevention of premature 
delivery

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 Coordinator 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 
collaborative research may encompass any area of maternal-fetal medicine.  
However, special interest is encouraged in developing strategies for the 
prevention of preterm birth, evaluation of the causes or treatments of medical 
complications during pregnancy, and in the evaluation of interventions used 
during pregnancy and childbirth.  The participating maternal-fetal medicine 
units (MFMUs), designated as  clinical centers,  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 
(funded through a separate RFA) will have primary responsibility for data 
management and analysis for Network research in collaboration with the 
Steering Committee.

The NICHD expects that ongoing clinical trials dealing with outcomes after 
cesarean section, progesterone for the prevention of premature delivery, 
antenatal magnesium, multiple doses of antenatal steroids, and factor V Leiden 
mutation probably will continue into the continuation grant period for 
existing centers.  New protocols may be developed before the start of the 
continuation.  Centers that join the Network in the next award period 
(beginning April 1, 2001) 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:  techniques to reduce the risk of preterm 
labor and birth, and the evaluation of interventions used in pregnancy and 
childbirth.

Guidance and Management Structures

The management of the MFMU Network includes three committees (the Steering 
Committee, Advisory Board, and Data Safety and Monitoring Committee) as 
described below in  Terms and Conditions of Award, under  Collaborative 
Responsibilities. 

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 and the NICHD.

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 
APPLICATION PROCEDURES/Application Instructions, below, for detailed 
application instructions):

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

The MFMU unit must have an established perinatal data system, preferably 
computerized, to collect and tabulate perinatal statistics.

A research nurse must be designated for the full-time nurse coordinator 
position.

To provide peer reviewers and NICHD an idea of the capabilities of 
investigators, all applicants must submit a  concept  protocol, briefly (two 
to three pages) summarizing a project that the applicant might submit to the 
Network for possible implementation at all Network centers.

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

Terms and Conditions of Award 

The following Terms and Conditions of Award 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 administrative and funding instrument used for this program will be the 
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 the 
performance of the activity.  Under the cooperative agreement, the NIH purpose 
is to support and/or stimulate the recipient’s activity by involvement in and 
otherwise working jointly with the award recipient in a partner role, but it 
is not to assume direction, prime responsibility, or a dominant role in the 
activity.  Consistent with this concept, the dominant role and prime 
responsibility for the activity resides with the awardee(s) for the project as 
a whole, although specific tasks and activities in carrying out the studies 
will be shared among the awardees and the (NICHD Program Coordinator, as 
described in these terms and conditions.   (The substantial programmatic 
involvement by the NICHD Program Coordinator is above and beyond the levels 
required for traditional program management and stewardship of awards.)

1. Awardee Rights and Responsibilities

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 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. 

The MFMU Network will retain custody of and have primary rights to the data 
developed under these awards, subject to Government rights of access 
consistent with current HHS, PHS, and NIH policies.

2. NICHD Staff Responsibilities

The role of the NICHD MFMU Program Coordinator 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.
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  Participation on the Steering Committee and all active subcommittees.

Traditional program management/stewardship responsibility for review and 
oversight of the cooperative agreement award will reside with the MFMU Program 
Official.  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  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 Board 
with the mutual consent of the Steering Committee.

3. Collaborative Responsibilities:

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

o  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.  Participating NICHD staff will include the 
Pregnancy and Perinatology Branch MFMU Program Coordinator and a 
representative from the Epidemiology and Biometry Research Program.  The MFMU 
Program Coordinator will be the only voting NICHD staff member of the Steering 
Committee.  A member of the NICHD Grants Management Branch advises the 
Steering Committee on funding matters.  An outside chairperson, who is not 
participating as a Principal Investigator, will be selected by the NICHD.

o  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 
data center Principal Investigator, and the MFMU Program Coordinator.  
Additional members will participate based on the need for specific expertise.

o  A Data Safety and Monitoring Committee (DSMC) will monitor the safety of 
ongoing clinical trials and advise on their conduct.  This committee 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.

4. Arbitration

Any disagreement that may arise on scientific/programmatic matters (within the 
scope of the award), between award recipients and the NICHD may be brought to 
arbitration.  An arbitration panel will be constituted, consisting of three 
members:  one selected by the Steering Committee (with the NICHD member not 
voting), or by the individual awardee in the event of an individual 
disagreement, a second member selected by NICHD, and the third member selected 
by the two previously selected members.  The decision of the arbitration panel 
will be binding. This special arbitration procedure in no way affects the 
awardee’s right to appeal an adverse action that is otherwise appealable in 
accordance with the PHS regulations at 42 CFR Part 50, Subpart D and HHS 
regulation at 45 CFR Part 16.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the NIH that women and members of minority groups and 
their 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 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,  published in the Federal Register of March 28, 1994 (FR 59-14508-
14513) and in the NIH Guide for Grants and Contracts, Volume 23, Number 11, 
March 18, 1994, and available at: 
http://grants.nih.gov/grants/guide/notice-files/not94-100.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,  published in the NIH Guide for Grants and 
Contracts, March 6, 1998, and available at:  
http://grants.nih.gov/grants/guide/notice-files/not98-024.html.

Investigators also may obtain copies of the policy from the program staff 
listed under INQUIRIES. 

LETTER OF INTENT

Prospective applicants are asked to submit a letter of intent that includes a 
descriptive title of the proposed research, the name, address, and telephone 
number of the Principal Investigator, the identities of other key personnel 
and participating institutions, and the number and title of this RFA.  
Although a letter of intent is required, is not binding, and does not enter 
into the review of a subsequent application, the information that it contains 
allows NICHD staff to estimate the potential review workload and plan the 
review.

The letter of intent is to be sent to Dr. Catherine Y. Spong at the address 
listed under INQUIRIES, below, by April 21, 2000.

URLs IN NIH GRANT APPLICATIONS OR APPENDICES

All applications and proposals for NIH funding must be self-contained within 
specified page limitations.  Unless otherwise specified in an NIH 
solicitation, Internet addresses (URLs) should not be used to provide 
information necessary to the review because reviewers are under no obligation 
to view the Internet sites.  Reviewers are cautioned that their anonymity may 
be compromised when they directly access an Internet site.

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 4/98) is to be used in 
applying for these grants.  These forms are available at most institutional 
offices of sponsored research, on the Internet at 
http://grants.nih.gov/grants/funding/phs398/phs398.html, and from the Division 
of Extramural Outreach and Information Resources, National Institutes of 
Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 
301-710-0267, E-mail: [email protected].

Application Instructions

The NICHD invites applications both from current members of the MFMU Network 
(competing renewal applications) and from prospective members (new 
applications).  Instructions accompanying the PHS 398 (rev. 4/98) are to be 
followed in completing these applications.  Applications should address the 
following items:

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 in detail during the current competitive 
segment (e.g., number of patients recruited to each study, subcommittee 
memberships and chairmanships)

New applicants should describe their recent participation in at least 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 as well as their experience in research design 
and implementation of collaborative clinical research (especially randomized 
clinical trials).  The approximate percentage time protected for research by 
the academic department should be specified. The Principal Investigator should 
be a practicing maternal-fetal medicine specialist.  Due to the demands and 
nature of the MFMU units, the identified Principal Investigator ideally should 
not have extensive departmental duties (e.g., as Department Chairman), rather 
he/she should be able to devote the required time to the development and 
implementation of the MFMU center. 

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 that 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 must be 
given of the proportions of various subgroups, including minorities, that have 
been eligible and actually have been randomized, in previous or current 
clinical trials (see also section on Inclusion of Women and Minorities).  In 
addition, centers with ongoing clinical trials should report those patients 
eligible for MFMU studies (not competing with institutional research).

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.
 
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 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.  All 
successful applicants must be willing to provide complete, accurate, and 
timely data to the MFMU.

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.

A description of the organization and service load of the Neonatal Intensive 
Care Unit at the institution, including the existing newborn follow-up program 
and its research activities, must be included.  If the institution submits 
applications in response to both the Neonatal Research Network RFA (HD-00-010) 
and the Maternal Fetal Medicine Unit RFA, the applicant must describe how the 
two research programs will be integrated.

8.  Proposed Protocol Concept (all applicants)

To provide peer reviewers and NICHD an idea of the capabilities of 
investigators, all applicants must submit a  concept  protocol, briefly (two 
to three pages) summarizing a project 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:

Strategies to prevent preterm birth.
Evaluation of the causes or treatments of medical complications during 
pregnancy.
Evaluation of interventions used during pregnancy and childbirth.

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.  In addition, the protocol should 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 providing letters to the Principal 
Investigator, and by citing evidence of past support. This institutional 
assurance to provide support should address areas such as fiscal 
administration, personnel management, space allocation, procurement, planning, 
and budgeting.

11.  Acceptance of Budgetary Mechanism (see also Budget Preparation below)

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 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 beyond what it might be otherwise.  
Capabilities in areas such as genetics, placental function, or clinical 
pharmacology are examples of relevant strengths that could be included.

Special administrative strengths also may be described.  For example, both 
competing and new applications may describe 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 requirements of this RFA must be met by such 
affiliated institutions. Another example of an administrative strength would 
be linkage with ongoing, specialized registries. Centers that propose to 
combine institutions or multiple sites must justify the proposed organization 
and provide a detailed logistical plan for cost-effective management.

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 that identifies the level of support should be included with the 
application.

C.  Budget Preparation

The instructions for budget requests provided with the research grant 
application form PHS 398 (rev 4/98) should be followed.  F&A costs will be 
awarded in the same manner as for research project grants (R01). 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 percent effort
Research Nurse Coordinator:  100 percent effort
Research Nurse:  100 percent effort
Data Entry Clerk:  50 percent effort
Supplies and Small Equipment (itemized and justified):  Not to Exceed $4,500
Travel (a total of 10 trips to Bethesda per Network team):  as appropriate
Other costs (itemized and individually justified):  Not to Exceed $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 centers will be based on individual 
protocols that will be funded through a capitation system.  Each MFMU Network 
center will be given base costs (listed above), in addition to a flat fee per 
patient successfully enrolled and completed.  For centers with GCRG funding, 
applicable capitation funds will be reduced relative to the amount of GCRC 
support. 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 of base salary and travel costs not to exceed three percent (the 
maximum amount available for equipment, supplies, and other costs will not 
increase).  Federal agencies shall use the negotiated rates for F&A costs in 
effect at the time of the initial award throughout each competitive segment of 
the project.  Award levels for sponsored agreements may not be adjusted in 
future years as a result of changes in negotiated rates.

Submission Instructions

The RFA label available in the PHS 398 (rev. 4/98) application form must be 
stapled to the bottom of the face page of the application and must display the 
RFA number HD-00-009.  A sample RFA label is available at 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.  Please note this is 
in the pdf format.  Failure to use this label could result in delayed 
processing of the application such that it may not reach the review committee 
in time for review.  In addition, the RFA title and number must be typed on 
line 2 of the face page of the application form and the YES box must be 
marked.

Submit a signed, typewritten original of the application, including the 
Checklist, and three signed photocopies, in one package to:

CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)

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

L.R. Stanford, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5E03, MSC 7510
Bethesda, MD  20892-7510
Rockville, MD 20852 (for express/courier service)
301-496-1485

Applications must be received by July 11, 2000.  If an application is received 
after that date, it will be returned to the applicant without review.  

The Center for Scientific Review (CSR) will not accept any application in 
response to this RFA that is essentially the same as one currently pending 
initial review, unless the applicant withdraws the pending application.  The 
CSR will not accept any application that is essentially the same as one 
already reviewed.  This does not preclude the submission of substantial 
revisions of applications already reviewed, but such applications must include 
an introduction addressing the previous critique.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by CSR and for 
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, all applications will receive a written critique and may undergo 
a process in which only those applications deemed to have the highest 
scientific merit will be discussed, assigned a priority score, and receive a 
second level review by the National Advisory Child Health and Human 
Development Council.

Review Criteria

o  Criteria for Evaluation of Concept Protocol

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  In 
their written comments, reviewers will be asked to discuss the following 
aspects of the application in order to judge the likelihood that the proposed 
research will have a substantial impact on the pursuit of these goals.  Each 
of these criteria will be addressed and considered in assigning the overall 
score, weighting them as appropriate for each application.  Note that the 
application does not need to be strong in all categories to be judged likely 
to have major scientific impact and thus deserve a high priority score.  For 
example, an investigator may propose to carry out important work that by its 
nature is not innovative, but is essential to move a field forward.

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

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

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

(4) Investigator:  Is the investigator appropriately trained and well suited 
to carry out this work?  Is the work proposed appropriate to the experience 
level of the Principal Investigator and other researchers (if any)?

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

o  Criteria for Evaluation of Overall Application

(1)  Qualifications, Experience, and Commitment of Key Personnel:

Scientific, clinical, and administrative abilities and academic productivity 
of the Principal Investigator and other team members,

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,

Commitment of staff time for the satisfactory conduct of the study,

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

(2)  Protocols and Procedures:

Quality of the unit’s participation in either (a) (new applicants) a 
randomized, clinical trial in the recent past, or (b) (current Network 
members) Network protocols during the current grant period,

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

Optional research strengths, as presented.

(3)  Facilities and Management

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

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

Optional administrative strengths, such as affiliations with other research 
units.

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

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

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

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

SCHEDULE

Letter of Intent Receipt Date:    April 21, 2000
Application Receipt Date:         July 11, 2000
Peer Review Date:                 October 2000
Council Review:                   January 2001
Earliest Anticipated Award Date:  April 1, 2001

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, as determined by peer review.  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:

Catherine Y. Spong, M.D.
Pregnancy and Perinatology Branch
Center for Research for Mothers and Children
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 4B03B, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 435-6894
FAX:  (301) 496-3790
E-mail:  [email protected] 

Direct inquiries regarding fiscal matters to:

Ms. Carolyn Kofa
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A17H, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 435-7006
FAX:  (301) 402-0915
E-mail:  [email protected] 

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No. 
93.865.  Awards are made under authorization of Sections 301 and 405 of the 
Public Health Service Act, as amended (42 USC 241 and 284) and administered 
under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 
74 and 92.  This program is not subject to the intergovernmental review 
requirements of Executive Order 12372 or Health Systems Agency review.

The PHS strongly encourages all grant 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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