Full Text HD-97-009
 
DATA COORDINATING CENTER for the MATERNAL-FETAL RESEARCH NETWORK
 
NIH GUIDE, Volume 26, Number 23, July 18, 1997
 
RFA:  HD-97-009
 
P.T. 34

Keywords: 
  Data Management/Analysis+ 
  Clinical Trial 

 
National Institute of Child Health and Human Development
 
Letter of Intent Receipt Date:  August 1, 1997
Application Receipt Date:  September 19, 1997
 
PURPOSE
 
The National Institute of Child Health and Human Development (NICHD)
has a strong and ongoing interest in clinical research in
maternal-fetal medicine, as exemplified by its establishment of the
Maternal-Fetal Medicine Units (MFMU) Network in 1986.  Support of the
Network has continued until the present time, with recompetition of
the clinical centers in 1991 and again in 1996.  Currently, the
Network consists of 13 clinical centers, a single data coordinating
center independent of any of the clinical centers, and NICHD.  The
Network Data Coordinating Center (DCC) is also supported with a
cooperative agreement.  The incumbent grantee has served the Network
since its inception.  The Center provides statistical consultation,
data management, and data analysis, in addition to various logistical
services required in the multi-center research program of the
Network.
 
The current competitive segment for the DCC ends March 31, 1998.  The
NICHD intends to continue support of the DCC for five years to permit
completion of ongoing studies and initiation of several new
randomized clinical trials and other studies in obstetrics.  NICHD
does not intend to limit the competition to the incumbent grant for
the DCC, but to invite other applications as well.
 
Therefore, the Pregnancy and Perinatology Branch, Center for Research
for Mothers and Children, NICHD, invites submissions of applications
for the DCC.
 
HEALTHY PEOPLE 2000
 
The Public Health Service is committed to achieving the health
promotion and disease prevention objectives of Healthy People 2000, a
PHS-led national activity.  This Request for Applications (RFA), Data
Coordinating Center for MFMU Network, is related to the priority area
of Maternal and Infant Health.  Potential applicants may obtain a
copy of Healthy People 2000" (Full Report:  Stock No.
017-001-00474-0) or Healthy People 2000" (Summary Report: Stock No.
017-001-00473) through the Superintendent of Documents, Government
Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238).
 
ELIGIBILITY REQUIREMENTS
 
Applications may be submitted by domestic organizations, public and
private, such as universities, colleges, hospitals, laboratories,
units of State and local governments, and eligible agencies of the
Federal government.  Racial/ethnic minority individuals, women, and
persons with disabilities are encouraged to apply as Principal
Investigators.  Organizations should have experience in functioning
as a statistical coordinating center for multi-center research,
including randomized controlled trials and observational studies of
both a medical (preferable neonatal and perinatal) and a
psychological nature.  The need for continuous and active
communication among sites and with the NICHD dictates that only U.S.
institutions with a branch or central office in the Washington, DC
metropolitan area are eligible to apply.
 
MECHANISM OF SUPPORT
 
The administrative and funding instrument to be used for this program
will be a cooperative agreement (U01), 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 partnership role.
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 of Award.
 
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, 1998.  NICHD intends that the ongoing Cooperative
Agreements will be recompeted every five years, depending on
available funds.
 
FUNDS AVAILABLE
 
It is anticipated that one award for a Data Center will be made, with
an estimated total cost of $2 million (including direct and
facilities and administrative costs) in the first year.  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.
 
RESEARCH OBJECTIVES
 
A. Background
 
In 1986, the National Institute of Child Health and Human Development
(NICHD) established an administrative framework to conduct
multicenter randomized controlled trials (RCTs) and other prospective
clinical studies in obstetrics.  The Maternal-Fetal Medicine Units
(MFMU) Network originally included seven MFMU divisions at leading
U.S. research universities, and was expanded in 1991 to encompass 11
centers.  NICHD is closely involved in the selection of research
topics, in the study designs, in analysis of data, and also provides
funding for the Network.  Finally, in 1996, another re-competition
enlarged the Network further to 13 centers representing about 70,000
births per year.
 
A major reason for establishing the Network was the persistence of a
relatively high rate of low birth weight infants in this country.
Premature and growth-restricted infants account for a
disproportionately large share of infant morbidity and mortality, and
subsequent developmental problems, such as cerebral palsy.  The
improvement in infant survival rates in the U.S. in recent years is
largely attributed to increasingly effective neonatal intensive care
of low birth weight infants.  Thus, further progress in perinatal
health will depend on the prevention of low birth weight.  The
primary purpose of the Network is to promote research emphasizing
such prevention.
 
The second factor leading to the establishment of the Network was the
growing recognition that modern obstetrical management-especially of
high-risk pregnancies-has sometimes utilized treatments that have not
been adequately tested for efficacy.  Like most other medical
specialties, maternal-fetal medicine has enthusiastically adopted
certain managements, only to have to modify or replace them after
extensive clinical experience has failed to confirm their promise.
Thus, another purpose of the Network was to foster research that
would provide better scientific evidence on which to base obstetric
practice, particularly before widespread application of new
approaches.
 
Currently, the Network is conducting several randomized trials and
observational studies relating to preterm birth prevention and
high-risk obstetrics.
 
B. Objectives
 
The awardee is expected to cooperate with the clinical investigators
at the 13 Network Clinical Centers, and with the Program Officer and
other participating staff at the NICHD, in the design, and conduct of
protocols, analysis of data, and reporting of results from Network
research. Systems for data collection, analysis, coordination, and
quality assurance are essential.  Required data summaries will be
provided to the Network Steering Committee, NICHD, the Data
Monitoring and Safety Committee, and others as determined by the
Steering Committee.  Logistical services for providing study drugs,
collected biological fluids, and other supplies for the conduct of
studies will also be provided.
 
Content of Application
 
The application should have (1) an introduction, either (2a) a
progress report (current DCC grantee only) or,(2b) a description of
relevant capabilities and experience (other applicants) and (3a) or
(3b) a research plan for the next competitive segment.  The progress
report/description and the research plan must incorporate the
following minimum requirements.
 
(1) Minimum Requirements for the Data Coordinating Center
 
o  Staff must be prepared to cooperate effectively in all Network
functions with NICHD and the clinical centers.
 
o  The Centers primary offices must be located in the Washington, DC
metropolitan area.
 
o  The Center must demonstrate prior experience as a data
coordinating center in multicenter studies in obstetrics during the
previous five years.
 
o  The Principal Investigator, and other staff, must have appropriate
expertise and capability in biostatistics, data management, data
analysis, and project management.
 
o  The Principal Investigator must possess a doctoral degree and be
willing to be committed to at least 85% time on Network activities.
 
o  The Center must have the ability to assist in designing protocols,
data collection forms, study manuals, and data collection systems,
including distributed data entry.
 
o  The Center must have experience in developing and maintaining data
quality control systems.
 
o  The Center should have the capability to generate monthly reports
on subject enrollment in several concurrent studies; quarterly
reports on enrollment and clinical center performance; appropriate
reports for the use of the Network Data and Safety Monitoring
Committee once or twice yearly; and special reports as may be needed
below.
 
o  The Center must demonstrate successful experience in assisting
clinical investigators prepare manuscripts on multicenter research
for publication.
 
o  The Center must have experience arranging logistical services for
multicenter clinical trials, such as assuring appropriately prepared
and labeled supplies of study medications for the clinical centers.
 
o  The Center must provide evidence of its management capability (a)
to estimate appropriate and reasonable resources needed for
individual projects in its role as a Data Coordinating Center of
multicenter trials, (b) to manage those resources efficiently during
the research, (c) to adjust the assigned resources as the work
changes qualitatively and quantitatively during the research, (d) to
report these resource allocations to NICHD periodically, and (e) to
sub-contract with outside organizations to supplement its own
resources, as needed.
 
(2a)Progress Report (incumbent center only)
 
o  Describe how the DCC has cooperated effectively in all MFMU
Network functions with the NICHD and the clinical centers.
 
o  Describe the DCC facility and how it has been used for MFMU
Network functions.
 
o  Describe how staff strengths in biostatistics, data management,
data analysis, and project management have been used in MFMU Network
activities.
 
o  Describe the commitment of the Principal Investigator during the
previous grant period.
 
o  Describe processes used by the DCC in assisting protocol design,
data forms preparation, manual preparation, and in data collection
for the Networks.
 
o  Describe the performance of the DCC in data quality control for
the Network.
 
o  Describe the record of the DCC in generating data and performance
reports on Network clinical center activities.
 
o  Describe the contributions of the DCC in preparing manuscripts
from MFMU Network studies.
 
o  Describe how logistical services have been arranged by the DCC for
MFMU Network protocols.
 
o  Describe the organizational systems used to assign and adjust its
resources to specific protocols conducted by the MFMU Network during
the previous grant period.
 
o  Illustrate the calculation of costs of all DCC work contributed to
the performance of one specific protocol conducted by the MFMU
Network during the previous grant period, namely, the Preterm
Premature Rupture of Membranes randomized clinical trial.
 
(2b) Description of Capabilities and Experience (new applicants only)
 
o  Describe the DCC applicants previous successful collaboration in
multicenter research in obstetrics within the last five years.
 
o  Describe the applicants facility and how it has been used for
multicenter clinical research.
 
o  Describe how DCC staff strengths in biostatistics, data
management, data analysis, and project management have been used in
multicenter clinical research.
 
o  Describe the extent of commitment of the DCC Principal
Investigator in previous multicenter clinical research.
 
o  Describe the processes used by the DCC applicant in assisting
protocol design, forms and manual preparation, and in data collection
for previous multicenter clinical research.
 
o  Describe the performance of the DCC applicant in data quality
control in previous multicenter clinical research.
 
o  Present the DCC applicants record in generating reports on data
and performance of clinical center activities in previous multicenter
clinical research.
 
o  Summarize the DCC applicants contributions in preparing
manuscripts from previous multicenter clinical research.
 
o  Describe how logistical services have been arranged by the DCC
applicant in previous multicenter clinical research.
 
o  Describe the organizational systems used by the DCC applicant to
assign and adjust its resources to participate in multicenter
clinical research.
 
o  Illustrate the calculation of costs of all the DCC applicants work
contributed to the performance of one specific clinical protocol
conducted in a multicenter setting during the past five years.  The
sample size and quantity of data accumulated and analyzed should be
specified.
 
(3a) Research Plan for the Next Applicant Competitive Segment for the
Incumbent
 
o  Statement of intent to collaborate in a manner consistent with the
terms of award.
 
o  Plans and estimated timetables for all ongoing and planned
(include BEAM, progesterone and terbutaline) MFMU Network protocols
to be completed, the data analyzed, the results published, and the
data archived.
 
o  Plans for staff allocation to meet the demands of the plans and
timetables in above.
 
o  Describe any planned modifications in the DCC processes to be used
in protocol design, data forms preparation, data collection, data
quality control, reports generation, manuscript preparation, and
provision of logistical services for MFMU Network protocols.
 
o  Describe any planned modifications in the organizational systems
to assign and adjust resource allocation during protocol performance.
This should include any potential for outsourcing to meet short-term
needs.
 
o  Describe new procedures to increase DCC operational efficiency and
to decrease cost.
 
o  Assume that three new protocols, including two randomized clinical
trials and one observational study, were planned but not yet
implemented by the Network Data Center applicant.  Assume, however,
for this exercise that the three studies plan to collect data on 1500
items and 500 items for the randomized trials, respectively, and on
300 and 800 items from the observational study during the first year
(assume no actual data collection).  Assume that the proportion of
distributed data entry for the two randomized trials is 90% and 30%,
respectively, and 100 and 50% for the observational study.  Using
these assumptions, estimate the minimal base costs associated with
providing professional and support staffing, and with the
preparations necessary to receive and process data from the four
studies during the first year.
 
o  Describe the method to be used by the applicant in calculating all
operational costs per protocol and per enrolled patient for all DCC
functions.
 
o  Describe in general terms a contingency plan to transfer all DCC
functions for one or more active protocols from the incumbent to
another DCC entity which may be successful in the competition.  This
contingency plan should address the feasibility of transferring
specific protocols at various stages of development, including
design, enrollment, and analysis.
 
(3b) Research Plan for the Next Competitive Segment for Other
(Non-Incumbent) Applicants
 
o  Describe the applicants perception of its potential role in the
MFMU Network.
 
o  Provide a statement of intent to collaborate in a manner
consistent with the terms of award.
 
o  Propose an operational structure for providing and coordinating
all DCC functions for several Network protocols simultaneously.  This
should include lines of responsibility/authority for professional
staff.
 
o  Description of any modifications in the applicants current
processes used to provide DCC functions that may be made if the
applicant were to be selected as the Network DCC.
 
o  Propose an idealized staffing pattern for providing DCC functions
from protocol design through analysis.  This should include
provisions for adjusting staff time commitments during the life of a
study.
 
o  Propose an administrative and management structure that would
support and enhance the operational structure.
 
o  Propose administrative and management functions that would assure
continuing attention to cost-efficiency and productivity.  This
should include adjustment of resource allocation during protocol
performance and the potential for outsourcing to meet short-term
needs.
 
o  Propose methods to be used to assure effective communication
between DCC staff and other components of the MFMU Network, including
NICHD and the 13 Clinical Centers.
 
o  Describe in general terms, a contingency plan to accept all DCC
responsibility and functions for one or more ongoing Network
protocols that might be transferred from the incumbent DCC.  This
plan should address the feasibility of protocol transfer at various
stages of development, including design, enrollment, and analysis.
 
o  Assume that three new protocols, including two randomized clinical
trials and one observational study, were planned but not yet
implemented by the Network Data Center applicant.  Assume, however,
for this exercise that the three studies plan to collect data on 1500
items and 500 items for the randomized trials, respectively, and on
300 and 800 items from the observational study during the first year
(assume no actual data collection).  Assume that the proportion of
distributed data entry for the two randomized trials is 90% and 30%,
respectively, and 100 and 50% for the observational study.  Using
these assumptions, estimate the minimal base costs associated with
providing professional and support staffing, and with the
preparations necessary to receive and process data from the four
studies during the first year.
 
o  Describe the method to be used by the applicant in calculating all
operational costs per protocol and per enrolled patient for all DCC
functions.
 
C. Reference Material
 
Information about protocols, their manual of operations, and about
characteristics of the data sets of the several studies will be
provided by NICHD staff at an open meeting to be held in Bethesda,
Maryland on August 4, 1997.  All interested applicants are invited to
attend at their own expense.  Details about the meeting will be
provided by the scientific project officer listed under INQUIRIES.
 
Budget Preparation
 
The instructions for budget requests provided with the Research Grant
application form (PHS 398) should be followed.  Facilities and
administrative costs will be awarded in the same manner as for
research project grants. 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 requests for all years.
 
Ongoing annual budgets of the Data Center will consist of base costs
(see Appendix I), in addition to a capitation fee.  At such time as
an application has been favorably recommended and is being considered
for funding, the Data Center will be required to complete a protocol
budget reflecting specific protocol-related costs to be based on the
number of patients to be recruited to the protocol and the actual
time and effort expended.  Capitation awards will be made before
implementation and will be revised based on actual recruitment and
management costs.  Funding for extended analyses will be limited and
must be justified on a protocol-by-protocol basis, based on actual
time required for analyses.  Biostatistical staff with advanced
degrees must be justified.
 
Future years budgets should be limited to base budget costs, with an
annual increment not to exceed three percent.
 
SPECIAL REQUIREMENTS
 
The NICHD has established the MFMU Network in order to conduct
clinically important research that requires a multicenter setting.
The Network consists currently of 13 clinical centers with central
data coordination and analysis.  Both the clinical centers and the
data coordinating center are supported by cooperative agreements,
which are assistance mechanisms that have substantial involvement of
NICHD program staff, beyond the level usually required for program
management of research grants.
 
1.  All components of the Network agree to accept the collaborative
and participatory nature of the Network concept.
 
2.  The Network Steering Committee, consisting of an outside
Chairperson, MFMU Network Program Officer, Data Coordinating Center
Principal Investigator, and Clinical Center Principal Investigators,
instigate and oversee all Network research. A staff member of the
Grants Management Branch, NICHD, serves in an advisory capacity to
the Committee.
 
a. The functions of the Steering Committee are as follows:
 
o  Identify study topics, considering the relevant research
questions, and available resources.
 
o  Protocol development, with delegation to protocol subcommittees.
 
o  Timely reporting of data.
 
o  Analysis and interpretation of data in conjunction with the DCC.
 
o  Participation in decision to modify or terminate a study based on
the advice of the Data and Safety Monitoring Committee, and the
NICHD.
 
o  Reporting of results via preparation of abstracts, manuscripts for
publication, and presentation at meetings.
 
3.  The NICHD staff member(s) on the Steering Committee will be
involved as follows:
 
o  Assist with the development of the study protocols.
 
o  Provide technical information for the development and review of
the capitation-based budgets by the Pregnancy and Perinatology Branch
Chief, including the identification of study costs and special
institutional needs.
 
o  In conjunction with the Principal Investigators, review and
comment on each stage of the program before subsequent stages are
started, including the options of modification, or termination by
mutual agreement.
 
o  Collaborate in analysis and reporting of results to the community
at large.
 
a. The NICHD staff member on the Steering Committee will also be
responsible for monitoring, using consultants, as appropriate, the
data management and quality assurance systems of the Data
Coordinating Center, and for evaluating the cost-effectiveness at the
Center.  Performance of the DCC will also be evaluated by:
 
o  Quality and quantity of participation in collaborative Network
research.
 
o  Reports to clinical centers on their performance.
 
o  Reports to the Data Monitoring and Safety Committee.
 
o  Annual progress reports for non-competitive renewal.
 
o  Site visit findings.
 
4.  An Advisory Board advises the Steering Committee in the
identification and prioritization of topics for Network research and
the preparation of publications.  The Advisory Board, chosen by the
NICHD with the advice of the Steering Committee, is composed of
individuals with expertise in clinical trials, biostatistics,
epidemiology, perinatology,and obstetrics; the Chairpersons of the
Maternal Fetal Research Network and the Neonatal Research Network,
the Program Officials of the both Networks, the Director of the CRMC;
and the Principal Investigators of the Data Centers.
 
5.  Programmatic responsibility for review and oversight of the
cooperative agreement will reside with Chief, Pregnancy and
Perinatology Branch.  The NICHD Program Official for the Network will
make recommendations to the Chief, Pregnancy and Perinatology Branch.
This role will include the following:
 
o  Option to withhold support from a participating clinical unit if
technical performance requirements such as complying with the
protocol, meeting enrollment targets and randomizing subjects are not
met.
 
o  Option to withhold support from the DCC if technical performance
requirements such as protocol support, data acquisition and analysis
targets, and adequate quality assurance of data, are not met.
 
o  Continual review of all activities to ensure objectives are being
met, to re-direct activities, or to improve cooperation and
performance.
 
6.  Cooperative agreements are assistance mechanisms and are subject
to the same administrative requirements as grants. As such, pertinent
DHHS, PHS, and NIH grant regulations, policies, and procedures are
applicable.  Business management aspects will be administered by the
NICHD Grants Management Branch.
 
7.  Funding of the DCC for the first year of the next competitive
segment will consist of two parts:
 
a. A base budget, representing all fixed costs estimated from the
anticipated pre-enrollment workload.
 
b. Capitation funding, based on the amount of data and the number of
patients enrolled in each of the active, enrolling protocols.
 
A capitation budget for each protocol, determined as follows:
 
o  The cost per patient will initially be determined with actual ime
and effort data, and may be corrected, after review by the NICHD,
during implementation.  Recruitment estimates (number of patients per
month) will be used to make an award at the start of implementation.
Awards may be revised (either upward or downward) as actual
recruitment rates are noted.
 
o  The foregoing budget mechanism is intended to provide equitable
and reasonable support for the research efforts actually expended in
these clinical studies.
 
8.  The Data and Safety Monitoring Committee (DSMC), is established
to review and interpret protocols, review specifications, and review
and interpret study data in order to insure the safety of study
subjects and provide the NICHD with advice on the progress of the
study.  The members of the DSMC are chosen by NICHD and are experts
in ethics, clinical trial design, biostatistics and neonatology.  The
Chairperson will be appointed by the NICHD.  The Deputy Director of
the Center for Research for Mothers and Children (CRMC), will serve
as the Executive Secretary of the DSMC and liaison to the Steering
Committee.
 
9.  Arbitration procedures will be instituted in addition to the
customary programmatic and financial negotiations which occur in the
administration of grants, only when agreement cannot be reached on
scientific programmatic issues between the awardee and the NICHD that
may arise after the award. In that event, an arbitration panel will
be formed consisting of one person selected by the Principal
Investigator, one person selected by the NICHD, and a third person
selected by these two members.  The decision of the arbitration panel
will be binding.
 
10.  The special 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 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 Grants Management Branch,
NICHD, in accordance with DHHS and NIH grants 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 policy results
from the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43).
 
All investigators proposing research involving human subjects should
read the "NIH Guidelines For Inclusion of Women and Minorities as
Subjects in Clinical Research," which have been published in the
Federal Register of March 28, 1994 (FR 59-14508-14513) and the NIH
Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994.
 
LETTER OF INTENT
 
Prospective applicants are asked to submit, by August 1, 1997, 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
IC 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
Pregnancy and Perinatology Branch
National Institute of Child Health and Human Development
6100 Bldg, Room 4B03 6100 Executive Blvd., MSC 7510
Bethesda, Maryland 20892-7510
Telephone:  301-496-5575
FAX: 301-496-3790
E-mail:  dm88q@nih.gov
 
APPLICATION PROCEDURES
 
The research grant application form PHS 398 (rev. 5/95) is to be used
in applying for these grants.  Applications kits are available at
most institutional offices of sponsored research and may be obtained
from the Division of Extramural Outreach and Information Resources,
National Institutes of Health, 6701 Rockledge Drive, MSC 7910,
Bethesda, MD 20892-7910, telephone 301/435-0714, email:
ASKNIH@odrockm1.od.nih.gov.
 
The RFA label in form PHS 398 (rev. 5/95) must be affixed to the
bottom of the face page of the original copy of the application.
Failure to use this label could result in delayed processing of the
application such that it will not reach the review committee in time
for review.  The title MFMU-DCC COOPERATIVE AGREEMENT and the RFA
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:
 
DIVISION OF RESEARCH GRANTS
NATIONAL INSTITUTES OF HEALTH
ROCKLEDGE BUILDING, ROOM 1040 - MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)
 
At the same time of submission, two additional copies of the
application must be sent to:
 
Division of Scientific Review
National Institute of Child Health and Human Development
Building 6100, Room 5E03
Bethesda, MD  20892
Rockville, MD  20852 (for express/courier service)
 
Applications must be received by September 19, 1997.  If an
application is received after that date, it will be returned to the
applicant without review.
 
Schedule
 
Letter of Intent Receipt Date:  August 1, 1997
Application Receipt Date:       September 19, 1997
Review by Advisory Council:     January 1998
Anticipated Award Date:         April 1, 1998
 
REVIEW CONSIDERATIONS
 
Upon receipt, applications will be reviewed for completeness by DRG
and responsiveness by NICHD.  Incomplete applications will be
returned to the applicant without further consideration.
Applications that are complete and responsive to the Request for
Applications will be evaluated for scientific and technical merit by
an appropriate peer review group convened by the NICHD in accordance
with the review criteria stated below.
 
As part of the initial merit review, a process may be used by the
initial review group in which applications will be determined to be
competitive or non-competitive based on their scientific merit
relative to other applications received in response to the RFA.
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.  Those
applications that are complete and responsive, will undergo further
scientific merit review.
 
Applications meeting the minimum requirements will be evaluated on
scientific and technical merit according to the criteria listed
below.
 
o  Qualifications, Experience, and Commitment of Key Personnel.
Scientific and administrative abilities of the Principal Investigator
and other team members; experience of the Principal Investigator and
other key personnel in statistical,data management, quality control,
study coordination, and administrative aspects.
 
o  Protocols and Procedures.  Quality of past performance and
proposed plans for:  study coordination, data collection, analysis
and monitoring; willingness to work cooperatively with other awardees
and NICHD in the manner summarized in the Terms of Award.
 
o  Facilities and Management.  Evidence of satisfactory facilities
and supporting environment, including space and equipment for work
proposed (any new equipment requested under this award must be
adequately justified); evidence of institutional support for
participation in a long term collaborative program.
 
o  Budget.  Appropriateness of proposed budget in light of budget
guidelines outlined in Appendix I. Adequacy of documentation of
willingness to follow capitation of specific operational costs.
 
o  Appropriateness of Plans for Protection of Human and Animal
Subjects and Compliance with NIH Policy on Inclusion of Women and
Minorities.
 
AWARD CRITERIA
 
Applications recommended by the NICHD Council will be considered for
award based primarily on scientific and technical merit.
Programmatic priorities and availability of funds may also determine
the award made.
 
INQUIRIES
 
Inquiries 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
Building 6100, Room 4B03H
Bethesda, MD 20892
Telephone:  301-496-5575
FAX:  301-496-3790
E-mail: dm88q@nih.gov
 
Inquiries regarding grants management and administrative policy may
be directed to:
 
Mary Ellen Colvin
Grants Management Branch
National Institute of Child Health and Human Development
Building 6100, Room 8A17 - MSC 7510
Bethesda, MD 20892-7510
Telephone:  301-496-1303
FAX: 301-402-0915
E-mail:  mc113b@nih.gov
 
AUTHORITY AND REGULATIONS
 
This program is described in the Catalog of Federal Domestic
Assistance No. 93.3865.  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 grant 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 routine education,
library, day care, health care or early childhood development
services are provided to children.  This is consistent with the PHS
mission to protect and advance the physical and mental health of the
American people.
 
Appendix I:
 
At the time of application, a base budget will be required, and a
description of a method to calculate operational costs will be
required.
 
The base budget will be one necessary to design protocols and to
prepare to receive data entered from the three hypothetical protocols
described in number eight, and in number 10, of the research plan
outlines for incumbent (3a) and other (3b) applicants, respectively.
In addition, other fixed DCC costs such as supplies and travel may be
included, as outlined below.
 
Personnel:
 
Principal Investigator 100% Biostatistical staff 200% (with graduate
degrees) Network Coordinator 100% Administrative Assistant 100%
 
Supplies:  $2,500
 
Travel:  four trips for four staff to make site visits to clinical
centers.
 
Operational Costs:  (No specific budget requested at time of
application)
 
Operational costs for the DCC are those costs incurred after the
start of patient enrollment.  They include:
 
o  Data entry, management, quality control
 
o  Report generation
 
o  Data analysis, manuscript preparation
 
o  Arrangement of logistical services for protocol-specific costs,
including subcontracts, supplies
 
o  DCC resource management, subcontracting
 
The methods to calculate these costs proposed by the applicant will
be used as the basis for individualizing cost recovery for each
protocol separately.  Agreement will be reached by discussions
between NICHD staff and the successful applicant.  Periodic
adjustment of these reimbursement arrangements will be made based on
actual experience with each protocol.
 
.

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