NETWORK ON THE NEUROBIOLOGY AND GENETICS OF AUTISM:  COLLABORATIVE PROGRAMS OF 
EXCELLENCE IN AUTISM (CPEA) DATA COORDINATING CENTER

RELEASE DATE:  July 10, 2002 (see addendum NOT-HD-02-009)

RFA:  HD-02-015

National Institute of Child Health and Human Development (NICHD) 
 (http://www.nichd.nih.gov)
National Institute on Deafness and Other Communication Disorders (NIDCD) 
 (http://www.nidcd.nih.gov) 

LETTER OF INTENT RECEIPT DATE:  October 25, 2002 

APPLICATION RECEIPT DATE:  November 26, 2002

THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanism of Support 
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS RFA

The National Institute of Child Health and Human Development (NICHD) and the 
National Institute on Deafness and Other Communication Disorders (NIDCD) 
solicit applications for the establishment of a Data Coordinating Center 
(DCC) to support the ongoing NICHD/NIDCD Network on the Neurobiology and 
Genetics of Autism:  Collaborative Programs of Excellence in Autism (CPEAs). 
The CPEA is a cohesive, multi-site, cooperative research program of site-
specific and collaborative research begun in 1997 that both individually and 
collectively conducts research on the etiology/pathophysiology, brain 
structure and/or function, behavior, genetics, and clinical course of autism. 

CPEA projects use common diagnostic measures and both site-specific and 
common core research measures to advance knowledge about autism and related 
disorders.  This Network requires each CPEA, in addition to their site-
specific research programs, to participate in trans-Network collaborative 
studies for which no single project has the needed expertise and/or subject 
population to investigate individually.  A Data Coordinating Center (DCC) 
will serve to centralize and standardize the data that can be used for 
addressing collective questions by the Network, as well as serving as a 
central repository to facilitate the timely ability of the Network to address 
urgent public health concerns related to autism.  Finally, the DCC will put 
data sets into a common format that will facilitate their use by CPEA member 
projects and could eventually serve as a data archive to preserve the data 
for later secondary analyses.  

Because the NIH plans to fund other Center programs of similar magnitude to 
the CPEAs that will also be devoted to autism research (e.g., the Studies to 
Advance Autism Research and Treatment (STAART) Centers, RFA MH-02-001), 
applicants should provide evidence that they have the capability to expand 
the scope of services provided to accommodate the needs of additional NIH 
initiatives, as needed. 

RESEARCH OBJECTIVES

Background 

The Network on the Neurobiology and Genetics of Autism:  Collaborative 
Programs of Excellence in Autism (CPEA) conducts research on autism spectrum 
disorders, which are present from birth or very early in development, and 
affect essential human behaviors such as communication, social interaction, 
and the establishment of relationships with others.  These developmental 
disorders, for which there is presently no cure and no approved medical 
treatment, generally have lifelong effects.  International epidemiologic 
studies indicate that rates of classic autism have more than doubled within 
the past 15 years (to one in 1000 prevalence for classic autism and one in 
500 for the broader autism spectrum).  Recent studies suggest an even more 
dramatic rise in cases of milder variants within the autism spectrum, with 
specific sites reporting prevalence rates of one in 150 or greater.  Although 
precise neurobiological mechanisms have not yet been determined, it is clear 
that autism spectrum disorders may result from a number of factors, including 
genetic susceptibility, developmental mechanisms intrinsic to the brain, and 
extrinsic factors.  The goal of the CPEA Network is to elucidate the genetic 
and neurobiologic factors that underlie the clinical manifestations of these 
disorders and, ultimately, to contribute to their prevention and cure.  

The CPEA Network of 10 multidisciplinary projects was established over a two-
year period in response to an RFA issued in 1997 to address gaps in autism 
research identified by an international group of autism experts at a 1995 NIH 
conference on the State of the Science in Autism.  Using common diagnostic 
standards and a core of common measures as well as site-specific measures, 
each individual CPEA is responsible for multidisciplinary, site-specific 
research that draws on the special expertise and resources in its own CPEA, 
as well as for participation in collaborative studies that require the 
combined subjects and expertise of multiple projects across the Network.  
This cooperative capability has enabled the Network to address questions of 
high scientific relevance and pressing public health urgency that would not 
be possible within the resources of a single, multidisciplinary project.

Each CPEA is studying particular basic and clinical aspects of the biological 
etiology or pathophysiology, brain structure and/or function, and clinical 
course of autism.  Each multidisciplinary project has a unique focus and 
research plan.  In addition, all projects use a common diagnostic protocol, 
core measures, and procedures to collectively address some research questions 
that require greater resources and/or sample sizes than any single project. 
Individually and/or collectively, the CPEAs investigate the causes, 
pathophysiology, diagnosis, and developmental course of autism.  CPEAs are 
not required to participate in all collaborative studies, but are expected to 
be active participants in selected collaborative studies that require their 
specific expertise or resources.  To date, such projects include completed 
and ongoing Network projects in areas such as genetics, communication, head 
circumference, early cognitive development, and executive function.  More 
detailed information concerning the scientific activities of the CPEA network 
can be found at http://www.nichd.nih.gov/autism/cpea.cfm and at 
http://www.nichd.nih.gov/autism/bib.cfm. 

Collaborative studies have also addressed urgent public health issues. 
Examples include clinical trials of the neuropeptide secretin (heralded as a 
cure for autism, but whose safety and efficacy had never been tested for 
children), an ongoing study of the hypothesized link between trivalent 
Measles/Mumps/Rubella (MMR) vaccine and the development of late onset or 
regressive autism (Collaborative Autism Regression/Vaccination Study), and a 
relatively recent collaborative effort to gather genetic data from all 
singleton proband families (in addition to genetic materials that were 
already being collected in selected CPEAs from multiplex families).  Studies 
designed to advance the application of methodological development in genetic 
analysis, neuroimaging, neuropsychology, and clinical research as applied to 
research on autism are also being conducted.

Research Scope

The NICHD and NIDCD intend to extend the CPEA Network, through a competitive, 
peer-reviewed process, for an additional five years to support established 
teams of investigators for research focused on basic and clinical research on 
the neurobiology and genetics of autism.  The extension of this Network will 
enable investigators to take advantage of the collective resources of the 
CPEA to address questions of high scientific and/or clinical relevance. 
In concert with the DCC, CPEAs will complete data collection, data reduction, 
and analyses from the first five years of the Network, including ongoing 
collaborative studies in progress, and design and implement new collaborative 
studies.  The NICHD and NIDCD intend for the extension of collaborative 
activities to be conceptualized and carried out by the Principal 
Investigators of the CPEAs in collaboration with the DCC.  

This Request for Applications invites applications to serve as the DCC for 
the CPEA Network, with capability of expanding to a similar role for other 
potential NIH initiatives. 

Guidance and Management Structure

A Steering Committee, a Network Advisory Board, and a Data Safety and 
Monitoring Committee (DSMC) will provide the overall guidance and management 
of the CPEA Network.  In addition, the Steering Committee will establish 
written Policies and Procedures that govern its operations, including 
publications.  These documents will be reviewed periodically and may be 
amended at the discretion of the Steering Committee.

MECHANISM OF SUPPORT
 
This RFA will use NIH Cooperative Research Project Grant (U01) award 
mechanism.  As an applicant you will be solely responsible for planning, 
directing, and executing the proposed project.  

The NIH U01 is a cooperative agreement award mechanism in which the Principal 
Investigator retains the primary responsibility and dominant role for 
planning, directing, and executing the proposed project, with NIH staff being 
substantially involved as a partner with the Principal Investigator, as 
described under the section "Cooperative Agreement Terms and Conditions of 
Award." 

FUNDS AVAILABLE

Although both the NICHD and the NICDC support the CPEA network sites, the 
NICHD will be the sole supporter of the CPEA DCC.  The NICHD intends to 
commit approximately $4.5 million in total costs [direct plus Facilities and 
Administrative (F&A) costs] for the five years from FY 2003 to FY 2007 to 
fund one DCC grant 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 
$500,000 in direct costs in the first year.  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.  At this time, it is not known if this 
RFA will be reissued.

ELIGIBLE INSTITUTIONS
 
You may submit an application if your institution has any of the following 
characteristics:

o For-profit or non-profit organization 
o Public or private institutions, such as universities, colleges, hospitals, 
and laboratories 
o Units of State and local governments
o Eligible agencies of the Federal government  
o Domestic 

Institutions that are currently a part of the CPEA Network may apply for a 
DCC grant; however, there should be no overlap of the duties of the personnel 
proposed in the DCC application and the duties of the personnel in the CPEA 
research site.

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS   

Any individual with the skills, knowledge, and resources necessary to carry 
out the proposed research is invited to work with their institution to 
develop an application for support.  Individuals from underrepresented racial 
and ethnic groups as well as individuals with disabilities are always 
encouraged to apply for NIH programs.   

SPECIAL REQUIREMENTS

Minimum Application Requirements

Applicants must address the following to be considered responsive to this 
RFA:

o  Evidence of Successful Past Performance

Data Center applicants must demonstrate prior experience in the design, 
conduct, data analysis, and data management of major collaborative clinical 
research projects involving pediatric through adult populations, and provide 
evidence of successful performance as a DCC for multi-site studies during the 
previous five years. 
 
o  Appropriate Staff Expertise and Capability

The DCC will consist of a Principal Investigator, a project coordinator, and 
other staff deemed necessary to carry out its mission.  The proposed DCC 
staff must be prepared to cooperate effectively in all network functions with 
NICHD and the CPEA Research Sites.  The Principal Investigator and other 
staff must have appropriate expertise and capability in biostatistics, 
developmental study design, development and support, data management, data 
analysis, and project management, including, but not limited to staff and 
site training and quality assurance procedures. 

o  Capacity and Ability to Manage Data and Communications

DCC applicants must have the ability to assist in designing protocols 
appropriate for pediatric through adult populations, data collection forms, 
manuals of operation, and data collection systems, including distributed data 
entry.  Applicants must have experience in developing and maintaining data 
quality control systems.  Applicants also must provide evidence of data 
management and program support capabilities by describing standard operating 
procedures that address:  (1) plans for data collection, management, 
analysis, and data quality control; and (2) plans for supporting an 
electronic mail/communications system to participants of the CPEA.

o  Evidence of Reporting and Publications Capabilities

DCC applicants must provide evidence of their capacity to generate monthly 
reports on subject enrollment for several concurrent studies; quarterly 
reports on enrollment and CPEA Research Site performance (including any 
efforts to reallocate study resources); appropriate reports for the use of 
the DSMC, Network Advisory Group, and Steering Committee meetings; and other 
special reports, as required.  The applicants must demonstrate successful 
experience in assisting investigators in preparing manuscripts for 
publication.

o  Experience in Providing Logistical and Other Support Services

DCC applicants must provide evidence of successful experience in arranging 
logistical support services for multi-center research, for example, meeting 
and conference support.

o  Evidence of On-site Monitoring Capabilities

DCC applicants must have experience and demonstrate capability in organizing 
and conducting on-site monitoring of multi-center research studies. 

o  Evidence of Technology Transfer and Data Management Training Capabilities 

DCC applicants must demonstrate their capability to assist the CPEA Research 
Sites to enhance their data management and communications activities.  
Evidence of training and technical assistance expertise and experience in 
this area must be provided.

o  Evidence of Management Capability

DCC applicants must provide evidence of superior ability to:  (1) estimate 
appropriate and reasonable resources needed for individual projects in their 
role as the DCC for the CPEA Network; (2) manage those resources efficiently 
during the research; (3) adjust the assigned staff and other resources in 
response to changing work needs as the projects undertaken by network members 
unfold; (4) report these resource allocations to NICHD periodically; (5)  
subcontract with outside organizations to supplement these resources, as 
needed; and (6) provide for an expansion of services to other NIH initiatives 
as deemed appropriate.

Budget Guidelines

The NICHD intends to commit a total of approximately $4.5 million to fund one 
Data Coordinating Center for the five years from FY 2003 to FY 2007.  For the 
purposes of this RFA, Data Coordinating Center applicants should provide a 
first-year budget request of up to $500,000 in direct costs.  Based on the 
expected growth in the number and extent of the collaborative network studies 
over the course of the award, the NICHD anticipates that the budgets for the 
Years 02 through 05 will escalate proportionately.  The first year budget 
request submitted with the application should include, at a minimum, the 
following:

o  Salary and administrative support for the Principal Investigator, project 
coordinator, and other staff as required to meet the first-year 
responsibilities of the Data Center.  Future budgets will be determined on a 
year-to-year basis, depending on the needs of the CPEA and possible 
additional NIH initiatives in autism research.

o  Estimated travel costs and related expenses for the Principal Investigator 
and other Data Center staff for travel to required Steering Committee 
meetings (three times per year in Bethesda, Maryland). 

o  Estimated travel costs and related expenses for the Principal Investigator 
and other Data Center staff for travel, once per year, to each of the 
research sites for the purposes of assisting in the standardization of 
collaborative protocols across sites, data management and analysis, and 
quality control and quality assurance.  Individual site visits will be 
subject to approval by, and coordination with, the NICHD Project Officer.   

o  Travel and logistical support expenses for members of the DSMC and the 
Network Advisory Board.  For the purposes of this RFA, applicants should 
estimate three meetings per year for the DSMC, one meeting per year for the 
Network Advisory Board, and a committee composition of five to seven members. 

o  Expenses related to communications, supplies, equipment, and other items 
identified as essential to the establishment and operation of the DCC.  

o  Clearly specified plans and procedures for monitoring of DCC budgetary 
expenditures.

o  Estimated cost of accumulating and maintaining network data, and preparing 
datasets for network analysis.
 
Percent Effort

The DCC Principal Investigator must expend at least 40 percent effort 
annually on the award in each year of support.

Cooperative Agreement Terms and Conditions of Award

Cooperative agreements are assistance mechanisms and are subject to the same 
administrative requirements as grants.  The following terms and conditions 
will be incorporated into the award statement and provided to each Principal 
Investigator as well as the institutional officials at the time of the award.  
These terms are in addition to, and not in lieu of, otherwise applicable OMB 
guidelines, HHS Grant Administration Regulations at 45 CFR Part 74 and 92, 
and other HHS, PHS, and NIH grant administration policies.  The NICHD Grants 
Management Branch, in accordance with HHS, PHS, and NIH Grant Administration 
policies, will administer business management aspects of these awards.  

The administrative funding instrument used for this program will be the U01, 
an "assistance" mechanism (rather than an "acquisition" mechanism), in which 
substantial NIH scientific and/or programmatic involvement with the PI is 
anticipated during performance of the activities. Under the cooperative 
agreement, the NIH purpose is to support and/or stimulate the PI's activities 
by involvement in and otherwise working jointly with the PI in a partnership 
role; it is not to assume direction, prime responsibility, or a dominant role 
in the activities.  Consistent with this concept, the dominant role and prime 
responsibility resides with the PI for the project as a whole, although 
specific tasks and activities may be shared between the awardee and the NIH 
Project Scientists assigned to the CPEA network.  The NIH Project Scientists 
include those from the NICHD and the NIDCD since both Institutes support the 
individual CPEA sites. The tasks and activities shared between the DCC PI and 
the NIH Project Scientists are described more fully below.  
The cooperative agreement funding mechanism will require collaboration among 
the NIH Project Scientists, the DCC Principal Investigator, and the Principal 
Investigators of the CPEA Network Sites.  The NICHD Project Scientist will 
coordinate the activities of the CPEA Network, and will facilitate 
communication and the exchange of information.

1.  Primary Rights and Responsibilities of the Awardee

The awardee will agree to accept the participatory and cooperative nature of 
the group process.  The Data Center grant will be administered by NICHD, but 
as part of the overall network, the Data Center will be involved with both 
the NICHD and the NIDCD.  For example, the awardee is required to submit 
annual progress reports to NICHD, as appropriate, and to provide study and 
site performance information as stipulated by NICHD and NIDCD.

The DCC will provide research support services to the CPEA Network.  These 
will include establishment and maintenance of a centralized information 
management system to help the CPEA Network Research Sites collect, edit, 
store, analyze, publish, and disseminate results from their individual 
projects as well as from shared research.  The DCC will serve as a central 
repository for data on all new collaborative projects, and may assume 
responsibility for data management for studies undertaken before the award of 
the grant.  It will assist the NIH Project Scientists of the NICHD and NIDCD 
in monitoring research progress, and will work to ensure data integrity, 
accuracy, and accessibility among all CPEA research sites.  It will offer 
technical assistance and analytical support for all sites, as needed. 

All activities of the DCC must be closely coordinated with the Steering 
Committee.  In support of all research projects undertaken by the CPEA 
Network, the DCC staff will:

o  Support the activities of the Network Advisory Group, Steering Committee, 
and the DSMC through provision of materials/documentation support, meeting 
planning and logistics, and conference call coordination.

o  Provide advice on study design (including designs relevant to 
developmental/longitudinal research questions), data collection, data 
analysis, and publication development to all CPEA research projects.

o  As an essential element of support to the Network Steering Committee, 
provide the necessary statistical expertise and expertise in data analysis, 
to ensure optimization of study design and potential outcomes.  Actively 
participate in and, as deemed appropriate, lead the analyses of collaborative 
CPEA studies and assist CPEA participants in the drafting and publication of 
collaborative study results.

o  Prepare, design, and disseminate operations manuals, data collection 
forms, databases, and results reporting summaries for CPEA research projects.

o  Compile for the Network Advisory Group, the Steering Committee, the DSMC, 
the NIH Project Scientists of the NICHD and NIDCD, site visit reports, 
monthly and quarterly subject enrollment reports, meeting summaries, 
quarterly Research Site performance and progress reports, and other reports 
as needed.

o  Create and maintain a high-quality database to support collaborative 
research, supervise all data collection procedures, and arrange for the most 
efficient transfer of study data where indicated.

o  In collaborative studies, provide support, as necessary, to ensure that 
all CPEA Network sites and investigators fully comply with NIH regulatory 
requirements, including Human Subject Protections, informed consent, 
reporting of adverse events, human and animal subject safety and welfare 
provisions.

o  Provide training to all Research Site personnel as needed for 
standardization of collaborative protocols across sites, data management and 
analysis, and quality control and quality assurance.

o  In coordination with the NIH, provide periodic, on-site, quality control 
monitoring at the Research Sites for those studies being performed at that 
site.

o  Organize and participate in regular conference calls and network meetings. 

2.  NICHD and NIDCD Responsibilities  

NICHD and NIDCD Project Scientists:

The NICHD and NIDCD Network Project Scientists are partners within the 
Network representing the government's interest in the substantive work of the 
Network.  The primary role of the Project Scientists is to facilitate the 
work of the Network and to connect the Network to public policy operations 
within the government.  He/she will:

o  Assist in all functions of the Steering Committee, including:  reviewing 
and commenting on each stage of the program before subsequent stages are 
started; exercising the option of recommending the addition, modification or 
termination of aspects of the program.

o  Assist with the development of common protocols.

o  Assist in the analysis, interpretation, and reporting of findings in the 
scientific literature and other media to the community at large and the 
public policy community within the Federal government.

NICHD Project Officer:

NICHD will appoint a Project Officer, apart from the Project Scientist, who 
will:

o  Have the option to withhold support to a participating institution if 
technical performance requirements, such as compliance with the collaborative 
protocols, are not met.

o  Carry out continuous review of all activities to ensure objectives are 
being met and all regulatory, fiscal, and administrative matters are handled 
according to NIH guidelines.

o  Perform other duties required for normal program stewardship of grants. 

3.  Collaborative Responsibilities

A Steering Committee, a Network Advisory Board, and a Data Safety and 
Monitoring Committee (DSMC) will provide the overall guidance and management 
of the CPEA Network.  In addition, the Steering Committee will establish 
written Policies and Procedures that govern its operations, including 
publications.  These documents will be reviewed periodically and may be 
amended at the discretion of the Steering Committee.

Steering Committee 

Planning and implementation of the cooperative aspects of the study will be 
done by a Steering Committee consisting of the Principal Investigator of each 
of the Research Sites, the Principal Investigator of the DCC, and the NICHD 
and NIDCD Project Scientists.  The NIH Project Scientists of NICHD and NICDC 
have a total of one shared vote when voting on the Steering Committee.  All 
other participants have one vote each.  The Steering Committee will formulate 
a research plan for cooperative research that will distill the several 
individual cooperative research plans into a coherent plan.  The cooperative 
research plan will be agreed upon by majority vote of the Steering Committee, 
but each Principal Investigator will have the right of approval for any 
aspect of the cooperative research plan involving them.  Due publication 
credit will be given to all work done cooperatively.  The Steering Committee 
will:  

o  Agree to accept the coordinating role of the committee and the cooperative 
nature of the group process.

o  Plan the design and implementation of the cooperative research protocols.

o  Advise the NIH regarding allocation of funds for cooperative research 
protocols.

o  Advise the NIH regarding allocation of funds for individual research 
protocols.

o  Formulate publication policy and appoint a Publication Subcommittee, as 
judged necessary by the Steering Committee.

o  Publish results, conclusions, and interpretations of the cooperative 
protocols.

Network Advisory Board 

A Network Advisory Board will advise the Steering Committee in the 
identification and prioritization of topics for Network research.  The 
Advisory Board, chosen by NICHD and NIDCD, will comprise senior scientists in 
the areas central to the work of the Network who are not affiliated with 
NICHD or NIDCD or part of the Network.  

As well as serving in an advisory capacity to the Steering Committee as 
deemed necessary, the Advisory Board will serve as the second level of review 
for projects approved by the Steering Committee as part of the research 
activities of the Network.  The Network's scope is defined as the sum of the 
approved individual and cooperative research plans of participating 
cooperative agreements in the Network. 

Data and Safety Monitoring Committee

A Data and Safety Monitoring Committee (DSMC), established by NICHD and 
NIDCD, will advise the NIH and the CPEA Network, including the DCC, on 
research design issues, data quality and analysis, and ethical and human 
subject issues.  It also will monitor the safety of any ongoing clinical 
research.  DSMC membership will include, but not be limited to, individuals 
with expertise in clinical trial design and conduct, and relevant basic, 
medical, neurobiological, and behavioral sciences research.  The DCC will 
prepare reports and provide coordination, support, and funding for travel and 
logistics arrangements related to DSMC meetings and actions.

4.  Arbitration Procedures

When agreement between an awardee and NIH staff cannot be reached on 
programmatic and scientific-technical issues that may arise after the award, 
an arbitration panel will be formed.  The panel will consist of one person 
selected by the Principal Investigators, one person selected by the NIH 
staff, and a third person selected by the first two members selected.  The 
decision of the arbitration panel, by majority vote, will be binding.  These 
special arbitration procedures in no way affect the awardees right to appeal 
an adverse action in accordance with PHS regulations at 42 CFR Part 50, 
Subpart D, and HHS regulations at 45 CFR Part 16.  

WHERE TO SEND INQUIRIES

We encourage inquiries concerning this RFA and welcome the opportunity to 
answer questions from potential applicants.  Inquiries may fall into three 
areas:  scientific/research, peer review, and financial or grants management 
issues:

o Direct your questions about scientific/research issues to:

Dr. Lisa Freund
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 4B05, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 435-6879 
FAX:  (301) 480 0230
Email:  freundl@mail.nih.gov  

o Direct your questions about peer review issues to:

Robert Stretch, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 496-1485
FAX: (301) 402-4104
Email:  rstretch@nih.gov

o Direct your questions about financial or grants management matters to:

Nicolas Mitrano
Grants Management Specialist
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A17, MSC 7510
Bethesda, MD 20892-7510
Telephone:  (301) 435-6976FAX:  (301) 480-4783
Email:  mitranon@mail.nih.gov

LETTER OF INTENT
 
Prospective applicants are asked to submit a letter of intent that includes 
the following information:

o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel 
o Participating institutions
o Number and title of this RFA 

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 NICHD staff to estimate the potential review workload and 
plan the review.
 
The letter of intent is to be sent by the date listed at the beginning of 
this document.  The letter of intent should be sent to:

Dr. Lisa Freund
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 4B05, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 435-6879 
FAX:  (301) 480 0230
Email:  freundl@mail.nih.gov 

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 435-0714, 
Email: GrantsInfo@nih.gov.
 
USING THE RFA LABEL:  The RFA label available in the PHS 398 (rev. 5/2001) 
application form must be affixed to the bottom of the face page of the 
application.  Type the RFA number on the label.  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. The RFA label is also available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
 
SENDING AN APPLICATION TO THE NIH:  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 must be 
sent to:

Robert Stretch, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD  20892
Rockville, MD 20852 (for express/courier service)
Telephone:  (301) 496-1485

APPLICATION PROCESSING:  Applications must be received by the application 
receipt date listed in the heading of this RFA.  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.

PEER REVIEW PROCESS  
 
Upon receipt, applications will be reviewed for completeness by the CSR 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 NICHD in accordance with the review criteria stated below.  
As part of the initial merit review, all applications will:

o Receive a written critique
o Undergo a process in which only those applications deemed to have the 
highest scientific merit, generally the top half of the applications under 
review, will be discussed and assigned a priority score
o Receive a second level review by the National Advisory Child Health and 
Human Development Council. 
 
REVIEW CRITERIA

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  In 
the written review, comments on the following aspects of the application will 
be made 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 the assignment of the overall score, 
which is to reflect the overall impact of the project on the field, weighing 
the criteria appropriately for each application.  An application does not 
need to be strong in all categories to be judged likely to have a major 
scientific impact and thus deserve a high merit rating.  

Applications submitted in response to this RFA will be reviewed on the 
following criteria relevant to the successful establishment and performance 
of a data coordinating center.

o Organizational experience and capabilities, including, but not limited to: 
adequacy of site support, governance support, and staff training plans, 
including onsite training: adequacy of plans to guarantee the quality and 
integrity of collected data; adequacy of plans to maintain accurate and 
timely information on the progress of studies and site performance; adequacy 
of plans to facilitate and maintain close communication with NIH and among 
the other CPEA Network components; evidence of high-quality past performance 
in relevant data coordination activities; flexibility of plans to respond to 
the changing analytic needs of the CPEA Network; adequacy of plans and 
procedures for monitoring DCC expenditures; and demonstrated willingness and 
ability to adhere to the terms and conditions of the Cooperative Agreement 
award. 

o Staff experience and capabilities, including, but not limited to:  adequacy 
of the proposed resources, including staffing, for supporting the CPEA 
Network; demonstration of innovative analytic approaches to evaluating 
research data; and adequacy of the qualifications and research experience of 
the management and analytic team.

o Specialized capabilities and experience in large scale network 
coordination, including, but not limited to:  adequacy of experience in and 
plans for conducting periodic onsite monitoring of multi-site studies; 
adequacy of previous experience with design, administration, management, and 
coordination of multi-site studies; demonstrated willingness and ability to 
expand resources, personnel, and facilities to serve as the DCC for other NIH 
initiatives if deemed appropriate to meet future needs.

ADDITIONAL REVIEW CRITERIA:  In addition to the above criteria, your 
application will also be reviewed with respect to the following:

o PROTECTIONS:  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.

o INCLUSION:  The adequacy of plans to include subjects from both genders, 
all racial and ethnic groups (and subgroups), and children as appropriate for 
the scientific goals of the research.  Plans for the recruitment and 
retention of subjects will also be evaluated.  (See Inclusion Criteria 
included in the section on Federal Citations, below.)

o BUDGET:  The reasonableness of the proposed budget and the requested period 
of support in relation to the proposed research.

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Date:            October 25, 2002       
Application Receipt Date:         November 26, 2002     
Peer Review Date:                 May 2003             
Council Review:                   June 2003
Earliest Anticipated Start Date:  July 1, 2003

AWARD CRITERIA

Criteria that will be used to make award decisions include:

o Scientific merit (as determined by peer review)
o Availability of funds
o Responsiveness to the goals and objectives of the RFA

REQUIRED FEDERAL CITATIONS 

MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD:  Research components 
involving Phase I and II clinical trials must include provisions for 
assessment of patient eligibility and status, rigorous data management, 
quality assurance, and auditing procedures.  In addition, it is NIH policy 
that all clinical trials require data and safety monitoring, with the method 
and degree of monitoring being commensurate with the risks (NIH Policy for 
Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 
1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH:  It is the policy of 
the NIH that women and members of minority groups and their sub-populations 
must be included in all NIH-supported clinical research projects unless a 
clear and compelling justification is provided indicating 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 clinical research should read the AMENDMENT "NIH 
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research - Amended, October, 2001," published in the NIH Guide for Grants and 
Contracts on October 9, 2001 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete
copy of the updated Guidelines is available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.   
The amended policy incorporates: the use of an NIH definition of clinical 
research; updated racial and ethnic categories in compliance with the new OMB 
standards; clarification of language governing NIH-defined Phase III clinical 
trials consistent with the new PHS Form 398; and updated roles and 
responsibilities of NIH staff and the extramural community.  The policy 
continues to require for all NIH-defined Phase III clinical trials that: a) all 
applications or proposals and/or protocols must provide a description of plans 
to conduct analyses, as appropriate, to address differences by sex/gender 
and/or racial/ethnic groups, including subgroups if applicable; and b) 
investigators must report annual accrual and progress in conducting analyses, 
as appropriate, by sex/gender and/or racial/ethnic group differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: 
The NIH maintains a policy 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 that is available at 
http://grants.nih.gov/grants/funding/children/children.htm. 

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS:  NIH 
policy requires education on the protection of human subject participants for 
all investigators submitting NIH proposals for research involving human 
subjects.  You will find this policy announcement in the NIH Guide for Grants 
and Contracts Announcement, dated June 5, 2000, at   
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT:  The 
Office of Management and Budget (OMB) Circular A-110 has been revised to 
provide public access to research data through the Freedom of Information Act 
(FOIA) under some circumstances.  Data that are (1) first produced in a 
project that is supported in whole or in part with Federal funds and (2) 
cited publicly and officially by a Federal agency in support of an action 
that has the force and effect of law (i.e., a regulation) may be accessed 
through FOIA.  It is important for applicants to understand the basic scope 
of this amendment.  NIH has provided guidance at 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this RFA in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time.  If so, the application should 
include a description of the archiving plan in the study design and include 
information about this in the budget justification section of the 
application.  In addition, applicants should think about how to structure 
informed consent statements and other human subjects procedures given the 
potential for wider use of data collected under this award.

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.  Furthermore, 
we caution reviewers that their anonymity may be compromised when they 
directly access an Internet site.

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 
RFA is related to one or more of the priority areas.  Potential applicants 
may obtain a copy of "Healthy People 2010" at 
http://www.health.gov/healthypeople.

AUTHORITY AND REGULATIONS:  This program is described in the Catalog of 
Federal Domestic Assistance Nos. 93.865 (NICHD) and 93.173 (NIDCD) and is not 
subject to the intergovernmental review requirements of Executive Order 12372 
or Health Systems Agency review.  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 described at 
http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 
42 CFR 52 and 45 CFR Parts 74 and 92.  

The PHS strongly encourages all grant recipients to provide a smoke-free 
workplace and discourage the 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.

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