HUMAN PANCREATIC ISLET CELL RESOURCES ADMINISTRATIVE AND BIOINFORMATICS 
COORDINATING CENTER

Release Date:  November 8, 2001

RFA:  RFA-RR-02-002

National Center for Research Resources
 (http://www.ncrr.nih.gov)

Letter of Intent Receipt Date:  January 7, 2002
Application Receipt Date:       February 22, 2002

PURPOSE

The National Center for Research Resources (NCRR) invites applications 
to establish the Administrative and Bioinformatics Coordinating Center 
(ABCC) to coordinate the activities of the consortium of Islet Cell 
Resource centers (ICRs).  Ten ICRs have recently been established to 
isolate, purify and characterize human pancreatic islet cells for 
transplantation into diabetic patients.  

Applicants will compete under this RFA to coordinate ICRs' activities, 
organize their meetings, and correlate data that reflect the efficacy 
of both the methods used to prepare islets and the assays to predict 
functionality and clinical outcome. The ABCC will also manage the 
relevant laboratory and clinical data generated through the activities 
of the ICRs.  While the ABCC may be located within the same institution 
as one of the selected ICRs, the director of the ABCC must remain 
independent of that ICR and any other ICR to both preserve the 
integrity of the studies and avoid any perceived or real conflict of 
interest. 

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic for-profit and not-for-profit 
organizations, public and private organizations, such as universities, 
colleges, hospitals, laboratories, units of state and local 
governments, and eligible agencies of the Federal government.  Foreign 
institutions are not eligible to receive awards under this 
solicitation.  

Individual members of racial and/or ethnic minority groups, women, and 
persons with disabilities are encouraged to apply as principal 
investigators.  All current policies and requirements that govern the 
research grant programs of the National Institutes of Health (NIH) will 
apply to the grant awarded under this RFA.  

MECHANISM OF SUPPORT

The administrative and funding instrument to be used for this program 
will be the cooperative agreement (U42), an assistance mechanism rather 
than an acquisition mechanism, in which substantial NIH scientific 
and/or programmatic involvement with the awardees is anticipated during 
performance of the activity.  Under a cooperative agreement, the NIH 
supports and/or stimulates the recipients' activities by working in 
partnership with the awardee, without assuming the direction of, prime 
responsibility for, or dominance in the activities.  Responsibilities 
for the project as a whole reside with the awardees, although specific 
tasks and activities are shared among the awardees and the NIH 
Institutes and Centers (ICs). Details of the responsibilities, 
relationships, and governance of studies funded under a cooperative 
agreement are discussed later in this document under the section 
entitled "Terms and Conditions of the Award."  

The anticipated award date is July 2002.  The total project period 
for an application submitted in response to this RFA may not exceed 
five years. Although this RFA is currently anticipated to be a one-time 
solicitation, if it is determined that there is a sufficient, 
continuing need, NCRR will invite competitive new and/or competitive 
continuation cooperative agreement applications for review in accord 
with the procedures described in REVIEW CONSIDERATIONS.  

FUNDS AVAILABLE

One award for an ABCC will be made under this RFA.  Over its five-year 
duration, the award would be up to $3.5 million (total direct costs) to 
support its infrastructure.   

Although the financial plans of the NCRR 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 
applications of appropriate scientific and technical merit.  Designated 
funding levels are subject to change at any time prior to final award, 
due to unforeseen budgetary, administrative, or scientific 
developments.  It is not known if new or competing renewal applications 
will be accepted or if this RFA will be reissued.

RESEARCH OBJECTIVES

Background

Diabetes mellitus affects approximately 16 million people in the United 
States.  Individuals with Type I diabetes have lost their ability to 
manufacture sufficient amounts of insulin due to autoimmune destruction 
of the insulin-producing beta cells that are grouped with other types 
of secretory cells within the "islets of Langerhans" of the pancreas.

While injection of exogenous insulin has long been the standard 
treatment for patients with Type I diabetes, transplantation of human 
islet cells may be an alternative.  However, the recovery of functional 
pancreatic islets is a complex procedure and needs to be optimized.  
Several aspects of the process may be critical: the clinical status of 
the donor before removal of the pancreas, surgical procedures involved 
in its excision, the enzymatic dispersal of the pancreatic components, 
the transplantation procedure and the recipient's immunosuppression 
remain to be optimized. 

Selection of appropriate recipients for islet transplantation requires 
characterization of the target population with particular attention to 
their response to insulin therapy.  Reports from the Diabetes Control 
and Complications Trial (DCCT) suggest that intensive treatment 
regimens that achieve tight control of blood glucose can significantly 
reduce the onset and progression of resultant complications in 
individuals with Type I diabetes.  However, some diabetic patients 
practicing tight control experience lability of blood glucose levels in 
response to changes in health status, diet, exercise, or insulin dose. 
Because even small changes in their daily regimen may interfere with 
glucose control, these diabetic patients are said to be "brittle".  For 
this subpopulation, insulin therapy is life saving, but may lead to 
frequent adverse events such as severe hypoglycemia. Islet cell 
transplantation could provide significant benefits to brittle diabetics 
for whom effective regulation by insulin therapy is difficult. 

Objectives and Scope

The objectives of this RFA are to establish a coordinating center that 
will facilitate the ICR efforts to optimize 1) isolation procedures to 
obtain high yields of functional islet cells and providing well-
characterized islet cells for transplantation into Type I diabetes 
patients, 2) the distribution of islet cells to investigators for 
clinical or basic research, and 3) the development of isolation 
procedures that result in maximal islet cell function upon 
transplantation.

The ABCC will 1) be responsible for the organization and conduct of 
Steering Committee meetings whose agendas would include review of 
requests for islets and evaluation of ICR progress; 2) develop 
databases, collect data, organize and analyze the methods and assays 
used to produce islet cells and correlate these data with post-
transplant islet cell function; 3) correlate clinical trial data such 
as patient and donor demographics and baseline assessments, and 
relevant laboratory and clinical data that result from the use of the 
islets generated.  The ABCC will maintain the database into which all 
ICRs and collaborating institutions will deposit their data for 
subsequent analysis.  Respondents to this RFA should also address 
issues such as data storage, archiving, retrieval, analysis and data 
mining, quality control issues, security, and information transfer in 
the application.

Applicants should also include proposals to assist the network of ICRs 
in: 1) recruiting and evaluating pancreas donors, 2) obtaining human 
pancreata; 3) distributing islets to both clinical and basic science 
researchers; 4) ensuring quality control of islet cell isolation and 
provide a scientific basis for their use in transplantation or basic 
research; 5) determining the physiologic and genomic components that 
are correlated with longevity, function and portability of pancreatic 
islets; 6) facilitating approved transplantation protocols and 
correlate consequent clinical responses with characteristics of the 
islets provided.
 
The research plan should follow the instructions in the PHS 398 
application form (rev. 5/01, http://grants.nih.gov/grants/forms.htm).

Program Structure

Applicants should possess expertise and technologies relevant to this 
RFA, providing a structure that can coordinate activities between basic 
science investigators and clinicians to translate basic research 
discoveries into clinical applications.  This includes a thorough 
understanding of current Good Manufacturing Practice (cGMP), Good 
Laboratory Practice (GLP), clinical trial and cell therapy procedures, 
and expertise in biostatistics and bioinformatics.

The ABCC will serve the administrative functions common to the ICRs, 
house the bioinformatics core, maintain the consolidated database, 
provide administrative oversight of the Steering Committee and 
coordinate ICR activities such as complex assays and unique 
technologies that would best be housed in a generally accessible, 
single core.  Independence of the ABCC applicant from any ICR must be 
clearly described in a manner that documents the absence of a conflict 
of interest.  The application for this award should include a plan that 
describes its proposed function, its resources and how it would 
facilitate ICR interactions.  

The Steering Committee will be responsible for scientific oversight and 
development of collaborative interactions among the ICRs. An ABCC 
representative will assist the Steering Committee Chairman and 
participate in Steering Committee meetings as a voting member.  

NIH-supported investigators from both within and outside of the ICRs 
must submit requests to the Steering Committee through the ABCC for 
islets or for any ICR core service.  The Steering Committee would then 
evaluate these requests based on scientific merit.  If required, the 
NCRR may provide a core with additional support for such requests by 
considering the scientific review, program relevance and availability 
of funds.

Specialized Resource Facilities and Services

Applicants should document the availability of unique expertise and 
equipment that would assist the awardee in achieving the goals outlined 
within this RFA.

The application should, at minimum, address:

Experience of key personnel
Experience in coordinating multi-center research programs
Biostatistical and bioinformatics experience and plans 
Existing computer facilities
Coordination of core resources among ICRs
Human Subjects issues
Data Safety Monitoring Plan
Proposed Steering Committee function
Interaction with the ICRs

SPECIAL REQUIREMENTS

The cooperative agreement (U42) will require collaboration among the 
NCRR Program Coordinator, the ICR Steering Committee and its Chairman 
and the ABCC in order to assure efficiency and progress toward the 
stated goals of this RFA.   Plans to develop these synergistic 
relationships should be addressed in each application.  The following 
terms and conditions will be incorporated into the award statement and 
provided to both the Principal Investigator and institutional official 
at the time of award.

Terms and Conditions of Award

These special Terms and Conditions of Award are in addition to, and not 
in lieu of, otherwise applicable OMB administrative guidelines, HHS 
Grant Administration Regulations at 45 CFR Parts 74 and 92, and other 
HHS, PHS, and NIH Grant Administration policy statements.

1.  Awardee Rights and Responsibilities

The ABCC Director must agree to participate as a voting member of the 
ICR Steering Committee.  The ABCC Director, in cooperation with the 
Steering Committee Chairman, ICR Directors, and the other Steering 
Committee members, will be responsible for developing the details of 
the ICR operating policies and documents, including the definition of 
objectives, protocols, implementation, and interaction between the ICRs 
to establish a clinical islet cell resource program that is responsive, 
efficient, and ethical. 

The ABCC Director will have primary responsibility, with concurrence 
from the Chairman of the ICR Steering Committee and the NCRR Program 
Coordinator, in organizing Steering Committee meetings.  The ABCC will 
be responsible for administrative matters related to Steering Committee 
meetings, including preparing agendas, writing and distributing 
minutes, communicating with outside investigators and the lay public 
and receiving investigators' applications that request ICR services. 

In addition, the ABCC will maintain close contact with the ICRs, the 
NCRR Program Coordinator, and the ICR Steering Committee.  It will 
assist in coordinating the research programs and core resources among 
the ICRs, provide biostatistical and bioinformatics support to the 
ICRs, maintain current and relevant databases, arrange appropriate 
advertising and publicity for the ICRs upon approval by the Steering 
Committee and prepare a comprehensive annual report for the program in 
a timely fashion.  

The ABCC Director must present an update of his/her relevant activities 
at each meeting that will be held either by telephone conference call 
or in the metropolitan Washington D.C. area.  The ABCC will be 
responsible for all administrative aspects of the Steering Committee 
meetings.  The ABCC Director will be responsible for submission of the 
ABCC Annual Progress Report and other reports to NCRR in compliance 
with NIH and other Federal Guidelines.

2.  I/C Staff Responsibilities

One Health Scientist Administrator from the NCRR will be designated to 
serve as the NCRR Program Coordinator of this cooperative agreement. 
This individual will assist in coordinating the activities of the ICRs 
and ABCC and in facilitating exchange of information between them and 
NCRR.

NCRR reserves the right to terminate or modify this award in the event 
of (a) failure to develop, implement or maintain mutually acceptable 
procedures, (b) substantial shortfall in efficiency, data reporting, 
quality control, or other such major breach, (c) substantive changes in 
agreed-upon policies or procedures with which the Funding Entities 
cannot concur, (d) ethical issues, (e) significant non-compliance with 
relevant Federal guidelines.

3.  Collaborative Responsibilities

The ICR Steering Committee membership will include the ICR Directors, 
the ABCC Director, the NCRR Program Coordinator, one NIDDK Program 
Officer, one JDRFI Representative, and outside experts recommended by 
the ICR Directors to balance the composition and size of the Steering 
Committee to both provide requisite expertise and guarantee that the 
entire number of NIH representatives does not exceed 40 percent of the 
total membership.  Each member, including the outside experts, will 
have one vote on matters discussed at the Steering Committee meeting.  
The ICR Steering Committee Chairperson is appointed by the Director of 
the Division of Clinical Research, NCRR.

The Steering Committee coordinates and facilitates the activities 
supported by this cooperative agreement. As a member of the Steering 
Committee, the Director of the ABCC will participate in the 
establishment of the policies and operating procedures of both itself 
and the ICRs.  The ABCC will assist in the generation of the Policy and 
Procedure Document. The Document will include descriptions of the 
requirements for basic and clinical research protocols to use ICR-
generated islets including quality control, quality assurance, testing 
procedures, human subjects protection, conflict of interest, and 
intellectual property and regulatory issues as they evolve throughout 
the duration of the studies.  The Steering Committee will also make 
provisions for an arbitration panel as described below.  Criteria for 
accession and discontinuance of use of the ICR facility will also be 
delineated. The Director of NCRR will review and must approve these ICR 
guidelines prior to their implementation.

The Steering Committee will meet three times during the first year of 
ICR awards and semi-annually, thereafter.  The ABCC will work with the 
ICR Directors to formulate consistent policies for dealing with 
recurring situations that require coordinated action at Steering 
Committee meetings.  

Data and Safety Monitoring Board

All clinical protocols supported by ICR resources must engage a Data 
and Safety Monitoring Board (DSMB), which will provide overall 
monitoring of interim data and safety issues.  The DSMBs should be 
assembled by the institutions or funding organizations that sponsor 
those clinical protocols.  

Intellectual Property

The Bayh-Dole Act is implemented through Department of Commerce 
regulations 37 CFR 401.  These regulations define terms, parties, 
responsibilities, prescribe the order of disposition of rights, 
prescribe a chronology of reporting requirements, and delineate the 
basis for and extent of government actions to retain rights.   The 
patent rights clauses are found at 37 CFR Part 401.14 and are 
accessible from the Interagency Edison web page, www.iedison.gov .  ICR 
awardees will have primary rights to their data developed under these 
awards, subject to Government rights of access consistent with current 
Federal policies.  

Database

Information developed as a result of ICR activities will be held in a 
central database by the ABCC.  Such data will include, for 
example, laboratory procedures, methods of data analysis and reports.  
The database will not be distributed to the public until the relevant 
studies have been completed and only with the concurrence of the 
Steering Committee.  The database must be designed to protect patient 
identity and ensure the privacy of their medical and genetic data.

Publication

After approval by the Steering Committee, the awardee will facilitate 
the publication and public dissemination of results, data and other 
information developed by this cooperative agreement.  Such documents, 
written by an individual ICR or by a consortium of ICRs, may be 
published only after approval by the Steering Committee.  However, 
during or within three years beyond the end date of the project support 
period, unpublished data, unpublished results, data sets not previously 
released, or other study materials or products are to be made available 
to any third party only with the approval of the Funding Entities and 
in accordance with the stipulations within this document.

Arbitration

Any disagreement that may arise between the award recipient and NCRR on 
scientific or programmatic matters may be brought to arbitration.  A 
panel of external consultants will be created, and convened as needed, 
to resolve any irreconcilable differences of opinion related to such 
matters.  The panel will include one member selected by the awardee, 
one member selected by NCRR, and a third member chosen by the other two 
members of the arbitration panel.  These special arbitration procedures 
in no way affect an awardee's right to appeal an adverse determination 
in accordance with PHS regulations at 42 CFR part 50, subpart D and HHS 
regulations at 45 CFR part 16.  Applicants should anticipate probable 
areas of conflict and put forward an arbitration plan in their 
applications.

LETTERS OF INTENT

Prospective applicants are asked to submit a letter of intent that 
includes a descriptive title of the proposed application, the name, 
address, and telephone number of the Principal Investigator and his/her 
institution, the identities of other key personnel, and the number and 
title of this RFA.  Although a letter of intent is neither required nor 
binding, and does not enter into the review of a subsequent 
application, its contents allow NCRR staff to estimate the potential 
review workload and plan the review.

The letter of intent is to be faxed, e-mailed, or mailed to Charles H. 
Hollingsworth, Dr.P.H., at the address listed under INQUIRIES by 
January 7, 2002.

APPLICATION PROCEDURES

The PHS 398 research grant application instructions and forms (rev. 
5/2001) available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html must be used in 
applying for these grants. This version of the PHS 398 is available in 
an interactive, searchable format.  For further assistance contact 
GrantsInfo, Telephone 301/435-0714, Email:  GrantsInfo@nih.gov.

Material to Include in the Application

An application to establish the ABCC should be submitted by the 
proposed Director who will be responsible for organizing and 
maintaining the ABCC program.  A clear description of the plans for 
communication, interaction, collaboration and sharing between ICRs 
should be included.  The proposed Director should also articulate 
procedures for handling day-to-day issues, both administrative and 
scientific. The Director should have the responsibility for oversight 
and coordination of all projects or components involving the ABCC.  
Support for at least 0.25 FTE will be provided for the position of ABCC 
Director.  Provision will be made for partial support for qualified 
support staff to assist in the direction of the ABCC and additional 
support for individuals to perform technical procedures. The 
application should detail how this would be accomplished 

In addition, the applicant must describe any collaborating institution 
that would participate with the ABCC in achieving the goals described 
in this RFA.  Each application must also describe any institutional 
oversight procedures to be employed and must clearly outline the 
proposed administrative and organizational structure of their proposed 
ABCC, including integration, collaborative arrangements, and roles for 
key participants from all institutions engaged in ABCC activities. The 
applicant must also state willingness to participate in the Steering 
Committee and agree to abide by its governance.

Description of Proposed Resources

Applicants to this RFA should consider the points below as examples of 
relevant information to include in the application.  These are examples 
only and should not be construed as being required or limiting. 
Applicants are encouraged to address these and/or other points 
pertinent to the objectives of the RFA.

Each application for the ABCC award must propose the procedures to 
administer the ICR Program, identify functions common to all ICRs that 
will be facilitated, describe the procedures that will maintain a 
current database and manage an intranet web site.  Only one ABCC will 
be selected based upon peer-review of these proposals.  

Convey an understanding of the scientific, statistical, logistical, 
and technical issues underlying multi-center studies, including those 
relating to islet cell isolation and islet cell transplantation.

Describe the qualifications of the applicant to take a leadership 
role in the area of study design, statistics, logistics, data 
acquisition and management, patient confidentiality, handling of 
laboratory specimens, quality control, data analysis, cGMP and GLP 
compliance and network coordination. 

Describe plans for interaction with the NIDDK-supported Islet Cell 
Transplant Registry.

Since the ICRs must comply with the intent of cGMP for Phase I and II 
clinical trials, isolation of islet cells must follow a set of current, 
scientifically sound methods, practices or principles that are 
implemented and documented during product development and production to 
ensure the consistent production of islet cells that can be 
administered safely and with consistent purity and functional capacity.  
Describe the applicant's experience in and knowledge of elements of 
cGMP that would be used in the isolation of islet cells, such as: 
a)adequate documentation/records; b) production and process controls; 
c) quality control/assurance; and d) submission of relevant information 
to the FDA in support of an IND application.  

Address the expertise, training and experience of the proposed ABCC 
staff, including the administrative abilities, in operating a 
"coordinating center" of the kind described in this RFA.

Provide a plan to acquire, transfer, manage, analyze and monitor 
basic laboratory information and clinical data generated through the 
use of ICR resources.

Propose a process to coordinate the activities of all of the ICRs and 
those of the Steering Committee.  Include the administrative, 
supervisory, and collaborative arrangements for achieving the goals of 
the program, and a willingness to cooperate with the ICRs, the Steering 
Committee and NCRR Program Coordinator.

Describe the facilities, equipment, and organizational structure 
available to coordinate ICR basic and clinical research activities.

Describe how assay and disbursement data will be tracked for each lot 
of islet cells.

Outline the procedure to collate and analyze data from ongoing 
clinical and basic research studies that use ICR resources.

Describe any data management services will be provided to the ICRs.

Provide a description of the statistical support for protocol design 
and analyses of completed protocols.

Describe the plan to interact with the DSMBs that are responsible for 
oversight of the clinical protocols that utilize ICR resources.

Propose how timely reports will be made to DSMBs, the Steering 
Committee, and other relevant oversight and regulatory bodies.

Detail how privacy and security of all patient information as well as 
access by controlled authorization will be ensured.

Describe how investigators could be assisted during their preparation 
of abstracts and manuscripts and how the publications would be tracked.

Justify the proposed budget and personnel requested.

Since human somatic cell transplantation involves the administration of 
materials of biological products, it is regulated by the Center for 
Biologics Evaluation and Research (CBER), FDA.  IND applications are 
filed concerning clinical use of such products.  Respondents to this 
RFA should convey their familiarity with such requirements for 
clinical, pre-clinical and animal studies.

CBER has prepared documents relevant to this RFA that include:

Information on Submitting an Investigational New Drug Application, 
including cGMP and GLP, for a Biological Product available at:
http://www.fda.gov/cber/ind/ind.htm

PANCREATIC ISLET SPECIFIC DOCUMENTS

Dear Colleague Letter to Transplant Centers: Allogeneic Pancreatic 
Islets for Transplantation (9/2000) available at:
http://www.fda.gov/cber/ltr/allpan090800.pdf

Transcript of discussion of allogeneic pancreatic islets by FDA 
Biologic Response Modifier Advisory Committee (3/20-21/2000) available 
at: http://www.fda.gov/ohrms/dockets/ac/cber00.htm

PROPOSED AND FINAL RULES IMPACTING HUMAN ISLETS

FEDERAL REGISTER Establishment Registration and Listing for 
Manufacturers of Human Cellular and Tissue-Based Products; Final Rule 
(1/2001) available at: http://www.fda.gov/cber/rules/frtisreg011901.pdf

FEDERAL REGISTER Current Good Tissue Practice for Manufacturers of 
Human Cellular and Tissue-Based Products; Inspection and Enforcement; 
Proposed Rule (1/2001) available at: 
http://www.fda.gov/cber/rules.htm#gtp

CELL/TISSUE BASED DOCUMENTS

"Guidance for Industry: Guidance for Human Somatic Cell Therapy and 
Gene Therapy" (1998)available at: 
http://www.fda.gov/cber/gdlns/somgene.pdf

"Points to Consider in the Characterization of Cell Lines Used to 
Produce Biologicals" (1993) available at:  
http://www.fda.gov/cber/gdlns/ptccell.pdf

"Points to Consider in the Manufacture and Testing of Monoclonal 
Antibody Products for Human Use" (1997) available at: 
http://www.fda.gov/cber/gdlns/ptc_mab.pdf

Application of GMP to Gene Therapy Products Used in Clinical Trials 
(5/31/2000)  http://www.fda.gov/cber/summaries/malarkey053100.ppt

Copies of Points to Consider documents are available from:

The Division of Congressional and Public Affairs
CBER
HFM-12
1401 Rockville Pike, Suite 200 N
Rockville, MD  20852-1448
Telephone:  (301) 594-0830

CBER staff members are also available to respond to questions at (301) 594-0830.

BUDGET AND RELATED ISSUES

Applicants should complete the budget information as directed in the 
PHS 398 application form.

Allowable costs

In order to fully achieve the goal of this initiative, an award of up 
to $700,000 total direct costs will be awarded annually to the ABCC for 
support of administrative and bioinformatics activities.  

Applications should present five budget periods of 12 months each that 
provide adequate budget justification for all applicable direct and F&A 
costs.  An estimate of personnel costs needs, including the principal 
investigators, other professional and support staff must be included.  
A minimum effort of 0.25 FTE is required for the ABCC Director.  
Estimates of travel costs to Steering Committee and Data Committee 
meetings as well as a statement that indicates a willingness to 
participate in these meetings must also be included.  

APPLICATIONS NOT CONFORMING TO THESE GUIDELINES WILL BE CONSIDERED 
UNRESPONSIVE TO THIS RFA AND WILL BE RETURNED WITHOUT FURTHER REVIEW

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.

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
Two Rockledge Centre, Room 1040-MSC7710
6701 Rockledge Drive
Bethesda, MD  20892-7710
(or Bethesda, MD  20817 if express mail or courier service is used)

At the time of submission, two additional copies of the application 
must be sent to the Director, Office of Review, NCRR, at the address 
listed under INQUIRIES.

Applications must be received by February 22, 2002.  If an application 
is received after this 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 an application already 
reviewed, but such applications must include an Introduction addressing 
the previous critique.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by the 
Center for Scientific Review and for responsiveness by NCRR.  
Applications that are incomplete or non-responsive will be returned to 
the applicant without further consideration.  Applications must adhere 
to the page limitations and Special Application Requirements noted 
under the section APPLICATION PROCEDURES above to be considered 
responsive.  

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 Office of Review, NCRR 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 merit, generally the top half 
of the applications under review, will be discussed, assigned a 
priority score, and receive a second level review by the National 
Advisory Research Resources Council.

Review Criteria

The goals of NIH-supported research are to advance understanding of 
biological systems, improve the control of disease, and enhance the 
health of humankind.  The scientific and technical merits of the 
proposed activities and the organizational plans for participating in 
this cooperative agreement and the extent to which they address the 
overall goals and objectives of the RFA will be reviewed.  

ABCC applicants will be evaluated on the basis of:

Responsiveness and innovative approaches to major objectives of this 
RFA;

Prior experience in organizing and oversight of multi-centered basic 
and translational research studies and plans to extend this to the ICRs;

Planned organization, oversight and administration of the ICR Program;

Knowledge and experience in clinical trial oversight and cGMP and GLP 
compliance regulations

Plans to coordinate ICR activities and to make ICR cores and resources 
available to other ICRs and NIH-supported investigators; 

Adequacy of ancillary facilities and equipment;

Evidence of institutional support;

Adequacy of the biostatistical and data acquisition/storage methods to be used;

Integration of ABCC efforts with bioinformatics cores located within 
ICR institutions.  

Availability of computer technologies and equipment suitable for ICR oversight;

Qualifications of personnel;

Letters of planned or existing collaboration;  

Letters of reference from principal investigators who have participated 
in multi-center basic research or clinical research trial overseen by 
the ABCC applicant. 

ABCC applications will also be evaluated with regard to the likelihood 
that they will function in a synergistic manner and interact well with 
the other proposed components.  Appropriateness of their proposed 
budgets will also be considered.

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

The adequacy of plans to include, recruit and retain both genders, 
minorities and their subgroups, and children as appropriate for the 
scientific goals of the 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.  

The training course(s) taken by key personnel addressing the protection 
of human subjects must be included in the application.  For this 
purpose, key personnel are defined as individuals who design or conduct 
clinical research protocols.  

A discussion of data safety monitoring must also accompany the 
application.

Schedule

Letter of Intent Receipt Date:  January 7, 2002
Application Receipt Date:       February 22, 2002
Peer Review Date:               March-April 2002
Council Review:                 May 16, 2002
Anticipated Award Date:         July 2002

AWARD CRITERIA

Factors that will be considered in making awards include: a) the 
administrative and scientific merit of the proposed program as 
determined by peer review in addition to the quality of the response to 
the requirements stated in this RFA; b) relevance to the overall 
programs and priorities of NCRR, c) compatibility of the features 
proposed in the plan with the qualifications of the applicant; and d) 
the availability of funds.  The earliest anticipated date of award is 
July 2002.  The award will be subject to administrative review by NCRR 
staff upon receipt of each annual non-competitive renewal application.

INQUIRIES

Inquiries concerning this RFA are encouraged.  We welcome the 
opportunity to clarify any issues or respond to questions from 
potential applicants.

Direct inquiries regarding programmatic issues to:

Richard A. Knazek, M.D. 
Medical Officer
Division of Clinical Research 
National Center for Research Resources
One Rockledge Centre, Room 6030
6705 Rockledge Drive, MSC 7965
Bethesda, MD  20892-7965
Telephone:  (301) 435-0792
FAX:  (301) 480-3661
Email:  richardk@ncrr.nih.gov

Direct inquiries regarding review issues to:

Charles H. Hollingsworth, Dr.P.H.
Director, Office of Review
National Center for Research Resources
One Rockledge Centre, Room 6018
6705 Rockledge Drive, MSC 7965
Bethesda, MD  20892-7965
Telephone:  (301) 435-0806
FAX:  (301) 480-3660
Email:  charlesh@ncrr.nih.gov

Direct inquiries regarding fiscal matters to:

Ms. Mary Niemiec
Section Grants Management Officer
Office of Grants Management
National Center for Research Resources
One Rockledge Centre, Room 6086
6705 Rockledge Drive, MSC 7965
Bethesda, MD  20892-7965
Telephone:  (301) 435-0844
FAX:  (301) 480-3777
Email:  maryn@ncrr.nih.gov 

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.

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 all priority areas.  Potential applicants may obtain a copy 
of "Healthy People 2010" at http://www.health.gov/healthypeople/.

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 sub-populations 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 
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 research involving human subjects should 
read the AMENDED "NIH Policy and Guidelines on the Inclusion of Women 
and Minorities as  Subjects in Clinical Research - Amended, October, 
2001," 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_20
01.htm,  announced 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.  The amended policy incorporates: the use of an NIH 
definition of clinical research; updated racial and ethnic categories; 
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 with this 
policy.  The amended policy provides additional guidance on the 
analyses and reporting of analyses of sex/gender, racial/ethnic and 
relevant subpopulation differences in intervention effects for NIH-
defined Phase III clinical trials. 

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 NIH, unless there are clear and compelling scientific and 
ethical reasons not to include them. This policy applies to all initial 
(Type I) 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 was published 
in the NIH Guide for Grants and Contracts, March 6, 1998 and is 
available at the following URL address: 
http://grants.nih.gov/grants/guide/notice-files/not98-024.html. 

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

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.

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance 
No. 93.333.  Awards are made under authorization of the Public Health 
Service Act, Titles III and IV, Sections 301, 479, and 480, as amended, 
Public Laws 78-410 and 99-158, 42 U.S.C. 241, 287, and 287a, as 
amended, and administered under NIH grants policies and Federal 
Regulations 42 CFR 52 and 45 CRF Part 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 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.


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