[Federal Register: September 23, 2004 (Volume 69, Number 184)]
[Notices]
[Page 57033-57034]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23se04-71]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N-0408]
Regulatory Site Visit Training Program
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration's (FDA's) Center for
Biologics Evaluation and Research (CBER) is announcing the initiation
of a Regulatory Site Visit Training Program. This program is intended
to give CBER's regulatory review staff, compliance staff, and other
relevant staff an opportunity to visit biologics facilities. The visit
is intended to provide first hand experience to CBER staff and to give
a better understanding of the biologics industry, including its
challenges and its operations. The purpose of this notice is to invite
biologics companies interested in participating in this program to
contact CBER for more information.
DATES: Submit a written or electronic requests for participation in
this program by October 25, 2004.
ADDRESSES: If your biologics facility is interested in offering a site
visit or learning more about this training opportunity for CBER staff,
you should submit a request to participate in this program to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic
requests to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT: Lonnie Warren-Myers, Division of
Manufacturers Assistance and Training, Center for Biologics Evaluation
and Research (HFM-49), Food and Drug Administration, 1401 Rockville
Pike, suite 200N, Rockville, MD 20852-1448, 301-827-2000, FAX: 301-827-
3079, e-mail: cbertrainingsuggestions@cber.fda.gov.
SUPPLEMENTARY INFORMATION:
I. Background
CBER regulates biological products including blood and blood
products, vaccines, and cellular and gene therapies. CBER is committed
to advancing the public health through innovative regulations that help
ensure the safety, effectiveness, and timely delivery to patients of
biological products. CBER has initiated various training and
development programs to promote high performance of its regulatory
review staff, compliance staff, and other relevant CBER staff. CBER
seeks to continuously enhance and update review efficiency and quality
as well as the quality of its regulatory efforts and interactions. CBER
is initiating the Regulatory Site Visit Training Program to provide
CBER staff the opportunity to visit biologics facilities to observe
first-hand the industry's biologic development and manufacturing
processes and thereby obtain better understanding of the biologics
industry and its operations.
Further, this program is intended to improve CBER's understanding
of current practices, regulatory impacts and needs, and improve
communication between CBER staff and industry. The first phase of the
program will focus on blood, plasma, and fractionation industries
including transfusion centers, although other industries may be
considered including vaccines, cellular and gene therapy, and tissues.
II. The Regulatory Site Visit Training Program
A. Regulatory Site Visits
In this program, over a period of time to be agreed upon with the
biologics facility, small groups (five or less) of CBER staff may
observe operations of biologics manufacturing, packaging, pathology/
toxicology laboratory testing, and regulatory affairs operations. These
visits, or any part of the program, are not intended as a mechanism to
inspect, assess, judge, or perform a regulatory enforcement function,
but are meant to improve mutual understanding and to
[[Page 57034]]
provide an avenue for open dialog between the biologics industry and
CBER.
B. Site Selection
All travel expenses associated with the site visits will be the
responsibility of CBER. Therefore, selection of potential biologics
facilities will be based on the coordination of CBER's priorities for
staff training and the limited available resources for this program.
Dated: September 16, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-21318 Filed 9-22-04; 8:45 am]
BILLING CODE 4160-01-S