[Federal Register: September 23, 2004 (Volume 69, Number 184)]
[Page 57033-57034]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2004N-0408]

Regulatory Site Visit Training Program

AGENCY: Food and Drug Administration, HHS.

ACTION:  Notice.


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.


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 

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]