[Federal Register Volume 71, Number 69 (Tuesday, April 11, 2006)]
[Notices]
[Pages 18340-18341]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-5221]


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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 reannouncing the invitation 
for participation in its Regulatory Site Visit Training Program (RSVP). 
This training program is intended to give CBER's regulatory review, 
compliance, and other relevant staff an opportunity to visit biologics 
facilities. These visits are intended to allow CBER staff to directly 
observe routine manufacturing practices and to give staff a better 
understanding of the biologics industry, including its challenges and 
operations. This notice invites biologics facilities interested in 
participating in this program to contact CBER for more information.

DATES: Submit written or electronic requests for participation in this 
program by May 11, 2006.

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 the 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://www.fda.gov/dockets/ecomments.
    If your biologics facility has previously responded to the notice 
announced in the Federal Register of September 23, 2004 (69 FR 57033), 
and you wish to continue to be considered for this year's program, you 
should notify CBER of your continued interest by sending an e-mail to 
[email protected].

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: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    CBER regulates biological products including blood and blood 
products, vaccines, and cellular, tissue, and gene therapies. CBER is 
committed to advancing the public health through innovative activities 
that help ensure the safety, effectiveness, and timely delivery of 
biological products to patients. To support this primary goal, CBER has 
initiated various training and development programs to promote high 
performance of its regulatory review, compliance, and other relevant 
staff. CBER seeks to continuously enhance and update review efficiency 
and quality, and the quality of its regulatory efforts and 
interactions, by providing

[[Page 18341]]

staff with a better understanding of the biologics industry and its 
operations.
    CBER initiated its RSVP in 2005. This program is intended to 
improve CBER's understanding of current practices, regulatory impacts 
and needs, and communication between CBER staff and industry. CBER is 
reannouncing the invitation for participation in its RSVP, and is 
requesting those firms who previously applied and are still interested 
in participating to reaffirm their interest, as well as encouraging new 
interested parties to apply.

II. RSVP

A. Regulatory Site Visits

    In this program, over a period of time to be agreed upon with the 
facility, small groups of CBER staff may observe operations of 
biologics establishments, including, for example, blood and tissue 
establishments. The visits may include packaging facilities, quality 
control and pathology/toxicology laboratories, 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 
function, but are meant to improve mutual understanding and to 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 facilities 
will be based on the coordination of CBER's priorities for staff 
training as well as the limited available resources for this program. 
In addition to logistical and other resource factors to consider, a key 
element of site selection is a successful compliance record with CBER 
or another agency for which we have a memorandum of understanding.

    Dated: March 31, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-5221 Filed 4-10-06; 8:45 am]
BILLING CODE 4160-01-S