Document ID: FDA-2008-N-0045-0008
Agency: fda
Document Type: Notice
Title: Regulatory Site Visit Training Program; December 24, 2008
Posted Date: 2008-12-24T05:00Z

[Federal Register: December 24, 2008 (Volume 73, Number 248)]
[Notices]               
[Page 79133-79134]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24de08-91]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0045] (formerly 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 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 CBER staff a better 
understanding of the biologics industry, including its challenges and 
operations. The purpose of this notice is to invite biologics 
facilities to contact CBER for more information if they are interested 
in participating in this program.

DATES: Submit a written or electronic request for participation in this 
program by January 23, 2009. The request should include a description 
of your facility relative to products regulated by CBER. Please specify 
the physical address of the site(s) you are offering.

ADDRESSES: If your biologics facility is interested in offering a site 
visit or learning more about this training opportunity for CBER staff, 
or if your biologics facility responded to a previous RSVP notice 
announced in the Federal Register, 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.regulations.gov.

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, email: matt@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    CBER regulates certain 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 compliance staff, regulatory review 
staff, 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 CBER staff with a better 
understanding of the biologics industry and its operations. Further, 
CBER seeks to improve: (1) Its understanding of current industry 
practices, and regulatory impacts and needs; and (2) communication 
between CBER staff and industry. CBER initiated its RSVP in 2005, and 
through these annual notices, is requesting those firms that have 
previously applied and are still interested in participating, to 
reaffirm their interest, as well as

[[Page 79134]]

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 dialogue 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. A 
key element of site selection is a successful compliance record with 
CBER or another agency for which we have a memorandum of understanding. 
Facilities should also be advised that if a site visit involves a 
separate physical location of another firm under contract to the 
applicant, then this contract site must be in agreement to participate 
in the program, as well as have a satisfactory compliance history.

III. Requests for Participation

    Requests are to be identified with the docket number found in the 
brackets in the heading of this document. Received requests are 
available for public examination in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: December 19, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-30659 Filed 12-23-08; 8:45 am]

BILLING CODE 4160-01-S