[Federal Register Volume 76, Number 234 (Tuesday, December 6, 2011)]
[Page 76168]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-31152]

[[Page 76168]]



Food and Drug Administration

[Docket No. FDA-2011-N-0824]

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 an 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 document is to invite biologics 
facilities to contact CBER for more information if they are interested 
in participating in this program.

DATES: Submit either an electronic or written request for participation 
in this program by January 5, 2012. The request should include a 
description of your facility relative to products regulated by CBER. 
Please specify the physical address(es) of the site(s) you are 

ADDRESSES: If your biologics facility is interested in offering a site 
visit, submit either an electronic request to http://www.regulations.gov or a written request to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852. If you previously responded to earlier 
requests to participate in this program and you continue to be 
interested in participating, please renew your request through a 
submission to the Division of Dockets Management.

FOR FURTHER INFORMATION CONTACT: Lonnie W. Henderson, 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: [email protected].


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 availability 
of biological products to patients. To support this primary goal, CBER 
has initiated various training and development programs, including 
programs to further enhance 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 enhance: (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. Through these annual notices, CBER is requesting that those 
firms that have previously applied and are still interested in 
participating reaffirm their interest. CBER is also requesting that new 
interested parties apply.


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 the following: (1) Packaging 
facilities, (2) quality control and pathology/toxicology laboratories, 
and (3) 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

    CBER will be responsible for all travel expenses associated with 
the site visits. 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 FDA or another 
Agency with which we have a memorandum of understanding. If a site 
visit also involves a visit to a separate physical location of another 
firm under contract to the applicant, the other firm also needs to 
agree to participate in the program, as well as have a satisfactory 
compliance history.

III. Requests for Participation

    Identify requests for participation 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 
(see ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: November 30, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-31152 Filed 12-5-11; 8:45 am]