[Federal Register Volume 80, Number 31 (Tuesday, February 17, 2015)]
[Notices]
[Pages 8329-8330]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-03117]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0824]
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 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 March 19, 2015. 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
offering.
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: Loni Warren Henderson, Division of
Manufacturers Assistance and Training, Center for Biologics Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 71, Rm. G112, Silver Spring, MD 20993-0002, 240-402-7800, FAX:
301-595-1243, [email protected].
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 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.
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 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.
[[Page 8330]]
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 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
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: February 10, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-03117 Filed 2-13-15; 8:45 am]
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