80 FR 8329 - Regulatory Site Visit Training Program

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 31 (February 17, 2015)

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.

[Federal Register Volume 80, Number 31 (Tuesday, February 17, 2015)]
[Notices]
[Pages 8329-8330]
From the Federal Register Online  [www.thefederalregister.org]
[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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