[Federal Register Volume 75, Number 26 (Tuesday, February 9, 2010)]
[Notices]
[Page 6404]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-2758]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 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 March 11, 2010. 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, 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. 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, e-mail: <a href="/cdn-cgi/l/email-protection#deb3bfaaaa9eb8babff0b6b6adf0b9b1a8"><span class="__cf_email__" data-cfemail="d5b8b4a1a195b3b1b4fbbdbda6fbb2baa3">[email protected]</span></a>.

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, 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 requesting 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. 
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

    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: February 4, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-2758 Filed 2-8-10; 8:45 am]
BILLING CODE 4160-01-S


</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>