Federal Register: February 9, 2010 (Volume 75, Number 26)
DOCID: fr09fe10-89 FR Doc 2010-2758
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket ID: [Docket No. FDA-2008-N-0045] (formerly Docket No. 2004N-0408)
NOTICE: NOTICES
DOCID: fr09fe10-89
ACTION: Medical Devices Regulated by the Center for Biologics Evaluation and Research:
DOCUMENT ACTION: Notice.
SUBJECT CATEGORY:
Regulatory Site Visit Training 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.
DOCUMENT 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.
SUMMARY:
Regulatory Site Visit Training Program
SUPPLEMENTAL 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. 20102758 Filed 2810; 8:45 am]
BILLING CODE 416001S
FOR FURTHER INFORMATION CONTACT
Lonnie W. Henderson, Division of Manufacturers Assistance and Training, Center for Biologics Evaluation and Research (HFM49), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 208521448, 3018272000, FAX: 301827 3079, email: matt@fda.hhs.gov.