E6-5221. 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 reannouncing the invitation for participation in its Regulatory Site Visit Training Program (RSVP). This training program is intended to give CBER's 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 staff a better understanding of the biologics industry, including its challenges and operations. This notice invites biologics facilities interested in participating in this program to contact CBER for more information.

DATES:

Submit written or electronic requests for participation in this program by May 11, 2006.

ADDRESSES:

If your biologics facility is interested in offering a site visit or learning more about this training opportunity for CBER staff, 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.fda.gov/​dockets/​ecomments.

If your biologics facility has previously responded to the notice announced in the Federal Register of September 23, 2004 (69 FR 57033), and you wish to continue to be considered for this year's program, you should notify CBER of your continued interest by sending an e-mail to [e-mail].

FOR FURTHER INFORMATION CONTACT:

Lonnie Warren-Myers, 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: [phone], e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

I. Background

CBER regulates 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 timely delivery of biological products to patients. To support this primary goal, CBER has initiated various training and development programs to promote high performance of its regulatory review, compliance, 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 staff with a better understanding of the biologics industry and its operations.

CBER initiated its RSVP in 2005. This program is intended to improve CBER's understanding of current practices, regulatory impacts and needs, and communication between CBER staff and industry. CBER is reannouncing the invitation for participation in its RSVP, and is requesting those firms who previously applied and are still interested in participating to reaffirm their interest, as well as encouraging 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 dialog 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 CBER or another agency for which we have a memorandum of understanding.

Dated: March 31, 2006.

Jeffrey Shuren,

Assistant Commissioner for Policy.