E8-30659. 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 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 January 23, 2009. The request should include a description of your facility relative to products regulated by CBER. Please specify the physical address of the site(s) you are offering.

ADDRESSES:

If your biologics facility is interested in offering a site visit or learning more about this training opportunity for CBER staff, or if your biologics facility responded to a previous RSVP notice announced in the Federal Register, 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.

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], email: [e-mail].

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 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 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 improve: (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 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 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. A key element of site selection is a successful compliance record with CBER or another agency for which we have a memorandum of understanding. Facilities should also be advised that if a site visit involves a separate physical location of another firm under contract to the applicant, then this contract site must be in agreement 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: December 19, 2008.

Jeffrey Shuren,

Associate Commissioner for Policy and Planning.