E9-6687. Center for Biologics Evaluation and Research eSubmitter Pilot Evaluation Program for Source Plasma Establishments

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 to participate in a pilot evaluation program for CBER's eSubmitter Program (eSubmitter). CBER's eSubmitter has been customized as an automated biologics license application (BLA) and BLA supplement (BLS) submission system for blood and blood components. Participation in the pilot program is open to blood establishments that collect Source Plasma. The pilot program is intended to provide industry and CBER regulatory review staff the opportunity to evaluate the eSubmitter system and determine if it facilitates the BLA/BLS submission process. The purpose of this notice is to invite blood establishments that collect Source Plasma to submit a request to CBER if they are interested in participating in this pilot program.

DATES:

Submit a written or electronic request for participation in this program by April 27, 2009. You should include the following information in your request: contact name, contact phone number, e-mail address, name of the establishment, address, and license number (if applicable).

ADDRESSES:

If you are interested in participating in this program, 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:

Lore Fields, Center for Biologics Evaluation and Research (HFM-375), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-6143, Fax: [phone], or e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

I. Background

CBER regulates certain biological products, including blood and blood products, and is committed to advancing the public health through innovative activities that help ensure the safety, effectiveness and timely delivery of these products to patients. Further, CBER seeks to continuously enhance and update review efficiency and quality, and the quality of its regulatory efforts and interactions, by providing CBER staff and industry with improved processes. In support of this goal, CBER has participated in the FDA development of a computer-assisted automated BLA/BLS submission program called eSubmitter to improve the process for providing certain regulatory submissions to FDA. The eSubmitter will include programs to submit applications for licensure, supplements to an approved license, and amendments to pending applications or supplements.

II. The eSubmitter Pilot Evaluation Program Expectations

The eSubmitter pilot evaluation program is expected to last approximately 6 months. During this period of time, participants will complete BLA/BLS regulatory submissions using the eSubmitter template developed at CBER for use by Source Plasma establishments. The eSubmitter was developed using the same review criteria for applications for these products as currently used in the BLA/BLS review process at CBER. During the BLA/BLS submission process, the participants will enter the requested information into the eSubmitter tool and attach requested documents as an Adobe document (pdf format). This information will be saved onto a CD-ROM and mailed to CBER for review. Paper copies of submissions will not be required. CBER will review the information provided on the CD-ROM and the attachments according to current managed review procedures.

During the BLA/BLS submission process, CBER staff will be available to answer any questions or concerns that may arise. As each submission is completed, the users will be asked to comment on the eSubmitter program. These discussions will assist CBER in the final development and release of this electronic tool for use by industry.

III. Requests for Participation

Requests to participate in the eSubmitter pilot are to be identified with the docket number found in brackets in the heading of this document. Once requests for participation are received, FDA will contact interested establishments to discuss the pilot program.

Dated: March 20, 2009.

Jeffrey Shuren,

Associate Commissioner for Policy and Planning.