E8-21968. Structured Product Labeling Content of Labeling and Electronic Drug Establishment Registration and Drug Listing for the Biologics Industry; Public Workshop

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of public workshop.

The Food and Drug Administration (FDA) is announcing a public workshop entitled “Structured Product Labeling (SPL) Content of Labeling and Electronic Drug Establishment Registration and Drug Listing for the Biologics Industry.” The purpose of the public workshop is to provide the biologics industry with guidance on submitting to FDA content of labeling in SPL format, present an overview of FDA's voluntary pilot program for electronic submission of drug establishment registration and drug listing information under the regulations, and exhibit vendor SPL authoring tools that may be used in the creation and manipulation of SPL content of labeling.

Date and Time: The public workshop will be held on November 17, 2008, from 8:30 a.m. to 4 p.m.

Location: The public workshop will be held at the Universities at Shady Grove, Multipurpose Room, Building II, 9630 Gudelsky Dr., Rockville, MD 20850.

Contact Person: Donna Lipscomb, Center for Biologics Evaluation and Research (HFM-43), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-2000, FAX: [phone]; e-mail: [e-mail] (Subject line: CBER SPL Public Workshop).

Registration: Mail, FAX, or e-mail your registration information (including name, title, firm name, address, telephone and fax numbers) to the contact person by October 30, 2008. There is no registration fee for the public workshop. Early registration is recommended because seating is limited. Registration on the day of the public workshop will be provided on a space-available basis beginning at 8 a.m.

Vendor Registration: Vendors wishing to exhibit their SPL authoring tools at this public workshop must register and submit their registration information (including name, title, firm name, address, telephone and fax numbers) to the contact person by October 30, 2008, via e-mail to [e-mail].

If you need special accommodations due to a disability, please contact Donna Lipscomb (see Contact Person) at least 7 days in advance.

SUPPLEMENTARY INFORMATION:

FDA is announcing a public workshop to provide the biologics industry with guidance on submitting to FDA content of labeling in SPL format and to present an overview of FDA's voluntary pilot program for electronic submission of drug establishment registration and drug listing information under the regulations in part 207 (21 CFR part 207).

FDA's Center for Biologics Evaluation and Research (CBER) has stated in a memorandum, posted on July 11, 2008, to Docket No. FDA-1992-S-0039 (formerly 1992S-0251), that beginning October 15, 2008, SPL in XML (extensible markup language) is the acceptable presentation in electronic format for the submission of content of labeling that CBER can process, review, and archive. This applies to the content of labeling with original submissions, supplements, and annual reports. Individuals may electronically access CBER's notification on the submission of SPL content of labeling at http://www.fda.gov/​oc/​datacouncil/​spl.html.

In the Federal Register of July 11, 2008 (73 FR 39964), FDA announced the availability of a draft guidance for industry entitled “Providing Regulatory Submissions in Electronic Format—Drug Establishment Registration and Drug Listing.” This draft guidance established a pilot program for industry to voluntarily submit drug establishment registration and drug listing information in SPL format. The draft guidance only applies to drug establishments that currently register their establishments and list their products under the regulations in part 207 and explains how to transition from submitting the required information on paper to submitting the required information using the SPL standard. The draft guidance also describes how to voluntarily submit additional useful, but not required, information that currently is often included by industry in their registration and listing paper submissions. FDA plans to complete the voluntary pilot program and begin receiving drug establishment and drug listing information only electronically and only in SPL format (including labeling) beginning June 1, 2009, unless a waiver is granted.

This public workshop will feature presentations by FDA experts on SPL content of labeling and electronic drug establishment registration and drug listing. In addition, registrants will have access to a vendor exhibition of SPL authoring tools.

Dated: September 15, 2008.

Jeffrey Shuren,

Associate Commissioner for Policy and Planning.