
[Federal Register: September 19, 2008 (Volume 73, Number 183)]
[Notices]               
[Page 54405-54406]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19se08-60]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0038]

 
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.

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    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

[[Page 54406]]

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: 301-827-3079; 
e-mail: spl@fda.hhs.gov (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 spl@fda.hhs.gov.
    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.
[FR Doc. E8-21968 Filed 9-18-08; 8:45 am]

BILLING CODE 4160-01-S
