[Federal Register Volume 68, Number 71 (Monday, April 14, 2003)]
[Notices]
[Pages 17959-17960]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-9063]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 03N-0134]


Team Biologics Program Effectiveness; Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
following public meeting: Team Biologics Program Effectiveness. The 
Center for Biologics Evaluation and Research and the Office of 
Regulatory Affairs, FDA, are sponsoring an open public meeting to 
solicit views and comments in an effort to measure the effectiveness of 
the Team Biologics Program as it relates to the inspections of 
manufacturers of vaccines, allergenics, fractionated plasma products, 
licensed in vitro diagnostics, and therapeutic products. The goal of 
the public meeting is to give stakeholders the opportunity to provide 
input on how they think the agency should measure the effectiveness of 
the Team Biologics Program. We will use the information obtained to 
identify criteria to prospectively evaluate the Team Biologics Program.

DATES: The public meeting will be held on Wednesday, May 21, 2003, from 
8 a.m. to 12 noon.
    Submit requests via fax or e-mail by May 1, 2003, to make an oral 
presentation. Submit a copy of all presentation materials by May 15, 
2003. If you are not making an oral presentation, submit registration 
information by May 12, 2003.
    Submit written or electronic comments by June 10, 2003.

ADDRESSES: The public meeting will be held at the Parklawn Bldg., 
conference room D, 5600 Fishers Lane, Rockville, MD 20857.
    Submit requests to make an oral presentation, registration 
information, and any presentation material to Melanie Whelan (see FOR 
FURTHER INFORMATION CONTACT). The requested registration information is 
listed in section II of this document.
    Submit written comments to the Dockets Management Branch (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Melanie N. Whelan, Center for 
Biologics Evaluation and Research (HFM-43), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
2000, FAX 301-827-3079, or e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Scope of Public Meeting

    FDA is seeking input on ways to evaluate the Team Biologics 
Program. The Team Biologics Program, established in 1997, is a 
partnership between FDA's Center for Biologics Evaluation and Research 
and the Office of Regulatory Affairs, which uses the diverse skills and 
knowledge of both organizations to focus resources on inspectional and 
compliance issues in the biologics area. Comments are sought at this 
public meeting about specific methods, tools, criteria, and metrics 
that could be used in this effort. In presentations we ask that you

[[Page 17960]]

specifically address criteria that FDA may consider in assessing the 
following areas:
    1. Industry compliance with applicable laws and regulations,
    2. The consistency of our inspection and compliance activities,
    3. The effects of our inspection and compliance activities on 
product quality, and
    4. The impact of our approach on public health.

II. Registration and Requests for Oral Presentations

    You must preregister by May 1, 2003, if you would like to make an 
oral presentation. Please send your name, title, affiliation, street 
address, e-mail address, and telephone and fax numbers, along with a 
short description of the topics you wish to address, to Melanie Whelan. 
Due to the time constraints of this meeting, only 15 oral presentation 
requests can be accepted, and each presentation will be limited to 10 
minutes. Each person who submits a request will receive a response by 
May 6, 2003, stating whether they have been included in the program. 
Please submit a copy of all presentation materials to Melanie Whelan by 
May 15, 2003.
    We encourage early registration because seating is limited to the 
first 100 registrants. Registration closes on Monday, May 12, 2003. 
Please send your name and affiliation to Melanie Whelan. You will 
receive confirmation of your registration. There is no registration 
fee.
    If you need special accommodations due to a disability, please 
contact Melanie Whelan at least 7 days in advance.

III. Request for Comments

    The agency has established a docket to receive any ideas regarding 
the Team Biologics Program. Regardless of attendance at the public 
meeting, interested persons may submit to the Dockets Management Branch 
(see ADDRESSES) written or electronic comments. Submit a single copy of 
electronic comments or two copies of any mailed comments, except that 
individuals may submit one paper copy. Comments are to be identified 
with the docket number found in brackets in the heading of this 
document. Received comments may be seen in the Dockets Management 
Branch between 9 a.m. and 4 p.m., Monday through Friday.

IV. Transcripts

    Transcripts of the meeting may be requested in writing from the 
Freedom of Information Office (HFI-35), Food and Drug Administration, 
rm. 12A-16, 5600 Fishers Lane, Rockville, MD 20857, approximately 15 
working days after the meeting at a cost of 10 cents per page. The 
transcript of the public meeting will be available for review at the 
Dockets Management Branch and on the Internet at http://www.fda.gov/ohrms/dockets. The transcript will also be placed on the Internet at 
http://www.fda.gov/cber/minutes/workshop-min.htm.

    Dated: April 8, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-9063 Filed 4-11-03; 8:45 am]
BILLING CODE 4160-01-S