[Federal Register Volume 68, Number 23 (Tuesday, February 4, 2003)]
[Notices]
[Pages 5644-5645]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-2603]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Food and Drug Administration/Small Business Town Meeting for 
Pharmaceutical Industry

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public town meeting.

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SUMMARY: The Food and Drug Administration (FDA) (Center for Drug 
Evaluation and Research and the Central Region and Philadelphia 
District) is announcing a town meeting for small businesses on FDA 
requirements for approval and marketing of drug products. Topics for 
discussion include: Over-the-counter (OTC) monographs, labeling, 
registration, listing, FDA meetings process, imports and exports, 
financial incentives, and navigating the FDA Web site. This half day 
meeting targets small pharmaceutical concerns.
    Date and Time: The town meeting will be held on Wednesday, March 5, 
2003, from 12 noon to 4 p.m.
    Location: The town meeting will be held at the William J. Green 
Federal Bldg., conference rooms A and B, 2d floor, Sixth and Arch St., 
Philadelphia, PA.
    Contact: Marie Falcone, Industry and Small Business Representative, 
Food and Drug Administration, Central Region, room 900 U.S. 
Customhouse, 200 Chestnut St., Philadelphia, PA 19106, 215-597-2120, 
ext. 4003, FAX 215-597-5798, or e-mail: [email protected].
    Registration: To access registration form, see http://www.fda.gov/cder/meeting/pharmbus2003/default.html. Send registration information 
(including name, title, firm name, address, telephone, and fax number) 
to Marie Falcone by February 14, 2003.
    There is no registration fee, however, space is limited, therefore 
interested parties are encouraged to register early. Registration will 
close after the meeting slots are filled. Those accepted into the

[[Page 5645]]

course will receive written confirmation. Registration at the site will 
be done on a space available basis on the day of the town meeting, 
beginning at 11 a.m. Please arrive early to ensure prompt registration. 
Bring photo identification for security check at building entrance. If 
you need special accommodations due to a disability, please contact 
Marie Falcone at least 7 days in advance of the workshop.

SUPPLEMENTARY INFORMATION: The ``FDA Small Business Town Meeting for 
Pharmaceutical Industry'' town meeting helps fulfill the Department of 
Health and Human Services' and FDA's important mission to protect the 
public health by educating regulated industry on FDA requirements to 
produce safe and effective drug products. FDA has made assurance of 
safe and effective drug products a high priority.
    The workshop helps to implement the objectives of section 406 of 
the FDA Modernization Act (21 U.S.C. 393) and the FDA Plan for 
Statutory Compliance, which includes working more closely with 
stakeholders and ensuring access to needed scientific and technical 
expertise. The workshop also furthers the goals of the Small Business 
Regulatory Enforcement Fairness Act (Public Law 104-121) by providing 
outreach activities by Government agencies directed to small 
businesses.

    Dated: January 28, 2003.
Margaret M. Dotzel,
Assistant Commissioner for Policy.
[FR Doc. 03-2603 Filed 2-3-03; 8:45 am]
BILLING CODE 4160-01-S