[Federal Register Volume 64, Number 148 (Tuesday, August 3, 1999)]
[Notices]
[Page 42136]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-19791]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Food and Drug Administration/Industry Exchange Workshop on Scale-
Up and Postapproval Changes, Supplements, and Other Postapproval 
Changes; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of workshop.

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SUMMARY:  The Food and Drug Administration (FDA), Office of the 
Commissioner, Office of Regulatory Affairs, Center for Drug Evaluation 
and Research, and the Southeast Region Small Business Assistance 
Office, in cooperation with the North Carolina Regulatory Affairs Forum 
(NCRAF) is announcing the following workshop: FDA/Industry Exchange 
Workshop on Scale-Up and Postapproval Changes (SUPAC), Supplements, and 
Other Postapproval Changes. The workshop is intended to review the 
scientific, regulatory, and quality basis of SUPAC; discuss current 
issues; and provide attendees with information on the impact of the 
SUPAC guidances that have been finalized, as well as future agency 
efforts in this area.
    Date and Time: The workshop will be held on Tuesday, August 17, 
1999, from 8 a.m. to 5 p.m. Send information regarding registration by 
August 10, 1999.
    Location: The workshop will be held at the Durham Marriott at the 
Civic Center, 201 Foster St., Durham, NC 27701, 919-768-6000, FAX 919-
768-6037. Persons needing hotel rooms should mention that they are 
attending the SUPAC workshop. A special rate is available until July 
23, 1999.
    Contact: Barbara Ward-Groves, Industry and Small Business 
Representative, Food and Drug Administration, 60 Eighth St. NE., 
Atlanta, GA 30309, 404-253-2238.
    Registration: Send registration information (including name, title, 
firm name, address, telephone, and fax number), along with a $75 check 
(which will cover refreshments, lunch, and materials) made payable to 
NCRAF, P.O. Box 13474, Research Triangle Park, NC 27709, c/o Jamie 
Morgan, 919-845-8055, by August 10, 1999. Space is limited, therefore, 
interested parties are encouraged to register early. Limited on-site 
registration may be available. Please arrive early to ensure prompt 
registration. If you need special accommodations due to a disability, 
please contact Jamie Morgan at least 7 days in advance.
SUPPLEMENTARY INFORMATION:  The workshop meets the requirements set 
forth in section 406 of the FDA Modernization Act of 1997 (21 U.S.C 
393) and discussed in the FDA Plan for Statutory Compliance, which 
include working more closely with stakeholders; maximizing the 
availability of, and clarifying information about the process for 
review and submissions; and ensuring access to needed scientific and 
technical expertise.
    The workshop also complies with the Small Business Regulatory 
Enforcement Fairness Act (Pub. L. 104-121) that requires outreach 
activities by Government agencies directed to small businesses.
     The topics to be discussed include the following: (1) The history 
of SUPAC development; (2) comparison of SUPAC immediate-release solid 
dosage forms, modified-release oral dosage
forms, and semisolid-topical dosage forms; (3) bulk actives 
postapproval changes; (4) postapproval changes sterile aqueous 
solutions; (5) FDA field staff's involvement in SUPAC; (6) description 
and use of the equipment addenda to SUPAC; and (7) facts, figures, and 
future directions.



    Dated: July 27, 1999
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-19791 Filed 8-2-99; 8:45 am]
BILLING CODE 4160-01-F