[Federal Register Volume 65, Number 35 (Tuesday, February 22, 2000)]
[Notices]
[Pages 8717-8718]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-4158]


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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 (SUPAC), 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 Central Region Small Business Office, and the 
Northeast Region Small Business Office, in cooperation with the 
International Society for Pharmaceutical Engineering (ISPE) is 
announcing the following workshops: FDA/Industry Exchange Workshops on 
Scale-Up and Postapproval Changes (SUPAC), Supplements, and Other 
Postapproval Changes. The workshops are 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: See Table 1 following the ``Location'' section of 
this document.
    Location: See Table 1 below.

                                                     Table 1
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          Workshop Address                     Date and Local Time                   FDA Contact Person
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Newark Airport Marriot, Newark        Monday, March 20, 2000, from 9 a.m.   Marie T. Falcone
 International Airport, Newark, NJ     to 5 p.m.
 07114, 1-800-882-1037, FAX: 973-623-
 7618
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Chicago Marriott Schaumburg, 50       Monday, April 10, 2000, from 9 a.m.    Do.
 North Martingale Rd., Schaumburg,     to 5 p.m.
 IL 60173, 847-240-0100, FAX: 847-
 240-2388
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Providence Marriott, One Ohms St.,    Thursday, May 4, 2000, from 9 a.m.     Do.
 Providence, RI 02904, 1-800-937-      to 5 p.m.
 7768, FAX: 401-861-3550
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    Persons needing hotel rooms should mention that they are attending 
the ISPE, FDA/SUPAC workshop.
    Contact: Marie T. Falcone, Industry and Small Business 
Representative, FDA, rm. 900 U.S. Customhouse, Second and Chestnut 
Sts., Philadelphia, PA 19106, 215-597-2120, ext. 4003, e-mail: 
[email protected].
    Registration: Send registration information (including name, title, 
firm name, address, telephone, and fax number), along with a $295 check 
(member) or $450 (nonmembers) (which will cover refreshments, lunch, 
and materials) made payable to ISPE, 3816 W. Linebaugh Ave., suite 412, 
Tampa, FL 33624, 813-960-2105, or visit the ISPE at the Internet at 
http://www.ispe.org. Registrations are due 1 week prior to the start of 
each course. 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 ISPE at 
least 7 days in advance.

SUPPLEMENTARY INFORMATION: The workshops further implement the FDA Plan 
for Statutory Compliance (developed under Section 406 of the FDA 
Modernization Act (21 U.S.C. 393)) by 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 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

[[Page 8718]]

and use of the equipment addenda to SUPAC; and (7) facts, figures, and 
future directions.
    The workshop also complies with the Small Business Regulatory 
Enforcement Fairness Act (Public Law 104-121), which requires outreach 
activities by government agencies directed to small businesses.

    Dated: February 16, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-4158 Filed 2-16-00; 4:19 pm]
BILLING CODE 4160-01-F