[Federal Register: February 22, 2000 (Volume 65, Number 35)]
[Notices]
[Page 8717-8718]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22fe00-70]

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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:
mfalcone@ora.fda.gov.
    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