[Federal Register Volume 65, Number 130 (Thursday, July 6, 2000)]
[Notices]
[Pages 41680-41681]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-16979]


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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 Assistance Office, 
and the Pacific Region Small Business Office, in cooperation with the 
International Society for Pharmaceutical Engineering (ISPE) is 
announcing two workshops entitled 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.

[[Page 41681]]



                                                                         Table 1
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                              Workshop Address                                                           Date and Local Time
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Long Beach Convention Center,                                                Tuesday, September 26, 2000,
  300 East Ocean Blvd.,                                                        9 a.m. to 4:30 p.m.
  Long Beach, CA 90802.                                                        Pacific time.
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Embassy Suites, 150 Anza Blvd.,                                              Friday, December 8, 2000,
  Burlingame, CA 94010,                                                        9 a.m. to 4:30 p.m.
  650-340-0327.                                                                Pacific time.
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    Contact: Marcia Madrigal, Industry and Small Business 
Representative, Food and Drug Administration, Oakland Federal Bldg., 
1301 Clay St., suite 1180N, Oakland, CA 94612, 510-637-3980; FAX 510-
637-3977 or via e-mail: [email protected].
    Registration: The registration fee is $295 for ISPE members and 
$450 for nonmembers (which will cover refreshments, lunch, and 
materials). The ISPE tax number is FEI 59-2009272. Contact ISPE for 
registration forms, and other registration details at ISPE 3816 W. 
Linebaugh Ave, suite 412, Tampa, FL 33624, 813-960-2105; FAX 813-264-
2816, or visit the ISPE website 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 
onsite registration may be available. Please arrive early to ensure 
prompt registration. Persons needing hotel rooms for the Embassy Suites 
location on December 8, 2000, should mention that they are attending 
the FDA/SUPAC workshop. A special rate is available until November 16, 
2000, or until the room block is exhausted, whichever comes first.
    If you need special accommodations due to a disability, please 
contact ISPE at least 7 days in advance.

SUPPLEMENTARY INFORMATION: The workshops are designed to help achieve 
objectives 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 workshops also are consistent with the Small Business 
Regulatory Enforcement Fairness Act (Public Law 104-121), as outreach 
activities by Government agencies directed to small businesses.
    The topics to be discussed include the following: (1) The history 
of SUPAC development; (2) the impact of scale-up postapproval change 
guidances and of the regulation rewrite of 21 CFR 314.70 (Supplements 
and other changes to an approved application); (3) comparison of SUPAC 
immediate-release solid dosage forms, modified-release oral dosage 
forms, and semisolid-topical dosage forms; (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: June 27, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-16979 Filed 7-5-00; 8:45 am]
BILLING CODE 4160-01-F