[Federal Register Volume 64, Number 150 (Thursday, August 5, 1999)]
[Proposed Rules]
[Pages 42625-42626]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-20088]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 314

[Docket Nos. 99N-0193 and 99D-0529]


Changes to an Approved NDA or ANDA; Proposed Rule and Draft 
Companion Guidance; Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Announcement of public meeting.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
meeting to discuss proposed amendments to its regulations on 
postapproval changes to the chemistry, manufacturing, and controls of 
approved drugs, and a draft companion guidance. FDA is inviting 
interested parties, including industry, health professionals, patients, 
and patient advocacy groups to present their perspectives on the 
proposed amendments and the draft companion guidance.

DATES: The meeting will be held on Thursday, August 19, 1999, from 9 
a.m. to 5 p.m. Registration and requests to make an oral presentation 
should be received by Monday, August 13, 1999.

ADDRESSES: The meeting will be held at the Hilton Hotel, 620 Perry 
Pkwy., Gaithersburg, MD. To register and request time for an oral 
presentation, send or fax written material to the listed contact 
person.

FOR FURTHER INFORMATION CONTACT: Susan C. Lange, Office of New Drug 
Chemistry (HFD-800), Center for Drug Evaluation and Research, Food and 
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-
5918, FAX 301-594-0746.

SUPPLEMENTARY INFORMATION: Section 116 of the Food and Drug 
Administration Modernization Act of 1997 provides for the revision of 
Sec. 314.70 (21 CFR 314.70) of FDA regulations concerning postapproval 
changes to the chemistry, manufacturing, and controls of approved 
drugs. In the Federal Register of June 28, 1999 (64 FR 34608), the 
agency published a proposed rule entitled ``Supplements and Other 
Changes to an Approved Application,'' proposing amendments to 
Sec. 314.70. The comment period for the proposed rule closes on 
September 13, 1999 (Docket No. 99N-0193). In the same issue of the 
Federal Register (64 FR 34660), the agency announced the availability 
of a draft guidance for industry entitled ``Changes to an Approved NDA 
or ANDA.'' The comment period for the draft guidance closes on August 
27, 1999 (Docket No. 99D-0529). To ensure broad public input on the 
proposed rule and the draft guidance, the agency is holding a public 
meeting on the proposed amendments to Sec. 314.70 and the draft 
guidance for industry.
     To provide a framework for presentations, discussions of revisions 
to Sec. 314.70 will be organized according to the following sections in 
the proposed regulation: (1) Section 314.70(a)--Changes to an approved 
application; (2) Sec. 314.70(b)--Changes requiring a prior approval 
supplement; (3) Sec. 314.70(c)--Changes being effected supplement; (4) 
Sec. 314.70(d)--Changes for description in an annual report; and (5) 
Sec. 314.70(e)--Protocols.
     The presentation topics for the draft guidance will be organized 
as follows: (1) Assessing the effect of manufacturing changes; (2) 
components and composition; (3) sites; (4) manufacturing process; (5) 
specifications; (6) package; (7) labeling; (8) miscellaneous changes; 
and (9) multiple changes.
     When submitting a request for an oral presentation at the August 
19, 1999, meeting, please specify your

[[Page 42626]]

presentation topic. The time allowed for each presenter will depend on 
the number of presentation requests.
     Registration information (including name, title, firm name, 
address, telephone, and fax number) and requests for presentation 
(including specific topic) should be submitted to the listed contact 
person by Friday, August 13, 1999. Space is limited, therefore, 
interested parties are encouraged to register early. Special 
accommodations due to disability should be submitted at least 7 days in 
advance.
    Transcripts of the meeting may be requested in writing from the 
Freedom of Information Office (HFI-35), Food and Drug Administration, 
5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857, approximately 15 
working days after the meeting at a cost of 10 cents per page.

    Dated: July 28, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-20088 Filed 8-4-99; 8:45 am]
BILLING CODE 4160-01-F