[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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of a draft guidance for industry entitled ``Changes to an Approved NDA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