03-22628. Manufacturing Subcommittee of the Advisory Committee for Pharmaceutical Science; Amendment of Notice

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Manufacturing Subcommittee of the Advisory Committee for Pharmaceutical Science. This meeting was announced in the Federal Register of August 14, 2003 (68 FR 48614). The amendment is being made to reflect a change in the date and time, agenda, and procedure portions of the meeting. Due to administrative complications, all topics previously announced will be discussed on September 17, 2003. There are no other changes.

FOR FURTHER INFORMATION CONTACT:

Hilda Scharen, Center for Drug Evaluation and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093), Rockville MD 20857, 301-827-7001, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 12539. Please call the Information Line for up-to-date information on this meeting.

SUPPLEMENTARY INFORMATION:

In the Federal Register of August 14, 2003, FDA announced that a meeting of the Manufacturing Subcommittee of the Advisory Committee for Pharmaceutical Science would be held on September 17 and 18, 2003. On page 48614, in the second column, the agenda portion of the meeting is amended to read as follows:

Date and Time: The meeting will be held on September 17, 2003, from 8:30 a.m. to 5 p.m.

Agenda: On September 17, 2003, the subcommittee will discuss the following topics: (1) Quality by design and how it is distinct from approaches that attempt to test in quality; and (2) define principles by which risk management is integrated into decisionmaking.

Procedures: Oral presentations from the public will be scheduled between approximately 11:30 a.m. and 12:30 p.m.

This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.

Dated: August 29, 2003.

Peter J. Pitts,

Associate Commissioner for External Relations.