Clinical Pharmacology 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 Clinical Pharmacology Subcommittee of the Advisory Committee for Pharmaceutical Science. This meeting was announced in the Federal Register of October 4, 2004 (69 FR 59238). The amendment is being made to reflect changes in the Agenda and Location portions of the document. 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, FAX: 301-827-6776, e-mail: SCHARENh@cder.fda.gov, 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 October 4, 2004, FDA announced that a meeting of the Clinical Pharmacology Subcommittee of the Advisory Committee for Pharmaceutical Science would be held on November 3 and 4, 2004. On page 59238, in the third column, the Location and Agenda portions of the meeting are amended to read as follows:

Location: Hilton Washington DC North, The Ballrooms, 620 Perry Pkwy., Gaithersburg, MD.

Agenda: On November 3, 2004, the subcommittee will address the following issues: (1) Receive topic updates for ongoing FDA activities previously presented to the subcommittee; (2) discuss and provide comments on the evidence for updating labels of approved drugs to include integrating pharmacogenetic, pharmacokinetic, and prognostic biomarkers for the purpose of optimizing therapeutic response and reducing risks of toxicity, with CAMPTOSAR (irinotecan hydrochloride), by Pfizer Inc., as an example; and (3) discuss and provide comments on metabolism- and transporter-based drug-drug interactions included as recommendations in a draft guidance for industry being prepared by FDA. On November 4, 2004, the subcommittee will discuss and provide comments on a new critical path project related to general aspects of the transition of biomarkers to surrogate endpoints, with a focus on planning and process, rather than on specific biomarkers or surrogate endpoints.

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.