[Federal Register: October 22, 2004 (Volume 69, Number 204)]
[Notices]               
[Page 62058]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22oc04-64]                         


[[Page 62058]]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

 
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.

    Dated: October 14, 2004.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 04-23626 Filed 10-21-04; 8:45 am]

BILLING CODE 4160-01-S