62058 Federal Register / Vol. 69, No. 204 / Friday, October 22, 2004 / Notices 

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

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

Science Board to the Food and Drug 

Administration; Notice of Meeting

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public.

Name of Committee: Science Board to the 

Food and Drug Administration.

General Function of the Committee: The 

Board shall provide advice primarily to the 

agency’s Senior Science Advisor and, as 

needed, to the Commissioner and other 

appropriate officials on specific complex and 

technical issues as well as emerging issues 

within the scientific community in industry 

and academia. Additionally, the Board will 

provide advice to the agency on keeping pace 

with technical and scientific evolutions in 

the fields of regulatory science, on 

formulating an appropriate research agenda, 

and on upgrading its scientific and research 

facilities to keep pace with these changes. It 

will also provide the means for critical 

review of agency-sponsored intramural and 

extramural scientific research programs.

Date and Time: The meeting will be held 

on November 5, 2004, 8 a.m. to 5 p.m.

Location: 5630 Fishers Lane, rm. 1066, 

Rockville, MD 20852.

Contact Person: Jan Johannessen, Office of 

the Commissioner (HF–33), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–6687, 

jjohannessen@fda.gov, or FDA Advisory 

Committee Information Line, 1–800–741–

8138 (301–443–0572 in the Washington, DC 

area), code 3014512603. Please call the 

Information Line for up-to-date information 

on this meeting.

Agenda: The Board will hear about and 

discuss: (1) An update on the FDA Critical 

Path Initiative (http://www.fda.gov/oc/

initiatives/criticalpath/), including an 

overview of docket submissions, current 

status, reports on related activities (Medical 

Technology Innovation Task Force and Foods 

Critical Path White Paper), and future plans; 

(2) FDA’s final report on pharmaceutical 

current good manufacturing practices (http:/

/www.fda.gov/cder/gmp/gmp2004/

GMP_finalreport2004.htm); and (3) an 

internal peer review of the Office of 

Regulatory Affairs’ pesticide program, 

including plans for the establishment of a 

Science Board subcommittee to conduct an 

external program peer review.

Procedure: Interested persons may present 

data, information, or views, orally or in 

writing, on issues pending before the 

committee. Written submissions may be 

made to the contact person by October 29, 

2004. Oral presentations from the public will 

be scheduled between approximately 1 p.m. 

and 2 p.m. Time allotted for each 

presentation may be limited. Those desiring 

to make formal oral presentations should 

notify the contact person before October 29, 

2004, and submit a brief statement of the 

general nature of the evidence or arguments 

they wish to present, the names and 

addresses of proposed participants, and an 

indication of the approximate time requested 

to make their presentation.

Persons attending FDA’s advisory 

committee meetings are advised that the 

agency is not responsible for providing 

access to electrical outlets.

FDA welcomes the attendance of the 

public at its advisory committee meetings 

and will make every effort to accommodate 

persons with physical disabilities or special 

needs. If you require special accommodations 

due to a disability, please contact Jan 

Johannessen at least 7 days in advance of the 

meeting.

Notice of this meeting is given under the 

Federal Advisory Committee Act (5 U.S.C. 

app. 2).

Dated: October 14, 2004.

Sheila Dearybury Walcoff,

Associate Commissioner for External 

Relations.

[FR Doc. 04–23625 Filed 10–21–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

National Advisory Council on Nurse 

Education and Practice; Notice of 

Meeting 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Public Law 92–463), notice is hereby 

given of the following meeting: