Federal Register / Vol. 70, No. 205 / Tuesday, October 25, 2005 / Notices 61625 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

No. of Respondents Annual Frequency per 

Response Total Annual Responses Hours per Response Total Hours 

200 30 (maximum) 6,000 0 .5 3,000 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

FDA projects 30 emergency risk 

related surveys per year with a sample 

of between 50 and 200 respondents per 

survey. FDA also projects a response 

time of 0.5 hours per response. These 

estimates are based on the maximum 

sample size per questionnaire that FDA 

can analyze in a timely manner. The 

annual frequency of response was 

determined by the maximum number of 

questionnaires that will be sent to any 

individual respondent. Some 

respondents may be contacted only one 

time per year, while other respondents 

may be contacted several times 

annually, depending on the human 

drug, biologic, or medical device under 

evaluation. It is estimated that, given the 

expected type of issues that will be 

addressed by the surveys, it will take 0.5 

hours for a respondent to gather the 

requested information and fill in the 

answers. 

Dated: October 17, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–21240 Filed 10–24–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

Clinical Pharmacology Subcommittee 

of the Advisory Committee for 

Pharmaceutical Science; 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: Clinical 

Pharmacology Subcommittee of the 

Advisory Committee for Pharmaceutical 

Science. 

General Function of the Committee: 

To provide advice and 

recommendations to the agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on November 14, 2005, from 8:30 

a.m. to 5:30 p.m. and on November 15, 

2005, from 8:30 a.m. to 1:30 p.m. 

Location: Food and Drug 

Administration, Center for Drug 

Evaluation and Research Advisory 

Committee Conference Room, rm. 1066, 

5630 Fishers Lane, Rockville, MD. 

Contact Person: Mimi Phan, 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: phanm@cder.fda.gov, 

or FDA Advisory Committee 

Information Line, 1–800–741–8138 

(301–443–0572 in the Washington, DC 

area), code 3014512539. Please call the 

Information Line for up-to-date 

information on this meeting. 

Agenda: On November 14, 2005, the 

subcommittee will: (1) Receive an 

update on previous Clinical 

Pharmacology Subcommittee meeting 

recommendations and an introduction 

to the topics of this meeting, (2) discuss 

and provide comments on the evidence 

and process for translation of 

pharmacogenetic information (e.g., 

Cytochrome P 2C9 polymorphisms) into 

label updates for approved products, (3) 

discuss current evidence related to the 

pharmacogenetics of warfarin as a 

potential basis for label updates, and (4) 

discuss and provide comments on the 

critical path pilot project, the End-ofPhase 2A meetings which will include 

a case study. On November 15, 2005, the 

subcommittee will discuss and and 

provide comments on: (1) An update on 

the critical path biomarker-surrogate 

endpoint project, (2) the use of 

biomarker information in labels to 

facilitate individualizing 

pharmacotherapy, and (3) the analytical 

and clinical validation criteria for 

approving a clinical assay (‘‘diagnostic 

test’’). The background material will 

become available no later than the day 

before the meeting and will be posted 

on FDA’s Web site at http:// 

www.fda.gov/ohrms/dockets/ac/ 

acmenu.htm under the heading 

‘‘Advisory Committee for 

Pharmaceutical Science.’’ (Click on the 

year 2005 and scroll down to the 

Advisory Committee for Pharmaceutical 

Science meetings.) 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the subcommittee. Written 

submissions may be made to the contact 

person by November 4, 2005. Oral 

presentations from the public will be 

scheduled between approximately 11:15 

a.m. and 11:30 a.m. and 3:35 p.m. and 

3:50 p.m. on November 14, 2005, and 

between approximately 11:20 a.m. and 

11:50 a.m. on November 15, 2005. Time 

allotted for each presentation may be 

limited. Those desiring to make formal 

oral presentations should notify the 

contact person before November 4, 

2005, 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 Mimi Phan 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 18, 2005. 

Jason Brodsky, 

Acting Associate Commissioner for External 

Relations. 

[FR Doc. 05–21241 Filed 10–24–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Advisory Committee on Infant 

Mortality; Notice of Meeting 

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

the Federal Advisory Committee Act 

(Pub. L. 92–463), notice is hereby given 

of the following meeting: 

Name: Advisory Committee on Infant 

Mortality (ACIM).