Federal Register / Vol. 73, No. 29 / Tuesday, February 12, 2008 / Notices 8047 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

Advisory Committee for 

Pharmaceutical Science and Clinical 

Pharmacology; 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: Advisory 

Committee for Pharmaceutical Science 

and Clinical Pharmacology. 

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 March 18, 2008, from 8:30 a.m. 

to 5 p.m. and on March 19, 2008, from 

8:30 a.m. to 12:30 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: 

mimi.phan@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in 

Washington, DC area), code 

3014512539. Please call the Information 

Line for up-to-date information on this 

meeting. A notice in the Federal 

Register about last minute modifications 

that impact a previously announced 

advisory committee meeting cannot 

always be published quickly enough to 

provide timely notice. Therefore, you 

should always check the agency’s Web 

site and call the appropriate advisory 

committee hot line/phone line to learn 

about possible modifications before 

coming to the meeting. 

Agenda: On March 18, 2008, the 

committee will: (1) Discuss and provide 

comments on three new topics of this 

meeting; first new topic: The new 

clinical pharmacogenomics (PGx) 

concept paper. Key issues in the 

concept paper include an industry 

survey on the collection of PGx samples, 

and the applications of PGx in clinical 

development will be presented and (2) 

discuss and provide comments on the 

second new topic: Quantitative clinical 

pharmacology: Critical path 

opportunities. An example of a disease 

model and its applications will be 

presented. The regulatory experience, 

designs, and implications of pediatric 

studies will be discussed. On March 19, 

2008, the committee will consider the 

third new topic: Renal impairment 

concept paper. The effects of renal 

impairment on Cytochrom P (CYP)/ 

transporter, methods of evaluation of 

renal function, and the effects of 

hemodialysis on drug clearance will be 

discussed. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

available at http://www.fda.gov/ohrms/ 

dockets/ac/acmenu.htm, click on the 

year 2008 and scroll down to the 

appropriate advisory committee link. 

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 on or before March 4, 2008. Oral 

presentations from the public will be 

scheduled between approximately 10:30 

a.m. and 11 a.m. each day. Those 

desiring to make formal oral 

presentations should notify the contact 

person 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 on or before February 

27, 2008. Time allotted for each 

presentation may be limited. If the 

number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by February 28, 2008. 

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. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://www.fda.gov/oc/advisory/ 

default.htm for procedures on public 

conduct during advisory committee 

meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: February 4, 2008. 

Randall W. Lutter, 

Deputy Commissioner for Policy. 

[FR Doc. E8–2540 Filed 2–11–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

[USCG–2008–0075] 

Commercial Fishing Industry Vessel 

Safety Advisory Committee 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of Open Teleconference 

Meeting. 

SUMMARY: This notice announces a 

teleconference of the Commercial 

Fishing Industry Vessel Safety Advisory 

Committee (CFIVSAC). The purpose of 

the teleconference is for CFIVSAC to 

discuss and prepare recommendations 

for the Coast Guard concerning the work 

of the Communications Subcommittee 

and the Risk Management 

Subcommittee and to discuss other 

CFIVSAC actions resulting from its last 

public meeting on November 13 and 14, 

2007. 

DATES: The teleconference call will take 

place on Wednesday, February 27, 2008, 

from 1:30 p.m. until approximately 3 

p.m. Eastern Standard Time. 

ADDRESSES: Committee members and 

members of the public may participate 

by dialing 1–877–451–9782 on a touchtone phone. You will then be prompted 

to enter your ‘‘participant code 

number,’’ which is 9559674#. Please 

ensure that you enter the # mark after 

the participant code. Public 

participation is welcomed; however, the 

number of teleconference lines is 

limited, and lines are available firstcome, first-served. Members of the 

public may also participate by coming 

to Room 1116 U.S. Coast Guard 

Headquarters; 2100 Second Street, SW., 

Washington, DC 20593–0001. We 

request that members of the public who 

plan to attend this meeting notify Mr. 

Mike Rosecrans at 202–372–1245 so that 

mstockstill on PROD1PC66 with NOTICES

8048 Federal Register / Vol. 73, No. 29 / Tuesday, February 12, 2008 / Notices 

he may notify building security officials. 

You may also gain access to this docket 

at http://dms.dot.gov/search/ 

searchFormSimple.cfm. Background 

information is available at http:// 

www.fishsafe.info. 

FOR FURTHER INFORMATION CONTACT: Mr. 

Mike Rosecrans, Assistant Executive 

Director of CFIVSAC, telephone 202–

372–1245, fax 202–372–1917. 

SUPPLEMENTARY INFORMATION: The 

Federal Advisory Committee Act 

requires that public notice of these 

meetings be announced in the Federal 

Register [5 U.S.C. App. (Pub. L. 92–

463)]. CFIVSAC is chartered under that 

Act. It provides advice and makes 

recommendations to the Secretary on 

issues regarding safety of commercial 

fishing industry vessels. 

Tentative Agenda: Wednesday, 

February 27, 2008 1:30 p.m.: Welcome, 

introduction of new members and 

Opening Remarks—CFIVSAC Chairman 

Mr. Jerry Dzugan. 

Open discussion concerning the work 

of the Communications Subcommittee 

and Task 07–01 Completion of Fishing 

Vessel Digest. 

Discussion of the work of the Risk 

Management Subcommittee and Task 

07–02—Roles and Mission and Risk 

Management Best Practices. 

Discussion of Task 07–03—Long 

Range Goals for the Committee. 

Public comment period. 

Discussion of plans for next meeting. 

3 p.m.: Adjourn. 

This tentative agenda is subject to 

change and the meeting may adjourn 

early if all 

Committee business has been 

completed. 

Public Participation 

The Chairman of CFIVSAC is 

empowered to conduct the 

teleconference in a way that will, in his 

judgment, facilitate the orderly conduct 

of business. During its teleconference, 

the Committee welcomes public 

comment. The Committee will make 

every effort to hear the views of all 

interested parties, including the public. 

Written comments may be submitted to 

Mr. Mike Rosecrans, Assistant Executive 

Director, CFIVSAC; Commandant (CG–

5433); 2100 Second Street, SW., 

Washington, DC 20593–0001. 

Information on Services for Individuals 

With Disabilities 

For information on facilities or 

services for individuals with disabilities 

or to request special assistance at the 

meeting, contact Mr. Rosecrans as soon 

as possible. 

Dated: February 7, 2008. 

H.L. Hime, 

Acting Director of Commercial Standards and 

Regulations. 

[FR Doc. 08–656 Filed 2–8–08; 1:54 pm] 

BILLING CODE 4910–15–P 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Customs and Border Protection 

Accreditation and Approval of SGS 

North America, Inc., as a Commercial 

Gauger and Laboratory 

AGENCY: U.S. Customs and Border 

Protection, Department of Homeland 

Security. 

ACTION: Notice of accreditation and 

approval of SGS North America, Inc., as 

a commercial gauger and laboratory. 

SUMMARY: Notice is hereby given that, 

pursuant to 19 CFR 151.12 and 19 CFR 

151.13, SGS North America, Inc., 2 

Avenue J, Bayonne, NJ 07002, has been 

approved to gauge and accredited to test 

petroleum and petroleum products, 

organic chemicals and vegetable oils for 

customs purposes, in accordance with 

the provisions of 19 CFR 151.12 and 19 

CFR 151.13. anyone wishing to employ 

this entity to conduct laboratory 

analyses and gauger services should 

request and receive written assurances 

from the entity that it is accredited or 

approved by the U.S. Customs and 

Border Protection to conduct the 

specific test or gauger service requested. 

Alternatively, inquiries regarding the 

specific test or gauger service this entity 

is accredited or approved to perform 

may be directed to the U.S. Customs and 

Border Protection by calling (202) 344–

1060. The inquiry may also be sent to 

cbp.labhq@dhs.gov. Please reference the 

Web site listed below for a complete 

listing of CBP approved gaugers and 

accredited laboratories. http://cbp.gov/ 

xp/cgov/import/operations_support/ 

labs_scientific_svcs/ 

commercial_gaugers/. 

DATES: The accreditation and approval 

of SGS North America, Inc., as 

commercial gauger and laboratory 

became effective on September 20, 2007. 

The next triennial inspection date will 

be scheduled for September 2010. 

FOR FURTHER INFORMATION CONTACT: 

Commercial Gauger Laboratory Program 

Manager, Laboratories and Scientific 

Services, U.S. Customs and Border 

Protection, 1300 Pennsylvania Avenue, 

NW., Suite 1500N, Washington, DC 

20229, 202–344–1060. 

Dated: January 31, 2008. 

Ira S. Reese, 

Executive Director, Laboratories and 

Scientific Services. 

[FR Doc. 08–589 Filed 2–11–08; 8:45 am] 

BILLING CODE 9111–14–M 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Customs and Border Protection 

Accreditation and Approval of 

Inspectorate America Corporation, as a 

Commercial Gauger and Laboratory 

AGENCY: U.S. Customs and Border 

Protection, Department of Homeland 

Security. 

ACTION: Notice of accreditation and 

approval of Inspectorate America 

Corporation, as a commercial gauger 

and laboratory. 

SUMMARY: Notice is hereby given that, 

pursuant to 19 CFR 151.12 and 19 CFR 

151.13, Inspectorate America 

Corporation, 1404 Joliet Road, Suite G, 

Romeoville, IL 60446, has been 

approved to gauge and accredited to test 

petroleum and petroleum products, 

organic chemicals and vegetable oils for 

customs purposes, in accordance with 

the provisions of 19 CFR 151.12 and 19 

CFR 151.13. Anyone wishing to employ 

this entity to conduct laboratory 

analyses and gauger services should 

request and receive written assurances 

from the entity that it is accredited or 

approved by the U.S. Customs and 

Border Protection to conduct the 

specific test or gauger service requested. 

Alternatively, inquiries regarding the 

specific test or gauger service this entity 

is accredited or approved to perform 

may be directed to the U.S. Customs and 

Border Protection by calling (202) 344–

1060. The inquiry may also be sent to 

cbp.labhq@dhs.gov. Please reference the 

Web site listed below for a complete 

listing of CBP approved gaugers and 

accredited laboratories. http://cbp.gov/ 

xp/cgov/import/operations_support/ 

labs_scientific_svcs/ 

commercial_gaugers/. 

DATES: The accreditation and approval 

of Inspectorate America Corporation, as 

commercial gauger and laboratory 

became effective on August 08, 2007. 

The next triennial inspection date will 

be scheduled for August 2010. 

FOR FURTHER INFORMATION CONTACT: 

Commercial Gauger Laboratory Program 

Manager, Laboratories and Scientific 

Services, U.S. Customs and Border 

Protection, 1300 Pennsylvania Avenue, 

NW., Suite 1500N, Washington, DC 

20229, 202–344–1060. 

mstockstill on PROD1PC66 with NOTICES