Federal Register / Vol. 73, No. 32 / Friday, February 15, 2008 / Notices 8885 

studies that should be conducted for 

drug metabolites that are present at 

greater than 10 percent of the parent 

drug systemic exposure as measured in 

plasma. 

A draft version of this guidance was 

made available for public comment in 

2005 (70 FR 32839, June 6, 2005). All of 

the public comments we received have 

been considered and the guidance was 

revised as appropriate. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the agency’s 

current thinking on the safety testing of 

drug metabolites. It does not create or 

confer any rights for or on any person 

and does not operate to bind FDA or the 

public. An alternative approach may be 

used if such approach satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Please note that on January 15, 2008, 

the FDA Web site transitioned to the 

Federal Dockets Management System 

(FDMS). FDMS is a Government-wide, 

electronic docket management system. 

Electronic submissions will be accepted 

by FDA through FDMS only. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/cder/guidance/ 

index.htm or http://www.fda.gov/ 

ohrms/dockets/default.htm. 

Dated: February 8, 2008. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E8–2827 Filed 2–14–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

Anti-Infective Drugs Advisory 

Committee; Amendment of Notice 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

amendment to the notice of a meeting of 

the Anti-Infective Drugs Advisory 

Committee. This meeting was 

announced in the Federal Register of 

January 11, 2008 (73 FR 2055). The 

amendment is being made to reflect a 

change in the Date and Time and 

Agenda portions of the document. There 

are no other changes. 

FOR FURTHER INFORMATION CONTACT: 

Sohail Mosaddegh, Center for Drug 

Evaluation and Research (HFD–21), 

Food and Drug Administration, 5600 

Fishers Lane, Rockville, MD 20857, 

301–827–7001, or FDA Advisory 

Committee Information Line, 1–800–

741–8138 (301–443–0572 in the 

Washington, DC area), code 

3014512530. Please call the Information 

Line for up-to-date information on this 

meeting. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of January 11, 2008, 

FDA announced that a meeting of the 

Anti-Infective Drugs Advisory 

Committee would be held on February 

27 and 28, 2008. On page 2056, in the 

first column, the Date and Time and 

Agenda portions are amended to read as 

follows: 

Date and Time: The meeting will be 

held on February 27, 2008, from 8 a.m. 

to 5 p.m. 

Agenda: On February 27, 2008, the 

committee will discuss new drug 

application (NDA) 022–110, telavancin 

powder for reconstitution and 

intravenous administration, Theravance, 

Inc., proposed for the treatment of 

complicated skin and skin structure 

infection. 

This notice is issued under the 

Federal Advisory Committee Act (U.S.C. 

app. 2) and 21 CFR part 14, relating to 

advisory committees. 

Dated: February 11, 2008. 

Randall W. Lutter, 

Deputy Commissioner for Policy. 

[FR Doc. E8–2824 Filed 2–14–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the following 

meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, Molecular 

and Cellular Sciences Special Emphasis 

Panel. 

Date: February 28, 2008. 

Time: 11 a.m. to 2 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892, 

(Telephone Conference Call). 

Contact Person: Noni Byrnes, PhD, 

Scientific Review Administrator, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5130, 

MSC 7840, Bethesda, MD 20892, (301) 435–

1023, byrnesn@csr.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, Member 

Conflict: Stress. 

Date: February 29, 2008. 

Time: 12 p.m. to 2 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892, 

(Telephone Conference Call). 

Contact Person: Christine L. Melchior, 

PhD, Scientific Review Administrator, Center 

for Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5176, 

MSC 7844, Bethesda, MD 20892, (301) 435–

1713, melchioc@csr.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, Member 

Conflict: Innate Immunity and Inflammation. 

Date: March 7, 2008. 

Time: 10 a.m. to 12 p.m. 

Agenda: To review and evaluate grant 

applications. 


rwilkins on PROD1PC63 with NOTICES
8886 Federal Register / Vol. 73, No. 32 / Friday, February 15, 2008 / Notices 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892, 

(Telephone Conference Call). 

Contact Person: Betty Hayden, PhD, 

Scientific Review Administrator, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4206, 

MSC 7812, Bethesda, MD 20892, 301–435–

1223, haydenb@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, Red Cell 

Cytoskeleton. 

Date: March 10, 2008. 

Time: 3 p.m. to 4:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892. 

(Telephone Conference Call). 

Contact Person: Manjit Hanspal, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4138, 

MSC 7804, Bethesda, MD 20892, 301–435–

1195. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, 

Neuroimmunology and Neurological 

Disorders. 

Date: March 12, 2008. 

Time: 3 p.m. to 6 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892. 

(Telephone Conference Call). 

Contact Person: Vilen A. Movsesyan, PhD, 

Scientific Review Administrator, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4040M, 

MSC 7806, Bethesda, MD 20892, 301–402–

7278, movsesyanv@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, Parasites. 

Date: March 13, 2008. 

Time: 12:30 p.m. to 3:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Telephone Conference Call). 

Contact Person: Marian Wachtel, PhD, 

Scientific Review Administrator, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3208, 

MSC 7858, Bethesda, MD 20892, 301–435–

1148, wachtelm@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, 

Fellowships. 

Date: March 20–21, 2008. 

Time: 9 a.m. to 10 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Malgorzata Klosek, PhD, 

Scientific Review Administrator, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4188, 

MSC 7849, Bethesda, MD 20892, 301–435–

2211, klosekm@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, Member 

Conflict: Oral, Dental and Craniofacial 

Sciences. 

Date: March 20, 2008. 

Time: 2 p.m. to 6 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Telephone Conference Call). 

Contact Person: J. Terrell Hoffeld, DDS, 

PhD, Dental Officer, USPHS, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4116, 

MSC 7816, Bethesda, MD 20892, 301–435–

1781, th88q@nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, Small 

Business Grant Applications: Immunology. 

Date: March 21, 2008. 

Time: 8:30 a.m. to 6 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: State Plaza Hotel, 2117 E Street, 

NW., Washington, DC 20037. 

Contact Person: Stephen M. Nigida, PhD, 

Health Scientist Administrator, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4212, 

MSC 7812, Bethesda, MD 20892. 301–435–

1222, nigidas@csr.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research; 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: February 8, 2008. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 08–687 Filed 2–14–08; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the following 

meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications 

and/or contract proposals and the 

discussions could disclose confidential 

trade secrets or commercial property 

such as patentable material, and 

personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel; 

Development of Anticancer Agents. 

Date: March 7, 2008. 

Time: 8:30 a.m. to 5 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: The Legacy Rockville, 1775 

Rockville Pike, Rockville, MD 20852. 

Contact Person: Joyce C. Pegues, PhD, 

Scientific Review Officer, Special Review 

and Logistics Branch, Division of Extramural 

Activities, NIH National Cancer Institute, 

6116 Executive Boulevard, Room 7149, 

Bethesda, MD 20892–8329, 301–594–1286, 

peguesj@mail.nih.gov. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel; 

Pharmacodynamic Assays. 

Date: March 11, 2008. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: The Legacy Hotel and Meeting 

Center, Bethesda, MD 20852. 

Contact Person: Thomas M. Vollberg, PhD, 

Scientific Review Officer, Special Review 

and Logistics Branch, Division of Extramural 

Activities, National Cancer Institute, 6116 

Executive Boulevard, Room 7142, Bethesda, 

MD 20892, 301–594–9582, 

vollbert@mail.nih.gov. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel; Small 

Grants for Behavioral Research in Cancer 

Control. 

Date: March 12, 2008. 

Time: 8 a.m. to 7 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Ramada Inn Rockville, 1775 

Rockville Pike, Rockville, MD 20852. 

Contact Person: Rhonda J. Moore, PhD, 

Scientific Review Officer, Special Review 

and Logistics Branch, Division of Extramural 

Activities, National Cancer Institute, NIH, 

6116 Executive Boulevard, Room 7151, 

Bethesda, MD 20892–8329, 301–451–9385, 

moorerh@mail.nih.gov. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel; Biopsy 

Instruments and Devices that Preserve 

Molecular Profiles in Tumors. 

Date: March 14, 2008. 

Time: 10:30 a.m. to 5 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: National Institutes of Health, 6130 

Executive Blvd., Conference Room J, 

Rockville, MD 20851, (Telephone Conference 

Call). 

Contact Person: Kenneth L. Bielat, PhD, 

Scientific Review Officer, Special Review 

Logistics Branch, Division of Extramural 

Activities, National Cancer Institute, 6116 

Executive Boulevard, Room 7147, Bethesda, 

MD 20892–8329, 301–496–7576, 

bielatk@mail.nih.gov. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel; Advanced 

Genomic Data Analysis and Visualization 

Methods for TCGA Data. 

Date: April 2, 2008. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 


rwilkins on PROD1PC63 with NOTICES