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Federal Register / Vol. 73, No.

32 / Friday, February 15, 2008 / Notices 8885

studies that should be conducted for DEPARTMENT OF HEALTH AND DEPARTMENT OF HEALTH AND
drug metabolites that are present at HUMAN SERVICES HUMAN SERVICES
greater than 10 percent of the parent
drug systemic exposure as measured in Food and Drug Administration National Institutes of Health
plasma.
Anti-Infective Drugs Advisory Center for Scientific Review; Notice of
A draft version of this guidance was Committee; Amendment of Notice Closed Meetings
made available for public comment in
2005 (70 FR 32839, June 6, 2005). All of Pursuant to section 10(d) of the
AGENCY: Food and Drug Administration, Federal Advisory Committee Act, as
the public comments we received have HHS. amended (5 U.S.C. Appendix 2), notice
been considered and the guidance was
ACTION: Notice. is hereby given of the following
revised as appropriate.
meetings.
This guidance is being issued The meetings will be closed to the
SUMMARY: The Food and Drug
consistent with FDA’s good guidance public in accordance with the
Administration (FDA) is announcing an
practices regulation (21 CFR 10.115). amendment to the notice of a meeting of provisions set forth in sections
The guidance represents the agency’s the Anti-Infective Drugs Advisory 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
current thinking on the safety testing of as amended. The grant applications and
Committee. This meeting was
drug metabolites. It does not create or the discussions could disclose
announced in the Federal Register of
confer any rights for or on any person confidential trade secrets or commercial
January 11, 2008 (73 FR 2055). The
and does not operate to bind FDA or the property such as patentable material,
amendment is being made to reflect a
public. An alternative approach may be and personal information concerning
change in the Date and Time and
used if such approach satisfies the individuals associated with the grant
Agenda portions of the document. There applications, the disclosure of which
requirements of the applicable statutes are no other changes.
and regulations. would constitute a clearly unwarranted
FOR FURTHER INFORMATION CONTACT: invasion of personal privacy.
II. Comments Sohail Mosaddegh, Center for Drug Name of Committee: Center for Scientific
Evaluation and Research (HFD–21), Review Special Emphasis Panel, Molecular
Interested persons may submit to the and Cellular Sciences Special Emphasis
Food and Drug Administration, 5600
Division of Dockets Management (see Panel.
Fishers Lane, Rockville, MD 20857,
ADDRESSES) written or electronic Date: February 28, 2008.
301–827–7001, or FDA Advisory
comments regarding this document. Time: 11 a.m. to 2 p.m.
Committee Information Line, 1–800– Agenda: To review and evaluate grant
Submit a single copy of electronic 741–8138 (301–443–0572 in the applications.
comments or two paper copies of any Washington, DC area), code Place: National Institutes of Health, 6701
mailed comments, except that 3014512530. Please call the Information Rockledge Drive, Bethesda, MD 20892,
individuals may submit one paper copy. Line for up-to-date information on this (Telephone Conference Call).
Comments are to be identified with the meeting. Contact Person: Noni Byrnes, PhD,
docket number found in brackets in the Scientific Review Administrator, Center for
heading of this document. Received SUPPLEMENTARY INFORMATION: In the Scientific Review, National Institutes of
Federal Register of January 11, 2008, Health, 6701 Rockledge Drive, Room 5130,
comments may be seen in the Division MSC 7840, Bethesda, MD 20892, (301) 435–
of Dockets Management between 9 a.m. FDA announced that a meeting of the
1023, byrnesn@csr.nih.gov.
and 4 p.m., Monday through Friday. Anti-Infective Drugs Advisory This notice is being published less than 15
Committee would be held on February days prior to the meeting due to the timing
Please note that on January 15, 2008,
27 and 28, 2008. On page 2056, in the limitations imposed by the review and
the FDA Web site transitioned to the first column, the Date and Time and funding cycle.
Federal Dockets Management System Agenda portions are amended to read as Name of Committee: Center for Scientific
(FDMS). FDMS is a Government-wide, follows: Review Special Emphasis Panel, Member
electronic docket management system. Conflict: Stress.
Electronic submissions will be accepted Date and Time: The meeting will be Date: February 29, 2008.
by FDA through FDMS only. held on February 27, 2008, from 8 a.m. Time: 12 p.m. to 2 p.m.
to 5 p.m. Agenda: To review and evaluate grant
III. Electronic Access Agenda: On February 27, 2008, the applications.
Place: National Institutes of Health, 6701
Persons with access to the Internet committee will discuss new drug Rockledge Drive, Bethesda, MD 20892,
may obtain the document at either application (NDA) 022–110, telavancin (Telephone Conference Call).
http://www.fda.gov/cder/guidance/ powder for reconstitution and Contact Person: Christine L. Melchior,
index.htm or http://www.fda.gov/ intravenous administration, Theravance, PhD, Scientific Review Administrator, Center
Inc., proposed for the treatment of for Scientific Review, National Institutes of
ohrms/dockets/default.htm. Health, 6701 Rockledge Drive, Room 5176,
complicated skin and skin structure
Dated: February 8, 2008. MSC 7844, Bethesda, MD 20892, (301) 435–
infection. 1713, melchioc@csr.nih.gov.
Jeffrey Shuren, This notice is issued under the This notice is being published less than 15
Assistant Commissioner for Policy. Federal Advisory Committee Act (U.S.C. days prior to the meeting due to the timing
[FR Doc. E8–2827 Filed 2–14–08; 8:45 am] app. 2) and 21 CFR part 14, relating to limitations imposed by the review and
advisory committees. funding cycle.
BILLING CODE 4160–01–S
Name of Committee: Center for Scientific
rwilkins on PROD1PC63 with NOTICES

Dated: February 11, 2008. Review Special Emphasis Panel, Member


Randall W. Lutter, Conflict: Innate Immunity and Inflammation.
Deputy Commissioner for Policy. Date: March 7, 2008.
Time: 10 a.m. to 12 p.m.
[FR Doc. E8–2824 Filed 2–14–08; 8:45 am] Agenda: To review and evaluate grant
BILLING CODE 4160–01–S applications.

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