Federal Register / Vol. 72, No. 51 / Friday, March 16, 2007 / Notices 12621 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

Advisory Committee for 

Pharmaceutical Science and Clinical 

Pharmacology (formerly called 

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: Advisory 

Committee for Pharmaceutical Science 

and Clinical Pharmacology (formerly 

called 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 May 1 and 2, 2007, from 8:30 

a.m. to 5 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: Victoria FerrettiAceto, 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: 

Victoria.FerrettiAceto@fda.hhs.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 May 1, 2007, the 

committee will do the following: (1) 

Receive and discuss updates from the 

October 18 and 19, 2006, Clinical 

Pharmacology Subcommittee Meeting 

and the April 30, 2007, Manufacturing 

Subcommittee Meeting; (2) receive an 

update, discuss and make comments on 

current strategies and directions for the 

Critical Path Initiative; (3) receive an 

update and discuss revisions to the FDA 

draft guidance for industry entitled 

‘‘Comparability Protocols — Chemistry, 

Manufacturing, and Controls 

Information;’’ (4) discuss current 

thinking on risk-based approaches to 

managing post-approval activity. On 

May 2, 2007, the committee will do the 

following: (1) Receive an update from 

the Office of Generic Drugs (OGD) on 

the bioequivalence of highly variable 

drugs, (2) receive an update on and 

discuss general strategies within the 

OGD pertaining to the bioequivalence of 

narrow therapeutic index drug products, 

and (3) discuss and provide comments 

on the topic of alcohol-induced dose 

dumping. 

FDA intends to make background 

material available to the public no later 

than 1 business day 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 2007 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 April 17, 2007. Oral 

presentations from the public will be 

scheduled between approximately 1 

p.m. and 2 p.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 April 9, 

2007. Time allotted for each 

presentation may be limited. If the 

number of registrants requesting to 

speak is greater than can be reasonable 

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 April 10, 2007. 

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 Victoria 

Ferretti-Aceto 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: March 8, 2007. 

Randall W. Lutter, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E7–4797 Filed 3–15–07; 8:45 am] 

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DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Center for Research 

Resources; Notice of Closed Meeting 

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 

meeting. 

The meeting 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: National Center for 

Research Resources Special Emphasis Panel, 

TSPC–SEP Teleconference. 

Date: March 27, 2007. 

Time: 11 a.m. to 1 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, One 

Democracy Plaza, 6701 Democracy 

Boulevard, Bethesda, MD 20892 (Telephone 

Conference Call). 

Contact Person: John R. Glowa, PhD, 

Scientific Review Administrator, National 

Center for Research Resources, or National 

Institutes of Health, 6701 Democracy Blvd., 

1 Democracy Plaza, Room 1078—Msc 4874, 

Bethesda, MD 20892–4874, 301–435–0807, 

glowaj@mail.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. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research; 93.371, Biomedical 

Technology; 93.389, Research Infrastructure; 

93.306, 93.333, National Institutes of Health, 

HHS) 

Dated: March 8, 2007. 

Anna Snouffer, 

Acting Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 07–1225 Filed 3–15–07; 8:45 am] 

BILLING CODE 4140–01–M 


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