Federal Register / Vol. 72, No. 42 / Monday, March 5, 2007 / Notices 9765 

Name of Committee: Arthritis 

Advisory Committee. 

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 April 12, 2007, from 8:30 a.m. 

to 5 p.m. 

Addresses: Electronic comments 

should be submitted to http:// 

www.fda.gov/dockets/ecomments. 

Select ‘‘2007N–0055—Arcoxia—

Arthritis Advisory Committee Meeting, 

April 12, 2007’’ and follow the prompts 

to submit your statement. Written 

comments should be submitted to the 

Division of Dockets Management (HFA–

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852, by close of business on 

March 29, 2007. All comments will be 

posted without change, including any 

personal information provided. 

Comments received on or before March 

29, 2007, will be provided to the 

committee before the meeting. 

Location: Hilton Washington DC 

North/Gaithersburg, The Ballrooms, 620 

Perry Pkwy., Gaithersburg, MD. 

Contact Person: Johanna Clifford, 

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: 

Johanna.Clifford@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), code 

3014512532. Please call the Information 

Line for up-to-date information on this 

meeting. 

Agenda: The committee will discuss 

new drug application (NDA) 21–389/ 

21–772, ARCOXIA (etoricoxib), Merck & 

Co., Inc., proposed treatment for the 

relief of signs and symptoms of 

osteoarthritis. 

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 March 29, 2007. 

Oral presentations from the public will 

be scheduled between approximately 

11:30 a.m. and 12:30 p.m. 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 March 

21, 2007. 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 March 22, 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 Johanna 

Clifford 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: February 26, 2007. 

Randall W. Lutter, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E7–3722 Filed 3–2–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

Cardiovascular and Renal Drugs 

Advisory Committee; 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: Cardiovascular 

and Renal Drugs Advisory Committee 

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 April 18, 2007, from 8 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: Cathy A. Groupe, 

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: 

Cathy.Groupe@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), code 

3014512533. Please call the information 

line for up-to-date information on this 

meeting. 

Agenda: The committee will discuss 

supplemental new drug application 

(sNDA) 20–758/S–037, AVALIDE 

(irbesartan plus hydrochlorothiazide), 

Bristol-Myers Squibb Co. The sponsor is 

seeking approval for first-line use in 

hypertensive patients unlikely to 

achieve blood pressure goals on one 

drug. The committee will be asked to 

consider what constitutes adequate data 

to support such a claim and how the 

information can be most usefully 

displayed in labeling. 

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 3, 2007. Oral 

presentations from the public will be 

scheduled between approximately 8:30 

a.m. to 9:30 a.m. 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 


erjones on PRODPC74 with NOTICES
9766 Federal Register / Vol. 72, No. 42 / Monday, March 5, 2007 / Notices 

proposed participants and an indication 

of the approximate time requested to 

make their presentation on or before 

March 26, 2007. 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 March 27, 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 Cathy 

Groupe 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: February 26, 2007. 

Randall W. Lutter, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E7–3721 Filed 3–2–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007N–0061] 

Cellular, Tissue, and Gene Therapies 

Advisory Committee; 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). At least one portion of the 

meeting will be closed to the public. 

Name of Committee: Cellular, Tissue, 

and Gene Therapies Advisory 

Committee. 

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 29, 2007, from 8 a.m. to 

approximately 6:30 p.m. and on March 

30, 2007 from 8 a.m. to approximately 

3 p.m. 

Address: Electronic comments should 

be submitted to http://www.fda.gov/ 

dockets/ecomments. Select Docket No. 

2007N–0061, ‘‘Sipuleucel-T Dendreon,’’

and follow prompts to submit your 

statement. Written comments should be 

submitted to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852, by close of 

business on March 22, 2007. All 

comments received will be posted 

without change, including any personal 

information provided. Comments 

received on or before March 22, 2007, 

will be provided to the committee 

before or at the meeting. 

Location: Hilton Washington DC 

North/Gaithersburg, 620 Perry Pkwy., 

Gaithersburg, MD, Grand Ballroom. 

Contact Person: Gail Dapolito or 

Rosanna L. Harvey, Center for Biologics 

Evaluation and Research (HFM–71), 

Food and Drug Administration, 1401 

Rockville Pike, Rockville, MD 20852, 

301–827–1289, FAX: 301–827–0294, or 

FDA Advisory Committee Information 

Line, 1–800–741–8138 (301–443–0572 

in the Washington, DC area), code 

3014512389. Please call the Information 

Line for up-to-date information on this 

meeting. 

Agenda: On March 29, 2007, in open 

session, the committee will discuss 

Sipuleucel-T, Dendreon (BLA–STN 

125197) indicated for the treatment of 

men with asymptomatic metastatic 

hormone refractory prostate cancer. The 

committee will also hear overviews of 

research programs in the Division of 

Cellular and Gene Therapies, Center for 

Biologics Evaluation and Research. On 

March 30, 2007, in open session, the 

committee will discuss the draft 

document entitled ‘‘Guidance for 

Industry: Minimally Manipulated, 

Unrelated, Allogeneic Placental/ 

Umbilical Cord Blood Intended for 

Hematopoietic Reconstitution in 

Patients with Hematological 

Malignancies.’’ For a copy of the draft 

guidance visit http://www.fda.gov/cber/ 

gdlns/cordbld.pdf. The committee will 

also discuss scientific issues regarding 

minimally manipulated, unrelated 

allogeneic peripheral blood stem cells. 

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: On March 29, 2007, from 

8 a.m. to approximately 5:30 p.m., and 

on March 30, 2007, from 8 a.m. to 

approximately 3 p.m., the meeting is 

open to the public. 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 15, 2007. 

Oral presentations from the public will 

be scheduled between approximately 

11:30 a.m. and 12:30 p.m. on March 29, 

2007, and between 10 a.m. and 11 a.m. 

on March 30, 2007. 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 March 7, 2007. 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 March 8, 2007. 

Closed Committee Deliberations: On 

March 29, 2007, at approximately 5:30 

p.m., the meeting will be closed to 

permit discussion where disclosure 

would constitute a clearly unwarranted 

invasion of personal privacy (5 U.S.C. 

552b(c)(6)). The committee will discuss 

a report of intramural research programs 

in the Division of Cellular and Gene 

Therapies. 

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 Gail Dapolito 

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: February 26, 2007. 

Randall W. Lutter, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E7–3712 Filed 3–2–07; 8:45 am] 

BILLING CODE 4160–01–S 


erjones on PRODPC74 with NOTICES