1696 Federal Register / Vol. 77, No. 7 / Wednesday, January 11, 2012 / Notices 

determine whether AVALIDE 

(hydrochlorothiazide and irbesartan), 

oral tablets, 25 mg/300 mg, were 

withdrawn from sale for reasons of 

safety or effectiveness. In addition, 

Lupin Pharmaceuticals, Inc. submitted a 

citizen petition dated November 10, 

2011 (Docket No. FDA–2011–P–0822), 

under § 10.30, also requesting that the 

Agency determine whether AVALIDE 

(hydrochlorothiazide and irbesartan), 

oral tablets, 25 mg/300 mg, were 

withdrawn from sale for reasons of 

safety or effectiveness. Although the 

citizen petitions did not address the 

12.5 mg/75 mg strength, that strength 

has also been discontinued. On our own 

initiative, we have also determined 

whether that strength was withdrawn 

for safety or effectiveness reasons. 

After considering the citizen petitions 

and reviewing Agency records, and 

based on the information we have at this 

time, FDA has determined under 

§ 314.161 that AVALIDE 

(hydrochlorothiazide and irbesartan), 

oral tablets, 25 mg/300 mg and 12.5 mg/ 

75 mg were not withdrawn for reasons 

of safety or effectiveness. The 

petitioners have identified no data or 

other information suggesting that 

AVALIDE (hydrochlorothiazide and 

irbesartan), oral tablets, 25 mg/300 mg 

and 12.5 mg/75 mg were withdrawn for 

reasons of safety or effectiveness. We 

have carefully reviewed our files for 

records concerning the withdrawal of 

AVALIDE (hydrochlorothiazide and 

irbesartan), oral tablets, 25 mg/300 mg 

and 12.5 mg/75 mg from sale. We have 

also independently evaluated relevant 

literature and data for possible 

postmarketing adverse events. We have 

reviewed the available evidence and 

determined that AVALIDE 

(hydrochlorothiazide and irbesartan), 

oral tablets, 25 mg/300 mg and 12.5 mg/ 

75 mg were not withdrawn from sale for 

reasons of safety or effectiveness. 

Accordingly, the Agency will 

continue to list AVALIDE 

(hydrochlorothiazide and irbesartan), 

oral tablets, 25 mg/300 mg and 12.5 mg/ 

75 mg, in the ‘‘Discontinued Drug 

Product List’’ section of the Orange 

Book. The ‘‘Discontinued Drug Product 

List’’ delineates, among other items, 

drug products that have been 

discontinued from marketing for reasons 

other than safety or effectiveness. 

ANDAs that refer to AVALIDE 

(hydrochlorothiazide and irbesartan), 

oral tablets, 25 mg/300 mg and 12.5 mg/ 

75 mg, may be approved by the Agency 

as long as they meet all other legal and 

regulatory requirements for the approval 

of ANDAs. If FDA determines that 

labeling for this drug product should be 

revised to meet current standards, the 

Agency will advise ANDA applicants to 

submit such labeling. 

Dated: January 5, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–312 Filed 1–10–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0001] 

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 14, 2012, from 7:30 a.m. 

to 3 p.m. 

Location: Gaylord National Hotel and 

Convention Center, Maryland Ballroom 

C, 201 Waterfront St., National Harbor, 

MD 20745. The hotel’s phone number is 

(301) 965–4000. 

Contact Person: Yvette Waples, Center 

for Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 31, Rm. 2417, 

Silver Spring, MD 20993–0002, (301) 

796–9001, FAX: (301) 847–8533, email: 

ACPS–CP@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–(800) 741–8138 ((301) 443–0572 in 

the Washington, DC area), and follow 

prompts to the desired center or product 

area. 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: The committee will discuss 

the clinical pharmacology aspects of 

pediatric clinical trial design and dosing 

to optimize pediatric drug development. 

FDA will seek input on how to 

strategically inform pediatric clinical 

trial design and dosing by utilizing 

existing knowledge, including available 

adult and nonclinical data. The 

discussion will include the role of 

modeling and simulation including 

physiologically-based pharmacokinetic 

modeling in pediatric drug 

development. Modeling and simulation 

is the application of mathematical 

approaches to predicting what will 

happen in a clinical trial with pediatric 

patients when a particular dose of a 

drug is used. 

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/

AdvisoryCommittees/Calendar/

default.htm. 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 February 29, 2012. 

Oral presentations from the public will 

be scheduled between approximately 

10:45 a.m. and 11:45 a.m. Those 

individuals interested in making 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 21, 2012. 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 22, 2012. 

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 


pmangrum on DSK3VPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 7 / Wednesday, January 11, 2012 / Notices 1697 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Yvette 

Waples 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/

AdvisoryCommittees/AboutAdvisory

Committees/ucm111462.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: January 5, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–324 Filed 1–10–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0001] 

Arthritis 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: 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 March 12, 2012, from 8 a.m. to 

5:30 p.m. 

Location: FDA White Oak Campus, 

10903 New Hampshire Ave., Building 

31 Conference Center, the Great Room, 

(rm. 1503), Silver Spring, MD 20993– 

0002. Information regarding special 

accommodations due to a disability, 

visitor parking, and transportation may 

be accessed at: http://www.fda.gov/ 

AdvisoryCommittees/default.htm; under 

the heading ‘‘Resources for You,’’ click 

on ‘‘Public Meetings at the FDA White 

Oak Campus.’’ Please note that visitors 

to the White Oak Campus must enter 

through Building 1. 

Contact Person: Philip A. Bautista, 

Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 31, rm. 2417, Silver Spring, 

MD 20993–0002, (301) 796–9001, FAX: 

(301) 847–8533, email: 

AAC@fda.hhs.gov, or FDA Advisory 

Committee Information Line, 1–(800) 

741–8138 ((301) 443–0572 in the 

Washington, DC area), and follow the 

prompts to the desired center or product 

area. 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: The committee will discuss 

the anti-nerve growth factor (Anti-NGF) 

drug class that is currently under 

development and the safety issues 

possibly related to these drugs. These 

drugs are being developed for the 

treatment of a variety of chronic painful 

conditions including osteoarthritis, 

chronic lower back pain, diabetic 

peripheral neuropathy, post-herpetic 

neuralgia, chronic pancreatitis, 

endometriosis, interstitial cystitis, 

vertebral fracture, thermal injury, and 

cancer pain. The committee will be 

asked to determine whether reports of 

joint destruction represent a safety 

signal related to the Anti-NGF class of 

drugs, and whether the risk benefit 

balance for these drugs favors continued 

development of the drugs as analgesics. 

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/ 

AdvisoryCommittees/Calendar/ 

default.htm. 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 February 27, 2012. 

Oral presentations from the public will 

be scheduled between approximately 

1:30 p.m. and 2:30 p.m. Those 

individuals interested in making 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 16, 2012. 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 17, 2012. 

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 Philip A. 

Bautista 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/ 

AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm111462.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: January 5, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–326 Filed 1–10–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Indian Health Service 

Agency Information Collection 

Activities: Fast Track Generic 

Clearance for the Collection of 

Qualitative Feedback on Agency 

Service Delivery: IHS Web Site 

Customer Service Satisfaction Survey 

AGENCY: Indian Health Service, HHS. 

ACTION: 30-Day notice of submission of 

information collection approval from 

the Office of Management and Budget 

(OMB) and request for comments. 


pmangrum on DSK3VPTVN1PROD with NOTICES