16038 Federal Register / Vol. 77, No. 53 / Monday, March 19, 2012 / Notices 

receive an electronic copy of the 

document or send a fax request to 301– 

847–8149 to receive a hard copy. Please 

use the document number 1746 to 

identify the guidance you are 

requesting. 

IV. Paperwork Reduction Act of 1995 

This guidance contains information 

collection provisions that are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (PRA) (44 U.S.C. 

3501–3520). The collection(s) of 

information in this guidance was 

approved under OMB control number 

0910–0700. This final guidance also 

refers to currently approved collections 

of information found in FDA 

regulations. These collections of 

information are subject to review by 

OMB under the PRA. The collections of 

information in 21 CFR part 820 are 

currently approved under OMB control 

number 0910–0073 and the collections 

of information for the Inspection by 

Accredited Persons Program are 

currently approved under OMB control 

number 0910–0569. 

V. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES), either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. Identify comments 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. 

Dated: March 13, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–6503 Filed 3–16–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0001] 

Endocrinologic and Metabolic 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: Endocrinologic 

and Metabolic 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 May 10, 2012, from 8 a.m. to 

5 p.m. 

Location: DoubleTree by Hilton Hotel 

Washington, DC-Silver Spring, The 

Ballrooms, 8727 Colesville Rd., Silver 

Spring, MD. The hotel telephone 

number is 301–589–5200. 

Contact Person: Paul Tran, 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: 

EMDAC@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 safety and efficacy of new drug 

application (NDA) 22–529 (lorcaserin 

hydrochloride) tablets, manufactured by 

Arena Pharmaceuticals, Inc., as an 

adjunct to diet and exercise for weight 

management in patients with a body 

mass index (BMI) equal to or greater 

than 30 kilograms (kg) per square meter 

or a BMI equal to or greater than 27 kg 

per square meter if accompanied by 

weight-related comorbidities. 

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 April 26, 2012. Oral 

presentations from the public will be 

scheduled between approximately 1 

p.m. and 2 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 April 18, 

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 April 19, 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 Paul Tran 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: March 13, 2012. 

Jill Hartzler Warner, 

Acting Associate Commissioner for Special 

Medical Programs. 

[FR Doc. 2012–6483 Filed 3–16–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0001] 

Circulatory System Devices Panel of 

the Medical Devices Advisory 

Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 


emcdonald on DSK29S0YB1PROD with NOTICES
Federal Register / Vol. 77, No. 53 / Monday, March 19, 2012 / Notices 16039 

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: Circulatory 

System Devices Panel of the Medical 

Devices 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 25 and 26, 2012, from 8 

a.m. to 6 p.m. 

Location: Holiday Inn, Ballroom, 2 

Montgomery Village Ave., Gaithersburg, 

MD 20879. The hotel’s phone number is 

301–948–8900. 

Contact Person: Jamie Waterhouse, 

Center for Devices and Radiological 

Health, Food and Drug Administration, 

10903 New Hampshire Ave., Silver 

Spring, MD 20993, 301–796–3063, 

email: Jamie.Waterhouse@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 

On April 25, 2012, the committee will 

discuss, make recommendations and 

vote on information related to a 

supplement to the premarket approval 

application (PMA) for the HeartWare 

Ventricular Assist System (HVAS) 

sponsored by HeartWare, Inc. The 

HVAS is an implantable electrically 

powered centrifugal-flow rotary blood 

pump with external driver and power 

source(s). It is the first ventricular assist 

device that does not require the creation 

of an abdominal pump pocket. The 

HVAS is indicated for use as a bridge to 

cardiac transplantation in patients who 

are at risk of death from refractory, 

advanced heart failure. 

On April 26, 2012, the committee will 

discuss, make recommendations and 

vote on information related to the PMA 

for the Subcutaneous Implantable 

Cardioverter Defibrillator (S–ICD) 

System sponsored by Cameron Health, 

Inc. The S–ICD is the first implantable 

defibrillator that does not require the 

implantation of an electrode either on or 

in the heart. The S–ICD is intended to 

provide defibrillation therapy for the 

treatment of life-threatening ventricular 

tachyarrhythmias. The device is capable 

of delivering high energy defibrillation 

shocks as well as bradycardia demand 

mode cardiac pacing. The study 

provides data from the treatment of 

induced acute and chronic episodes of 

ventricular tachycardia/ventricular 

fibrillation and spontaneous episodes. 

In addition to the investigational device 

exemption study, clinical data were also 

obtained from using studies outside the 

United States and registries. 

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 

April 17, 2012. Oral presentations from 

the public will be scheduled between 

approximately 1 p.m. and 2 p.m. on 

April 25 and 26, 2012. 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 April 10, 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 April 12, 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 AnnMarie 

Williams, at 

AnnMarie.Williams@fda.hhs.gov, 301– 

796–5966, 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: March 13, 2012. 

Jill Hartzler Warner, 

Acting Associate Commissioner for Special 

Medical Programs. 

[FR Doc. 2012–6484 Filed 3–16–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0190] 

Abbott Laboratories et al.; Withdrawal 

of Approval of 35 New Drug 

Applications and 64 Abbreviated New 

Drug Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is withdrawing 

approval of 35 new drug applications 

(NDAs) and 64 abbreviated new drug 

applications (ANDAs) from multiple 

applicants. The holders of the 

applications notified the Agency in 

writing that the drug products were no 

longer marketed and requested that the 

approval of the applications be 

withdrawn. 

DATES: Effective Date: April 18, 2012. 

FOR FURTHER INFORMATION CONTACT: 

Florine P. Purdie, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 6366, 

Silver Spring, MD 20993–0002, 301– 

796–3601. 

SUPPLEMENTARY INFORMATION: The 

holders of the applications listed in 

table 1 in this document have informed 


emcdonald on DSK29S0YB1PROD with NOTICES