Federal Register / Vol. 75, No. 248 / Tuesday, December 28, 2010 / Notices 81617 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Section 523 of the FD&C Act No. of 

respondents 

Annual 

frequency per 

response 

Total annual 

responses 

Hours per 

response Total hours 

Requests for accreditation ................................................... 1 1 1 24 24 

510(k) reviews conducted by accredited third parties ......... 10 26 260 40 10,400 

Total .............................................................................. ........................ ........................ ........................ ........................ 10,424 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Section 523 of the FD&C Act No. of 

recordkeepers 

Annual 

frequency per 

recordkeeping 

Total annual 

records 

Hours 

per record Total hours 

510(k) reviews ...................................................................... 10 26 260 10 2,600 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Dated: December 21, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–32603 Filed 12–27–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–P–0326] 

Determination That TRANDATE 

(Labetalol Hydrochloride) Tablets, 300 

Milligrams and 400 Milligrams, Were 

Not Withdrawn From Sale for Reasons 

of Safety or Effectiveness 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

that TRANDATE (labetalol 

hydrochloride) tablets, 300 milligrams 

(mg) and 400 mg, were not withdrawn 

from sale for reasons of safety or 

effectiveness. This determination means 

that FDA will not begin procedures to 

withdraw approval of abbreviated new 

drug applications (ANDAs) that refer to 

these drug products, and it will allow 

FDA to continue to approve ANDAs that 

refer to the products as long as the 

ANDAs meet relevant legal and 

regulatory requirements. 

FOR FURTHER INFORMATION CONTACT: 

Deborah Livornese, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 6306, 

Silver Spring, MD 20993–0002, 301– 

796–0719. 

SUPPLEMENTARY INFORMATION: In 1984, 

Congress enacted the Drug Price 

Competition and Patent Term 

Restoration Act of 1984 (Pub. L. 98–417) 

(the 1984 amendments), which 

authorized the approval of duplicate 

versions of drug products approved 

under an ANDA procedure. ANDA 

applicants must, with certain 

exceptions, show that the drug for 

which they are seeking approval 

contains the same active ingredient in 

the same strength and dosage form as 

the ‘‘listed drug,’’ which is a version of 

the drug that was previously approved. 

ANDA applicants do not have to repeat 

the extensive clinical testing otherwise 

necessary to gain approval of a new 

drug application (NDA). The only 

clinical data required in an ANDA are 

data to show that the drug that is the 

subject of the ANDA is bioequivalent to 

the listed drug. 

The 1984 amendments include what 

is now section 505(j)(7) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

355(j)(7)), which requires FDA to 

publish a list of all approved drugs. 

FDA publishes this list as part of the 

‘‘Approved Drug Products With 

Therapeutic Equivalence Evaluations,’’ 

which is known generally as the 

‘‘Orange Book.’’ Under FDA regulations, 

drugs are removed from the list if the 

Agency withdraws or suspends 

approval of the drug’s NDA or ANDA 

for reasons of safety or effectiveness or 

if FDA determines that the listed drug 

was withdrawn from sale for reasons of 

safety or effectiveness (§ 314.162 (21 

CFR 314.162)). Under § 314.161(a)(1) (21 

CFR 314.161(a)(1)), the Agency must 

determine whether a listed drug was 

withdrawn from sale for reasons of 

safety or effectiveness before an ANDA 

that refers to that listed drug may be 

approved. FDA may not approve an 

ANDA that does not refer to a listed 

drug. Under § 314.161(a)(2), FDA must 

determine whether a listed drug was 

withdrawn from sale for reasons of 

safety or effectiveness whenever a listed 

drug is voluntarily withdrawn from sale 

and ANDAs that refer to the listed drug 

have been approved. Section 314.161(d) 

provides that if FDA determines that a 

listed drug was withdrawn from sale for 

reasons of safety or effectiveness, the 

Agency will initiate proceedings that 

could result in the withdrawal of 

approval of the ANDAs that refer to the 

listed drug. 

TRANDATE (labetalol hydrochloride) 

tablets, 300 mg and 400 mg, are the 

subject of NDA 18–716, held by 

Prometheus Laboratories, Inc., and 

initially approved on August 1, 1984. 

TRANDATE is indicated for the 

management of hypertension. 

TRANDATE (labetalol hydrochloride) 

tablets, 300 mg and 400 mg, are 

currently listed in the ‘‘Discontinued 

Drug Product List’’ section of the Orange 

Book. TRANDATE (labetalol 

hydrochloride) tablets, 400 mg, have 

never been marketed. In previous 

instances (see, e.g., 72 FR 9763, March 

5, 2007; 61 FR 25497, May 21, 1996), the 

Agency has determined that, for 

purposes of §§ 314.161 and 314.162, 

never marketing an approved drug 

product is equivalent to withdrawing 

the drug from sale. 

JRRapoza Associates, Inc., submitted a 

citizen petition dated June 16, 2010 

(Docket No. FDA–2010–P–0326), under 

21 CFR 10.30, requesting that the 

Agency determine whether TRANDATE 

(labetalol hydrochloride) tablets, 300 

mg, were withdrawn from sale for 

reasons of safety or effectiveness. 

Although the citizen petition did not 

address the 400 mg strength, on our own 

initiative, we have also determined 

whether that strength was withdrawn 

for safety or effectiveness reasons. 

After considering the citizen petition 

and reviewing Agency records, FDA has 

determined under § 314.161 that 


emcdonald on DSK2BSOYB1PROD with NOTICES
81618 Federal Register / Vol. 75, No. 248 / Tuesday, December 28, 2010 / Notices 

TRANDATE (labetalol hydrochloride) 

tablets, 300 mg and 400 mg, were not 

withdrawn for reasons of safety or 

effectiveness. The petitioner has 

identified no data or other information 

suggesting that TRANDATE (labetalol 

hydrochloride) tablets, 300 mg and 400 

mg, were withdrawn for reasons of 

safety or effectiveness. We have 

carefully reviewed our files for records 

concerning the withdrawal of 

TRANDATE (labetalol hydrochloride) 

tablets, 300 mg and 400 mg, from sale. 

We have also independently evaluated 

relevant literature and data for possible 

postmarketing adverse events and have 

found no information that would 

indicate that this product was 

withdrawn from sale for reasons of 

safety or effectiveness. 

Accordingly, the Agency will 

continue to list TRANDATE (labetalol 

hydrochloride) tablets, 300 mg and 400 

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. FDA will not 

begin procedures to withdraw approval 

of approved ANDAs that refer to the 

TRANDATE products listed in this 

document. Additional ANDAs that refer 

to these products may also 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: December 21, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–32507 Filed 12–27–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0001] 

Anesthetic and Life Support 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: Anesthetic and Life 

Support 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 March 10, 2011, from 8 a.m. to 4:30 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 ‘‘White Oak Conference 

Center Parking and Transportation 

Information for FDA Advisory Committee 

Meetings’’. Please note that visitors to the 

White Oak Campus must enter through 

Building 1. 

Contact Person: Kalyani Bhatt, 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, e-mail: kalyani.bhatt@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 upto-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 March 10, 2011, the committee 

will: (1) Receive updates regarding 

neurodegenerative findings (findings related 

to degeneration in the nervous system) in 

juvenile animals exposed to anesthetic drugs, 

as well as results from human 

epidemiological studies using anesthesia in 

children (information related to studies of 

patterns and causes of disease); (2) discuss 

the relevance of these findings to pediatric 

patients and provide guidance for future 

preclinical and clinical studies; and (3) 

discuss the potential implications of these 

data upon the practice of pediatric anesthesia 

as well as the communication of the risk of 

sedative/anesthetic agents to prescribers and 

parents. 

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 24, 2011. 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 

February 15, 2011. 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 16, 2011. 

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 Kalyani 

Bhatt 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: December 21, 2010. 

Jill Hartzler Warner, 

Acting Associate Commissioner for Special 

Medical Programs. 

[FR Doc. 2010–32591 Filed 12–27–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0001] 

Request for Notification From 

Consumer Organizations Interested in 

Participating in the Selection Process 

for Nominations for Voting and/or 

Nonvoting Consumer Representatives 

on Public Advisory Committees or 

Panels and Request for Nominations 

for Voting and/or Nonvoting Consumer 

Representatives on Public Advisory 

Committees or Panels 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 


emcdonald on DSK2BSOYB1PROD with NOTICES