14810 Federal Register / Vol. 77, No. 49 / Tuesday, March 13, 2012 / Notices 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Form Number of 

respondents 

Annual 

frequency per 

response 

Total annual 

responses 

Hours per 

response Total hours 

FDA 3792 ............................................................................. 9 1 9 0.5 4.5 

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

Dated: March 7, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–6034 Filed 3–12–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0085] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Cooperative Manufacturing 

Arrangements for Licensed Biologics 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Cooperative Manufacturing 

Arrangements for Licensed Biologics’’ 

has been approved by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995. 

FOR FURTHER INFORMATION CONTACT: AIla 

S. Mizrachi, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

7726, ila.mizrachi@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: On August 

10, 2011, the Agency submitted a 

proposed collection of information 

entitled ‘‘Cooperative Manufacturing 

Arrangements for Licensed Biologics’’ to 

OMB for review and clearance under 44 

U.S.C. 3507. An Agency may not 

conduct or sponsor, and a person is not 

required to respond to, a collection of 

information unless it displays a 

currently valid OMB control number. 

OMB has now approved the information 

collection and has assigned OMB 

control number 0910–0629. The 

approval expires on February 28, 2015. 

A copy of the supporting statement for 

this information collection is available 

on the Internet at http:// 

www.reginfo.gov/public/do/PRAMain. 

Dated: March 6, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–6021 Filed 3–12–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–P–0527] 

Determination That DURANEST 

(Etidocaine Hydrochloride) Injection, 

0.5%, and Five Other DURANEST Drug 

Products 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 the DURANEST (etidocaine 

hydrochloride) drug products listed in 

this document were not withdrawn from 

sale for reasons of safety or 

effectiveness. This determination will 

allow FDA to approve abbreviated new 

drug applications (ANDAs) that refer to 

these drug products if all other legal and 

regulatory requirements are met. 

FOR FURTHER INFORMATION CONTACT: 

Rachel Bressler, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 6302, 

Silver Spring, MD 20993–0002, 301– 

796–4288. 

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 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 (21 CFR 314.162). 

A person may petition the Agency to 

determine, or the Agency may 

determine on its own initiative, whether 

a listed drug was withdrawn from sale 

for reasons of safety or effectiveness. 

This determination may be made at any 

time after the drug has been withdrawn 

from sale, but must be made prior to 

approving an ANDA that refers to the 

listed drug (§ 314.161 (21 CFR 314.161)). 

FDA may not approve an ANDA that 

does not refer to a listed drug. 

The drug products listed in the table 

in this document are no longer being 

marketed. DURANEST is indicated for 

infiltration anesthesia, peripheral nerve 

blocks (e.g., brachial plexus, intercostal 

retrobular, ulnar, inferior alveolar), and 

central nerve block (i.e., lumbar or 

caudal epidural blocks). 

Application 

No. Drug Applicant Initial approval date 

NDA 17–751 DURANEST (epinephrine bitartrate; etidocaine hydrochloride) Injection 

1%.

AstraZeneca Pharmaceutical .......... August 30, 

1976. 

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