Federal Register / Vol. 77, No. 49 / Tuesday, March 13, 2012 / Notices 14809 

information collection should be sent 

directly to the following: Office of 

Management and Budget, Paperwork 

Reduction Project, Fax: 202–395–6974, 

Attn: Desk Officer for the 

Administration for Children and 

Families. 

Dated: March 7, 2012. 

Steven M. Hanmer, 

Reports Clearance, Officer; Office of Planning, 

Research and Evaluation. 

[FR Doc. 2012–5951 Filed 3–12–12; 8:45 am] 

BILLING CODE 4184–37–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0194] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request; Biosimilars User 

Fee Cover Sheet; Form FDA 3792 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal Agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments 

concerning Form FDA 3792, entitled 

‘‘Biosimilars User Fee Cover Sheet.’’ 

DATES: Submit written or electronic 

comments on the collection of 

information by May 14, 2012. 

ADDRESSES: Submit electronic 

comments to http:// 

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Juanmanuel Vilela, Office of 

Information Management, Food and 

Drug Administration, 1350 Piccard Dr., 

PI50–400B, Rockville, MD 20850, 301– 

796–7651, 

Juanmanuel.vilela@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60 day notice in 

the Federal Register concerning each 

proposed collection of information 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on: (1) Whether the proposed 

collection of information is necessary 

for the proper performance of FDA’s 

functions, including whether the 

information will have practical utility; 

(2) the accuracy of FDA’s estimate of the 

burden of the proposed collection of 

information, including the validity of 

the methodology and assumptions used; 

(3) ways to enhance the quality, utility, 

and clarity of the information to be 

collected; and (4) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

when appropriate, and other forms of 

information technology. 

The March 23, 2010 Affordable Care 

Act contains a subtitle called the 

Biologics Price Competition and 

Innovation Act of 2009 (BPCI Act) that 

amends the Public Health Service Act 

(PHS Act) and other statutes to create an 

abbreviated approval pathway for 

biological products shown to be 

biosimilar to or interchangeable with an 

FDA-licensed reference biological 

product. Section 351(k) of the PHS Act, 

added by the BPCI Act, allows a 

company to submit an application for 

licensure of a biosimilar or 

interchangeable biological product. The 

BPCI Act also amends section 735 of the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) to include 351(k) 

applications in the definition of ‘‘human 

drug application’’ for the purposes of 

the prescription drug user fee 

provisions. The authority conferred by 

the FD&C Act’s prescription drug user 

fee provisions expires in September, 

2012. The BPCI Act directs FDA to 

develop recommendations for a 

biosimilar biological product user fee 

program for fiscal years 2013 through 

2017. FDA’s recommendations for a 

biosimilar biological product user fee 

program were submitted to Congress on 

January 13, 2012. If enacted into law, 

FDA’s proposed biosimilar biological 

product user fee program would require 

FDA to assess and collect user fees for 

certain meetings concerning biosimilar 

biological product development (BPD 

meetings), investigational new drug 

applications (INDs) intended to support 

a biosimilar biological product 

application, and biosimilar biological 

product applications and supplements. 

Proposed Form FDA 3792, the 

Biosimilars User Fee Cover Sheet, 

requests the minimum necessary 

information to determine the amount of 

the fee required, and to account for and 

track user fees. The form would provide 

a cross-reference of the fees submitted 

for a submission with the actual 

submission by using a unique number 

tracking system. The information 

collected would be used by FDA’s 

Center for Drug Evaluation and Research 

and Center for Biologics Evaluation and 

Research to initiate the administrative 

screening of biosimilar biological 

product INDs, applications, and 

supplements, and to account for and 

track user fees associated with BPD 

meetings. 

Respondents to this proposed 

collection of information would be 

manufacturers of biosimilar biological 

product candidates. Based on FDA’s 

database system, there are an estimated 

18 manufacturers that fall into this 

category. However, not all 

manufacturers will have submissions in 

a given year and some may have 

multiple submissions. FDA estimates 

nine annual responses that include the 

following: Six INDs or BPD meetings, 

two applications, and one supplement. 

The estimated hours per response are 

based on FDA’s past experience with 

other submissions, and average 30 

minutes. 

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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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