14808 Federal Register / Vol. 77, No. 49 / Tuesday, March 13, 2012 / Notices 

valid authorization. In order to be valid, 

an authorization must include specified 

core elements and statements. CMS will 

make available to PCIP applicants and 

enrollees a standard, valid authorization 

to enable beneficiaries to request the 

disclosure of their protected health 

information. CMS will make available to 

PCIP applicants and enrollees a 

standard, valid authorization to enable 

beneficiaries to communicate with PCIP 

about their personal health information. 

This is a critical tool because the 

population the PCIP program serves is 

comprised of individuals with preexisting conditions who may be 

incapacitated and need an advocate to 

help them apply for or receive benefits 

from the program. This standard 

authorization will simplify the process 

of requesting information disclosure for 

beneficiaries and minimize the response 

time for the PCIP program; Form 

Number: CMS–10428 (OMB 0938–New); 

Frequency: Occasionally; Affected 

Public: Private Sector (Business or other 

for-profit and Not-for-profit 

institutions); Number of Respondents: 

2,100; Total Annual Responses: 2,100; 

Total Annual Hours: 525. (For policy 

questions regarding this collection 

contact Laura Dash at 410–786–8623. 

For all other issues call 410–786–1326.) 

CMS is requesting OMB review and 

approval of this collection by March 22, 

2012. To be assured consideration, 

comments and recommendations for the 

proposed information collections must 

be received by via one of the methods 

below on March 19, 2012. 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access CMS’ Web Site 

address at http://www.cms.gov/ 

PaperworkReductionActof1995/PRAL/ 

list.asp or Email your request, including 

your address, phone number, OMB 

number, and CMS document identifier, 

to Paperwork@cms.hhs.gov, or call the 

Reports Clearance Office on (410) 786– 

1326. 

Interested persons are invited to send 

comments regarding the burden or any 

other aspect of these collections of 

information requirements. However, as 

noted above, comments on these 

information collection and 

recordkeeping requirements must be 

received via one of the following 

methods by March 19, 2012. 

1. Electronically. You may submit 

your comments electronically to http:// 

www.regulations.gov. Follow the 

instructions for ‘‘Comment or 

Submission’’ or ‘‘More Search Options’’ 

to find the information collection 

document(s) accepting comments. 

2. By regular mail. You may mail 

written comments to the following 

address: CMS, Office of Strategic 

Operations and Regulatory Affairs, 

Division of Regulations Development, 

Attention: Document Identifier CMS– 

10417, Room C4–26–05, 7500 Security 

Boulevard, Baltimore, Maryland 21244– 

1850. 

3. By Email to OMB. OMB, Office of 

Information and Regulatory Affairs, 

Attention: CMS Desk Officer, Email: 

OIRA_submission@omb.eop.gov. 

Dated: March 8, 2012. 

Martique Jones, 

Director, Regulations Development Group, 

Division B, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2012–6035 Filed 3–12–12; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; 

Comment Request 

Title: Descriptive Study of Tribal 

Temporary Assistance for Needy 

Families (TANF) Programs—Interview 

Guides. 

OMB No.: New Collection. 

Description: The Administration for 

Children and Families (ACF) is 

proposing an information collection 

activity as part of the Descriptive Study 

of Tribal TANF Programs. The proposed 

information collection consists of semistructured interviews and focus groups 

with key Tribal TANF respondents on 

questions of Tribal TANF 

administration, policies, service 

delivery, and program context. Through 

this information collection, ACF seeks 

to gain an in-depth, systematic 

understanding of program 

implementation, operations, outputs 

and outcomes in selected sites, and 

identify promising practices and other 

areas for further study. 

Respondents: Semi-structured 

interviews will be held with Tribal 

TANF administrators and staff, and staff 

of related programs. Focus groups will 

be held with Tribal TANF clients. 

Annual Burden Estimates 

Please note that the burden rates 

below are revised since the 60 day 

Federal Register Notice to reflect lower 

burden hours. 

TABLE 1—ANNUAL BURDEN ESTIMATES

Instrument 

Annual 

number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total annual 

burden hours 

Discussion Guide for use with tribal TANF Administrators ............................. 4 1 1.5 6 

Discussion Guide for use with tribal TANF Staff ............................................. 12 1 1 12 

Discussion Guide for use with Focus Groups with tribal TANF clients .......... 20 1 2 40 

Discussion guide for use with staff of related programs ................................. 20 1 1 20 

All instruments: ......................................................................................... ........................ ........................ ........................ 78 

Additional Information 

Copies of the proposed collection may 

be obtained by writing to the 

Administration for Children and 

Families, Office of Planning, Research, 

and Evaluation, 370 L’Enfant 

Promenade, SW., Washington, DC 

20447, Attn: OPRE Reports Clearance 

Officer. All requests should be 

identified by the title of the information 

collection. Email address: 

OPREinfocollection@acf.hhs.gov. OMB 

Comment: OMB is required to make a 

decision concerning the collection of 

information between 30 and 60 days 

after publication of this document in the 

Federal Register. Therefore, a comment 

is best assured of having its full effect 

if OMB receives it within 30 days of 

publication. Written comments and 

recommendations for the proposed 

mstockstill on DSK4VPTVN1PROD with NOTICES

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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