14404 Federal Register / Vol. 76, No. 51 / Wednesday, March 16, 2011 / Notices 

ANNUAL BURDEN ESTIMATES

Annual number of 

respondents 

Number of 

responses per 

respondent 

Average burden 

hours per 

response 

Total burden 

hours 

Field clearance instrument: 

Discussion Guide for use with Researchers, Policy Experts, and State Level Coordinators ............................. 10 1 1 10 

Discussion Guide for Use with Program Directors ........... 20 2 2 80 

Discussion Guide for Use with Program Staff ................. 40 1 2 80 

Focus Group Discussion Guide for use with Program 

Participants ................................................................... 100 1 1 .5 150 

Discussion Guide for Use with School Administrators ..... 70 1 1 70 

Short Survey with Program Directors ............................... 70 1 0 .25 17 .5 

Short Survey with Program Staff ...................................... 140 1 0 .25 35 

Short Survey with School Administrators ......................... 70 1 0 .25 17 .5 

Estimated Annual Burden Sub-total for Field Clearance ....................................................................... .............................. .............................. .............................. 460 

In-Depth Implementation Instrument: 

Master Topic Guide Interviews for General Staff and 

Community Members .................................................... 40 1 1 .5 60 

Focus Group Discussion Guide with Frontline Staff ........ 30 1 1 .5 45 

Focus Group Discussion Guide with Participating Youths 150 1 1 .5 225 

Focus Group Discussion Guide with Control Group 

Schools About Counterfactuals .................................... 40 1 1 40 

Estimated Annual Burden Sub-total for In-Depth Implementation .......................................................... .............................. .............................. .............................. 370 

Baseline Instrument: 

Baseline Instrument for study participants ....................... 2500 1 .5 1250 

Administrative Data Collection instrument for Schools 

and Organizations ......................................................... 100 1 4 400 

Estimated Annual Burden Sub-total for Baseline ..... .............................. .............................. .............................. 1650 

TOTAL Estimated Annual Burden ..................... .............................. .............................. .............................. 2640 

In compliance with the requirements 

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

Paperwork Reduction Act of 1995, the 

Administration for Children and 

Families is soliciting public comment 

on the specific aspects of the 

information collection described above. 

Copies of the proposed collection of 

information can be obtained and 

comments may be forwarded 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. E-mail address: 

OPREinfocollection@acf.hhs.gov. All 

requests should be identified by the title 

of the information collection. 

The Department specifically requests 

comments on (a) whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

the quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Consideration will be given to 

comments and suggestions submitted 

within 60 days of this publication. 

Dated: March 9, 2011. 

Steven M. Hanmer, 

Reports Clearance Officer. 

[FR Doc. 2011–5962 Filed 3–15–11; 8:45 am] 

BILLING CODE 4184–37–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0541] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Guidance for Industry on Special 

Protocol Assessment 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Guidance for Industry on Special 

Protocol Assessment’’ has been 

approved by the Office of Management 

and Budget (OMB) under the Paperwork 

Reduction Act of 1995. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Berbakos, Office of 

Information Management, Food and 

Drug Administration, 1350 Piccard Dr., 

PI50–400B, Rockville, MD 20850, 301– 

796–3792, 

Elizabeth.Berbakos@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of October 26, 2010 (75 

FR 65636), the Agency announced that 

the proposed information collection had 

been submitted 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 0910–0470. The 


jlentini on DSKJ8SOYB1PROD with NOTICES
Federal Register / Vol. 76, No. 51 / Wednesday, March 16, 2011 / Notices 14405 

approval expires on February 28, 2014. 

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 10, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–6092 Filed 3–15–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0468] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Patent Term Restoration, Due 

Diligence Petitions, Filing, Format, and 

Content of Petitions 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Patent Term Restoration, Due Diligence 

Petitions, Filing, Format, and Content of 

Petitions’’ has been approved by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Berbakos, Office of 

Information Management, Food and 

Drug Administration, 1350 Piccard Dr., 

PI50–400B, Rockville, MD 20850, 301– 

796–3792, 

Elizabeth.Berbakos@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of January 12, 2011 (76 

FR 2127), the Agency announced that 

the proposed information collection had 

been submitted 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 0910–0233. The 

approval expires on February 28, 2014. 

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 10, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–6091 Filed 3–15–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0122] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Focus Groups About Drug Products, 

as Used by the Food and Drug 

Administration 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Focus Groups About Drug Products, as 

Used by the Food and Drug 

Administration’’ has been approved by 

the Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Berbakos, Office of 

Information Management, Food and 

Drug Administration, 1350 Piccard Dr., 

PI50–400B, Rockville, MD 20850, 301– 

796–3792, 

Elizabeth.Berbakos@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of July 9, 2010 (75 FR 

39541), the Agency announced that the 

proposed information collection had 

been submitted 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 0910–0677. The 

approval expires on July 31, 2012. 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 10, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–6093 Filed 3–15–11; 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; Proposed Collection; 

Comment Request; Guidance for 

Industry: Cooperative Manufacturing 

Arrangements for Licensed Biologics 

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, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the proposed extension of the collection 

of information concerning the guidance 

for industry on cooperative 

manufacturing arrangements for 

licensed biologics. 

DATES: Submit either electronic or 

written comments on the collection of 

information by May 16, 2011. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to: http:// 

www.regulations.gov. Submit written 

comments on the collection of 

information 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– 

796–3794, 

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 


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