Federal Register / Vol. 76, No. 51 / Wednesday, March 16, 2011 / Notices 14403 

the Centers for Disease Control and 

Prevention (CDC), the Food and Drug 

Administration (FDA), and the National 

Institutes of Health (NIH). The Task 

Force also includes the Agency for 

Healthcare Research and Quality 

(AHRQ), the Centers for Medicare and 

Medicaid Services (CMS), the Health 

Resources and Services Administration 

(HRSA), the HHS Office of the Assistant 

Secretary for Preparedness and 

Response (HHS/ASPR), the Department 

of Agriculture (USDA), the Department 

of Defense (DoD), the Department of 

Veterans Affairs (VA), and the 

Environmental Protection Agency 

(EPA). 

In 2001, the Task Force developed an 

initial Action Plan, outlining specific 

issues, goals, and actions important for 

addressing the problem of AR. This 

document, entitled A Public Health 

Action Plan to Combat Antimicrobial 

Resistance, Part I: Domestic Issues, 

reflected a broad-based consensus of 

participating Federal agencies, which 

was reached with individual input from 

State and local health agencies, 

universities, professional societies, 

pharmaceutical companies, healthcare 

delivery organizations, agricultural 

producers, consumer groups, and other 

members of the public. Continued 

collaboration with these partners has 

been vital to achieving successful 

implementation of the Action Plan. 

This draft document, A Public Health 

Action Plan to Combat Antimicrobial 

Resistance, is a revision of the 2001 

interagency action plan. The revised 

Action Plan provides an updated 

blueprint for specific, coordinated 

Federal action to address emerging 

threats in AR. The document covers a 

broad spectrum of AR issues, addressing 

resistance in a wide range of pathogens 

(bacteria, viruses, fungi, and parasites) 

and settings (human medicine, 

veterinary medicine, agriculture, animal 

production, and others). 

The Action Plan includes action items 

organized into four focus areas: 

Surveillance, Prevention and Control, 

Research, and Product Development. 

The Action Plan contains specific action 

items, projects, and implementation 

steps. Wherever possible, action items 

are populated with specific projects or 

implementation steps to provide greater 

specificity for planned Federal 

activities. The action items, projects, 

and implementation steps do not 

represent an exhaustive list of activities. 

Dated: March 11, 2011. 

Tanja Popovic, 

Deputy Associate Director for Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2011–6100 Filed 3–15–11; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity: Comment Request 

Title: Personal Responsibility 

Education Program (PREP) MultiComponent Evaluation. 

OMB No.: New collection. 

Description: The Family Youth 

Services Bureau (HHS/ACF/ACYF/ 

FYSB) and the Office of Planning 

Research and Evaluation (HHS/ACF/ 

OPRE) in the Administration for 

Children and Families (ACF) are 

proposing three data collection 

activities to be undertaken for the 

Personal Responsibility Education 

Program (PREP) Multi-Component 

Evaluation. 

The impact study included in the 

PREP Multi-Component Evaluation is a 

random assignment evaluation which 

will expand available evidence on 

whether the replication of evidencebased effective programs, or the 

substantial incorporation of elements of 

these programs, funded as part of the 

Personal Responsibility Education 

Program, are effective at delaying sexual 

activity, increasing condom or 

contraceptive use for sexually active 

youth, or reducing pregnancy among 

youth. The evaluation will document 

and test a range of pregnancy prevention 

approaches in up to five program sites. 

The findings from the evaluation will be 

of interest to the general public, to 

policy-makers, and to organizations 

interested in teen pregnancy prevention. 

This Federal Register Notice is to 

notify the public regarding Data 

Collection for the Baseline, Field 

Collection, and In-Depth 

Implementation Components of the 

Impact and In-Depth Implementation 

Evaluation of the Personal 

Responsibility Education Program 

(PREP) Multi-Component Evaluation. 

Field Collection: The field collection 

activity involves the collection of 

information from observations of 

program activities and interviews with a 

range of experts and persons involved 

with programs about various aspects of 

existing prevention programs and topics 

the experts view as important to address 

through evaluation. These data will be 

used to help enhance decisions about 

the types of programs to be evaluated in 

the studies. 

In-Depth Implementation: The 

implementation data collection activity 

as part of the in-depth implementation 

portion of the PREP Multi-Component 

Evaluation involves the collection of 

information from program records and 

site visits at two to three points in the 

program implementation period. 

Understanding the programs, 

documenting their implementation and 

context, and assessing fidelity of 

implementation will allow for 

description of each implemented 

program and the treatment-control 

contrast evaluated in each site. It will 

also help in interpreting impact 

findings, differences in impacts across 

programs, and differences in impacts 

across locations or population 

subgroups. 

Baseline: The baseline data collection 

activity will present respondents with 

carefully selected questions about 

demographics and risk and protective 

factors related to teen pregnancy. Also 

proposed is a collection of school 

records, performance, and program 

participation for the youth. Information 

from this data collection will be used to 

perform meaningful analysis to 

determine significant program effects. 

Respondents: 

Field Clearance: Researchers; Policy 

Experts; State Level Coordinators; 

Program Directors; Program Staff; 

Program Participants; School 

Administrators. 

In-Depth Implementation: General 

Staff; Community Members; Frontline 

Staff; Participating Youth; and Control 

Group Schools. 

Baseline: Study participants (i.e., 

adolescents, and schools and 

organizations responsible for 

administrative data); Schools and 

Organizations. 


jlentini on DSKJ8SOYB1PROD with NOTICES
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