17130 Federal Register / Vol. 76, No. 59 / Monday, March 28, 2011 / Notices 

Seleda M. Perryman, 

Office of the Secretary, Paperwork Reduction 

Act Clearance Officer. 

[FR Doc. 2011–7171 Filed 3–25–11; 8:45 am] 

BILLING CODE 4150–05–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Document Identifier: OS–0990–New; 60– 

day Notice] 

Agency Information Collection 

Request. 60-Day Public Comment 

Request 

AGENCY: Office of the Secretary, HHS. 

In compliance with the requirement 

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

Paperwork Reduction Act of 1995, the 

Office of the Secretary (OS), Department 

of Health and Human Services, is 

publishing the following summary of a 

proposed information collection request 

for public comment. Interested persons 

are invited to send comments regarding 

this burden estimate or any other aspect 

of this collection of information, 

including any of the following subjects: 

(1) The necessity and utility of the 

proposed information collection for the 

proper performance of the agency’s 

functions; (2) the accuracy of the 

estimated burden; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) the 

use of automated collection techniques 

or other forms of information 

technology to minimize the information 

collection burden. 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, e-mail your request, 

including your address, phone number, 

OMB number, and OS document 

identifier, to 

Sherette.funncoleman@hhs.gov, or call 

the Reports Clearance Office on (202) 

690–6162. Written comments and 

recommendations for the proposed 

information collections must be directed 

to the OS Paperwork Clearance Officer 

at the above email address within 60- 

days. 

Proposed Project: Wellness Program 

Study: Assessing the Impact of 

Workplace Health and Wellness 

Programs—OMB No. 0990–NEW— 

Assistant Secretary for Planning 

Evaluation (ASPE) 

Abstract: The Office of the Assistant 

Secretary for Planning and Evaluation 

(ASPE) and the Employee Benefits 

Security Administration (EBSA) is 

requesting Office of Management and 

Budget (OMB) approval on a new 

collection to conduct a survey on 

employers to learn about their 

experiences and attitudes regarding 

workplace wellness programs. ASPE 

will use the employers’ experience to 

assess the effectiveness and impact of 

workplace wellness programs, as well as 

identify best practices and lessons 

learned in program implementation 

with a particular focus on the use of 

incentives. As part of the study, a onetime, self-administered survey will be 

administered to 3,000 employers 

selected from the Dun & Bradstreet 

database, a comprehensive listing of 

private companies and government 

agencies in the U.S. The survey will 

assess prevalence and type of wellness 

programs as well as the use of employee 

incentives. The survey design and 

content is informed by a review of the 

literature on the characteristics, 

prevalence and impact of workplace 

wellness programs. Data collection will 

also include employee focus groups and 

key informant semi-structured 

interviews at each of 4 employer sites 

that will inform in-depth case studies of 

those employers. The focus groups will 

consist of 12 employees and will be 

conducted to get the end-user 

perspective on the impact and 

effectiveness of the wellness program. 

The key informant interviews will be 

carried out with 5 wellness leaders at 

each employer, and will gather 

information on employer background, 

health insurance and wellness programs 

offered, and anticipated changes due to 

the Affordable Care Act. Data collection 

activities will be completed within 18 

months of OMB Clearance. 

EXHIBIT 1—ESTIMATE OF ANNUALIZED TIME BURDEN TO RESPONDENTS

Forms Type of 

respondent 

Number of 

respondents 

Number of responses 

per respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

Survey ................................... Human Resource Manager .......................... 3,000 1 30/60 1,500 

Focus Group Protocol ........... Employees in All Occupations ..................... 48 1 1.5 72 

Key Informant Interview 

Script.

Human Resource Manager .......................... 20 1 45/60 15 

Total ............................... ....................................................................... ........................ ........................ ........................ 1,587 

Seleda Perryman, 

Office of the Secretary, Paperwork Reduction 

Act Clearance Officer. 

[FR Doc. 2011–7172 Filed 3–25–11; 8:45 am] 

BILLING CODE 4150–05–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Office of Planning, Research and 

Evaluation Advisory Committee on 

Head Start Research and Evaluation 

AGENCY: Administration for Children 

and Families, Department of Health and 

Human Services (HHS). 

ACTION: Notice. 

SUMMARY: This notice announces a 

forthcoming meeting of a public 

advisory committee of the 

Administration for Children and 

Families (ACF). The meeting will be 

open to the public. 

Name of Committee: Advisory 

Committee for Head Start Research and 

Evaluation. 

General Function of Committee: The 

Advisory Committee for Head Start 

Research and Evaluation will provide 

feedback on the published final report 

for the Head Start Impact Study, offering 

interpretations of the findings, 

discussing implications for practice and 

policy, and providing recommendations 

on follow-up research, including 

additional analysis of the Head Start 

Impact Study data. The Committee will 


Emcdonald on DSK2BSOYB1PROD with NOTICES
Federal Register / Vol. 76, No. 59 / Monday, March 28, 2011 / Notices 17131 

also be asked to provide 

recommendations to the Secretary 

regarding how to improve Head Start 

and other early childhood programs by 

enhancing the use of research-informed 

practices in early childhood. Finally, 

the Committee will be asked to provide 

recommendations on the overall Head 

Start research agenda, including—but 

not limited to—how the Head Start 

Impact Study fits within this agenda. 

The Committee will provide advice 

regarding future research efforts to 

inform HHS about how to guide the 

development and implementation of 

best practices in Head Start and other 

early childhood programs around the 

country. 

DATES: The meeting will be held on 

April 12th and April 13th, 2011, from 

8:30 a.m. to 5 p.m. 

ADDRESSES: Hyatt Arlington, 1325 

Wilson Boulevard, Arlington, VA 22209, 

Phone: 703–525–1234. 

FOR FURTHER INFORMATION CONTACT: 

Jennifer Brooks, Office of Planning, 

Research, and Evaluation, e-mail 

jennifer.brooks@acf.hhs.gov or call (202) 

205–8212. 

Agenda: The committee will review 

information on the federal Head Start 

program and the children and families 

it serves, hear information about the 

early Head Start program, and learn 

about the latest research in the area of 

quality teaching and learning. 

Procedure: Interested persons may 

present data, information or views, in 

writing, on issues pending before the 

Committee. Written submissions may be 

made to the contact person on or before 

April 1, 2011. All written materials 

provided to the contact person will be 

shared with the Committee members. 

ACF welcomes the attendance of the 

public at this advisory committee 

meeting and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Jennifer 

Brooks at least seven days in advance of 

the meeting. Information about the 

committee and this meeting can be 

found at the committee Web site, 

http://www.acf.hhs.gov/programs/opre/ 

hs/advisory_com/. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Robert Sargis, 

Reports Clearance Officer, Administration for 

Children and Families. 

[FR Doc. 2011–7170 Filed 3–25–11; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0016] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Recordkeeping 

and Records Access Requirements for 

Food Facilities 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by April 27, 

2011. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0560. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley, Jr., Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

3793. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Recordkeeping and Records Access 

Requirements for Food Facilities—21 

CFR 1.337, 1.345, and 1.352 (OMB 

Control Number 0910–0560)—Extension 

The Public Health Security and 

Bioterrorism Preparedness and 

Response Act of 2002 (the Bioterrorism 

Act) added section 414 of the Federal 

Food, Drug, and Cosmetic Act (the 

FD&C Act) (21 U.S.C. 350c), which 

requires that persons who manufacture, 

process, pack, hold, receive, distribute, 

transport, or import food in the United 

States establish and maintain records 

identifying the immediate previous 

sources and immediate subsequent 

recipients of food. Sections 1.326 

through 1.363 of FDA’s regulations (21 

CFR 1.326 through 1.363) set forth the 

requirements for recordkeeping and 

records access. The requirement to 

establish and maintain records improves 

FDA’s ability to respond to, and further 

contain, threats of serious adverse 

health consequences or death to humans 

or animals from accidental or deliberate 

contamination of food. 

Description of Respondents: Persons 

that manufacture, process, pack, hold, 

receive, distribute, transport, or import 

food in the United States are required to 

establish and maintain records, 

including persons that engage in both 

interstate and intrastate commerce. 

FDA’s regulations require that records 

for non-transporters include the name 

and full contact information of sources, 

recipients, and transporters, an adequate 

description of the food including the 

quantity and packaging, and the receipt 

and shipping dates (§§ 1.337 and 1.345). 

Required records for transporters 

include the names of consignor and 

consignee, points of origin and 

destination, date of shipment, number 

of packages, description of freight, route 

of movement and name of each carrier 

participating in the transportation, and 

transfer points through which shipment 

moved (§ 1.352). Existing records may 

be used if they contain all of the 

required information and are retained 

for the required time period. 

In the Federal Register of January 13, 

2011 (76 FR 2396), FDA published a 60- 

day notice requesting public comment 

on the proposed collection of 

information. FDA received one letter 

containing multiple comments in 

response to the notice. 

(Comment 1) One comment was 

generally supportive of the necessity of 

the information collection and its 

practical utility. 

(Response) FDA agrees. As discussed 

previously in this document, the 

requirement to establish and maintain 

records improves FDA’s ability to 

respond to, and further contain, threats 

of serious adverse health consequences 

or death to humans or animals from 

accidental or deliberate contamination 

of food. 

(Comment 2) Another comment stated 

that accurate recordkeeping is integral 

to the effective and timely tracing of 

food products through the supply chain 

and, to support effective product 

tracing, suggested that industry should 

determine the Critical Tracking Events 

(CTEs) and the Key Data Elements 

(KDEs) necessary for product tracing; 

FDA should encourage the adoption of 

standard ways to express this 


Emcdonald on DSK2BSOYB1PROD with NOTICES