Federal Register / Vol. 76, No. 8 / Wednesday, January 12, 2011 / Notices 2123 

AHRQ healthcare research and 

healthcare information dissemination 

functions, including whether the 

information will have practical utility; 

(b) the accuracy of AHRQ’s estimate of 

burden (including hours and costs) of 

the proposed collection(s) of 

information; (c) ways to enhance the 

quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information upon the 

respondents, including the use of 

automated collection techniques or 

other forms of information technology. 

Comments submitted in response to 

this notice will be summarized and 

included in the Agency’s subsequent 

request for OMB approval of the 

proposed information collection. All 

comments will become a matter of 

public record. 

Dated: January 4, 2011. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 2011–405 Filed 1–11–11; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–11–11AD] 

Agency Forms Undergoing Paperwork 

Reduction Act Review 

The Centers for Disease Control and 

Prevention (CDC) publishes a list of 

information collection requests under 

review by the Office of Management and 

Budget (OMB) in compliance with the 

Paperwork Reduction Act (44 U.S.C. 

Chapter 35). To request a copy of these 

requests, call the CDC Reports Clearance 

Officer at (404) 639–5960 or send an 

e-mail to omb@cdc.gov. Send written 

comments to CDC Desk Officer, Office of 

Management and Budget, Washington, 

DC or by fax to (202) 395–5806. Written 

comments should be received within 30 

days of this notice. 

Proposed Project 

Surveys of State, Tribal, Local, and 

Territorial (STLT) Governmental Health 

Agencies—New—Office of the Director, 

Office for State, Tribal Local and 

Territorial Support (OSTLTS), Centers 

for Disease Control and Prevention 

CDC). 

Background and Brief Description 

CDC’s mission includes addressing 

the leading causes of disease, injury, 

and disability in the United States, 

including a focus on tobacco control; 

improving nutrition, physical activity, 

and food safety; reducing healthcareassociated infections; preventing motor 

vehicle injuries; preventing teen 

pregnancy; and preventing HIV. CDC’s 

priorities for approaching improvements 

to public health include—strengthening 

surveillance, epidemiology, and 

laboratory science; better supporting 

efforts in states and communities; and 

pursuing policies that have an impact. 

As such, CDC’s relationship with state, 

local, tribal and territorial (STLT) 

governmental health officials is key to 

its emergency preparedness, health 

promotion and disease prevention 

responsibilities. 

CDC is requesting a three-year 

approval for a generic clearance to 

assess information related to a myriad of 

public health issues that affect STLT 

health agencies. Information will be 

used to assess situational awareness of 

current public health emergencies, make 

decisions that will affect planning, 

response and recovery activities of 

subsequent emergencies, and fill gaps in 

knowledge that will strengthen 

surveillance, epidemiology, and 

laboratory science; better supporting 

efforts in states and communities. CDC 

will conduct short surveys, across a 

range of public health topics, using 

standard questionnaire administration 

approaches (e.g., phone, Web, e-mail, 

and paper, in person). 

The burden is calculated based on the 

assumption of querying at most 100% of 

all available State, territorial (60) and 

county (3000) health officials/ 

employees and a representative sample 

of at most 100 municipal/city 

employees. CDC estimates that it will 

conduct up to 48 queries with State, 

territorial or tribal health officials/ 

employees, 6 queries with county health 

employees, and 6 queries with 

municipal health employees each year. 

The total annualized burden hour 

estimate is 40,080. There are no costs to 

respondents other than their time. 

TOTAL ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondent No. of 

respondents 

No. of 

responses per 

respondent 

Average 

Burden per 

response 

(in Hours) 

State, Territorial, Tribal Health Officials/Employees .................................................................... 60 48 1 

County Health Employees ........................................................................................................... 3000 6 2 

Municipal/City Health Employees ................................................................................................ 100 6 2 

Total ...................................................................................................................................... ........................ ........................ ........................

Dated: January 6, 2011. 

Carol E. Walker, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. 2011–460 Filed 1–11–11; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0273] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Current Good Manufacturing Practice 

Quality System Regulation 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Current Good Manufacturing Practice 

Quality System Regulation’’ has been 

approved by the Office of Management 

and Budget (OMB) under the Paperwork 

Reduction Act of 1995. 

FOR FURTHER INFORMATION CONTACT: 

Daniel Gittleson, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

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2124 Federal Register / Vol. 76, No. 8 / Wednesday, January 12, 2011 / Notices 

400B, Rockville, MD 20850, 301–796– 

5156, Daniel.Gittleson@FDA.HHS.GOV. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of October 18, 2010 (75 

FR 63834), 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 0910–0073. The 

approval expires on December 31, 2013. 

A copy of the supporting statement for 

this information collection is available 

on the Internet at http:// 

www.reginfo.gov/public/do/PRAMain. 

Dated: January 6, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–455 Filed 1–11–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0017] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Voluntary National 

Retail Food Regulatory Program 

Standards 

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 information collection provisions of 

the Voluntary National Retail Food 

Regulatory Program Standards. 

DATES: Submit either electronic or 

written comments on the collection of 

information by March 14, 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: 

Denver Presley, Jr., Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

3793. 

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, 

including each proposed extension of an 

existing 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 these topics: (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. 

Voluntary National Retail Food 

Regulatory Program Standards (OMB 

Control Number 0910–0621—Extension) 

The Program Standards define nine 

essential elements of an effective 

regulatory program for retail food 

establishments, establish basic quality 

control criteria for each element, and 

provide a means of recognition for those 

State, local, and tribal regulatory 

programs that meet the Program 

Standards. The program elements 

addressed by the Program Standards are 

as follows: (1) Regulatory foundation, 

(2) trained regulatory staff, (3) 

inspection program based on Hazard 

Analysis and Critical Control Point 

(HACCP) principles, (4) uniform 

inspection program, (5) foodborne 

illness and food defense preparedness 

and response, (6) compliance and 

enforcement, (7) industry and 

community relations, (8) program 

support and resources, and (9) program 

assessment. Each standard includes a 

list of records needed to document 

compliance with the standard (referred 

to in the Program Standards document 

as ‘‘quality records’’) and has one or 

more corresponding appendices that 

contain forms and worksheets to 

facilitate the collection of information 

needed to assess the retail food 

regulatory program against that 

standard. The respondents are state, 

local, and tribal government Agencies. 

Regulatory Agencies may use existing, 

available records or may choose to 

develop and use alternate forms and 

worksheets that capture the same 

information. 

In the course of their normal 

activities, State, local, and tribal 

regulatory Agencies already collect and 

keep on file many of the records needed 

as quality records to document 

compliance with each of the Program 

Standards. Although the detail and 

format in which this information is 

collected and recorded may vary by 

jurisdiction, records that are kept as a 

usual and customary part of normal 

Agency activities include inspection 

records, written quality assurance 

procedures and records of quality 

assurance checks, staff training 

certificates and other training records, a 

log or database of food-related illness or 

injury complaints, records of 

investigations resulting from such 

complaints, an inventory of inspection 

equipment, records of outside audits, 

and records of outreach efforts (e.g., 

meeting agendas and minutes, 

documentation of food safety education 

activities). No new recordkeeping 

burden is associated with these existing 

records, which are already a part of 

usual and customary program 

recordkeeping activities by state, local, 

and tribal regulatory Agencies, and 

which can serve as quality records 

under the Program Standards. 

State, local, and tribal regulatory 

Agencies that enroll in the Program 

Standards and seek listing in the FDA 

National Registry are required to report 

to FDA on the completion of the 

following three management tasks 

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