Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Current Good Manufacturing Practice Quality System Regulation, 2123-2124 [2011-455]

Download as PDF 2123 Federal Register / Vol. 76, No. 8 / Wednesday, January 12, 2011 / Notices 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. 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. Dated: January 4, 2011. Carolyn M. Clancy, Director. 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) [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 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). 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 No. of respondents Type of respondent No. of responses per respondent Average Burden per response (in Hours) State, Territorial, Tribal Health Officials/Employees .................................................................... County Health Employees ........................................................................................................... Municipal/City Health Employees ................................................................................................ 60 3000 100 48 6 6 1 2 2 Total ...................................................................................................................................... ........................ ........................ ........................ DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2011–460 Filed 1–11–11; 8:45 am] mstockstill on DSKH9S0YB1PROD with NOTICES Dated: January 6, 2011. Carol E. Walker, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [Docket No. FDA–2010–N–0273] Food and Drug Administration BILLING CODE 4163–18–P 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. VerDate Mar<15>2010 17:25 Jan 11, 2011 Jkt 223001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 ACTION: Notice. 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– SUMMARY: E:\FR\FM\12JAN1.SGM 12JAN1 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. 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 mstockstill on DSKH9S0YB1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 17:25 Jan 11, 2011 Jkt 223001 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 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 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 E:\FR\FM\12JAN1.SGM 12JAN1

Agencies

[Federal Register Volume 76, Number 8 (Wednesday, January 12, 2011)]
[Notices]
[Pages 2123-2124]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-455]


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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.

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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-

[[Page 2124]]

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]
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