Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Pretesting of Tobacco Communications, 22553 [2013-08860]

Download as PDF 22553 Federal Register / Vol. 78, No. 73 / Tuesday, April 16, 2013 / Notices Non-tuberculous Mycobacterium Drug Susceptibility Testing is used to monitor and evaluate performance and practices among national laboratories performing M. tuberculosis susceptibility testing. Participation in this program is one way laboratories can ensure high-quality laboratory testing, resulting in accurate and reliable testing results. By providing an evaluation program to assess the ability of the laboratories to test for drug resistant M. tuberculosis strains, laboratories also have a selfassessment tool to aid in optimizing their skills in susceptibility testing. The information obtained from the laboratories on susceptibility practices and procedures is used to establish variables related to good performance, assessing training needs, and aid with the development of practice standards. Participants in this program include domestic clinical and public health laboratories. Data collection from laboratory participants occurs twice per year. The data collected in this program will include the susceptibility test results of primary and secondary drugs, drug concentrations, and test methods performed by laboratories on a set of performance evaluation (PE) samples. The PE samples are sent to participants twice a year. Participants also report demographic data such as laboratory type and the number of tests performed annually. There is no cost to respondents to participate other than their time. The total estimated annual burden hours are 156. ESTIMATED ANNUALIZED BURDEN HOURS Type of respondent Form name Domestic Laboratory ............... MPEP Participant Biosafety Compliance Letter of Agreement ......... Mycobacterium tuberculosis Results Worksheet ................... Online Survey Instrument ....................................................... Ron A. Otten, Director, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention. [FR Doc. 2013–08861 Filed 4–15–13; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–0876] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Pretesting of Tobacco Communications AGENCY: Dated: April 11, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–08860 Filed 4–15–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Pretesting of Tobacco Communications’’ 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– 400B, Rockville, MD 20850, 301–796– 5156, daniel.gittleson@fda.hhs.gov. SUPPLEMENTARY INFORMATION: On January 28, 2013, the Agency submitted a proposed collection of information entitled ‘‘Pretesting of Tobacco SUMMARY: mstockstill on DSK4VPTVN1PROD with NOTICES Communications’’ 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 0910–0674. The approval expires on March 31, 2016. A copy of the supporting statement for this information collection is available on the Internet at http://www.reginfo.gov/ public/do/PRAMain. Food and Drug Administration, HHS. ACTION: Number of respondents VerDate Mar<15>2010 17:58 Apr 15, 2013 Jkt 229001 Food and Drug Administration [Docket No. FDA–2013–N–0391] Generic Drug Facilities, Sites, and Organizations AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that the generic drug facility selfidentification reporting period for fiscal year (FY) 2014 will begin on May 1, 2013, and close on June 1, 2013. Generic drug facilities, certain sites, and organizations identified in a generic drug submission are required by the PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 93 93 93 Number of responses per respondent Average burden per response (in hours) 2 2 2 5/60 30/60 15/60 Generic Drug User Fee Amendments of 2012 (GDUFA) to submit, update, or reconfirm identification information to FDA annually. DATES: For FY 2014, identification information must be submitted, updated, or reconfirmed between May 1, 2013, and June 1, 2013. ADDRESSES: Electronic tools for submitting the required information may be found on FDA’s Web site at the following addresses: • eSubmitter tool: http:// www.fda.gov/ForIndustry/ FDAeSubmitter/ucm108165.htm. • Structured Product Labeling (SPL) Xforms: http://www.fda.gov/ ForIndustry/DataStandards/ StructuredProductLabeling/ ucm189651.htm. Other applications are available commercially. FOR FURTHER INFORMATION CONTACT: Jaewon Hong, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Rm. 4145, Silver Spring, MD 20993, 301–796–6707, AskGDUFA@fda.hhs.gov. GDUFA (Pub. L. 112–144, Title III) was signed into law by the President on July 9, 2012, as part of the Food and Drug Administration Safety and Innovation Act. GDUFA is designed to speed the delivery of safe and effective generic drugs to the public and reduce costs to industry. GDUFA enables FDA to assess user fees to fund critical and measurable enhancements to FDA’s generic drugs program. GDUFA will also significantly SUPPLEMENTARY INFORMATION: E:\FR\FM\16APN1.SGM 16APN1

Agencies

[Federal Register Volume 78, Number 73 (Tuesday, April 16, 2013)]
[Notices]
[Page 22553]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-08860]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0876]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Pretesting of Tobacco Communications

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 ``Pretesting of Tobacco 
Communications'' 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., 
PI50-400B, Rockville, MD 20850, 301-796-5156, 
daniel.gittleson@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: On January 28, 2013, the Agency submitted a 
proposed collection of information entitled ``Pretesting of Tobacco 
Communications'' 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 0910-0674. The approval 
expires on March 31, 2016. A copy of the supporting statement for this 
information collection is available on the Internet at http://www.reginfo.gov/public/do/PRAMain.

    Dated: April 11, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-08860 Filed 4-15-13; 8:45 am]
BILLING CODE 4160-01-P