Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Experimental Study on the Public Display of Lists of Harmful and Potential Harmful Tobacco Constituents, 22887 [2013-08906]

Download as PDF 22887 Federal Register / Vol. 78, No. 74 / Wednesday, April 17, 2013 / Notices ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Number of responses per respondent Average burden per response (in hours) Respondents Form name Central Cancer Registries in States, Territories, and the District of Columbia. Standard NPCR CSS Report 38 2 2 Enhanced NPCR Report ....... 10 2 2 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. 2013–08912 Filed 4–16–13; 8:45 am] approval expires on March 31, 2016. A copy of the supporting statement for this information collection is available on the Internet at https://www.reginfo.gov/ public/do/PRAMain. Dated: April 11, 2013. Leslie Kux, Assistant Commissioner for Policy. BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2013–08906 Filed 4–16–13; 8:45 am] BILLING CODE 4160–01–P Food and Drug Administration DEPARTMENT OF HEALTH AND HUMAN SERVICES [Docket No. FDA–2011–N–0867] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Experimental Study on the Public Display of Lists of Harmful and Potential Harmful Tobacco Constituents AGENCY: Food and Drug Administration, HHS. ACTION: The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Experimental Study on the Public Display of Lists of Harmful and Potential Harmful Tobacco Constituents’’ 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 May 8, 2012, the Agency submitted a proposed collection of information entitled ‘‘Experimental Study on the Public Display of Lists of Harmful and Potential Harmful Tobacco Constituents’’ 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 0910–0736. The sroberts on DSK5SPTVN1PROD with NOTICES SUMMARY: 16:50 Apr 16, 2013 [Docket No. FDA–2011–D–0104] Guidance for Industry on NonPenicillin Beta-Lactam Drugs: A Current Good Manufacturing Practices Framework for Preventing CrossContamination; Availability AGENCY: Notice. VerDate Mar<15>2010 Food and Drug Administration Jkt 229001 Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ‘‘Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination.’’ This guidance describes the importance of implementing controls to prevent crosscontamination of finished pharmaceuticals and active pharmaceutical ingredients (APIs) with non-penicillin beta-lactams. This guidance also provides information regarding the relative health risk of, and the potential for, cross-reactivity in the classes of sensitizing beta-lactams (including both penicillins and nonpenicillin beta-lactams), beta-lactamase inhibitors, and beta-lactam intermediates and derivatives. Finally, this guidance clarifies that manufacturers should generally utilize separate facilities for manufacture of non-penicillin beta-lactams because those compounds pose health risks associated with cross-reactivity. DATES: Submit either electronic or written comments on Agency guidances at any time. SUMMARY: PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. Submit electronic comments on the guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Paula Katz, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 4314, Silver Spring, MD 20993–0002, 301–796–6972. SUPPLEMENTARY INFORMATION: ADDRESSES: I. Background FDA is announcing the availability of a guidance for industry entitled ‘‘NonPenicillin Beta-Lactam Drugs: A CGMP Framework for Preventing CrossContamination.’’ This guidance describes the importance of implementing controls to prevent crosscontamination of finished pharmaceuticals and APIs with nonpenicillin beta-lactam drugs. This guidance also provides information regarding the relative health risk of, and the potential for, cross-reactivity in the classes of sensitizing beta-lactams (including both penicillins and nonpenicillin beta-lactams). Finally, this guidance clarifies that manufacturers should generally utilize separate facilities for manufacture of nonpenicillin beta-lactams because those compounds pose health risks associated with cross-reactivity. Although the existing current good manufacturing practices (CGMP) regulations require separation of manufacturing facilities to avoid crosscontamination, the only class of products for which the regulations specify particular separation E:\FR\FM\17APN1.SGM 17APN1

Agencies

[Federal Register Volume 78, Number 74 (Wednesday, April 17, 2013)]
[Notices]
[Page 22887]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-08906]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0867]

Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Experimental Study on the Public
Display of Lists of Harmful and Potential Harmful Tobacco Constituents

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``Experimental Study on the Public
Display of Lists of Harmful and Potential Harmful Tobacco
Constituents'' 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 May 8, 2012, the Agency submitted a
proposed collection of information entitled ``Experimental Study on the
Public Display of Lists of Harmful and Potential Harmful Tobacco
Constituents'' 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 0910-0736. The approval
expires on March 31, 2016. A copy of the supporting statement for this
information collection is available on the Internet at https://www.reginfo.gov/public/do/PRAMain.

Dated: April 11, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-08906 Filed 4-16-13; 8:45 am]
BILLING CODE 4160-01-P

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