Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Adverse Experience Reporting for Licensed Biological Products; and General Records, 72710 [2011-30326]

Download as PDF 72710 Federal Register / Vol. 76, No. 227 / Friday, November 25, 2011 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Food and Drug Administration [Docket No. FDA–2010–D–0350] [Docket No. FDA–2011–N–0231] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Adverse Experience Reporting for Licensed Biological Products; and General Records AGENCY: Food and Drug Administration, HHS. ACTION: 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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of the draft guidance entitled ‘‘Tobacco Retailer Training Programs.’’ DATES: Submit written or electronic comments on the collection of information by January 24, 2012. ADDRESSES: Submit electronic comments on the collection of information to https:// 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. Identify comments with the docket number found in brackets in the heading of this document. 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: Under the Paperwork Reduction Act of 1995 (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 SUMMARY: Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Adverse Experience Reporting for Licensed Biological Products; and General Records’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. SUMMARY: Ila S. Mizrachi, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50– 400B, Rockville, MD 20850, (301) 796– 7726, ila.mizrachi@fda.hhs.gov. FOR FURTHER INFORMATION CONTACT: On July 19, 2011, the Agency submitted a proposed collection of information entitled ‘‘Adverse Experience Reporting for Licensed Biological Products; and General Records’’ 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 0910–0308. The approval expires on November 30, 2014. A copy of the supporting statement for this information collection is available on the Internet at https:// www.reginfo.gov/public/do/PRAMain. SUPPLEMENTARY INFORMATION: Dated: November 18, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. wreier-aviles on DSK7SPTVN1PROD with NOTICES Agency Information Collection Activities; Proposed Collection; Comment Request; Draft Guidance for Tobacco Retailers on Tobacco Retailer Training Programs [FR Doc. 2011–30326 Filed 11–23–11; 8:45 am] BILLING CODE 4160–01–P VerDate Mar<15>2010 14:31 Nov 23, 2011 Jkt 226001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 the Federal Register concerning each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, in the Federal Register of July 16, 2010 (75 FR 41498), FDA published a notice of availability of the draft guidance document providing a 60-day public comment period on the collection of information provisions. An electronic version of the guidance document is available on the Internet at https://www.regulations.gov (Docket No. FDA–2010–D–0350) and https:// www.fda.gov/TobaccoProducts/ GuidanceComplianceRegulatory Information/default.htm. FDA received seven comments in response to the notice of availability, with four comments pertaining to the information collection. FDA is republishing notice of the proposed collection of information in order to comply with section 3506(c)(2)(A) of the PRA. We invite comments only on the proposed collection of information set forth in this document. FDA will respond to comments on the collection of information provisions received in response to this notice and to the July 16, 2010, notice in a 30-day notice announcing that a proposed collection of information has been submitted to OMB for review and clearance under the PRA. With respect to the collection of information associated with the draft guidance, 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. Information Request Regarding Draft Guidance for Tobacco Retailers on Tobacco Retailer Training Programs (OMB Control Number 0910–New) The Tobacco Control Act does not require retailers to implement retailer training programs. However, the statute does provide for lesser civil money penalties for violations of access, advertising, and promotion restrictions of regulations promulgated under section 906(d) of the Federal Food, E:\FR\FM\25NON1.SGM 25NON1

Agencies

[Federal Register Volume 76, Number 227 (Friday, November 25, 2011)]
[Notices]
[Page 72710]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-30326]



[[Page 72710]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0231]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Adverse Experience Reporting for 
Licensed Biological Products; and General Records

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 ``Adverse Experience Reporting for 
Licensed Biological Products; and General Records'' has been approved 
by the Office of Management and Budget (OMB) under the Paperwork 
Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, 
Rockville, MD 20850, (301) 796-7726, ila.mizrachi@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: On July 19, 2011, the Agency submitted a 
proposed collection of information entitled ``Adverse Experience 
Reporting for Licensed Biological Products; and General Records'' 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 0910-0308. The approval expires on November 
30, 2014. A copy of the supporting statement for this information 
collection is available on the Internet at https://www.reginfo.gov/public/do/PRAMain.

    Dated: November 18, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-30326 Filed 11-23-11; 8:45 am]
BILLING CODE 4160-01-P

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