Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Premarket Approval of Medical Devices, 4917-4918 [2011-1756]

Download as PDF 4917 Federal Register / Vol. 76, No. 18 / Thursday, January 27, 2011 / Notices TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN FOR BIOLOGICS 1—Continued 21 CFR Section No. of respondents Annual frequency per response Total annual responses Hours per response Total hours 312.38(b) and (c) ....................... 312.42(e) .................................... 312.44(c) and (d) ....................... 312.45(a) and (b) ....................... 312.47(b) .................................... 312.53(c) .................................... 312.54(a) and (b) ....................... 312.55(b) .................................... 312.56(b) and (d) ....................... 312.58(a) .................................... 312.64(a) through (d) ................. 312.70(a) .................................... 312.110(b) .................................. 312.130(d) .................................. 117 74 17 60 43 348 1 138 14 8 6,003 6 21 1 1.3 1.5 1.1 1.8 1.5 6.6 1 2.5 1.6 1 3.5 1 1 1 152 111 19 108 65 2,297 1 345 22 8 21,010 6 21 1 28 284 16 12 160 80 48 48 80 8 24 40 75 8 4,256 31,524 304 1,296 10,400 183,760 48 16,560 1,760 64 504,240 240 1,575 8 Total .................................... ................................ .................................. ................................ ................................ 4,350,287 1 There are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 4—ESTIMATED ANNUAL RECORDKEEPING BURDEN FOR BIOLOGICS 1 Number of recordkeepers 21 CFR Section Annual frequency per recordkeeping Total annual records Hours per record Total hours 312.52(a) .................................. 312.57(a) and (b) ..................... 312.62(a) .................................. 312.62(b) .................................. 312.160(a)(3) ........................... 312.160(c) ................................ 139 433 5,570 5,570 146 146 1.4 2.6 1 10 1.4 1.4 195 1,126 5,570 55,700 204 204 2 100 40 40 0.5 0.5 390 112,600 222,800 2,228,000 102 102 Total .................................. ................................ .................................. ................................ .................................. 2,563,994 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: January 20, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50– 400B, Rockville, MD 20850, 301–796– 3794, e-mail: Jonnalynn.Capezzuto@fda.hhs.gov. [FR Doc. 2011–1758 Filed 1–26–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–N–0084] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Pretesting of Tobacco Communications AGENCY: Food and Drug Administration, HHS. mstockstill on DSKH9S0YB1PROD with NOTICES ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitle ‘‘Pretesting of Tobacco Communications’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. SUMMARY: VerDate Mar<15>2010 17:51 Jan 26, 2011 Jkt 223001 In the Federal Register of August 6, 2010 (75 FR 47600), 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 0910–0674. The approval expires on January 31, 2013. 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: January 21, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–1757 Filed 1–26–11; 8:45 am] BILLING CODE 4160–01–P PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–N–0250] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Premarket Approval of Medical Devices AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Premarket Approval of Medical Devices’’ 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: In the Federal Register of September 24, 2010 SUMMARY: E:\FR\FM\27JAN1.SGM 27JAN1 4918 Federal Register / Vol. 76, No. 18 / Thursday, January 27, 2011 / Notices (75 FR 58396), 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 0910–0231. The approval expires on December 31, 2013. A copy of the supporting statement for this information collection is available on the Internet at https:// www.reginfo.gov/public/do/PRAMain. Dated: January 21, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. information collection and has assigned OMB control number 0910–0466. The approval expires on January 31, 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: January 21, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–1755 Filed 1–26–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–D–0143; (formerly Docket No. FDA–2008–D–0128)] [FR Doc. 2011–1756 Filed 1–26–11; 8:45 am] BILLING CODE 4160–01–P Drug-Induced Liver Injury: Are We Ready to Look?; Public Conference; Request for Comments DEPARTMENT OF HEALTH AND HUMAN SERVICES AGENCY: Notice of public conference; request for comments. ACTION: [Docket No. FDA–2010–N–0357] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Hazard Analysis and Critical Control Point Procedures for the Safe and Sanitary Processing and Importing of Juice AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Hazard Analysis and Critical Control Point Procedures for the Safe and Sanitary Processing and Importing of Juice’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. 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: In the Federal Register of September 23, 2010 (75 FR 57962), 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 mstockstill on DSKH9S0YB1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 17:51 Jan 26, 2011 Jkt 223001 Food and Drug Administration, HHS. Food and Drug Administration The Food and Drug Administration (FDA) is announcing a public conference entitled ‘‘DrugInduced Liver Injury: Are We Ready to Look?’’ The public conference will be cosponsored with the American Association for the Study of Liver Diseases (AASLD) and the Pharmaceutical and Research Manufacturers of America to discuss and debate issues regarding druginduced liver injury (DILI). The purpose of this conference is to consider the effect of the recommendations in the guidance for industry entitled ‘‘DrugInduced Liver Injury: Premarketing Clinical Evaluation’’ since its publication in July 2009 and to seek suggestions for future revision. DATES: The public conference will be held on March 23, 2011, from 8 a.m. to 6 p.m. and March 24, 2011, from 8 a.m. until 3:30 p.m. Submit either electronic or written comments on Agency guidance at any time. ADDRESSES: The conference will take place at the National Labor College, 10000 New Hampshire Ave., Silver Spring, MD 20993. Submit written requests for single copies of the 2009 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 SUMMARY: PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 requests. See the SUPPLEMENTARY section for electronic access to the 2009 guidance document. Submit electronic comments on the 2009 guidance and the issues and questions presented at the conference 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: Lana L. Pauls, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 4307, Silver Spring, MD 20993–0002, 301– 796–0518, e-mail: lana.pauls@fda.hhs.gov. SUPPLEMENTARY INFORMATION: INFORMATION I. Background In July 2009, FDA made available a guidance for industry entitled ‘‘DrugInduced Liver Injury: Premarketing Clinical Evaluation’’ (see 74 FR 38035, July 30, 2009). The 2009 guidance explains that DILI has been the most frequent cause of safety-related drug marketing withdrawals for the past 50 years, and that hepatoxicity has limited the use of many drugs that have been approved and prevented the approval of others. It discusses methods of detecting DILI by periodic tests of serum enzyme activities and bilirubin concentration elevations, and how those laboratory tests might change over time, along with symptoms and physical findings, to allow estimation of severity of the injury. It suggests some rules for stopping or interrupting drug treatment, and the need to obtain additional clinical information to estimate the likelihood of the true cause. Public comments on the draft guidance were sought in 2007 and 2008, and those comments were taken into consideration when issuing the final guidance in July 2009. II. The Public Conference A. Why are we holding this conference? The purpose of the 2011 conference is to discuss the most current information and thinking about how drugs cause liver injury and why certain individuals are more susceptible than others, combining views of both basic science and clinical experts, and selecting for specific debate and discussion issues such as: • Liver injury and dysfunction in patients, • Liver reaction to injury, • Biomarkers and predictors of liver injury and dysfunction, and • Postmarketing DILI. E:\FR\FM\27JAN1.SGM 27JAN1

Agencies

[Federal Register Volume 76, Number 18 (Thursday, January 27, 2011)]
[Notices]
[Pages 4917-4918]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-1756]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0250]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Premarket Approval of Medical 
Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
collection of information entitled ``Premarket Approval of Medical 
Devices'' 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: In the Federal Register of September 24, 
2010

[[Page 4918]]

(75 FR 58396), 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 0910-0231. 
The approval expires on December 31, 2013. A copy of the supporting 
statement for this information collection is available on the Internet 
at https://www.reginfo.gov/public/do/PRAMain.

    Dated: January 21, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-1756 Filed 1-26-11; 8:45 am]
BILLING CODE 4160-01-P

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