Federal Register / Vol. 77, No. 115 / Thursday, June 14, 2012 / Notices 35689

adopted this process as a means to Podofilox Dated: June 8, 2012. develop and disseminate product- R Leslie Kux, specific BE recommendations and Rotigotine Assistant Commissioner for Policy. Rufinamide provide a meaningful opportunity for [FR Doc. 2012–14477 Filed 6–13–12; 8:45 am] the public to consider and comment on T those recommendations. Under that Tapentadol HCl BILLING CODE 4160–01–P process, draft recommendations are Tetrabenazine Z posted on FDA’s Web site and DEPARTMENT OF HEALTH AND announced periodically in the Federal Zolpidem tartrate HUMAN SERVICES Register. The public is encouraged to III. Drug Products for Which Revised submit comments on those Draft Product-Specific BE Food and Drug Administration recommendations within 60 days of Recommendations Are Available their announcement in the Federal Register. FDA considers any comments FDA is announcing revised draft [Docket No. FDA–2010–D–0146] received and either publishes final product-specific BE recommendations Guidance for Industry on Irritable recommendations or publishes revised for drug products containing the Bowel Syndrome—Clinical Evaluation draft recommendations for comment. following active ingredients: of Drugs for Treatment; Availability; Recommendations were last announced D in the Federal Register of March 28, Dexamethasone; tobramycin (multiple Correction 2012 (77 FR 18827). This notice RLDs) AGENCY: Food and Drug Administration, announces draft product-specific E recommendations, either new or Everolimus HHS. L revised, that are being posted on FDA’s ACTION: Notice; correction. Web site concurrently with publication Loteprednol etabonate of this notice. Loteprednol etabonate; tobramycin S SUMMARY: The Food and Drug II. Drug Products for Which New Draft Sorafenib tosylate Administration (FDA) is correcting a Product-Specific BE Recommendations For a complete history of previously notice that appeared in the Federal Are Available published Federal Register notices Register of May 31, 2012 (77 FR 32124). The document announced the FDA is announcing new draft related to product-specific BE product-specific BE recommendations recommendations, please go to http:// availability of a guidance for industry for drug products containing the www.regulations.gov and enter docket entitled ‘‘Irritable Bowel Syndrome— following active ingredients: number FDA–2007–D–0369. Clinical Evaluation of Drugs for These draft and revised draft Treatment.’’ The document was A guidances are being issued consistent Aliskiren hemifumarate; amlodipine published with an incorrect docket with FDA’s good guidance practices besylate number. This document corrects that regulation (21 CFR 10.115). These Alvimopan error. guidances represent the Agency’s Azilsartan medoxomil current thinking on product-specific FOR FURTHER INFORMATION CONTACT: B Joyce Strong, Office of Policy and Bacitracin design of BE studies to support ANDAs. Boceprevir They do not create or confer any rights Planning, Food and Drug C for or on any person and do not operate Administration, 10903 New Hampshire Cefpodoxime proxetil (multiple to bind FDA or the public. An Ave., Bldg. 32, Rm. 3208, Silver Spring, reference listed drugs (RLDs)) alternative approach may be used if MD 20993–0002, 301–796–9148. Cefprozil (multiple RLDs) such approach satisfies the requirements of the applicable statutes SUPPLEMENTARY INFORMATION: In FR Doc. Cetirizine HCl 2012–13143, appearing on page 32124 Ciprofloxacin HCl; hydrocortisone and regulations. in the Federal Register of Thursday, Clomiphene citrate IV. Comments D May 31, 2012, the following correction Dabigatran etexilate mesylate Interested persons may submit to the is made: Dexamethasone; tobramycin Division of Dockets Management (see 1. On page 32124, in the first column, Dinoprostone ADDRESSES) either electronic or written in the headings section of the document, Diphenhydramine; ibuprofen comments on any of the specific BE ‘‘[Docket No. FDA–2012–D–0146]’’ is E recommendations posted on FDA’s Web corrected to read ‘‘[Docket No. FDA– Erythromycin site. Identify comments with the docket 2010–D–0146]’’. F number found in brackets in the Famotidine; ibuprofen heading of this document. The Dated: June 8, 2012. G guidances, notices, and received Leslie Kux, Gabapentin enacarbil comments may be seen in the Division Assistant Commissioner for Policy. I of Dockets Management between 9 a.m. [FR Doc. 2012–14485 Filed 6–13–12; 8:45 am] and 4 p.m., Monday through Friday. Itraconazole BILLING CODE 4160–01–P K V. Electronic Access Ketoconazole L Persons with access to the Internet Lacosamide may obtain the document at either M http://www.fda.gov/Drugs/Guidance Malathion ComplianceRegulatoryInformation/ Morphine sulfate; naltrexone HCl Guidances/default.htm or http:// P www.regulations.gov.

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