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Federal Register / Vol. 77, No. 16 / Wednesday, January 25, 2012 / Notices 3777

Any application by Mr. Izurieta for revised draft product-specific BE FDA’s Web site in the period from termination of debarment under section recommendations listed in this notice December 1, 2009, through June 30, 306(d)(1) (21 U.S.C. 335a(d)(1)) of the by March 26, 2012. 2011. FD&C Act should be identified with ADDRESSES: Submit written requests for II. Drug Products for Which New Draft Docket No. FDA–2011–N–0592 and sent single copies of the individual BE Product-Specific BE Recommendations to the Division of Dockets Management guidances to the Division of Drug Are Available (see ADDRESSES). All such submissions Information, Center for Drug Evaluation are to be filed in four copies. The public and Research, Food and Drug FDA is announcing draft BE product- availability of information in these Administration, 10903 New Hampshire specific recommendations for drug submissions is governed by 21 CFR Ave., Bldg. 51, Rm. 2201, Silver Spring, products containing the following active 10.20(j). MD 20993–0002. Send one self- ingredients: Publicly available submissions may addressed adhesive label to assist that A be seen in the Division of Dockets office in processing your requests. See Acetaminophen Management between 9 a.m. and 4 p.m., the SUPPLEMENTARY INFORMATION section Acetaminophen; (multiple Monday through Friday. for electronic access to the draft reference listed drugs (RLDs)) Acetaminophen; Butalbital; Dated: January 11, 2012. guidance recommendations. Submit electronic comments on the (multiple RLDs) Armando Zamora, Acetaminophen; Hydrocodone Bitartrate Acting Director, Office of Enforcement, Office draft product-specific BE (multiple RLDs) of Regulatory Affairs. recommendations to http:// Acetaminophen Oxycodone (multiple RLDs) [FR Doc. 2012–1489 Filed 1–24–12; 8:45 am] www.regulations.gov. Submit written Acetazolamide comments to the Division of Dockets Adapalene BILLING CODE 4160–01–P Management (HFA–305), Food and Drug Aliskiren Hemifumarate; Valsartan Administration, 5630 Fishers Lane, Rm. Altretamine 1061, Rockville, MD 20852. Amantadine HCl (multiple RLDs) DEPARTMENT OF HEALTH AND HCl HUMAN SERVICES FOR FURTHER INFORMATION CONTACT: HCl (multiple RLDs) Doan T. Nguyen, Center for Drug Besylate; Telmisartan Food and Drug Administration Evaluation and Research (HFD–600), Amlodipine; Hydrochlorothiazide; Valsartan Food and Drug Administration, 7519 Amoxicillin; Clavulanate Potassium [Docket No. FDA–2007–D–0369; (Formerly (multiple RLDs) Docket No. 2007D–0168)] Standish Pl., Rockville, MD 20855, (240) 276–8608. Aripiprazole ; Butalbital; Caffeine (multiple RLDs) Draft and Revised Draft Guidances for SUPPLEMENTARY INFORMATION: Aspirin; Dipyridamole Industry Describing Product-Specific I. Background Aspirin; Oxycodone Bioequivalence Recommendations; Aspirin; Butalbital; Caffeine; Availability In the Federal Register of May 31, Phosphate 2007, FDA announced the availability of Atovaquone AGENCY: Food and Drug Administration, a draft guidance for industry entitled Auranofin HHS. ‘‘Bioequivalence Recommendations for (multiple RLDs) ACTION: Notice. Specific Products,’’ which explained the B process that would be used to make (multiple RLDs) SUMMARY: The Food and Drug product-specific BE recommendations Benazepril HCl Administration (FDA) is announcing the available to the public on FDA’s Web Benzoyl Peroxide Clindamycin Phosphate availability of additional draft and site at http://www.fda.gov/Drugs/ (multiple RLDs) revised draft product-specific GuidanceCompliance Benzoyl Peroxide; Erythromycin (multiple bioequivalence (BE) recommendations. RLDs) RegulatoryInformation/Guidances/ Betamethasone Acetate; Sodium Phosphate The recommendations provide product- default.htm. As described in that draft specific guidance on the design of BE Betamethasone Dipropionate; Calcipotriene guidance, FDA adopted this process as Hydrate (multiple RLDs) studies to support abbreviated new drug a means to develop and disseminate Betamethasone Dipropionate; Clotrimazole applications (ANDAs). In the Federal product-specific BE recommendations Betamethasone; Clotrimazole Register of May 31, 2007 (72 FR 30386), and provide a meaningful opportunity Bexarotene FDA announced the availability of a for the public to consider and comment Bosentan HCl draft guidance for industry entitled on those recommendations. Under that ‘‘Bioequivalence Recommendations for Buprenorphine HCl; Naloxone HCl process, draft recommendations are Bupropion HBr Specific Products,’’ explaining the posted on the FDA’s Web site and process that would be used to make Bupropion HCl announced periodically in the Federal Buspirone product-specific BE recommendations Register. The public is encouraged to Butoconazole Nitrate (multiple RLDs) available to the public on FDA’s Web submit comments on those C site. The BE recommendations recommendations within 60 days of Calcipotriene (multiple RLDs) identified in this notice were developed their announcement in the Federal using the process described in that Carbidopa; Levodopa Register. FDA considers any comments guidance. received and either publishes final Carvedilol Phosphate DATES: Although you can comment on recommendations or publishes revised Cefaclor any guidance at any time (see 21 CFR draft recommendations for comment. Cefadroxil; Cefadroxil Hemihydrate 10.115(g)(5)), to ensure that the Agency Recommendations were last announced Cefditoren Pivoxil considers your comments on these draft in the Federal Register of December 1, Cefixime Cefuroxime Axetil (multiple RLDs) and revised draft guidances before it 2009 (74 FR 62793). This notice Cetirizine HCl begins work on the final versions of the announces draft product-specific Chlorambucil guidances, submit either electronic or recommendations, either new or Chlorpheniramine Polistirex; Hydrocodone written comments on the draft and revised, that have been posted on the Polistirex

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Chlorthalidone (multiple RLDs) H Nystatin (multiple RLDs) Choline Fenofibrate (multiple RLDs) Hydrochlorothiazide; Moexipril O Ciclopirox (multiple RLDs) Hydrochlorothiazide; Octreotide HCl (multiple RLDs) Homatropine Methylbromide; Hydrocodone Clarithromycin Bitartrate Orlistat (multiple RLDs) Clindamycin Phosphate (multiple RLDs) Hydralazine; Isosorbide Clobetasol Propionate (multiple RLDs) Citrate Hydrochlorothiazide Oseltamivir Phosphate (multiple RLDs) Hydrochlorothiazide; Quinapril HCl Clonidine Oxybutynin Hydrocodone; Ibuprofen (multiple RLDs) Oxycodone Clotrimazole (multiple RLDs) Hydromorphone HCl Clozapine Oxycodone HCl (multiple RLDs) Hydroxychloroquine Colchicine Hydroxyzine HCl (multiple RLDs) Colesevelam HCl P I Cyclobenzaprine Palonosetron HCl D Ibuprofen (multiple RLDs) Pantoprazole Sodium Iloperidone Paroxetine Dapsone (multiple RLDs) Pamoate Darunavir Ethanolate Penbutolol Imiquimod (multiple RLDs) V Potassium Indomethacin (multiple RLDs) Dexamethasone; Tobramycin Perphenazine (multiple RLDs) Dexlansoprazole K Phenelzine Sulfate Phytonadione Pioglitazone HCl Diclofenac Potassium L Diclofenac Sodium (multiple RLDs) Pitavastatin ; Valerate Labetalol HCl Potassium Citrate Diethylpropion Pramipexole Dihydrochloride ; Ibuprofen Lansoprazole Prasugrel HCl (multiple RLDs) Lapatinib Ditosylate Prednisolone Acetate Divalproex Sodium Lenalidomide Dolasetron Mesylate Leuprolide Acetate (multiple RLDs) HCl (multiple RLDs) Donepezil HCl Levetiracetam HCl Doxazosin Mesylate HCl HCl (multiple RLDs) Lithium Carbonate (multiple RLDs) Protriptyline HCl Doxorubicin HCl Loratadine; Pseudoephedrine Sulfate Pseudoephedrine HCl Dronabinol R Dronedarone HCl Loteprednol Lubiprostone Rabeprazole Sodium E Ranitidine HCl M Econazole Nitrate Ergocalciferol Maraviroc Rifabutin Erythromycin (multiple RLDs) Risedronate Erythromycin Ethylsuccinate; Sulfisoxazole Meclizine HCl (multiple RLDs) Acetyl Ritonavir Esomeprazole (multiple RLDs) Rivastigmine Esomeprazole Magnesium; Naproxen Mestranol; Norethindrone Ropinirole HCl Estradiol (multiple RLDs) Metformin HCl; Pioglitazone HCl S Methimazole Conjugated Synthetic A Sevelamer Carbonate Ethacrynic Acid Methoxsalen (multiple RLDs) Methylphenidate Sitagliptin Phosphate Ethinyl Estradiol; Norethindrone (multiple RLDs) Ethinyl Estradiol; Norethindrone Acetate Methylphenidate HCl Methylprednisolone Spironolactone Ethinyl Estradiol; (multiple Sulfacetamide Sodium RLDs) HCl Metolazone Sulfasalazine (multiple RLDs) Etodolac Sunitinib Malate Etoposide Tartrate; Hydrochlorothiazide Everolimus Metronidazole (multiple RLDs) T F Tapentadol HCl Milnacipran HCl Tazarotene (multiple RLDs) Febuxostat Minocycline HCl Terbinafine HCl (multiple RLDs) Terconazole (multiple RLDs) Fenofibrate Mirtazapine Tetracycline Fenofibric Acid Misoprostol Theophylline (multiple RLDs) Fentanyl Citrate Molindone HCl Tioconazole Fesoterodine Fumarate Morphine Sulfate (multiple RLDs) Tizanidine HCl Mupirocin Topotecan Flucytosine Mupirocin (multiple RLDs) Tranexamic Acid Fluorouracil (multiple RLDs) Mycophenolate Mofetil Trazodone HCl (multiple RLDs) HCl (multiple RLDs) N Tretinoin Fluticasone Propionate Naltrexone HCl Triamcinolone Acetonide (multiple RLDs) Fluvoxamine Maleate Naproxen Naproxen Sodium Trimethoprim G Naproxen Sodium; Sumatriptan Succinate U Galantamine HBr Nebivolol Ursodiol Gemfibrozil ; Simvastatin Nicotine Polacrilex V Griseofulvin Valproic Acid Griseofulvin Microcrystalline Nilotinib HCl Monohydrate Venlafaxine HCl Guanfacine HCl Nitroglycerin (multiple RLDs) HCl

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W Nilutamide default.htm or http:// Warfarin Sodium Nitroglycerin www.regulations.gov. Z O Dated: January 19, 2012. Zolmitriptan Omeprazole Leslie Kux, Orlistat (multiple RLDs) Oxymorphone HCl Acting Assistant Commissioner for Policy. [FR Doc. 2012–1433 Filed 1–24–12; 8:45 am] III. Drug Products for Which Revised P Draft Product-Specific BE BILLING CODE 4160–01–P Prednisolone Recommendations Are Available Progesterone FDA is announcing revised draft BE R DEPARTMENT OF HEALTH AND product-specific recommendations for Rivastigmine HUMAN SERVICES drug products containing the following Rivastigmine Tartrate active ingredients. These Ropinirole Food and Drug Administration recommendations were previously S posted on the FDA’s Web site: [Docket No. FDA–1999–D–4079 (Formerly Scopolamine Docket No. 1999D–0254)] A Sevelamer Carbonate (multiple RLDs) Amantadine HCl Sevelamer HCl (multiple RLDs) Guidance for Industry on Product Atorvastatin Sirolimus Name Placement, Size, and B T Prominence in Advertising and Bupropion HBr Telmisartan Promotional Labeling; Availability Tiagabine HCl C AGENCY: Food and Drug Administration, Calcipotriene Tranexamic Acid HHS. Calcium Acetate Triamcinolone Acetonide (multiple RLDs) ACTION: Notice. Calcitriol V Capecitabine (multiple RLDs) SUMMARY: The Food and Drug Cefditoren Pivoxil Varenicline Tartrate Administration (FDA) is announcing the Ciclopirox Venlafaxine HCl availability of a guidance document Clotrimazole For a complete history of previously entitled ‘‘Product Name Placement, Colesevelam HCl (multiple RLDs) published Federal Register notices, Size, and Prominence in Advertising D please go to http://www.regulations.gov and Promotional Labeling.’’ The Darunavir Ethanolate and enter docket number FDA–2007–D– guidance is intended to clarify for ; Ethinyl Estradiol 0369. applicants the requirements for product Desvenlafaxine Succinate These draft and revised draft name placement, size, prominence, and Diclofenac Sodium guidances are being issued consistent frequency in promotional labeling and Diclofenac Sodium; Misoprostol with FDA’s good guidance practices Disulfiram advertising for prescription human and Donepezil HCl (multiple RLDs) regulation (21 CFR 10.115). The animal drugs and biological products. guidances represent the Agency’s E This guidance finalizes the draft current thinking on product-specific guidance published in January 1999. Emtricitabine design of BE studies to support ANDAs. Esomeprazole Magnesium DATES: Submit either electronic or They do not create or confer any rights written comments on Agency guidances Estradiol for or on any person and do not operate Ethinyl Estradiol; Ethynodiol Diacetate at any time. to bind FDA or the public. An (multiple RLDs) ADDRESSES: Submit written requests for alternative approach may be used if Ethinyl Estradiol; Norethindrone single copies of the guidance to the such approach satisfies the F Division of Drug Information, Center for requirements of the applicable statutes Drug Evaluation and Research, Food (multiple RLDs) and regulations. Fentanyl and Drug Administration, 10903 New Fentanyl Citrate IV. Comments Hampshire Ave., Bldg. 51, Rm. 2201, Fluorouracil (multiple RLDs) Interested persons may submit to the Silver Spring, MD 20993–0002; or Office G Division of Dockets Management (see of Communication, Outreach and Glyburide Metformin ADDRESSES) either electronic or written Development (HFM–40), Center for Granisetron HCl comments on any of the specific BE Biologics Evaluation and Research, L recommendations posted on FDA’s Web Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, Labetalol HCl site. It is only necessary to send one set Lamotrigine (multiple RLDs) of comments. Identify comments with MD 20852–1448. Send one self- Lapatinib Ditosylate the docket number found in brackets in addressed adhesive label to assist that the heading of this document. The office in processing your requests. See Levonorgestrel (multiple RLDs) guidance, notices, and received the SUPPLEMENTARY INFORMATION section Linezolid comments may be seen in the Division for electronic access to the guidance M of Dockets Management between 9 a.m. document. Memantine HCl and 4 p.m., Monday through Friday. Submit electronic comments on the Mercaptopurine (multiple RLDs) guidance to http://www.regulations.gov. Metformin HCl (multiple RLDs) V. Electronic Access Submit written comments to the Minoxidil Persons with access to the Internet Division of Dockets Management (HFA– Morphine may obtain the document at either 305), Food and Drug Administration, N http://www.fda.gov/Drugs/ 5630 Fishers Lane, Rm. 1061, Rockville, Nebivolol GuidanceCompliance MD 20852. Niacin RegulatoryInformation/Guidances/ FOR FURTHER INFORMATION CONTACT:

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