2016-01686.Pdf

4914 Federal Register / Vol. 81, No. 18 / Thursday, January 28, 2016 / Notices ComplianceRegulatoryInformation/ TABLE 1—NEW DRAFT PRODUCT-SPE- DEPARTMENT OF HEALTH AND Guidances/default.htm. CIFIC BE RECOMMENDATIONS FOR HUMAN SERVICES As described in that guidance, FDA DRUG PRODUCTS—Continued adopted this process as a means to Food and Drug Administration develop and disseminate product- Spinosad. specific BE recommendations and Trametinib dimethyl sulfoxide. [Docket No. FDA–2012–N–0438] provide a meaningful opportunity for Vorapaxar sulfate. the public to consider and comment on Agency Information Collection those recommendations. Under that III. Drug Products for Which Revised Activities; Announcement of Office of process, draft recommendations are Draft Product-Specific BE Management and Budget Approval; posted on FDA’s Web site and Recommendations are Available Early Food Safety Evaluation of New announced periodically in the Federal Non-Pesticidal Proteins Produced by FDA is announcing the availability of Register. The public is encouraged to New Plant Varieties Intended for Food a revised draft guidance for industry on submit comments on those Use recommendations within 60 days of product-specific BE recommendations for drug products containing the their announcement in the Federal AGENCY: Food and Drug Administration, following active ingredients: Register. FDA considers any comments HHS. received and either publishes final recommendations or publishes revised TABLE 2—REVISED DRAFT PRODUCT- ACTION: Notice. draft recommendations for comment. SPECIFIC BE RECOMMENDATIONS Recommendations were last announced FOR DRUG PRODUCTS SUMMARY: The Food and Drug in the Federal Register on September Administration (FDA) is announcing 21, 2015 (80 FR 57000). This notice Abiraterone acetate. that a collection of information entitled announces draft product-specific Amphotericin B. ‘‘Early Food Safety Evaluation of New recommendations, either new or Ciprofloxacin hydrochloride; hydrocortisone. Non-Pesticidal Proteins Produced by revised, that are posted on FDA’s Web Colesevelam hydrochloride. New Plant Varieties Intended for Food site. Drospirenone; estradiol. Use’’ has been approved by the Office of II. Drug Products for Which New Draft Guanfacine hydrochloride. Management and Budget (OMB) under Product-Specific BE Recommendations Lidocaine. the Paperwork Reduction Act of 1995. Lomitapide mesylate. are Available Methylphenidate hydrochloride. FOR FURTHER INFORMATION CONTACT: FDA FDA is announcing the availability of Phytonadione. PRA Staff, Office of Operations, Food new draft guidances for industry on Rivastigmine tartrate. and Drug Administration, 8455 product-specific BE recommendations Colesville Rd., COLE–14526, Silver for drug products containing the For a complete history of previously Spring, MD 20993–0002, following active ingredients: published Federal Register notices [email protected]. related to product-specific BE SUPPLEMENTARY INFORMATION: On TABLE 1—NEW DRAFT PRODUCT-SPE- recommendations, go to http:// October 8, 2015, the Agency submitted CIFIC BE RECOMMENDATIONS FOR www.regulations.gov and enter Docket a proposed collection of information DRUG PRODUCTS No. FDA–2007–D–0369. entitled ‘‘Early Food Safety Evaluation Alprostadil. These draft guidances are being of New Non-Pesticidal Proteins Atazanavir sulfate; cobicistat. issued consistent with FDA’s good Produced by New Plant Varieties Beclomethasone dipropionate. guidance practices regulation (21 CFR Intended for Food Use’’ to OMB for Betamethasone dipropionate. 10.115). These draft guidances, when review and clearance under 44 U.S.C. Betamethasone valerate. finalized, will represent the current 3507. An Agency may not conduct or Betaxolol hydrochloride. thinking of FDA on the product-specific sponsor, and a person is not required to Ciclesonide. design of BE studies to support ANDAs. respond to, a collection of information Clobetasol propionate. They do not establish any rights for any Desonide (multiple reference listed drugs). unless it displays a currently valid OMB person and are not binding on FDA or Diflorasone diacetate (multiple reference list- control number. OMB has now the public. You can use an alternative ed drugs). approved the information collection and approach if it satisfies the requirements Difluprednate emulsion. has assigned OMB control number Elvitegravir. of the applicable statutes and Erythromycin. regulations. 0910–0583. The approval expires on Ethinyl estradiol; norethindrone acetate. November 30, 2018. A copy of the Flurandrenolide. II. Electronic Access supporting statement for this Formoterol fumarate; mometasone furoate. information collection is available on Persons with access to the Internet Ingenol mebutate (multiple strengths). the Internet at http://www.reginfo.gov/ may obtain the draft guidance at either Mercaptopurine. public/do/PRAMain. Methylphenidate hydrocholoride. http://www.fda.gov/Drugs/Guidance Metronidazole. ComplianceRegulatoryInformation/ Dated: January 22, 2016. Mometasone furoate. Guidances/default.htm or http:// Leslie Kux, Naftifine hydrochloride (multiple reference www.regulations.gov. Associate Commissioner for Policy. listed drugs). Nicotine. Dated: January 22, 2016. [FR Doc. 2016–01686 Filed 1–27–16; 8:45 am] Olanzapine pamoate. Leslie Kux, BILLING CODE 4164–01–P Omega-3-carboxylic acids. Associate Commissioner for Policy. Prednisone. Ranitidine hydrochloride. [FR Doc. 2016–01682 Filed 1–27–16; 8:45 am] Riociguat. BILLING CODE 4164–01–P VerDate Sep<11>2014 13:19 Jan 27, 2016 Jkt 238001 PO 00000 Frm 00008 Fmt 4703 Sfmt 9990 E:\FR\FM\28JAN1.SGM 28JAN1 wgreen on DSK2VPTVN1PROD with NOTICES.

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