Federal Register / Vol. 83, No. 141 / Monday, July 23, 2018 / Notices 34853

TABLE 1—NEW DRAFT PRODUCT-SPE- 10.115). These draft guidances, when This notice is being published less than 15 CIFIC GUIDANCES FOR DRUG PROD- finalized, will represent the current days prior to the meeting due to the timing limitations imposed by the review and UCTS—Continued thinking of FDA on, among other things, the product-specific design of BE funding cycle. Beclomethasone dipropionate. studies to support ANDAs. They do not (Catalogue of Federal Domestic Assistance Betamethasone dipropionate. establish any rights for any person and Program Nos. 93.306, Comparative Medicine; Betrixaban. 93.333, Clinical Research, 93.306, 93.333, are not binding on FDA or the public. 93.337, 93.393–93.396, 93.837–93.844, Ciprofloxacin. You can use an alternative approach if Deferasirox. 93.846–93.878, 93.892, 93.893, National Dexamethasone; Neomycin sulfate; Poly- it satisfies the requirements of the Institutes of Health, HHS) myxin b sulfate. applicable statutes and regulations. This Dated: July 17, 2018. guidance is not subject to Executive Epinephrine. Sylvia L. Neal, Ethinyl estradiol; Norethindrone acetate. Order 12866. Finafloxacin. Program Analyst, Office of Federal Advisory Fluocinolone acetonide. IV. Electronic Access Committee Policy. [FR Doc. 2018–15605 Filed 7–20–18; 8:45 am] Loteprednol etabonate. Persons with access to the internet Mecamylamine hydrochloride. BILLING CODE 4140–01–P Methscopolamine bromide. may obtain the draft guidances at either Methylphenidate. https://www.fda.gov/Drugs/Guidance Metyrosine. ComplianceRegulatoryInformation/ DEPARTMENT OF HEALTH AND Moxifloxacin hydrochloride. Guidances/default.htm or https:// HUMAN SERVICES Nebivolol hydrochloride; Valsartan. www.regulations.gov. Nimodipine. Dated: July 18, 2018. National Institutes of Health Nitisinone. Omeprazole. Leslie Kux, Center for Scientific Review; Notice of Rifapentine. Associate Commissioner for Policy. Closed Meetings Ritonavir. [FR Doc. 2018–15735 Filed 7–20–18; 8:45 am] Sodium polystyrene sulfonate. BILLING CODE 4164–01–P Pursuant to section 10(d) of the Triamcinolone acetonide. Federal Advisory Committee Act, as Valbenazine tosylate. amended, notice is hereby given of the DEPARTMENT OF HEALTH AND following meetings. III. Drug Products for Which Revised HUMAN SERVICES The meetings will be closed to the Draft Product-Specific Guidances are public in accordance with the Available National Institutes of Health provisions set forth in sections FDA is announcing the availability of 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Center for Scientific Review; Notice of as amended. The grant applications and revised draft product-specific guidances Closed Meeting for industry for drug products the discussions could disclose confidential trade secrets or commercial containing the following active Pursuant to section 10(d) of the ingredients: property such as patentable material, Federal Advisory Committee Act, as and personal information concerning amended, notice is hereby given of the individuals associated with the grant TABLE 2—REVISED DRAFT PRODUCT- following meeting. SPECIFIC GUIDANCES FOR DRUG applications, the disclosure of which The meeting will be closed to the would constitute a clearly unwarranted PRODUCTS public in accordance with the invasion of personal privacy. provisions set forth in sections Abiraterone acetate. Name of Committee: Center for Scientific Dapagliflozin propanediol; Metformin hydro- 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Review Special Emphasis Panel; Urologic chloride. as amended. The grant applications and and Urogynecologic Applications. Diclofenac sodium. the discussions could disclose Date: July 20, 2018. Donepezil hydrochloride; Memantine hydro- confidential trade secrets or commercial Time: 10:00 a.m. to 11:00 a.m. chloride. property such as patentable material, Agenda: To review and evaluate grant Esomeprazole strontium. and personal information concerning applications. Ethosuximide. individuals associated with the grant Place: National Institutes of Health, 6701 Glatiramer acetate. Rockledge Drive, Bethesda, MD 20892 applications, the disclosure of which (Telephone Conference Call). Hydrocodone bitartrate. would constitute a clearly unwarranted Lansoprazole. Contact Person: Ganesan Ramesh, Ph.D., Latanoprost. invasion of personal privacy. Center for Scientific Review, National Leucovorin calcium. Name of Committee: Center for Scientific Institutes of Health, 6701 Rockledge Drive, Methylphenidate hydrochloride. Review Special Emphasis Panel; PAR–17– Room 2182, MSC 7818, Bethesda, MD 20892, Morphine sulfate; Naltrexone hydrochloride. 031: Role of Age-Associated Metabolic 301–827–5467, [email protected]. Nisoldipine. Changes in Alzhemimer’s Disease. This notice is being published less than 15 Oxycodone hydrochloride. Date: July 31, 2018. days prior to the meeting due to the timing Ticagrelor. Time: 10:00 a.m. to 2:00 p.m. limitations imposed by the review and Triamcinolone acetonide. Agenda: To review and evaluate grant funding cycle. applications. Name of Committee: Center for Scientific For a complete history of previously Place: National Institutes of Health, 6701 Review Special Emphasis Panel; PAR Panel: published Federal Register notices Rockledge Drive, Bethesda, MD 20892 Review of Aging Applications. related to product-specific guidances, go (Virtual Meeting). Date: August 13, 2018. to https://www.regulations.gov and Contact Person: Samuel C. Edwards, Ph.D., Time: 10:00 a.m. to 1:00 p.m. Chief, BDCN IRG, Center for Scientific Agenda: To review and evaluate grant enter Docket No. FDA–2007–D–0369. Review, National Institutes of Health, 6701 applications. These draft guidances are being Rockledge Drive, Room 5210, MSC 7846, Place: National Institutes of Health, 6701 issued consistent with FDA’s good Bethesda, MD 20892, (301) 435–1246, Rockledge Drive, Bethesda, MD 20892 guidance practices regulation (21 CFR [email protected]. (Virtual Meeting).

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