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

TABLE 1—NEW DRAFT PRODUCT-SPECIFIC GUIDANCES FOR DRUG PRODUCTS—Continued 

Beclomethasone dipropionate. 

Betamethasone dipropionate. 

Betrixaban. 

Ciprofloxacin. 

Deferasirox. 

Dexamethasone; Neomycin sulfate; Polymyxin b sulfate. 

Epinephrine. 

Ethinyl estradiol; Norethindrone acetate. 

Finafloxacin. 

Fluocinolone acetonide. 

Loteprednol etabonate. 

Mecamylamine hydrochloride. 

Methscopolamine bromide. 

Methylphenidate. 

Metyrosine. 

Moxifloxacin hydrochloride. 

Nebivolol hydrochloride; Valsartan. 

Nimodipine. 

Nitisinone. 

Omeprazole. 

Rifapentine. 

Ritonavir. 

Sodium polystyrene sulfonate. 

Triamcinolone acetonide. 

Valbenazine tosylate. 

III. Drug Products for Which Revised 

Draft Product-Specific Guidances are 

Available 

FDA is announcing the availability of 

revised draft product-specific guidances 

for industry for drug products 

containing the following active 

ingredients: 

TABLE 2—REVISED DRAFT PRODUCTSPECIFIC GUIDANCES FOR DRUG

PRODUCTS

Abiraterone acetate. 

Dapagliflozin propanediol; Metformin hydrochloride. 

Diclofenac sodium. 

Donepezil hydrochloride; Memantine hydrochloride. 

Esomeprazole strontium. 

Ethosuximide. 

Glatiramer acetate. 

Hydrocodone bitartrate. 

Lansoprazole. 

Latanoprost. 

Leucovorin calcium. 

Methylphenidate hydrochloride. 

Morphine sulfate; Naltrexone hydrochloride. 

Nisoldipine. 

Oxycodone hydrochloride. 

Ticagrelor. 

Triamcinolone acetonide. 

For a complete history of previously 

published Federal Register notices 

related to product-specific guidances, go 

to https://www.regulations.gov and 

enter Docket No. FDA–2007–D–0369. 

These draft guidances are being 

issued consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). These draft guidances, when 

finalized, will represent the current 

thinking of FDA on, among other things, 

the product-specific design of BE 

studies to support ANDAs. They do not 

establish any rights for any person and 

are not binding on FDA or the public. 

You can use an alternative approach if 

it satisfies the requirements of the 

applicable statutes and regulations. This 

guidance is not subject to Executive 

Order 12866. 

IV. Electronic Access 

Persons with access to the internet 

may obtain the draft guidances at either 

https://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm or https://

www.regulations.gov. 

Dated: July 18, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–15735 Filed 7–20–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; PAR–17– 

031: Role of Age-Associated Metabolic 

Changes in Alzhemimer’s Disease. 

Date: July 31, 2018. 

Time: 10:00 a.m. to 2:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Samuel C. Edwards, Ph.D., 

Chief, BDCN IRG, Center for Scientific 

Review, National Institutes of Health, 6701 

Rockledge Drive, Room 5210, MSC 7846, 

Bethesda, MD 20892, (301) 435–1246, 

edwardss@csr.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: July 17, 2018. 

Sylvia L. Neal, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2018–15605 Filed 7–20–18; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Urologic 

and Urogynecologic Applications. 

Date: July 20, 2018. 

Time: 10:00 a.m. to 11:00 a.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Telephone Conference Call). 

Contact Person: Ganesan Ramesh, Ph.D., 

Center for Scientific Review, National 

Institutes of Health, 6701 Rockledge Drive, 

Room 2182, MSC 7818, Bethesda, MD 20892, 

301–827–5467, ganesan.ramesh@nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; PAR Panel: 

Review of Aging Applications. 

Date: August 13, 2018. 

Time: 10:00 a.m. to 1:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 


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