Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices 46079 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://www.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of this guidance to the Division 

of Drug Information, Center for Drug 

Evaluation and Research, Food and 

Drug Administration (CDER), 10001 

New Hampshire Ave., Hillandale 

Building, 4th Floor, Silver Spring, MD 

20993–0002, or the Office of 

Communication, Outreach and 

Development, Center for Biologics 

Evaluation and Research (CBER), Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 3128, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. The guidance may also be 

obtained by mail by calling CBER at 1– 

800–835–4709 or 240–402–8010. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance 

document. 

FOR FURTHER INFORMATION CONTACT:

Regarding the guidance: Norman R. 

Schmuff, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 21, Rm. 2526, Silver Spring, 

MD 20993–0002, Norman.Schmuff@

fda.hhs.gov; or Stephen Ripley, Center 

for Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

7301, Silver Spring, MD 20993–0002, 

240–402–7911. Regarding the ICH: 

Amanda Roache, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 1176, 

Silver Spring, MD 20993–0002, 301– 

796–4548. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In recent years, many important 

initiatives have been undertaken by 

regulatory authorities and industry 

associations to promote international 

harmonization of regulatory 

requirements. FDA has participated in 

many meetings designed to enhance 

harmonization and is committed to 

seeking scientifically-based harmonized 

technical procedures for pharmaceutical 

development. One of the goals of 

harmonization is to identify and then 

reduce differences in technical 

requirements for drug development 

among regulatory agencies. 

ICH was organized to provide an 

opportunity for harmonization 

initiatives to be developed with input 

from both regulatory and industry 

representatives. FDA also seeks input 

from consumer representatives and 

others. ICH is concerned with 

harmonization of technical 

requirements for the registration of 

pharmaceutical products for human use 

among regulators around the world. The 

six founding members of the ICH are the 

European Commission; the European 

Federation of Pharmaceutical Industries 

Associations; the Japanese Ministry of 

Health, Labour, and Welfare; the 

Japanese Pharmaceutical Manufacturers 

Association; CDER and CBER, FDA; and 

the Pharmaceutical Research and 

Manufacturers of America. The 

Standing Members of the ICH 

Association include Health Canada and 

Swissmedic. Any party eligible as a 

member in accordance with the ICH 

Articles of Association can apply for 

membership in writing to the ICH 

Secretariat. The ICH Secretariat, which 

coordinates the preparation of 

documentation, operates as an 

international nonprofit organization and 

is funded by the members of the ICH 

Association. 

The ICH Assembly is the overarching 

body of the Association and includes 

representatives from each of the ICH 

members and observers. 

The M4 guidance provides guidance 

on the organization of the CTD and 

eCTD for Modules 2 through 5 

providing direction on the location and 

hierarchy of headings within modules, 

document pagination and segregation, 

section numbering within documents, 

and the formatting of the table of 

contents. The guidance updates the 

Quality-related sections of the 

Granularity Document Annex, Module 

2.3 Quality Overall Summary, and 

Module 3 Quality. The guidance 

provides separate tables describing the 

recommended granularity for paper and 

eCTD v3.2.2 submissions, and for paper 

and eCTD v4 submissions, and includes 

‘‘Appendices for eCTD v4 Submissions’’ 

to facilitate the implementation of the 

next major version of the eCTD. This 

guidance replaces both the August 2001 

FDA GIF ‘‘M4: Organization of the CTD’’ 

and the October 2005 FDA GIF 

‘‘Granularity Document Annex to M4: 

Organization of the CTD.’’ This merger 

reflects the 2002 addition of the Annex: 

Granularity Document into the ‘‘M4 

Organization of the Common Technical 

Document for the Registration of 

Pharmaceuticals for Human Use.’’ 

There have been no updates or 

changes relative to Module 4 or Module 

5. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on the organization of 

the CTD for the registration of 

pharmaceuticals for human use. It does 

not establish any rights for any person 

and is not binding on FDA or the public. 

You can use an alternative approach if 

it satisfies the requirements of the 

applicable statutes and regulations. 

II. Electronic Access 

Persons with access to the internet 

may obtain the document at https://

www.regulations.gov, https://

www.fda.gov/Drugs/ 

GuidanceCompliance

RegulatoryInformation/Guidances/ 

default.htm, or https://www.fda.gov/ 

BiologicsBloodVaccines/ 

GuidanceCompliance

RegulatoryInformation/Guidances/ 

default.htm. 

Dated: September 28, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–21229 Filed 10–2–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–4563] 

Johnson & Johnson Consumer Inc. et 

al.; Withdrawal of Approval of 7 New 

Drug Applications and 71 Abbreviated 

New Drug Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is withdrawing 

approval of 7 new drug applications 

(NDAs) and 71 abbreviated new drug 

applications (ANDAs) from multiple 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
46080 Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices 

applicants. The holders of the 

applications notified the Agency in 

writing that the drug products were no 

longer marketed and requested that the 

approval of the applications be 

withdrawn. 

DATES: Withdrawal of approval is 

effective November 2, 2017. 

FOR FURTHER INFORMATION CONTACT: 

Florine P. Purdie, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6248, 

Silver Spring, MD 20993–0002, 301– 

796–3601. 

SUPPLEMENTARY INFORMATION: The 

holders of the applications listed in the 

table have informed FDA that these drug 

products are no longer marketed and 

have requested that FDA withdraw 

approval of the applications pursuant to 

the process in § 314.150(c) (21 CFR 

314.150(c)). The applicants have also, 

by their requests, waived their 

opportunity for a hearing. Withdrawal 

of approval of an application or 

abbreviated application under 

§ 314.150(c) is without prejudice to 

refiling. 

Application No. Drug Applicant 

NDA 014349 ........................... Delfen (nonoxynol-9) Contraceptive Foam, 12.5% ............ Johnson & Johnson Consumer Inc., 199 Grandview Rd., Skillman, NJ 

08558. 

ANDA 019346 ......................... Dextrose 60% Injection USP in Plastic Container .............. Hospira, Inc., 275 North Field Dr., Dept. 389, Bldg. H2–2, Lake Forest, 

IL 60045. 

NDA 019810 ........................... Prilosec (omeprazole) Delayed-Release Capsules, 10 milligrams (mg), 20 mg, and 40 mg.AstraZeneca Pharmaceuticals LP, One MedImmune Way, Gaithersburg, 

MD 20878. 

NDA 020184 ........................... Aceon (perindopril erbumine) Tablets, 2 mg, 4 mg, and 8 

mg.

Symplmed Pharmaceuticals, LLC, 5375 Medspace Way, Cincinnati, OH 

45227. 

NDA 022345 ........................... Potiga (ezogabine) Tablets, 50 mg, 200 mg, 300 mg, and 

400 mg.

GlaxoSmithKline Intellectual Property Management LTD England, c/o 

GlaxoSmithKline, 1250 South Collegeville Road, P.O. Box 5089, 

Collegeville, PA 19426. 

NDA 021712 ........................... Fluxid (famotidine) Orally Disintegrating Tablets, 20 mg 

and 40 mg.

UCB, Inc., 1950 Lake Park Dr., Bldg. 2100, Smyrna, GA 30080. 

ANDA 040108 ......................... Acetazolamide for Injection USP, Equivalent to (EQ) 500 

mg base/vial.

Hospira, Inc. 

ANDA 040206 ......................... Digoxin Injection USP, 0.25 mg/milliliter (mL) .................... Do. 

ANDA 040527 ......................... Phentermine Hydrochloride (HCl) Capsules USP, 37.5 mg Sun Pharmaceutical Industries, Inc., 270 Prospect Plains Rd., Cranbury, 

NJ 08512. 

ANDA 040899 ......................... Hydroxyzine HCl Tablets USP, 10 mg, 25 mg, and 50 mg Do. 

ANDA 060099 ......................... Penicillin G Procaine for Injection, 300,000 units/vial and 

1,500,000 units/vial.

Pfizer Inc., 235 East 42nd St., New York, NY 10017. 

ANDA 063161 ......................... Tobramycin Injection USP, EQ 40 mg base/mL ................ Hospira, Inc. 

ANDA 070171 ......................... Naloxone HCl Injection USP, 0.02 mg/mL ......................... Do. 

ANDA 070186 ......................... Disopyramide Phosphate Capsules USP, EQ 100 mg 

base.

Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, 

Inc., 425 Privet Rd., Horsham, PA 19044. 

ANDA 070233 ......................... Propranolol HCl Tablets USP, 20 mg ................................. Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044. 

ANDA 070255 ......................... Naloxone HCl Injection, 0.4 mg/mL .................................... Hospira, Inc. 

ANDA 070698 ......................... Methyldopate HCl Injection USP, 50 mg/mL, ADD-Vantage Vial.Do. 

ANDA 070699 ......................... Methyldopate HCl Injection USP, 50 mg/mL, Fliptop Vial .. Do. 

ANDA 070739 ......................... Verapamil HCl Injection, 2.5 mg/mL, 2 mL Abbojet-PA Syringe.Do. 

ANDA 070740 ......................... Verapamil HCl Injection, 2.5 mg/mL, 4 mL Abbojet Syringe Vial.Do. 

ANDA 070803 ......................... Enflurane USP, 99.9% ........................................................ Abbott Laboratories, Hospital Products Division, 200 Abbott Park Rd., 

D389, Bldg. J45–2, Abbott Park, IL 60064. 

ANDA 070888 ......................... Aminocaproic Acid Injection USP, 250 mg/mL ................... Hospira, Inc. 

ANDA 071357 ......................... Tolazamide Tablets USP, 100 mg ...................................... Sun Pharmaceutical Industries, Inc. 

ANDA 071438 ......................... Ritodrine HCl in Dextrose 5% Injection, 30 mg/100 mL .... Hospira, Inc. 

ANDA 071618 ......................... Ritodrine HCl Injection USP, 10 mg/mL ............................. Do. 

ANDA 071619 ......................... Ritodrine HCl Injection USP, 15 mg/mL ............................. Do. 

ANDA 071982 ......................... Droperidol and Fentanyl Citrate Injection, 2.5 mg/mL and 

EQ 0.05 mg base/mL.

Do. 

ANDA 072321 ......................... Pancuronium Bromide Injection, 2 mg/mL ......................... Do. 

ANDA 073199 ......................... Sulfamethoxazole and Trimethoprim Injection USP, 80 

mg/mL and 16 mg/mL.

Do. 

ANDA 073310 ......................... Tolmetin Sodium Tablets USP, EQ 200 mg base .............. Sun Pharmaceutical Industries, Inc. 

ANDA 073428 ......................... CO–LAV (polyethylene glycol 3350 and electrolytes) for 

Oral Suspension.

Vintage Pharmaceuticals, 150 Vintage Dr., Huntsville, AL 35811. 

ANDA 073433 ......................... GO–EVAC (polyethylene glycol 3350 and electrolytes) for 

Oral Suspension.

Do. 

ANDA 073677 ......................... Carbastat (carbachol) Intraocular Solution, 0.01% ............. Novartis Pharmaceuticals Corp., One Health Plaza, East Hanover, NJ 

07936. 

ANDA 074168 ......................... Diltiazem HCl Tablets USP, 30 mg, 60 mg, 90 mg, and 

120 mg.

Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, 

Inc. 

ANDA 074280 ......................... Lorazepam Injection USP, 2 mg/mL and 4 mg/mL ............ Hospira, Inc. 

ANDA 074296 ......................... Cimetidine HCl Injection, EQ 300 mg base/2 mL 

(Carpuject).

Do. 

ANDA 074412 ......................... Cimetidine HCl Injection, EQ 300 mg base/2 mL .............. Do. 

ANDA 074422 ......................... Cimetidine HCl Injection, EQ 300 mg base/2 mL, ADDVantage Vial.Do. 

ANDA 074468 ......................... Cimetidine HCl in Sodium Chloride 0.9% Injection in Plastic Container, EQ 90 mg base/100 mL, EQ 120 mg 

base/100 mL, EQ 180 mg base/100 mL, EQ 240 mg 

base/100 mL, EQ 360 mg/100 mL, and EQ 480 mg 

base/100 mL.

Do. 

ANDA 074620 ......................... Butorphanol Tartrate Injection USP, 1 mg/mL and 2 mg/ 

mL.

Do. 

ANDA 074758 ......................... Acyclovir for Injection USP, EQ 500 mg base/vial and EQ 

1 gram (g) base/vial.

Do. 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices 46081 

Application No. Drug Applicant 

ANDA 074801 ......................... Ketorolac Tromethamine Injection USP, 15 mg/mL and 30 

mg/mL.

Do. 

ANDA 075385 ......................... Buspirone HCl Tablets USP, 5 mg, 10 mg, and 15 mg ..... Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, 

Inc. 

ANDA 075453 ......................... Doxazosin Tablets USP, EQ 1 mg base, EQ 2 mg base, 

EQ 4 mg base, and EQ 8 mg base.

Do. 

ANDA 076883 ......................... Sotalol HCl Tablets USP, 80 mg, 120 mg, and 160 mg .... Teva Pharmaceuticals USA, Inc. 

ANDA 077052 ......................... Citalopram Hydrobromide Tablets, EQ 10 mg base, EQ 

20 mg base, and EQ 40 mg base.

Sun Pharmaceutical Industries, Inc. 

ANDA 077937 ......................... Meloxicam Tablets, 7.5 mg and 15 mg .............................. Do. 

ANDA 078081 ......................... Amlodipine Besylate Tablets, EQ 2.5 mg base, EQ 5 mg 

base, and EQ 10 mg base.

Do. 

ANDA 078158 ......................... Fosphenytoin Sodium Injection USP, EQ 50 mg Phenytoin Soudium/mL.Hospira, Inc. 

ANDA 078483 ......................... Zolpidem Tartrate Extended-Release Tablets USP, 6.25 

mg and 12.5 mg.

Synthon Pharmaceuticals, Inc., 1007 Slater Rd., Suite 150, Durham, NC 

27703. 

ANDA 080136 ......................... Isoniazid Tablets, 100 mg ................................................... Sun Pharmaceutical Industries, Inc. 

ANDA 080209 ......................... Prednisone Tablets USP, 5 mg .......................................... Contract Pharmacal Corp., c/o SciRegs International Inc., 6333 

Summercrest Dr., Columbia, MD 21045. 

ANDA 080224 ......................... Sorbitol; Mannitol Irrigation Solution, 2.7 g/100 mL; 540 

mg/100 mL.

Hospira, Inc. 

ANDA 083345 ......................... Potassium Chloride for Injection Concentrate USP, 1 

milliequivalent (mEQ)/mL, 1.5 mEQ/mL, and 2 mEQ/mL.

Do. 

ANDA 083808 ......................... Quinidine Sulfate Tablets USP, 200 mg ............................. Contract Pharmacal Corp., c/o SciRegs International Inc. 

ANDA 084623 ......................... Chlordiazepoxide HCl Capsules USP, 10 mg .................... Upsher-Smith Laboratories, Inc., 6701 Evenstad Dr., Maple Grove, MN 

55369. 

ANDA 084644 ......................... Chlordiazepoxide HCl Capsules USP, 5 mg ...................... Do. 

ANDA 084710 ......................... Ogen (estropipate) Vaginal Cream USP, 1.5 mg/g ............ Pfizer Inc. 

ANDA 085061 ......................... Folic Acid Tablets USP, 1 mg ............................................ Contract Pharmacal Corp., c/o SciRegs International Inc. 

ANDA 085933 ......................... Phentermine HCl Tablets USP ........................................... Lemmon Co., 650 Cathill Rd., Sellersville, PA 18960. 

ANDA 086494 ......................... Chlordiazepoxide HCl Capsules, 25 mg ............................. Teva Pharmaceuticals USA, Inc. 

ANDA 086821 ......................... Hydroxyzine HCl Injection USP, 50 mg/mL ........................ Hospira, Inc. 

ANDA 087416 ......................... Hydroxyzine HCl Injection USP, 25 mg/mL, Carpuject ...... Do. 

ANDA 087546 ......................... Hydroxyzine HCl Injection USP, 50 mg/mL, Carpuject ...... Do. 

ANDA 087862 ......................... Hydroxyzine HCl Tablets USP, 100 mg ............................. Sun Pharmaceutical Industries, Inc. 

ANDA 088147 ......................... Aminophylline in Sodium Chloride 0.45% Injection, 100 

mg/100 mL and 200 mg/100 mL.

Hospira, Inc. 

ANDA 088367 ......................... Lidocaine HCl Injection USP, 10% ..................................... Do. 

ANDA 088542 ......................... Lidocaine HCl Injection USP, 4% ....................................... Do. 

ANDA 089162 ......................... Cyclopentolate HCl Ophthalmic Solution, 1% .................... Alcon Pharmaceuticals, Ltd., 6201 South Freeway TC–45, Fort Worth, 

TX 76134. 

ANDA 089347 ......................... Diatrizoate Meglumine and Diatrizoate Sodium Injection 

USP, 66%; 10%.

Bracco Diagnostics Inc., 259 Prospect Plains Rd., Bldg. H, Monroe 

Township, NJ 08831. 

ANDA 089393 ......................... Glycopyrrolate Injection USP, 0.2 mg/mL .......................... Hospira, Inc. 

ANDA 089488 ......................... Diphenhydramine HCl Capsules, 25 mg ............................ Sun Pharmaceutical Industries, Inc. 

ANDA 089521 ......................... Phenytoin Sodium Injection USP, 50 mg/mL, Ampule ....... Hospira, Inc. 

ANDA 089537 ......................... Procainamide HCl Injection USP, 500 mg/mL, Carpuject .. Do. 

ANDA 089744 ......................... Phenytoin Sodium Injection USP, 50 mg/mL, Carpuject .... Do. 

ANDA 089915 ......................... Leucovorin Calcium for Injection, EQ 100 mg base/vial .... Pharmachemie B.V., c/o SICOR Pharmaceuticals, Inc., 19 Hughes, 

Irvine, CA 92618. 

NDA 202258 ........................... Victrelis (boceprevir) Capsules, 200 mg ............................. Merck Sharp & Dohme Corp., Subsidiary of Merck & Company, Inc., 1 

Merck Dr., P.O. Box 100, Whitehouse Station, NJ 08889. 

NDA 203093 ........................... Vitekta (elvitegravir) Tablets, 85 mg and 150 mg .............. Gilead Sciences, Inc., 333 Lakeside Dr., Foster City, CA 94404. 

Therefore, approval of the 

applications listed in the table, and all 

amendments and supplements thereto, 

is hereby withdrawn, effective 

November 2, 2017. Introduction or 

delivery for introduction into interstate 

commerce of products without 

approved new drug applications 

violates section 301(a) and (d) of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 331(a) and (d)). Drug 

products that are listed in the table that 

are in inventory on the date that this 

notice becomes effective (see DATES) 

may continue to be dispensed until the 

inventories have been depleted or the 

drug products have reached their 

expiration dates or otherwise become 

violative, whichever occurs first. 

Dated: September 27, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–21177 Filed 10–2–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–4977] 

Joint Meeting of the 

Psychopharmacologic Drugs Advisory 

Committee and the Drug Safety and 

Risk Management Advisory 

Committee; Notice of Meeting; 

Establishment of a Public Docket; 

Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; establishment of a 

public docket; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) 

announces a forthcoming public 


asabaliauskas on DSKBBXCHB2PROD with NOTICES