Federal Register / Vol. 83, No. 1 / Tuesday, January 2, 2018 / Notices 131 

TABLE 1—Continued 

Application 

No. Drug Applicant 

ANDA 086034 Isosorbide Dinitrate Tablets USP, 5 mg ..................................... Do. 

ANDA 086188 Gerimal (ergoloid mesylates) Sublingual Tablets, 1 mg ............ Do. 

ANDA 086385 Nandrolone Decanoate Injection, 50 mg/mL .............................. Do. 

ANDA 086562 Wigraine (ergotamine tartrate and caffeine) Tablets USP, 1 

mg/100 mg.

Organon USA, Inc., Subsidiary of Merck & Co., Inc., 2000 Galloping Hill Rd., Kenilworth, NJ 07033. 

ANDA 086742 Choledyl SA (oxtriphylline) Extended-Release Tablets, 600 mg Warner Chilcott Co., LLC, Subsidiary of Teva Pharmaceuticals 

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

ANDA 086863 Chlorpromazine HCl Oral Concentrate USP, 100 mg/mL .......... Actavis Mid Atlantic, LLC, Subsidiary of Teva Pharmaceuticals 

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

ANDA 087233 Ergoloid Mesylates Sublingual Tablets USP, 0.5 mg ................. Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals 

USA, Inc. 

ANDA 087244 Ergoloid Mesylates Tablets USP, 1 mg ...................................... Do. 

ANDA 

087318..

Tolbutamide Tablets USP, 500 mg ............................................ Do. 

ANDA 087727 Aminophylline Oral Solution USP, 105 mg/5 mL (Dye Free) ..... Actavis Mid Atlantic, LLC, Subsidiary of Teva Pharmaceuticals 

USA, Inc. 

ANDA 088128 Nandrolone Decanoate Injection, 200 mg/mL ............................ Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals 

USA, Inc. 

ANDA 088337 Ergostat (ergotamine tartrate) Sublingual Tablets USP, 2 mg ... Do. 

ANDA 088477 Thioridazine HCl Tablets USP, 15 mg ....................................... Do. 

ANDA 088561 Thioridazine HCl Tablets USP, 10 mg ....................................... Do. 

ANDA 088564 Thioridazine HCl Tablets USP, 100 mg ..................................... Do. 

ANDA 088724 Methyclothiazide Tablets USP, 5 mg ......................................... Do. 

ANDA 088734 Meclizine HCl Tablets, 25 mg ..................................................... Pliva, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. 

ANDA 088769 Mepivacaine HCl Injection USP, 1% .......................................... Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals 

USA, Inc. 

ANDA 088770 Mepivacaine HCl Injection USP, 2% .......................................... Do. 

ANDA 088872 Thioridazine HCl Tablets USP, 200 mg ..................................... Do. 

ANDA 089026 Procainamide HCl Extended-Release Tablets USP, 250 mg .... Do. 

ANDA 089027 Procainamide HCl Extended-Release Tablets USP, 500 mg .... Do. 

ANDA 089530 Prochlorperazine Edisylate Injection USP, EQ 5 mg base/mL .. Do. 

Therefore, approval of the 

applications listed in table 1, and all 

amendments and supplements thereto, 

is hereby withdrawn as of February 1, 

2018. 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 table 1 

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: December 26, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–28254 Filed 12–29–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–5715] 

Watson Laboratories, Inc., and Barr 

Laboratories, Inc., Subsidiaries of Teva 

Pharmaceuticals USA, Inc.; Withdrawal 

of Approval of 54 Abbreviated New 

Drug Applications; Correction 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; correction. 

SUMMARY: The Food and Drug 

Administration (FDA) is correcting a 

notice that appeared in the Federal 

Register of October 24, 2017. The 

document announced the withdrawal of 

approval of 54 abbreviated new drug 

applications (ANDAs) from two 

applicants, effective November 24, 2017. 

The notice inadvertently announced the 

withdrawal of approval for ANDA 

087296 for Chlorthalidone Tablets USP, 

25 milligrams, held by Watson 

Laboratories, Inc., a subsidiary of Teva 

Pharmaceuticals USA, Inc., 425 Privet 

Rd., Horsham, PA 19044. FDA confirms 

that the approval of ANDA 087296 is 

still in effect. 

FOR FURTHER INFORMATION CONTACT: 

Trang Tran, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 75, Rm. 1671, Silver Spring, 

MD 20993–0002, 240–402–7945. 

SUPPLEMENTARY INFORMATION: In FR Doc. 

2017–23046, appearing on page 49214 

in the Federal Register of Tuesday, 

October 24, 2017, the following 

correction is made: 

1. On page 49215, in table 1, the entry 

for ANDA 087296 is removed. 

Dated: December 26, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–28253 Filed 12–29–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–D–1846] 

Labeling for Combined Hormonal 

Contraceptives; Draft Guidance for 

Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 


daltland on DSKBBV9HB2PROD with NOTICES
132 Federal Register / Vol. 83, No. 1 / Tuesday, January 2, 2018 / Notices 

1See the final rule ‘‘Requirements on Content and 

Format of Labeling for Human Prescription Drug 

and Biological Products’’ (71 FR 3922, January 24, 

2006) (21 CFR 201.56(d)(1) and 201.57(c)(9)(i) 

through (iii)); see also the guidance for industry 

entitled ‘‘Labeling for Human Prescription Drug and 

Biological Products—Implementing the PLR 

Content and Format Requirements’’ available at 

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

GuidanceComplianceRegulatoryInformation/ 

Guidances/UCM075082.pdf. 

2See the final rule ‘‘Content and Format of 

Labeling for Human Prescription Drug and 

Biological Products; Requirements for Pregnancy 

and Lactation Labeling’’ (79 FR 72064, December 4, 

2014) (21 CFR 201.56(d) and 201.57); see also the 

draft guidance for industry entitled ‘‘Pregnancy, 

Lactation, and Reproductive Potential: Labeling for 

Human Prescription Drug and Biological Products— 

Content and Format’’ available at https://

www.fda.gov/downloads/Drugs/ 

GuidanceComplianceRegulatoryInformation/ 

Guidances/UCM425398.pdf. When final, this 

guidance will represent FDA’s current thinking on 

this topic. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a draft 

guidance for industry entitled ‘‘Labeling 

for Combined Hormonal 

Contraceptives.’’ This draft guidance 

provides recommendations on 

information that should be included in 

the prescribing information for 

combined hormonal contraceptives 

(CHCs), which contain estrogen and 

progestin. CHC products include 

combined oral contraceptives (COCs), as 

well as non-oral products such as 

transdermal systems and vaginal rings. 

Many of the labeling recommendations 

in this draft guidance represent class 

labeling that should be included in all 

CHC prescribing information. The draft 

guidance reflects many of the 

modifications to prescribing information 

mandated by the physician labeling rule 

(PLR) and the pregnancy and lactation 

labeling rule (PLLR). General advice is 

provided where modifications to the 

prescribing information for specific 

products are needed. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by March 5, 2018 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2017–D–1846 for ‘‘Labeling for 

Combined Hormonal Contraceptives; 

Draft Guidance for Industry.’’ Received 

comments will be placed in the docket 

and, except for those submitted as 

‘‘Confidential Submissions,’’ publicly 

viewable at https://www.regulations.gov 

or at the Dockets Management Staff 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘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 the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002. Send one self-addressed adhesive 

label to assist that office in processing 

your requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Jennifer Dao, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 22, Rm. 5333, Silver Spring, 

MD 20993–0002, 301–796–8189. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Labeling for Combined Hormonal 

Contraceptives.’’ This draft guidance 

provides recommendations on 

information that should be included in 

the prescribing information for CHCs, 

which contain estrogen and a progestin. 

Such products include COCs, as well as 

non-oral products such as transdermal 

systems and vaginal rings. Many of the 

labeling recommendations in this draft 

guidance represent class labeling that 

should be included in all CHC 

prescribing information. The draft 

guidance reflects many of the 

modifications to prescribing information 

mandated by the PLR 1 and the PLLR.2


daltland on DSKBBV9HB2PROD with NOTICES
Federal Register / Vol. 83, No. 1 / Tuesday, January 2, 2018 / Notices 133 

General advice is provided where 

modifications of the prescribing 

information for specific products are 

needed. 

FDA previously issued draft guidance 

on the prescribing information for COCs 

in March 2004 and invited public 

comment. That draft guidance was 

withdrawn in July 2015. However, the 

development of the current draft 

guidance took into consideration public 

comments submitted to the 2004 draft 

guidance that were science-based and 

consistent with current PLR and PLLR 

labeling regulations. This draft guidance 

has been broadened to incorporate the 

more general class of CHCs. 

FDA invites comments on the content 

of this draft guidance. In particular, 

FDA seeks comments on the proposed 

language under section 7.1 of labeling 

that identifies a drug interaction with all 

metabolic enzyme inducers. A variety of 

metabolic enzyme inducers have been 

reported to decrease the plasma 

concentration of the estrogen and/or 

progestin components of CHCs. FDA 

seeks comments and data regarding 

specific enzyme inducers or classes of 

inducers (e.g., cytochrome p450 3A 

strong inducers) that interact with 

CHCs; in particular, comments are 

requested on whether the CHC labeling 

should include specific inducers or 

classes of inducers, or if it should 

remain broad and essentially cover all 

possible cytochrome p (CYP) enzyme 

inducers of any pathway and potency. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the current thinking of FDA 

on labeling for CHCs. 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. This 

guidance is not subject to Executive 

Order 12866. 

II. Paperwork Reduction Act of 1995 

This draft guidance refers to 

previously approved collections of 

information that are subject to review by 

the Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (44 U.S.C. 3501–3520). The 

collections of information in 21 CFR 

201.56 and 201.57 (‘‘Requirements on 

Content and Format of Labeling for 

Human Prescription Drug and Biological 

Products’’) are approved under OMB 

control number 0910–0572. The 

collections of information from the final 

rule entitled ‘‘Content and Format of 

Labeling for Human Prescription Drug 

and Biological Products; Requirements 

for Pregnancy and Lactation Labeling’’ 

are approved under OMB control 

number 0910–0624. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at either 

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

ComplianceRegulatoryInformation/ 

Guidances/default.htm or https://

www.regulations.gov/. 

Dated: December 26, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–28252 Filed 12–29–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–2347] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Food and 

Cosmetic Export Certificate 

Application Process 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on the information 

collection provisions associated with 

export certificate applications for FDAregulated food and cosmetic products. 

DATES: Submit either electronic or 

written comments on the collection of 

information by March 5, 2018. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before March 5, 

2018. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of March 5, 2018. Comments 

received by mail/hand delivery/courier 

(for written/paper submissions) will be 

considered timely if they are 

postmarked or the delivery service 

acceptance receipt is on or before that 

date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2014–N–2347 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; Food and 

Cosmetic Export Certificate Application 

Process.’’ Received comments, those 

filed in a timely manner (see 

ADDRESSES), will be placed in the docket 

and, except for those submitted as 

‘‘Confidential Submissions,’’ publicly 

viewable at https://www.regulations.gov 

or at the Dockets Management Staff 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 


daltland on DSKBBV9HB2PROD with NOTICES