Federal Register / Vol. 86, No. 5 / Friday, January 8, 2021 / Notices 1515 

consumer organizations that are 

participating in the selection process 

with the opportunity to vote on the 

listed nominees. Only organizations 

vote in the selection process. Persons 

who nominate themselves to serve as 

voting or nonvoting consumer 

representatives will not participate in 

the selection process. 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app. 2) and 21 CFR part 14, 

relating to advisory committees. 

Dated: January 4, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–00124 Filed 1–7–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–3240] 

List of Bulk Drug Substances for 

Which There Is a Clinical Need Under 

Section 503B of the Federal Food, 

Drug, and Cosmetic Act; Reopening of 

the Comment Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; reopening of the 

comment period. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

reopening the comment period for a 

notice that appeared in the Federal 

Register of July 31, 2020, in which FDA 

identified certain bulk drug substances 

(active pharmaceutical ingredients) that 

FDA has considered and proposes to 

include or not include on the list of bulk 

drug substances for which there is a 

clinical need (the 503B Bulks List). The 

Agency is taking this action in response 

to a request received during the initial 

comment period, which asked the 

Agency to allow interested persons 

additional time to submit comments. 

DATES: FDA is reopening the comment 

period on the notice published on July 

31, 2020 (85 FR 46126). Submit either 

electronic or written comments by 

February 8, 2021. 

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 February 8, 

2021. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of February 8, 2021. 

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– 

2018–N–3240 for ‘‘List of Bulk Drug 

Substances for Which There is a Clinical 

Need Under Section 503B of the Federal 

Food, Drug, and Cosmetic Act.’’ 

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, 240–402–7500. 

• 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.govinfo.gov/content/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, 240–402–7500. 

FOR FURTHER INFORMATION CONTACT: 

Dominic Markwordt, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 5104, 

Silver Spring, MD 20993, 301–796– 

9349. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of July 31, 2020 (85 FR 

46126), FDA published a notice that 

identified four bulk drug substances that 

FDA considered and proposed to 

include on the 503B Bulks List: 

diphenylcyclopropenone (DPCP), 

glycolic acid, squaric acid dibutyl ester 

(SADBE), and trichloroacetic acid 

(TCA). The July 31, 2020, notice also 

identified 19 bulk drug substances that 

FDA considered and proposed not to 

include on the 503B Bulks List: 

Diazepam, dobutamine hydrochloride 


tkelley on DSKBCP9HB2PROD with NOTICES
1516 Federal Register / Vol. 86, No. 5 / Friday, January 8, 2021 / Notices 

(HCl), dopamine HCl, edetate calcium 

disodium, folic acid, glycopyrrolate, 

hydroxyzine HCl, ketorolac 

tromethamine, labetalol HCl, mannitol, 

metoclopramide HCl, moxifloxacin HCl, 

nalbuphine HCl, polidocanol, potassium 

acetate, procainamide HCl, sodium 

nitroprusside, sodium thiosulfate, and 

verapamil HCl. Interested persons were 

originally given until September 29, 

2020, to comment on FDA’s proposals. 

During the comment period for the 

July 31, 2020, notice, FDA received a 

request to allow interested persons 

additional time to comment. The 

requester asserted that the time period 

of 60 days was insufficient to respond 

fully to FDA’s specific requests for 

comments and noted the commenter’s 

obligations to respond to the exigencies 

of COVID–19 pandemic. 

FDA has considered the request and 

other relevant factors, and accordingly 

is reopening the comment period for the 

July 31, 2020, notice for 30 days, until 

February 8, 2021. The Agency believes 

that an additional 30 days will allow 

adequate time for interested persons to 

submit comments. 

Dated: January 4, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–00123 Filed 1–7–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–2300] 

Determination That ARALEN 

(Chloroquine Phosphate) Oral Tablets, 

500 Milligrams, and Other Drug 

Products Were Not Withdrawn From 

Sale for Reasons of Safety or 

Effectiveness 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) has 

determined that the drug products listed 

in this document were not withdrawn 

from sale for reasons of safety or 

effectiveness. This determination means 

that FDA will not begin procedures to 

withdraw approval of abbreviated new 

drug applications (ANDAs) that refer to 

these drug products, and it will allow 

FDA to continue to approve ANDAs that 

refer to the products as long as they 

meet relevant legal and regulatory 

requirements. 

FOR FURTHER INFORMATION CONTACT: 

Stacy Kane, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 6236, Silver Spring, 

MD 20993–0002, 301–796–8363, 

Stacy.Kane@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 1984, 

Congress enacted the Drug Price 

Competition and Patent Term 

Restoration Act of 1984 (Pub. L. 98–417) 

(the 1984 amendments), which 

authorized the approval of duplicate 

versions of drug products approved 

under an ANDA procedure. ANDA 

applicants must, with certain 

exceptions, show that the drug for 

which they are seeking approval 

contains the same active ingredient in 

the same strength and dosage form as 

the ‘‘listed drug,’’ which is a version of 

the drug that was previously approved. 

ANDA applicants do not have to repeat 

the extensive clinical testing otherwise 

necessary to gain approval of a new 

drug application (NDA). 

The 1984 amendments include what 

is now section 505(j)(7) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

355(j)(7)), which requires FDA to 

publish a list of all approved drugs. 

FDA publishes this list as part of the 

‘‘Approved Drug Products With 

Therapeutic Equivalence Evaluations,’’ 

which is known generally as the 

‘‘Orange Book.’’ Under FDA regulations, 

a drug is removed from the list if the 

Agency withdraws or suspends 

approval of the drug’s NDA or ANDA 

for reasons of safety or effectiveness, or 

if FDA determines that the listed drug 

was withdrawn from sale for reasons of 

safety or effectiveness (21 CFR 314.162). 

Under § 314.161(a) (21 CFR 

314.161(a)), the Agency must determine 

whether a listed drug was withdrawn 

from sale for reasons of safety or 

effectiveness: (1) Before an ANDA that 

refers to that listed drug may be 

approved, (2) whenever a listed drug is 

voluntarily withdrawn from sale and 

ANDAs that refer to the listed drug have 

been approved, and (3) when a person 

petitions for such a determination under 

21 CFR 10.25(a) and 10.30. Section 

314.161(d) provides that if FDA 

determines that a listed drug was 

withdrawn from sale for safety or 

effectiveness reasons, the Agency will 

initiate proceedings that could result in 

the withdrawal of approval of the 

ANDAs that refer to the listed drug. 

FDA has become aware that the drug 

products listed in the table are no longer 

being marketed. 

Application 

No. Drug name Active ingredient(s) Strength(s) Dosage form/route Applicant 

NDA 006002 ARALEN ................... Chloroquine Phosphate.500 milligrams (mg) ................... Tablet; Oral ............... Sanofi-Aventis U.S. 

LLC. 

NDA 006134 DOLOPHINE HYDROCHLORIDE.Methadone Hydrochloride.5 mg; 10 mg ............................... Tablet; Oral ............... Hikma Pharmaceuticals PLC. 

NDA 007409 BENTYL .................... Dicyclomine Hydrochloride.10 mg ......................................... Capsule; Oral ........... Allergan Pharmaceuticals. 

Dicyclomine Hydrochloride.20 mg ......................................... Tablet; Oral.

NDA 008085 Methotrexate Sodium Methotrexate Sodium Equivalent to (EQ) 2.5 mg Base Tablet; Oral ............... DAVA Pharmaceuticals, Inc. 

NDA 008678 Isoniazid ................... Isoniazid ................... 100 mg; 300 mg ......................... Tablet; Oral ............... Sandoz. 

NDA 012945 DIAMOX ................... Acetazolamide .......... 500 mg ....................................... Extended-Release 

Capsule; Oral.

Teva Branded Pharmaceutical Products. 

NDA 014103 ONCOVIN ................. Vincristine Sulfate ..... 1 mg/milliliter (mL); 1 mg/Vial; 5 

mg/Vial.

Injectable; Injection ... Eli Lilly and Co. 

NDA 016792 SURMONTIL ............ Trimipramine Maleate EQ 25 mg/Base; EQ 50 mg/ 

Base; EQ 100 mg/Base.

Capsule; Oral ........... Teva Women’s 

Health, Inc. 


tkelley on DSKBCP9HB2PROD with NOTICES