33718 Federal Register / Vol. 86, No. 120 / Friday, June 25, 2021 / Notices 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR section; activity Number of 

recordkeepers 

Number of 

records per 

recordkeeper 2

Total 

annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

Subpart C: Sales restrictions 

203.23(a) and (b); returns ............. 2,200 71.9909 158,380 0.25 (15 minutes) .......................... 39,595 

203.23(c); documentation of storage of returns.2,200 71.9909 158,380 0.08 (∼6 minutes) .......................... 12,670 

Subpart D: Samples 

203.30–203.39; documentation regarding sample distributions.140 202 28,280 ∼.07–.08 (∼4–5 minutes) ............... 2,121 

Total ........................................ .......................... .......................... 345,040 ........................................................ 54,386 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

2 Rounded to the nearest whole number. 

Based on a review of Agency data, we 

assume 2,200 respondents may incur 

burden resulting from the information 

collection activity associated with the 

requirements in § 203.23(a) through (c). 

A total of 140 pharmaceutical 

companies have submitted information 

to the Agency on drug sample 

distribution under part 203. Those same 

respondents also have recordkeeping 

requirements under part 203. Our 

estimate of the burden of the average 

burden per recordkeeping reflects a 

cumulative average to cover all 

applicable requirements. Since our last 

request for OMB approval, we have 

adjusted our estimate of the overall 

burden downward to reflect a decrease 

of 2,567,713 hours and 64,432,232 

records annually. We attribute this 

adjustment to a more accurate reflection 

of the number of respondents to the 

information collection and clarification 

that burden attributable to requirements 

of the Drug Quality and Security Act are 

not included in this information 

collection. 

Dated: June 21, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–13597 Filed 6–24–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0492] 

Watson Laboratories, Inc. et al.; 

Withdrawal of Approval of 36 

Abbreviated New Drug Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

withdrawing approval of 36 abbreviated 

new drug applications (ANDAs) from 

multiple applicants. The applicants 

notified the Agency in writing that the 

drug products were no longer marketed 

and requested that the approval of the 

applications be withdrawn. 

DATES: Approval is withdrawn as of July 

26, 2021. 

FOR FURTHER INFORMATION CONTACT: 

Martha Nguyen, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 75, Rm. 1676, 

Silver Spring, MD 20993–0002, 240– 

402–6980, Martha.Nguyen@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

applicants 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 under the process 

described 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 

ANDA 062142 ...... Doxycycline Hyclate Capsules, Equivalent to (EQ) 50 milligrams (mg) base and EQ 200 mg base.Watson Laboratories, Inc. (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.), 400 Interpace 

Pkwy., Building A, Parsippany, NJ 07054. 

ANDA 062497 ...... Doxycycline Hyclate Capsules, EQ 50 mg base and EQ 100 

mg base.

Teva Pharmaceuticals USA, Inc. 400 Interpace Pkwy., Building A, Parsippany, NJ 07054. 

ANDA 065152 ...... Cephalexin Capsules, EQ 250 mg base and EQ 500 mg 

base.

Yung Shin Pharmaceutical Ind. Co. Ltd., authorized U.S. 

agent, Carlsbad Technology, Inc./Simon Law, 5922 

Farnsworth Ct., Suite 101, Carlsbad, CA 92008. 

ANDA 070550 ...... Propranolol Hydrochloride (HCl) Tablets, 40 mg .................... Watson Laboratories, Inc. 

ANDA 070551 ...... Propranolol HCl Tablets, 80 mg .............................................. Do. 

ANDA 070943 ...... Oxazepam Capsules, 10 mg ................................................... IVAX Pharmaceuticals Inc. (an indirect wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.), 400 Interpace 

Pkwy., Building A, Parsippany, NJ 07054. 

ANDA 070945 ...... Oxazepam Capsules, 30 mg ................................................... Do. 

ANDA 071446 ...... Temazepam Capsules, 15 mg ................................................ Watson Laboratories, Inc. 

ANDA 071447 ...... Temazepam Capsules, 30 mg ................................................ Do. 

ANDA 072952 ...... Oxazepam Capsules, 10 mg ................................................... Do. 

ANDA 073092 ...... Baclofen Tablets, 10 mg ......................................................... Do. 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 86, No. 120 / Friday, June 25, 2021 / Notices 33719 

Application 

No. Drug Applicant 

ANDA 074400 ...... Diflunisal Tablets, 250 mg and 500 mg .................................. Do. 

ANDA 074432 ...... Diclofenac Sodium Delayed Release Tablets, 50 mg and 75 

mg.

Pliva, Inc. (an indirect, wholly owned subsidiary of Teva 

Pharmaceuticals USA, Inc.), 400 Interpace Pkwy., Building 

A, Parsippany, NJ 07054. 

ANDA 074460 ...... Piroxicam Capsules, 10 mg and 20 mg .................................. Watson Laboratories, Inc. 

ANDA 074585 ...... Indapamide Tablets, 1.25 mg and 2.5 mg .............................. Do. 

ANDA 074698 ...... Baclofen Tablets, 10 mg and 20 mg ....................................... Do. 

ANDA 074711 ...... Mexiletine HCl Capsules, 150 mg, 200 mg and 250 mg ........ Do. 

ANDA 074723 ...... Diclofenac Sodium Delayed Release Tablets, 50 mg ............ Teva Pharmaceuticals USA, Inc. 

ANDA 074852 ...... Diltiazem HCl Extended Release Capsules, 120 mg, 180 

mg, and 240 mg.

Actavis Laboratories FL, Inc. (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.), 400 Interpace 

Pkwy., Building A, Parsippany, NJ 07054. 

ANDA 074865 ...... Mexiletine HCl Capsules, 150 mg, 200 mg, and 250 mg ....... Watson Laboratories, Inc. 

ANDA 074870 ...... Acyclovir Tablets, 400 mg and 800 mg .................................. Actavis Elizabeth LLC (an indirect, wholly owned subsidiary 

of Teva Pharmaceuticals USA, Inc.), 400 Interpace Pkwy., 

Building A, Parsippany, NJ 07054. 

ANDA 075101 ...... Acyclovir Capsules, 200 mg .................................................... Watson Laboratories, Inc. 

ANDA 076022 ...... Fluoxetine HCl Capsules, EQ 10 mg base and EQ 20 mg 

base.

Carlsbad Technology, Inc., 5922 Farnsworth Ct., Carlsbad, 

CA 92008. 

ANDA 078345 ...... Prednisolone Sodium Phosphate Solution, EQ 15 mg base/5 

milliliters (mL).

Amneal Pharmaceuticals, 85 Adams Ave., Hauppauge, NY 

11788. 

ANDA 080521 ...... Isoniazid Tablets, 300 mg ....................................................... Watson Laboratories, Inc. 

ANDA 086537 ...... Nitroglycerin Controlled-Release Capsules, 6.5 mg ............... Lumara Health, Inc., 1100 Winter St., Suite 3000, Waltham, 

MA 02451. 

ANDA 086889 ...... Disulfiram Tablets, 250 mg ..................................................... Watson Laboratories, Inc. 

ANDA 086890 ...... Disulfiram Tablets, 500 mg ..................................................... Watson Laboratories, Inc. 

ANDA 087975 ...... Nitroglycerin Controlled-Release Capsules, 2.5 mg ............... Sandoz Inc., 100 College Rd. West, Princeton, NJ 08540. 

ANDA 087976 ...... Nitroglycerin Controlled-Release Capsules, 6.5 mg ............... Do. 

ANDA 088509 ...... Nitroglycerin Controlled-Release Capsules, 9 mg .................. Do. 

ANDA 090833 ...... Carbidopa/Levodopa and Entacapone Tablets, 18.75 mg/ 

200 mg/75 mg, 25 mg/200 mg/100 mg, 31.25 mg/200 mg/ 

125 mg, 37.5 mg/200 mg/150 mg, and 50 mg/200 mg/200 

mg.

Morton Grove Pharmaceuticals Inc./Wockhardt USA LLC., 

6451 Main St., Morton Grove, IL 60053. 

ANDA 200771 ...... Irinotecan HCl Injection, 40 mg/2 mL (20 mg/mL) and 100 

mg/5 mL (20 mg/mL).

Heritage Pharmaceuticals Inc. d/b/a/Avet Pharmaceuticals 

Inc. U.S. Agent for Emcure Pharmaceuticals Limited, One 

Tower Center Blvd., East Brunswick, NJ 08816. 

ANDA 202063 ...... Gemcitabine HCl for Injection, EQ 200 mg base/vial; EQ 1 

gram base/vial.

Do. 

ANDA 204437 ...... Sodium Fluoride 18 Injection, 10–200 millicurie (mCi)/mL ..... UCSF Radiopharmaceutical Facility, 185 Berry St., Suite 

350, San Francisco, CA 94107. 

ANDA 208444 ...... Choline C–11 Injection, 4–33.1 mCi/mL ................................. Do. 

Therefore, approval of the 

applications listed in the table, and all 

amendments and supplements thereto, 

is hereby withdrawn as of July 26, 2021. 

Approval of each entire application is 

withdrawn, including any strengths and 

dosage forms inadvertently missing 

from the table. 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 July 26, 2021 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: June 21, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–13593 Filed 6–24–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Office of the Secretary; Notice of 

Meeting 

Pursuant to section 10(a) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of a 

meeting of the Interagency Autism 

Coordinating Committee. 

The meeting will be held as a virtual 

meeting and is open to the public. 

Individuals who plan to view the virtual 

meeting and need special assistance or 

other reasonable accommodations to 

view the meeting, should notify the 

Contact Person listed below in advance 

of the meeting. The open session will be 

videocast and can be accessed from the 

NIH Videocasting and Podcasting 

website (http://videocast.nih.gov/). 

Name of Committee: Interagency Autism 

Coordinating Committee. 

Date: July 21–22, 2021. 

Time: Wednesday, July 21, 2021—1:00 

p.m. to 4:00 p.m. ET, https://

videocast.nih.gov/watch=42326; Thursday, 

July 22, 2021—2:00 p.m. to 5:00 p.m. ET, 

https://videocast.nih.gov/watch=42327. 

Agenda: To discuss business, updates, and 

issues related to ASD research and services 

activities. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852 (Virtual 

Meeting). 

Cost: The meeting is free and open to the 

public. 

Registration: A registration web link will 

be posted on the IACC website 

(www.iacc.hhs.gov) prior to the meeting. Preregistration is recommended. 

Deadlines: Written/Virtual Public 

Comment Due Date: Friday, July 2, 2021, by 


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