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 


lotter on DSK11XQN23PROD with NOTICES1
33720 Federal Register / Vol. 86, No. 120 / Friday, June 25, 2021 / Notices 

5:00 p.m. ET. For instructions, see below. 

Public Comments provided via Live 

Feedback Form during the meeting: No 

preregistration required. For instructions, see 

https://iacc.hhs.gov/meetings/iacc-meetings/ 

live-feedback.shtml. 

Contact Person: Ms. Rebecca Martin, Office 

of Autism Research Coordination, National 

Institute of Mental Health, NIH, 6001 

Executive Boulevard, Bethesda, MD 20892– 

9669, Phone: 301–435–9269, Email: 

IACCPublicInquiries@mail.nih.gov. 

Public Comments: The IACC 

welcomes public comments from 

members of the autism community. 

Comments may be submitted in writing 

via email to IACCPublicInquiries@

mail.nih.gov or using the web form at: 

https://iacc.hhs.gov/meetings/publiccomments/submit/index.jsp by 5:00 

p.m. ET on Friday, July 2, 2021. 

Comments may be addressed to the 

Interagency Autism Coordinating 

Committee. A limited number of slots 

are available for individuals to provide 

a 2–3-minute summary or excerpt of 

their comment to the committee live 

during the virtual meeting using the 

virtual platform. For those interested in 

that opportunity, please indicate 

‘‘Interested in providing virtual 

comment’’ in your written submission, 

along with your name, address, email, 

phone number, and professional/ 

organizational affiliation so that OARC 

staff can contact you if a slot is available 

for you to provide a summary or excerpt 

of your comment via the virtual 

platform during the meeting. For any 

given meeting, priority for virtual 

comment slots will be given to 

commenters who have not previously 

provided virtual comments in the 

current calendar year. This will help 

ensure that as many individuals as 

possible have an opportunity to share 

comments. Commenters going over their 

allotted 3-minute slot may be asked to 

conclude immediately to allow other 

comments and the rest of the meeting to 

proceed on schedule. 

Public comments received by 5:00 

p.m. ET on Friday, July 2, 2021, will be 

provided to the Committee prior to the 

meeting for their consideration. Any 

written comments received after 5:00 

p.m. ET, Friday, July 2, 2021, may be 

provided to the Committee either before 

or after the meeting, depending on the 

volume of comments received and the 

time required to process them in 

accordance with privacy regulations and 

other applicable Federal policies. All 

public comments become part of the 

public record. Attachments of 

copyrighted publications are not 

permitted, but web links or citations for 

any copyrighted works cited may be 

provided. For public comment 

guidelines, see: https://iacc.hhs.gov/ 

meetings/public-comments/guidelines/. 

Individuals may also submit public 

comments to the IACC via a Live 

Feedback Form accessible from the 

webcast page on the days of the meeting 

during the time period announced. No 

pre-registration for Live Feedback 

comments is required. The link to the 

form will be accessible on the NIH 

Videocast website at https://

videocast.nih.gov and instructions are 

available on the IACC website: https:// 

iacc.hhs.gov/meetings/iacc-meetings/ 

live-feedback.shtml. This format is best 

suited for brief questions and comments 

for the committee. Submissions will be 

provided to the IACC and will become 

a part of the public record. 

Technical Issues: If you experience 

any technical problems with the 

webcast or conference call, please send 

an email to IACCPublicInquiries@

mail.nih.gov or use the Live Feedback 

form on the NIH Videocast meeting 

page. 

Meeting schedule subject to change. 

Disability Accommodations: All IACC 

Full Meetings provide Closed 

Captioning through the NIH videocast 

website. Individuals whose full 

participation in the meeting will require 

special accommodations (e.g., sign 

language or interpreting services, etc.) 

must submit a request to the Contact 

Person listed on the notice at least seven 

(7) business days prior to the meeting. 

Such requests should include a detailed 

description of the accommodation 

needed and a way for the IACC to 

contact the requester if more 

information is needed to fill the request. 

Special requests should be made at least 

seven (7) business days prior to the 

meeting; last minute requests may be 

made but may not be possible to 

accommodate. 

More Information: Information about 

the IACC is available on the website: 

http://www.iacc.hhs.gov. 

Dated: June 21, 2021. 

Melanie J. Pantoja, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2021–13528 Filed 6–24–21; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

Institute; 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: National Heart, Lung, 

and Blood Institute Special Emphasis Panel; 

NHLBI Outstanding Investigator Award 

(OIA)—R35. 

Date: August 4–5, 2021. 

Time: 11:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6705 

Rockledge Drive, Bethesda, MD 20817 

(Virtual Meeting). 

Contact Person: Kristen Page, Ph.D., 

Scientific Review Officer, Office of Scientific 

Review/DERA, National Heart, Lung, and 

Blood Institute, National Institutes of Health, 

6705 Rockledge Drive, Room 209–B, 

Bethesda, MD 20892, (301) 827–7953, 

kristen.page@nih.gov. 

Name of Committee: National Heart, Lung, 

and Blood Institute Special Emphasis Panel; 

Catalyze Enabling Technologies. 

Date: August 18, 2021. 

Time: 11:00 a.m. to 2:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6705 

Rockledge Drive, Bethesda, MD 20817 

(Virtual Meeting). 

Contact Person: Kristin Goltry, Ph.D., 

Scientific Review Officer, Office of Scientific 

Review/DERA, National Heart, Lung, and 

Blood Institute, National Institutes of Health, 

6705 Rockledge Drive, Room 209–B, 

Bethesda, MD 20892, (301) 435–0297, 

goltrykl@mail.nih.gov. 

Name of Committee: National Heart, Lung, 

and Blood Institute Special Emphasis Panel; 

Catalyze Product Definition. 

Date: August 19, 2021. 

Time: 11:00 a.m. to 4:00 p.m. 

Agenda: To review and evaluate grant 

applications and/or proposals. 

Place: National Institutes of Health, 6705 

Rockledge Drive, Bethesda, MD 20817 

(Virtual Meeting). 

Contact Person: Kristin Goltry, Ph.D., 

Scientific Review Officer, Office of Scientific 

Review/DERA, National Heart, Lung, and 

Blood Institute, National Institutes of Health, 

6705 Rockledge Drive, Room 209–B, 

Bethesda, MD 20892, (301) 435–0297, 

goltrykl@mail.nih.gov. 

Name of Committee: National Heart, Lung, 

and Blood Institute Special Emphasis Panel; 

Early Stage Investigatory (EIA) R35 Review 

Meeting. 

Date: August 25, 2021. 

Time: 10:00 a.m. to 6:00 p.m. 


lotter on DSK11XQN23PROD with NOTICES1