Office of the Secretary; Notice of Meeting, 33719-33720 [2021-13528]

Download as PDF Federal Register / Vol. 86, No. 120 / Friday, June 25, 2021 / Notices Application No. Drug Applicant ANDA 074400 ...... ANDA 074432 ...... Diflunisal Tablets, 250 mg and 500 mg .................................. Diclofenac Sodium Delayed Release Tablets, 50 mg and 75 mg. ANDA ANDA ANDA ANDA ANDA ANDA ...... ...... ...... ...... ...... ...... Piroxicam Capsules, 10 mg and 20 mg .................................. Indapamide Tablets, 1.25 mg and 2.5 mg .............................. Baclofen Tablets, 10 mg and 20 mg ....................................... Mexiletine HCl Capsules, 150 mg, 200 mg and 250 mg ........ Diclofenac Sodium Delayed Release Tablets, 50 mg ............ Diltiazem HCl Extended Release Capsules, 120 mg, 180 mg, and 240 mg. ANDA 074865 ...... ANDA 074870 ...... Mexiletine HCl Capsules, 150 mg, 200 mg, and 250 mg ....... Acyclovir Tablets, 400 mg and 800 mg .................................. ANDA 075101 ...... ANDA 076022 ...... Acyclovir Capsules, 200 mg .................................................... Fluoxetine HCl Capsules, EQ 10 mg base and EQ 20 mg base. Prednisolone Sodium Phosphate Solution, EQ 15 mg base/5 milliliters (mL). Isoniazid Tablets, 300 mg ....................................................... Nitroglycerin Controlled-Release Capsules, 6.5 mg ............... Do. Pliva, Inc. (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.), 400 Interpace Pkwy., Building A, Parsippany, NJ 07054. Watson Laboratories, Inc. Do. Do. Do. Teva Pharmaceuticals USA, Inc. Actavis Laboratories FL, Inc. (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.), 400 Interpace Pkwy., Building A, Parsippany, NJ 07054. Watson Laboratories, Inc. Actavis Elizabeth LLC (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.), 400 Interpace Pkwy., Building A, Parsippany, NJ 07054. Watson Laboratories, Inc. Carlsbad Technology, Inc., 5922 Farnsworth Ct., Carlsbad, CA 92008. Amneal Pharmaceuticals, 85 Adams Ave., Hauppauge, NY 11788. Watson Laboratories, Inc. Lumara Health, Inc., 1100 Winter St., Suite 3000, Waltham, MA 02451. Watson Laboratories, Inc. Watson Laboratories, Inc. Sandoz Inc., 100 College Rd. West, Princeton, NJ 08540. Do. Do. Morton Grove Pharmaceuticals Inc./Wockhardt USA LLC., 6451 Main St., Morton Grove, IL 60053. 074460 074585 074698 074711 074723 074852 ANDA 078345 ...... ANDA 080521 ...... ANDA 086537 ...... ANDA ANDA ANDA ANDA ANDA ANDA 086889 086890 087975 087976 088509 090833 ...... ...... ...... ...... ...... ...... ANDA 200771 ...... ANDA 202063 ...... lotter on DSK11XQN23PROD with NOTICES1 33719 Disulfiram Tablets, 250 mg ..................................................... Disulfiram Tablets, 500 mg ..................................................... Nitroglycerin Controlled-Release Capsules, 2.5 mg ............... Nitroglycerin Controlled-Release Capsules, 6.5 mg ............... Nitroglycerin Controlled-Release Capsules, 9 mg .................. 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. Irinotecan HCl Injection, 40 mg/2 mL (20 mg/mL) and 100 mg/5 mL (20 mg/mL). ANDA 204437 ...... Gemcitabine HCl for Injection, EQ 200 mg base/vial; EQ 1 gram base/vial. Sodium Fluoride 18 Injection, 10–200 millicurie (mCi)/mL ..... ANDA 208444 ...... Choline C–11 Injection, 4–33.1 mCi/mL ................................. 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. VerDate Sep<11>2014 18:38 Jun 24, 2021 Jkt 253001 Heritage Pharmaceuticals Inc. d/b/a/Avet Pharmaceuticals Inc. U.S. Agent for Emcure Pharmaceuticals Limited, One Tower Center Blvd., East Brunswick, NJ 08816. Do. UCSF Radiopharmaceutical Facility, 185 Berry St., Suite 350, San Francisco, CA 94107. Do. 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 PO 00000 Frm 00087 Fmt 4703 Sfmt 4703 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 (https://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 E:\FR\FM\25JNN1.SGM 25JNN1 33720 Federal Register / Vol. 86, No. 120 / Friday, June 25, 2021 / Notices lotter on DSK11XQN23PROD with NOTICES1 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 VerDate Sep<11>2014 18:38 Jun 24, 2021 Jkt 253001 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: https://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 PO 00000 Frm 00088 Fmt 4703 Sfmt 4703 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. E:\FR\FM\25JNN1.SGM 25JNN1

Agencies

[Federal Register Volume 86, Number 120 (Friday, June 25, 2021)]
[Notices]
[Pages 33719-33720]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-13528]


-----------------------------------------------------------------------

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 (https://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. Pre-registration is 
recommended.
    Deadlines: Written/Virtual Public Comment Due Date: Friday, July 
2, 2021, by

[[Page 33720]]

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: [email protected].

    Public Comments: The IACC welcomes public comments from members of 
the autism community. Comments may be submitted in writing via email to 
[email protected] or using the web form at: https://iacc.hhs.gov/meetings/public-comments/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 
[email protected] 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: https://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
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