Office of the Secretary; Notice of Meeting

CourtNational Institutes Of Health
Citation86 FR 33719
Published date25 June 2021
SectionNotices
Record Number2021-13528
33719
Federal Register / Vol. 86, No. 120 / Friday, June 25, 2021 / Notices
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 sub-
sidiary 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. Pre-
registration is recommended.
Deadlines: Written/Virtual Public
Comment Due Date: Friday, July 2, 2021, by
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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/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 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.
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