Notice of Closed Meeting, 18641 [2024-05458]
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Federal Register / Vol. 89, No. 51 / Thursday, March 14, 2024 / Notices
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Public Health Ethics and
Regulations, Office of Science, Centers for
Disease Control and Prevention.
[FR Doc. 2024–05386 Filed 3–13–24; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Food and Drug Administration
[Docket No. FDA–2023–N–5323]
[Docket Nos. FDA–2023–E–1620 and FDA–
2023–E–1597]
Hoffmann-La Roche, Inc., et al.;
Withdrawal of Approval of Two New
Drug Applications; Correction
Determination of Regulatory Review
Period for Purposes of Patent
Extension; PYRUKYND
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
Centers for Disease Control and
Prevention
Name of Committee: Disease, Disability,
and Injury Prevention and Control Special
Emphasis Panel (SEP)—PAR 18–812, NIOSH
Member Conflict Review.
Date: June 13, 2024.
Time: 1 p.m.–4 p.m., EDT.
Place: Teleconference.
Agenda: To review and evaluate grant
applications.
For Further Information Contact: Michael
Goldcamp, Ph.D., Scientific Review Officer,
Office of Extramural Programs, National
Institute for Occupational Safety and Health,
Centers for Disease Control and Prevention,
1095 Willowdale Road, Morgantown, West
Virginia 26505. Telephone: (304) 285–5951;
Email: MGoldcamp@cdc.gov.
The Director, Office of Strategic Business
Initiatives, Office of the Chief Operating
Officer, Centers for Disease Control and
Prevention, has been delegated the authority
to sign Federal Register notices pertaining to
announcements of meetings and other
committee management activities, for both
the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Kalwant Smagh,
Director, Office of Strategic Business
Initiatives, Office of the Chief Operating
Officer, Centers for Disease Control and
Prevention.
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register on December 18, 2023. The
document announced the withdrawal of
approval of two new drug applications
(NDA), withdrawn as of January 17,
2024. The document indicated that FDA
was withdrawing approval of NDA
022424, FLOWTUSS (guaifenesin 200
milligrams (mg)/5 milliliters (mL) and
hydrocodone bitartrate 2.5 mg/5 mL)
Oral Solution held by Chartwell RX
Sciences, LLC, 77 Brenner Dr., Congers,
NY 10920. Before FDA withdrew the
approval of this NDA, Chartwell RX
Sciences, LLC informed FDA that it did
not want the approval of the NDA
withdrawn. Because Chartwell RX
Sciences, LLC timely requested that
approval of NDA 022424 not be
withdrawn, the approval is still in
effect. This notice corrects that error.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226,
Silver Spring, MD 20993–0002, 301–
796–3137, Kimberly.Lehrfeld@
fda.hhs.gov.
In the
Federal Register of Monday, December
18, 2023 (88 FR 87433), appearing on
page 87433 in FR Doc. 2023–27661, the
following correction is made:
On page 87433, in the table, the entry
for NDA 022424 is removed.
SUPPLEMENTARY INFORMATION:
Dated: March 11, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–05426 Filed 3–13–24; 8:45 am]
BILLING CODE 4164–01–P
BILLING CODE 4163–18–P
16:47 Mar 13, 2024
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
[FR Doc. 2024–05458 Filed 3–13–24; 8:45 am]
VerDate Sep<11>2014
AGENCY:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for PYRUKYND and is publishing this
notice of that determination as required
by law. FDA has made the
determination because of the
submission of applications to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of
patents which claim that human drug
product.
SUMMARY:
Pursuant to 5 U.S.C. 1009(d), notice is
hereby given of the following meeting.
The meeting 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, and the Determination of
the Director, Office of Strategic Business
Initiatives, Office of the Chief Operating
Officer, CDC, pursuant to Public Law
92–463. 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.
ddrumheller on DSK120RN23PROD with NOTICES1
Food and Drug Administration,
HHS.
ACTION:
Notice of Closed Meeting
18641
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Anyone with knowledge that any
of the dates as published (see
SUPPLEMENTARY INFORMATION) are
incorrect must submit either electronic
or written comments and ask for a
redetermination by May 13, 2024.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
September 10, 2024. See ‘‘Petitions’’ in
the SUPPLEMENTARY INFORMATION section
for more information.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
May 13, 2024. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
timely if they are received on or before
that date.
DATES:
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
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]]>Agencies
[Federal Register Volume 89, Number 51 (Thursday, March 14, 2024)]
[Notices]
[Page 18641]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-05458]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Notice of Closed Meeting
Pursuant to 5 U.S.C. 1009(d), notice is hereby given of the
following meeting.
The meeting 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, and the Determination of the Director, Office of
Strategic Business Initiatives, Office of the Chief Operating Officer,
CDC, pursuant to Public Law 92-463. 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: Disease, Disability, and Injury Prevention
and Control Special Emphasis Panel (SEP)--PAR 18-812, NIOSH Member
Conflict Review.
Date: June 13, 2024.
Time: 1 p.m.-4 p.m., EDT.
Place: Teleconference.
Agenda: To review and evaluate grant applications.
For Further Information Contact: Michael Goldcamp, Ph.D.,
Scientific Review Officer, Office of Extramural Programs, National
Institute for Occupational Safety and Health, Centers for Disease
Control and Prevention, 1095 Willowdale Road, Morgantown, West
Virginia 26505. Telephone: (304) 285-5951; Email: [email protected].
The Director, Office of Strategic Business Initiatives, Office
of the Chief Operating Officer, Centers for Disease Control and
Prevention, has been delegated the authority to sign Federal
Register notices pertaining to announcements of meetings and other
committee management activities, for both the Centers for Disease
Control and Prevention and the Agency for Toxic Substances and
Disease Registry.
Kalwant Smagh,
Director, Office of Strategic Business Initiatives, Office of the Chief
Operating Officer, Centers for Disease Control and Prevention.
[FR Doc. 2024-05458 Filed 3-13-24; 8:45 am]
BILLING CODE 4163-18-P
