[Federal Register Volume 86, Number 206 (Thursday, October 28, 2021)]
[Notices]
[Pages 59734-59735]
[FR Doc No: 2021-23500]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0973]

Revocation of Authorization of Emergency Use of an In Vitro
Diagnostic Device for Detection and/or Diagnosis of COVID-19;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
revocation of the Emergency Use Authorization (EUA) (the Authorization)
issued to Life Technologies Corporation (a part of Thermo Fisher
Scientific, Inc.) (Thermo Fisher) for the TaqPath COVID-19 MS2 Combo
Kit 2.0. FDA revoked this Authorization on September 27, 2021, under
the Federal Food, Drug, and Cosmetic Act (FD&C Act). The revocation,
which includes an explanation of the reasons for revocation, is
reprinted in this document.

DATES: The Authorization for the TaqPath COVID-19 MS2 Combo Kit 2.0 is
revoked as of September 27, 2021.

ADDRESSES: Submit written requests for a single copy of the revocation
to the Office of Counterterrorism and Emerging Threats, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4338, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request or include a Fax number to which
the revocation may be sent. See the SUPPLEMENTARY INFORMATION section
for electronic access to the revocation.

FOR FURTHER INFORMATION CONTACT: Jennifer J. Ross, Office of
Counterterrorism and Emerging Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 1, Rm. 4332, Silver Spring, MD 20993-
0002,<PHONE_NUMBER> (this is not a toll-free number).

SUPPLEMENTARY INFORMATION:

I. Background

    Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) as amended by the
Project BioShield Act of 2004 (Pub. L. 108-276) and the Pandemic and
All-Hazards Preparedness Reauthorization Act of 2013 (Pub. L. 113-5)
allows FDA to strengthen the public health protections against
biological, chemical, nuclear, and radiological agents. Among other
things, section 564 of the FD&C Act allows FDA to authorize the use of
an unapproved medical product or an unapproved use of an approved
medical product in certain situations. On August 2, 2021, FDA issued an
EUA to Thermo Fisher for the TaqPath COVID-19 MS2 Combo Kit 2.0,
subject to the terms of the Authorization. Notice of the issuance of
the Authorization is published elsewhere in this issue of the Federal
Register, as required by section 564(h)(1) of the FD&C Act. The
authorization of a device for emergency use under section 564 of the
FD&C Act may, pursuant to section 564(g)(2) of the FD&C Act, be revoked
when the criteria under section 564(c) of the FD&C Act for issuance of
such authorization are no longer met (section 564(g)(2)(B) of the FD&C
Act), or other circumstances make such revocation appropriate to
protect the public health or safety (section 564(g)(2)(C) of the FD&C
Act).

II. EUA Revocation Request

    On September 22, 2021, Thermo Fisher requested the revocation of,
and on September 27, 2021, FDA revoked the Authorization for, the
TaqPath COVID-19 MS2 Combo Kit 2.0. Because Thermo Fisher has notified
FDA that it is longer commercially supporting the TaqPath COVID-19 MS2
Combo Kit 2.0 and requested FDA revoke the Authorization, FDA has
determined that it is appropriate to protect the public health or
safety to revoke this Authorization.

III. Electronic Access

    An electronic version of this document and the full text of the
revocation are available on the internet at https://www.regulations.gov/.

IV. The Revocation

    Having concluded that the criteria for revocation of the
Authorization under section 564(g) of the FD&C Act are met, FDA has
revoked the EUA for the TaqPath COVID-19 MS2 Combo Kit 2.0. The
revocation in its entirety follows and provides an explanation of the
reasons for revocation, as required by section 564(h)(1) of the FD&C
Act.
BILLING CODE 4164-01-P

[GRAPHIC] [TIFF OMITTED] TN28OC21.002

    Dated: October 22, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-23500 Filed 10-27-21; 8:45 am]
BILLING CODE 4164-01-C


[Federal Register: June 17, 2008 (Volume 73, Number 117)]
[Rules and Regulations]
[Page 34195]
[DOCID:fr17jn08-7]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2008-0044]
RIN 1625-AA00

Safety Zone; Milwaukee Harbor, Milwaukee, WI

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of final rule.

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SUMMARY: The Coast Guard will enforce the Milwaukee Harbor Safety Zone
in Milwaukee Harbor during June 2008. This action is necessary to
protect vessels and people from the hazards associated with fireworks
displays. This safety zone will restrict vessel traffic from portions
of the Captain of the Port Lake Michigan Zone.

DATES: Effective between June 7, 2008 and August 17, 2008.

FOR FURTHER INFORMATION CONTACT: Lieutenant Commander Kimber Bannan,
Prevention Department, Coast Guard Sector, Lake Michigan, Milwaukee, WI
at<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Coast Guard will enforce Safety Zones,
Milwaukee Harbor, Milwaukee, WI, 33 CFR 165.935 for the following
events:
    (1) Pride Fest fireworks display on June 07, 2008 from 9 p.m.
through 10 p.m.; and
    (2) Polish Fest fireworks display on June 20-21, 2008 from 10 p.m.
through 11 p.m.; and
    (3) Summerfest fireworks display on June 26, 2008 from 10 p.m.
through 11 p.m.; and
    (4) Festa Italiana fireworks display on July 17-20, 2008 from 10
p.m. through 11 p.m.; and
    (5) German Fest fireworks display on July 27, 2008 from 10 p.m.
through 11 p.m.; and
    (6) Arab World Fest fireworks display on August 9, 2008 from 10
p.m. through 11 p.m.; and
    (7) Irish Fest fireworks display on August 17, 2008 from 10 p.m.
through 11 p.m.
    All vessels must obtain permission from the Captain of the Port or
his on-scene representative to enter, move within or exit the safety
zone. Vessels and persons granted permission to enter the safety zone
shall obey all lawful orders or directions of the Captain of the Port
or a designated representative. While within a safety zone, all vessels
shall operate at the minimum speed necessary to maintain a safe course.
    This notice is issued under authority of 33 CFR 165.935 Safety
Zone, Milwaukee Harbor, Milwaukee, WI (72 FR 32522) and 5 U.S.C.
552(a). In addition to this notice in the Federal Register, the Coast
Guard will provide the maritime community with advance notification of
these enforcement periods via broadcast Notice to Mariners or Local
Notice to Mariners. The Captain of the Port will issue a Broadcast
Notice to Mariners notifying the public when enforcement of the safety
zone established by this section is suspended. The Captain of the Port
may be contacted via U.S. Coast Guard Sector Lake Michigan on channel
16, VHF-FM.

    Dated: May 22, 2008.
Bruce C. Jones,
Captain, U.S. Coast Guard, Captain of the Port Lake Michigan.
 [FR Doc. E8-13107 Filed 6-16-08; 8:45 am]

BILLING CODE 4910-15-P


[Federal Register Volume 74, Number 94 (Monday, May 18, 2009)]
[Rules and Regulations]
[Pages 23109-23110]
[FR Doc No: E9-11280]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2008-0731; Directorate Identifier 2008-NM-058-AD;
Amendment 39-15812; AD 2009-04-06]
RIN 2120-AA64

Airworthiness Directives; Boeing Model 747-100, 747-100B, 747-
100B SUD, 747-200B, 747-200C, 747-200F, 747-300, 747-400, 747-400D,
747-400F, 747SR, and 747SP Series Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule; correction.

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SUMMARY: The FAA is correcting typographical errors in an existing
airworthiness directive (AD) that was published previously in the
Federal Register. The error resulted in two incorrect paragraph
references. This AD applies to certain Boeing Model 747-100, 747-100B,
747-100B SUD, 747-200B, 747-200C, 747-200F, 747-300, 747-400, 747-400D,
747-400F, 747SR, and 747SP series airplanes. This AD requires
repetitive detailed inspections of the aft pressure bulkhead for
indications of ``oil cans'' and previous oil can repairs at reduced
compliance times, and corrective actions if necessary.

DATES: Effective April 2, 2009.

ADDRESSES: You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the regulatory evaluation,
any comments received, and other information. The address for the
Docket Office (telephone<PHONE_NUMBER>) is the Document Management
Facility, U.S. Department of Transportation, Docket Operations, M-30,
West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE.,
Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Ivan Li, Aerospace Engineer, Airframe
Branch, ANM-120S, FAA, Seattle Aircraft Certification Office, 1601 Lind
Avenue, SW., Renton, Washington 98057-3356; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: On January 29, 2009, the FAA issued AD 2009-
04-06, amendment 39-15812 (74 FR 8719, February 26, 2009), for certain
Boeing Model 747-100, 747-100B, 747-100B SUD, 747-200B, 747-200C, 747-
200F, 747-300, 747-400, 747-400D, 747-400F, 747SR, and 747SP series
airplanes. This AD requires repetitive detailed inspections of the aft
pressure bulkhead for indications of ``oil cans'' and previous oil can
repairs at reduced compliance times, and corrective actions if
necessary.
    As published, there are two locations in the AD that reference an
incorrect paragraph identifier.
    No other part of the regulatory information has been changed;
therefore, the final rule is not republished in the Federal Register.
    The effective date of this AD remains April 2, 2009.

Sec.  39.13  [Corrected]

    In the Federal Register of February 26, 2009, on page 8721, in the
first column, paragraph (i) of AD 2009-04-06 is corrected to read as
follows:
* * * * *
    (i) If no crack is found during the eddy current inspection
required by paragraph (h) of this AD, do the actions specified in
paragraph (i)(1) or (i)(2) of this AD, as applicable.
* * * * *

    In the Federal Register of February 26, 2009, on page 8721, in the
second column, paragraph (j)(1) of AD 2009-04-06 is corrected to read
as follows:
* * * * *
    (1) If no crack and no oil can are found, repeat the detailed
inspection in accordance with paragraph (g) of this AD.
* * * * *

    Issued in Renton, Washington, on May 6, 2009.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. E9-11280 Filed 5-15-09; 8:45 am]
BILLING CODE 4910-13-P