Revocation of Two Emergency Use Authorizations for In Vitro Diagnostic Devices for COVID-19 (January 2, 2026)
Summary
A Food and Drug Administration notice in the Federal Register, Vol. 91, No. 1, of Friday, January 2, 2026, announcing the revocation of two Emergency Use Authorizations for in vitro diagnostic devices for COVID–19, under Docket No. FDA–2022–N–0150 and FR Doc. 2025–24155. The revoked authorizations covered the Lucira by Pfizer COVID–19 & Flu Test and the Lucira by Pfizer COVID–19 & Flu Home Test, originally issued to Lucira Health, Inc. and later transferred to Pfizer Inc. According to the notice, Pfizer Inc. requested revocation on October 10, 2025, stating that no viable test reagents remained in the United States, and FDA revoked both authorizations under section 564(g)(2)(C) of the FD&C Act. The Federal Register pages also carry General Services Administration notices on foreign gifts minimal value and CY 2026 mileage rates.
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“Revocation of Two Emergency Use Authorizations for In Vitro Diagnostic Devices for COVID-19 (January 2, 2026).”
Original at www.govinfo.gov. Archived at Pandemic Darlings, https://pandemicdarlings.com/source-documents/fr-revocation-two-euas-ivd-covid-2026-01-02-2025-24155-922e2a437e/
, SHA-256 de82be49e853e10548cb22e50659825653362b859aa686f0a82a116726bb3a65.Full text
Federal Register / Vol. 91, No. 1 / Friday, January 2, 2026 / Notices 145
acquire voting shares of Green Belt Bank of the Federal Government and must be DATES: Applicability date: This notice
& Trust, both of Iowa Falls, Iowa. reported to GSA for disposal if not applies to travel and relocation
Board of Governors of the Federal Reserve immediately needed by the agency for performed on or after January 1, 2026,
System. official purposes. Additionally, those through December 31, 2026.
Michele Taylor Fennell, items initially retained by the agencies FOR FURTHER INFORMATION CONTACT: For
Associate Secretary of the Board.
for official use are reported to GSA upon clarification of content, please contact
termination of official use. Mr. Alexander Kurien, Deputy Associate
[FR Doc. 2025–24204 Filed 12–31–25; 8:45 am]
The foreign gifts and decorations Administrator, Office of Government-
BILLING CODE 6210–01–P
minimal value was last redefined wide Policy, at 202–495–9628, or by
effective January 1, 2023, at $480.00, email at travelpolicy@gsa.gov. Please
and therefore, must be redefined as of cite Notice of FTR Bulletin 26–02.
GENERAL SERVICES January 1, 2026, to reflect the CPI
ADMINISTRATION SUPPLEMENTARY INFORMATION: GSA is
increase of 8.99 percent for the required by statute to set the mileage
[Notice–MA–2025–19; Docket No. 2025– preceding three years. reimbursement rate for privately owned
0002; Sequence No. 17] Pursuant to FMR § 102–42.10, the automobiles (POA) as the single
approved revised minimal value will be standard mileage rate established by the
Revision to Foreign Gifts and published in an FMR Bulletin posted on Internal Revenue Service (IRS). The IRS
Decorations Minimal Value OGP’s website (www.gsa.gov/ mileage rate for medical or moving
foreigngifts). purposes is used to determine the POA
AGENCY: Office of Government-Wide
Calculations using the consumer rate when a Government-furnished
Policy (OGP), General Services prices over the past three years show
Administration (GSA). automobile is available and authorized
that the minimal value must increase and also represents the privately owned
ACTION: Notice of GSA Bulletin FMR B– 8.99 percent, or $43.15, from its current
2025–01, Foreign Gifts and Decorations vehicle (POV) standard mileage
$480.00. As in previous years, GSA is reimbursement rate for official
Minimal Value. rounding the amount to the nearest five relocation.
dollar increments. Finally, GSA conducts independent
SUMMARY: GSA, in consultation with the
Therefore, GSA is adjusting the new reviews of the cost of travel and the
U.S. Department of State, must redefine
minimal value to $525.00. Per FMR operation of privately owned airplanes
the minimal value of foreign gifts and
§ 102–42.10, an agency may, by and motorcycles on an annual basis to
decorations to reflect changes in the
regulation, specify a lower value than determine their corresponding mileage
Consumer Price Index (CPI) for the
this Government-wide value for its reimbursement rates. These reviews
preceding 3-year period, as specified
agency employees. evaluate various factors, such as the cost
under the law concerning the Receipt
FMR Bulletin B–2025–01 is available of fuel, depreciation of the original
and Disposition of Foreign Gifts and
at https://www.gsa.gov/policy- vehicle cost, maintenance and
Decorations. The minimal value was last
regulations/regulations/federal- insurance, state and Federal taxes, and
defined effective January 1, 2023, and
management-regulation/fmr-and- consumer price index data. FTR
must be redefined effective as of January
related-files. Bulletin 26–02 establishes and
1, 2026. This bulletin cancels FMR
Bulletin B–54, ‘‘Foreign Gift and Larry Allen, announces the new CY 2026 POV
Decoration Minimal Value,’’ issued Associate Administrator, Office of mileage reimbursement rates for official
April 25, 2023, as this bulletin provides Government-wide Policy. temporary duty and relocation travel.
updated information on the same topic. [FR Doc. 2025–24147 Filed 12–31–25; 8:45 am] This notice is the only notification to
DATES: Applicability Date: January 1, BILLING CODE 6820–14–P
agencies of revisions to the POV mileage
2026. This notice applies to foreign gifts rates for official travel and relocation, in
and decorations received on or after addition to the changes posted on GSA’s
January 1, 2026. GENERAL SERVICES website at https://gsa.gov/mileage.
FOR FURTHER INFORMATION CONTACT: For ADMINISTRATION Larry Allen,
clarification of content, contact William [Notice–MA–2026–01; Docket No. 2025– Associate Administrator, Office of
Garrett, Director, Personal Property 0002, Sequence No. 17] Government-wide Policy.
Policy, Office of Government-wide [FR Doc. 2025–24148 Filed 12–31–25; 8:45 am]
Policy, Office of Asset and Calendar Year (CY) 2026 Privately BILLING CODE 6820–14–P
Transportation Management, at 202– Owned Vehicle (POV) Mileage
368–8163, or by email at Reimbursement Rates; CY 2026
william.garrett@gsa.gov. Please cite Standard Mileage Rate for Moving
Notice of GSA Bulletin FMR B–2025– Purposes DEPARTMENT OF HEALTH AND
01. HUMAN SERVICES
AGENCY: Office of Government-Wide
SUPPLEMENTARY INFORMATION: Policy (OGP), General Services Food and Drug Administration
Administration (GSA).
Background [Docket No. FDA–2022–N–0150]
ACTION: Notice.
Foreign gifts and decorations above
the GSA-defined minimal value are SUMMARY: GSA is updating the mileage Revocation of Two Authorizations of
tkelley on LAP7H3WLY3PROD with NOTICES2
handled differently than lesser-valued reimbursement rate for privately owned Emergency Use of In Vitro Diagnostic
foreign gifts and decorations under the automobiles (POA), airplanes, and Devices for Detection and/or Diagnosis
provisions of 5 U.S.C. 7342 and Federal motorcycles as required by statute. This of COVID–19; Availability
Management Regulation (FMR) Part information will be available in FTR AGENCY: Food and Drug Administration,
102–42. Bulletin 26–02, which can be found on HHS.
Foreign gifts and decorations above GSA’s website at https://gsa.gov/
ACTION: Notice.
the minimal value become the property ftrbulletins.
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146 Federal Register / Vol. 91, No. 1 / Friday, January 2, 2026 / Notices
SUMMARY: The Food and Drug Act of 2013 (Pub. L. 113–5) allows FDA II. Authorizations Revocation Requests
Administration (FDA) is announcing the to strengthen the public health In a request received by FDA on
revocation of the Emergency Use protections against biological, chemical, October 10, 2025, Pfizer Inc. requested
Authorizations (EUAs) (the radiological, or nuclear agent or agents. the revocation of, and on October 22,
Authorizations) issued to Pfizer Inc. for Among other things, section 564 of the 2025, FDA revoked, the Authorization
the Lucira by Pfizer COVID–19 & Flu FD&C Act allows FDA to authorize the for the Pfizer Inc.’s Lucira by Pfizer
Test and Lucira by Pfizer COVID–19 & use of an unapproved medical product COVID–19 & Flu Test. Pfizer Inc.
Flu Home Test. FDA revoked the or an unapproved use of an approved notified FDA as the date of the letter
Authorizations under the Federal Food, medical product in certain situations. there is no viable Lucira by Pfizer
Drug, and Cosmetic Act (FD&C Act) as On November 22, 2022, FDA issued COVID–19 & Flu Test reagents
requested by the Authorization holder. the Authorization to Lucira Health, Inc. remaining in the United States, and
The revocations, which include an for the Lucira COVID–19 & Flu Test, requested FDA revoke the Pfizer Inc.’s
explanation of the reasons for each subject to the terms of the Lucira by Pfizer COVID–19 & Flu Test.
revocation, are reprinted at the end of Authorization.1 Notice of the issuance FDA has determined that it is
this document. of this Authorization was published in appropriate to protect the public health
DATES: The revocation of the the Federal Register on January 23, or safety to revoke this Authorization.
Authorizations for the Pfizer Inc.’s 2023 (88 FR 3995), as required by In a request received by FDA on
Lucira by Pfizer COVID–19 & Flu Test section 564(h)(1) of the FD&C Act. October 10, 2025, Pfizer Inc., requested
and Lucira by Pfizer COVID–19 & Flu the revocation of, and on October 22,
Home Test were effective as of October On February 24, 2023, FDA issued the
Authorization to Lucira Health, Inc. for 2025, FDA revoked, the Authorization
22, 2025. for the Pfizer Inc.’s Lucira by Pfizer
the Lucira COVID–19 & Flu Home Test,
ADDRESSES: Submit written requests for COVID–19 & Flu Home Test. Pfizer Inc.
subject to the terms of the
a single copy of the revocations to the notified FDA that as the date of the
Authorization.2 Notice of the issuance
Office of Policy, Center for Devices and letter there is no viable Lucira by Pfizer
of this Authorization was published in
Radiological Health, Food and Drug COVID–19 & Flu Home Test reagents
the Federal Register on March 10, 2023
Administration, 10903 New Hampshire remaining in the United States, and
(88 FR 15051), as required by section
Ave., Bldg. 66, Rm. 5441, Silver Spring, requested FDA revoke the Pfizer Inc.’s
564(h)(1) of the FD&C Act.
MD 20993–0002. Send one self- Lucira by Pfizer COVID–19 & Flu Home
addressed adhesive label to assist that Subsequent updates to the Test. FDA has determined that it is
office in processing your request or Authorizations were made available on appropriate to protect the public health
include a fax number to which the FDA’s website. The authorization of a or safety to revoke this Authorization.
revocations may be sent. See the device for emergency use under section
SUPPLEMENTARY INFORMATION section for 564 of the FD&C Act may, pursuant to III. Electronic Access
electronic access to the revocations. section 564(g)(2) of the FD&C Act, be An electronic version of this
FOR FURTHER INFORMATION CONTACT: Kim revoked when the criteria under section document and the full text of the
Sapsford-Medintz, Office of Product 564(c) of the FD&C Act for issuance of revocations are available on the internet
Evaluation and Quality, Center for such authorization are no longer met at https://www.regulations.gov/.
Devices and Radiological Health, Food (section 564(g)(2)(B) of the FD&C Act),
or other circumstances make such IV. The Revocations
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 3216, revocation appropriate to protect the Having concluded that the criteria for
Silver Spring, MD 20993–0002, 301– public health or safety (section revocation of the Authorizations under
796–0311 (this is not a toll-free 564(g)(2)(C) of the FD&C Act). section 564(g)(2)(C) of the FD&C Act are
number). met, FDA has revoked the EUA for
SUPPLEMENTARY INFORMATION:
1 Ownership of the EUA for the Lucira COVID–
Pfizer Inc.’s Lucira by Pfizer COVID–19
19 & Flu Test was transferred from Lucira Health & Flu Test and Lucira by Pfizer COVID–
Inc. to Pfizer Inc., on June 15, 2023, and the name
I. Background was changed to Lucira by Pfizer COVID–19 & Flu 19 & Flu Home Test. The revocations in
Section 564 of the FD&C Act (21 Test. their entirety follow and provide an
U.S.C. 360bbb–3) as amended by the 2 Ownership of the EUA for the Lucira COVID– explanation of the reasons for
19 & Flu Home Test was transferred from Lucira revocation, as required by section
Project BioShield Act of 2004 (Pub. L. Health Inc. to Pfizer Inc., on June 15, 2023, and the
108–276) and the Pandemic and All- name was changed to Lucira by Pfizer COVID–19
564(h)(1) of the FD&C Act.
Hazards Preparedness Reauthorization & Flu Home Test. BILLING CODE 4164–01–P
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Federal Register / Vol. 91, No. 1 / Friday, January 2, 2026 / Notices 147
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148 Federal Register / Vol. 91, No. 1 / Friday, January 2, 2026 / Notices
Lowell M. Zeta, DEPARTMENT OF HEALTH AND ACTION: Notice.
Acting Deputy Commissioner for Policy, HUMAN SERVICES
Legislation, and International Affairs. SUMMARY: The Food and Drug
[FR Doc. 2025–24155 Filed 12–31–25; 8:45 am] Food and Drug Administration Administration (FDA, Agency, or we)
has determined that MYSOLINE
BILLING CODE 4164–01–C
[Docket No. FDA–2022–P–3118] (primidone) suspension, 250 milligrams
(mg)/5 milliliters (mL), was withdrawn
Determination That MYSOLINE
tkelley on LAP7H3WLY3PROD with NOTICES2
from sale for reasons of safety or
(Primidone) Suspension, 250 effectiveness. The Agency will not
Milligrams/5 Milliliters, Was Withdrawn accept or approve abbreviated new drug
From Sale for Reasons of Safety or applications (ANDAs) for primidone
Effectiveness suspension, 250 mg/5 mL.
AGENCY: Food and Drug Administration, FOR FURTHER INFORMATION CONTACT:
HHS. Aaron Young, Center for Drug
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