Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19; Availability, 43411-43413 [2024-10910]

Download as PDF Federal Register / Vol. 89, No. 97 / Friday, May 17, 2024 / Notices record is inaccurate, incomplete, untimely, or irrelevant. Submit written requests for a single copy of the revocations to the Office of Policy, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993–0002. Send one selfaddressed adhesive label to assist that office in processing your request or include a fax number to which the revocations may be sent. See the SUPPLEMENTARY INFORMATION section for electronic access to the revocations. FOR FURTHER INFORMATION CONTACT: Kim Sapsford-Medintz, Office of Product Evaluation and Quality, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3216, Silver Spring, MD 20993–0002, 301– 796–0311 (this is not a toll-free number). ADDRESSES: NOTIFICATION PROCEDURES: To find out if the system of records contains a record about you, submit a written notification request to the System Manager identified in the ‘‘System Manager’’ section of this SORN. The request must identify this system of records, contain the same information required for an access request, and include verification of your identity in the same manner required for an access request. EXEMPTIONS PROMULGATED FOR THE SYSTEM: None. HISTORY: 87 FR 69026 (Nov. 17, 2022). [FR Doc. 2024–10838 Filed 5–16–24; 8:45 am] BILLING CODE 4184–42–P SUPPLEMENTARY INFORMATION: DEPARTMENT OF HEALTH AND HUMAN SERVICES I. Background Food and Drug Administration [Docket No. FDA–2022–N–0150] Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID–19; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to Bio-Rad Laboratories Inc., for the Bio-Rad SARS– CoV–2 ddPCR Kit, and Fast Track Diagnostics Luxembourg S.á.r.l. (A Siemens Healthineers Company), for the FTD SARS–CoV–2. FDA revoked the Authorizations under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as requested by the Authorization holders. The revocations, which include an explanation of the reasons for each revocation, are reprinted at the end of this document. DATES: The revocation of the Authorization for the Bio-Rad Laboratories Inc.’s Bio-Rad SARS–CoV– 2 ddPCR Kit is effective as of March 27, 2024. The revocation of the Authorization for the Fast Track Diagnostics Luxembourg S.á.r.l.’s (A Siemens Healthineers Company), FTD SARS–CoV–2 is effective as of April 18, 2024. khammond on DSKJM1Z7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:20 May 16, 2024 Jkt 262001 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 AllHazards Preparedness Reauthorization Act of 2013 (Pub. L. 113–5) allows FDA to strengthen the public health protections against biological, chemical, radiological, or nuclear agent or 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 May 1, 2020, FDA issued the Authorization to Bio-Rad Laboratories Inc., for the Bio-Rad SARS–CoV–2 ddPCR Kit, subject to the terms of the Authorization. Notice of the issuance of this Authorization was published in the Federal Register on July 14, 2020 (85 FR 42409), as required by section 564(h)(1) of the FD&C Act. On May 5, 2020, FDA issued the Authorization to Fast Track Diagnostics Luxembourg S.á.r.l. (a Siemens Healthineers Company) for the FTD SARS–CoV–2, subject to the terms of the Authorization. Notice of the issuance of this Authorization was published in the Federal Register on July 14, 2020 (85 FR 42409), as required by section 564(h)(1) of the FD&C Act. Subsequent updates to the Authorizations were made available on FDA’s website. 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 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 43411 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. Authorizations Revocation Requests In a request received by FDA on March 16, 2024, Bio-Rad Laboratories Inc., requested the revocation of, and on March 27, 2024, FDA revoked, the Authorization for the Bio-Rad Laboratories Inc.’s Bio-Rad SARS–CoV– 2 ddPCR Kit. Because Bio-Rad Laboratories Inc., notified FDA that they ceased United States distribution of the Bio-Rad SARS–CoV–2 ddPCR Kit and requested FDA revoke Bio-Rad Laboratories Inc.’s Bio-Rad SARS–CoV– 2 ddPCR Kit, FDA has determined that it is appropriate to protect the public health or safety to revoke this Authorization. In a request received by FDA on April 11, 2024, Fast Track Diagnostics Luxembourg S.á.r.l. (a Siemens Healthineers Company), requested the deregister of, and on April 18, 2024, FDA revoked, the Authorization for Fast Track Diagnostics Luxembourg S.á.r.l.’s FTD SARS–CoV–2. Because Fast Track Diagnostics Luxembourg S.á.r.l. notified FDA that they have ceased United States distribution of the FTD SARS–CoV–2 and requested FDA deregister the Fast Track Diagnostics Luxembourg S.á.r.l.’s FTD SARS–CoV–2, 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 revocations are available on the internet at https://www.regulations.gov/. IV. The Revocations Having concluded that the criteria for revocation of the Authorizations under section 564(g)(2)(C) of the FD&C Act are met, FDA has revoked the EUA of BioRad Laboratories Inc.’s Bio-Rad SARS– CoV–2 ddPCR Kit, and Fast Track Diagnostics Luxembourg S.á.r.l.’s (a Siemens Healthineers Company) FTD SARS–CoV–2. The revocations in their entirety follow and provide an explanation of the reasons for revocation, as required by section 564(h)(1) of the FD&C Act. BILLING CODE 4164–01–P E:\FR\FM\17MYN1.SGM 17MYN1 43412 Federal Register / Vol. 89, No. 97 / Friday, May 17, 2024 / Notices U.S. FOOD & DRUG AiH.AllilHl!ArlON March 27, 2024 EJizabeth Platt, MLS(ASCPf1'\ CLS, ACRP-CP, CMDA, CQA, CSSGB, Cl'vlQ/OE, RAC (Devices, Global, US) VP, Regulatory & Clinical Affairs Bio-Rad Laboratories Inc. 4000 Alfred.Nobel Drive Hercules, CA 94547 Re: Revocation of EUA200440 Dear Dr. Platt: TI1is letter is in response to the request frol'n Bio-Rad Laboratoi'ies Inc., in a letter dated March 16, 2024, that the U.S. Food and Drug Administration (FDA revoke the EUA for the Bio-Rad SARS-CoV-2 ddPCR Kit issued on May 1, 2020, reissued on September 18; 2020, and amended on December 9, 2020, September 23, 2021, and March 15, 2022. Bio-Rad Laboratories Inc. indicated that they have ceased United States distribution of the authorized product and requested that the EUA be revoked. FDA understands that as of the date of this letter there are no viable Bio-Rad SARS-CoV-2 ddPCR Kit reagents remaining in distribution in the United States. TI1e authorization of a device for emergency use under section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 360bbb-3) 111.ay, pursuant to section 564(g)(2) of the Act, be revoked when circumstances make such revocation appropriate to protect the public health or safety (section 564(g)(2)(C) ofthe Act). Because Bio-Rad Laboratories Inc. has requested that FDA revoke the EUA forthe Bio-Rad SARS-CoV-2 ddPCR Kit, FDA has detennined ihat it is appropriate fo protect the public health or safety to revoke this authorization. Accordingly, FDA hereby revokes ElJ A200440 for the Bio-Rad SARS-CoV-2 ddPCR Kit, pursuant to section 564(g)(2)(C) of the Act As of the date ofthis: letter, the Bio-Rad SARS-CoV-2 ddPCR Kit is no longer authorized for emergency use by FDA. Notice of this revocation will be published in the Federal Register, pursuant to section 564(h)(l) ofthe Act Sincerely; !isl/ VerDate Sep<11>2014 17:20 May 16, 2024 Jkt 262001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4725 E:\FR\FM\17MYN1.SGM 17MYN1 EN17MY24.029</GPH> khammond on DSKJM1Z7X2PROD with NOTICES Jeffrey E. Shuren, M.D., J.D. Director Center for Devices attd Radiological Health Food and Drug Administration Federal Register / Vol. 89, No. 97 / Friday, May 17, 2024 / Notices 43413 u.s~ FOOD & DRUG AbM!NIStRAfl'ON April 18, 2024 Oliver Jahnel Regutat-0ry Mairs Scientist, Molecular Diagnostics Fast Ttiick Diagnostics.Ltfiren,bourg S.uJ. A Siemens Heahhinee:rs Company 29, Rue Henri Koch L,4354.Esch•sur-Alzette;Luxembourg Re: Revocation ofEUA200571 ))ear OliverJah~l: This letter is .in respott'le to the request from Fast Track Diagnostics Luxembourg S.A.d. {a Sieinens Healthinee:rs Con1pany), in a11 email dated Aprill I,. 2~24, tbatthe U.S. Food and Drug Administration (FDA) deregister the EU A for the FTP SARS-CoV-2 issued on May 5, 2020. amended on July 9, 2020, reissued on January 26; 2021, and amended on April 7; W21, September 23, 2021,, and January 19, 2022. FastTrack Diagnostil::s Luxenibourg S;a.;r.l. indicated that they hawceased United States distribution ofthe atithorized.product and requested that the EUAbe detegisteted. Commt11'iication ,vith the company made ciear that, based on their request, :F'PA wotild revoke the EUA. FDA unde:rs~nds thaf as of the date ofthis letterthere are no viable :no SAA.S-CoV-2 reagents remaining in distribution)ll th!'l United States. The authorization ofa device for emergencyllSe under section 564 ofthe Federal F-0-0d, Drug, and C~eticAct (the Act)(2.l U.S,C; 360bhb-'3)m:ay, pursuant to sectio11 564(g)(2Jof the Act, be revoked when circumstmwes make such revocation: appropriate to protect the public health or safety(sectiott 564(g)(2)(C) ofthe Act} Because FastTrack Diagnostics Luxembourg S.a.r.L has requested that FDA deregi$terthe EUA forthe FTD SARS-CoV-2, FDAhas detertnin:ed that it is appropriate to protect the public health or safety to revoke this authorization. Accordingly, FDA hereby revokes ii:lM200571 for the FI1> SA:RS-C:◊ V-2~ p\lhluantto section S64(g)(2)(C)ofthe Act. A,s of the date of this letter; the FTD SARS-CoV-2 is.no longer authorized for emergency use by FDA Notfoitofthis revocation will be published in theFederal Register, pursuMt to section 564:(h)(l) ofthe Act. Sincerely, /Is// Dated: May 14, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024–10910 Filed 5–16–24; 8:45 am] khammond on DSKJM1Z7X2PROD with NOTICES BILLING CODE 4164–01–C DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2007–D–0369] Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is SUMMARY: VerDate Sep<11>2014 17:20 May 16, 2024 Jkt 262001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 announcing the availability of additional draft and revised draft product-specific guidances. The draft guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ‘‘Bioequivalence Recommendations for Specific Products’’ that explained the process that would be used to make productspecific guidances available to the public on FDA’s website. The draft E:\FR\FM\17MYN1.SGM 17MYN1 EN17MY24.030</GPH> Jeffrey E. Shuren, M.D., J.D. Director Centedbr Devices_and Radiological Health Foodand.DrugA.dminhitration

Agencies

[Federal Register Volume 89, Number 97 (Friday, May 17, 2024)]
[Notices]
[Pages 43411-43413]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-10910]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-0150]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
revocation of the Emergency Use Authorizations (EUAs) (the 
Authorizations) issued to Bio-Rad Laboratories Inc., for the Bio-Rad 
SARS-CoV-2 ddPCR Kit, and Fast Track Diagnostics Luxembourg 
S.[aacute].r.l. (A Siemens Healthineers Company), for the FTD SARS-CoV-
2. FDA revoked the Authorizations under the Federal Food, Drug, and 
Cosmetic Act (FD&C Act) as requested by the Authorization holders. The 
revocations, which include an explanation of the reasons for each 
revocation, are reprinted at the end of this document.

DATES: The revocation of the Authorization for the Bio-Rad Laboratories 
Inc.'s Bio-Rad SARS-CoV-2 ddPCR Kit is effective as of March 27, 2024. 
The revocation of the Authorization for the Fast Track Diagnostics 
Luxembourg S.[aacute].r.l.'s (A Siemens Healthineers Company), FTD 
SARS-CoV-2 is effective as of April 18, 2024.

ADDRESSES: Submit written requests for a single copy of the revocations 
to the Office of Policy, Center for Devices and Radiological Health, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 
5431, 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 revocations may be sent. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the revocations.

FOR FURTHER INFORMATION CONTACT: Kim Sapsford-Medintz, Office of 
Product Evaluation and Quality, Center for Devices and Radiological 
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
66, Rm. 3216, Silver Spring, MD 20993-0002, 301-796-0311 (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, radiological, or nuclear agent or 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 May 1, 2020, FDA 
issued the Authorization to Bio-Rad Laboratories Inc., for the Bio-Rad 
SARS-CoV-2 ddPCR Kit, subject to the terms of the Authorization. Notice 
of the issuance of this Authorization was published in the Federal 
Register on July 14, 2020 (85 FR 42409), as required by section 
564(h)(1) of the FD&C Act.
    On May 5, 2020, FDA issued the Authorization to Fast Track 
Diagnostics Luxembourg S.[aacute].r.l. (a Siemens Healthineers Company) 
for the FTD SARS-CoV-2, subject to the terms of the Authorization. 
Notice of the issuance of this Authorization was published in the 
Federal Register on July 14, 2020 (85 FR 42409), as required by section 
564(h)(1) of the FD&C Act.
    Subsequent updates to the Authorizations were made available on 
FDA's website. 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. Authorizations Revocation Requests

    In a request received by FDA on March 16, 2024, Bio-Rad 
Laboratories Inc., requested the revocation of, and on March 27, 2024, 
FDA revoked, the Authorization for the Bio-Rad Laboratories Inc.'s Bio-
Rad SARS-CoV-2 ddPCR Kit. Because Bio-Rad Laboratories Inc., notified 
FDA that they ceased United States distribution of the Bio-Rad SARS-
CoV-2 ddPCR Kit and requested FDA revoke Bio-Rad Laboratories Inc.'s 
Bio-Rad SARS-CoV-2 ddPCR Kit, FDA has determined that it is appropriate 
to protect the public health or safety to revoke this Authorization.
    In a request received by FDA on April 11, 2024, Fast Track 
Diagnostics Luxembourg S.[aacute].r.l. (a Siemens Healthineers 
Company), requested the deregister of, and on April 18, 2024, FDA 
revoked, the Authorization for Fast Track Diagnostics Luxembourg 
S.[aacute].r.l.'s FTD SARS-CoV-2. Because Fast Track Diagnostics 
Luxembourg S.[aacute].r.l. notified FDA that they have ceased United 
States distribution of the FTD SARS-CoV-2 and requested FDA deregister 
the Fast Track Diagnostics Luxembourg S.[aacute].r.l.'s FTD SARS-CoV-2, 
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 
revocations are available on the internet at https://www.regulations.gov/.

IV. The Revocations

    Having concluded that the criteria for revocation of the 
Authorizations under section 564(g)(2)(C) of the FD&C Act are met, FDA 
has revoked the EUA of Bio-Rad Laboratories Inc.'s Bio-Rad SARS-CoV-2 
ddPCR Kit, and Fast Track Diagnostics Luxembourg S.[aacute].r.l.'s (a 
Siemens Healthineers Company) FTD SARS-CoV-2. The revocations in their 
entirety follow and provide an explanation of the reasons for 
revocation, as required by section 564(h)(1) of the FD&C Act.
BILLING CODE 4164-01-P

[[Page 43412]]

[GRAPHIC] [TIFF OMITTED] TN17MY24.029


[[Page 43413]]


[GRAPHIC] [TIFF OMITTED] TN17MY24.030


    Dated: May 14, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-10910 Filed 5-16-24; 8:45 am]
BILLING CODE 4164-01-C
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