Revocation of Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19; Availability, 59734-59735 [2021-23500]

Download as PDF 59734 Federal Register / Vol. 86, No. 206 / Thursday, October 28, 2021 / Notices and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–7726, PRAStaff@ fda.hhs.gov. The following is a list of FDA information SUPPLEMENTARY INFORMATION: collections recently approved by OMB under section 3507 of the Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control number and expiration date of OMB approval for each information collection are shown in table 1. Copies of the supporting statements for the information collections are available on the internet at http://www.reginfo.gov/public/do/ PRAMain. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB Title of collection OMB control No. Infant Formula Requirements ........................................................................................................................ Shortages Data Collection ............................................................................................................................. Guidance on Labeling for Natural Rubber Latex Condoms .......................................................................... Section 513(g) Requests for Information ...................................................................................................... Dated: October 22, 2021. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2021–23504 Filed 10–27–21; 8:45 am] BILLING CODE 4164–01–P 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: 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 jspears on DSK121TN23PROD with NOTICES1 SUMMARY: 17:34 Oct 27, 2021 SUPPLEMENTARY INFORMATION: I. Background Notice. VerDate Sep<11>2014 Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4338, 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 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, 240–402–8155 (this is not a toll-free number). Jkt 256001 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, 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 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 Date approval expires 0910–0256 0910–0491 0910–0633 0910–0705 5/31/2024 6/30/2024 6/30/2024 6/30/2024 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 E:\FR\FM\28OCN1.SGM 28OCN1 Federal Register / Vol. 86, No. 206 / Thursday, October 28, 2021 / Notices [FR Doc. 2021–23500 Filed 10–27–21; 8:45 am] jspears on DSK121TN23PROD with NOTICES1 BILLING CODE 4164–01–C DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2021–N–1050] Agency Information Collection Activities; Proposed Collection; Comment Request; Targeted Mechanism of Action Presentations in Prescription Drug Promotion AGENCY: Food and Drug Administration, HHS. VerDate Sep<11>2014 17:34 Oct 27, 2021 Jkt 256001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 ACTION: Notice. The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice SUMMARY: E:\FR\FM\28OCN1.SGM 28OCN1 EN28OC21.002</GPH> Dated: October 22, 2021. Lauren K. Roth, Associate Commissioner for Policy. 59735

Agencies

[Federal Register Volume 86, Number 206 (Thursday, October 28, 2021)]
[Notices]
[Pages 59734-59735]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.

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

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, 240-402-8155 (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

[[Page 59735]]

[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