Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment; Guidance for Industry; Correction, 17475 [2024-05081]

Download as PDF Federal Register / Vol. 89, No. 48 / Monday, March 11, 2024 / Notices accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by April 25, 2024. For press inquiries, please contact the Office of Media Affairs at fdaoma@ fda.hhs.gov or 301–796–4540. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Christina Vert at CBERBPAC@fda.hhs.gov (see FOR FURTHER INFORMATION CONTACT) at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website at https://www.fda.gov/Advisory Committees/AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. 1001 et seq.). This meeting notice also serves as notice that, pursuant to 21 CFR 10.19, the requirements in 21 CFR 14.22(b), (f), and (g) relating to the location of advisory committee meetings are hereby waived to allow for this meeting to take place using an online meeting platform. This waiver is in the interest of allowing greater transparency and opportunities for public participation, in addition to convenience for advisory committee members, speakers, and guest speakers. The conditions for issuance of a waiver under 21 CFR 10.19 are met. Dated: March 5, 2024. Lauren K. Roth, Associate Commissioner for Policy. The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on February 22, 2024. The document announced the availability of a final guidance for industry entitled ‘‘Assessing COVID–19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID–19 Prevention or Treatment.’’ The document was published with an incorrect docket number. This document corrects that error. FOR FURTHER INFORMATION CONTACT: David Reasner, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6373, Silver Spring, MD 20993, 301–837– 7667; or James Myers, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240–402–7911. SUPPLEMENTARY INFORMATION: In the Federal Register of February 22, 2024 (89 FR 13351), in FR Doc. 2024–03622, the following correction is made: On page 13351, in the first column in the header of the document and in the third column in the second line of the first paragraph, ‘‘Docket No. FDA–2024– D–0584’’ is corrected to read ‘‘Docket No. FDA–2020–D–1824.’’ SUMMARY: Dated: March 5, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024–05081 Filed 3–8–24; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [FR Doc. 2024–05074 Filed 3–8–24; 8:45 am] [Docket No. FDA–2023–N–2057] BILLING CODE 4164–01–P Revocation of Emergency Use of a Drug Product During the COVID–19 Pandemic; Availability DEPARTMENT OF HEALTH AND HUMAN SERVICES AGENCY: Food and Drug Administration ACTION: ddrumheller on DSK120RN23PROD with NOTICES1 [Docket No. FDA–2020–D–1824] Assessing COVID–19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID–19 Prevention or Treatment; Guidance for Industry; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Correction. VerDate Sep<11>2014 18:24 Mar 08, 2024 Jkt 262001 Food and Drug Administration, HHS. Notice. The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorization (EUA) (the Authorization) issued to Eli Lilly and Co. (Lilly), for bamlanivimab and etesevimab administered together. FDA revoked the Authorization on December 14, 2023, under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The revocation, which includes an SUMMARY: PO 00000 Frm 00104 Fmt 4703 Sfmt 4703 17475 explanation of the reasons for the revocation, is reprinted in this document. DATES: The Authorization is revoked as of December 14, 2023. ADDRESSES: Submit written requests for a single copy of the revocation to the Office of Executive Programs, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, 6th Floor, 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 Authorization may be sent. See the SUPPLEMENTARY INFORMATION section for electronic access to the Authorization. FOR FURTHER INFORMATION CONTACT: Johanna McLatchy, Office of Executive Programs, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, 6th Floor, Silver Spring, MD 20993–0002, 301–796–3200 (this is not a toll-free number). SUPPLEMENTARY INFORMATION: I. Background Section 564 of the FD&C Act (21 U.S.C. 360bbb–3) 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 February 9, 2021, FDA issued an Authorization (EUA 094) to Lilly for bamlanivimab and etesevimab administered together, subject to the terms of the Authorization. Notice of the issuance of the Authorization was published in the Federal Register on May 27, 2021 (86 FR 28608), as required by section 564(h)(1) of the FD&C Act. The authorization of a drug 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 In a request received by FDA on October 23, 2023, Lilly requested revocation of, and on December 14, 2023, FDA revoked, the Authorization for bamlanivimab and etesevimab E:\FR\FM\11MRN1.SGM 11MRN1

Agencies

[Federal Register Volume 89, Number 48 (Monday, March 11, 2024)]
[Notices]
[Page 17475]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-05081]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-1824]


Assessing COVID-19-Related Symptoms in Outpatient Adult and 
Adolescent Subjects in Clinical Trials of Drugs and Biological Products 
for COVID-19 Prevention or Treatment; Guidance for Industry; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Correction.

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SUMMARY: The Food and Drug Administration (FDA) is correcting a notice 
that appeared in the Federal Register on February 22, 2024. The 
document announced the availability of a final guidance for industry 
entitled ``Assessing COVID-19-Related Symptoms in Outpatient Adult and 
Adolescent Subjects in Clinical Trials of Drugs and Biological Products 
for COVID-19 Prevention or Treatment.'' The document was published with 
an incorrect docket number. This document corrects that error.

FOR FURTHER INFORMATION CONTACT: David Reasner, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 6373, Silver Spring, MD 20993, 301-837-
7667; or James Myers, Center for Biologics Evaluation and Research, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 
7301, Silver Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION: In the Federal Register of February 22, 2024 
(89 FR 13351), in FR Doc. 2024-03622, the following correction is made:
    On page 13351, in the first column in the header of the document 
and in the third column in the second line of the first paragraph, 
``Docket No. FDA-2024-D-0584'' is corrected to read ``Docket No. FDA-
2020-D-1824.''

    Dated: March 5, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-05081 Filed 3-8-24; 8:45 am]
BILLING CODE 4164-01-P

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