Revocation of Emergency Use of a Drug Product During the COVID-19 Pandemic; Availability, 17475-17477 [2024-05085]

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 17476 Federal Register / Vol. 89, No. 48 / Monday, March 11, 2024 / Notices administered together. Because Lilly has informed FDA that all lots of bamlanivimab and etesevimab manufactured and labeled for use under EUA 094 have expired, and that Lilly does not intend to offer this product in the United States anymore, Lilly requested FDA revoke the EUA for bamlanivimab and etesevimab administered together. FDA has determined that it is appropriate to protect the public health or safety to revoke this Authorization. III. The Revocation Having concluded that the criteria for revocation of the Authorization under section 564(g)(2)(C) of the FD&C Act are met, FDA has revoked the EUA for bamlanivimab and etesevimab administered together. 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. IV. Electronic Access An electronic version of this document and the full text of the Authorization is available on the internet at: https://www.regulations.gov. BILLING CODE 4164–01–P December 14, 2023 Eli Lilly and Company Attention: Jennifer Riddle Camp Senior Director, GRA-NA Lilly Corporate Center Drop Code 2543 Indianapolis, IN 46285 Re: Revocation ofEUA.094 Dear Jennifer Riddle Camp: This letter is in response to the request from Eli Lilly and Compilliy (Lilly), received on October 23, 2023', that the U.S. Food and Drug Administration (FDA or Agency) revoke the EUA for bamlartivimab and etesevimab adnnnistered together. The EUA for bamlanivimab and etesevimab administered together was issued initially on February 9, 2021. Lilly has informed FDA that all lots of bamlanivimab and etesevimab manufactured and labeled for use under EUA 094 have expired and that Lilly does not intend to offer this product in the United States anymore. FDA understands that Lilly will promptly notify healthcare facilities. and providers that have received bamlanivimab and etesevimab administered together under the EUA to also stop using product that remains in distribution vvith instructions for product return. The authorization of a drug for emergency use under section 5M of the Federal Fomi, Drug, and Cosmetic. Act (the Act) (21 U.S. C. 360bbb-3) may, 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) of the Act). FDA has determined that it is appropriate to protect the public health or safety to revoke this authorization based on the reasons set forth in Lilly's request for revocation to the Agency. Accordingly, FDA hereby revokes EUA 094 for bamlartivima:b and elesevimab. admin.isiered together pursuant lo section 564(g)(2)(C) of the Act. As of the date ofthis letter, bamlanivimab and etesevimab. administered togetheris no longer authorized for emergency use by FDA At the time ofLilly'srcqucst, harnlanivirnab and clcscv\'rnab adrnlnistcrccftogctlrCI' wairnpfatifliot17.cd for u.,;c in Slates ducto the high frcgUL'licy of circulating SARS-CuV-2 variants thataro nunsusceptible to bamlanivimal:l and etesevimab. 1 Hily TCb•ion of-tM Utiilcd VerDate Sep<11>2014 18:24 Mar 08, 2024 Jkt 262001 PO 00000 Frm 00105 Fmt 4703 Sfmt 4725 E:\FR\FM\11MRN1.SGM 11MRN1 EN11MR24.002</GPH> ddrumheller on DSK120RN23PROD with NOTICES1 Notice Qf this revocation Will be published in the Federqt Regtster, pursuant to section 564(h)(I) oftheAct. Federal Register / Vol. 89, No. 48 / Monday, March 11, 2024 / Notices 17477 Sinc:t:~lf, PatrlliaA.. ·cavazzQnt·:;.•· ·.Patrizia:C:avazzQni, M,,t>; Ulr~t-ilt Center for DrugE:valuauon:.andResearch 11.s. F<>® and llnt~A.dmmitittation Association will be eligible to apply for a cooperative agreement under this announcement. We will notify any applicants we determine to be ineligible. [FR Doc. 2024–05085 Filed 3–8–24; 8:45 am] BILLING CODE 4164–01–C DEPARTMENT OF HEALTH AND HUMAN SERVICES Indian Health Service Funding Opportunity for Indians Into Psychology (InPsy) Announcement Type: New. Funding Announcement Number: HHS–2024–IHS–INPSY–0001. Assistance Listing (Catalog of Federal Domestic Assistance or CFDA) Number: 93.970. Key Dates Application Deadline Date: May 14, 2024. Earliest Anticipated Start Date: July 1, 2024. I. Step 1: Review the Opportunity Funding Details Type: Cooperative Agreement. Competition type: New. Expected total program funding: $805,932. Expected number of awards: 3. Funding range per award for the first budget year: $227,500 to $267,500. The period of performance is for 5 years. Continuation funding depends on the availability of funds and agency budget priorities. ddrumheller on DSK120RN23PROD with NOTICES1 Eligibility—Who can apply? Eligible Applicants Only the following type of organizations are eligible for this opportunity: Public and nonprofit private colleges and universities that offer a Ph.D. or Psy.D. in clinical programs accredited by the American Psychological VerDate Sep<11>2014 18:24 Mar 08, 2024 Jkt 262001 Eligibility Exceptions 1. Individuals including sole proprietorships and foreign organizations are not eligible. 2. We do not fund concurrent projects under this program. If you get an award under this announcement, we cannot later fund you under other InPsy programs while this award is active. Other Eligibility Criteria All schools and training programs must have current, unrestricted accreditation by the American Psychological Association (APA). All institutions must be fully accredited without restrictions at the time of application. See attachments for information you will submit to prove your eligibility. Cost Sharing or Matching This program has no cost-sharing requirement. If you choose to include cost-sharing funds, we will not consider it during our review. However, we will hold you accountable for any funds you add, including through reporting. Program Description Background The Indian Health Service (IHS) is responsible for providing federal health services to the American Indian and Alaska Native (AI/AN) people. Our mission is to raise the physical, mental, social, and spiritual health of American Indians and Alaska Natives to the highest level. The Indian Healthcare Improvement Act (https://www.ihs.gov/IHCIA/) authorizes the IHS to administer programs designed to attract and recruit qualified Indians into health professions to ensure the availability of health PO 00000 Frm 00106 Fmt 4703 Sfmt 4703 professionals to serve the AI/AN population. Purpose Our purpose is to increase the number of Indian clinical psychologists who deliver health care services to AI/AN communities. Our primary objectives are to: 1. Recruit and train Indian people to be clinical psychologists; 2. Provide stipends to people enrolled in schools of clinical psychology to pay tuition, books, fees, and stipends for living expenses. Required Activities 1. You must develop and maintain psychology education programs and recruit people to become clinical psychologists who will provide services to AI/AN people. 2. You must provide scholarship grants to AI/AN students enrolled in clinical psychology education programs. 3. Scholarship awards are for a oneyear period. 4. You may award additional stipend support to each eligible student for up to four years. See the project narrative and merit review sections for more detail on activities. Cooperative Agreement Terms Cooperative agreements use the same policies as grants. The difference is that the IHS will have substantial involvement in the project during the entire period of performance. Below is a detailed description of our level of involvement. The IHS program official will: • Work closely with your program director to ensure timely management and that you meet all goals and objectives of your proposed project. • Provide American Indians into Psychology scholarship materials and policies for student program reviews. • Initiate default proceedings within 90 days after receiving your notification that a student: E:\FR\FM\11MRN1.SGM 11MRN1 EN11MR24.003</GPH> Dated: March 5, 2024. Lauren K. Roth, Associate Commissioner for Policy.

Agencies

[Federal Register Volume 89, Number 48 (Monday, March 11, 2024)]
[Notices]
[Pages 17475-17477]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-05085]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-2057]


Revocation of Emergency Use of a Drug Product During the COVID-19 
Pandemic; 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 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 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

[[Page 17476]]

administered together. Because Lilly has informed FDA that all lots of 
bamlanivimab and etesevimab manufactured and labeled for use under EUA 
094 have expired, and that Lilly does not intend to offer this product 
in the United States anymore, Lilly requested FDA revoke the EUA for 
bamlanivimab and etesevimab administered together. FDA has determined 
that it is appropriate to protect the public health or safety to revoke 
this Authorization.

III. The Revocation

    Having concluded that the criteria for revocation of the 
Authorization under section 564(g)(2)(C) of the FD&C Act are met, FDA 
has revoked the EUA for bamlanivimab and etesevimab administered 
together. 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.

IV. Electronic Access

    An electronic version of this document and the full text of the 
Authorization is available on the internet at: https://www.regulations.gov.
BILLING CODE 4164-01-P
[GRAPHIC] [TIFF OMITTED] TN11MR24.002


[[Page 17477]]


[GRAPHIC] [TIFF OMITTED] TN11MR24.003


    Dated: March 5, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-05085 Filed 3-8-24; 8:45 am]
BILLING CODE 4164-01-C

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