Statement of Organization, Functions, and Delegations of Authority, 13126 [2023-04009]

Download as PDF ddrumheller on DSK120RN23PROD with NOTICES1 13126 Federal Register / Vol. 88, No. 41 / Thursday, March 2, 2023 / Notices in the body of your comments and you must identify the information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https:// www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240–402–7500. 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The committee will discuss supplemental new drug application (sNDA) 208558/S– 025, for LYNPARZA (olaparib) tablets, submitted by AstraZeneca Pharmaceuticals LP. The proposed indication (use) for this product is in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC). FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will VerDate Sep<11>2014 18:21 Mar 01, 2023 Jkt 259001 be made publicly available on FDA’s website at the time of the advisory committee meeting. Background material and the link to the online teleconference meeting room will be available at https://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee meeting link. 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If the number of registrants requesting to speak is greater than can be reasonably 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 7, 2023. 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 She-Chia Jankowski (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/ AdvisoryCommittees/AboutAdvisory Committees/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. app. 2). PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 Dated: February 24, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–04268 Filed 3–1–23; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Statement of Organization, Functions, and Delegations of Authority AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Secretary of Health and Human Services delegates to the Food and Drug Administration (FDA) Commissioner the authorities vested in the Secretary of Health and Human Services (the Secretary) under section 3855 of the Coronavirus Aid, Relief, and Economic Security (CARES) Act, as amended, to send annual letters to Congress regarding the progress of FDA in: evaluating the Over-the-Counter Monograph M012: Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use with respect to children under the age of 6, and as appropriate, revising that monograph through the order process of section 505G(b) of the Federal Food, Drug, and Cosmetic Act to address such children. These authorities may be redelegated. Exercise of this authority shall be in accordance with established policies, procedures, guidelines, and regulations as prescribed by the Secretary. DATES: This authority delegation was approved by the Secretary on February 22, 2023. SUMMARY: Dated: February 22, 2023. Xavier Becerra, Secretary, Department of Health and Human Services. [FR Doc. 2023–04009 Filed 3–1–23; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2023–D–0202] Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting Viral Pathogens; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. E:\FR\FM\02MRN1.SGM 02MRN1

Agencies

[Federal Register Volume 88, Number 41 (Thursday, March 2, 2023)]
[Notices]
[Page 13126]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-04009]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Statement of Organization, Functions, and Delegations of 
Authority

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Secretary of Health and Human Services delegates to the 
Food and Drug Administration (FDA) Commissioner the authorities vested 
in the Secretary of Health and Human Services (the Secretary) under 
section 3855 of the Coronavirus Aid, Relief, and Economic Security 
(CARES) Act, as amended, to send annual letters to Congress regarding 
the progress of FDA in: evaluating the Over-the-Counter Monograph M012: 
Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products 
for Over-the-Counter Human Use with respect to children under the age 
of 6, and as appropriate, revising that monograph through the order 
process of section 505G(b) of the Federal Food, Drug, and Cosmetic Act 
to address such children. These authorities may be redelegated. 
Exercise of this authority shall be in accordance with established 
policies, procedures, guidelines, and regulations as prescribed by the 
Secretary.

DATES: This authority delegation was approved by the Secretary on 
February 22, 2023.

    Dated: February 22, 2023.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2023-04009 Filed 3-1-23; 8:45 am]
BILLING CODE 4164-01-P
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