Determination of Regulatory Review Period for Purposes of Patent Extension; ENSPRYNG; Correction, 33614 [2023-10979]

Download as PDF 33614 Federal Register / Vol. 88, No. 100 / Wednesday, May 24, 2023 / Notices through the formation of its subsidiary bank, Zenith Bank & Trust, both of Scottsdale, Arizona. Estimated Time per Response: The time per response is estimated at 2.5 person-hours for reporting requirements. Total Annual Burden: For the 12 carriers with weekly reporting, the burden is calculated as 12 × 52 × 2.5 hours = 1,560 hours. Board of Governors of the Federal Reserve System. Ann E. Misback, Secretary of the Board. [FR Doc. 2023–11068 Filed 5–23–23; 8:45 am] William Cody, Secretary. BILLING CODE P ddrumheller on DSK120RN23PROD with NOTICES1 [FR Doc. 2023–11082 Filed 5–23–23; 8:45 am] BILLING CODE 6730–02–P DEPARTMENT OF HEALTH AND HUMAN SERVICES FEDERAL RESERVE SYSTEM Food and Drug Administration Formations of, Acquisitions by, and Mergers of Bank Holding Companies [Docket Nos. FDA–2020–E–2361; FDA– 2020–E–2362; and FDA–2020–E–2363] The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841 et seq.) (BHC Act), Regulation Y (12 CFR part 225), and all other applicable statutes and regulations to become a bank holding company and/or to acquire the assets or the ownership of, control of, or the power to vote shares of a bank or bank holding company and all of the banks and nonbanking companies owned by the bank holding company, including the companies listed below. The public portions of the applications listed below, as well as other related filings required by the Board, if any, are available for immediate inspection at the Federal Reserve Bank(s) indicated below and at the offices of the Board of Governors. This information may also be obtained on an expedited basis, upon request, by contacting the appropriate Federal Reserve Bank and from the Board’s Freedom of Information Office at https://www.federalreserve.gov/foia/ request.htm. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). Comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors, Ann E. Misback, Secretary of the Board, 20th Street and Constitution Avenue NW, Washington, DC 20551–0001, not later than June 23, 2023. A. Federal Reserve Bank of San Francisco: (Joseph Cuenco, Assistant Vice President, Formations & Transactions) 101 Market Street, San Francisco, California 94105–1579. Comments can also be sent electronically to: sf.fisc.comments.applications@ sf.frb.org. 1. VB&T Holding Company, LLC; to become a bank holding company VerDate Sep<11>2014 18:38 May 23, 2023 Jkt 259001 Determination of Regulatory Review Period for Purposes of Patent Extension; ENSPRYNG; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. The Food and Drug Administration (FDA or the Agency) is correcting a notice that appeared in the Federal Register of July 13, 2022. The document determined the regulatory review period for ENSPRYNG. After review of a timely request for reconsideration by the applicant of the calculation of the applicable regulatory review period of the biologic product ENSPRYNG in that notice, FDA has determined that a revision of the supplementary information section is warranted. This notice corrects the applicable regulatory review period language. SUMMARY: FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301–796–3600. SUPPLEMENTARY INFORMATION: In the Federal Register of July 13, 2022 (87 FR 41724), on page 41725, in the second column, under ‘‘II. Determination of Regulatory Review Period,’’ the first two sentences should be corrected to read as follows: ‘‘FDA has determined that the applicable regulatory review period for ENSPRYNG is 2,494 days. Of this time, 2,128 days occurred during the testing phase of the regulatory review period, while 366 days occurred during the approval phase.’’ Dated: May 18, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–10979 Filed 5–23–23; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Information Technology Advisory Committee 2023 Schedule of Meetings Office of the National Coordinator for Health Information Technology (ONC), HHS. ACTION: Notice of meetings. AGENCY: The Health Information Technology Advisory Committee (HITAC) was established in accordance with the 21st Century Cures Act and the Federal Advisory Committee Act. The HITAC, among other things, identifies priorities for standards adoption and makes recommendations to the National Coordinator for Health Information Technology (National Coordinator). The HITAC will hold public meetings throughout 2023. See list of public meetings below. FOR FURTHER INFORMATION CONTACT: Michael Berry, Designated Federal Officer, at Michael.Berry@hhs.gov, (202) 701–0795. SUPPLEMENTARY INFORMATION: Section 4003(e) of the 21st Century Cures Act (Pub. L. 114–255) establishes the Health Information Technology Advisory Committee (referred to as the ‘‘HITAC’’). The HITAC will be governed by the provisions of the Federal Advisory Committee Act (FACA) (Pub. L. 92– 463), as amended, (5 U.S.C. app.), which sets forth standards for the formation and use of federal advisory committees. SUMMARY: Composition The HITAC is comprised of at least 25 members, of which: • No fewer than 2 members are advocates for patients or consumers of health information technology; • 3 members are appointed by the HHS Secretary: Æ 1 of whom shall be appointed to represent the Department of Health and Human Services and Æ 1 of whom shall be a public health official; • 2 members are appointed by the majority leader of the Senate; • 2 members are appointed by the minority leader of the Senate; • 2 members are appointed by the Speaker of the House of Representatives; • 2 members are appointed by the minority leader of the House of Representatives; and • Other members are appointed by the Comptroller General of the United States. Members serve for one-, two-, or three-year terms. All members may be reappointed for a subsequent three-year E:\FR\FM\24MYN1.SGM 24MYN1

Agencies

[Federal Register Volume 88, Number 100 (Wednesday, May 24, 2023)]
[Notices]
[Page 33614]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-10979]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2020-E-2361; FDA-2020-E-2362; and FDA-2020-E-2363]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; ENSPRYNG; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
correcting a notice that appeared in the Federal Register of July 13, 
2022. The document determined the regulatory review period for 
ENSPRYNG. After review of a timely request for reconsideration by the 
applicant of the calculation of the applicable regulatory review period 
of the biologic product ENSPRYNG in that notice, FDA has determined 
that a revision of the supplementary information section is warranted. 
This notice corrects the applicable regulatory review period language.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory 
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.

SUPPLEMENTARY INFORMATION: In the Federal Register of July 13, 2022 (87 
FR 41724), on page 41725, in the second column, under ``II. 
Determination of Regulatory Review Period,'' the first two sentences 
should be corrected to read as follows: ``FDA has determined that the 
applicable regulatory review period for ENSPRYNG is 2,494 days. Of this 
time, 2,128 days occurred during the testing phase of the regulatory 
review period, while 366 days occurred during the approval phase.''

    Dated: May 18, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-10979 Filed 5-23-23; 8:45 am]
BILLING CODE 4164-01-P
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