Privacy Act of 1974; Rescindment of a System of Records, 24841 [2024-07430]

Download as PDF 24841 Federal Register / Vol. 89, No. 69 / Tuesday, April 9, 2024 / Notices Board of Governors of the Federal Reserve System. Michele Taylor Fennell, Deputy Associate Secretary of the Board. SYSTEM NAME AND NUMBER: Transportation Benefits Records, GSA/TRANSIT–1. HISTORY: [FR Doc. 2024–07504 Filed 4–8–24; 8:45 am] A SORN was previously published in the Federal Register at 76 FR 56762 on October 14, 2011. BILLING CODE P GENERAL SERVICES ADMINISTRATION [Notice–IE–2024–03; Docket No. 2024–0001; Sequence No. 9] Privacy Act of 1974; Rescindment of a System of Records [FR Doc. 2024–07430 Filed 4–8–24; 8:45 am] BILLING CODE 6820–AB–P Office of the Chief Privacy Officer; General Services Administration, (GSA). ACTION: Rescindment of a system of records notice. AGENCY: DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2024–N–1569] Pursuant to the Privacy Act of 1974 and Office of Management and Budget (OMB) Circular No. A–108, notice is hereby given that the GSA proposes to rescind the GSA/Transit–1, Transportation Benefits Records, System of Records Notice (SORN). This system of records contains information entered by GSA and provides transportation fringe benefits to employees who use mass transportation to commute to and from work. DATES: Effective immediately. ADDRESSES: Comments may be submitted to the Federal eRulemaking Portal, https://www.regulations.gov. Submit comments by searching for Notice–IE–2024–03, GSA/Transit–1. FOR FURTHER INFORMATION CONTACT: Call or email Richard Speidel, Chief Privacy Officer at 202–969–5830 and gsa.privacyact@gsa.gov. SUPPLEMENTARY INFORMATION: GSA proposes to rescind a System of Records, GSA/Transit–1. This Notice is being rescinded due to the records of GSA/Transit–1 being maintained under DOT/ALL–8, Parking and Transit Benefit System, managed by the Department of Transportation (DOT). The records under GSA/Transit–1 were transitioned to the DOT in 2017 and are now being maintained under DOT/ALL–8. SUMMARY: ddrumheller on DSK120RN23PROD with NOTICES1 Richard Speidel, Chief Privacy Officer, Office of the Deputy Chief Information Officer, General Services Administration. Determination That NALFON (Fenoprofen Calcium) Oral Capsules, Equivalent to 300 Milligram Base, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements. SUMMARY: FOR FURTHER INFORMATION CONTACT: Stacy Kane, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6236, Silver Spring, MD 20993–0002, 301–796–8363, Stacy.Kane@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of an ANDA to market a generic version of a previously approved drug product. To obtain approval, the ANDA applicant must show, among other things, that the generic drug product: (1) has the same active ingredient(s), dosage form, route of administration, strength, conditions of use, and (with certain exceptions) labeling as the listed drug, which is a version of the drug that was previously approved, and (2) is bioequivalent to the listed drug. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA). Section 505(j)(7) of the FD&C Act requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the ‘‘Approved Drug Products With Therapeutic Equivalence Evaluations,’’ which is generally known as the ‘‘Orange Book.’’ Under FDA regulations, a drug is removed from the list if the Agency withdraws or suspends approval of the drug’s NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162). Under § 314.161(a) (21 CFR 314.161(a)), the Agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness: (1) before an ANDA that refers to that listed drug may be approved, (2) whenever a listed drug is voluntarily withdrawn from sale and ANDAs that refer to the listed drug have been approved, and (3) when a person petitions for such a determination under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if FDA determines that a listed drug was withdrawn from sale for safety or effectiveness reasons, the Agency will initiate proceedings that could result in the withdrawal of approval of the ANDAs that refer to the listed drug. FDA has become aware that the drug products listed in the table are no longer being marketed. Application No. Drug name Active ingredient(s) Strength(s) Dosage form/route NDA 017604 ............ NALFON ........................... Fenoprofen Calcium ......... Capsule; Oral ................... Xspire Pharma. NDA 017087 ............ NDA 018801 ............ Enflurane .......................... Sterile Water For Injection Liquid; Inhalation .............. Liquid; N/A ....................... NDA 019152 ............ ETHRANE ........................ STERILE WATER FOR INJECTION. CALAN SR ....................... Equivalent to (EQ) 300 Milligrams (mg) Base. 99.9% ............................... 100% (1 Milliliter (mL)); 100% (5.2 mL). 120 mg; 180 mg, 240 mg Baxter Healthcare Corp. Hospira, A Pfizer Company. Pfizer Inc. NDA 019885 ............ ACCUPRIL ....................... Quinapril Hydrochloride ... VerDate Sep<11>2014 19:57 Apr 08, 2024 Jkt 262001 Verapamil Hydrochloride .. PO 00000 Frm 00066 EQ 5 mg Base; EQ 10 mg Base; EQ 20 mg Base; EQ 40 mg Base. Fmt 4703 Sfmt 4703 Tablet, Extended Release; Oral. Tablet; Oral ...................... E:\FR\FM\09APN1.SGM 09APN1 Applicant Pfizer Pharmaceuticals Ltd.

Agencies

General Services Administration

[Federal Register Volume 89, Number 69 (Tuesday, April 9, 2024)]
[Notices]
[Page 24841]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-07430]


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GENERAL SERVICES ADMINISTRATION

[Notice-IE-2024-03; Docket No. 2024-0001; Sequence No. 9]


Privacy Act of 1974; Rescindment of a System of Records

AGENCY: Office of the Chief Privacy Officer; General Services 
Administration, (GSA).

ACTION: Rescindment of a system of records notice.

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SUMMARY: Pursuant to the Privacy Act of 1974 and Office of Management 
and Budget (OMB) Circular No. A-108, notice is hereby given that the 
GSA proposes to rescind the GSA/Transit-1, Transportation Benefits 
Records, System of Records Notice (SORN). This system of records 
contains information entered by GSA and provides transportation fringe 
benefits to employees who use mass transportation to commute to and 
from work.

DATES: Effective immediately.

ADDRESSES: Comments may be submitted to the Federal eRulemaking Portal, 
https://www.regulations.gov. Submit comments by searching for Notice-IE-
2024-03, GSA/Transit-1.

FOR FURTHER INFORMATION CONTACT: Call or email Richard Speidel, Chief 
Privacy Officer at 202-969-5830 and [email protected].

SUPPLEMENTARY INFORMATION: GSA proposes to rescind a System of Records, 
GSA/Transit-1. This Notice is being rescinded due to the records of 
GSA/Transit-1 being maintained under DOT/ALL-8, Parking and Transit 
Benefit System, managed by the Department of Transportation (DOT). The 
records under GSA/Transit-1 were transitioned to the DOT in 2017 and 
are now being maintained under DOT/ALL-8.

System Name and Number:
    Transportation Benefits Records, GSA/TRANSIT-1.

History:
    A SORN was previously published in the Federal Register at 76 FR 
56762 on October 14, 2011.

Richard Speidel,
Chief Privacy Officer, Office of the Deputy Chief Information Officer, 
General Services Administration.
[FR Doc. 2024-07430 Filed 4-8-24; 8:45 am]
BILLING CODE 6820-AB-P

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