Air Products and Chemicals, Inc.; Withdrawal of Approval of a New Drug Application and New Animal Drug Application for Helium, USP, 19597 [2024-05742]

Download as PDF Federal Register / Vol. 89, No. 54 / Tuesday, March 19, 2024 / Notices information to national organizations included in The Union on all questions concerning scientific and sociological study on TB. The Union is uniquely qualified to combat TB and lung disease globally and to offer training and other capacity-building activities leading to health solutions for the poor in resource limited countries, the key activities under this NOFO, due to its WHOrecognized accomplishments and leadership role in the global TB fight since its founding in 1920. Summary of the Award Recipient: International Union Against Tuberculosis and Lung Disease (The Union). Purpose of the Award: The purpose of this award is to continue developing and updating TB scientific and programmatic resources, disseminating TB best practices, and building TB capacity. Amount of Award: For The Union, the approximate year 1 funding amount will be $500,000 in Federal Fiscal Year (FYY) 2024 funds, subject to the availability of funds. Funding amounts for years 2–5 will be set at continuation. Non-PEPFAR Authority: This program is authorized under section 307 of the Public Health Service Act (42 U.S.C. 242l), as amended and section 301(a) of the Public Health Service Act (42 U.S.C. 241(a)), as amended. Period of Performance: The period for this award will be September 30, 2024, through September 29, 2029. Dated: March 13, 2024. Jamie Legier, Acting Director, Office of Grants Services, Centers for Disease Control and Prevention. [FR Doc. 2024–05771 Filed 3–18–24; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2024–N–1181] Air Products and Chemicals, Inc.; Withdrawal of Approval of a New Drug Application and New Animal Drug Application for Helium, USP AGENCY: Food and Drug Administration, ddrumheller on DSK120RN23PROD with NOTICES1 HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) is withdrawing approval of the new drug application (NDA) 205864 and the new animal drug application (NADA) 141– 395 for the designated medical gas Helium, USP held by Air Products and SUMMARY: VerDate Sep<11>2014 19:45 Mar 18, 2024 Jkt 262001 Chemicals, Inc., 1940 Air Products Blvd., Allentown, PA 18106–5500 (Air Products). Air Products notified the Agency in writing that the drug product was no longer marketed and requested that the approval of the application be withdrawn. Approval is withdrawn as of April 18, 2024. DATES: FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993–0002, 301– 796–3137, Kimberly.Lehrfeld@ fda.hhs.gov; or Scott Fontana (HFV– 180), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240– 402–0656, Scott.Fontana@fda.hhs.gov. Air Products has informed FDA that it is no longer marketing the designated medical gas Helium, USP and has requested that FDA withdraw approval of NDA 205864 and NADA 141–395 under the processes in § 314.150© (21 CFR 314.150(c)) and § 514.115(d) (21 CFR 514.115(d)). Air Products has also, by its request, waived its opportunity for a hearing. Withdrawal of approval of an application or abbreviated application under § 314.150(c) or an NADA or abbreviated new animal drug application under § 514.115(d) is without prejudice to refiling. Therefore, approval of NDA 205864 and NADA 141–395, and all amendments and supplements thereto, are hereby withdrawn as of April 18, 2024. Introduction or delivery for introduction into interstate commerce of Helium, USP, without an approved new drug application or an approved new animal drug application violates sections 505(a), 512(a), 301(a), and 301(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(a), 360b(a)(1), 331(a), and 331(d)). Any Helium, USP manufactured by Air Products pursuant to these applications that is in inventory on April 18, 2024 may continue to be dispensed until the inventories have been depleted or the drug product has reached its expiration date or otherwise become violative, whichever occurs first. SUPPLEMENTARY INFORMATION: Dated: March 13, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024–05742 Filed 3–18–24; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 19597 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Committee on Vital and Health Statistics Centers for Disease Control and Prevention, Department of Health and Human Services. ACTION: Notice of meeting. AGENCY: Pursuant to the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) announces the following advisory committee meeting. This meeting is open to the public. The public is welcome to attend in person or to obtain the link to attend this meeting by following the instructions posted on the Committee website: https:// ncvhs.hhs.gov/meetings/full-committeemeeting-16/. Name: National Committee on Vital and Health Statistics (NCVHS) Meeting. DATES: Thursday, April 11, 2024: 9:15 a.m.–5:30 p.m. EDT and Friday, April 12, 2024: 8:30 a.m.–3:00 p.m. EDT. ADDRESSES: In-person/hybrid (includes virtual attendance option). FOR MORE INFORMATION CONTACT: Substantive program information may be obtained from Rebecca Hines, MHS, Executive Secretary, NCVHS, National Center for Health Statistics, Centers for Disease Control and Prevention, 3311 Toledo Road, Hyattsville, Maryland 20782, or via electronic mail to vgh4@ cdc.gov; or by telephone (301) 458– 4715. Summaries of meetings and a roster of Committee members are available on the NCVHS website https:// ncvhs.hhs.gov/, where further information including an agenda and instructions to access the broadcast of the meeting will be posted. Should you require reasonable accommodation, please telephone the CDC Office of Equal Employment Opportunity at (770) 488–3210 as soon as possible. SUPPLEMENTARY INFORMATION: Purpose: As outlined in its Charter, the National Committee on Vital and Health Statistics assists and advises the Secretary of HHS on health data, data standards, statistics, privacy, national health information policy, and the Department’s strategy to best address those issues. Under the Health Insurance Portability and Accountability Act of 1996 (HIPAA),1 NCVHS advises the Secretary on administrative simplification standards, including those for privacy, security, SUMMARY: 1 Public Law 104–191, 110 Stat. 1936 (Aug 21, 1996), available at https://www.congress.gov/104/ plaws/publ191/PLAW-104publ191.pdf. E:\FR\FM\19MRN1.SGM 19MRN1

Agencies

[Federal Register Volume 89, Number 54 (Tuesday, March 19, 2024)]
[Notices]
[Page 19597]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-05742]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-1181]


Air Products and Chemicals, Inc.; Withdrawal of Approval of a New 
Drug Application and New Animal Drug Application for Helium, USP

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is 
withdrawing approval of the new drug application (NDA) 205864 and the 
new animal drug application (NADA) 141-395 for the designated medical 
gas Helium, USP held by Air Products and Chemicals, Inc., 1940 Air 
Products Blvd., Allentown, PA 18106-5500 (Air Products). Air Products 
notified the Agency in writing that the drug product was no longer 
marketed and requested that the approval of the application be 
withdrawn.

DATES: Approval is withdrawn as of April 18, 2024.

FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 301-
796-3137, [email protected]; or Scott Fontana (HFV-180), 
Center for Veterinary Medicine, Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-402-0656, 
[email protected].

SUPPLEMENTARY INFORMATION: Air Products has informed FDA that it is no 
longer marketing the designated medical gas Helium, USP and has 
requested that FDA withdraw approval of NDA 205864 and NADA 141-395 
under the processes in Sec.  314.150(copyright) (21 CFR 314.150(c)) and 
Sec.  514.115(d) (21 CFR 514.115(d)). Air Products has also, by its 
request, waived its opportunity for a hearing. Withdrawal of approval 
of an application or abbreviated application under Sec.  314.150(c) or 
an NADA or abbreviated new animal drug application under Sec.  
514.115(d) is without prejudice to refiling.
    Therefore, approval of NDA 205864 and NADA 141-395, and all 
amendments and supplements thereto, are hereby withdrawn as of April 
18, 2024. Introduction or delivery for introduction into interstate 
commerce of Helium, USP, without an approved new drug application or an 
approved new animal drug application violates sections 505(a), 512(a), 
301(a), and 301(d) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(a), 360b(a)(1), 331(a), and 331(d)). Any Helium, USP 
manufactured by Air Products pursuant to these applications that is in 
inventory on April 18, 2024 may continue to be dispensed until the 
inventories have been depleted or the drug product has reached its 
expiration date or otherwise become violative, whichever occurs first.

    Dated: March 13, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-05742 Filed 3-18-24; 8:45 am]
BILLING CODE 4164-01-P

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