Compressed Medical Gases-Warning Letters for Specific Violations Covering Liquid and Gaseous Oxygen; Withdrawal of Compliance Policy Guide, 53311 [2015-21874]

Download as PDF Federal Register / Vol. 80, No. 171 / Thursday, September 3, 2015 / Notices nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States. Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than September 28, 2015. A. Federal Reserve Bank of Dallas (Robert L. Triplett III, Senior Vice President) 2200 North Pearl Street, Dallas, Texas 75201–2272: 1. Independent Bank Group, Inc., McKinney, Texas; to acquire 100 percent of the voting shares of Grand Bank, Dallas, Texas. Board of Governors of the Federal Reserve System, August 31, 2015. Michael J. Lewandowski, Associate Secretary of the Board. [FR Doc. 2015–21897 Filed 9–2–15; 8:45 am] BILLING CODE 6210–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–N–3043] Compressed Medical Gases-Warning Letters for Specific Violations Covering Liquid and Gaseous Oxygen; Withdrawal of Compliance Policy Guide AGENCY: Food and Drug Administration, Liquid and Gaseous Oxygen’’ (CPG 7132a.16). Subsequently, the Agency’s Manual of Compliance Policy Guides was reorganized and this material became Section 435.100. The CPG provided guidance to FDA district offices for issuing warning letters to firms that are engaged in filling cylinders with gas(es) for medical use that are not operating in conformance with the adulteration, misbranding, and/or new drug provisions of the Federal Food, Drug, and Cosmetic Act. On March 15, 2015, FDA implemented the revised Compliance Program Guidance Manual (CPGM) 7356.002E, entitled ‘‘Compressed Medical Gases,’’ available at http:// www.fda.gov/downloads/ICECI/ ComplianceManuals/ ComplianceProgramManual/ UCM125417.pdf. CPGM 7356.002E instructs FDA staff regarding a range of subjects, including, but not limited to, the inspections and investigations, regulatory and/or administrative action, and the issuance of warning letters related to compressed medical gases. As the CPGM 7356.002E articulates FDA’s current thinking on issuing warning letters related to compressed medical gases, CPG Section 435.100 is withdrawn. Dated: August 28, 2015. Steven Solomon, Deputy Associate Commissioner for Regulatory Affairs. [FR Doc. 2015–21874 Filed 9–2–15; 8:45 am] BILLING CODE 4164–01–P HHS. ACTION: Notice; withdrawal. The Food and Drug Administration (FDA) is announcing the withdrawal of Compliance Policy Guide (CPG) Section 435.100, entitled ‘‘Compressed Medical Gases—Warning Letters for Specific Violations Covering Liquid and Gaseous Oxygen.’’ DATES: The withdrawal is effective September 3, 2015. FOR FURTHER INFORMATION CONTACT: Mary E. Kennelly, Office of Regulatory Affairs, 10903 New Hampshire Ave., Bldg. 32, Rm. 4338, Silver Spring, MD 20993, 240–402–9577. SUPPLEMENTARY INFORMATION: A Compliance Policy Guide (CPG) on medical gases was originally issued on November 5, 1987, in the Agency’s Manual of Compliance Policy Guides. In a notice published in the Federal Register of September 16, 1992 (57 FR 42757), FDA announced the availability of a revised CPG on this topic entitled ‘‘Compressed Medical Gases—Warning Letters for Specific Violations Covering tkelley on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 14:42 Sep 02, 2015 Jkt 235001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–N–3137] Advisory Committee; Nonprescription Drugs Advisory Committee, Renewal AGENCY: Food and Drug Administration, HHS. Notice; renewal of advisory committee. ACTION: The Food and Drug Administration (FDA) is announcing the renewal of the Nonprescription Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Nonprescription Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the August 27, 2015, expiration date. SUMMARY: PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 53311 Authority for the Nonprescription Drugs Advisory Committee will expire on August 27, 2017, unless the Commissioner formally determines that renewal is in the public interest. FOR FURTHER INFORMATION CONTACT: Moon Hee V. Choi, Division of Advisory Committee and Consultant Management, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993–0002, 301–796–9001, NDAC@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102–3.65 and approval by the Department of Health and Human Services pursuant to 45 CFR part 11 and by the General Services Administration, FDA is announcing the renewal of the Nonprescription Drugs Advisory Committee. The Committee is a discretionary Federal advisory committee established to provide advice to the Commissioner. The Committee advises the Commissioner or designee in discharging responsibilities as they relate to helping to ensure safe and effective drugs for human use and, as required, any other product for which FDA has regulatory responsibility. The Committee reviews and evaluates available data concerning the safety and effectiveness of over-the-counter (nonprescription) human drug products, or any other FDA-regulated product, for use in the treatment of a broad spectrum of human symptoms and diseases and advises the Commissioner either on the promulgation of monographs establishing conditions under which these drugs are generally recognized as safe, effective, not misbranded, and on the approval of new drug applications. The Committee serves as a forum for the exchange of views regarding the prescription and nonprescription status, including switches from one status to another. The Committee may also conduct peer review of Agency sponsored intramural and extramural scientific biomedical programs in support of FDA’s mission and regulatory responsibilities. The Committee shall consist of a core of 10 voting members including the Chair. Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of internal medicine, family practice, clinical toxicology, clinical pharmacology, pharmacy, dentistry, and related specialties. Members will be invited to serve for overlapping terms of up to 4 years. Almost all non-Federal members of this committee serve as Special Government Employees. The core of DATES: E:\FR\FM\03SEN1.SGM 03SEN1

Agencies

[Federal Register Volume 80, Number 171 (Thursday, September 3, 2015)]
[Notices]
[Page 53311]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-21874]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-3043]


Compressed Medical Gases-Warning Letters for Specific Violations 
Covering Liquid and Gaseous Oxygen; Withdrawal of Compliance Policy 
Guide

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; withdrawal.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
withdrawal of Compliance Policy Guide (CPG) Section 435.100, entitled 
``Compressed Medical Gases--Warning Letters for Specific Violations 
Covering Liquid and Gaseous Oxygen.''

DATES: The withdrawal is effective September 3, 2015.

FOR FURTHER INFORMATION CONTACT: Mary E. Kennelly, Office of Regulatory 
Affairs, 10903 New Hampshire Ave., Bldg. 32, Rm. 4338, Silver Spring, 
MD 20993, 240-402-9577.

SUPPLEMENTARY INFORMATION: A Compliance Policy Guide (CPG) on medical 
gases was originally issued on November 5, 1987, in the Agency's Manual 
of Compliance Policy Guides. In a notice published in the Federal 
Register of September 16, 1992 (57 FR 42757), FDA announced the 
availability of a revised CPG on this topic entitled ``Compressed 
Medical Gases--Warning Letters for Specific Violations Covering Liquid 
and Gaseous Oxygen'' (CPG 7132a.16). Subsequently, the Agency's Manual 
of Compliance Policy Guides was reorganized and this material became 
Section 435.100. The CPG provided guidance to FDA district offices for 
issuing warning letters to firms that are engaged in filling cylinders 
with gas(es) for medical use that are not operating in conformance with 
the adulteration, misbranding, and/or new drug provisions of the 
Federal Food, Drug, and Cosmetic Act.
    On March 15, 2015, FDA implemented the revised Compliance Program 
Guidance Manual (CPGM) 7356.002E, entitled ``Compressed Medical 
Gases,'' available at http://www.fda.gov/downloads/ICECI/ComplianceManuals/ComplianceProgramManual/UCM125417.pdf. CPGM 7356.002E 
instructs FDA staff regarding a range of subjects, including, but not 
limited to, the inspections and investigations, regulatory and/or 
administrative action, and the issuance of warning letters related to 
compressed medical gases. As the CPGM 7356.002E articulates FDA's 
current thinking on issuing warning letters related to compressed 
medical gases, CPG Section 435.100 is withdrawn.

    Dated: August 28, 2015.
Steven Solomon,
Deputy Associate Commissioner for Regulatory Affairs.
[FR Doc. 2015-21874 Filed 9-2-15; 8:45 am]
BILLING CODE 4164-01-P