Compressed Medical Gases-Warning Letters for Specific Violations Covering Liquid and Gaseous Oxygen; Withdrawal of Compliance Policy Guide, 53311 [2015-21874]
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Federal Register / Vol. 80, No. 171 / Thursday, September 3, 2015 / Notices
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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 https://
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withdrawn.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.
-----------------------------------------------------------------------
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 https://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