Medical Devices; Change of Name; Technical Amendment, 35341 [E8-14153]
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Federal Register / Vol. 73, No. 121 / Monday, June 23, 2008 / Rules and Regulations
§ 558.485
[Amended]
12. In paragraph (b)(3) of § 558.485,
remove ‘‘021930’’ and in numerical
sequence add ‘‘012286’’.
I
§ 558.625
[Amended]
13. In paragraphs (b)(10) and (b)(12) of
§ 558.625, remove ‘‘021930’’ and in its
place add ‘‘No. 012286’’.
I
§ 558.630
[Amended]
14. In § 558.630, in paragraph (b)(2),
remove ‘‘021930’’ and in its place add
‘‘012286; and in paragraph (b)(5),
remove ‘‘021930’’ and in numerical
sequence add ‘‘012286’’.
I
Dated: June 9, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8–14149 Filed 6–20–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 860, 862, 864, 866, 868,
872, 874, 876, 878, 880, 882, 886, 888,
890, and 892
[Docket No. FDA–2008–N–0331]
Medical Devices; Change of Name;
Technical Amendment
AGENCY:
Food and Drug Administration,
HHS.
Final rule; technical
amendment.
ACTION:
SUMMARY: The Food and Drug
Administration (FDA) is amending its
regulations to implement a
nomenclature change and to ensure
accuracy and clarity in the agency’s
regulations.
DATES:
This rule is effective June 23,
2008.
Paul
S. Gadiock, Center for Devices and
Radiological Health (HFZ–215), Food
and Drug Administration, 1350 Piccard
Dr., Rockville, MD 20850, 240–276–
2343.
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
yshivers on PROD1PC62 with RULES
I. Background
This document amends FDA’s
regulations to reflect a nomenclature
change. It replaces the phrase ‘‘good
manufacturing practice regulations’’
with the phrase ‘‘good manufacturing
practice requirements of the quality
system regulation’’ in 21 CFR parts 860,
862, 864, 866, 868, 872, 874, 876, 878,
880, 882, 886, 888, 890, and 892.
VerDate Aug<31>2005
16:45 Jun 20, 2008
Jkt 214001
35341
Publication of this document
constitutes final action on these changes
under the Administrative Procedure Act
(5 U.S.C. 553). FDA has determined that
notice and public comment are
unnecessary because these changes are
nonsubstantive.
IV. Paperwork Reduction Act of 1995
FDA has determined that this final
rule contains no collections of
information. Therefore, clearance by the
Office of Management and Budget under
the Paperwork Reduction Act of 1995 is
not required.
II. Environmental Impact
V. Federalism
FDA has analyzed this final rule in
accordance with the principles set forth
in Executive Order 13132. FDA has
determined that the rule does not
contain policies that have substantial
direct effects on the States, on the
relationship between the National
Government and the States, or on the
distribution of power and
responsibilities among the various
levels of government. Accordingly, the
agency has concluded that the rule does
not contain policies that have
federalism implications as defined in
the Executive order and, consequently,
a federalism summary impact statement
is not required.
I Therefore, under the Federal Food,
Drug, and Cosmetic Act, and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR parts 860,
862, 864, 866, 868, 872, 874, 876, 878,
880, 882, 886, 888, 890, and 892 are
amended as follows:
The agency has determined under 21
CFR 25.30(i) that this final rule is of a
type that does not individually or
cumulatively have a significant effect on
the human environment. Therefore,
neither an environmental assessment
nor an environmental impact statement
is required.
III. Analysis of Impacts
FDA has examined the impacts of the
final rule under Executive Order 12866
and the Regulatory Flexibility Act (5
U.S.C. 601–612), and the Unfunded
Mandates Reform Act of 1995 (Public
Law 104–4). Executive Order 12866
directs agencies to assess all costs and
benefits of available regulatory
alternatives and, when regulation is
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety,
and other advantages; distributive
impacts; and equity). The agency
believes that this final rule is not a
significant regulatory action under the
Executive order.
The Regulatory Flexibility Act
requires agencies to analyze regulatory
options that would minimize any
significant impact of a rule on small
entities. Because this rule makes only
typographical and nonsubstantive
changes in existing regulations and does
not change in any way how devices are
regulated, the agency certifies that the
final rule will not have a significant
economic impact on a substantial
number of small entities.
Section 202(a) of the Unfunded
Mandates Reform Act of 1995 requires
that agencies prepare a written
statement, which includes an
assessment of anticipated costs and
benefits, before proposing ‘‘any rule that
includes any Federal mandate that may
result in the expenditure by State, local,
and tribal governments, in the aggregate,
or by the private sector, of $100,000,000
or more (adjusted annually for inflation)
in any one year.’’ The current threshold
after adjustment for inflation is $127
million, using the most current (2006)
Implicit Price Deflator for the Gross
Domestic Product. FDA does not expect
this final rule to result in any 1-year
expenditure that would meet or exceed
this amount.
PO 00000
Frm 00005
Fmt 4700
Sfmt 4700
PARTS 860, 862, 864, 866, 868, 872,
874, 876, 878, 880, 882, 886, 888, 890,
and 892—[AMENDED]
1. Parts 860, 862, 864, 866, 868, 872,
874, 876, 878, 880, 882, 886, 888, 890,
and 892 are amended by removing the
phrase ‘‘good manufacturing practice
regulations’’ wherever it appears and by
adding in its place the phrase ‘‘good
manufacturing practice requirements of
the quality system regulation’’.
I
Dated: June 13, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–14153 Filed 6–20–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 100
[Docket No. USCG–2008–0321]
Special Local Regulation; Thunderboat
Regatta; Mission Bay, San Diego, CA
Coast Guard, DHS.
Notice of enforcement of
regulation.
AGENCY:
ACTION:
E:\FR\FM\23JNR1.SGM
23JNR1
Agencies
[Federal Register Volume 73, Number 121 (Monday, June 23, 2008)]
[Rules and Regulations]
[Page 35341]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-14153]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 860, 862, 864, 866, 868, 872, 874, 876, 878, 880, 882,
886, 888, 890, and 892
[Docket No. FDA-2008-N-0331]
Medical Devices; Change of Name; Technical Amendment
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending its
regulations to implement a nomenclature change and to ensure accuracy
and clarity in the agency's regulations.
DATES: This rule is effective June 23, 2008.
FOR FURTHER INFORMATION CONTACT: Paul S. Gadiock, Center for Devices
and Radiological Health (HFZ-215), Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850, 240-276-2343.
SUPPLEMENTARY INFORMATION:
I. Background
This document amends FDA's regulations to reflect a nomenclature
change. It replaces the phrase ``good manufacturing practice
regulations'' with the phrase ``good manufacturing practice
requirements of the quality system regulation'' in 21 CFR parts 860,
862, 864, 866, 868, 872, 874, 876, 878, 880, 882, 886, 888, 890, and
892.
Publication of this document constitutes final action on these
changes under the Administrative Procedure Act (5 U.S.C. 553). FDA has
determined that notice and public comment are unnecessary because these
changes are nonsubstantive.
II. Environmental Impact
The agency has determined under 21 CFR 25.30(i) that this final
rule is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
III. Analysis of Impacts
FDA has examined the impacts of the final rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and
the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive
Order 12866 directs agencies to assess all costs and benefits of
available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The agency believes that
this final rule is not a significant regulatory action under the
Executive order.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because this rule makes only typographical and
nonsubstantive changes in existing regulations and does not change in
any way how devices are regulated, the agency certifies that the final
rule will not have a significant economic impact on a substantial
number of small entities.
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $127 million, using the most current (2006) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
final rule to result in any 1-year expenditure that would meet or
exceed this amount.
IV. Paperwork Reduction Act of 1995
FDA has determined that this final rule contains no collections of
information. Therefore, clearance by the Office of Management and
Budget under the Paperwork Reduction Act of 1995 is not required.
V. Federalism
FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that the rule
does not contain policies that have substantial direct effects on the
States, on the relationship between the National Government and the
States, or on the distribution of power and responsibilities among the
various levels of government. Accordingly, the agency has concluded
that the rule does not contain policies that have federalism
implications as defined in the Executive order and, consequently, a
federalism summary impact statement is not required.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act, and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
860, 862, 864, 866, 868, 872, 874, 876, 878, 880, 882, 886, 888, 890,
and 892 are amended as follows:
PARTS 860, 862, 864, 866, 868, 872, 874, 876, 878, 880, 882, 886,
888, 890, and 892--[AMENDED]
0
1. Parts 860, 862, 864, 866, 868, 872, 874, 876, 878, 880, 882, 886,
888, 890, and 892 are amended by removing the phrase ``good
manufacturing practice regulations'' wherever it appears and by adding
in its place the phrase ``good manufacturing practice requirements of
the quality system regulation''.
Dated: June 13, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-14153 Filed 6-20-08; 8:45 am]
BILLING CODE 4160-01-S