[Federal Register: June 23, 2008 (Volume 73, Number 121)]
[Rules and Regulations]
[Page 35341]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23jn08-4]
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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.
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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.
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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]
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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