[Federal Register Volume 73, Number 121 (Monday, June 23, 2008)]
[Rules and Regulations]
[Page 35341]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-14153]


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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