Medical Device Reporting; Premarket Approval of Medical Devices; Quality System Regulation; Technical Amendment, 16227-16228 [06-3089]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 71, Number 62 (Friday, March 31, 2006)]
[Rules and Regulations]
[Pages 16227-16228]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-3089]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 814 and 820

[Docket No. 2006N-0127]


Medical Device Reporting; Premarket Approval of Medical Devices; 
Quality System Regulation; Technical Amendment

AGENCY: Food and Drug Administration, HHS.

[[Page 16228]]


ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA) is issuing this final 
rule to correct some inadvertent typographical errors and other minor 
errors in certain device regulations. FDA intends for these corrections 
to improve the accuracy of the agency's regulations.

Effective Date: March 31, 2006.

FOR FURTHER INFORMATION CONTACT: Philip Desjardins, Center for Devices 
and Radiological Health (HFZ-215), Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850, 240-276-2343.

SUPPLEMENTARY INFORMATION:

I. Highlights of Final Rule

    FDA is making the following changes to correct typographical and 
other minor errors in certain device regulations:
    1. FDA is amending 21 CFR 814.126(b)(1)(iv) to replace ``8dd'' with 
``803.''
    2. FDA is amending 21 CFR 820.198(a)(3) to eliminate a reference to 
part 804, a part that does not exist.

II. Environmental Impact

    The agency has determined under 21 CFR 25.30(i) that this action 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 corrects only typographical errors 
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 $115 million, using the most current (2003) 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.

VI. The Technical Amendments

    This rule corrects certain minor errors in existing regulations. 
This administrative action is limited to correcting typographical 
errors and eliminating a reference to a nonexistent Code of Federal 
Regulations (CFR) part. It makes no changes in substantive 
requirements.
    Because the final rule is an administrative action, FDA has 
determined that it has no substantive impact on the public. It imposes 
no costs, and merely makes technical administrative changes in the CFR 
for the convenience of the public. FDA, therefore, for good cause, 
finds under 5 U.S.C. 553(b)(3)(B) and (d)(3) that notice and public 
comment are unnecessary.

List of Subjects

21 CFR Part 814

    Administrative practice and procedure, Confidential business 
information, Institutional review board requirements, Medical devices, 
Medical research, Reporting and recordkeeping requirements.

21 CFR Part 820

    Medical devices, Reporting and recordkeeping requirements.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act, and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 
814 and 820 are amended as follows:

PART 814--PREMARKET APPROVAL OF MEDICAL DEVICES

0
1. The authority citation for 21 CFR part 814 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 352, 353, 360, 360c-360j, 371, 372, 
373, 374, 375, 379, 379e, 381.

0
2. Amend paragraph (b)(1)(iv) of Sec.  814.126 by removing ``part 8dd'' 
and adding in its place ``part 803''.

PART 820--QUALITY SYSTEM REGULATION

0
3. The authority citation for 21 CFR part 820 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 352, 360, 360c, 360d, 360e, 360h, 
360i, 360j, 360l, 371, 374, 381, 383.

0
4. Amend paragraph (a)(3) of Sec.  820.198 by removing ``or 804''.

    Dated: March 24, 2006.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 06-3089 Filed 3-30-06; 8:45 am]
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