Document ID: FDA-2009-N-0141-0001
Agency: fda
Document Type: Rule
Title: Medical Devices; Technical Amendment
Posted Date: 2009-03-31T04:00Z

[Federal Register: March 31, 2009 (Volume 74, Number 60)]
[Rules and Regulations]               
[Page 14478]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31mr09-10]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 814

[Docket No. FDA-2009-N-0141]

 
Medical Devices; 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 a medical 
device regulation to correct a statutory reference to reflect the 
current citation and to ensure accuracy and clarity in the agency's 
regulations.

DATES:  This rule is effective March 31, 2009.

SUPPLEMENTARY INFORMATION: FDA is amending its regulation at 21 CFR 
814.20 to correct a statutory reference to reflect the current 
citation. FDA is revising Sec.  814.20(f) by replacing section ``706'' 
with section ``721.'' Publication of this document constitutes final 
action on the change under the Administrative Procedure Act (5 U.S.C. 
553). This technical amendment merely updates and corrects a statutory 
reference in the Code of Federal Regulations (CFR) that is no longer 
current. FDA therefore, for good cause, has determined that notice and 
public comment are unnecessary, under 5 U.S.C. 553(b)(3)(B). Further, 
this rule places no burden on affected parties for which such parties 
would need a reasonable time to prepare for the effective date of the 
rule. Accordingly, FDA, for good cause, has determined this technical 
amendment to be exempt under 5 U.S.C. 553(d)(3) from the 30 day 
effective date from publication.
    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. In 
addition, FDA has determined that this final rule contains no 
collections of information. Therefore, clearance by the Office 
Management and Budget under the Paperwork Reduction Act of 1995 is not 
required.
    For the effective date of this final rule, see the DATES section of 
this document.

List of Subjects in 21 CFR Part 814

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

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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 part 
814 is amended as follows:

PART 814--PREMARKET APPROVAL OF MEDICAL DEVICES

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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.

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2. In Sec.  814.20, paragraph (f) is revised to read as follows:

Sec.  814.20   Application.

* * * * *
    (f) If a color additive subject to section 721 of the act is used 
in or on the device and has not previously been listed for such use, 
then, in lieu of submitting a color additive petition under part 71, at 
the option of the applicant, the information required to be submitted 
under part 71 may be submitted as part of the PMA. When submitted as 
part of the PMA, the information shall be submitted in three copies 
each bound in one or more numbered volumes of reasonable size. A PMA 
for a device that contains a color additive that is subject to section 
721 of the act will not be approved until the color additive is listed 
for use in or on the device.
* * * * *

    Dated: March 24, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-7073 Filed 3-30-09; 8:45 am]

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