[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reference in the Code of Federal Regulations (CFR) that is no longer
current.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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