Document ID: FDA-2015-N-0828-0003
Agency: fda
Document Type: Rule
Title: Performance Standards for Ionizing Radiation Emitting Products;
Fluoroscopic Equipment; Correction; Confirmation of Effective Date
Posted Date: 2015-07-22T04:00Z

[Federal Register Volume 80, Number 140 (Wednesday, July 22, 2015)]
[Rules and Regulations]
[Page 43320]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-17930]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1020

[Docket No. FDA-2015-N-0828]

Performance Standards for Ionizing Radiation Emitting Products; 
Fluoroscopic Equipment; Correction; Confirmation of Effective Date

AGENCY: Food and Drug Administration, HHS.

ACTION: Direct final rule; confirmation of effective date.

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SUMMARY: The Food and Drug Administration (FDA or we) is confirming the 
effective date of August 26, 2015, for the direct final rule that 
appeared in the Federal Register of April 13, 2015. The direct final 
rule amends a Federal performance standard for ionizing radiation to 
correct a drafting error regarding fluoroscopic equipment measurement. 
We are taking this action to ensure clarity and improve the accuracy of 
the regulations. This document confirms the effective date of the 
direct final rule.

DATES: Effective date of the final rule published in the Federal 
Register of April 13, 2015 (80 FR 19530), confirmed: August 26, 2015.

FOR FURTHER INFORMATION CONTACT: Scott Gonzalez, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 4641, Silver Spring, MD 20993-0002, 301-796-5889.

SUPPLEMENTARY INFORMATION: In the Federal Register of April 13, 2015 
(80 FR 19530), FDA solicited comments concerning the direct final rule 
for a 75-day period ending June 29, 2015. We stated that the effective 
date of the direct final rule would be on August 26, 2015, 30 days 
after the end of the comment period, unless FDA received any 
significant adverse comment during the comment period. FDA did not 
receive any significant adverse comments.

    Authority: 21 U.S.C. 351, 352, 360e-360j, 360hh-360ss, 371, 381. 
Accordingly, the amendment issued thereby is effective.

    Dated: July 16, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-17930 Filed 7-21-15; 8:45 am]
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