Medical Devices; Classification of Accessories Distinct From Other Devices; Finalized List of Accessories Suitable for Class I; Correction, 22702 [2019-10399]

Download as PDF 22702 Federal Register / Vol. 84, No. 97 / Monday, May 20, 2019 / Rules and Regulations ACTION: DEPARTMENT OF HEALTH AND HUMAN SERVICES 21 CFR Part 886 [Docket No. FDA–2018–N–3066] Medical Devices; Classification of Accessories Distinct From Other Devices; Finalized List of Accessories Suitable for Class I; Correction Food and Drug Administration, HHS. Final classification action; correction. ACTION: The Food and Drug Administration (FDA) is correcting a document that appeared in the Federal Register of April 12, 2019. That document was published with the instruction to add a section to the incorrect subpart. This correction is being made to improve the accuracy of the final classification action. DATES: Effective May 20, 2019, and applicable May 13, 2019. FOR FURTHER INFORMATION CONTACT: Lisa Granger, Office of Policy and Planning, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3330, Silver Spring, MD 20993, 301– 796–9115. SUPPLEMENTARY INFORMATION: In FR Doc. 2019–07290 appearing on page 14865 in the Federal Register of Friday, April 12, 2019, the following correction is made: SUMMARY: § 886.4355 [Corrected] 1. On page 14870, in the second column, in part 886, amendatory instruction 11 is corrected to read as follows: ‘‘11. ‘‘Add § 886.4355 to subpart E to read as follows:’’ ■ Dated: May 14, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–10399 Filed 5–17–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HOMELAND SECURITY Coast Guard khammond on DSKBBV9HB2PROD with RULES 33 CFR Part 117 [Docket No. USCG–2018–0228] RIN 1625–AA09 Drawbridge Operation Regulation; Delaware River, Burlington, NJ and Bristol, PA AGENCY: Coast Guard, DHS. VerDate Sep<11>2014 15:55 May 17, 2019 Jkt 247001 The Coast Guard is temporarily modifying the operating schedule that governs the SR 413/ Burlington-Bristol Bridge across the Delaware River, mile 117.8, between Burlington, NJ and Bristol, PA. This temporary modification will allow the drawbridge to be maintained closed-tonavigation and is necessary to accommodate bridge maintenance. DATES: This temporary final rule is effective from June 19, 2019, through 7:59 a.m. on September 17, 2019. ADDRESSES: To view documents mentioned in this preamble as being available in the docket, go to https:// www.regulations.gov. Type USCG– 2018–0228 in the ‘‘SEARCH’’ box and click ‘‘SEARCH.’’ Click on Open Docket Folder on the line associated with this rulemaking. FOR FURTHER INFORMATION CONTACT: If you have questions on this rule, call or email Mr. Michael Thorogood, Bridge Administration Branch Fifth District, Coast Guard, telephone 757–398–6557, email Michael.R.Thorogood@uscg.mil. SUPPLEMENTARY INFORMATION: SUMMARY: Food and Drug Administration AGENCY: Temporary final rule. I. Table of Abbreviations CFR Code of Federal Regulations FR Federal Register OMB Office of Management and Budget NPRM Notice of Proposed Rulemaking (Advance, Supplemental) § Section U.S.C. United States Code II. Background Information and Regulatory History On April 26, 2018, the Coast Guard published a temporary deviation entitled ‘‘Drawbridge Operation Regulation; Delaware River, Burlington NJ and Bristol, PA’’ in the Federal Register (83 FR 18226). This temporary deviation was in place to facilitate bridge maintenance and painting of the vertical lift span of the drawbridge from May 1, 2018, through September 30, 2018. During the planned maintenance period, a work platform reduced one half of the bridge span vertical clearance to approximately 58 feet above mean high water in the closed position and approximately 132 feet above mean high water in the open position. On August 9, 2018, the Coast Guard published a cancellation of the temporary deviation entitled ‘‘Drawbridge Operation Regulation; Delaware River, Burlington NJ and Bristol, PA’’ in the Federal Register (83 FR 18226). The temporary deviation was cancelled due to delays in performing bridge maintenance outside the navigation span, thereby eliminating the PO 00000 Frm 00010 Fmt 4700 Sfmt 4700 need for maintaining the temporary deviation. Due to the cancellation of the work, the platform was not installed and the bridge is operating under its regular operating schedule in 33 CFR 117.716(a). In accordance with 33 CFR 117.35(e), the drawbridge was returned to its regular operating schedule immediately at the end of the cancellation date of the temporary deviation. On March 1, 2019, the Coast Guard published a notice for proposed rulemaking entitled ‘‘Drawbridge Operation Regulation; Delaware River, Burlington, NJ and Bristol, PA’’ in the Federal Register (84 FR 6992). We received no comments on this rule. III. Legal Authority and Need for Rule The Coast Guard is issuing this rule under authority 33 U.S.C. 499. The SR 413/Burlington-Bristol Bridge across the Delaware River, mile 117.8, between Burlington, NJ and Bristol, PA, is a vertical lift span bridge, and has a vertical clearance of 61 feet above mean high water in the closed position and 135 feet above mean high water in the open position. The current operating schedule for the drawbridge is published in 33 CFR 117.716(a). The Burlington County Bridge Commission, who owns and operates the SR 413/Burlington-Bristol Bridge across the Delaware River, mile 117.8, between Burlington, NJ and Bristol, PA, has requested this modification to allow the drawbridge to be maintained in the closed-to-navigation position to facilitate maintenance and painting of the vertical lift span of the drawbridge. Under this temporary final rule, the drawbridge will be maintained in the closed-to-navigation position and open on signal if at least a two-hour notice is given, from June 19, 2019, through 7:59 a.m. on September 17, 2019. At all other times, the drawbridge will operate per 33 CFR 117.716 (a). This temporary final rule is necessary to facilitate safe and effective bridge maintenance and painting of the vertical lift span of the drawbridge, while providing for the reasonable needs of navigation. Multiple work platforms will reduce the entire bridge span vertical clearance to approximately 58 feet above mean high water in the closed position and approximately 132 feet above mean high water in the open position. Maintenance personnel, equipment and materials will be located inside the work platforms while maintenance and painting is being performed. To facilitate an opening of the bridge, equipment and materials will need to be secured inside or removed from the work platforms and E:\FR\FM\20MYR1.SGM 20MYR1

Agencies

[Federal Register Volume 84, Number 97 (Monday, May 20, 2019)]
[Rules and Regulations]
[Page 22702]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-10399]



[[Page 22702]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 886

[Docket No. FDA-2018-N-3066]


Medical Devices; Classification of Accessories Distinct From 
Other Devices; Finalized List of Accessories Suitable for Class I; 
Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Final classification action; correction.

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SUMMARY: The Food and Drug Administration (FDA) is correcting a 
document that appeared in the Federal Register of April 12, 2019. That 
document was published with the instruction to add a section to the 
incorrect subpart. This correction is being made to improve the 
accuracy of the final classification action.

DATES: Effective May 20, 2019, and applicable May 13, 2019.

FOR FURTHER INFORMATION CONTACT: Lisa Granger, Office of Policy and 
Planning, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
32, Rm. 3330, Silver Spring, MD 20993, 301-796-9115.

SUPPLEMENTARY INFORMATION: In FR Doc. 2019-07290 appearing on page 
14865 in the Federal Register of Friday, April 12, 2019, the following 
correction is made:


Sec.  886.4355  [Corrected]

0
1. On page 14870, in the second column, in part 886, amendatory 
instruction 11 is corrected to read as follows:
    ``11. ``Add Sec.  886.4355 to subpart E to read as follows:''

    Dated: May 14, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-10399 Filed 5-17-19; 8:45 am]
 BILLING CODE 4164-01-P
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