Federal Register / Vol. 83, No. 160 / Friday, August 17, 2018 / Rules and Regulations 40985 

IX. Paperwork Reduction Act of 1995 

The Voluntary Malfunction Summary 

Reporting Program described in this 

Notice contains information collection 

provisions that are subject to review by 

the Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (44 U.S.C. 3501–3520). 

These provisions have been approved 

under OMB control number 0910–0437. 

This document also refers to 

previously approved collections of 

information. These collections of 

information are subject to review by the 

OMB under the PRA (44 U.S.C. 3501– 

3520). The collections of information in 

part 4, subpart B, regarding 

postmarketing safety reporting for 

combination products have been 

approved under OMB control number 

0910–0834; the collections of 

information in part 803, regarding 

medical device reporting, have been 

approved under OMB control number 

0910–0437; the collections of 

information in 806, regarding 

corrections and removals, have been 

approved under OMB control number 

0910–0359; the collections of 

information in 21 CFR part 807, subpart 

E, regarding premarket notification, 

have been approved under OMB control 

number 0910–0120; the collections of 

information in 21 CFR part 814, 

subparts A through E, regarding 

premarket approval, have been 

approved under OMB control number 

0910–0231; the collections of 

information in 21 CFR part 810, 

regarding medical device recall 

authority, have been approved under 

OMB control number 0910–0432; the 

collections of information in part 820, 

regarding quality system regulations, 

have been approved under OMB control 

number 0910–0073; the collections of 

information in 21 CFR parts 1002 

through 1050, regarding radiological 

health, have been approved under OMB 

control number 0910–0025; the 

collections of information regarding the 

MedWatch: The Food and Drug 

Administration Medical Products 

Reporting Program have been approved 

under OMB control number 0910–0291; 

and the collections of information 

regarding the Adverse Event Program for 

Medical Devices (Medical Product 

Safety Network (MedSun)) have been 

approved under OMB control number 

0910–0471. 

X. References 

The following references are on 

display in the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852 and are available 

for viewing by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday; they are also available 

electronically at https://

www.regulations.gov. FDA has verified 

the website addresses, as of the date this 

document publishes in the Federal 

Register, but websites are subject to 

change over time. 

1. Medical Device User Fee Agreement IV 

Commitment Letter, available at https:// 

www.fda.gov/downloads/ForIndustry/ 

UserFees/MedicalDeviceUserFee/ 

UCM535548.pdf. 

2. Food and Drug Administration, ‘‘Medical 

Device Reporting—Alternative Summary 

Reporting (ASR) Program; Guidance for 

Industry,’’ (October 19, 2000); available 

at https://www.fda.gov/downloads/ 

MedicalDevices/DeviceRegulation

andGuidance/GuidanceDocuments/ 

ucm072102.pdf. 

3. Food and Drug Administration, ‘‘Medical 

Device Reporting for Manufacturers; 

Guidance for Industry and Food and 

Drug Administration Staff,’’ (November 

8, 2016); available at https://

www.fda.gov/downloads/ 

medicaldevices/deviceregulationand

guidance/guidancedocuments/ 

ucm359566.pdf. 

4. Food and Drug Administration, ‘‘Center for 

Devices and Radiological Health Appeals 

Processes; Guidance for Industry and 

Food and Drug Administration Staff,’’ 

(May 17, 2013); available at https://

www.fda.gov/downloads/ 

MedicalDevices/DeviceRegulationand

Guidance/GuidanceDocuments/ 

UCM284670.pdf. 

5. Food and Drug Administration, 

‘‘International Medical Device Regulators 

Forum,’’ available at https://

www.fda.gov/MedicalDevices/ 

InternationalPrograms/IMDRF/ 

default.htm. 

6. Appendix A, ‘‘Case Examples of Summary 

Malfunction Reporting,’’ available in 

Docket No. FDA–2017–N–6730. 

7. Food and Drug Administration, 

‘‘Postmarketing Safety Reporting for 

Combination Products; Draft Guidance 

for Industry and Food and Drug 

Administration Staff,’’ (March 2018); 

available at https://www.fda.gov/ 

downloads/RegulatoryInformation/ 

Guidances/UCM601454.pdf. 

8. Food and Drug Administration, 

‘‘Compliance Policy for Combination 

Product Postmarketing Safety Reporting, 

Immediately in Effect Guidance for 

Industry and Food and Drug 

Administration Staff,’’ available at 

https://www.fda.gov/Regulatory

Information/Guidances/ucm601456.htm. 

9. Food and Drug Administration, Form FDA 

3500A, available at https://www.fda.gov/ 

downloads/aboutfda/reportsmanuals

forms/forms/ucm048334.pdf. 5. 

10. Electronic Medical Device Reporting 

(eMDR) (manufacturers may obtain 

information on how to prepare and 

submit reports in an electronic format 

that FDA can process, review, and 

archive), available at: https://

www.fda.gov/ForIndustry/ 

FDAeSubmitter/ucm107903.htm. 

Dated: August 13, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–17770 Filed 8–16–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 117 

[Docket No. USCG–2018–0775] 

Drawbridge Operation Regulation; 

Columbia River, Portland, OR and 

Vancouver, WA 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of deviation from 

drawbridge regulation. 

SUMMARY: The Coast Guard has issued a 

temporary deviation from the operating 

schedule that governs the Interstate 5 (I– 

5) Bridges across the Columbia River, 

mile 106.5, between Portland, Oregon, 

and Vancouver, Washington. The 

deviation is necessary to facilitate the 

presence of participants in the Hands 

Across the Bridge Project. This 

deviation allows the bridges to remain 

in the closed-to-navigation position 

during the event. 

DATES: This deviation is effective from 

11 a.m. to 2 p.m. on September 3, 2018. 

ADDRESSES: The docket for this 

deviation, USCG–2018–0775 is available 

at http://www.regulations.gov. Type the 

docket number in the ‘‘SEARCH’’ box 

and click ‘‘SEARCH.’’ Click on Open 

Docket Folder on the line associated 

with this deviation. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this temporary 

deviation, call or email Mr. Steven 

Fischer, Bridge Administrator, 

Thirteenth Coast Guard District; 

telephone 206–220–7282, email d13-pfd13bridges@uscg.mil. 

SUPPLEMENTARY INFORMATION: Oregon 

Department of Transportation (bridge 

owner) requested a temporary deviation 

from the operating schedule for the I–5 

Bridges, mile 106.5, across the Columbia 

River between Vancouver, WA, and 

Portland, OR, to facilitate safe passage of 

participants in the Hands Across the 

Bridge Project. The I–5 Bridges provides 

three designated navigation channels 

with vertical clearances ranging from 39 

to 72 feet above Columbia River Datum 

0.0 while the lift spans are in the closedto-navigation position. The normal 

operating schedule for the I–5 Bridges is 

33 CFR 117.869. The subject bridges 

need not open to marine vessels during 


daltland on DSKBBV9HB2PROD with RULES
40986 Federal Register / Vol. 83, No. 160 / Friday, August 17, 2018 / Rules and Regulations 

the deviation period from 11 a.m. to 2 

p.m. on September 3, 2018. The bridge 

shall operate in accordance with 33 CFR 

117.869 at all other times. Waterway 

usage on this part of the Columbia River 

includes vessels ranging from large 

commercial ships, tug and tow vessels 

to recreational pleasure craft. 

Vessels able to pass under the bridges 

in the closed-to-navigation positions 

may do so at any time. Both bridges will 

be able to open for emergencies, and 

there is no immediate alternate route for 

vessels to pass. The Coast Guard will 

also inform the users of the waterways 

through our Local and Broadcast 

Notices to Mariners of the change in 

operating schedule for the bridge so that 

vessels can arrange their transits to 

minimize any impact caused by the 

temporary deviation. 

In accordance with 33 CFR 117.35(e), 

the drawbridges must return to their 

regular operating schedule immediately 

at the end of the effective period of this 

temporary deviation. This deviation 

from the operating regulations is 

authorized under 33 CFR 117.35. 

Dated: August 9, 2018. 

Steven M. Fischer, 

Bridge Administrator, Thirteenth Coast Guard 

District. 

[FR Doc. 2018–17801 Filed 8–16–18; 8:45 am] 

BILLING CODE 9110–04–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 117 

[Docket No. USCG–2018–0676] 

Drawbridge Operation Regulation; 

Willamette River at Portland, OR 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of deviation from 

drawbridge regulation; modification. 

SUMMARY: The Coast Guard has modified 

a temporary deviation from the 

operating schedule that governs the 

Hawthorne Bridge crosses the 

Willamette River, mile 13.1, at Portland, 

OR. The deviation is necessary to 

accommodate a filming event for a 

movie. This modified deviation changes 

the period the bridge is authorized to 

remain in the closed-to-navigation 

position. 

DATES: This modified deviation is 

effective from 6 p.m. on September 8, 

2018, to 12:01 a.m. on September 9, 

2018. 

ADDRESSES: The docket for this 

deviation, USCG–2018–0676 is available 

at http://www.regulations.gov. Type the 

docket number in the ‘‘SEARCH’’ box 

and click ‘‘SEARCH.’’ Click on Open 

Docket Folder on the line associated 

with this deviation. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this 

modification, call or email Mr. Steven 

Fischer, Bridge Administrator, 

Thirteenth Coast Guard District; 

telephone 206–220–7282, email d13-pfd13bridges@uscg.mil. 

SUPPLEMENTARY INFORMATION: On July 

19, 2018, we published a temporary 

deviation entitled ‘‘Drawbridge 

Operation Regulation; Willamette River 

at Portland, OR’’ in the Federal Register 

(83 FR 34041). That temporary deviation 

allowed the subject bridge to not open 

to marine vessels from 6 p.m. on 

September 1, 2018 to 12:01 a.m. on 

September 2, 2018. Multnomah County, 

the bridge owner, requested a 

modification of the current published 

deviation to the following times: 6 p.m. 

on September 8, 2018, to 12:01 a.m. on 

September 9, 2018. This change is due 

to scheduling issues with the filming 

crew for a movie. 

The Hawthorne Bridge provides a 

vertical clearance of 49 feet in the 

closed-to-navigation position referenced 

to the vertical clearance above Columbia 

River Datum 0.0. The subject bridge 

operates per 33 CFR 117.897(c)(3)(v). 

Waterway usage on this part of the 

Willamette River includes vessels 

ranging from commercial tug and barge 

to small pleasure craft. The Coast Guard 

requested objections to this 

modification from local mariners via 

email. No objections were submitted to 

us. Waterway usage on this part of the 

Willamette River includes vessels 

ranging from commercial tug and barge 

to small pleasure craft. 

Vessels able to pass through the 

bridge in the closed-to-navigation 

position may do so at any time. The 

bridge will be able to open for 

emergencies, and there is no immediate 

alternate route for vessels to pass. The 

Coast Guard will inform the users of the 

waterway, through our Local and 

Broadcast Notices to Mariners, of the 

change in operating schedule for the 

bridge so that vessel operators can 

arrange their transits to minimize any 

impact caused by the temporary 

deviation. 

In accordance with 33 CFR 117.35(e), 

the drawbridge must return to its regular 

operating schedule immediately at the 

end of the effective period of this 

temporary deviation. This deviation 

from the operating regulations is 

authorized under 33 CFR 117.35. 

Dated: August 9, 2018. 

Steven M. Fischer, 

Bridge Administrator, Thirteenth Coast Guard 

District. 

[FR Doc. 2018–17800 Filed 8–16–18; 8:45 am] 

BILLING CODE 9110–04–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 9 and 721 

[EPA–HQ–OPPT–2017–0414; FRL–9971–37] 

RIN 2070–AB27 

Significant New Use Rules on Certain 

Chemical Substances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Direct final rule. 

SUMMARY: EPA is promulgating 

significant new use rules (SNURs) under 

the Toxic Substances Control Act 

(TSCA) for 27 chemical substances 

which were the subject of 

premanufacture notices (PMNs). The 

chemical substances are subject to 

Orders issued by EPA pursuant to 

section 5(e) of TSCA. This action 

requires persons who intend to 

manufacture (defined by statute to 

include import) or process any of these 

27 chemical substances for an activity 

that is designated as a significant new 

use by this rule to notify EPA at least 

90 days before commencing that 

activity. The required notification 

initiates EPA’s evaluation of the 

intended use within the applicable 

review period. Persons may not 

commence manufacture or processing 

for the significant new use until EPA 

has conducted a review of the notice, 

made an appropriate determination on 

the notice, and has taken such actions 

as are required with that determination. 

DATES: This rule is effective on October 

16, 2018. For purposes of judicial 

review, this rule shall be promulgated at 

1 p.m. (e.s.t.) on August 31, 2018. 

Written adverse comments on one or 

more of these SNURs must be received 

on or before September 17, 2018 (see 

Unit VI. of the SUPPLEMENTARY

INFORMATION). If EPA receives written 

adverse comments on one or more of 

these SNURs before September 17, 2018, 

EPA will withdraw the relevant sections 

of this direct final rule before its 

effective date. 

For additional information on related 

reporting requirement dates, see Units 

I.A., VI., and VII. of the SUPPLEMENTARY

INFORMATION. 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 


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