82 FR 50082 - Drawbridge Operation Regulation; Nanticoke River, Seaford, DE
DEPARTMENT OF HOMELAND SECURITY
Coast Guard Federal Register Volume 82, Issue 208 (October 30, 2017)
Coast Guard
Federal Register Volume 82, Issue 208 (October 30, 2017)
| Page Range | 50082-50084 | |
| FR Document | 2017-23559 |
[Federal Register Volume 82, Number 208 (Monday, October 30, 2017)] [Rules and Regulations] [Pages 50082-50084] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-23559] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 117 [Docket No. USCG 2017-0162] RIN 1625-AA09 Drawbridge Operation Regulation; Nanticoke River, Seaford, DE AGENCY: Coast Guard, DHS. ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: The Coast Guard is modifying the operating schedule that governs the SR 13 Bridge across the Nanticoke River, mile 39.6, in Seaford, Delaware (DE). This modification will require the [[Page 50083]] bridge to open on signal every Saturday and Sunday during the winter season, if at least 24 hours notice is given. This action is necessary to balance bridge operations and maintenance with the existing needs of navigation. DATES: This rule is effective November 29, 2017. ADDRESSES: To view documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov. Type USCG- 2017-0162 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. Martin A. Bridges, Fifth Coast Guard District (dpb), at (757) 398-6422, email [email protected]. SUPPLEMENTARY INFORMATION section below for instructions on submitting comments. SUPPLEMENTARY INFORMATION: I. Table of Abbreviations CFR Code of Federal Regulations DHS Department of Homeland Security FR Federal Register NPRM Notice of proposed rulemaking Sec. Section U.S.C. United States Code II. Background Information and Regulatory History On July 5, 2017, we published a notice of proposed rulemaking entitled, ``Drawbridge Regulation; Nanticoke River, Seaford, DE'' in the Federal Register (see 82 FR 127). We did not receive any comments on the proposed rule. III. Legal Authority and Need for Rule The Coast Guard is issuing this rule under authority 33 U.S.C. 499. The US 13 Bridge across the Nanticoke River, Mile 39.6, in Seaford, DE, owned and operated by the Delaware Department of Transportation, has a vertical clearance of 3 feet above mean high water in the closed-to- navigation position. There is a monthly average of three bridge openings on Saturdays and Sundays, from 7:30 a.m. to 3:30 p.m., from November 1 through March 31, which allow one or more vessels to transit through the bridge during each opening. The bridge is normally maintained in the closed position, due to the volume of vehicular traffic crossing the bridge. The current operating schedule is published in 33 CFR 117.243(b). The Coast Guard's authority to make a permanent change to a drawbridge operating schedule is contained in 33 CFR 117.8. The Nanticoke River is used predominately by recreational vessels and pleasure craft. The three-year average number of bridge openings, maximum number of bridge openings, and weekend bridge openings between 7:30 a.m. and 3:30 p.m., by month and overall for 2014 through 2016, as drawn from the data contained in the bridge tender logs provided by the Delaware Department of Transportation, is presented below. ---------------------------------------------------------------------------------------------------------------- Proposed weekends-- Month Average Maximum average openings 7:30 openings openings a.m.-3:30 p.m. ---------------------------------------------------------------------------------------------------------------- January.................................................. 11 31 3 February................................................. 1 3 1 March.................................................... 21 53 4 April.................................................... 72 91 N/A May...................................................... 138 192 N/A June..................................................... 150 168 N/A July..................................................... 280 175 N/A August................................................... 198 223 N/A September................................................ 144 214 N/A October.................................................. 51 66 N/A November................................................. 8 13 5 December................................................. 1 4 1 Monthly.................................................. 89 223 3 Daily.................................................... 3 7 <1 ---------------------------------------------------------------------------------------------------------------- IV. Discussion of Comments, Changes and the Final Rule The Delaware Department of Transportation has requested to modify the operating regulation for the bridge, due to the limited number of requested openings of the bridge on Saturday and Sunday, from 7:30 a.m. to 3:30 p.m., from November 1 through March 31, over a period of approximately the past three years. The data presented in the table above demonstrate that the requested modification may be implemented with minimal impact to navigation. The modification requested will require the bridge to open on signal on Saturday and Sunday; from 7:31 a.m. to 3:29 p.m., from November 1 through March 31, if at least 24 hours notice is given. All other provisions of 33 CFR 117.243 (b) will remain the same. The Coast Guard provided a comment period of 60 days and received zero comments on the proposed rule. V. Regulatory Analysis We developed this rule after considering numerous statutes and Executive Orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive Orders, and we discuss First Amendment rights of protesters. A. Regulatory Planning and Review Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. This rule has not been designated a ``significant regulatory action,'' under Executive Order 12866. Accordingly, it has not been reviewed by the Office of Management and Budget (OMB) and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771. This is not considered a significant regulatory action. This determination is based on the findings that: (1) The potential impact is small, given the limited number of vessels requiring a bridge opening during the time frame of the proposed modification, and (2) vessels will be able to transit through the bridge during the time frame of the proposed modification, given the bridge will open on signal, if at least 24 hours notice is given. [[Page 50084]] B. Impact on Small Entities The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as amended, requires federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term ``small entities'' comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard received zero comments from the Small Business Administration on this rule. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. While some owners or operators of vessels intending to transit the bridge may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator. Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT, above. Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard. C. Collection of Information This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). D. Federalism and Indian Tribal Government A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132. Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. We received zero comments on this rule. E. Unfunded Mandates Reform Act The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this proposed rule will not result in such an expenditure, we do discuss the effects of this proposed rule elsewhere in this preamble. We received zero comments on this rule. F. Environment We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have made a determination that this action is one of a category of actions which do not individually or cumulatively have a significant effect on the human environment. This rule simply promulgates the operating regulations or procedures for drawbridges. This action is categorically excluded from further review, under figure 2-1, paragraph (32)(e), of the Instruction. A preliminary Record of Environmental Consideration and a Memorandum for the Record are not required for this rule. G. Protest Activities The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the FOR FURTHER INFORMATION CONTACT section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places or vessels. List of Subjects in 33 CFR Part 117 Bridges. For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 117 as follows: PART 117--DRAWBRIDGE OPERATION REGULATIONS 0 1. The authority citation for part 117 continues to read as follows: Authority: 33 U.S.C. 499; 33 CFR 1.05-1; Department of Homeland Security Delegation No. 0170.1. 0 2. Revise Sec. 117.243(b) to read as follows: Sec. 117.243 Nanticoke River. * * * * * (b) The draw of the SR 13 Bridge, mile 39.6, in Seaford shall: (1) Open on signal, except from 6 p.m. to 8 a.m., from April 1 through October 31; from November 1 through March 31, Monday to Friday and on Saturday and Sunday from 3:30 p.m. to 7:30 a.m., if at least four hours notice is given. (2) Open on signal, on Saturday and Sunday, from 7:31 a.m. through 3:29 p.m., from November 1 through March 31, if at least 24 hours notice is given. Dated: October 10, 2017. M.L. Austin, Rear Admiral, U.S. Coast Guard, Commander, Fifth Coast Guard District. [FR Doc. 2017-23559 Filed 10-27-17; 8:45 am] BILLING CODE 9110-04-P
![50082 Federal Register / Vol. 82, No. 208 / Monday, October 30, 2017 / Rules and Regulations
TABLE 1—NON-EEG PHYSIOLOGICAL SIGNAL BASED SEIZURE MONITORING SYSTEM RISKS AND MITIGATION MEASURES—
Continued
Identified risks Mitigation measures
Incorrect alerts, including:
• Missing a seizure—device fails to identify physiological signal Clinical performance testing;
that is associated with a seizure; or. Non-clinical performance testing;
• False alarm—device mistakenly identifies a physiological signal Software verification, validation, and hazard analysis;
as being associated with a seizure. Labeling; and
Training.
FDA has determined that special Therefore, under the Federal Food, monitoring for seizure-related activity in
controls, in combination with the Drug, and Cosmetic Act and under the intended population and for the
general controls, address these risks to authority delegated to the Commissioner intended use setting. Performance
health and provide reasonable assurance of Food and Drugs, 21 CFR part 882 is measurements must include positive
of the safety and effectiveness. In order amended as follows: percent agreement and false alarm rate.
for a device to fall within this (5) Training must be provided for
classification, and thus avoid automatic PART 882—NEUROLOGICAL DEVICES intended users that includes
classification in class III, it would have information regarding the proper use of
to comply with the special controls ■ 1. The authority citation for part 882 the device and factors that may affect
named in this final order. The necessary continues to read as follows: the collection of the physiologic data.
special controls appear in the regulation Authority: 21 U.S.C. 351, 360, 360c, 360e, (6) The labeling must include health
codified by this order. This device is 360j, 360l, 371. care professional labeling and patient-
subject to premarket notification ■ 2. Add § 882.1580 to subpart B to read caregiver labeling. The health care
requirements under section 510(k) of the as follows: professional and the patient-caregiver
FD&C Act. labeling must include the following
At the time of classification, non-EEG § 882.1580 Non-electroencephalogram information:
physiological signal based seizure (EEG) physiological signal based seizure (i) A detailed summary of the clinical
monitoring systems are for prescription monitoring system. performance testing, including any
use only. Prescription devices are (a) Identification. A non- adverse events and complications.
exempt from the requirement for electroencephalogram (non-EEG) (ii) Any instructions technicians and
adequate directions for use for the physiological signal based seizure clinicians should convey to patients and
layperson under section 502(f)(1) of the monitoring system is a noninvasive caregivers regarding the proper use of
FD&C Act (21 U.S.C. 352(f)(1)) and 21 prescription device that collects the device and factors that may affect
CFR 801.5, as long as the conditions of physiological signals other than EEG to the collection of the physiologic data.
21 CFR 801.109 are met. identify physiological signals that may (iii) Instructions to technicians and
be associated with a seizure. clinicians regarding how to set the
III. Analysis of Environmental Impact (b) Classification. Class II (special device threshold to achieve the
The Agency has determined under 21 controls). The special controls for this intended performance of the device.
CFR 25.34(b) that this action is of a type device are: Dated: October 24, 2017.
that does not individually or (1) The technical parameters of the
Lauren Silvis,
cumulatively have a significant effect on device, hardware and software, must be
Chief of Staff.
the human environment. Therefore, fully characterized and include the
following information: [FR Doc. 2017–23516 Filed 10–27–17; 8:45 am]
neither an environmental assessment
nor an environmental impact statement (i) Hardware specifications must be BILLING CODE 4164–01–P
is required. provided. Appropriate verification,
validation, and hazard analysis must be
IV. Paperwork Reduction Act of 1995 performed. DEPARTMENT OF HOMELAND
This final order establishes special (ii) Software, including any SECURITY
controls that refer to previously proprietary algorithm(s) used by the
approved collections of information device to achieve its intended use, must Coast Guard
found in other FDA regulations. These be described in detail in the Software
collections of information are subject to Requirements Specification (SRS) and 33 CFR Part 117
review by the Office of Management and Software Design Specification (SDS). [Docket No. USCG 2017–0162]
Budget (OMB) under the Paperwork Appropriate software verification,
Reduction Act of 1995 (44 U.S.C. 3501– validation, and hazard analysis must be RIN 1625–AA09
3520). The collections of information in performed. Drawbridge Operation Regulation;
part 807, subpart E, regarding premarket (2) The patient-contacting
Nanticoke River, Seaford, DE
notification submissions have been components of the device must be
approved under OMB control number demonstrated to be biocompatible. AGENCY: Coast Guard, DHS.
nlaroche on DSK9F9SC42PROD with RULES
0910–0120, and the collections of (3) The device must be designed and ACTION: Final rule.
information in 21 CFR part 801, tested for electrical, thermal, and
regarding labeling have been approved mechanical safety and electromagnetic SUMMARY: The Coast Guard is modifying
under OMB control number 0910–0485. compatibility (EMC). the operating schedule that governs the
(4) Clinical performance testing must SR 13 Bridge across the Nanticoke
List of Subjects in 21 CFR Part 882 demonstrate the ability of the device to River, mile 39.6, in Seaford, Delaware
Medical devices. function as an assessment aid for (DE). This modification will require the
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![50084 Federal Register / Vol. 82, No. 208 / Monday, October 30, 2017 / Rules and Regulations
B. Impact on Small Entities between the national government and coordinate protest activities so that your
The Regulatory Flexibility Act of 1980 the States, or on the distribution of message can be received without
(RFA), 5 U.S.C. 601–612, as amended, power and responsibilities among the jeopardizing the safety or security of
requires federal agencies to consider the various levels of government. We have people, places or vessels.
potential impact of regulations on small analyzed this rule under that Order and
have determined that it is consistent List of Subjects in 33 CFR Part 117
entities during rulemaking. The term
with the fundamental federalism Bridges.
‘‘small entities’’ comprises small
principles and preemption requirements For the reasons discussed in the
businesses, not-for-profit organizations
described in Executive Order 13132. preamble, the Coast Guard amends 33
that are independently owned and Also, this rule does not have tribal
operated and are not dominant in their CFR part 117 as follows:
implications under Executive Order
fields, and governmental jurisdictions 13175, Consultation and Coordination PART 117—DRAWBRIDGE
with populations of less than 50,000. with Indian Tribal Governments, OPERATION REGULATIONS
The Coast Guard received zero because it does not have a substantial
comments from the Small Business direct effect on one or more Indian ■ 1. The authority citation for part 117
Administration on this rule. The Coast tribes, on the relationship between the continues to read as follows:
Guard certifies under 5 U.S.C. 605(b) Federal Government and Indian tribes, Authority: 33 U.S.C. 499; 33 CFR 1.05–1;
that this rule will not have a significant or on the distribution of power and Department of Homeland Security Delegation
economic impact on a substantial responsibilities between the Federal No. 0170.1.
number of small entities. While some Government and Indian tribes. We
owners or operators of vessels intending ■ 2. Revise § 117.243(b) to read as
received zero comments on this rule. follows:
to transit the bridge may be small
entities, for the reasons stated in section E. Unfunded Mandates Reform Act § 117.243 Nanticoke River.
V.A above, this rule will not have a The Unfunded Mandates Reform Act * * * * *
significant economic impact on any of 1995 (2 U.S.C. 1531–1538) requires (b) The draw of the SR 13 Bridge, mile
vessel owner or operator. Federal agencies to assess the effects of 39.6, in Seaford shall:
Under section 213(a) of the Small their discretionary regulatory actions. In (1) Open on signal, except from 6 p.m.
Business Regulatory Enforcement particular, the Act addresses actions to 8 a.m., from April 1 through October
Fairness Act of 1996 (Pub. L. 104–121), that may result in the expenditure by a 31; from November 1 through March 31,
we want to assist small entities in State, local, or tribal government, in the Monday to Friday and on Saturday and
understanding this rule. If the rule aggregate, or by the private sector of Sunday from 3:30 p.m. to 7:30 a.m., if
would affect your small business, $100,000,000 (adjusted for inflation) or at least four hours notice is given.
organization, or governmental more in any one year. Though this (2) Open on signal, on Saturday and
jurisdiction and you have questions proposed rule will not result in such an Sunday, from 7:31 a.m. through 3:29
concerning its provisions or options for expenditure, we do discuss the effects of p.m., from November 1 through March
compliance, please contact the person this proposed rule elsewhere in this 31, if at least 24 hours notice is given.
listed in the FOR FURTHER INFORMATION preamble. We received zero comments
CONTACT, above. Dated: October 10, 2017.
on this rule.
Small businesses may send comments M.L. Austin,
on the actions of Federal employees F. Environment Rear Admiral, U.S. Coast Guard, Commander,
who enforce, or otherwise determine We have analyzed this rule under Fifth Coast Guard District.
compliance with, Federal regulations to Department of Homeland Security [FR Doc. 2017–23559 Filed 10–27–17; 8:45 am]
the Small Business and Agriculture Management Directive 023–01 and BILLING CODE 9110–04–P
Regulatory Enforcement Ombudsman Commandant Instruction M16475.lD,
and the Regional Small Business which guides the Coast Guard in
Regulatory Fairness Boards. The complying with the National ENVIRONMENTAL PROTECTION
Ombudsman evaluates these actions Environmental Policy Act of 1969 AGENCY
annually and rates each agency’s (NEPA) (42 U.S.C. 4321–4370f), and
responsiveness to small business. If you have made a determination that this 40 CFR Part 180
wish to comment on actions by action is one of a category of actions [EPA–HQ–OPP–2017–0155; FRL–9968–12]
employees of the Coast Guard, call 1– which do not individually or
888–REG–FAIR (1–888–734–3247). The cumulatively have a significant effect on Hexythiazox; Pesticide Tolerances
Coast Guard will not retaliate against the human environment. This rule
small entities that question or complain simply promulgates the operating AGENCY: Environmental Protection
about this rule or any policy or action regulations or procedures for Agency (EPA).
of the Coast Guard. drawbridges. This action is categorically ACTION: Final rule.
excluded from further review, under
C. Collection of Information SUMMARY: This regulation amends an
figure 2–1, paragraph (32)(e), of the
This rule calls for no new collection Instruction. A preliminary Record of existing tolerance for residues of the
of information under the Paperwork Environmental Consideration and a ovicide/miticide hexythiazox in/on hop,
Reduction Act of 1995 (44 U.S.C. 3501– Memorandum for the Record are not dried cones, by increasing the current
3520). required for this rule. tolerance from 2.0 parts per million
(ppm) to 20 ppm. Gowan Company
nlaroche on DSK9F9SC42PROD with RULES
D. Federalism and Indian Tribal G. Protest Activities requested modification of this tolerance
Government The Coast Guard respects the First under the Federal Food, Drug, and
A rule has implications for federalism Amendment rights of protesters. Cosmetic Act (FFDCA).
under Executive Order 13132, Protesters are asked to contact the DATES: This regulation is effective
Federalism, if it has a substantial direct person listed in the FOR FURTHER October 30, 2017. Objections and
effect on the States, on the relationship INFORMATION CONTACT section to requests for hearings must be received
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Document Created: 2017-10-28 00:28:36
Document Modified: 2017-10-28 00:28:36
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final rule. | |
| Dates | This rule is effective November 29, 2017. | |
| Contact | If you have questions on this rule, call or email Mr. Martin A. Bridges, Fifth Coast Guard District (dpb), at (757) 398-6422, email [email protected] | |
| FR Citation | 82 FR 50082 | |
| RIN Number | 1625-AA09 |
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