Federal Register / Vol. 82, No. 213 / Monday, November 6, 2017 / Rules and Regulations 51347 

compliance dates (Ref. 1). If a contract 

prevents a co-manufacturer from being 

able to review a brand owner’s 

documentation of supplier verification 

activities, the co-manufacturer would 

not be able to verify suppliers based on 

its review of that documentation. 

Consequently, the co-manufacturer 

would need to conduct supplier 

verification activities (e.g., on-site 

audits) that might otherwise not be 

required. 

To provide time for contracts to be 

revised to allow co-manufacturers to 

review all necessary documentation 

from the brand owner, FDA is 

announcing that, under certain 

circumstances and on a temporary basis, 

we do not intend to take enforcement 

action against a receiving facility that is 

a co-manufacturer, and that is not in 

compliance with certain supply-chain 

program requirements (§§ 117.410(d) 

and 117.415(a)(3) or §§ 507.110(d) and 

507.115(a)(3)) for food manufactured for 

the brand owner until November 6, 

2019. Furthermore, we do not intend to 

take enforcement action under the FSVP 

regulation against an importer who is 

relying on § 1.502(c)(3) but whose 

supply-chain program is subject to 

enforcement discretion regarding 

§§ 117.410(d) and 117.415(a)(3) or 

§§ 507.110(d) and 507.115(a)(3). 

The guidance represents the current 

thinking of FDA on this topic. It does 

not establish any rights for any person 

and is not binding on FDA or the public. 

You can use an alternative approach if 

it satisfies the requirements of the 

applicable statues and regulations. 

II. Paperwork Reduction Act of 1995 

This guidance refers to previously 

approved collections of information 

found in FDA regulations. These 

collections of information 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). The collections of information in 

part 117 have been approved under 

OMB control number 0910–0751. The 

collections of information in part 507 

have been approved under OMB control 

number 0910–0789. 

III. Electronic Access 

Persons with access to the internet 

may obtain the document at https://

www.fda.gov/Food/Guidance

Regulation/GuidanceDocuments

RegulatoryInformation/default.htm, 

https://www.fda.gov/AnimalVeterinary/ 

GuidanceComplianceEnforcement/ 

default.htm, or https://

www.regulations.gov. Use the FDA Web 

sites listed in the previous sentence to 

find the most current version of the 

guidance. 

IV. Reference 

The following reference is on display 

in the Dockets Management Staff (see 

ADDRESSES) and is available for viewing 

by interested persons between 9 a.m. 

and 4 p.m., Monday through Friday; it 

is also available electronically at https:// 

www.regulations.gov. 

1. Letter from Grocery Manufacturers 

Association to Dr. Stephen Ostroff, 

Acting Commissioner of Food and Drugs, 

February 7, 2017. 

Dated: October 31, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–24098 Filed 11–3–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket Number USCG–2017–1011] 

RIN 1625–AA00 

Safety Zone, Delaware River; Pipeline 

Removal 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule. 

SUMMARY: The Coast Guard is 

establishing temporary safety zones in 

the Mifflin Range on the Delaware River 

to facilitate pipeline removal in 

preparation for the deepening of the 

Delaware River. The safety zones will be 

established for the waters in the vicinity 

of the dredge, dredge equipment, dive 

operations, and pipe removal 

operations. This regulation is necessary 

to provide for the safety of life on 

navigable waters of the Delaware River 

in the vicinity of pipeline removal 

operations and to protect mariners from 

the hazards associated with dredging 

and pipeline removal operations. Entry 

of vessels or persons into these zones is 

prohibited unless specifically 

authorized by the Captain of the Port 

Delaware Bay. 

DATES: This rule is effective from 

November 6, 2017, through December 4, 

2017. 

ADDRESSES: To view documents 

mentioned in this preamble as being 

available in the docket, go to http://

www.regulations.gov, type USCG–2017– 

1011 in the ‘‘SEARCH’’ box and click 

‘‘SEARCH.’’ Click on Open Docket 

Folder on the line associated with this 

rule. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this rule, call or 

email Petty Officer Edmund Ofalt, 

Waterways Management Branch, U.S. 

Coast Guard Sector Delaware Bay; 

telephone (215) 271–4814, email 

Edmund.J.Ofalt@uscg.mil. 

SUPPLEMENTARY INFORMATION: 

I. Table of Abbreviations 

CFR Code of Federal Regulations 

COTP Captain of the Port 

DHS Department of Homeland Security 

FR Federal Register 

NPRM Notice of proposed rulemaking 

§ Section 

U.S.C. United States Code 

II. Background Information and 

Regulatory History 

The Coast Guard is issuing this 

temporary rule without prior notice and 

opportunity to comment pursuant to 

authority under section 4(a) of the 

Administrative Procedure Act (APA) (5 

U.S.C. 553(b)). This provision 

authorizes an agency to issue a rule 

without prior notice and opportunity to 

comment when the agency for good 

cause finds that those procedures are 

‘‘impracticable, unnecessary, or contrary 

to the public interest.’’ Under 5 U.S.C. 

553(b)(B), the Coast Guard finds that 

good cause exists for not publishing a 

notice of proposed rulemaking (NPRM) 

with respect to this rule due to the short 

time period between when Sector 

Delaware Bay received complete details 

of this project, October 20, 2017, and the 

date when these safety zones needed to 

go into effect by. It is impracticable and 

contrary to the public interest to publish 

an NPRM to provide a notice and 

opportunity for comment period 

because the safety zones must be 

established by November 6, 2017 to 

ensure safety of life on navigable waters 

in the vicinity of dredging operations, 

underwater cutting operations, and 

pipeline removal operations and to 

protect mariners from hazards 

associated with the same. 

Under 5 U.S.C. 553(d)(3), the Coast 

Guard finds that good cause exists for 

making this rule effective less than 30 

days after publication in the Federal 

Register. Delaying the effective date of 

this rule would be impracticable and 

contrary to the public interest because 

immediate action is needed to mitigate 

the hazards presented to safety of life on 

the Delaware River by the presence of 

dredge equipment, dredging operations, 

dive operations, and pipeline removal 

operations. 


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51348 Federal Register / Vol. 82, No. 213 / Monday, November 6, 2017 / Rules and Regulations 

III. Legal Authority and Need for Rule 

The Coast Guard is issuing this rule 

under authority in 33 U.S.C. 1231. The 

Captain of the Port (COTP) Delaware 

Bay has determined that potential 

hazards associated with dredging, dive 

operations, and pipeline removal 

operations starting November 6, 2017, 

will be a safety concern for vessels 

attempting to transit the Delaware River 

along the Mifflin Range. This rule is 

needed to protect personnel, vessels, 

and the marine environment on the 

navigable waters within the safety zone 

while dredging, dive operations, and 

pipeline removal operations are being 

conducted. 

IV. Discussion of the Rule 

This rule establishes two safety zones 

on a portion of the Mifflin Range, just 

upriver of the green 63 buoy, in the 

Delaware River from November 6, 2017, 

through December 4, 2017, unless 

cancelled earlier by the COTP, to 

facilitate dredging, dive operations, and 

pipeline removal. Dredging operations 

to expose the pipeline will commence 

on November 6, 2017. The hopper 

dredge 549 will be conducting the 

dredging operations and will be 

attended by the towing vessel SHELBY. 

Dive operations will commence 

approximately one week after the 

completion of dredging operations and 

will continue through completion of 

removal of the pipeline. 

Safety zone one includes all navigable 

waters within 250 yards of the dredge 

barge 549 and associated pipeline 

removal equipment, to include any 

equipment located within Anchorage 9 

near the entrance to Mantua Creek 

found in 33 CFR 110.157(a)(10). 

Safety zone two includes all navigable 

waters within 250 yards of the dive 

barge 543 and all associated pipeline 

removal equipment, to include any 

equipment located within Anchorage 9 

near the entrance to Mantua Creek 

Found in 33 CFR 110.157 (a)(10). 

Vessels requesting to transit either 

safety zone must contact the towing 

vessel SHELBY on VHF–FM channel 13 

or 65, at least 1 hour, as well as 30 

minutes prior to arrival to arrange safe 

passage. Vessels may also contact the 

COTP for permission to enter or transit 

either safety zone on VHF–FM channel 

16. 

V. Regulatory Analyses 

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 protestors. 

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, this rule 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 regulatory action determination 

is based on the size, location, and 

duration of the safety zones. Although 

this regulation will restrict access to 

regulated areas, the effect of this rule 

will not be significant because there are 

a number of alternate anchorages 

available. Furthermore, vessels may be 

permitted to transit through the safety 

zone with the permission of the COTP 

or make satisfactory passing 

arrangements with the towing vessel 

SHELBY in accordance with this rule 

and the Rules of the Road (33 CFR 

subchapter E). Extensive notification of 

the safety zones to the maritime public 

will be made via maritime advisories 

allowing mariners to alter their plans 

accordingly. 

B. Impact on Small Entities 

The Regulatory Flexibility Act of 

1980, 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 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 safety 

zone 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 section. 

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 will not call for a new 

collection of information under the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501–3520). 

D. Federalism and Indian Tribal 

Governments 

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. If you 

believe this rule has implications for 

federalism or Indian tribes, please 

contact the person listed in the FOR

FURTHER INFORMATION CONTACT section 

above. 

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 


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Federal Register / Vol. 82, No. 213 / Monday, November 6, 2017 / Rules and Regulations 51349 

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 rule 

will not result in such an expenditure, 

we do discuss the effects of this rule 

elsewhere in this preamble. 

F. Environment 

We have analyzed this rule under 

Department of Homeland Security 

Management Directive 023–01 and 

Commandant Instruction M16475.lD, 

which guide the Coast Guard in 

complying with the National 

Environmental Policy Act of 1969 (42 

U.S.C. 4321–4370f), and have 

determined that this action is a category 

of actions that do not individually or 

cumulatively have a significant effect on 

the human environment. This rule 

involves a safety zone that encompasses 

all navigable waters within 250 yards of 

a dredge, diving operations, pipeline 

removal operations and all associated 

equipment. It is categorically excluded 

from further review under paragraph 

34(g) of Figure 2–1 of the Commandant 

Instruction. A Record of Environmental 

Consideration supporting this 

determination is available in the docket 

where indicated under ADDRESSES. 

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 165 

Harbors, Marine Safety, Navigation 

(water), Reporting and recordkeeping 

requirements, Security measures, 

Waterways. 

For the reasons discussed in the 

preamble, the Coast Guard amends 33 

CFR part 165 as follows: 

PART 165—REGULATED NAVIGATION 

AREAS AND LIMITED ACCESS AREAS 

■ 1. The authority citation for part 165 

continues to read as follows: 

Authority: 33 U.S.C. 1231; 50 U.S.C. 191; 

33 CFR 1.05–1, 6.04–1, 6.04–6, and 160.5; 

Department of Homeland Security Delegation 

No. 0170.1. 

■ 2. Add § 165.T05–1011, to read as 

follows: 

§ 165.T05–1011 Safety Zone, Delaware 

River; Pipeline Removal. 

(a) Location. The following areas are 

safety zones: 

(1) Safety zone one includes all 

navigable waters within 250 yards of the 

dredge barge 549 and associated 

equipment operating in Mifflin Range 

and Anchorage 9 near the entrance to 

Mantua Creek, upriver of green buoy 63, 

on the Delaware River. 

(2) Safety zone two includes all 

navigable waters within 250 yards of the 

dive barge 543 and associated 

equipment operating in Mifflin range 

and Anchorage 9 near the entrance to 

Mantua Creek, upriver of green buoy 63, 

on the Delaware River. 

(b) Definitions. (1) Captain of the Port 

means the Commander Sector Delaware 

Bay or any Coast Guard commissioned, 

warrant, or petty officer who has been 

authorized by the Captain of the Port to 

act on his behalf. 

(2) Designated representative means 

any Coast Guard commissioned, warrant 

or petty officer who has been authorized 

by the Captain of the Port, Delaware 

Bay, to assist with the enforcement of 

safety zones described in paragraph (a) 

of this section. 

(c) Regulations. The general safety 

zone regulations found in 33 CFR part 

165 subpart C apply to the safety zone 

created by this section. 

(1) Entry into or transiting within 

either safety zone is prohibited unless 

vessels obtain permission from the 

Captain of the Port via VHF–FM 

channel 16, or make satisfactory passing 

arrangements via VHF–FM channels 13 

or 65, with the towing vessel SHELBY 

per this section and the rules of the 

Road (33 CFR subchapter E). Vessels 

requesting to transit shall contact the 

towing vessel SHELBY on channel 13 or 

65, at least 1 hour, as well as 30 

minutes, prior to arrival. 

(2) Vessels granted permission to 

enter and transit the safety zone must do 

so in accordance with any directions or 

orders of the Captain of the Port, his 

designated representative, or the towing 

vessel SHELBY. No person or vessel 

may enter or remain in a safety zone 

without permission from the Captain of 

the Port or the towing vessel SHELBY. 

(3) At least one side of the main 

navigational channel will be kept clear 

for safe passage of vessels. 

(4) This section applies to all vessels 

that intend to transit through the safety 

zone except vessels that are engaged in 

the following operations: Enforcement 

of laws; service of aids to navigation, 

and emergency response. 

(d) Enforcement periods. This section 

will be enforced from November 6, 

2017, through December, 4 2017. 

Dated: November 1, 2017. 

Scott E. Anderson, 

Captain, U.S. Coast Guard, Captain of the 

Port, Delaware Bay. 

[FR Doc. 2017–24068 Filed 11–3–17; 8:45 am] 

BILLING CODE 9110–04–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R01–OAR–2017–0138; FRL–9970–41– 

Region 1] 

Air Plan Approval; New Hampshire; 

Rules for Open Burning and 

Incinerators; Withdrawal of Direct Final 

Rule 

AGENCY: Environmental Protection 

Agency. 

ACTION: Withdrawal of direct final rule. 

SUMMARY: Due to the receipt of an 

adverse comment, the Environmental 

Protection Agency (EPA) is withdrawing 

the September 6, 2017 direct final rule 

approving a State Implementation Plan 

(SIP) revision submitted by the State of 

New Hampshire. New Hampshire’s SIP 

revision establishes emission standards 

and operating practices for incinerators 

and wood waste burners that are not 

regulated pursuant to federal incinerator 

standards. This action is being taken in 

accordance with the Clean Air Act. 

DATES: The direct final rule was 

published on September 6, 2017 (82 FR 

42037), and is withdrawn effective 

November 6, 2017. 

FOR FURTHER INFORMATION CONTACT: 

Alison Simcox, Air Quality Planning 

Unit, U.S. Environmental Protection 

Agency, New England Regional Office, 5 

Post Office Square—Suite 100, (Mail 

code OEP05–2), Boston, MA 02109— 

3912, telephone (617) 918–1684, 

facsimile (617) 918–0684, email 

simcox.alison@epa.gov. 

SUPPLEMENTARY INFORMATION: In the 

direct final rule, EPA stated that if 

adverse comments were submitted by 

October 6, 2017, the rule would be 

withdrawn and not take effect. EPA 

received an adverse comment prior to 

the close of the comment period and, 

therefore, is withdrawing the direct final 

rule. EPA will address the comment in 

a subsequent final action based upon 

the proposed rule also published on 

September 6, 2017 (82 FR 42054). EPA 

will not institute a second comment 

period on this action. 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Carbon monoxide, 


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