Federal Register / Vol. 82, No. 164 / Friday, August 25, 2017 / Rules and Regulations 40485 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2013–N–1425 for ‘‘What You Need To 

Know About the FDA Regulation: 

Mitigation Strategies to Protect Food 

Against Intentional Adulteration—Small 

Entity Compliance Guide.’’ Received 

comments will be placed in the docket 

and, except for those submitted as 

‘‘Confidential Submissions,’’ publicly 

viewable at https://www.regulations.gov 

or at the Dockets Management Staff 

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

Monday through Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: http://www.fda.gov/ 

regulatoryinformation/dockets/ 

default.htm. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff office, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

Submit written requests for single 

copies of the SECG to the Office of 

Analytics and Outreach, Center for Food 

Safety and Applied Nutrition, Food and 

Drug Administration, 5001 Campus Dr., 

College Park, MD 20740. Send two selfaddressed adhesive labels to assist that 

office in processing your request. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the SECG. 

FOR FURTHER INFORMATION CONTACT: 

Ryan Newkirk, Center for Food Safety 

and Applied Nutrition, Food and Drug 

Administration, 5001 Campus Dr., 

College Park, MD 20740, 240–402–3712. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of May 27, 

2016 (81 FR 34166), we issued a final 

rule titled ‘‘Mitigation Strategies to 

Protect Food Against Intentional 

Adulteration’’ (the final rule) in which 

we require domestic and foreign food 

facilities that are required to register 

under the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) to address 

hazards that may be introduced with the 

intention to cause wide scale public 

health harm. The final rule, which is 

codified at part 121 (21 CFR part 121), 

became effective July 26, 2016, but has 

compliance dates staggered starting 3 

years after publication of the final rule. 

We examined the economic 

implications of the final rule as required 

by the Regulatory Flexibility Act (5 

U.S.C. 601–612) and determined that 

the final rule will have a significant 

economic impact on a substantial 

number of small entities. In compliance 

with section 212 of the Small Business 

Regulatory Enforcement Fairness Act 

(Pub. L. 104–121, as amended by Pub. 

L. 110–28), we are making available the 

SECG to reduce the burden of 

determining how to comply by further 

explaining and clarifying the actions 

that a small entity must take to comply 

with the rule. 

We are issuing the SECG consistent 

with our good guidance practices 

regulation (21 CFR 10.115(c)(2)). The 

SECG 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 

statutes and regulations. This is not a 

significant regulatory action subject to 

Executive Order 12866 and does not 

impose any additional burden on 

regulated entities. 

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 121 have been approved under 

OMB control number 0910–0812. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the SECG at either https:// 

www.fda.gov/FoodGuidances, or https:// 

www.regulations.gov. Use the FDA Web 

site listed in the previous sentence to 

find the most current version of the 

guidance. 

Dated: August 21, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–18028 Filed 8–24–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket No. USCG–2017–0317] 

Safety Zones; Recurring Annual 

Events Held in Coast Guard Sector 

Boston Captain of the Port Zone 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of enforcement of 

regulation. 

SUMMARY: The Coast Guard will enforce 

two safety zones within the Captain of 

the Port Boston zone on August 31, 

2017. This action is necessary to ensure 

the safety of vessels, spectators, and 

participants from hazards associated 

with fireworks displays. During the 


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40486 Federal Register / Vol. 82, No. 164 / Friday, August 25, 2017 / Rules and Regulations 

enforcement period, no person or vessel, 

except for the safety vessels assisting 

with the events, may enter the safety 

zones without permission of the Captain 

of the Port (COTP) or his designated onscene representative. 

DATES: The regulation in 33 CFR 

165.119(a)(2) and (4) will be enforced 

during the dates and times in the table 

displayed in SUPPLEMENTARY

INFORMATION below. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions about this notice of 

enforcement, call or email Mark Cutter, 

Sector Boston Waterways Management 

Division, U.S. Coast Guard; telephone 

617–223–4000, email Mark.E.Cutter@

uscg.mil. 

SUPPLEMENTARY INFORMATION: The Coast 

Guard will enforce the safety zones 

listed in 33 CFR 165.119(a)(2) and (4) on 

the specified dates and times as 

indicated in the following table: 

33 CFR 165.119 

Name Location Date Time 

Long Wharf Safety Zone .... All U.S. navigable waters of Boston inner Harbor within a 700-foot radius of the fireworks barge in approximate position 42°21′41.2′′ N. 

071°02′36.5′′ W. (NAD 1983), located off of Long Wharf, Boston, MA.

August 31, 2017 ... 8 p.m. to 10 p.m. 

Pier 6 Safety Zone ............. All U.S. navigable waters of Boston inner Harbor within a 700-foot radius of the fireworks barge in approximate position 42°21′11.9′′ N. 

071°02′1.3′′ W. (NAD 1983), located off of Pier 6, South Boston, MA.

August 31, 2017 ... 8 p.m. to 10 p.m. 

The final rule establishing these safety 

zones was published in the Federal 

Register on May 12, 2014 (79 FR 26846). 

This notice of enforcement is issued 

under authority of 33 CFR 165.119 and 

5 U.S.C. 552 (a). During the enforcement 

period, persons and vessels are 

prohibited from entering into, transiting 

through, mooring, or anchoring within 

the safety zone unless they receive 

permission from the COTP or 

designated representative. In addition to 

this notice of enforcement in the 

Federal Register, the Coast Guard plans 

to provide mariners with advanced 

notification of this enforcement period 

via the Local Notice to Mariners. 

Dated: August 21, 2017. 

C.C. Gelzer, 

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

Port Boston. 

[FR Doc. 2017–18030 Filed 8–24–17; 8:45 am] 

BILLING CODE 9110–04–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket Number USCG–2017–0811] 

RIN 1625–AA00 

Safety Zone, Delaware River; Dredging 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule; with 

request for comments. 

SUMMARY: The Coast Guard is 

establishing temporary safety zones in 

portions of Bellevue Range, Marcus 

Hook Range, Anchorage 7 off Marcus 

Hook Range, Chester Range, and 

Eddystone Range, on the Delaware 

River, in Philadelphia, PA. The safety 

zone will temporarily restrict vessel 

traffic from transiting or anchoring in a 

portion of the Delaware River while 

dredging operations are being 

conducted to facilitate the Delaware 

River Main Channel Deepening project 

for the main navigational channel of the 

Delaware River. This regulation is 

necessary to provide for the safety of life 

on navigable waters of the Delaware 

River, in the vicinity of dredging 

activity and is intended to protect 

mariners from the hazards associated 

with pipe-laying and dredging 

operations. 

DATES: This rule is effective from 

August 30, 2017, through March 15, 

2018. 

ADDRESSES: You may submit comments 

identified by docket number USCG– 

2017–0811 using the Federal 

eRulemaking Portal at http://

www.regulations.gov. See the ‘‘Public 

Participation and Request for 

Comments’’ portion of the 

SUPPLEMENTARY INFORMATION section for 

further instructions on submitting 

comments. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions about this 

rulemaking, call or email Petty Officer 

Amanda Boone, U.S. Coast Guard, 

Sector Delaware Bay, Waterways 

Management Division, telephone (215) 

271–4814, email Amanda.N.Boone@

uscg.mil. 

SUPPLEMENTARY INFORMATION: 

I. Table of Abbreviations 

CFR Code of Federal Regulations 

DHS Department of Homeland Security 

E.O. Executive Order 

FR Federal Register 

Pub. L. Public Law 

§ Section 

U.S.C. United States Code 

COTP Captain of the Port 

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 because doing 

so would be impractical and contrary to 

the public interest. Final details for the 

dredging operation were not received by 

the Coast Guard until August 10, 2017. 

Vessels transiting through Bellevue 

Range, Chester Range, Eddystone Range, 

and Marcus Hook Range or attempting 

to enter the waters of Anchorage 7 off 

Marcus Hook Range during dredging 

operations may be at risk. We are taking 

immediate action to help protect the 

safety of the project personnel, vessels, 

and the marine environment on the 

navigable waters within the safety zones 

while dredging is being conducted. It is 

important to have these regulations in 

effect during dredging operations and it 

is impracticable to delay the regulations. 

We are issuing this rule and, under 5 

U.S.C. 553(d)(3), the Coast Guard finds 

that good cause exists for making it 

effective less than 30 days after 

publication in the Federal Register 

because doing so would be contrary to 

the public interest. Allowing this 

dredging operation to go forward 

without safety zones in place would 

expose mariners and the public to 

unnecessary dangers. 


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