40484 Federal Register / Vol. 82, No. 164 / Friday, August 25, 2017 / Rules and Regulations 

(viii) Messier-Bugatti-Dowty Service 

Bulletin 631–32–219, dated March 3, 2014, 

which was incorporated by reference on 

December 29, 2015 (80 FR 73096, November 

24, 2015). 

(ix) Messier-Bugatti-Dowty Service Bulletin 

631–32–220, dated March 3, 2014, which was 

incorporated by reference on December 29, 

2015 (80 FR 73096, November 24, 2015). 

(x) Messier-Bugatti-Dowty Service Bulletin 

631–32–232, dated December 8, 2014, which 

is not incorporated by reference in this AD. 

(r) Other FAA AD Provisions 

The following provisions also apply to this 

AD: 

(1) Alternative Methods of Compliance 

(AMOCs): The Manager, International 

Section, Transport Standards Branch, FAA, 

has the authority to approve AMOCs for this 

AD, if requested using the procedures found 

in 14 CFR 39.19. In accordance with 14 CFR 

39.19, send your request to your principal 

inspector or local Flight Standards District 

Office, as appropriate. If sending information 

directly to the manager of the International 

Branch, send it to the attention of the person 

identified in paragraph (s)(2) of this AD. 

Information may be emailed to: 9-ANM-116- 

AMOC-REQUESTS@faa.gov. 

(i) Before using any approved AMOC, 

notify your appropriate principal inspector, 

or lacking a principal inspector, the manager 

of the local flight standards district office/ 

certificate holding district office. 

(ii) AMOCs approved previously for AD 

2015–23–12 are approved as AMOCs for the 

corresponding provisions of this AD. 

(2) Contacting the Manufacturer: As of the 

effective date of this AD, for any requirement 

in this AD to obtain corrective actions from 

a manufacturer, the action must be 

accomplished using a method approved by 

the Manager, International Section, Transport 

Standards Branch, FAA; or the EASA; or 

ATR—GIE Avions de Transport Re ́gional’s 

EASA DOA. If approved by the DOA, the 

approval must include the DOA-authorized 

signature. 

(s) Related Information 

(1) Refer to Mandatory Continuing 

Airworthiness Information (MCAI) EASA 

Airworthiness Directive 2016–0135, dated 

July 8, 2016, for related information. This 

MCAI may be found in the AD docket on the 

Internet at http://www.regulations.gov by 

searching for and locating Docket No. FAA– 

2017–0516. 

(2) For more information about this AD, 

contact Shahram Daneshmandi, Aerospace 

Engineer, International Section, Transport 

Standards Branch, FAA, 1601 Lind Avenue 

SW., Renton, WA 98057–3356; telephone 

425–227–1112; fax 425–227–1149. 

(3) Service information identified in this 

AD that is not incorporated by reference is 

available at the addresses specified in 

paragraphs (t)(5) and (t)(6) of this AD. 

(t) Material Incorporated by Reference 

(1) The Director of the Federal Register 

approved the incorporation by reference 

(IBR) of the service information listed in this 

paragraph under 5 U.S.C. 552(a) and 1 CFR 

part 51. 

(2) You must use this service information 

as applicable to do the actions required by 

this AD, unless this AD specifies otherwise. 

(3) The following service information was 

approved for IBR on September 29, 2017. 

(i) Messier-Bugatti-Dowty Service Bulletin 

631–32–213, Revision 2, dated March 15, 

2016. 

(ii) Messier-Bugatti-Dowty Service Bulletin 

631–32–214, Revision 1, dated March 15, 

2016. 

(iii) Messier-Bugatti-Dowty Service 

Bulletin 631–32–215, Revision 1, dated 

March 15, 2016. 

(iv) Messier-Bugatti-Dowty Service Bulletin 

631–32–216, Revision 3, dated March 15, 

2016. 

(v) Messier-Bugatti-Dowty Service Bulletin 

631–32–219, Revision 1, dated March 15, 

2016. 

(vi) Messier-Bugatti-Dowty Service Bulletin 

631–32–220, Revision 1, dated March 15, 

2016. 

(vii) Messier-Bugatti-Dowty Service 

Bulletin 631–32–224, dated March 15, 2016. 

(viii) Messier-Bugatti-Dowty Service 

Bulletin 631–32–231, dated March 15, 2016. 

(ix) Messier-Bugatti-Dowty Service Bulletin 

631–32–232, Revision 1, dated March 15, 

2016. 

(x) Messier-Bugatti-Dowty Service Bulletin 

631–32–233, dated March 15, 2016. 

(xi) Messier-Bugatti-Dowty Service Bulletin 

631–32–234, dated March 15, 2016. 

(xii) Messier-Bugatti-Dowty Service 

Bulletin 631–32–235, dated March 15, 2016. 

(4) The following service information was 

approved for IBR on December 29, 2015 (80 

FR 73096, November 24, 2015). 

(i) Messier-Bugatti-Dowty Service Bulletin 

631–32–213, dated December 16, 2013. 

(ii) Messier-Bugatti-Dowty Service Bulletin 

631–32–214, dated January 13, 2014. 

(iii) Messier-Bugatti-Dowty Service 

Bulletin 631–32–215, dated January 13, 2014. 

(iv) Messier-Bugatti-Dowty Service Bulletin 

631–32–216, Revision 1, dated December 17, 

2013. Pages 4, 5, and 8 of this service bulletin 

are the original issue and are dated October 

30, 2013. 

(v) Messier-Bugatti-Dowty Service Bulletin 

631–32–219, dated March 3, 2014. 

(vi) Messier-Bugatti-Dowty Service Bulletin 

631–32–220, dated March 3, 2014. 

(5) For service information identified in 

this AD, contact ATR–GIE Avions de 

Transport Re ́gional, 1, Alle ́e Pierre Nadot, 

31712 Blagnac Cedex, France; telephone +33 

(0) 5 62 21 62 21; fax +33 (0) 5 62 21 67 18; 

email continued.airworthiness@atr.fr; 

Internet http://www.aerochain.com. 

(6) You may view this service information 

at the FAA, Transport Standards Branch, 

1601 Lind Avenue SW., Renton, WA. For 

information on the availability of this 

material at the FAA, call 425–227–1221. 

(7) You may view this service information 

that is incorporated by reference at the 

National Archives and Records 

Administration (NARA). For information on 

the availability of this material at NARA, call 

202–741–6030, or go to: http://

www.archives.gov/federal-register/cfr/ibrlocations.html. 

Issued in Renton, Washington, on August 

8, 2017. 

Dionne Palermo, 

Acting Director, System Oversight Division, 

Aircraft Certification Service. 

[FR Doc. 2017–17398 Filed 8–24–17; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 121 

[Docket No. FDA–2013–N–1425] 

Mitigation Strategies To Protect Food 

Against Intentional Adulteration: What 

You Need To Know About the Food 

and Drug Administration Regulation: 

Small Entity Compliance Guide; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notification of availability. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is announcing the availability of a 

guidance for industry entitled 

‘‘Mitigation Strategies to Protect Food 

Against Intentional Adulteration: What 

You Need To Know About the FDA 

Regulation: Small Entity Compliance 

Guide.’’ The small entity compliance 

guide (SECG) is intended to help small 

entities comply with the final rule 

entitled ‘‘Mitigation Strategies to Protect 

Food Against Intentional Adulteration.’’ 

DATES: The announcement of the 

guidance is published in the Federal 

Register on August 25, 2017. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time 

comments as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 


pmangrum on DSK3GDR082PROD with RULES
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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