Federal Register / Vol. 83, No. 161 / Monday, August 20, 2018 / Rules and Regulations 42025 

• 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– 

2012–D–1002 for ‘‘Questions and 

Answers Regarding Food Facility 

Registration (Seventh Edition).’’ 

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 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: https://www.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

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, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the guidance to the Office of 

Compliance, Division of Field Programs 

and Guidance, 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 guidance. 

FOR FURTHER INFORMATION CONTACT: 

Courtney Buchanan, Center for Food 

Safety and Applied Nutrition, Food and 

Drug Administration, 5001 Campus Dr., 

College Park, MD 20740, 240–402–2487. 

SUPPLEMENTARY INFORMATION: 

I. Background 

We are announcing the availability of 

a guidance for industry entitled 

‘‘Questions and Answers Regarding 

Food Facility Registration (Seventh 

Edition).’’ This guidance provides 

updated information relating to the food 

facility registration requirements in the 

FD&C Act. We are issuing this guidance 

consistent with our good guidance 

practices regulation (21 CFR 10.115). 

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 statutes and regulations. This 

guidance is not subject to Executive 

Order 12866. 

In the Federal Register of December 

27, 2016 (81 FR 95068), we made 

available a draft guidance for industry 

entitled ‘‘Questions and Answers 

Regarding Food Facility Registration 

(Seventh Edition)’’ and gave interested 

parties an opportunity to submit 

comments by March 27, 2017, for us to 

consider before beginning work on the 

final version of the guidance. We 

received numerous comments on the 

draft guidance and have modified the 

final guidance where appropriate. In 

addition, we made editorial changes to 

improve clarity. The guidance 

announced in this notice finalizes the 

draft guidance dated December 2016. 

FDA is also publishing elsewhere in 

this issue of the Federal Register 

notification of availability of a 

supplemental draft guidance document 

entitled ‘‘Supplemental Questions and 

Answers Regarding Food Facility 

Registration’’ that includes additional 

questions and answers to clarify our 

thinking about who should register in 

certain situations involving more than 

one possible registrant, such as a lessor 

and one or more lessees for an 

establishment. When the draft guidance 

is finalized, we intend to incorporate it 

into a future edition of the guidance 

document that is the subject of this 

notification. 

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 

21 CFR 1.230 through 1.235 and 21 CFR 

1.245 have been approved under OMB 

control number 0910–0502. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at either 

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

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

FDA website listed in the previous 

sentence to find the most current 

version of the guidance. 

Dated: August 14, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–17853 Filed 8–17–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF DEFENSE 

Office of the Secretary 

32 CFR Part 295 

[Docket ID: DOD–2017–OS–0024] 

RIN 0790–AJ65 

Office of the Inspector General, 

Freedom of Information Act Program 

AGENCY: Office of Inspector General, 

DoD. 

ACTION: Final rule. 

SUMMARY: This final rule removes DoD’s 

regulation concerning the Office of the 

Inspector General (OIG), Freedom of 


daltland on DSKBBV9HB2PROD with RULES
42026 Federal Register / Vol. 83, No. 161 / Monday, August 20, 2018 / Rules and Regulations 

Information Act program. On February 

6, 2018, the DoD published a revised 

FOIA program rule as a result of the 

FOIA Improvement Act of 2016. When 

the DoD FOIA program rule was revised, 

it included DoD component information 

and removed the requirement for 

component supplementary rules. The 

DoD now has one DoD-level rule for the 

FOIA program that contains all the 

codified information required for the 

Department. Therefore, this part can be 

removed from the CFR. 

DATES: This rule is effective on August 

20, 2018. 

FOR FURTHER INFORMATION CONTACT: 

Mark Dorgan at 703–604–9873. 

SUPPLEMENTARY INFORMATION: It has been 

determined that publication of this CFR 

part removal for public comment is 

impracticable, unnecessary, and 

contrary to public interest since it is 

based on removing DoD internal 

policies and procedures that are 

publically available on the Department’s 

website. 

OIG internal guidance concerning the 

implementation of the FOIA within OIG 

will continue to be published in 

Inspector General Instruction 5400.7 

(available at http://www.dodig.mil/ 

Portals/48/Documents/Policy/IGDINST

%205400.7%20AIG-AM%20signed

%204-16-10.pdf). 

This rule is one of 14 separate DoD 

FOIA rules. With the finalization of the 

DoD-level FOIA rule at 32 CFR part 286, 

the Department is eliminating the need 

for this separate FOIA rule and reducing 

costs to the public as explained in the 

preamble of the DoD-level FOIA rule 

published at 83 FR 5196–5197. 

This rule is not significant under 

Executive Order (E.O.) 12866, 

‘‘Regulatory Planning and Review,’’ 

therefore, E.O. 13771, ‘‘Reducing 

Regulation and Controlling Regulatory 

Costs’’ does not apply. 

List of Subjects in 32 CFR Part 295 

Freedom of information. 

PART 295—[REMOVED] 

■ Accordingly, by the authority of 5 

U.S.C. 301, 32 CFR part 295 is removed. 

Dated: August 15, 2018. 

Aaron T. Siegel, 

Alternate OSD Federal Register Liaison 

Officer, Department of Defense. 

[FR Doc. 2018–17884 Filed 8–17–18; 8:45 am] 

BILLING CODE 5001–06–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 100 

[Docket No. USCG–2018–0781] 

Special Local Regulation; Wheeling 

Vintage Regatta, Wheeling, WV 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of enforcement of 

regulation. 

SUMMARY: The Coast Guard will enforce 

a special local regulation for certain 

navigable waters of the Ohio River 

during the Wheeling Vintage Regatta on 

September 1, 2018 and September 2, 

2018, to provide for the safety of 

persons, vessels, and the marine 

environment on the navigable 

waterways during this event. Our 

special local regulations for annual 

marine events in the Eighth Coast Guard 

District identify the regulated area for 

this event in Wheeling, WV. During the 

enforcement period, entry into this zone 

is prohibited unless authorized by the 

Captain of the Port Marine Safety Unit 

Pittsburgh or a designated 

representative. 

DATES: The regulations in 33 CFR 

100.801, Table 1, line 25, will be 

enforced from 9 a.m. to 6 p.m. each day 

from September 1, 2018 through 

September 2, 2018. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions about this notice of 

enforcement, call or email Petty Officer 

Charles Morris, Marine Safety Unit 

Pittsburgh, U.S. Coast Guard; telephone 

412–221–0807, email Charles.F.Morris@

uscg.mil. 

SUPPLEMENTARY INFORMATION: The Coast 

Guard will enforce a temporary special 

local regulation for the Wheeling 

Vintage Regatta in 33 CFR 100.801, 

Table 1, Sector Ohio Valley Annual and 

Recurring Marine Events, line 25 from 9 

a.m. to 6 p.m. each day from September 

1, 2018 through September 2, 2018. This 

action is being taken to provide for the 

safety of persons, vessels, and the 

marine environment on the navigable 

waters of the Ohio River during this 

event. Our regulation for marine events 

within the Eighth Coast Guard District, 

§ 100.801, specifies the location of the 

regulated area for the Wheeling Vintage 

Regatta, which covers a one-mile stretch 

of the Ohio River. Persons and vessels 

must not enter the regulated area unless 

registered with the sponsor as 

participants, official patrol vessels, or 

authorized by the Captain of the Port 

Marine Safety Unit Pittsburgh (COTP) or 

a designated representative. Persons or 

vessels desiring to enter into or pass 

through the area must request 

permission from the COTP or a 

designated representative. They can be 

reached on VHF–FM channel 16. If 

permission is granted, all persons and 

vessel shall comply with the 

instructions of the COTP or designated 

representative. 

In addition to this notice of 

enforcement in the Federal Register, the 

COTP or a designated representative 

will inform the public through 

Broadcast Notices to Mariners (BNMs), 

Local Notices to Mariners (LNMs), 

Marine Safety Information Bulletins 

(MSIBs), and/or through other means of 

public notice as appropriate at least 24 

hours in advance of each enforcement. 

Dated: August 14, 2018. 

A.W. Demo, 

Commander, U.S. Coast Guard, Captain of 

the Port Marine Safety Unit Pittsburgh. 

[FR Doc. 2018–17856 Filed 8–17–18; 8:45 am] 

BILLING CODE 9110–04–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket Number USCG–2018–0750] 

RIN 1625–AA00 

Safety Zone; Allegheny River Miles 0.7 

to 1.0, Pittsburgh, PA 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule. 

SUMMARY: The Coast Guard is 

establishing a temporary safety zone for 

all navigable waters of the Allegheny 

River, extending the entire width of the 

river, from mile marker (MM) 0.7 to MM 

1.0. This safety zone is necessary to 

protect persons, vessels, and the marine 

environment from potential hazards 

associated with a fireworks display. 

Entry of persons or vessels into this 

zone is prohibited unless authorized by 

the Captain of the Port Marine Safety 

Unit Pittsburgh or a designated 

representative. 

DATES: This rule is effective from 7:30 

p.m. through 9 p.m. on September 11, 

2018. 

ADDRESSES: To view documents 

mentioned in this preamble as being 

available in the docket, go to http://

www.regulations.gov, type USCG–2018– 

0750 in the ‘‘SEARCH’’ box and click 

‘‘SEARCH.’’ Click on Open Docket 

Folder on the line associated with this 

rule. 


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