42024 Federal Register / Vol. 83, No. 161 / Monday, August 20, 2018 / Rules and Regulations 

parties were invited to participate in 

this rulemaking effort by submitting 

written comments on the proposal to the 

FAA. Five comments were received in 

support of the action. One commenter 

had concerns that were not substantive 

to the establishment of Class E airspace. 

The concerns addressed the quality of 

the altimeter values reported by the 

Creswell Automated Weather Observing 

System (AWOS) and the potential for 

conflict with the visual flight rules 

(VFR) traffic pattern. The concerns 

regarding AWOS have been forwarded 

to the servicing System Support Center. 

The RNAV procedure at Hobby Field 

should only be used when the wind is 

favoring runway 16, so the VFR traffic 

pattern should shift to match. 

Class E airspace designations are 

published in paragraph 6005 of FAA 

Order 7400.11B, dated August 3, 2017, 

and effective September 15, 2017, which 

is incorporated by reference in 14 CFR 

71.1. The Class E airspace designation 

listed in this document will be 

published subsequently in the Order. 

Availability and Summary of 

Documents for Incorporation by 

Reference 

This document amends FAA Order 

7400.11B, Airspace Designations and 

Reporting Points, dated August 3, 2017, 

and effective September 15, 2017. FAA 

Order 7400.11B is publicly available as 

listed in the ADDRESSES section of this 

document. FAA Order 7400.11B lists 

Class A, B, C, D, and E airspace areas, 

air traffic service routes, and reporting 

points. 

The Rule 

This amendment to Title 14, Code of 

Federal Regulations (14 CFR) part 71 

establishes Class E airspace extending 

upward from 700 feet above the surface 

at Hobby Field, Creswell, OR, to 

accommodate new RNAV procedures at 

this airport for the safety and 

management of IFR operations. 

Regulatory Notices and Analyses 

The FAA has determined that this 

regulation only involves an established 

body of technical regulations for which 

frequent and routine amendments are 

necessary to keep them operationally 

current, non-controversial and unlikely 

to result in adverse or negative 

comments. It, therefore: (1) Is not a 

‘‘significant regulatory action’’ under 

Executive Order 12866; (2) is not a 

‘‘significant rule’’ under DOT 

Regulatory Policies and Procedures (44 

FR 11034; February 26, 1979); and (3) 

does not warrant preparation of a 

Regulatory Evaluation as the anticipated 

impact is so minimal. Since this is a 

routine matter that only affects air traffic 

procedures and air navigation, it is 

certified that this rule, when 

promulgated, will not have a significant 

economic impact on a substantial 

number of small entities under the 

criteria of the Regulatory Flexibility Act. 

Environmental Review 

The FAA has determined that this 

action qualifies for categorical exclusion 

under the National Environmental 

Policy Act in accordance with FAA 

Order 1050.1F, ‘‘Environmental 

Impacts: Policies and Procedures,’’ 

paragraph 5–6.5a. This airspace action 

is not expected to cause any potentially 

significant environmental impacts, and 

no extraordinary circumstances exist 

that warrant preparation of an 

environmental assessment. 

Lists of Subjects in 14 CFR Part 71 

Airspace, Incorporation by reference, 

Navigation (air). 

Adoption of the Amendment 

In consideration of the foregoing, the 

Federal Aviation Administration 

amends 14 CFR part 71 as follows: 

PART 71—DESIGNATION OF CLASS A, 

B, C, D, AND E AIRSPACE AREAS; AIR 

TRAFFIC SERVICE ROUTES; AND 

REPORTING POINTS 

■ 1. The authority citation for part 71 

continues to read as follows: 

Authority: 49 U.S.C. 106(f), 106(g); 40103, 

40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 

1959–1963 Comp., p. 389. 

§ 71.1 [Amended] 

■ 2. The incorporation by reference in 

14 CFR 71.1 of FAA Order 7400.11B, 

Airspace Designations and Reporting 

Points, dated August 3, 2017, and 

effective September 15, 2017, is 

amended as follows: 

Paragraph 6005 Class E Airspace Areas 

Extending Upward From 700 Feet or More 

Above the Surface of the Earth. 

* * * * * 

ANM OR E5 Creswell, OR [New] 

Hobby Field, OR 

(Lat. 43°55′51′′ N, long. 123°00′24′′ W) 

That airspace extending upward from 700 

feet above the surface within a 2.1-mile 

radius of Hobby Field, and within 1.8 miles 

each side of the 354° bearing from the airport 

extending from the 2.1-mile radius to 7.1 

miles north of the airport. 

Issued in Seattle, Washington, on August 

13, 2018. 

Shawn M. Kozica, 

Manager, Operations Support Group, Western 

Service Center. 

[FR Doc. 2018–17821 Filed 8–17–18; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 1 

[Docket No. FDA–2012–D–1002] 

Questions and Answers Regarding 

Food Facility Registration (Seventh 

Edition); Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notification of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

announcing the availability of a final 

guidance for industry entitled 

‘‘Questions and Answers Regarding 

Food Facility Registration (Seventh 

Edition).’’ The guidance provides 

updated information relating to the food 

facility registration requirements in the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act). 

DATES: The announcement of the 

guidance is published in the Federal 

Register on August 20, 2018. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time 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 

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. 


daltland on DSKBBV9HB2PROD with RULES
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 


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