1052 Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Proposed Rules 

Finally, the FAA proposes 

administrative modifications to the 

airport’s associated legal description. 

Reference to the Battle very high 

frequency omnidirectional range tactical 

air navigation (VORTAC) on line 3 of 

the existing Class E5 legal descriptions 

is no longer needed and should be 

removed. The airspace should be 

described using the airport reference 

point. 

Regulatory Notices and Analyses 

The FAA has determined that this 

proposed regulation only involves an 

established body of technical 

regulations for which frequent and 

routine amendments are necessary to 

keep them operationally current. 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 will 

only affect air traffic procedures and air 

navigation, it is certified that this 

proposed 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 

This proposal will be subject to an 

environmental analysis in accordance 

with FAA Order 1050.1F, 

‘‘Environmental Impacts: Policies and 

Procedures’’ prior to any FAA final 

regulatory action. 

List of Subjects in 14 CFR Part 71 

Airspace, Incorporation by reference, 

Navigation (air). 

The Proposed Amendment 

In consideration of the foregoing, the 

Federal Aviation Administration 

proposes to amend 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 14 CFR 

part 71 continues to read as follows: 

Authority: 49 U.S.C. 106(f); 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 JO 7400.11J, 

Airspace Designations and Reporting 

Points, dated July 31, 2024, and 

effective September 15, 2024, is 

amended as follows: 

Paragraph 6002 Airspace Areas Designated 

as Surface Area. 

* * * * * 

ANM NV E2 Battle Mountain, NV 

[Amended] 

Battle Mountain Airport, NV 

(Lat. 40°35′57′′ N, long. 116°52′28′′ W) 

That airspace extending upward from the 

surface within a 4.4-mile radius of the airport 

and within 1.8 miles southeast and 1.9 miles 

northwest of the 228° bearing extending from 

the 4.4-mile radius to 4.5 miles southwest of 

the airport. 

* * * * * 

Paragraph 6004 Airspace Areas Designated 

as an Extension to a Class D or Class E 

Surface Area. 

* * * * * 

ANM NV E4 Battle Mountain, NV [New] 

Battle Mountain Airport, NV 

(Lat. 40°35′57′′ N, long. 116°52′28′′ W) 

That airspace extending upward from the 

surface within 2.9 miles southeast and 3.4 

miles northwest of the 221° bearing 

extending from the 4.4-mile radius to 10.4 

miles southwest of the airport excluding that 

airspace within the Battle Mountain Airport 

Class E2. 

* * * * * 

Paragraph 6005 Class E Airspace Areas 

Extending Upward From 700 Feet or More 

Above the Surface of the Earth. 

ANM NV E5 Battle Mountain, NV 

[Amended] 

Battle Mountain Airport, NV 

(Lat. 40°35′57′′ N, long. 116°52′28′′ W) 

That airspace extending upward from 700 

feet above the surface within a 5-mile radius 

of the airport, within 4.9 miles northwest and 

1.9 miles southeast of the 051° bearing 

extending from the 5-mile radius to 11.1 

miles northeast of the airport, within 3.5 

miles southeast and 3.6 miles northwest of 

the 221° bearing extending from the 5-mile 

radius to 11.5 miles southwest of the airport, 

within 1.8 miles either side of the 319° 

bearing extending from the 5-mile radius to 

6.7 miles northwest of the airport, and within 

a 5.5-mile radius clockwise from 40°41′1′′ N, 

116°55′12′′ W to 40°41′19′′ N, 116°53′58′′ W. 

* * * * * 

Issued in Washington, DC, on December 

30, 2024. 

B.G. Chew, 

Group Manager, Operations Support Group, 

Western Service Center. 

[FR Doc. 2024–31694 Filed 1–6–25; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 106 and 117 

[Docket No. FDA–2024–D–2604] 

Establishing Sanitation Programs for 

Low-Moisture Ready-To-Eat Human 

Foods and Taking Corrective Actions 

Following a Pathogen Contamination 

Event; Draft Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

Department of Health and Human 

Services (HHS). 

ACTION: Notification of availability. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is announcing the availability of a 

draft guidance for industry entitled 

‘‘Establishing Sanitation Programs for 

Low-Moisture Ready-to-Eat Human 

Foods and Taking Corrective Actions 

Following a Pathogen Contamination 

Event.’’ The draft guidance, when 

finalized, will explain FDA’s current 

thinking on establishing a routine 

sanitation program for low-moisture 

ready-to-eat human foods (LMRTE 

foods) that can help prevent 

contamination of food or a food-contact 

surface with a pathogen and will 

explain our current thinking for 

corrective actions, including corrective 

actions to remediate contamination of 

food-contact surfaces, if prevention 

fails. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by May 7, 2025, to ensure that the 

Agency considers your comment on the 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance 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 


ddrumheller on DSK120RN23PROD with PROPOSALS1
Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Proposed Rules 1053 

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. 

• 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– 

2024–D–2604 for ‘‘Establishing 

Sanitation Programs for Low-Moisture 

Ready-to-Eat Human Foods and Taking 

Corrective Actions Following a 

Pathogen Contamination Event.’’ 

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, 240–402–7500. 

• 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.’’ We 

will review this copy, including the 

claimed confidential information, in our 

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.govinfo.gov/content/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, 240–402–7500. 

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 draft guidance to the Office 

of Microbiological Food Safety, Human 

Foods Program, 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 draft 

guidance. 

FOR FURTHER INFORMATION CONTACT: 

Benjamin Warren, Office of 

Microbiological Food Safety, Human 

Foods Program, Food and Drug 

Administration, 5001 Campus Dr., 

College Park, MD 20740, 240–645–7004, 

Benjamin.Warren@fda.hhs.gov; or Linda 

S. Kahl, Office of Policy, Regulations, 

and Information, Human Foods 

Program, Food and Drug 

Administration, 5001 Campus Dr., 

College Park, MD 20740, 240–402–2784, 

Linda.Kahl@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

We are announcing the availability of 

a draft guidance for industry entitled 

‘‘Establishing Sanitation Programs for 

Low-Moisture Ready-to-Eat Human 

Foods and Taking Corrective Actions 

Following a Pathogen Contamination 

Event.’’ We are issuing the draft 

guidance consistent with our good 

guidance practices regulation (21 CFR 

10.115). The draft guidance, when 

finalized, will represent 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 alternate approach if it 

satisfies the requirements of the 

applicable statutes and regulations. 

We are issuing this draft guidance to 

help manufacturers/processors of 

LMRTE foods comply with 21 CFR part 

117 and, for powdered infant formula, 

21 CFR part 106. Examples of LMRTE 

foods are powdered infant formula, 

peanut butter, nut butters, powdered 

drink mixes, chocolate, medical foods in 

powdered and paste forms, processed 

tree nuts, milk powders, powdered 

spices, snack foods such as chips and 

crackers, granola bars, and dry cereal. 

When finalized, the recommendations 

in this guidance can help 

manufacturers/processors of LMRTE 

foods consider and take actions to help 

ensure a safe and sanitary food supply 

through current good manufacturing 

practices and to establish and 

implement hazard analysis and riskbased preventive controls for these 

foods. The draft guidance, when 

finalized, will explain our current 

thinking on establishing a routine 

sanitation program for LMRTE foods 

that can help prevent contamination of 

food or a food-contact surface with a 

pathogen and will explain our current 

thinking on recommendations for 

corrective actions, including corrective 

actions to remediate contamination of 

food-contact surfaces, if prevention 

fails. 

II. Paperwork Reduction Act of 1995 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. The previously approved 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (PRA) (44 U.S.C. 

3501–3521). The collections of 

information in 21 CFR part 106 have 

been approved under OMB control 

number 0910–0256. The collections of 

information in 21 CFR part 117 have 

been approved under OMB control 

number 0910–0751. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

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

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents, or 

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

FDA website listed in the previous 

sentence to find the most current 

version of the guidance. 


ddrumheller on DSK120RN23PROD with PROPOSALS1
1054 Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Proposed Rules 

Dated: December 27, 2024. 

Kimberlee Trzeciak, 

Deputy Commissioner for Policy, Legislation, 

and International Affairs. 

[FR Doc. 2024–31528 Filed 1–6–25; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF THE INTERIOR 

Fish and Wildlife Service 

50 CFR Part 17 

[Docket No. FWS–R6–ES–2024–0115; 

FXES1113090FEDR–256–FF09E22000] 

RIN 1018–BH97 

Endangered and Threatened Wildlife 

and Plants; Removal of Ute Ladies’- 

Tresses From the List of Endangered 

and Threatened Plants 

AGENCY: Fish and Wildlife Service, 

Interior. 

ACTION: Proposed rule. 

SUMMARY: We, the U.S. Fish and 

Wildlife Service (Service), propose to 

remove Ute ladies’-tresses (Spiranthes 

diluvialis) from the Federal List of 

Endangered and Threatened Plants. This 

determination also serves as our 12- 

month finding on a petition to delist Ute 

ladies’-tresses. After a review of the best 

available scientific and commercial 

information, we find that delisting the 

species is warranted. Our review 

indicates that the threats to Ute ladies’- 

tresses have been eliminated or reduced 

to the point that the species no longer 

meets the definition of an endangered or 

threatened species under the 

Endangered Species Act of 1973, as 

amended (Act). Accordingly, we 

propose to delist Ute ladies’-tresses. If 

we finalize this rule as proposed, the 

prohibitions and conservation measures 

provided by the Act, particularly 

through sections 7 and 9, would no 

longer apply to Ute ladies’-tresses. We 

request information and comments from 

the public regarding this proposed rule 

and the draft post-delisting monitoring 

(PDM) plan for Ute ladies’-tresses. 

DATES: We will accept comments 

received or postmarked on or before 

March 10, 2025. Comments submitted 

electronically using the Federal 

eRulemaking Portal (see ADDRESSES, 

below) must be received by 11:59 p.m. 

eastern time on the closing date. We 

must receive requests for public 

hearings, in writing, at the address 

shown in FOR FURTHER INFORMATION

CONTACT by February 21, 2025. 

ADDRESSES: You may submit comments 

by one of the following methods: 

(1) Electronically: Go to the Federal 

eRulemaking Portal: https://

www.regulations.gov. In the Search box, 

enter FWS–R6–ES–2024–0115, which is 

the docket number for this rulemaking. 

Then, click on the Search button. On the 

resulting page, in the Search panel on 

the left side of the screen, under the 

Document Type heading, check the 

Proposed Rule box to locate this 

document. You may submit a comment 

by clicking on ‘‘Comment.’’ 

(2) By hard copy: Submit by U.S. mail 

to: Public Comments Processing, Attn: 

FWS–R6–ES–2024–0115, U.S. Fish and 

Wildlife Service, MS: PRB/3W, 5275 

Leesburg Pike, Falls Church, VA 22041– 

3803. 

We request that you send comments 

only by the methods described above. 

We will post all comments on https:// 

www.regulations.gov. This generally 

means that we will post any personal 

information you provide us (see 

Information Requested, below, for more 

information). 

Availability of supporting materials: 

This proposed rule and supporting 

documents, including the 5-year review, 

draft recovery plan, draft post-delisting 

monitoring plan (PDM), and the species 

status assessment (SSA) report, are 

available at https://www.regulations.gov 

under Docket No. FWS–R6–ES–2024– 

0115 and on the Service’s website at 

https://ecos.fws.gov/ecp/species/2159. 

FOR FURTHER INFORMATION CONTACT: 

George Weekley, Field Office 

Supervisor, U.S. Fish and Wildlife 

Service, Utah Ecological Services Field 

Office, 2369 West Orton Circle, Suite 50, 

West Valley City, UT 84119; telephone 

801–239–0561. Individuals in the 

United States who are deaf, deafblind, 

hard of hearing, or have a speech 

disability may dial 711 (TTY, TDD, or 

TeleBraille) to access 

telecommunications relay services. 

Individuals outside the United States 

should use the relay services offered 

within their country to make 

international calls to the point-ofcontact in the United States. Please see 

Docket No. FWS–R6–ES–2024–0115 on 

https://www.regulations.gov for a 

document that summarizes this 

proposed rule. 

SUPPLEMENTARY INFORMATION: 

Executive Summary 

Why we need to publish a rule. Under 

the Act, a species warrants delisting if 

it no longer meets the definition of an 

endangered species (in danger of 

extinction throughout all or a significant 

portion of its range) or a threatened 

species (likely to become an endangered 

species within the foreseeable future 

throughout all or a significant portion of 

its range). Ute ladies’-tresses is listed as 

threatened, and we are proposing to 

delist it. We have determined Ute 

ladies’-tresses does not meet the Act’s 

definition of an endangered or 

threatened species. Delisting a species 

can be completed only by issuing a rule 

through the Administrative Procedure 

Act rulemaking process (5 U.S.C. 551 et 

seq.). 

What this document does. This action 

proposes to remove Ute ladies’-tresses 

from the List of Endangered and 

Threatened Plants (i.e., ‘‘delist’’ the 

species) based on its recovery. 

The basis for our action. Under the 

Act, we may determine that a species is 

an endangered species or a threatened 

species because of any of five factors: 

(A) The present or threatened 

destruction, modification, or 

curtailment of its habitat or range; (B) 

overutilization for commercial, 

recreational, scientific, or educational 

purposes; (C) disease or predation; (D) 

the inadequacy of existing regulatory 

mechanisms; or (E) other natural or 

manmade factors affecting its continued 

existence. The determination to delist a 

species must be based on an analysis of 

the same factors. 

Under the Act, we must review the 

status of all listed species at least once 

every 5 years. We must delist a species 

if we determine, based on the best 

available scientific and commercial 

data, that the species is neither an 

endangered species nor a threatened 

species. Our regulations at 50 CFR 

424.11(e) identify four reasons why we 

might determine a species shall be 

delisted: (1) The species is extinct; (2) 

the species has recovered to the point at 

which it no longer meets the definition 

of an endangered species or a threatened 

species; (3) new information that has 

become available since the original 

listing decision shows the listed entity 

does not meet the definition of an 

endangered species or a threatened 

species; or (4) new information that has 

become available since the original 

listing decision shows the listed entity 

does not meet the definition of a 

species. We have determined that Ute 

ladies’-tresses has recovered to the point 

at which it no longer meets the 

definition of an endangered species or a 

threatened species; therefore, we are 

proposing to delist it. 

Information Requested 

We intend that any final action 

resulting from this proposed rule will be 

based on the best scientific and 

commercial data available and be as 

accurate and as effective as possible. 

Therefore, we request comments or 


ddrumheller on DSK120RN23PROD with PROPOSALS1