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for Low-Moisture Ready-To-Eat Human Foods and Taking Corrective Actions Following a Pathogen Contamination Event; Draft Guidance for Industry; Availability, 1052-1054 [2024-31528]

Download as PDF 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 ddrumheller on DSK120RN23PROD with PROPOSALS1 Authority: 49 U.S.C. 106(f); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959– 1963 Comp., p. 389. [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 ■ VerDate Sep<11>2014 16:20 Jan 06, 2025 Jkt 265001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Paragraph 6002 Airspace Areas Designated as Surface Area. Food and Drug Administration * 21 CFR Parts 106 and 117 * * ANM NV E2 [Amended] * * Battle Mountain, NV 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 [Amended] Battle Mountain, NV 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. * 1. The authority citation for 14 CFR part 71 continues to read as follows: ■ § 71.1 effective September 15, 2024, is amended as follows: * * * * 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 PO 00000 Frm 00004 Fmt 4702 Sfmt 4702 [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 Food and Drug Administration, Department of Health and Human Services (HHS). ACTION: Notification of availability. AGENCY: 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. SUMMARY: 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: DATES: 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 E:\FR\FM\07JAP1.SGM 07JAP1 Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Proposed Rules ddrumheller on DSK120RN23PROD with PROPOSALS1 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 VerDate Sep<11>2014 16:20 Jan 06, 2025 Jkt 265001 1053 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-201509-18/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. 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. FOR FURTHER INFORMATION CONTACT: II. Paperwork Reduction Act of 1995 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 PO 00000 Frm 00005 Fmt 4702 Sfmt 4702 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. E:\FR\FM\07JAP1.SGM 07JAP1 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 Fish and Wildlife Service, Interior. ACTION: Proposed rule. AGENCY: 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 12month 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: ddrumheller on DSK120RN23PROD with PROPOSALS1 SUMMARY: VerDate Sep<11>2014 16:20 Jan 06, 2025 Jkt 265001 (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 PO 00000 Frm 00006 Fmt 4702 Sfmt 4702 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 E:\FR\FM\07JAP1.SGM 07JAP1

Agencies

[Federal Register Volume 90, Number 4 (Tuesday, January 7, 2025)]
[Proposed Rules]
[Pages 1052-1054]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-31528]


=======================================================================
-----------------------------------------------------------------------

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

[[Page 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 self-addressed 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, 
[email protected]; 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, 
[email protected].

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 risk-based 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.


[[Page 1054]]


    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

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