Food and Drug Administration Enforcement Policy for Association of American Feed Control Officials-Defined Animal Feed Ingredients; Guidance for Industry; Availability, 84819-84820 [2024-24715]

Download as PDF Federal Register / Vol. 89, No. 206 / Thursday, October 24, 2024 / Rules and Regulations transportation for the passenger’s convenience that departs before the payment can be made, the payment shall be sent to the passenger within 24 hours. The air carrier may offer free or discounted transportation in place of the cash payment. In that event, the carrier must disclose all material restrictions on the use of the free or discounted transportation before the passenger decides whether to accept the transportation in lieu of a cash or check payment. The passenger may insist on the cash/check payment or refuse all compensation and bring private legal action. Passenger’s Options Acceptance of the compensation may relieve (name of air carrier) from any further liability to the passenger caused by its failure to honor the confirmed reservation. However, the passenger may decline the payment and seek to recover damages in a court of law or in some other manner. * * * * * PART 254—DOMESTIC BAGGAGE LIABILITY 4. The authority citation for 14 CFR part 254 continues to read as follows: ■ Authority: 49 U.S.C. 40113, 41501, 41504, 41510, 41702, and 41707. § 254.4 [Amended] 5. Section 254.4 is amended by removing ‘‘$3,800’’ and adding ‘‘$4,700’’ in its place. ■ § 254.5 [Amended] 6. Section 254.5 is amended in paragraph (b) by removing ‘‘$3,800’’ and adding ‘‘$4,700’’ in its place. ■ Issued in Washington, DC, pursuant to authority delegated in 49 CFR 1.27(n). Subash Iyer, Acting General Counsel. [FR Doc. 2024–23588 Filed 10–23–24; 8:45 am] BILLING CODE 4910–9X–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Chapter I lotter on DSK11XQN23PROD with RULES1 [Docket No. FDA–2024–D–2977] Food and Drug Administration Enforcement Policy for Association of American Feed Control Officials— Defined Animal Feed Ingredients; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. VerDate Sep<11>2014 16:50 Oct 23, 2024 Jkt 265001 ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry #293 entitled ‘‘FDA Enforcement Policy for AAFCODefined Animal Feed Ingredients.’’ This communicates FDA’s enforcement policy regarding ingredients listed in chapter six of the 2024 Association of American Feed Control Officials (AAFCO) Official Publication after the Agency’s memorandum of understanding with AAFCO expired on October 1, 2024. DATES: The announcement of the guidance is published in the Federal Register on October 24, 2024. ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time as follows: SUMMARY: 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. • 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 PO 00000 Frm 00021 Fmt 4700 Sfmt 4700 84819 identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2024–D–2977 for ‘‘FDA Enforcement Policy for AAFCO-Defined Animal Feed Ingredients.’’ 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.’’ 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.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 guidance to the Policy and Regulations Staff, Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., E:\FR\FM\24OCR1.SGM 24OCR1 84820 Federal Register / Vol. 89, No. 206 / Thursday, October 24, 2024 / Rules and Regulations Rockville, MD 20855. Send one selfaddressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Charlotte Conway, Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240–402–6768, Charlotte.Conway@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of August 9, 2024 (89 FR 65294), FDA published the notice of availability for a draft guidance #293 entitled ‘‘FDA Enforcement Policy for AAFCO-Defined Animal Feed Ingredients,’’ giving interested persons until September 9, 2024, to comment on the draft guidance. FDA received numerous comments on the draft guidance, including comments from the animal food industry, AAFCO, a veterinary association, a State food and agriculture department, and private citizens, and those comments were considered as the guidance was finalized. The guidance was revised to provide clarification regarding where the referenced ingredient definitions are available to the public. In addition, editorial changes were made to improve clarity. The guidance announced in this document finalizes the draft guidance dated August 9, 2024.1 This level 1 guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on ‘‘FDA Enforcement Policy for AAFCO-Defined Animal Feed Ingredients.’’ 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. II. Paperwork Reduction Act of 1995 This guidance contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required. lotter on DSK11XQN23PROD with RULES1 III. Electronic Access Persons with access to the internet may obtain the guidance at https:// 15:49 Oct 23, 2024 Jkt 265001 Dated: October 18, 2024. Eric Flamm, Acting Associate Commissioner for Policy. [FR Doc. 2024–24715 Filed 10–23–24; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF THE TREASURY Office of Foreign Assets Control 31 CFR Part 587 Publication of Russian Harmful Foreign Activities Sanctions Regulations Web General License 13K Office of Foreign Assets Control, Treasury. ACTION: Publication of a web general license. AGENCY: The Department of the Treasury’s Office of Foreign Assets Control (OFAC) is publishing one general license (GL) issued pursuant to the Russian Harmful Foreign Activities Sanctions Regulations: GL 13K, which was previously made available on OFAC’s website. DATES: GL 13K was issued on September 30, 2024. See SUPPLEMENTARY INFORMATION for additional relevant dates. SUMMARY: FOR FURTHER INFORMATION CONTACT: OFAC: Assistant Director for Licensing, 202–622–2480; Assistant Director for Regulatory Affairs, 202–622–4855; or Assistant Director for Compliance, 202– 622–2490 or https://ofac.treasury.gov/ contact-ofac. SUPPLEMENTARY INFORMATION: Electronic Availability This document and additional information concerning OFAC are available on OFAC’s website: https:// ofac.treasury.gov/. Background 1 The Office of the Federal Register has published this document under the category ‘‘Rules and Regulations’’ pursuant to 1 CFR 5.9(b). The Office of the Federal Register’s categorization is solely for purposes of publication in the Federal Register and does not change the nature of the document and is not intended to affect its validity, content, or intent. See 1 CFR 5.1(c). VerDate Sep<11>2014 www.fda.gov/AnimalVeterinary/ GuidanceComplianceEnforcement/ GuidanceforIndustry/default.htm, https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments, or https:// www.regulations.gov. On September 30, 2024, OFAC issued GL 13K to authorize certain transactions otherwise prohibited by the Russian Harmful Foreign Activities Sanctions Regulations, 31 CFR part 587. GL 13K superseded GL 13J and was made available on OFAC’s website (https:// ofac.treasury.gov/) when it was issued. The text of this GL is provided below. PO 00000 Frm 00022 Fmt 4700 Sfmt 9990 OFFICE OF FOREIGN ASSETS CONTROL Russian Harmful Foreign Activities Sanctions Regulations 31 CFR Part 587 GENERAL LICENSE NO. 13K Authorizing Certain Administrative Transactions Prohibited by Directive 4 Under Executive Order 14024 (a) Except as provided in paragraph (b) of this general license, U.S. persons, or entities owned or controlled, directly or indirectly, by a U.S. person, are authorized to pay taxes, fees, or import duties, and purchase or receive permits, licenses, registrations, certifications, or tax refunds to the extent such transactions are prohibited by Directive 4 under Executive Order 14024, Prohibitions Related to Transactions Involving the Central Bank of the Russian Federation, the National Wealth Fund of the Russian Federation, and the Ministry of Finance of the Russian Federation, provided such transactions are ordinarily incident and necessary to the day-to-day operations in the Russian Federation of such U.S. persons or entities, through 12:01 a.m. eastern standard time, January 8, 2025. (b) This general license does not authorize: (1) Any debit to an account on the books of a U.S. financial institution of the Central Bank of the Russian Federation, the National Wealth Fund of the Russian Federation, or the Ministry of Finance of the Russian Federation; or (2) Any transactions otherwise prohibited by the Russian Harmful Foreign Activities Sanctions Regulations, 31 CFR part 587 (RuHSR), including transactions involving any person blocked pursuant to the RuHSR, unless separately authorized. (c) Effective September 30, 2024, General License No. 13J, dated July 10, 2024, is replaced and superseded in its entirety by this General License No. 13K. Lisa M. Palluconi, Acting Director, Office of Foreign Assets Control. Dated: September 30, 2024. Lisa M. Palluconi, Acting Director, Office of Foreign Assets Control. [FR Doc. 2024–24737 Filed 10–23–24; 8:45 am] BILLING CODE 4810–AL–P E:\FR\FM\24OCR1.SGM 24OCR1

Agencies

[Federal Register Volume 89, Number 206 (Thursday, October 24, 2024)]
[Rules and Regulations]
[Pages 84819-84820]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-24715]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Chapter I

[Docket No. FDA-2024-D-2977]


Food and Drug Administration Enforcement Policy for Association 
of American Feed Control Officials--Defined Animal Feed Ingredients; 
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a final guidance for industry #293 entitled ``FDA 
Enforcement Policy for AAFCO-Defined Animal Feed Ingredients.'' This 
communicates FDA's enforcement policy regarding ingredients listed in 
chapter six of the 2024 Association of American Feed Control Officials 
(AAFCO) Official Publication after the Agency's memorandum of 
understanding with AAFCO expired on October 1, 2024.

DATES: The announcement of the guidance is published in the Federal 
Register on October 24, 2024.

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.
     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-2977 for ``FDA Enforcement Policy for AAFCO-Defined Animal 
Feed Ingredients.'' 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.'' 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.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 guidance to the 
Policy and Regulations Staff, Center for Veterinary Medicine, Food and 
Drug Administration, 7500 Standish Pl.,

[[Page 84820]]

Rockville, MD 20855. Send one self-addressed adhesive label to assist 
that office in processing your requests. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Charlotte Conway, Center for 
Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-402-6768, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of August 9, 2024 (89 FR 65294), FDA 
published the notice of availability for a draft guidance #293 entitled 
``FDA Enforcement Policy for AAFCO-Defined Animal Feed Ingredients,'' 
giving interested persons until September 9, 2024, to comment on the 
draft guidance. FDA received numerous comments on the draft guidance, 
including comments from the animal food industry, AAFCO, a veterinary 
association, a State food and agriculture department, and private 
citizens, and those comments were considered as the guidance was 
finalized. The guidance was revised to provide clarification regarding 
where the referenced ingredient definitions are available to the 
public. In addition, editorial changes were made to improve clarity. 
The guidance announced in this document finalizes the draft guidance 
dated August 9, 2024.\1\
---------------------------------------------------------------------------

    \1\ The Office of the Federal Register has published this 
document under the category ``Rules and Regulations'' pursuant to 1 
CFR 5.9(b). The Office of the Federal Register's categorization is 
solely for purposes of publication in the Federal Register and does 
not change the nature of the document and is not intended to affect 
its validity, content, or intent. See 1 CFR 5.1(c).
---------------------------------------------------------------------------

    This level 1 guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The guidance represents 
the current thinking of FDA on ``FDA Enforcement Policy for AAFCO-
Defined Animal Feed Ingredients.'' 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.

II. Paperwork Reduction Act of 1995

    This guidance contains no collection of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: October 18, 2024.
Eric Flamm,
Acting Associate Commissioner for Policy.
[FR Doc. 2024-24715 Filed 10-23-24; 8:45 am]
BILLING CODE 4164-01-P

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