Foreign Supplier Verification Programs for Importers of Food for Humans and Animals: Guidance for Industry; Availability, 1503-1505 [2023-00391]

Download as PDF 1503 Federal Register / Vol. 88, No. 7 / Wednesday, January 11, 2023 / Rules and Regulations TABLE 1 TO PARAGRAPH (b)(1) Date of violation and corresponding penalty U.S. Code citation Civil monetary penalty description 10/23/2004 through 10/22/2008 I 10/23/2008 through 10/22/2012 I 10/23/2012 through 11/01/2015 I 11/02/2015 to present Civil Monetary Penalty Imposed By The Commission In An Administrative Action 7 U.S.C. 9 (section 6(c) of the Commodity Exchange Act). 7 U.S.C. 13a (section 6b of the Commodity Exchange Act). For any person other than a registered entity 1 .... $130,000 $130,000 $140,000 $194,710 For a registered entity 1 or any of its directors, officers or employees. 625,000 675,000 700,000 1,072,570 140,000 214,514 Civil Monetary Penalty Imposed By A Federal District Court In A Civil Injunctive Action 7 U.S.C. 13a–1 (section 6c of the Commodity Exchange Act). 1 The Any Person ........................................................... 130,000 140,000 term ‘‘registered entity’’ is defined in 7 U.S.C. 1a (section 1a of the Commodity Exchange Act). (2) For manipulation or attempted manipulation violations: TABLE 1 TO PARAGRAPH (b)(2) Date of violation and corresponding penalty U.S. Code citation Civil monetary penalty description 10/23/2004 through 05/21/2008 I 05/22/2008 through 08/14/2011 I 08/15/2011 through 11/01/2015 I 11/02/2015 to present Civil Monetary Penalty Imposed By The Commission In An Administrative Action 7 U.S.C. 9 (section 6(c) of the Commodity Exchange Act). 7 U.S.C. 13a (section 6b of the Commodity Exchange Act). For any person other than a registered entity 1 .... $130,000 $1,000,000 $1,025,000 $1,404,520 625,000 1,000,000 1,025,000 1,404,520 1,025,000 1,404,520 entity 1 For a registered or any of its directors, officers or employees. Civil Monetary Penalty Imposed By A Federal District Court In A Civil Injunctive Action 7 U.S.C. 13a–1 (section 6c of the Commodity Exchange Act). 1 The Any Person ........................................................... 1,000,000 term ‘‘registered entity’’ is defined in 7 U.S.C. 1a (section 1a of the Commodity Exchange Act). Issued in Washington, DC, on January 6, 2023, by the Commission. Robert Sidman, Deputy Secretary of the Commission. DEPARTMENT OF HEALTH AND HUMAN SERVICES Note: The following appendix will not appear in the Code of Federal Regulations. 21 CFR Part 1 Appendix to Annual Adjustment of Civil Monetary Penalties to Reflect Inflation—2023—Commission Voting Summary Foreign Supplier Verification Programs for Importers of Food for Humans and Animals: Guidance for Industry; Availability Food and Drug Administration [Docket No. FDA–2017–D–5225] On this matter, Chairman Behnam and Commissioners Johnson, Goldsmith Romero, Mersinger, and Pham voted in the affirmative. No Commissioner voted in the negative. [FR Doc. 2023–00396 Filed 1–10–23; 8:45 am] BILLING CODE 6351–01–P lotter on DSK11XQN23PROD with RULES1 130,000 VerDate Sep<11>2014 16:09 Jan 10, 2023 Jkt 259001 AGENCY: Food and Drug Administration, HHS. ACTION: Notification of availability. The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance entitled ‘‘Foreign Supplier Verification Programs for Importers of Food for Humans and Animals: Guidance for Industry.’’ This guidance document provides our thinking on how importers of food for humans and animals can comply with the regulation on foreign supplier verification programs (FSVPs) issued on November 27, 2015. The guidance announced in SUMMARY: PO 00000 Frm 00007 Fmt 4700 Sfmt 4700 this notice finalizes the draft guidance of the same title dated January 24, 2018. DATES: The announcement of guidance is published in the Federal Register on January 11, 2023. 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 as a manufacturing process. Please note that if you include your name, contact information, or other information that E:\FR\FM\11JAR1.SGM 11JAR1 1504 Federal Register / Vol. 88, No. 7 / Wednesday, January 11, 2023 / Rules and Regulations lotter on DSK11XQN23PROD with RULES1 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– 2017–D–5225 for ‘‘Foreign Supplier Verification Programs for Importers of Food for Humans and Animals: Guidance for Industry.’’ 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 VerDate Sep<11>2014 16:09 Jan 10, 2023 Jkt 259001 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 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 draft guidance. FOR FURTHER INFORMATION CONTACT: Compliance Policy Staff, Office of Compliance, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, CFSANCompliancePolicy@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of November 27, 2015 (80 FR 74226), we issued a final rule adopting a regulation on FSVPs for importers of food for humans and animals (FSVP final rule) (see, 21 CFR part 1, subpart L). The FSVP final rule implements section 301 of the FDA Food Safety Modernization Act (FSMA) (Pub. L. 111–353), which enables the Agency to better protect public health by helping to ensure the safety and security of the food supply. Section 301 of FSMA added section 805 to the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 384a) to require persons who import food into the United States to perform risk-based foreign supplier verification activities. In addition to directing FDA to issue regulations on the content of FSVPs, section 805 of the FD&C Act directs FDA to issue guidance to assist importers in developing FSVPs. In accordance with section 805 of the FD&C Act, we are announcing the availability of a final guidance entitled, ‘‘Foreign Supplier Verification Programs PO 00000 Frm 00008 Fmt 4700 Sfmt 4700 for Importers of Food for Humans and Animals: Guidance for Industry.’’ This guidance provides our thinking on how to comply with the FSVP regulation, including, but not limited to, requirements to analyze the hazards in food, evaluate a potential foreign supplier’s performance and the risk posed by a food, and determine and conduct appropriate foreign supplier verification activities. The guidance also addresses how importers can meet the modified FSVP requirements for importers of dietary supplements, very small importers, importers of food from certain small foreign suppliers, and importers of food from countries whose food safety systems we have officially recognized as comparable or determined to be equivalent to that of the United States. In the Federal Register of January 24, 2018 (83 FR 3443) we made available a draft guidance for industry entitled ‘‘Foreign Supplier Verification Programs for Importers of Food for Humans and Animals’’ and gave interested parties an opportunity to submit comments by May 25, 2018, for us to consider before beginning work on the final version of the guidance. We received several comments on the draft guidance and those comments were considered as the guidance was finalized. A summary of changes includes additional clarification regarding to what foods the FSVP regulation applies, what information must be included in the FSVP, who may develop and perform FSVP activities, what hazard analysis must be conducted, what foreign supplier approval and verification activities must be conducted, what requirements apply for importing a food for which the hazards will be controlled after importation, how FSVP records must be maintained, what FSVP requirements apply for imported dietary supplement components, and what FSVP requirements apply to very small importers or when importing food for certain small foreign suppliers. In addition, editorial changes were made to improve clarity. The guidance announced in this notice finalizes the draft guidance dated January 24, 2018. This 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 ‘‘Foreign Supplier Verification Programs for Importers of Food for Humans and Animals: Guidance for Industry.’’ 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. E:\FR\FM\11JAR1.SGM 11JAR1 Federal Register / Vol. 88, No. 7 / Wednesday, January 11, 2023 / Rules and Regulations II. Paperwork Reduction Act of 1995 While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501– 3521) is not required for this guidance. The previously approved collections of information are subject to review by OMB under the PRA. The collections of information in 21 CFR part 1, subpart L have been approved under OMB control number 0910–0752. III. Electronic Access Persons with access to the internet may obtain the guidance at either https://www.fda.gov/FoodGuidances, https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments, or https:// www.regulations.gov. Use the FDA website listed in the previous sentence to find the most current version of the guidance. Dated: January 5, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–00391 Filed 1–10–23; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF STATE 22 CFR Parts 35, 103, 127, and 138 [Public Notice: 11959] RIN 1400–AF59 Department of State 2023 Civil Monetary Penalties Inflationary Adjustment Department of State. Final rule. AGENCY: ACTION: This final rule is issued to adjust the civil monetary penalties (CMP) for regulatory provisions maintained and enforced by the Department of State. The revised CMP adjusts the amount of civil monetary penalties assessed by the Department of State based on the December 2022 guidance from the Office of Management and Budget and by recent legislation. For penalties adjusted according to the December 2022 guidance, the new amounts will apply only to those penalties assessed on or after the effective date of this rule, regardless of the date on which the underlying facts or violations occurred. For the penalty adjusted according to recent legislation, the new amounts will apply only to those penalties assessed lotter on DSK11XQN23PROD with RULES1 SUMMARY: VerDate Sep<11>2014 16:09 Jan 10, 2023 Jkt 259001 for violations occurring on or after December 27, 2022. DATES: This final rule is effective on January 11, 2023. FOR FURTHER INFORMATION CONTACT: Alice Kottmyer, Attorney-Adviser, Office of Management, kottmyeram@ state.gov. ATTN: Regulatory Change, CMP Adjustments, (202) 647–2318. SUPPLEMENTARY INFORMATION: The Federal Civil Penalties Inflation Adjustment Act of 1990, Pub. L. 101– 410, as amended by the Debt Collection Improvement Act of 1996, Pub. L. 104– 134, required the head of each agency to adjust its CMPs for inflation no later than October 23, 1996 and required agencies to make adjustments at least once every four years thereafter. The Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, Section 701 of Pub. L. 114–74 (the 2015 Act) further amended the 1990 Act by requiring agencies to adjust CMPs, if necessary, pursuant to a ‘‘catch-up’’ adjustment methodology prescribed by the 2015 Act, which mandated that the catch-up adjustment take effect no later than August 1, 2016. Additionally, the 2015 Act required agencies to make annual adjustments to their respective CMPs in accordance with guidance issued by the Office of Management and Budget (OMB). Based on these statutes, the Department of State (the Department) published a final rule in June 2016 1 to implement the ‘‘catch-up’’ provisions; and annual updates to its CMPs in January 2017,2 January 2018,3 March 2019 (delayed due to the Government shutdown),4 January 2020,5 February 2021 (delayed due to transition issues),6 and January 2022.7 On December 15, 2022, OMB notified agencies that the annual cost-of-living adjustment multiplier for fiscal year (FY) 2023, based on the Consumer Price Index, is 1.07745. Additional information may be found in OMB Memorandum M–23–05 at: https:// www.whitehouse.gov/wp-content/ uploads/2022/12/M-23-05-CMP-CMPGuidance.pdf. This final rule amends Department CMPs for fiscal year 2023, with the exception of the CMP for violation of 22 U.S.C 2778 at 22 CFR 127.10(a)(1)(i), which is amended in accordance with section 9708 of the James M. Inhofe National Defense 1 81 FR 36771 (Jun. 8, 2016). 2 82 FR 3168 (Jan. 11, 2017). 3 83 FR 234 (Jan. 3, 2018). 4 84 FR 9957 (Mar. 19, 2019). 5 85 FR 2020 (Jan. 14, 2020). 6 86 FR 7804 (Feb. 2, 2021). 7 87 FR 1072 (Jan. 10, 2022). PO 00000 Frm 00009 Fmt 4700 Sfmt 4700 1505 Authorization Act for Fiscal Year 2023, Pub. L. 117–263. Overview of the Areas Affected by This Rule Within the Department of State (title 22, Code of Federal Regulations), this rule affects four areas: (1) Part 35, which implements the Program Fraud Civil Remedies Act of 1986 (PFCRA), codified at 31 U.S.C. 3801–3812; (2) Part 103, which implements the Chemical Weapons Convention Implementation Act of 1998 (CWC Act) (22 U.S.C. 6761); (3) Part 127, which implements the penalty provisions of sections 38(e), 39A(c), and 40(k) of the Arms Export Control Act (AECA) (22 U.S.C. 2778(e), 2779a(c), and 2780(k)); and (4) Part 138, which implements section 319 of Pub. L. 101–121, codified at 31 U.S.C. 1352, which prohibits recipients of Federal contracts, grants, and loans from using appropriated funds for lobbying the executive or legislative branches of the Federal Government in connection with a specific contract. Specific Changes to 22 CFR Made by this Rule I. Part 35 The PFCRA, enacted in 1986, authorizes agencies, with approval from the Department of Justice, to pursue individuals or firms for false claims. Applying the FY 2023 inflationary adjustment of 1.07745, the new maximum penalty is $13,508 for each false claim or statement, up to a maximum of $405,270. II. Part 103 The CWC Act provided domestic implementation of the Convention on the Prohibition of the Development, Production, Stockpiling, and Use of Chemical Weapons and on Their Destruction. The penalty provisions of the CWC Act are codified at 22 U.S.C. 6761. Applying the FY 2023 multiplier, the new maximum amounts are as follows: prohibited acts related to inspections, $45,429; for recordkeeping violations, $9,086. III. Part 127 The Assistant Secretary of State for Political-Military Affairs is responsible for the imposition of CMPs under the International Traffic in Arms Regulations (ITAR), which is administered by the Directorate of Defense Trade Controls (DDTC). E:\FR\FM\11JAR1.SGM 11JAR1

Agencies

[Federal Register Volume 88, Number 7 (Wednesday, January 11, 2023)]
[Rules and Regulations]
[Pages 1503-1505]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-00391]


=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket No. FDA-2017-D-5225]


Foreign Supplier Verification Programs for Importers of Food for 
Humans and Animals: 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 entitled ``Foreign Supplier 
Verification Programs for Importers of Food for Humans and Animals: 
Guidance for Industry.'' This guidance document provides our thinking 
on how importers of food for humans and animals can comply with the 
regulation on foreign supplier verification programs (FSVPs) issued on 
November 27, 2015. The guidance announced in this notice finalizes the 
draft guidance of the same title dated January 24, 2018.

DATES: The announcement of guidance is published in the Federal 
Register on January 11, 2023.

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 as a manufacturing process. Please note that if you include your 
name, contact information, or other information that

[[Page 1504]]

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-2017-D-5225 for ``Foreign Supplier Verification Programs for 
Importers of Food for Humans and Animals: Guidance for Industry.'' 
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 draft guidance to 
the Center for Food Safety and Applied Nutrition, 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: Compliance Policy Staff, Office of 
Compliance, Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 5001 Campus Dr., College Park, MD 20740, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of November 27, 2015 (80 FR 74226), we 
issued a final rule adopting a regulation on FSVPs for importers of 
food for humans and animals (FSVP final rule) (see, 21 CFR part 1, 
subpart L). The FSVP final rule implements section 301 of the FDA Food 
Safety Modernization Act (FSMA) (Pub. L. 111-353), which enables the 
Agency to better protect public health by helping to ensure the safety 
and security of the food supply.
    Section 301 of FSMA added section 805 to the Federal Food, Drug, 
and Cosmetic Act (FD&C Act) (21 U.S.C. 384a) to require persons who 
import food into the United States to perform risk-based foreign 
supplier verification activities. In addition to directing FDA to issue 
regulations on the content of FSVPs, section 805 of the FD&C Act 
directs FDA to issue guidance to assist importers in developing FSVPs.
    In accordance with section 805 of the FD&C Act, we are announcing 
the availability of a final guidance entitled, ``Foreign Supplier 
Verification Programs for Importers of Food for Humans and Animals: 
Guidance for Industry.'' This guidance provides our thinking on how to 
comply with the FSVP regulation, including, but not limited to, 
requirements to analyze the hazards in food, evaluate a potential 
foreign supplier's performance and the risk posed by a food, and 
determine and conduct appropriate foreign supplier verification 
activities. The guidance also addresses how importers can meet the 
modified FSVP requirements for importers of dietary supplements, very 
small importers, importers of food from certain small foreign 
suppliers, and importers of food from countries whose food safety 
systems we have officially recognized as comparable or determined to be 
equivalent to that of the United States.
    In the Federal Register of January 24, 2018 (83 FR 3443) we made 
available a draft guidance for industry entitled ``Foreign Supplier 
Verification Programs for Importers of Food for Humans and Animals'' 
and gave interested parties an opportunity to submit comments by May 
25, 2018, for us to consider before beginning work on the final version 
of the guidance. We received several comments on the draft guidance and 
those comments were considered as the guidance was finalized. A summary 
of changes includes additional clarification regarding to what foods 
the FSVP regulation applies, what information must be included in the 
FSVP, who may develop and perform FSVP activities, what hazard analysis 
must be conducted, what foreign supplier approval and verification 
activities must be conducted, what requirements apply for importing a 
food for which the hazards will be controlled after importation, how 
FSVP records must be maintained, what FSVP requirements apply for 
imported dietary supplement components, and what FSVP requirements 
apply to very small importers or when importing food for certain small 
foreign suppliers. In addition, editorial changes were made to improve 
clarity. The guidance announced in this notice finalizes the draft 
guidance dated January 24, 2018.
    This 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 ``Foreign Supplier Verification Programs for 
Importers of Food for Humans and Animals: Guidance for Industry.'' 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.

[[Page 1505]]

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does 
refer to previously approved FDA collections of information. Therefore, 
clearance by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required for this guidance. The previously approved collections of 
information are subject to review by OMB under the PRA. The collections 
of information in 21 CFR part 1, subpart L have been approved under OMB 
control number 0910-0752.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
either 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.

    Dated: January 5, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-00391 Filed 1-10-23; 8:45 am]
BILLING CODE 4164-01-P

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