Uniform Compliance Date for Food Labeling Regulations, 462-464 [2020-29273]

Download as PDF 462 Federal Register / Vol. 86, No. 3 / Wednesday, January 6, 2021 / Rules and Regulations 3. This rule does not contain policies associated with Federalism as that term is defined under Executive Order 13132. 4. Pursuant to section 1762 of ECRA (see 50 U.S.C. 4821), this action is exempt from the Administrative Procedure Act requirements (under 5 U.S.C. 553) for notice of proposed rulemaking, opportunity for public participation, and delay in effective date. This rule only updates Supplement No. 5 to Part 774 to the EAR by extending the date of the period of validity of 0D521 software in Supplement No. 5 to Part 774 for one year. This revision is merely technical and in accordance with established 0Y521 ECCN series procedure and purpose, which was proposed to the public and subject of comment. This rule clarifies information, which serves to avoid confusing readers about the 0D521 item’s status. It does not alter any right, obligation or prohibition that applies to any person under the EAR. 5. Because a notice of proposed rulemaking and an opportunity for public comment are not required to be given for this rule by 5 U.S.C. 553, or by any other law, the analytical requirements of the Regulatory Flexibility Act, 5 U.S.C. 601, et seq., are not applicable. Accordingly, no regulatory flexibility analysis is required, and none has been prepared. List of Subjects in 15 CFR Part 774 Exports, Reporting and recordkeeping requirements. Accordingly, part 774 of the Export Administration Regulations (15 CFR parts 730 through 774) is amended as follows: 1. The authority citation for part 774 continues to read as follows: ■ jbell on DSKJLSW7X2PROD with RULES Authority: 50 U.S.C. 4801–4852; 50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; 10 U.S.C. 8720; 10 U.S.C. 8730(e); 22 U.S.C. 287c, 22 U.S.C. 3201 et seq.; 22 U.S.C. 6004; 42 U.S.C. 2139a; 15 U.S.C. 1824; 50 U.S.C. 4305; 22 U.S.C. 7201 et seq.; 22 U.S.C. 7210; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783. [Amended] 2. In Supplement No. 5 to part 774, amend the table, under the heading ‘‘0D521. Software’’ entry No 1, by ■ VerDate Sep<11>2014 16:19 Jan 05, 2021 Jkt 253001 Matthew S. Borman, Deputy Assistant Secretary for Export Administration. [FR Doc. 2020–28776 Filed 1–5–21; 8:45 am] BILLING CODE 3510–33–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 101 [Docket No. FDA–2000–N–0011] Uniform Compliance Date for Food Labeling Regulations Food and Drug Administration, Department of Helath and Human Services (HHS). ACTION: Final rule. AGENCY: The Food and Drug Administration (FDA or we) is establishing January 1, 2024, as the uniform compliance date for food labeling regulations that are published on or after January 1, 2021, and on or before December 31, 2022. We periodically announce uniform compliance dates for new food labeling requirements to minimize the economic impact of labeling changes. DATES: This rule is effective January 6, 2021. Submit either electronic or written comments on the final rule by March 8, 2021. ADDRESSES: You may submit comments as follows: SUMMARY: Electronic Submissions PART 774—THE COMMERCE CONTROL LIST Supplement No. 5 to Part 774 revising the date in the third column to read: ‘‘January 6, 2022’’. 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. PO 00000 Frm 00024 Fmt 4700 Sfmt 4700 • 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– 2000–N–0011 for ‘‘Uniform Compliance Date for Food Labeling Regulations.’’ Received comments, those filed in a timely manner, 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:// E:\FR\FM\06JAR1.SGM 06JAR1 jbell on DSKJLSW7X2PROD with RULES Federal Register / Vol. 86, No. 3 / Wednesday, January 6, 2021 / Rules and Regulations 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. FOR FURTHER INFORMATION CONTACT: Carrol Bascus, Center for Food Safety and Applied Nutrition (HFS–24), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240–402– 3835. SUPPLEMENTARY INFORMATION: We periodically issue regulations requiring changes in the labeling of food. If the compliance dates of these labeling changes were not coordinated, the cumulative economic impact on the food industry of having to respond separately to each change would be substantial. Therefore, we periodically have announced uniform compliance dates for new food labeling requirements (see e.g., the Federal Register of October 19, 1984 (49 FR 41019); December 24, 1996 (61 FR 67710); December 27, 1996 (61 FR 68145); December 23, 1998 (63 FR 71015); November 20, 2000 (65 FR 69666); December 31, 2002 (67 FR 79851); December 21, 2006 (71 FR 76599); December 8, 2008 (73 FR 74349); December 15, 2010 (75 FR 78155); November 28, 2012 (77 FR 70885); December 10, 2014 (79 FR 73201); November 25, 2016 (81 FR 85156); and December 20, 2018 (83 FR 65294)). Use of a uniform compliance date provides for an orderly and economical industry adjustment to new labeling requirements by allowing sufficient lead time to plan for the use of existing label inventories and the development of new labeling materials. We have determined under 21 CFR 25.30(k) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. This final rule contains no collections of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required. We have examined the impacts of the final rule under Executive Order 12866, Executive Order 13563, Executive Order 13771, the Regulatory Flexibility Act (5 VerDate Sep<11>2014 16:19 Jan 05, 2021 Jkt 253001 U.S.C. 601–612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104–4). Executive Orders 12866 and 13563 direct us to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). Executive Order 13771 requires that the costs associated with significant new regulations ‘‘shall, to the extent permitted by law, be offset by the elimination of existing costs associated with at least two prior regulations.’’ We believe that this final rule is not a significant regulatory action as defined by Executive Order 12866. The establishment of a uniform compliance date does not in itself lead to costs or benefits. We will assess the costs and benefits of the uniform compliance date in the regulatory impact analyses of the labeling rules that take effect at that date. The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because the final rule does not impose compliance costs on small entities, we certify that the final rule will not have a significant economic impact on a substantial number of small entities. The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before issuing ‘‘any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.’’ The current threshold after adjustment for inflation is $156 million, using the most current (2019) Implicit Price Deflator for the Gross Domestic Product. This final rule would not result in an expenditure in any year that meets or exceeds this amount. We have analyzed this final rule in accordance with the principles set forth in Executive Order 13132. We have determined that the rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, we have concluded that the rule does not contain policies that have federalism implications as defined in the Executive Order and, consequently, a federalism PO 00000 Frm 00025 Fmt 4700 Sfmt 4700 463 summary impact statement is not required. This action is not intended to change existing requirements for compliance dates contained in final rules published before January 1, 2021. Therefore, all final rules published by FDA in the Federal Register before January 1, 2021, will still go into effect on the date stated in the respective final rule. We generally encourage industry to comply with new labeling regulations as quickly as feasible, however. Thus, when industry members voluntarily change their labels, it is appropriate that they incorporate any new requirements that have been published as final regulations up to that time. In rulemaking that began with publication of a proposed rule on April 15, 1996 (61 FR 16422), and ended with a final rule on December 24, 1996 (61 FR 67710) (together ‘‘the 1996 rulemaking’’), we provided notice and an opportunity for comment on the practice of establishing uniform compliance dates by issuance of a final rule announcing the date. We received no comments objecting to this practice during the 1996 rulemaking, nor have we received comments objecting to this practice since we published a uniform compliance date final rule on December 20, 2018. Therefore, we find good cause to dispense with issuance of a proposed rule inviting comment on the practice of establishing the uniform compliance date because such prior notice and comment are unnecessary. Interested parties will have an opportunity to comment on the compliance date for each individual food labeling regulation as part of the rulemaking process for that regulation. Consequently, FDA finds any further advance notice and opportunity for comment unnecessary for establishment of the uniform compliance date. Nonetheless, under 21 CFR 10.40(e)(1), we are providing an opportunity for comment on whether the uniform compliance date established by this final rule should be modified or revoked. In addition, we find good cause for this final rule to become effective on the date of publication of this action. A delayed effective date is unnecessary in this case because the establishment of a uniform compliance date does not impose any new regulatory requirements on affected parties. Instead, this final rule provides affected parties with notice of our policy to identify January 1, 2024, as the compliance date for final food labeling regulations that require changes in the labeling of food products and that publish on or after January 1, 2021, and on or before December 31, 2022, unless E:\FR\FM\06JAR1.SGM 06JAR1 464 Federal Register / Vol. 86, No. 3 / Wednesday, January 6, 2021 / Rules and Regulations special circumstances justify a different compliance date. Thus, affected parties do not need time to prepare before the rule takes effect. Therefore, we find good cause for this final rule to become effective on the date of publication of this action. The new uniform compliance date will apply only to final FDA food labeling regulations that require changes in the labeling of food products and that publish on or after January 1, 2021, and on or before December 31, 2022. Those regulations will specifically identify January 1, 2024, as their compliance date. All food products subject to the January 1, 2024, compliance date must comply with the appropriate regulations when initially introduced into interstate commerce on or after January 1, 2024. If any food labeling regulation involves special circumstances that justify a compliance date other than January 1, 2024, we will determine for that regulation an appropriate compliance date, which will be specified when the final regulation is published. Dated: December 29, 2020. Stephen M. Hahn, Commissioner of Food and Drugs. Dated: December 30, 2020. Alex M. Azar II, Secretary, Department of Health and Human Services. [FR Doc. 2020–29273 Filed 12–31–20; 4:15 pm] BILLING CODE 4164–01–P DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 1 [TD 9937] RIN 1545–BP46 Rollover Rules for Qualified Plan Loan Offset Amounts Internal Revenue Service (IRS), Treasury. ACTION: Final regulations. AGENCY: This document sets forth final regulations relating to amendments made to section 402(c) of the Internal Revenue Code (Code) by section 13613 of the Tax Cuts and Jobs Act (TCJA). Section 13613 of TCJA provides an extended rollover period for a qualified plan loan offset, which is a type of plan loan offset. These regulations affect participants, beneficiaries, sponsors, and administrators of qualified employer plans. DATES: Effective Date: These regulations are effective on January 6, 2021. jbell on DSKJLSW7X2PROD with RULES SUMMARY: VerDate Sep<11>2014 16:19 Jan 05, 2021 Jkt 253001 Applicability Date: For date of applicability, see § 1.402(c)–3(b)(2). FOR FURTHER INFORMATION CONTACT: Naomi Lehr at (202) 317–4102, Vernon Carter at (202) 317–6799, or Pamela Kinard at (202) 317–6000 (not toll-free numbers). SUPPLEMENTARY INFORMATION: Background This document amends 26 CFR part 1, by adding § 1.402(c)–3 to the Income Tax Regulations to reflect changes to section 402(c) of the Code, as amended by section 13613 of TCJA (Pub. L. 115– 97 (131 Stat. 2054)). 1. Plan Loans, Eligible Rollover Distributions, and Plan Loan Offset Amounts Section 72(p)(1) of the Code provides that if, during any taxable year, a participant or beneficiary receives (directly or indirectly) any amount as a loan from a qualified employer plan (as defined in section 72(p)(4)(A)),1 that amount shall be treated as having been received by the individual as a distribution from the plan. For certain plan loans, section 72(p)(2) provides an exception to the general treatment of loans as distributions under section 72(p)(1). For the exception under section 72(p)(2) to apply so that a plan loan is not treated as a distribution under section 72(p)(1) for the taxable year in which the loan is received, the loan generally must satisfy three requirements: (1) The loan, by its terms, must satisfy the limits on loan amounts, as described in section 72(p)(2)(A); (2) The loan, by its terms, generally must be repayable within 5 years, as described in section 72(p)(2)(B); and (3) The loan must require substantially level amortization over the term of the loan, as described in section 72(p)(2)(C). Section 401(a)(31) requires that a plan qualified under section 401(a) provide for the direct transfer of eligible rollover distributions. A similar rule applies to section 403(a) annuity plans, section 403(b) tax-sheltered annuities, and section 457 eligible governmental plans. See generally sections 403(a)(1), 403(b)(10), and 457(d)(1)(C). Sections 402(c)(3) and 408(d)(3) provide that any amount distributed from a qualified plan or individual retirement account or annuity (IRA) will be excluded from income if it is 1 Under section 72(p)(4), a qualified employer plan means a qualified plan, a section 403(a) annuity plan, a section 403(b) plan, and any governmental plan. PO 00000 Frm 00026 Fmt 4700 Sfmt 4700 transferred to an eligible retirement plan no later than the 60th day following the day the distribution is received. A similar rule applies to section 403(a) annuity plans, section 403(b) taxsheltered annuities, and section 457 eligible governmental plans. See generally sections 403(a)(4)(B), 403(b)(8)(B), and 457(e)(16)(B). Sections 402(c)(3)(B) and 408(d)(3)(I) provide that the Secretary may waive the 60-day rollover requirement ‘‘where the failure to waive such requirement would be against equity or good conscience, including casualty, disaster, or other events beyond the reasonable control of the individual subject to such requirement.’’ See generally Rev. Proc. 2020–46, 2020–45 I.R.B. 995, which sets forth a self-certification procedure that taxpayers may use in certain circumstances to claim a waiver of the 60-day deadline for completing a rollover under section 402(c)(3)(B) or 408(d)(3)(I), and Rev. Proc. 2020–4, 2020–1 I.R.B. 148, which sets forth procedures that taxpayers may use to request a waiver of the 60-day rollover deadline by submitting a request for a private letter ruling.2 Section 1.402(c)–2, Q&A–3(a), provides that, unless specifically excluded, an eligible rollover distribution means any distribution to an employee (or to a spousal distributee described in § 1.402(c)–2, Q&A–12(a)) of all or any portion of the balance to the credit of the employee in a qualified plan. Section 1.402(c)–2, Q&A–3(b), provides that certain distributions (for example, required minimum distributions under section 401(a)(9)) are not eligible rollover distributions. Section 1.402(c)–2, Q&A–9(a), provides that a distribution of a plan loan offset amount (as defined in § 1.402(c)–2, Q&A–9(b)) is an eligible rollover distribution if it satisfies § 1.402(c)–2, Q&A–3. Thus, an amount not exceeding the plan loan offset amount may be rolled over by the employee (or spousal distributee) to an eligible retirement plan within the 60day period described in section 402(c)(3), unless the plan loan offset amount fails to be an eligible rollover distribution for another reason. Section 1.402(c)–2, Q&A–9(b), provides that a distribution of a plan loan offset amount is a distribution that occurs when, under the plan terms governing the loan, the employee’s 2 Note that the 60-day rollover deadline can also be extended to provide temporary relief during a disaster or an emergency response. For example, in response to the COVID–19 pandemic, Notice 2020– 23, 2020–18 I.R.B. 742, extended the 60-day rollover deadline to July 15, 2020, for distributions made between April 1, 2020, and July 14, 2020. E:\FR\FM\06JAR1.SGM 06JAR1

Agencies

[Federal Register Volume 86, Number 3 (Wednesday, January 6, 2021)]
[Rules and Regulations]
[Pages 462-464]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-29273]


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

Food and Drug Administration

21 CFR Part 101

[Docket No. FDA-2000-N-0011]


Uniform Compliance Date for Food Labeling Regulations

AGENCY: Food and Drug Administration, Department of Helath and Human 
Services (HHS).

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA or we) is establishing 
January 1, 2024, as the uniform compliance date for food labeling 
regulations that are published on or after January 1, 2021, and on or 
before December 31, 2022. We periodically announce uniform compliance 
dates for new food labeling requirements to minimize the economic 
impact of labeling changes.

DATES: This rule is effective January 6, 2021. Submit either electronic 
or written comments on the final rule by March 8, 2021.

ADDRESSES: You may submit comments 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-2000-N-0011 for ``Uniform Compliance Date for Food Labeling 
Regulations.'' Received comments, those filed in a timely manner, 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://

[[Page 463]]

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.

FOR FURTHER INFORMATION CONTACT: Carrol Bascus, Center for Food Safety 
and Applied Nutrition (HFS-24), Food and Drug Administration, 5001 
Campus Dr., College Park, MD 20740, 240-402-3835.

SUPPLEMENTARY INFORMATION: We periodically issue regulations requiring 
changes in the labeling of food. If the compliance dates of these 
labeling changes were not coordinated, the cumulative economic impact 
on the food industry of having to respond separately to each change 
would be substantial. Therefore, we periodically have announced uniform 
compliance dates for new food labeling requirements (see e.g., the 
Federal Register of October 19, 1984 (49 FR 41019); December 24, 1996 
(61 FR 67710); December 27, 1996 (61 FR 68145); December 23, 1998 (63 
FR 71015); November 20, 2000 (65 FR 69666); December 31, 2002 (67 FR 
79851); December 21, 2006 (71 FR 76599); December 8, 2008 (73 FR 
74349); December 15, 2010 (75 FR 78155); November 28, 2012 (77 FR 
70885); December 10, 2014 (79 FR 73201); November 25, 2016 (81 FR 
85156); and December 20, 2018 (83 FR 65294)). Use of a uniform 
compliance date provides for an orderly and economical industry 
adjustment to new labeling requirements by allowing sufficient lead 
time to plan for the use of existing label inventories and the 
development of new labeling materials.
    We have determined under 21 CFR 25.30(k) that this action is of a 
type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.
    This final rule contains no collections of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.
    We have examined the impacts of the final rule under Executive 
Order 12866, Executive Order 13563, Executive Order 13771, the 
Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded 
Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 
13563 direct us to assess all costs and benefits of available 
regulatory alternatives and, when regulation is necessary, to select 
regulatory approaches that maximize net benefits (including potential 
economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). Executive Order 13771 
requires that the costs associated with significant new regulations 
``shall, to the extent permitted by law, be offset by the elimination 
of existing costs associated with at least two prior regulations.'' We 
believe that this final rule is not a significant regulatory action as 
defined by Executive Order 12866.
    The establishment of a uniform compliance date does not in itself 
lead to costs or benefits. We will assess the costs and benefits of the 
uniform compliance date in the regulatory impact analyses of the 
labeling rules that take effect at that date.
    The Regulatory Flexibility Act requires us to analyze regulatory 
options that would minimize any significant impact of a rule on small 
entities. Because the final rule does not impose compliance costs on 
small entities, we certify that the final rule will not have a 
significant economic impact on a substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires 
us to prepare a written statement, which includes an assessment of 
anticipated costs and benefits, before issuing ``any rule that includes 
any Federal mandate that may result in the expenditure by State, local, 
and tribal governments, in the aggregate, or by the private sector, of 
$100,000,000 or more (adjusted annually for inflation) in any one 
year.'' The current threshold after adjustment for inflation is $156 
million, using the most current (2019) Implicit Price Deflator for the 
Gross Domestic Product. This final rule would not result in an 
expenditure in any year that meets or exceeds this amount.
    We have analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. We have determined that the rule 
does not contain policies that have substantial direct effects on the 
States, on the relationship between the National Government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government. Accordingly, we have concluded that the 
rule does not contain policies that have federalism implications as 
defined in the Executive Order and, consequently, a federalism summary 
impact statement is not required.
    This action is not intended to change existing requirements for 
compliance dates contained in final rules published before January 1, 
2021. Therefore, all final rules published by FDA in the Federal 
Register before January 1, 2021, will still go into effect on the date 
stated in the respective final rule. We generally encourage industry to 
comply with new labeling regulations as quickly as feasible, however. 
Thus, when industry members voluntarily change their labels, it is 
appropriate that they incorporate any new requirements that have been 
published as final regulations up to that time.
    In rulemaking that began with publication of a proposed rule on 
April 15, 1996 (61 FR 16422), and ended with a final rule on December 
24, 1996 (61 FR 67710) (together ``the 1996 rulemaking''), we provided 
notice and an opportunity for comment on the practice of establishing 
uniform compliance dates by issuance of a final rule announcing the 
date. We received no comments objecting to this practice during the 
1996 rulemaking, nor have we received comments objecting to this 
practice since we published a uniform compliance date final rule on 
December 20, 2018. Therefore, we find good cause to dispense with 
issuance of a proposed rule inviting comment on the practice of 
establishing the uniform compliance date because such prior notice and 
comment are unnecessary. Interested parties will have an opportunity to 
comment on the compliance date for each individual food labeling 
regulation as part of the rulemaking process for that regulation. 
Consequently, FDA finds any further advance notice and opportunity for 
comment unnecessary for establishment of the uniform compliance date. 
Nonetheless, under 21 CFR 10.40(e)(1), we are providing an opportunity 
for comment on whether the uniform compliance date established by this 
final rule should be modified or revoked.
    In addition, we find good cause for this final rule to become 
effective on the date of publication of this action. A delayed 
effective date is unnecessary in this case because the establishment of 
a uniform compliance date does not impose any new regulatory 
requirements on affected parties. Instead, this final rule provides 
affected parties with notice of our policy to identify January 1, 2024, 
as the compliance date for final food labeling regulations that require 
changes in the labeling of food products and that publish on or after 
January 1, 2021, and on or before December 31, 2022, unless

[[Page 464]]

special circumstances justify a different compliance date. Thus, 
affected parties do not need time to prepare before the rule takes 
effect. Therefore, we find good cause for this final rule to become 
effective on the date of publication of this action.
    The new uniform compliance date will apply only to final FDA food 
labeling regulations that require changes in the labeling of food 
products and that publish on or after January 1, 2021, and on or before 
December 31, 2022. Those regulations will specifically identify January 
1, 2024, as their compliance date. All food products subject to the 
January 1, 2024, compliance date must comply with the appropriate 
regulations when initially introduced into interstate commerce on or 
after January 1, 2024. If any food labeling regulation involves special 
circumstances that justify a compliance date other than January 1, 
2024, we will determine for that regulation an appropriate compliance 
date, which will be specified when the final regulation is published.

    Dated: December 29, 2020.
Stephen M. Hahn,
Commissioner of Food and Drugs.
    Dated: December 30, 2020.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2020-29273 Filed 12-31-20; 4:15 pm]
BILLING CODE 4164-01-P
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