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: 

PART 774—THE COMMERCE 

CONTROL LIST 

■ 1. The authority citation for part 774 

continues to read as follows:

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. 

Supplement No. 5 to Part 774 [Amended] 

■ 2. In Supplement No. 5 to part 774, 

amend the table, under the heading

‘‘0D521. Software’’ entry No 1, by

revising the date in the third column to 

read: ‘‘January 6, 2022’’. 

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 

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:// 


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Federal Register / Vol. 86, No. 3 / Wednesday, January 6, 2021 / Rules and Regulations 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 


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464 Federal Register / Vol. 86, No. 3 / Wednesday, January 6, 2021 / Rules and Regulations 

1Under 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. 

2Note 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. 

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 

AGENCY: Internal Revenue Service (IRS), 

Treasury. 

ACTION: Final regulations. 

SUMMARY: 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. 

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 

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 60- 

day 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 


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