2986 Federal Register / Vol. 86, No. 9 / Thursday, January 14, 2021 / Rules and Regulations 

(2) If it has not already done so, 

provide the respondent with a written 

summary of the legal basis for the 

allegation(s). In addition, the 

Commission may, but is not required to 

provide a response to the defenses 

raised by respondent; 

(3) Provide a written basis for any 

monetary or other relief including the 

calculations underlying the initial 

conciliation proposal, and an 

explanation thereof. A written 

explanation is not required for 

subsequent offers and counteroffers; 

(4) If it has not already done so, 

advise the respondent in writing that 

the Commission has designated the case 

as systemic, class, or pattern or practice, 

if the designation has been made at the 

time of the conciliation, and the basis 

for the designation; and 

(5) Provide the respondent at least 14 

calendar days to respond to the 

Commission’s initial conciliation 

proposal. 

(c) The Commission shall not disclose 

any information pursuant to paragraph 

(b) of this section where another federal 

law prohibits disclosure of that 

information or where the information is 

protected by privilege. 

(d) Any information the Commission 

provides pursuant to paragraph (b) of 

this section to the respondent, except 

for information about another charging 

party or aggrieved individual, will also 

be provided to the charging party, upon 

request. Any information the 

Commission provides pursuant to 

paragraph (b) of this section to the 

respondent about an aggrieved 

individual will be provided to the 

aggrieved individual, upon request. 

■ 3. Amend § 1626.15 by adding a new 

sentence to the end of paragraph (d) to 

read as follows: 

§ 1626.15 Commission enforcement. 

* * * * * 

(d) * * * Any conciliation process 

under this paragraph shall follow the 

procedures as described in § 1626.12. 

* * * * * 

[FR Doc. 2021–00701 Filed 1–13–21; 8:45 am] 

BILLING CODE 6570–01–P 

POSTAL SERVICE 

39 CFR Part 233 

Inspection Service Authority; Civil 

Monetary Penalty Inflation Adjustment 

AGENCY: Postal ServiceTM. 

ACTION: Interim final rule. 

SUMMARY: This document updates postal 

regulations by implementing inflation 

adjustments to civil monetary penalties 

that may be imposed under consumer 

protection and mailability provisions 

enforced by the Postal Service pursuant 

to the Deceptive Mail Prevention and 

Enforcement Act and the Postal 

Accountability and Enhancement Act. 

These adjustments are required under 

the Federal Civil Penalties Inflation 

Adjustment Act of 1990, as amended by 

the Federal Civil Penalties Inflation 

Adjustment Act Improvements Act of 

2015. This document includes the 

adjustments for 2021 for statutory civil 

monetary penalties subject to the 2015 

Act. 

DATES: Effective date: January 14, 2021. 

FOR FURTHER INFORMATION CONTACT: 

Steven Sultan, (202) 268–7385, 

SESultan@uspis.gov. 

SUPPLEMENTARY INFORMATION: The 

Federal Civil Penalties Inflation 

Adjustment Act Improvements Act of 

2015 (2015 Act), Public Law 114–74, 

129 Stat. 584, amended the Federal Civil 

Penalties Inflation Adjustment Act of 

1990 (1990 Act), Public Law 101–410, 

104 Stat. 890 (28 U.S.C. 2461 note), to 

improve the effectiveness of civil 

monetary penalties and to maintain 

their deterrent effect. Section 3 of the 

1990 Act specifically includes the Postal 

Service in the definition of ‘‘agency’’ 

subject to its provisions. 

Beginning in 2017, the 2015 Act 

requires the Postal Service to make an 

annual adjustment for inflation to civil 

penalties that meet the definition of 

‘‘civil monetary penalty’’ under the 

1990 Act. The Postal Service must make 

the annual adjustment for inflation and 

publish the adjustment in the Federal 

Register by January 15 of each year. 

Each penalty will be adjusted as 

instructed by the Office of Management 

and Budget (OMB) based on the 

Consumer Price Index (CPI–U) from the 

most recent October. OMB has 

furnished detailed instructions 

regarding the annual adjustment for 

2021 in memorandum M–21–10, 

Implementation of Penalty Inflation 

Adjustments for 2021, Pursuant to the 

Federal Civil Penalties Inflation 

Adjustment Act Improvements Act of 

2015 (December 23, 2020), https://

www.whitehouse.gov/wp-content/ 

uploads/2020/12/M-21-10.pdf. This 

year, OMB has advised that an 

adjustment multiplier of 1.01182 will be 

used. The new penalty amount must be 

rounded to the nearest dollar. 

The 2015 Act allows the interim final 

rule and annual inflation adjustments to 

be published without prior public 

notice or opportunity for public 

comment. 

Adjustments to Postal Service Civil 

Monetary Penalties 

Civil monetary penalties may be 

assessed for postal offenses under 

sections 106 and 108 of the Deceptive 

Mail Prevention and Enforcement Act, 

Public Law 106–168, 113 Stat. 1811, 

1814 (see, 39 U.S.C. 3012(a), (c)(1), (d), 

and 3017 (g)(2), (h)(1)(A)); and section 

1008 of the Postal Accountability and 

Enhancement Act, Public Law 109–435, 

120 Stat. 3259–3261 (see, 39 U.S.C. 3018 

(c)(1)(A)). The statutory civil monetary 

penalties subject to the 2015 Act and the 

amount of each penalty after 

implementation of the annual 

adjustment for inflation are as follows: 

39 U.S.C. 3012(a)—False 

Representations and Lottery Orders 

Under 39 U.S.C. 3005(a)(1)–(3), the 

Postal Service may issue administrative 

orders prohibiting persons from using 

the mail to obtain money through false 

representations or lotteries. Persons who 

evade, attempt to evade, or fail to 

comply with an order to stop such 

prohibited practices may be liable to the 

United States for a civil penalty under 

39 U.S.C. 3012(a). The regulations 

implemented pursuant to this section 

currently impose a $73,951 penalty for 

each mailing less than 50,000 pieces, 

$147,899 for each mailing of 50,000 to 

100,000 pieces, and $14,791 for each 

additional 10,000 pieces above 100,000 

not to exceed $2,957,993. The new 

penalties will be as follows: A $74,825 

penalty for each mailing less than 

50,000 pieces, $149,647 for each mailing 

of 50,000 to 100,000 pieces, and $14,966 

for each additional 10,000 pieces above 

100,000 not to exceed $2,992,956. 

39 U.S.C. 3012(c)(1)—False 

Representation and Lottery Penalties in 

Lieu of or as Part of an Order 

In lieu of or as part of an order issued 

under 39 U.S.C. 3005(a)(1)–(3), the 

Postal Service may assess a civil 

penalty. Currently, the amount of this 

penalty, set in the implementing 

regulations to 39 U.S.C. 3012(c)(1), is 

$36,975 for each mailing that is less 

than 50,000 pieces, $73,951 for each 

mailing of 50,000 to 100,000 pieces, and 

an additional $7,395 for each additional 

10,000 pieces above 100,000 not to 

exceed $1,478,996. The new penalties 

will be $37,412 for each mailing that is 

less than 50,000 pieces, $74,825 for each 

mailing of 50,000 to 100,000 pieces, and 

an additional $7,482 for each additional 

10,000 pieces above 100,000 not to 

exceed $1,496,478. 


khammond on DSKJM1Z7X2PROD with RULES
Federal Register / Vol. 86, No. 9 / Thursday, January 14, 2021 / Rules and Regulations 2987 

1Executive Order on Protecting and Improving 

Medicare for Our Nation’s Seniors, available at 

https://www.whitehouse.gov/presidential-actions/ 

executive-order-protecting-improving-medicarenations-seniors/. 

2 Id. 

39 U.S.C. 3012(d)—Misleading 

References to the United States 

Government; Sweepstakes and 

Deceptive Mailings 

Persons may be liable to the United 

States for a civil penalty under 39 U.S.C. 

3012(d) for sending certain deceptive 

mail matter described in 39 U.S.C. 

3001((h)–(k), including: 

• Solicitations making false claims of 

Federal Government connection or 

approval; 

• Certain solicitations for the 

purchase of a product or service that 

may be obtained without cost from the 

Federal Government; 

• Solicitations containing improperly 

prepared ‘‘facsimile checks’’; and 

• Certain solicitations for ‘‘skill 

contests’’ and ‘‘sweepstakes’’ sent to 

individuals who, in accordance with 39 

U.S.C. 3017(d), have requested that such 

materials not be mailed to them. 

Currently, under the implementing 

regulations, this penalty is not to exceed 

$14,791 for each mailing. The new 

penalty will be $14,966. 

39 U.S.C. 3017(g)(2)—Commercial Use 

of Lists of Persons Electing Not To 

Receive Skill Contest or Sweepstakes 

Mailings 

Under 39 U.S.C. 3017(g)(2), the Postal 

Service may impose a civil penalty 

against a person who provides 

information for commercial use about 

individuals who, in accordance with 39 

U.S.C. 3017(d), have elected not to 

receive certain sweepstakes and contest 

information. Currently, this civil 

penalty may not exceed $2,957,993 per 

violation, pursuant to the implementing 

regulations. The new penalty may not 

exceed $2,992,956 per violation. 

39 U.S.C. 3017(h)(1)(A)—Reckless 

Mailing of Skill Contest or Sweepstakes 

Matter 

Currently, under 39 U.S.C. 

3017(h)(1)(A) and its implementing 

regulations, any promoter who 

recklessly mails nonmailable skill 

contest or sweepstakes matter may be 

liable to the United States in the amount 

of $14,791 per violation for each mailing 

to an individual. The new penalty is 

$14,966 per violation. 

39 U.S.C. 3018(c)(1)(A)—Hazardous 

Material 

Under 39 U.S.C. 3018(c)(1)(A), the 

Postal Service may impose a civil 

penalty payable into the Treasury of the 

United States on a person who 

knowingly mails nonmailable hazardous 

materials or fails to follow postal laws 

on mailing hazardous materials. 

Currently, this civil penalty is at least 

$320, but not more than $127,525 for 

each violation, pursuant to the 

implementing regulations. The new 

penalty is at least $324, but not more 

than $129,032 for each violation. 

List of Subjects in 39 CFR Part 233 

Administrative practice and 

procedure, Banks, Banking, Credit, 

Crime, Infants and children, Law 

enforcement, Penalties, Privacy, 

Seizures and forfeitures. 

For the reasons set out in the 

preamble, the Postal Service amends 39 

CFR part 233 as follows: 

PART 233—INSPECTION SERVICE 

AUTHORITY 

■ 1. The authority citation for part 233 

continues to read as follows: 

Authority: 39 U.S.C. 101, 102, 202, 204, 

401, 402, 403, 404, 406, 410, 411, 1003, 

3005(e)(1), 3012, 3017, 3018; 12 U.S.C. 3401– 

3422; 18 U.S.C. 981, 983, 1956, 1957, 2254, 

3061; 21 U.S.C. 881; Pub. L. 101–410, 104 

Stat. 890 (28 U.S.C. 2461 note); Pub. L. 104– 

208, 110 Stat. 3009; Secs. 106 and 108, Pub. 

L. 106–168, 113 Stat. 1806 (39 U.S.C. 3012, 

3017); Pub. L. 114–74, 129 Stat. 584. 

§ 233.12 [Amended] 

■ 2. In § 233.12: 

■ a. In paragraph (a), remove ‘‘$73,951’’ 

and add in its place ‘‘$74,825’’, remove 

‘‘$147,899’’ and add in its place 

‘‘$149,647’’, remove ‘‘$14,791’’ and add 

in its place ‘‘$14,966’’, and remove 

‘‘$2,957,993’’ and add in its place 

‘‘$2,992,956’’. 

■ b. In paragraph (b), remove ‘‘$36,975’’ 

and add in its place ‘‘$37,412’’, remove 

‘‘$73,951’’ and add in its place 

‘‘$74,825’’, remove ‘‘$7,395’’ and add in 

its place ‘‘$7,482’’, and remove 

‘‘$1,478,996’’ and add in its place 

‘‘$1,496,478’’. 

■ c. In paragraph (c)(4), remove 

‘‘$14,791’’ and add in its place 

‘‘$14,966’’. 

■ d. In paragraph (d), remove 

‘‘$2,957,993’’ and add in its place 

‘‘$2,992,956’’. 

■ e. In paragraph (e), remove ‘‘$14,791’’ 

and add in its place ‘‘$14,966’’. 

■ f. In paragraph (f), remove ‘‘$320’’ and 

add in its place ‘‘$324’’ and remove 

‘‘$127,525’’ and add in its place 

‘‘$129,032’’. 

Joshua Hofer, 

Attorney, Federal Compliance. 

[FR Doc. 2021–00447 Filed 1–13–21; 8:45 am] 

BILLING CODE 7710–12–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Part 405 

[CMS–3372–F] 

RIN 0938–AT88 

Medicare Program; Medicare Coverage 

of Innovative Technology (MCIT) and 

Definition of ‘‘Reasonable and 

Necessary’’ 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Final rule. 

SUMMARY: This final rule establishes a 

Medicare coverage pathway to provide 

Medicare beneficiaries nationwide with 

faster access to new, innovative medical 

devices designated as breakthrough by 

the Food and Drug Administration 

(FDA). The Medicare Coverage of 

Innovative Technology (MCIT) pathway 

will result in 4 years of national 

Medicare coverage starting on the date 

of FDA market authorization or a 

manufacturer chosen date within 2 

years thereafter. This rule also 

implements regulatory standards to be 

used in making reasonable and 

necessary determinations under section 

1862(a)(1)(A) of the Social Security Act 

(the Act) for items and services that are 

furnished under Part A and Part B. 

DATES: This final rule is effective on 

March 15, 2021. 

FOR FURTHER INFORMATION CONTACT: 

Tamara Syrek Jensen and JoAnna 

Baldwin, (410) 786–2281 or 

CAGinquiries@cms.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Department is committed to 

ensuring Medicare beneficiaries have 

access to new cures and technologies 

that improve health outcomes. Section 6 

of the October 3, 2019 Executive Order 

13890 (E.O. 13890) ‘‘Executive Order on 

Protecting and Improving Medicare for 

Our Nation’s Seniors,’’ 1 directs the 

Secretary to ‘‘propose regulatory and 

sub-regulatory changes to the Medicare 

program to encourage innovation for 

patients’’ including by ‘‘streamlining the 

approval, coverage, and coding 

process’’.2 The E.O. 13890 explicitly 


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