Federal Register / Vol. 86, No. 32 / Friday, February 19, 2021 / Rules and Regulations 10181 

1The effective date of the amendments to 42 CFR 

1001.952 (h)(6) through (9), (cc), and (dd) published 

at 85 FR 76666, November 30, 2020, was 

subsequently delayed until March 22, 2021. 86 FR 

7815 (Feb. 2, 2021). 

2Pharmaceutical Care Management Association 

v. United States Department of Health & Human 

Services et al., No. 1:21–cv–00095 (D. DC. filed Jan. 

12, 2021). 

3Pharmaceutical Care Management Association 

v. United States Department of Health & Human 

Services et al., No. 1:21–cv–00095 (D. DC Jan. 30, 

2021)) (order granting joint stipulation and 

postponing effective date), Doc. No. 19. 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of Inspector General 

42 CFR Part 1001 

RIN 0936–AA08 

Fraud And Abuse; Removal of Safe 

Harbor Protection for Rebates 

Involving Prescription 

Pharmaceuticals and Creation of New 

Safe Harbor Protection for Certain 

Point-of-Sale Reductions in Price on 

Prescription Pharmaceuticals and 

Certain Pharmacy Benefit Manager 

Service Fees; Delayed Effective Date 

AGENCY: Office of Inspector General 

(OIG), Health and Human Services 

(HHS). 

ACTION: Final rule; notification of courtordered delay of effective date. 

SUMMARY: As required by an order 

issued by the U.S. District Court for the 

District of Columbia, this action 

provides notice of the delay of the 

effective date of certain amendments to 

the safe harbors to the Federal antikickback statute that were promulgated 

in a final rule (‘‘Fraud And Abuse; 

Removal of Safe Harbor Protection for 

Rebates Involving Prescription 

Pharmaceuticals And Creation of New 

Safe Harbor Protection for Certain Pointof-Sale Reductions in Price on 

Prescription Pharmaceuticals and 

Certain Pharmacy Benefit Manager 

Service Fees’’) published on November 

30, 2020. The new effective date for 

these certain amendments is January 1, 

2023. 

DATES: As of February 19, 2021, this 

action delays the published effective 

date of the amendments to 42 CFR 

1001.952(h)(5) published November 30, 

2020, at 85 FR 76666, and corrected at 

86 FR 7815, February 2, 2021, until 

January 1, 2023. 

FOR FURTHER INFORMATION CONTACT: 

Aaron Zajic, (202) 619–0335. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of November 30, 2020, 

the Department issued a final rule 

establishing four changes to the 

regulatory safe harbors to the Federal 

anti-kickback statute (Social Security 

Act Section 1128B(b)). Specifically, the 

final rule (1) amended 42 CFR 

1001.952(h)(5) to remove safe harbor 

protection for reductions in price for 

prescription pharmaceutical products 

provided to plan sponsors under Part D; 

(2) created a new safe harbor at 

§ 1001.952(cc) for certain point-of-sale 

reductions in price offered by 

manufacturers on prescription 

pharmaceutical products that are 

payable under Medicare Part D or by 

Medicaid managed care organizations 

that meet certain criteria; (3) created a 

new safe harbor at § 1001.952(dd) for 

fixed fees that manufacturers pay to 

pharmacy benefit managers (PBMs) for 

services rendered to the manufacturers 

that meet specified criteria; and (4) 

added new paragraphs (6)–(9) to 42 CFR 

1001.952(h), defining certain terms. The 

final rule was published with an 

effective date of January 29, 2021, 

except for the amendments to 42 CFR 

1001.952(h)(5), which were to be 

effective on January 1, 2022.1

On January 12, 2021, a lawsuit 

challenging the final rule was filed in 

the U.S. District Court for the District of 

Columbia.2 On January 30, 2021, the 

Court issued an order postponing until 

January 1, 2023 the effective date of all 

provisions of the final rule that were 

scheduled to take effect on January 1, 

2022.3 Consistent with that order, the 

Department is taking this action to 

notify the public that the effective date 

of the amendments to paragraph 42 CFR 

1001.952 (h)(5) in the final rule is now 

January 1, 2023. Pursuant to the court 

order, any obligation to comply with a 

deadline tied to the effective date of 

these amendments is similarly 

postponed, and those obligations and 

deadlines are now tied to the postponed 

effective date. 

To the extent that 5 U.S.C. 553 applies 

to this action, implementation of this 

action without opportunity for public 

comment is based on the good cause 

exception in 5 U.S.C. 553(b)(B). Seeking 

public comment is impracticable, 

unnecessary, and contrary to the public 

interest. The one-year postponement of 

the effective date, until January 1, 2023, 

is required by court order in accordance 

with the court’s authority to postpone a 

rule’s effective date pending judicial 

review (5 U.S.C. 705). Seeking prior 

public comment on this postponement 

would have been impracticable, as well 

as contrary to the public interest in the 

orderly issue and implementation of 

regulations. 

Norris Cochran, 

Acting Secretary. 

[FR Doc. 2021–03167 Filed 2–18–21; 8:45 am] 

BILLING CODE P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Parts 0, 1, 27, 90 

[ET Docket No. 18–295; FCC 20–51; WT 

Docket No. 17–200; FCC 20–67, FRS 17383] 

Unlicensed Use of the 6 GHz Band; 

Review of the Commission’s Rules 

Governing the 896–901/935–940 MHz 

Band 

AGENCY: Federal Communications 

Commission. 

ACTION: Final rule; announcement of 

compliance date. 

SUMMARY: In this document, the 

Commission announces that the Office 

of Management and Budget has 

approved the information collection 

requirements associated with the rules 

and policies adopted in the Federal 

Communications Commission’s 6 GHz 

Report and Order, FCC 20–51, making 

1,200 megahertz of spectrum in the 6 

GHz band (5.925–7.125 GHz) available 

for unlicensed use, and 900 MHz Report 

and Order, FCC 20–67, establishing 

rules for broadband license operations 

in the 897.5–900.5/936.5–939.5 MHz 

segment of the 900 MHz band (896–901/ 

935–940 MHz), and that compliance 

with the new requirements is now 

required. 

DATES: Compliance date: Compliance 

with 47 CFR 27.1503 and 27.1505, 

published at 85 FR 43124 on July 16, 

2020, is required on February 19, 2021. 

FOR FURTHER INFORMATION CONTACT: 

Jaclyn Rosen, Mobility Division, 

Wireless Telecommunications Bureau, 

at (202) 418–0154 or Jaclyn.Rosen@

fcc.gov. 

SUPPLEMENTARY INFORMATION: This 

document announces that the Office of 

Management and Budget (OMB) 

approved the information collection 

requirements in 47 CFR 27.1503(b)(1), 

(b)(2), (b)(3), (c)(1) and 47 CFR 

27.1505(a), (b), on December 10, 2020. 

These rules were adopted in the 6 GHz 

Order, FCC 20–51, published at 85 FR 

31390 on May 26, 2020, and, 900 MHz 

Report and Order, FCC 20–67, 

published at 85 FR 43124 on July 16, 

2020. Compliance with all new or 

amended rules adopted in the 6 GHz 

Order that do not require OMB approval 


tkelley on DSKBCP9HB2PROD with RULES
10182 Federal Register / Vol. 86, No. 32 / Friday, February 19, 2021 / Rules and Regulations 

is required as of July 27, 2020, see 85 

FR 31390 (May 26, 2020). Compliance 

with all new or amended rules adopted 

in the 900 MHz Report and Order that 

do not require OMB approval is 

required as of August 17, 2020, see 85 

FR 43124 (July 16, 2020). 

If you have any comments on the 

burden estimates listed below, or how 

the Commission can improve the 

collections and reduce any burdens 

caused thereby, please contact Cathy 

Williams, Cathy.Williams@fcc.gov, 

regarding OMB Control Number 3060– 

0798. Please include the OMB Control 

Number in your correspondence. 

To request materials in accessible 

formats for people with disabilities 

(Braille, large print, electronic files, 

audio format), send an email to fcc504@

fcc.gov or call the Consumer and 

Governmental Affairs Bureau at (202) 

418–0530 (voice), (202) 418–0432 

(TTY). 

Synopsis 

As required by the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3507), 

the Commission is notifying the public 

that it received final OMB approval on 

December 10, 2020, for the information 

collection requirements contained in 47 

CFR 27.1503(b)(1), (b)(2), (b)(3), (c)(1) 

and 27.1505(a), (b). Under 5 CFR part 

1320, an agency may not conduct or 

sponsor a collection of information 

unless it displays a current, valid OMB 

Control Number. 

No person shall be subject to any 

penalty for failing to comply with a 

collection of information subject to the 

Paperwork Reduction Act that does not 

display a current, valid OMB Control 

Number. The OMB Control Number for 

the information collection requirements 

in 47 CFR 27.1503(b)(1), (b)(2), (b)(3), 

(c)(1), 27.1505(a), (b) is 3060–0798. 

The foregoing notice is required by 

the Paperwork Reduction Act of 1995, 

Public Law 104–13, October 1, 1995, 

and 44 U.S.C. 3507. 

The total annual reporting burdens 

and costs for the respondents are as 

follows: 

OMB Control Number: 3060–0798. 

OMB Approval Date: December 10, 

2020. 

OMB Expiration Date: December 31, 

2023. 

Title: FCC Application for Radio 

Service Authorization Wireless 

Telecommunications Bureau; Public 

Safety and Homeland Security Bureau. 

Form Number: FCC Form 601. 

Respondents: Individuals and 

households; Business or other for-profit 

entities; State, Local or Tribal 

Government; Not for profit institutions. 

Number of Respondents and 

Responses: 255,552 respondents; 

255,552 responses. 

Estimated Time per Response: 0.5 

hours to 1.25 hours. 

Frequency of Response: 

Recordkeeping requirement; third party 

disclosure requirement; on occasion 

reporting requirement and periodic 

reporting requirement. 

Obligation to Respond: Required to 

obtain or retain benefits. Statutory 

authority for this information collection 

is contained in 47 U.S.C. 151, 152, 154, 

155(c), 157, 201, 202, 208, 214, 301, 

302a, 303, 307, 308, 309, 310, 311, 314, 

316, 319, 324, 331, 332, 333, 336, 534, 

535 and 554. 

Total Annual Burden: 225,808 hours. 

Total Annual Cost: $72,474,000. 

Privacy Act Impact Assessment: Yes. 

Nature and Extent of Confidentiality: 

The information collected under this 

collection will be made publicly 

available. However, to the extent 

information submitted pursuant to this 

information collection is determined to 

be confidential, it will be protected by 

the Commission. If a respondent seeks 

to have information collected pursuant 

to this information collection withheld 

from public inspection, the respondent 

may request confidential treatment 

pursuant to section 0.459 of the 

Commission’s rules for such 

information. 

Needs and Uses: FCC Form 601 is a 

consolidated, multi-part application 

form that is used for market-based and 

site-based licensing for wireless 

telecommunications services, including 

public safety, which are filed through 

the Commission’s Universal Licensing 

System (ULS) or any other electronic 

filing interface the Commission 

develops. FCC Form 601 is composed of 

a main form that contains 

administrative information and a series 

of schedules used for filing technical 

and other information. This form is used 

to apply for a new license, to amend or 

withdraw a pending application, to 

modify or renew an existing license, 

cancel a license, request a duplicate 

license, submit required notifications, 

request an extension of time to satisfy 

construction requirements, request an 

administrative update to an existing 

license (such as mailing address 

change), or request a Special Temporary 

Authority License. Respondents are 

encouraged to submit FCC Form 601 

electronically and are required to do so 

when applying for an authorization for 

which the applicant was the winning 

bidder in a spectrum auction. 

On April 23, 2020, the Commission 

adopted a Report and Order and Further 

Notice of Proposed Rulemaking in ET 

Docket 18–295, FCC 20–51, (6 GHz 

Report and Order) that requires 

temporary fixed microwave licensees to 

register temporary fixed links in the 

ULS database in order to receive 

protection from unlicensed devices 

operating in the 6 GHz band. Automated 

frequency coordination (AFC) 

administrators will use this information 

to determine where unlicensed devices 

can operate. Temporary fixed licensees 

were not previously required to file 

applications with the Commission when 

they commenced operation, so this is a 

new filing requirement. In addition to 

creating this new filing requirement, 

two new data fields will be required to 

describe when the temporary fixed links 

will be operational, so that the AFCs 

will know when to protect the 

temporary fixed links. For this purpose, 

a ‘‘start date’’ and ‘‘end date’’ will be 

added to the Form 601, Schedule I. 

Further, on May 13, 2020, the 

Commission adopted a Report and 

Order, 20–67 (900 MHz Report and 

Order), which realigned the 900 MHz 

band to make available six of the band’s 

ten megahertz for the deployment of 

broadband services and technologies. 

The 900 MHz band currently is 

designated for narrowband land mobile 

radio communications by Business/ 

Industrial/Land Transportation (B/ILT) 

Pool licensees and Specialized Mobile 

Radio (SMR) providers. The 900 MHz 

Report and Order realigned the 900 

MHz band to enable a broadband 

transition from interleaved SMR and B/ 

ILT blocks to one broadband segment 

and two narrowband segments. To 

facilitate the transition, the Commission 

adopted a negotiation-based mechanism 

which, if private agreements are 

reached, will make available on a 

county-by-county basis six megahertz of 

low-band spectrum for the development 

of broadband technologies and services, 

while reserving the remaining four 

megahertz of the band for continued 

narrowband operations. If negotiations 

for the acquisition, relocation, and 

protection of 900 MHz incumbents in a 

market are successful and granting an 

application is otherwise in the public 

interest, the Commission will issue new 

initial licenses to applicants meeting 

eligibility requirements. 

The 900 MHz Report and Order 

established license application 

requirements, including requirements 

that an applicant for a new 900 MHz 

broadband license demonstrate, as part 

of its application, that it satisfies the 

eligibility conditions (Eligibility 

Certification) and submit a plan for 

transitioning the 900 MHz band in a 

particular county (Transition Plan), to 

assess whether a grant of a 900 MHz 


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Federal Register / Vol. 86, No. 32 / Friday, February 19, 2021 / Rules and Regulations 10183 

broadband license is in the public 

interest. 

In addition, the Commission adopted 

a two-fold performance requirement 

whereby a 900 MHz broadband licensee 

must: (1) Provide reliable signal 

coverage and offer broadband service; 

and (2) meet either (a) a population 

coverage requirement, or (b) a 

geographic coverage requirement. 

The information required in this 

collection will be used to ensure that a 

grant of a 900 MHz broadband license 

is in the public interest and to ensure 

that licensees use 900 MHz spectrum 

productively, provide service in a 

timely manner, and promote the 

provision of innovative services and 

technologies in unserved areas, 

particularly rural markets. The 

collection is also necessary for the 

Commission to satisfy its oversight 

responsibilities and/or agency specific/ 

government-wide reporting obligations. 

Federal Communications Commission. 

Marlene Dortch, 

Secretary. 

[FR Doc. 2021–00782 Filed 2–18–21; 8:45 am] 

BILLING CODE 6712–01–P 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 622 

[Docket No. 160426363–7275–02] 

RTID 0648–XA879 

Coastal Migratory Pelagic Resources 

of the Gulf of Mexico and Atlantic 

Region; 2020–2021 Commercial Hookand-Line Closure for King Mackerel in 

the Gulf of Mexico Southern Zone 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Temporary rule; closure. 

SUMMARY: NMFS implements an 

accountability measure (AM) to close 

the hook-and-line component of the 

commercial sector for king mackerel in 

the Gulf of Mexico (Gulf) southern zone. 

This closure is necessary to protect the 

Gulf king mackerel resource. 

DATES: This temporary rule is effective 

from 12:01 a.m., local time, on February 

22, 2021, through June 30, 2021. 

FOR FURTHER INFORMATION CONTACT: 

Kelli O’Donnell, NMFS Southeast 

Regional Office, telephone: 727–824– 

5305, email: kelli.odonnell@noaa.gov. 

SUPPLEMENTARY INFORMATION: The 

fishery for coastal migratory pelagic fish 

in the Gulf includes king mackerel, 

Spanish mackerel, and cobia, and is 

managed under the Fishery 

Management Plan for the Coastal 

Migratory Pelagic Resources of the Gulf 

of Mexico and Atlantic Region (FMP). 

The FMP was prepared by the Gulf of 

Mexico and South Atlantic Fishery 

Management Councils and is 

implemented by NMFS under the 

authority of the Magnuson-Stevens 

Fishery Conservation and Management 

Act (Magnuson-Stevens Act) through 

regulations at 50 CFR part 622. All 

weights for Gulf migratory group king 

mackerel (Gulf king mackerel) apply as 

either round or gutted weight. 

The commercial sector for Gulf king 

mackerel is divided into western, 

northern, and southern zones. The 

southern zone encompasses an area of 

the exclusive economic zone (EEZ) off 

Collier and Monroe Counties in south 

Florida. The southern zone includes the 

EEZ south of a line extending due west 

from the boundary of Lee and Collier 

Counties on the Florida west coast, and 

south of a line extending due east from 

the boundary of Monroe and MiamiDade Counties on the Florida east coast 

(50 CFR 622.369(a)(1)(iii)). 

The commercial annual catch limit 

(ACL) for Gulf king mackerel is divided 

into separate ACLs for the hook-and-line 

and run-around gillnet components of 

the commercial sector. The commercial 

hook-and-line quota (equivalent to the 

commercial hook-and-line ACL) for Gulf 

king mackerel in the southern zone is 

575,400 lb (260,997 kg) for the current 

fishing year of July 1, 2020, through 

June 30, 2021 (50 CFR 

622.384(b)(1)(iii)(A)). 

Regulations at 50 CFR 622.388(a)(1) 

require NMFS to close any component 

of the king mackerel commercial sector 

when its applicable quota has been 

reached or is projected to be reached by 

filing a notification with the Office of 

the Federal Register. NMFS has 

determined the 2020–2021 hook-andline commercial quota for Gulf king 

mackerel in the southern zone will be 

reached by February 22, 2021. 

Accordingly, the hook-and-line 

component of the commercial sector for 

Gulf king mackerel in the southern zone 

is closed from February 22, 2021, 

through the end of the fishing year on 

June 30, 2021. The commercial hookand-line component for Gulf king 

mackerel in the southern zone will 

reopen on July 1, 2021. 

NMFS has also determined that the 

Gulf king mackerel commercial quota 

for vessels using run-around gillnet gear 

in the southern zone was reached on 

January 28, 2021, and therefore on that 

date, NMFS closed the southern zone to 

commercial king mackerel fishing using 

run-around gillnet gear (86 FR 7815, 

February 2, 2021). Accordingly, all 

commercial fishing for Gulf king 

mackerel in the southern zone is closed 

effective at 12:01 a.m. local time on 

February 22, 2021. The commercial runaround gillnet component for Gulf king 

mackerel in the southern zone will 

reopen at 6 a.m. local time on January 

18, 2022. 

A person aboard a vessel that has a 

valid Federal commercial permit for 

king mackerel may continue to retain 

king mackerel under the recreational 

bag and possession limits specified in 

50 CFR 622.382(a)(1)(ii) and (a)(2), as 

long as the recreational sector for Gulf 

king mackerel is open (50 CFR 

622.384(e)(1)). 

During the commercial closure, king 

mackerel caught with hook-and-line 

gear from the closed zone may not be 

purchased or sold, including those 

harvested under the recreational bag 

and possession limits. This prohibition 

does not apply to king mackerel caught 

with hook-and-line gear from the closed 

zone that were harvested, landed 

ashore, and sold prior to the closure and 

were held in cold storage by a dealer or 

processor (50 CFR 622.384(e)(2)). 

Classification 

NMFS issues this action pursuant to 

section 305(d) of the Magnuson-Stevens 

Act. This action is required by 50 CFR 

622.388(a)(1), which was issued 

pursuant to section 304(b) of the 

Magnuson-Stevens Act, and is exempt 

from review under Executive Order 

12866. 

Pursuant to 5 U.S.C. 553(b)(B), there 

is good cause to waive prior notice and 

an opportunity for public comment on 

this action, as notice and comment is 

unnecessary and contrary to the public 

interest. Such procedures are 

unnecessary because the regulations 

associated with the commercial quota 

and associated AM for Gulf king 

mackerel have already been subject to 

notice and public comment, and all that 

remains is to notify the public of the 

closure. Prior notice and opportunity for 

public comment on this action is 

contrary to the public interest because 

of time required to provide notice and 

an opportunity for public comment. 

There is a need to immediately 

implement the closure to protect the 

Gulf king mackerel resource, because 

the capacity of the fishing fleet allows 

for rapid harvest of the commercial 

quota, and any delay in the closure 

could result in the commercial quota 

being exceeded. 

For the aforementioned reasons, there 

is good cause under 5 U.S.C. 553(d)(3) 


tkelley on DSKBCP9HB2PROD with RULES