Federal Register / Vol. 86, No. 1 / Monday, January 4, 2021 / Notices 99 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10137 and CMS– 

R–262] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, Health and Human 

Services (HHS). 

ACTION: Notice. 

SUMMARY: The Centers for Medicare & 

Medicaid Services (CMS) is announcing 

an opportunity for the public to 

comment on CMS’ intention to collect 

information from the public. Under the 

Paperwork Reduction Act of 1995 

(PRA), federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension or reinstatement of an existing 

collection of information, and to allow 

a second opportunity for public 

comment on the notice. Interested 

persons are invited to send comments 

regarding the burden estimate or any 

other aspect of this collection of 

information, including the necessity and 

utility of the proposed information 

collection for the proper performance of 

the agency’s functions, the accuracy of 

the estimated burden, ways to enhance 

the quality, utility, and clarity of the 

information to be collected, and the use 

of automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

DATES: Comments on the collection(s) of 

information must be received by the 

OMB desk officer by February 3, 2021. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. 

To obtain copies of a supporting 

statement and any related forms for the 

proposed collection(s) summarized in 

this notice, you may make your request 

using one of following: 

1. Access CMS’ website address at 

website address at https://www.cms.gov/ 

Regulations-and-Guidance/Legislation/ 

PaperworkReductionActof1995/PRAListing.html. 

2. Call the Reports Clearance Office at 

(410) 786–1326. 

FOR FURTHER INFORMATION CONTACT: 

William Parham at (410) 786–4669. 

SUPPLEMENTARY INFORMATION: Under the 

Paperwork Reduction Act of 1995 (PRA) 

(44 U.S.C. 3501–3520), federal agencies 

must obtain approval from the Office of 

Management and Budget (OMB) for each 

collection of information they conduct 

or sponsor. The term ‘‘collection of 

information’’ is defined in 44 U.S.C. 

3502(3) and 5 CFR 1320.3(c) and 

includes agency requests or 

requirements that members of the public 

submit reports, keep records, or provide 

information to a third party. Section 

3506(c)(2)(A) of the PRA (44 U.S.C. 

3506(c)(2)(A)) requires federal agencies 

to publish a 30-day notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension or 

reinstatement of an existing collection 

of information, before submitting the 

collection to OMB for approval. To 

comply with this requirement, CMS is 

publishing this notice that summarizes 

the following proposed collection(s) of 

information for public comment: 

1. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Solicitation for 

Applications for Medicare Prescription 

Drug Plan 2022 Contracts; Use: Coverage 

for the prescription drug benefit is 

provided through contracted 

prescription drug plans (PDPs) or 

through Medicare Advantage (MA) 

plans that offer integrated prescription 

drug and health care coverage (MA–PD 

plans). Cost Plans that are regulated 

under Section 1876 of the Social 

Security Act, and Employer Group 

Waiver Plans (EGWP) may also provide 

a Part D benefit. Organizations wishing 

to provide services under the 

Prescription Drug Benefit Program must 

complete an application, negotiate rates, 

and receive final approval from CMS. 

Existing Part D Sponsors may also 

expand their contracted service area by 

completing the Service Area Expansion 

(SAE) application. 

Collection of this information is 

mandated in Part D of the Medicare 

Prescription Drug, Improvement, and 

Modernization Act of 2003 (MMA) in 

Subpart 3. The application requirements 

are codified in Subpart K of 42 CFR 423 

entitled ‘‘Application Procedures and 

Contracts with PDP Sponsors.’’ 

The information will be collected 

under the solicitation of proposals from 

PDP, MA–PD, Cost Plan, Program of All 

Inclusive Care for the Elderly (PACE), 

and EGWP applicants. The collected 

information will be used by CMS to: (1) 

Ensure that applicants meet CMS 

requirements for offering Part D plans 

(including network adequacy, 

contracting requirements, and 

compliance program requirements, as 

described in the application), (2) 

support the determination of contract 

awards. Form Number: CMS–10137 

(OMB control number: 0938–0936); 

Frequency: Yearly; Affected Public: 

Private Sector: Business or other forprofits and Not-for-profit institutions 

and State, Local or Tribal Governments; 

Number of Respondents: 658; Total 

Annual Responses: 331; Total Annual 

Hours: 1,550. (For policy questions 

regarding this collection, contact 

Arianne Spaccarelli at 410–786–5715.) 

2. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: CMS Plan 

Benefit Package (PBP) and Formulary 

CY 2022; Use: Under the Medicare 

Modernization Act (MMA), Medicare 

Advantage (MA) and Prescription Drug 

Plan (PDP) organizations are required to 

submit plan benefit packages for all 

Medicare beneficiaries residing in their 

service area. The plan benefit package 

submission consists of the Plan Benefit 

Package (PBP) software, formulary file, 

and supporting documentation, as 

necessary. MA and PDP organizations 

use the PBP software to describe their 

organization’s plan benefit packages, 

including information on premiums, 

cost sharing, authorization rules, and 

supplemental benefits. They also 

generate a formulary to describe their 

list of drugs, including information on 

prior authorization, step therapy, 

tiering, and quantity limits. 

CMS requires that MA and PDP 

organizations submit a completed PBP 

and formulary as part of the annual 

bidding process. During this process, 

organizations prepare their proposed 

plan benefit packages for the upcoming 

contract year and submit them to CMS 

for review and approval. CMS uses this 

data to review and approve the benefit 

packages that the plans will offer to 

Medicare beneficiaries. This allows 

CMS to review the benefit packages in 

a consistent way across all submitted 

bids during with incredibly tight 

timeframes. This data is also used to 

populate data on Medicare Plan Finder, 

which allows beneficiaries to access and 

compare Medicare Advantage and 

Prescription Drug plans. Form Number: 

CMS–R–262 (OMB control number: 

0938–0763); Frequency: Yearly; Affected 

Public: Private Sector: Business or other 

for-profits and Not-for-profit institutions 

and State, Local or Tribal Governments; 

Number of Respondents: 753; Total 

100 Federal Register / Vol. 86, No. 1 / Monday, January 4, 2021 / Notices 

Annual Responses: 8,090; Total Annual 

Hours: 74,038. (For policy questions 

regarding this collection, contact Kristy 

Holtje at 410–786–2209.) 

Dated: December 29, 2020. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2020–29116 Filed 12–31–20; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–1415] 

Sunrise Lee: Final Debarment Order 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

issuing an order under the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act) permanently debarring Sunrise Lee 

from providing services in any capacity 

to a person that has an approved or 

pending drug product application. FDA 

bases this order on a finding that Ms. 

Lee was convicted of a felony under 

Federal law for conduct that relates to 

the regulation of a drug product under 

the FD&C Act. Ms. Lee was given notice 

of the proposed permanent debarment 

and an opportunity to request a hearing 

to show why she should not be 

debarred. As of October 8, 2020 (30 days 

after receipt of the notice), Ms. Lee had 

not responded. Ms. Lee’s failure to 

respond and request a hearing 

constitutes a waiver of her right to a 

hearing concerning this action. 

DATES: This order is applicable January 

4, 2021. 

ADDRESSES: Submit applications for 

termination of debarment to the Dockets 

Management Staff, Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852, 240–402– 

7500, or at https://www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Jaime Espinosa, (ELEM–4029) Division 

of Enforcement, Office of Strategic 

Planning and Operational Policy, Office 

of Regulatory Affairs, Food and Drug 

Administration, 12420 Parklawn Dr., 

Rockville, MD 20857, 240–402–8743, or 

at debarments@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 306(a)(2)(B) of the FD&C Act 

(21 U.S.C. 335a(a)(2)(B)) requires 

debarment of an individual from 

providing services in any capacity to a 

person that has an approved or pending 

drug product application if FDA finds 

that the individual has been convicted 

of a felony under Federal law for 

conduct relating to the regulation of any 

drug product under the FD&C Act. On 

January 22, 2020, Ms. Lee was convicted 

as defined in section 306(l)(1) of the 

FD&C Act when judgment was entered 

against her in the U.S. District Court for 

the District of Massachusetts, after a jury 

verdict, on one count of Racketeering 

Conspiracy in violation of 18 U.S.C. 

1962(d). The pattern of racketeering 

activity she was convicted of included 

engaging in multiple acts of mail fraud 

(18 U.S.C. 1341) and wire fraud (18 

U.S.C. 1343). 

The factual basis for this conviction is 

as follows: Ms. Lee held executive 

management positions, to include 

Regional Sales Manager for the MidAtlantic Region, Regional Director for 

the Central Region, and Regional 

Director for the West Region, of Insys 

Therapeutics Inc. (Insys), a Delaware 

Corporation, with headquarters in 

Chandler, Arizona. Insys developed and 

owned a drug called SUBSYS, a liquid 

formulation of fentanyl to be applied 

under the tongue. FDA approved 

SUBSYS for the management of 

breakthrough pain in adult cancer 

patients who are already receiving and 

are already tolerant to opioid therapy for 

their underlying persistent cancer pain. 

From 2012 and continuing through 

2015, Ms. Lee participated in a 

conspiracy whereby employees of Insys 

bribed medical practitioners in various 

states to get those practitioners to 

increase prescribing SUBSYS to their 

patients, many of whom did not have 

cancer. Ms. Lee, along with her coconspirators, measured the effect of 

these bribes on each practitioner’s 

prescribing habits and on the revenue 

that each bribed practitioner generated 

for Insys. Ms. Lee, along with her coconspirators, reduced or eliminated 

bribes paid to those practitioners who 

failed to meet the minimum 

prescription requirements or failed to 

generate enough revenue to justify 

additional bribes. To further this 

conspiracy, Ms. Lee’s co-conspirators 

mislead and defrauded health insurance 

providers to ensure those providers 

approved payment for SUBSYS. Insys 

achieved this goal by establishing the 

‘‘Insys Reimbursement Center,’’ which 

was designed to shift the burden of 

seeking prior authorization for SUBSYS 

from practitioners to Insys. This allowed 

Insys to determine what medical 

information was presented to insurers. 

Ms. Lee’s co-conspirators directed Insys 

employees to mislead insurers to obtain 

payment authorization. 

As a result of this conviction, FDA 

sent Ms. Lee by certified mail on August 

3, 2020, a notice proposing to 

permanently debar her from providing 

services in any capacity to a person that 

has an approved or pending drug 

product application. The proposal was 

based on a finding, under section 

306(a)(2)(B) of the FD&C Act, that Ms. 

Lee was convicted of a felony under 

Federal law for conduct relating to the 

regulation of a drug product under the 

FD&C Act. The proposal also offered 

Ms. Lee an opportunity to request a 

hearing, providing her 30 days from the 

date of receipt of the letter in which to 

file the request, and advised her that 

failure to request a hearing constituted 

an election not to use the opportunity 

for a hearing and a waiver of any 

contentions concerning this action. Ms. 

Lee received the proposal on September 

8, 2020. She did not request a hearing 

within the timeframe prescribed by 

regulation and has, therefore, waived 

her opportunity for a hearing and any 

contentions concerning her debarment 

(21 CFR part 12). 

II. Findings and Order 

Therefore, the Assistant 

Commissioner, Office of Human and 

Animal Food Operations, under section 

306(a)(2)(B) of the FD&C Act, under 

authority delegated to the Assistant 

Commissioner, finds that Ms. Sunrise 

Lee has been convicted of a felony 

under Federal law for conduct 

otherwise relating to the regulation of a 

drug product under the FD&C Act. 

As a result of the foregoing finding, 

Ms. Lee is permanently debarred from 

providing services in any capacity to a 

person with an approved or pending 

drug product application, effective (see 

DATES) (see sections 306(a)(2)(B) and 

(c)(2)(A)(ii) of the FD&C Act). Any 

person with an approved or pending 

drug product application who 

knowingly employs or retains as a 

consultant or contractor, or otherwise 

uses the services of Ms. Lee in any 

capacity during her debarment, will be 

subject to civil money penalties (section 

307(a)(6) of the FD&C Act (21 U.S.C. 

335b(a)(6))). If Ms. Lee provides services 

in any capacity to a person with an 

approved or pending drug product 

application during her period of 

debarment, she will be subject to civil 

money penalties (section 307(a)(7) of the 

FD&C Act). In addition, FDA will not 

accept or review any abbreviated new 

drug application from Ms. Lee during 

her period of debarment, other than in 

connection with an audit under section