Agency Information Collection Activities: Submission for OMB Review; Comment Request, 99-100 [2020-29116]
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Federal Register / Vol. 86, No. 1 / Monday, January 4, 2021 / Notices
2. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
Centers for Medicare & Medicaid
William Parham at (410) 786–4669.
Services
SUPPLEMENTARY INFORMATION: Under the
[Document Identifier: CMS–10137 and CMS– Paperwork Reduction Act of 1995 (PRA)
R–262]
(44 U.S.C. 3501–3520), federal agencies
must obtain approval from the Office of
Agency Information Collection
Management and Budget (OMB) for each
Activities: Submission for OMB
collection of information they conduct
Review; Comment Request
or sponsor. The term ‘‘collection of
information’’ is defined in 44 U.S.C.
AGENCY: Centers for Medicare &
3502(3) and 5 CFR 1320.3(c) and
Medicaid Services, Health and Human
includes agency requests or
Services (HHS).
requirements that members of the public
ACTION: Notice.
submit reports, keep records, or provide
information to a third party. Section
SUMMARY: The Centers for Medicare &
Medicaid Services (CMS) is announcing 3506(c)(2)(A) of the PRA (44 U.S.C.
3506(c)(2)(A)) requires federal agencies
an opportunity for the public to
to publish a 30-day notice in the
comment on CMS’ intention to collect
Federal Register concerning each
information from the public. Under the
proposed collection of information,
Paperwork Reduction Act of 1995
including each proposed extension or
(PRA), federal agencies are required to
reinstatement of an existing collection
publish notice in the Federal Register
of information, before submitting the
concerning each proposed collection of
collection to OMB for approval. To
information, including each proposed
extension or reinstatement of an existing comply with this requirement, CMS is
publishing this notice that summarizes
collection of information, and to allow
the following proposed collection(s) of
a second opportunity for public
information for public comment:
comment on the notice. Interested
1. Type of Information Collection
persons are invited to send comments
Request: Revision of a currently
regarding the burden estimate or any
approved collection; Title of
other aspect of this collection of
information, including the necessity and Information Collection: Solicitation for
Applications for Medicare Prescription
utility of the proposed information
collection for the proper performance of Drug Plan 2022 Contracts; Use: Coverage
for the prescription drug benefit is
the agency’s functions, the accuracy of
provided through contracted
the estimated burden, ways to enhance
prescription drug plans (PDPs) or
the quality, utility, and clarity of the
information to be collected, and the use through Medicare Advantage (MA)
plans that offer integrated prescription
of automated collection techniques or
other forms of information technology to drug and health care coverage (MA–PD
plans). Cost Plans that are regulated
minimize the information collection
under Section 1876 of the Social
burden.
Security Act, and Employer Group
DATES: Comments on the collection(s) of Waiver Plans (EGWP) may also provide
information must be received by the
a Part D benefit. Organizations wishing
OMB desk officer by February 3, 2021.
to provide services under the
ADDRESSES: Written comments and
Prescription Drug Benefit Program must
recommendations for the proposed
complete an application, negotiate rates,
information collection should be sent
and receive final approval from CMS.
within 30 days of publication of this
Existing Part D Sponsors may also
notice to www.reginfo.gov/public/do/
expand their contracted service area by
PRAMain. Find this particular
completing the Service Area Expansion
information collection by selecting
(SAE) application.
‘‘Currently under 30-day Review—Open
Collection of this information is
for Public Comments’’ or by using the
mandated in Part D of the Medicare
search function.
Prescription Drug, Improvement, and
To obtain copies of a supporting
Modernization Act of 2003 (MMA) in
statement and any related forms for the
Subpart 3. The application requirements
proposed collection(s) summarized in
are codified in Subpart K of 42 CFR 423
this notice, you may make your request
entitled ‘‘Application Procedures and
using one of following:
Contracts with PDP Sponsors.’’
The information will be collected
1. Access CMS’ website address at
website address at https://www.cms.gov/ under the solicitation of proposals from
PDP, MA–PD, Cost Plan, Program of All
Regulations-and-Guidance/Legislation/
Inclusive Care for the Elderly (PACE),
PaperworkReductionActof1995/PRAand EGWP applicants. The collected
Listing.html.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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99
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
E:\FR\FM\04JAN1.SGM
04JAN1
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.
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:
SUMMARY:
I. Background
Section 306(a)(2)(B) of the FD&C Act
(21 U.S.C. 335a(a)(2)(B)) requires
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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.
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Sfmt 4703
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
E:\FR\FM\04JAN1.SGM
04JAN1
]]>Agencies
[Federal Register Volume 86, Number 1 (Monday, January 4, 2021)]
[Notices]
[Pages 99-100]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-29116]
[[Page 99]]
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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/PRA-Listing.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 for-profits 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
[[Page 100]]
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
