Eisai, Inc.; Withdrawal of Approval of Two New Drug Application for BELVIQ (lorcaserin hydrochloride) and BELVIQ XR (lorcaserin hydrocholoride), 58063-58064 [2020-20458]
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Federal Register / Vol. 85, No. 181 / Thursday, September 17, 2020 / Notices
(Nov. 20, 2009); Presidential
Memorandum on Enhancing Payment
Accuracy through a ‘‘Do Not Pay List’’
(June 18, 2010); 31 U.S.C. 3351 et seq.;
OMB Memorandum M–18–20
Transmittal of Appendix C to OMB
Circular A–123, Requirements for
Payment Integrity Improvement (June
16, 2018), and 5 U.S.C. 552a.
PURPOSE(S):
The purpose of the matching program
is to provide CMS with information
from Treasury’s Working System which
CMS will use to identify Medicare
providers and suppliers who are
ineligible for Medicare enrollment; to
promptly suspend or revoke the
Medicare billing privileges of the
identified disqualified providers and
suppliers; to enable recoupment of past
payments made to those providers and
suppliers; to assist CMS in detecting
and preventing fraud, waste, abuse and
in avoiding making future improper
payments to disqualified providers and
suppliers; and to enhance patient safety
for beneficiaries in CMS programs.
CATEGORIES OF INDIVIDUALS:
The categories of individuals involved
in the matching program are individual
providers and suppliers who bill
Medicare for payment.
jbell on DSKJLSW7X2PROD with NOTICES
CATEGORIES OF RECORDS:
The categories of records used in the
matching program are identifying data,
and payment eligibility status data. To
request information from Treasury’s
Working System, CMS will provide
Fiscal Service with the following
information about a Medicare provider
or supplier: Tax Identification Number
(TIN), Business Name, Person First
Name, Person Middle Name, Person
Last Name, Address, City Name, State
Code, Person Date of Birth, Person Sex,
Vendor/Payee Phone Number, Vendor/
Payee Email Address.
When Fiscal Service is able to match
the TIN and other identifying data
provided by CMS, Fiscal Service will
disclose to CMS the following
information about that provider or
supplier:
Record Code.
Payee Identifier.
Agency Location Code.
Tax Identification Type.
Tax Identification Number.
Business or Individual or
Government.
DUNS Number.
Payee Business Name.
Payee Business DBA Name.
Person Full Name.
Person First Name.
Person Middle Name.
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17:37 Sep 16, 2020
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Person Last Name.
Address.
Person Date of Birth.
Person Sex.
Vendor/Payee Status.
Phone Type.
Vendor/Payee Phone Number.
Vendor/Payee Fax Number.
Vendor/Payee Email Address.
Vendor/Payee Active Date.
Vendor/Payee Expiration Date.
Agency Record Grouping.
Other Agency Data.
Match Type.
Match Source.
Match Level.
Match Date/Time.
Matched Party Type.
Matched Tax ID Number.
Matched Tax ID Type Code
(alternate).
Matched Tax ID Number (alternate).
Match DUNS Number.
Matched Full Name.
Matched First Name.
Matched Middle Name.
Matched Last Name.
Matched Business Name.
Matched DBA Business Name.
Matched Birth Date.
Matched Death Date.
Matched List Status Code.
Matched List Status Code Description.
Matched List Effective Date.
Matched Address.
Matched City.
Matched State Code.
Matched Zip Code.
Matched Country Code.
SYSTEM(S) OF RECORDS:
The records used in this matching
program will be disclosed from the
following systems of records, as
authorized by relevant routine uses
published in the System of Records
Notices (SORNs) cited below:
A. SYSTEM OF RECORDS MAINTAINED BY CMS:
• The Provider Enrollment, Chain,
and Ownership System (PECOS),
System No. 09–70–0532, 71 FR 60536
(Oct. 13, 2006), 78 FR 32257 (May 29,
2013) and 83 FR 6591 (Feb. 14, 2018).
B. SYSTEM OF RECORDS MAINTAINED BY FISCAL
SERVICE:
• The Department of the Treasury,
Bureau of the Fiscal Service .017—Do
Not Pay Payment Verification Records,
85 FR 11776 at 11803 (Feb. 27, 2020).
[FR Doc. 2020–19956 Filed 9–16–20; 8:45 am]
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58063
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA 2020–N–1735]
Eisai, Inc.; Withdrawal of Approval of
Two New Drug Application for BELVIQ
(lorcaserin hydrochloride) and BELVIQ
XR (lorcaserin hydrocholoride)
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is withdrawing
the approval of two new drug
applications for BELVIQ (lorcaserin
hydrochloride (HCl)) tablets and
BELVIQ XR (lorcaserin HCl) extendedrelease tablets held by Eisai, Inc., 155
Tice Blvd., Woodcliff Lake, NJ 07677
(Eisai). Eisai requested withdrawal of
these applications and has waived its
opportunity for a hearing.
DATES: Approval is withdrawn as of
September 17, 2020.
FOR FURTHER INFORMATION CONTACT:
Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226,
Silver Spring, MD 20993–0002, 301–
796–3137.
SUPPLEMENTARY INFORMATION: FDA
approved NDA 022529 for BELVIQ
(lorcaserin HCl) 10 milligrams (mg)
tablets and NDA 208524 for BELVIQ XR
(lorcaserin HCl) 20 mg extended-release
tablets on June 27, 2012 and July 15,
2016, respectively, as an adjunct to a
reduced-calorie diet and increased
physical activity for chronic weight
management in adults with an initial
body mass index (BMI) of:
• 30 kg/m2 or greater (obese) or
• 27 kg/m2 or greater (overweight) in
the presence of at least one weightrelated comorbid condition, (e.g.,
hypertension, dyslipidemia, type 2
diabetes).
On January 14, 2019, FDA issued a
Drug Safety Communication alerting the
public that results from a clinical trial
assessing the risk of heart-related
problems show a possible increased risk
of cancer with BELVIQ and BELVIQ XR
(see https://www.fda.gov/drugs/drugsafety-and-availability/safety-clinicaltrial-shows-possible-increased-riskcancer-weight-loss-medicine-belviqbelviq-xr). On February 13, 2020, FDA
announced it had asked Eisai to
voluntarily withdraw BELVIQ and
BELVIQ XR from the U.S. market
because a safety clinical trial showed an
increased occurrence of cancer (see
SUMMARY:
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58064
Federal Register / Vol. 85, No. 181 / Thursday, September 17, 2020 / Notices
https://www.fda.gov/drugs/drug-safetyand-availability/fda-requestswithdrawal-weight-loss-drug-belviqbelviq-xr-lorcaserin-market).
On February 13, 2020, Eisai requested
that FDA withdraw approval of NDA
022529 for BELVIQ and NDA 208524 for
BELVIQ XR under § 314.150(d) (21 CFR
314.150(d)), and waived its opportunity
for a hearing.
For the reasons discussed above, and
pursuant to the applicant’s request,
approval of NDA 022529 BELVIQ
(lorcaserin HCl) tablets and 208524
BELVIQ XR (lorcaserin HCl) extendedrelease tablets, and all amendments and
supplements thereto, are withdrawn
under § 314.150(d). Distribution of
BELVIQ into interstate commerce
without an approved application is
illegal and subject to regulatory action
(see sections 505(a) and 301(d) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355(a) and 331(d)).
Dated: September 11, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–20458 Filed 9–16–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[OMHA–2002–N]
Medicare Program; Administrative Law
Judge Hearing Program for Medicare
Claim and Entitlement Appeals;
Quarterly Listing of Program
Issuances—April Through June 2020
Office of Medicare Hearings
and Appeals (OMHA), HHS.
ACTION: Notice.
AGENCY:
This quarterly notice lists the
OMHA Case Processing Manual (OCPM)
instructions that were published from
April through June 2020. This manual
standardizes the day-to-day procedures
for carrying out adjudicative functions,
in accordance with applicable statutes,
regulations, and OMHA directives, and
gives OMHA staff direction for
processing appeals at the OMHA level
of adjudication.
FOR FURTHER INFORMATION CONTACT: Jon
Dorman, by telephone at (571) 457–
7220, or by email at jon.dorman@
hhs.gov.
SUPPLEMENTARY INFORMATION:
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
I. Background
The Office of Medicare Hearings and
Appeals (OMHA), a staff division within
the Office of the Secretary within the
U.S. Department of Health and Human
Services (HHS), administers the
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17:37 Sep 16, 2020
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nationwide Administrative Law Judge
hearing program for Medicare claim;
organization, coverage, and at-risk
determination; and entitlement appeals
under sections 1869, 1155,
1876(c)(5)(B), 1852(g)(5), and 1860D–
4(h) of the Social Security Act (the Act).
OMHA ensures that Medicare
beneficiaries and the providers and
suppliers that furnish items or services
to Medicare beneficiaries, as well as
Medicare Advantage organizations
(MAOs), Medicaid State agencies, and
applicable plans, have a fair and
impartial forum to address
disagreements with Medicare coverage
and payment determinations made by
Medicare contractors, MAOs, or Part D
plan sponsors (PDPSs), and
determinations related to Medicare
eligibility and entitlement, Part B late
enrollment penalty, and income-related
monthly adjustment amounts (IRMAA)
made by the Social Security
Administration (SSA).
The Medicare claim, organization
determination, coverage determination,
and at-risk determination appeals
processes consist of four levels of
administrative review, and a fifth level
of review with the Federal district
courts after administrative remedies
under HHS regulations have been
exhausted. The first two levels of review
are administered by the Centers for
Medicare & Medicaid Services (CMS)
and conducted by Medicare contractors
for claim appeals, by MAOs and an
Independent Review Entity (IRE) for
Part C organization determination
appeals, or by PDPSs and an IRE for Part
D coverage determination and at-risk
determination appeals. The third level
of review is administered by OMHA and
conducted by Administrative Law
Judges and attorney adjudicators. The
fourth level of review is administered by
the HHS Departmental Appeals Board
(DAB) and conducted by the Medicare
Appeals Council (Council). In addition,
OMHA and the DAB administer the
second and third levels of appeal,
respectively, for Medicare eligibility,
entitlement, Part B late enrollment
penalty, and IRMAA reconsiderations
made by SSA; a fourth level of review
with the Federal district courts is
available after administrative remedies
within SSA and HHS have been
exhausted.
Sections 1869, 1155, 1876(c)(5)(B),
1852(g)(5), and 1860D–4(h) of the Act
are implemented through the
regulations at 42 CFR part 405 subparts
I and J; part 417, subpart Q; part 422,
subpart M; part 423, subparts M and U;
and part 478, subpart B. As noted above,
OMHA administers the nationwide
Administrative Law Judge hearing
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program in accordance with these
statutes and applicable regulations. To
help ensure nationwide consistency in
that effort, OMHA established a manual,
the OCPM. Through the OCPM, the
OMHA Chief Administrative Law Judge
establishes the day-to-day procedures
for carrying out adjudicative functions,
in accordance with applicable statutes,
regulations, and OMHA directives. The
OCPM provides direction for processing
appeals at the OMHA level of
adjudication for Medicare Part A and B
claims; Part C organization
determinations; Part D coverage
determinations and at-risk
determinations; and SSA eligibility and
entitlement, Part B late enrollment
penalty, and IRMAA determinations.
Section 1871(c) of the Act requires
that the Secretary publish a list of all
Medicare manual instructions,
interpretive rules, statements of policy,
and guidelines of general applicability
not issued as regulations at least every
three months in the Federal Register.
II. Format for the Quarterly Issuance
Notices
This quarterly notice provides the
specific updates to the OCPM that have
occurred in the three-month period of
April through June 2020. A hyperlink to
the available chapters on the OMHA
website is provided below. The OMHA
website contains the most current, upto-date chapters and revisions to
chapters, and will be available earlier
than we publish our quarterly notice.
We believe the OMHA website provides
more timely access to the current OCPM
chapters for those involved in the
Medicare claim; organization, coverage,
and at-risk determination; and
entitlement appeals processes. We also
believe the website offers the public a
more convenient tool for real time
access to current OCPM provisions. In
addition, OMHA has a listserv to which
the public can subscribe to receive
notification of certain updates to the
OMHA website, including when new or
revised OCPM chapters are posted. If
accessing the OMHA website proves to
be difficult, the contact person listed
above can provide the information.
III. How To Use the Notice
This notice lists the OCPM chapters
and subjects published during the
quarter covered by the notice so the
reader may determine whether any are
of particular interest. The OCPM can be
accessed at https://www.hhs.gov/about/
agencies/omha/the-appeals-process/
case-processing-manual/.
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]]>Agencies
[Federal Register Volume 85, Number 181 (Thursday, September 17, 2020)]
[Notices]
[Pages 58063-58064]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-20458]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA 2020-N-1735]
Eisai, Inc.; Withdrawal of Approval of Two New Drug Application
for BELVIQ (lorcaserin hydrochloride) and BELVIQ XR (lorcaserin
hydrocholoride)
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is withdrawing the
approval of two new drug applications for BELVIQ (lorcaserin
hydrochloride (HCl)) tablets and BELVIQ XR (lorcaserin HCl) extended-
release tablets held by Eisai, Inc., 155 Tice Blvd., Woodcliff Lake, NJ
07677 (Eisai). Eisai requested withdrawal of these applications and has
waived its opportunity for a hearing.
DATES: Approval is withdrawn as of September 17, 2020.
FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 301-
796-3137.
SUPPLEMENTARY INFORMATION: FDA approved NDA 022529 for BELVIQ
(lorcaserin HCl) 10 milligrams (mg) tablets and NDA 208524 for BELVIQ
XR (lorcaserin HCl) 20 mg extended-release tablets on June 27, 2012 and
July 15, 2016, respectively, as an adjunct to a reduced-calorie diet
and increased physical activity for chronic weight management in adults
with an initial body mass index (BMI) of:
30 kg/m\2\ or greater (obese) or
27 kg/m2 or greater (overweight) in the presence of at
least one weight-related comorbid condition, (e.g., hypertension,
dyslipidemia, type 2 diabetes).
On January 14, 2019, FDA issued a Drug Safety Communication
alerting the public that results from a clinical trial assessing the
risk of heart-related problems show a possible increased risk of cancer
with BELVIQ and BELVIQ XR (see https://www.fda.gov/drugs/drug-safety-and-availability/safety-clinical-trial-shows-possible-increased-risk-cancer-weight-loss-medicine-belviq-belviq-xr). On February 13, 2020,
FDA announced it had asked Eisai to voluntarily withdraw BELVIQ and
BELVIQ XR from the U.S. market because a safety clinical trial showed
an increased occurrence of cancer (see
[[Page 58064]]
https://www.fda.gov/drugs/drug-safety-and-availability/fda-requests-withdrawal-weight-loss-drug-belviq-belviq-xr-lorcaserin-market).
On February 13, 2020, Eisai requested that FDA withdraw approval of
NDA 022529 for BELVIQ and NDA 208524 for BELVIQ XR under Sec.
314.150(d) (21 CFR 314.150(d)), and waived its opportunity for a
hearing.
For the reasons discussed above, and pursuant to the applicant's
request, approval of NDA 022529 BELVIQ (lorcaserin HCl) tablets and
208524 BELVIQ XR (lorcaserin HCl) extended-release tablets, and all
amendments and supplements thereto, are withdrawn under Sec.
314.150(d). Distribution of BELVIQ into interstate commerce without an
approved application is illegal and subject to regulatory action (see
sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355(a) and 331(d)).
Dated: September 11, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-20458 Filed 9-16-20; 8:45 am]
BILLING CODE 4164-01-P
