Secura Bio, Inc.; Withdrawal of Approval of New Drug Application for FARYDAK (Panobinostat) Capsules, 10 Milligrams, 15 Milligrams, and 20 Milligrams, 16742-16743 [2022-06182]
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16742
Federal Register / Vol. 87, No. 57 / Thursday, March 24, 2022 / Notices
Assistance, Administration for Children
and Families, HHS.
ACTION: Request for public comment.
The Administration for
Children and Families (ACF) is
requesting a 3-year extension of the
form OFA–0086: NEW Plan Guidance
and NEW Program Report (OMB #0970–
0174, expiration 8/31/2022). There are
minor changes requested to both
documents.
SUMMARY:
Comments due within 60 days of
publication. In compliance with the
requirements of the Paperwork
Reduction Act of 1995, ACF is soliciting
public comment on the specific aspects
DATES:
of the information collection described
above.
ADDRESSES: You can obtain copies of the
proposed collection of information and
submit comments by emailing
infocollection@acf.hhs.gov. Identify all
requests by the title of the information
collection.
SUPPLEMENTARY INFORMATION:
Description: The NEW Program Plan
Guidance documents specify the
information needed to complete a NEW
program plan and explain the process
for plan submission every third year and
to complete the annual program report.
The program plan is the application for
NEW program funding and documents
how the grantee will carry out its NEW
program. ACF proposes a change in how
draft plans are submitted. The program
report provides HHS, Congress, and
grantees information to document and
assess the activities and
accomplishments of the NEW program.
ACF proposes to extend data collection
with revisions that clarify that programs
should not count more than once
individuals who meet multiple
categories; for example, persons age 20
are both youth and adults, but they
should be counted as one or the other,
not both.
Respondents: Indian tribes and tribal
coalitions that operate NEW programs.
ANNUAL BURDEN ESTIMATES
Total number
of respondents
(over 3 yrs.)
Instrument
Average
burden hours
per response
Annual burden
hours
NEW Program Plan Guidance .........................................................................
NEW Program Report ......................................................................................
40
40
1 .333
1
29
15
386
600
Total Estimated Annual Burden ...............................................................
........................
........................
........................
986
1 We
have used .333 responses per year to represent one submission of the NEW Program Plan Guidance during the 3-year approval period.
Comments: The Department
specifically requests comments on (a)
whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) the quality, utility,
and clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Authority: 42 U.S.C. 612.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2022–06271 Filed 3–23–22; 8:45 am]
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Annual
number of
responses per
respondent
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
796–3137, Kimberly.Lehrfeld@
fda.hhs.gov.
Food and Drug Administration
SUPPLEMENTARY INFORMATION:
[Docket No. FDA–2022–N–0352]
Secura Bio, Inc.; Withdrawal of
Approval of New Drug Application for
FARYDAK (Panobinostat) Capsules, 10
Milligrams, 15 Milligrams, and 20
Milligrams
Food and Drug Administration,
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of the new drug
application (NDA) for FARYDAK
(panobinostat) Capsules, 10 milligrams
(mg), 15 mg, and 20 mg, held by Secura
Bio, Inc., 1995 Village Center Circle,
Suite 128, Las Vegas, NV 89134. Secura
Bio, Inc. has voluntarily requested that
FDA withdraw approval of this
application and has waived its
opportunity for a hearing.
DATES: Approval is withdrawn as of
March 24, 2022.
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–
SUMMARY:
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On
February 23, 2015, FDA approved NDA
205353 for FARYDAK (panobinostat)
Capsules, 10 mg, 15 mg, and 20 mg, in
combination with bortezomib and
dexamethasone for the treatment of
patients with multiple myeloma who
have received at least two prior
regimens, including bortezomib and an
immunomodulatory agent, under the
Agency’s accelerated approval
regulations, 21 CFR part 314, subpart H.
The accelerated approval of FARYDAK
(panobinostat) Capsules, 10 mg, 15 mg,
and 20 mg, for multiple myeloma
included a required postmarketing trial
intended to verify the clinical benefit of
FARYDAK.
On September 24, 2021, FDA
published the Federal Register notice
‘‘Oncologic Drugs Advisory Committee;
Notice of Meeting; Establishment of a
Public Docket; Request for Comments,’’
announcing that FARYDAK
(panobinostat) Capsules would be
discussed at an Oncologic Drug
Advisory Committee Meeting (ODAC)
scheduled for December 2, 2021 (86 FR
53067). On November 19, 2021, FDA
met with Secura Bio, Inc. to discuss the
planned ODAC meeting. The topics
discussed included the lack of initiation
of the postmarketing trial intended to
verify clinical benefit.
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Federal Register / Vol. 87, No. 57 / Thursday, March 24, 2022 / Notices
On November 22, 2021, Secura Bio,
Inc. submitted a letter asking FDA to
withdraw approval of NDA 205353 for
FARYDAK (panobinostat) Capsules, 10
mg, 15 mg, and 20 mg, pursuant to
§ 314.150(d) (21 CFR 314.150(d)) and
waiving its opportunity for a hearing. In
the letter, Secura Bio, Inc. stated they
are requesting withdrawal of approval of
the NDA for FARYDAK because it was
not feasible for them to complete the
required postmarketing clinical trials.
On November 26, 2021, FDA
acknowledged Secura Bio, Inc.’s request
for withdrawal of approval of the NDA
and waiver of its opportunity for
hearing. FDA also cancelled the ODAC
meeting scheduled for December 2,
2021, since the applicant’s withdrawal
request made discussion at an advisory
committee meeting moot.
For the reasons discussed above, and
in accordance with the applicant’s
request, approval of NDA 205353 for
FARYDAK (panobinostat) Capsules, 10
mg, 15 mg, and 20 mg, and all
amendments and supplements thereto,
is withdrawn under § 314.150(d).
Distribution of FARYDAK
(panobinostat) Capsules, 10 mg, 15 mg,
and 20 mg, 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)).
DATES:
Dated: March 18, 2022.
Andi Lipstein Fristedt,
Deputy Commissioner for Policy, Legislation,
and International Affairs, U.S. Food and Drug
Administration.
OMB Control Number 0910–NEW
[FR Doc. 2022–06182 Filed 3–23–22; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–0371]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Accelerated
Approval Disclosures on Direct-toConsumer Prescription Drug Websites
AGENCY:
Food and Drug Administration,
khammond on DSKJM1Z7X2PROD with NOTICES
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) is
announcing that a proposed collection
of information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
SUMMARY:
VerDate Sep<11>2014
17:39 Mar 23, 2022
Jkt 256001
Submit written comments
(including recommendations) on the
collection of information by April 25,
2022.
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The title
of this information collection is
‘‘Accelerated Approval Disclosures on
Direct-to-Consumer Prescription Drug
Websites.’’ Also include the FDA docket
number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
ADDRESSES:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Accelerated Approval Disclosures on
Direct-to-Consumer Prescription Drug
Websites
Section 1701(a)(4) of the Public
Health Service Act (PHS Act) (42 U.S.C.
300u(a)(4)) authorizes FDA to conduct
research relating to health information.
Section 1003(d)(2)(C) of the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 393(d)(2)(C)) authorizes
FDA to conduct research relating to
drugs and other FDA regulated products
in carrying out the provisions of the
FD&C Act.
The Office of Prescription Drug
Promotion’s (OPDP) mission is to
protect the public health by helping to
ensure that prescription drug promotion
is truthful, balanced, and accurately
communicated. OPDP’s research
program provides scientific evidence to
help ensure that our policies related to
prescription drug promotion will have
the greatest benefit to public health.
Toward that end, we have
consistently conducted research to
evaluate the aspects of prescription drug
promotion that are most central to our
mission, focusing in particular on three
main topic areas: Advertising features,
including content and format; target
populations; and research quality.
Through the evaluation of advertising
features, we assess how elements such
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16743
as graphics, format, and disease and
product characteristics impact the
communication and understanding of
prescription drug risks and benefits.
Focusing on target populations allows
us to evaluate how understanding of
prescription drug risks and benefits may
vary as a function of audience, and our
focus on research quality aims at
maximizing the quality of our research
data through analytical methodology
development and investigation of
sampling and response issues. This
study will inform the first topic area,
advertising features, including content
and format; and the second topic area,
target populations.
Because we recognize the strength of
data and the confidence in the robust
nature of the findings is improved
through the results of multiple
converging studies, we continue to
develop evidence to inform our
thinking. We evaluate the results from
our studies within the broader context
of research and findings from other
sources, and this larger body of
knowledge collectively informs our
policies as well as our research program.
Our research is documented on our
homepage, which can be found at:
https://www.fda.gov/about-fda/centerdrug-evaluation-and-research-cder/
office-prescription-drug-promotionopdp-research. The website includes
links to the latest Federal Register
notices and peer-reviewed publications
produced by our office. The website
maintains information on studies we
have conducted, dating back to a directto-consumer (DTC) survey conducted in
1999.
I. Background
Pursuant to section 506(c) of the
FD&C Act (21 U.S.C. 356(c)) and 21 CFR
part 314, subpart H (or 21 CFR part 601,
subpart E for biological products), FDA
may grant accelerated approval to a drug
product under section 505(c) of the
FD&C Act (21 U.S.C. 355(c)) or a
biological product under section 351(a)
of the PHS Act (42 U.S.C. 262(a)). This
pathway enables faster approval of
prescription drugs intended to treat
serious or life-threatening illnesses.
Accelerated approval may be based on
a determination that a drug product has
an effect on a surrogate endpoint (for
example, a blood test result) that is
reasonably likely to predict clinical
benefit, or on a clinical endpoint that
can be measured earlier than
irreversible morbidity or mortality, that
is reasonably likely to predict an effect
on irreversible morbidity or mortality or
other clinical benefit (i.e., an
intermediate clinical endpoint). In
approving a drug under the accelerated
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]]>Agencies
[Federal Register Volume 87, Number 57 (Thursday, March 24, 2022)]
[Notices]
[Pages 16742-16743]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-06182]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-0352]
Secura Bio, Inc.; Withdrawal of Approval of New Drug Application
for FARYDAK (Panobinostat) Capsules, 10 Milligrams, 15 Milligrams, and
20 Milligrams
AGENCY: Food and Drug Administration, Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of the new drug application (NDA) for FARYDAK
(panobinostat) Capsules, 10 milligrams (mg), 15 mg, and 20 mg, held by
Secura Bio, Inc., 1995 Village Center Circle, Suite 128, Las Vegas, NV
89134. Secura Bio, Inc. has voluntarily requested that FDA withdraw
approval of this application and has waived its opportunity for a
hearing.
DATES: Approval is withdrawn as of March 24, 2022.
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, [email protected].
SUPPLEMENTARY INFORMATION: On February 23, 2015, FDA approved NDA
205353 for FARYDAK (panobinostat) Capsules, 10 mg, 15 mg, and 20 mg, in
combination with bortezomib and dexamethasone for the treatment of
patients with multiple myeloma who have received at least two prior
regimens, including bortezomib and an immunomodulatory agent, under the
Agency's accelerated approval regulations, 21 CFR part 314, subpart H.
The accelerated approval of FARYDAK (panobinostat) Capsules, 10 mg, 15
mg, and 20 mg, for multiple myeloma included a required postmarketing
trial intended to verify the clinical benefit of FARYDAK.
On September 24, 2021, FDA published the Federal Register notice
``Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment
of a Public Docket; Request for Comments,'' announcing that FARYDAK
(panobinostat) Capsules would be discussed at an Oncologic Drug
Advisory Committee Meeting (ODAC) scheduled for December 2, 2021 (86 FR
53067). On November 19, 2021, FDA met with Secura Bio, Inc. to discuss
the planned ODAC meeting. The topics discussed included the lack of
initiation of the postmarketing trial intended to verify clinical
benefit.
[[Page 16743]]
On November 22, 2021, Secura Bio, Inc. submitted a letter asking
FDA to withdraw approval of NDA 205353 for FARYDAK (panobinostat)
Capsules, 10 mg, 15 mg, and 20 mg, pursuant to Sec. 314.150(d) (21 CFR
314.150(d)) and waiving its opportunity for a hearing. In the letter,
Secura Bio, Inc. stated they are requesting withdrawal of approval of
the NDA for FARYDAK because it was not feasible for them to complete
the required postmarketing clinical trials. On November 26, 2021, FDA
acknowledged Secura Bio, Inc.'s request for withdrawal of approval of
the NDA and waiver of its opportunity for hearing. FDA also cancelled
the ODAC meeting scheduled for December 2, 2021, since the applicant's
withdrawal request made discussion at an advisory committee meeting
moot.
For the reasons discussed above, and in accordance with the
applicant's request, approval of NDA 205353 for FARYDAK (panobinostat)
Capsules, 10 mg, 15 mg, and 20 mg, and all amendments and supplements
thereto, is withdrawn under Sec. 314.150(d). Distribution of FARYDAK
(panobinostat) Capsules, 10 mg, 15 mg, and 20 mg, 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: March 18, 2022.
Andi Lipstein Fristedt,
Deputy Commissioner for Policy, Legislation, and International Affairs,
U.S. Food and Drug Administration.
[FR Doc. 2022-06182 Filed 3-23-22; 8:45 am]
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