Issuance of Priority Review Voucher; Rare Pediatric Disease Product, 81933-81934 [2020-27778]
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81933
Federal Register / Vol. 85, No. 243 / Thursday, December 17, 2020 / Notices
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With respect to the following
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State Enforcement Notifications—21
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OMB Control Number 0910–0275—
Extension
This information collection supports
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Cosmetic Act (FD&C Act) (21 U.S.C.
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according to § 100.2 (21 CFR 100.2). The
information required in a letter of
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We estimate the burden of this
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TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR section
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
100.2(d) ................................................................................
1
1
1
10
10
1 There
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The estimated reporting burden for
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estimate that one or fewer notifications
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we have not received any new
enforcement notifications in the last 3
years, we believe these information
collection provisions should be
extended to provide for the potential
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future need of a State government to
submit enforcement notifications
informing us when it intends to take
enforcement action under the FD&C Act
against a particular food located in the
State.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: December 9, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
Issuance of Priority Review Voucher;
Rare Pediatric Disease Product
[FR Doc. 2020–27748 Filed 12–16–20; 8:45 am]
ACTION:
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Food and Drug Administration
[Docket No. FDA–2020–N–0026]
AGENCY:
Food and Drug Administration,
HHS.
Notice.
The Food and Drug
Administration (FDA) is announcing the
issuance of a priority review voucher to
the sponsor of a rare pediatric disease
SUMMARY:
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Federal Register / Vol. 85, No. 243 / Thursday, December 17, 2020 / Notices
product application. The Federal Food,
Drug, and Cosmetic Act (FD&C Act)
authorizes FDA to award priority review
vouchers to sponsors of approved rare
pediatric disease product applications
that meet certain criteria. FDA is
required to publish notice of the award
of the priority review voucher. FDA has
determined that ZOKINVY (lonafarnib),
manufactured by Eiger
BioPharmaceuticals, Inc., meets the
criteria for a priority review voucher.
FOR FURTHER INFORMATION CONTACT:
Althea Cuff, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–4061, Fax: 301–796–9856,
email: althea.cuff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is
announcing the issuance of a priority
review voucher to the sponsor of an
approved rare pediatric disease product
application. Under section 529 of the
FD&C Act (21 U.S.C. 360ff), FDA will
award priority review vouchers to
sponsors of approved rare pediatric
disease product applications that meet
certain criteria. FDA has determined
that ZOKINVY (lonafarnib),
manufactured by Eiger
BioPharmaceuticals, Inc., meets the
criteria for a priority review voucher.
ZOKINVY (lonafarnib) is indicated in
patients 12 months of age and older
with a body surface area of 0.39 m2 and
above:
• To reduce the risk of mortality in
Hutchinson-Gilford progeria
syndrome
• For the treatment of processingdeficient progeroid laminopathies
with either:
Æ Heterozygous LMNA mutation with
progerin-like protein accumulation
or
Æ Homozygous or compound
heterozygous ZMPSTE24 mutations
For further information about the Rare
Pediatric Disease Priority Review
Voucher Program and for a link to the
full text of section 529 of the FD&C Act,
go to https://www.fda.gov/ForIndustry/
DevelopingProductsforRareDiseases
Conditions/RarePediatricDiseasePriority
VoucherProgram/default.htm. For
further information about ZOKINVY
(lonafarnib), go to the ‘‘Drugs@FDA’’
website at https://
www.accessdata.fda.gov/scripts/cder/
daf/.
Dated: December 14, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–27778 Filed 12–16–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Presidential Advisory
Council on Combating AntibioticResistant Bacteria
Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
AGENCY:
ACTION:
Notice.
As stipulated by the Federal
Advisory Committee Act, the
Department of Health and Human
Services (HHS) is hereby giving notice
that a meeting is scheduled to be held
for the Presidential Advisory Council on
Combating Antibiotic-Resistant Bacteria
(PACCARB). The meeting will be open
to the public via webex and
teleconference; a pre-registered public
comment session will be held during
the meeting. Pre-registration is required
for members of the public who wish to
attend the meeting via webex/
teleconference. Individuals who wish to
send in their pre-recorded or written
public comments should send an email
to CARB@hhs.gov. Registration
information is available on the website
https://www.hhs.gov/paccarb and must
be completed by February 8, 2021.
Additional information about registering
for the meeting and providing public
comment can be obtained at https://
www.hhs.gov/paccarb on the Meetings
page.
SUMMARY:
The meeting is scheduled to be
held on February 10, 2021, from 10:00
a.m. to 4:00 p.m. and February 11, 2021,
from 10:00 a.m. to 3:30 p.m. ET (times
are tentative and subject to change). The
confirmed times and agenda items for
the meeting will be posted on the
website for the PACCARB at https://
www.hhs.gov/paccarb when this
information becomes available. Preregistration for attending the meeting is
required to be completed no later than
February 8, 2021.
DATES:
Instructions regarding
attending this meeting virtually will be
posted one week prior to the meeting at:
https://www.hhs.gov/paccarb.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Jomana Musmar, M.S., Ph.D.,
Designated Federal Officer, Presidential
Advisory Council on Combating
Antibiotic-Resistant Bacteria, Office of
the Assistant Secretary for Health, U.S.
Department of Health and Human
Services, Room L616, Switzer Building,
330 C St. SW, Washington, DC 20201.
Phone: 202–746–1512; Email: CARB@
hhs.gov.
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The
Presidential Advisory Council on
Combating Antibiotic-Resistant Bacteria
(PACCARB), established by Executive
Order 13676, is continued by Section
505 of Public Law 116–22, the
Pandemic and All-Hazards
Preparedness and Advancing Innovation
Act of 2019 (PAHPAIA). Activities and
duties of the Advisory Council are
governed by the provisions of the
Federal Advisory Committee Act
(FACA), Public Law 92–463, as
amended (5 U.S.C. App.), which sets
forth standards for the formation and
use of federal advisory committees.
The PACCARB shall advise and
provide information and
recommendations to the Secretary
regarding programs and policies
intended to reduce or combat antibioticresistant bacteria that may present a
public health threat and improve
capabilities to prevent, diagnose,
mitigate, or treat such resistance. The
PACCARB shall function solely for
advisory purposes.
Such advice, information, and
recommendations may be related to
improving: The effectiveness of
antibiotics; research and advanced
research on, and the development of,
improved and innovative methods for
combating or reducing antibiotic
resistance, including new treatments,
rapid point-of-care diagnostics,
alternatives to antibiotics, including
alternatives to animal antibiotics, and
antimicrobial stewardship activities;
surveillance of antibiotic-resistant
bacterial infections, including publicly
available and up-to-date information on
resistance to antibiotics; education for
health care providers and the public
with respect to up-to-date information
on antibiotic resistance and ways to
reduce or combat such resistance to
antibiotics related to humans and
animals; methods to prevent or reduce
the transmission of antibiotic-resistant
bacterial infections; including
stewardship programs; and coordination
with respect to international efforts in
order to inform and advance the United
States capabilities to combat antibiotic
resistance.
The February 10–11, 2021, public
meeting will be dedicated to
presentations from two new working
groups of the PACCARB, one on InterProfessional Education and another on
Antibiotics Access and Use, which were
formed in response to a task letter from
the Assistant Secretary for Health. The
two-day virtual public meeting will also
include an update on the impact of
COVID–19 on antimicrobial resistance.
The meeting agenda will be posted on
the PACCARB website at https://
SUPPLEMENTARY INFORMATION:
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]]>Agencies
[Federal Register Volume 85, Number 243 (Thursday, December 17, 2020)]
[Notices]
[Pages 81933-81934]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-27778]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-0026]
Issuance of Priority Review Voucher; Rare Pediatric Disease
Product
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
issuance of a priority review voucher to the sponsor of a rare
pediatric disease
[[Page 81934]]
product application. The Federal Food, Drug, and Cosmetic Act (FD&C
Act) authorizes FDA to award priority review vouchers to sponsors of
approved rare pediatric disease product applications that meet certain
criteria. FDA is required to publish notice of the award of the
priority review voucher. FDA has determined that ZOKINVY (lonafarnib),
manufactured by Eiger BioPharmaceuticals, Inc., meets the criteria for
a priority review voucher.
FOR FURTHER INFORMATION CONTACT: Althea Cuff, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-4061, Fax: 301-
796-9856, email: [email protected].
SUPPLEMENTARY INFORMATION: FDA is announcing the issuance of a priority
review voucher to the sponsor of an approved rare pediatric disease
product application. Under section 529 of the FD&C Act (21 U.S.C.
360ff), FDA will award priority review vouchers to sponsors of approved
rare pediatric disease product applications that meet certain criteria.
FDA has determined that ZOKINVY (lonafarnib), manufactured by Eiger
BioPharmaceuticals, Inc., meets the criteria for a priority review
voucher.
ZOKINVY (lonafarnib) is indicated in patients 12 months of age and
older with a body surface area of 0.39 m\2\ and above:
To reduce the risk of mortality in Hutchinson-Gilford progeria
syndrome
For the treatment of processing-deficient progeroid
laminopathies with either:
[cir] Heterozygous LMNA mutation with progerin-like protein
accumulation or
[cir] Homozygous or compound heterozygous ZMPSTE24 mutations
For further information about the Rare Pediatric Disease Priority
Review Voucher Program and for a link to the full text of section 529
of the FD&C Act, go to https://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/RarePediatricDiseasePriorityVoucherProgram/default.htm. For further
information about ZOKINVY (lonafarnib), go to the ``[email protected]'' website
at https://www.accessdata.fda.gov/scripts/cder/daf/.
Dated: December 14, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-27778 Filed 12-16-20; 8:45 am]
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