Meeting of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria, 81934-81935 [2020-27769]
Download as PDF
<![CDATA[
81934
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]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
18:52 Dec 16, 2020
Jkt 253001
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.
PO 00000
Frm 00066
Fmt 4703
Sfmt 4703
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:
E:\FR\FM\17DEN1.SGM
17DEN1
Federal Register / Vol. 85, No. 243 / Thursday, December 17, 2020 / Notices
www.hhs.gov/paccarb when it has been
finalized. All agenda items are tentative
and subject to change.
Instructions regarding attending this
meeting virtually will be posted one
week prior to the meeting at: https://
www.hhs.gov/paccarb.
Members of the public will have the
opportunity to provide comments prior
to the public meeting by emailing
CARB@hhs.gov. Public comments
should be sent in by midnight February
7, 2021 and should be limited to no
more than one page. All public
comments received prior to February 7,
2021, will be provided to Advisory
Council members and will be
acknowledged during the public
teleconference.
Dated: December 4, 2020.
Jomana F. Musmar,
Designated Federal Officer, Presidential
Advisory Council on Combating AntibioticResistant Bacteria, Office of the Assistant
Secretary for Health.
[FR Doc. 2020–27769 Filed 12–16–20; 8:45 am]
BILLING CODE 4150–44–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Statement of Organization, Functions,
and Delegations of Authority
Office of the Assistant
Secretary, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
The Department of Health and
Human Services (HHS) is updating the
organizational structure of the Office of
Grants in the Office of the Assistant
Secretary for Financial Resources
(ASFR), which is located within the
Office of the Secretary. ASFR is
modifying the Office of Grants
organizational structure to further
improve and streamline its operation
and to assume responsibility for
maintaining and operating the
GrantSolutions System currently
aligned to the National Grant Center of
Excellence (COE) in the Administration
for Children and Families (ACF). The
changes proposed affect HHS
organizational Chapter AM Section
AMU1 and AMU2 and Chapter KP
Section KPA.
ADDRESSES: 200 Independence Ave. SW,
Washington, DC 20201, (202) 619–0142.
FOR FURTHER INFORMATION CONTACT:
Alice Bettencourt, Deputy Assistant
Secretary for Grants, Alice.Bettencourt@
hhs.gov or (202) 619–0142.
SUPPLEMENTARY INFORMATION:
SUMMARY:
VerDate Sep<11>2014
18:52 Dec 16, 2020
Jkt 253001
81935
Chapter AMU, the Office of Grants
Section AMU1 and AMU2
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
The Office of Grants (AMU)
organizational structure and
responsibilities remain as described in
Federal Register Document 2019–
09459, with two divisional
modifications.
1. The Division of Systems (AMU2) is
renamed the Division of Information
and Solutions. The Division of
Information and Solutions is headed by
a Director and develops, manages, and
operates major, grant-shared services
and solution offerings for HHS, as
directed by the Secretary of HHS or
delegated authority. Organizational
units within AMU2 may be adjusted
from time to time and as necessary to
accommodate new, changing, or
discontinued shared services or solution
offerings. The Division of Information
and Solutions assumes responsibility for
operating and maintaining the
GrantSolutions system in its current
form as well as for future
GrantSolutions development efforts.
The Division of Information and
Solutions will also manage
GrantSolutions-related customer
relationships and agreements, formerly
managed by the National Grant COE in
ACF.
2. The Division of Grant Policy,
Oversight, and Evaluation (AMU1) is
renamed the Division of Policy,
Oversight, and Evaluation.
National Institutes of Health
Chapter KP, the Office of the Deputy
Associate Secretary for Administration
(ODASA) in ACF, Section KPA,
National Grants Center of Excellence
ODASA dissolves the National Grant
COE, in compliance with OMB Memo
Memorandum M–18–24, Strategies to
Reduce Grant Recipient Reporting
Burden, which rescinded all Center of
Excellence designations. Responsibility
for operating and managing the
GrantSolutions system moves to The
Office of Grants, Division of Information
and Solutions (AMU2).
Dated: December 10, 2020.
Alex M. Azar II,
Secretary, Department of Health & Human
Services.
[FR Doc. 2020–27814 Filed 12–16–20; 8:45 am]
BILLING CODE 4150–24–P
PO 00000
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; Emergency Awards: Rapid
Investigation of Severe Acute Respiratory
Syndrome Coronavirus 2 (SARS–CoV–2) and
Coronavirus Disease 2019 (COVID–19).
Date: January 14–15, 2021.
Time: 10:30 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3E61,
Rockville, MD 20892 (Virtual Meeting).
Contact Person: Ann Marie M. Brighenti,
Ph.D., Scientific Review Officer, Scientific
Review Program, Division of Extramural
Activities, National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3E61,
Rockville, MD 20852, 301–761–3100, annmarie.brighenti@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: December 11, 2020.
Tyeshia M. Roberson,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–27780 Filed 12–16–20; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
Frm 00067
Fmt 4703
Sfmt 4703
E:\FR\FM\17DEN1.SGM
17DEN1
]]>Agencies
[Federal Register Volume 85, Number 243 (Thursday, December 17, 2020)]
[Notices]
[Pages 81934-81935]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-27769]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Meeting of the Presidential Advisory Council on Combating
Antibiotic-Resistant Bacteria
AGENCY: Office of the Assistant Secretary for Health, Office of the
Secretary, Department of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: 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
[email protected]. 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.
DATES: 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. Pre-registration for attending the meeting is
required to be completed no later than February 8, 2021.
ADDRESSES: Instructions regarding attending this meeting virtually will
be posted one week prior to the meeting at: https://www.hhs.gov/paccarb.
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:
[email protected].
SUPPLEMENTARY INFORMATION: 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 antibiotic-resistant 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 Inter-
Professional 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://
[[Page 81935]]
www.hhs.gov/paccarb when it has been finalized. All agenda items are
tentative and subject to change.
Instructions regarding attending this meeting virtually will be
posted one week prior to the meeting at: https://www.hhs.gov/paccarb.
Members of the public will have the opportunity to provide comments
prior to the public meeting by emailing [email protected]. Public comments
should be sent in by midnight February 7, 2021 and should be limited to
no more than one page. All public comments received prior to February
7, 2021, will be provided to Advisory Council members and will be
acknowledged during the public teleconference.
Dated: December 4, 2020.
Jomana F. Musmar,
Designated Federal Officer, Presidential Advisory Council on Combating
Antibiotic-Resistant Bacteria, Office of the Assistant Secretary for
Health.
[FR Doc. 2020-27769 Filed 12-16-20; 8:45 am]
BILLING CODE 4150-44-P
