National Advisory Committee on Children and Disasters: Establishment, 28965-28966 [2020-10323]
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Federal Register / Vol. 85, No. 94 / Thursday, May 14, 2020 / Notices
Dated: May 8, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–10336 Filed 5–13–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Advisory Committee on
Children and Disasters: Establishment
Office of the Assistant
Secretary for Preparedness and
Response (ASPR), Department of Health
and Human Services (HHS).
ACTION: Notice.
AGENCY:
The Office of the Assistant
Secretary for Preparedness and
Response (ASPR), in the Department of
Health and Human Services (HHS)
Office of the Secretary announces
establishment of the National Advisory
Committee on Children and Disasters
(NACCD). The Advisory Committee will
provide advice and consultation to the
HHS Secretary on pediatric medical
disaster planning, preparedness,
response, and recovery with respect to
the medical and public health needs of
children in relation to disasters. The
Office of the Assistant Secretary for
Preparedness and Response (ASPR)
shall provide management and
administrative oversight to support the
activities of the Advisory Committee.
The Office of the Secretary is accepting
application submissions from qualified
individuals who wish to be considered
for membership on the NACCD. Up to
13 new voting members with expertise
in pediatric medical disaster planning,
preparedness, response, or recovery will
be selected for the Committee. Please
visit the NACCD website at
www.phe.gov/naccd for all application
submission information and
instructions. Application submissions
will be accepted for 30 calendar days
from the date this posting is published
in the Federal Register.
Application Period: The application
period is from midnight (Eastern Time)
May 27th–June 27th.
FOR FURTHER INFORMATION CONTACT:
Maxine Kellman, DVM, Ph.D., PMP,
Alternate Designated Federal Official for
National Advisory Committees,
Washington, DC, Office (202) 260–0447
or email maxine.kellman@hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant
to the Federal Advisory Committee Act
(FACA) of 1972, the HHS Secretary, in
consultation with the Secretary of the
U.S. Department of Homeland Security,
established the National Advisory
Committee on Children and Disasters
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:29 May 13, 2020
Jkt 250001
(NACCD). Section 2811A of the Public
Health Service Act, as amended by
Pandemic and All Hazard Preparedness
and Advancing Innovation Act of 2019
(42 U.S.C. 300hh–10b) requires that the
Secretary for Health and Human
Services (HHS) establish the National
Advisory Committee on Children and
Disasters (NACCD) to provide advice
and consultation to the HHS Secretary
with respect to the medical and public
health needs of children in relation to
disasters. The purpose of the NACCD is
to provide advice and consultation to
the HHS Secretary with respect to the
medical and public health needs of
children in relation to disasters. The
Office of the Assistant Secretary for
Preparedness and Response provides
management and administrative
oversight to support the activities of the
NACCD.
Description of Duties: The NACCD: (1)
Provides advice and consultation with
respect to the activities addressing atrisk individuals carried out as
applicable and appropriate (2) evaluates
and provides input with respect to the
medical and public health needs of
children as they relate to preparation
for, response to, and recovery from allhazards emergencies; (3) provides
advice and consultation with respect to
state emergency preparedness and
response activities and children,
including related drills and exercises
pursuant to the preparedness goals
under the National Health Security
Strategy; and (4) provides advice and
recommendations to the HHS Secretary
with respect to children and the medical
and public health grants and
cooperative agreements implementing
the Public Health Emergency
Preparedness and Hospital Preparedness
Programs and other activities, as
applicable to preparedness and response
activities.
Structure: The Advisory Committee
consists of not more than 13 voting
members, including the Chairperson.
Members will be appointed by the HHS
Secretary, in consultation with such
other Secretaries as may be appropriate,
from among the nation’s preeminent
scientific, public health, and medical
experts in areas consistent with the
purpose and functions of the NACCD.
Section 2811A(d)(2) of the Public Health
Services (PHS) Act States:
(2) REQUIRED NON–FEDERAL
MEMBERS.—The Secretary, in
consultation with such other heads of
Federal agencies as may be appropriate,
shall appoint to the Advisory
Committee under paragraph (1) at least
13 individuals, including—
(A) at least 2 non-Federal
professionals with expertise in pediatric
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Fmt 4703
Sfmt 4703
28965
medical disaster planning,
preparedness, response, or recovery;
(B) at least 2 representatives from
State, local, Tribal, or territorial
agencies with expertise in pediatric
disaster planning, preparedness,
response, or recovery;
(C) at least 4 members representing
health care professionals, which may
include members with expertise in
pediatric emergency medicine; pediatric
trauma, critical care, or surgery; the
treatment of pediatric patients affected
by chemical, biological, radiological, or
nuclear agents, including emerging
infectious diseases; pediatric mental or
behavioral health related to children
affected by a public health emergency;
or pediatric primary care; and
(D) other members as the Secretary
determines appropriate, of whom—
(i) at least one such member shall
represent a children’s hospital;
(ii) at least one such member shall be
an individual with expertise in schools
or child care settings;
(iii) at least one such member shall be
an individual with expertise in children
and youth with special health care
needs; and
(iv) at least one such member shall be
an individual with expertise in the
needs of parents or family caregivers,
including the parents or caregivers of
children with disabilities in the
following categories: Non-federal health
care professionals and representatives
from state, local, territorial, or tribal
agencies.
The NACCD shall also have up to 12
federal, non-voting members (ex officio),
including the following officials or their
designees:
A. The Assistant Secretary for
Preparedness and Response;
B. The Director of the Biomedical
Advanced Research and Development
Authority;
C. The Director of the Centers for
Disease Control and Prevention;
D. The Commissioner of Food and
Drugs;
E. The Director of the National
Institutes of Health;
F. The Assistant Secretary of the
Administration for Children and
Families;
G. The Administrator of the Health
Resources and Services Administration;
H. The Administrator of the Federal
Emergency Management Agency;
I. The Administrator of the
Administration for Community Living;
J. The Secretary of Education;
K. The Assistant Secretary for Mental
Health and Substance Use; and
L. The Administrator of the
Environmental Protection Agency.
A voting member of the NACCD shall
serve for a term of three years, except
E:\FR\FM\14MYN1.SGM
14MYN1
28966
Federal Register / Vol. 85, No. 94 / Thursday, May 14, 2020 / Notices
that the Secretary may adjust the terms
of appointees who are initially
appointed after the date of enacted of
the Pandemic and All-Hazards
Preparedness and Advancing Innovation
Act of 2019 (June 24, 2019) in order to
provide for a staggered term of
appointment for all members. A voting
member may serve not more than three
terms on the NACCD, and not more than
two of such terms may be served
consecutively. Voting members shall not
be full-time or permanent part-time
federal employees but shall be
appointed by the Secretary as Special
Government Employees (5 U.S.C. 3109).
A member may serve after the
expiration of his/her term until a
successor has been appointed. Members
whose term expires after this charter’s
renewal date will have a term length
contingent upon renewal of the advisory
committee. Vacancies will be filled as
members rotate out or resign using the
same procedures as the initial selection
process.
Robert P. Kadlec,
Assistant Secretary for Preparedness and
Response.
[FR Doc. 2020–10323 Filed 5–13–20; 8:45 am]
BILLING CODE 4150–37–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive
Patent License: Development and
Commercialization of Mono-Specific
Chimeric Antigen Receptor (CAR)
Therapies for the Treatment of Cluster
of Differentiation 33 (CD33) Expressing
Malignancies
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The National Cancer Institute,
an institute of the National Institutes of
Health, Department of Health and
Human Services, is contemplating the
grant of an Exclusive Patent License to
practice the inventions embodied in the
Patents and Patent Applications listed
in the Supplementary Information
section of this Notice to Vor Biopharma
Inc. (‘‘Vor’’), located in Cambridge, MA.
DATES: Only written comments and/or
applications for a license which are
received by the National Cancer
Institute’s Technology Transfer Center
on or before June 15, 2020 will be
considered.
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
Requests for copies of the
patent applications, inquiries, and
ADDRESSES:
VerDate Sep<11>2014
18:29 May 13, 2020
Jkt 250001
comments relating to the contemplated
Exclusive Patent License should be
directed to: Jim Knabb, Senior
Technology Transfer Manager, NCI
Technology Transfer Center, 9609
Medical Center Drive, RM 1E530, MSC
9702, Bethesda, MD 20892–9702 (for
business mail), Rockville, MD 20850–
9702; Telephone: (240)-276–7856;
Facsimile: (240)-276–5504; Email:
jim.knabb@nih.gov.
SUPPLEMENTARY INFORMATION:
Intellectual Property
E–097–2018–0: Anti-CD33 Chimeric
Antigen Receptors for Treatment of
Human Acute Myeloid Leukemia
1. U.S. Provisional Patent Application
62/643,015, filed March 14, 2018
(E–097–2018–0–US–01);
2. International Patent Application PCT/
US2019/022,309, filed March 14,
2019 (E–097–2018–0–PCT–02)
The patent rights in these inventions
have been assigned and/or exclusively
licensed to the government of the
United States of America.
The prospective exclusive license
territory may be worldwide, and the
fields of use may be limited to the
following:
An exclusive license to:
The development of a chimeric
antigen receptor (CAR) therapy monospecific for CD33 for the prophylaxis or
treatment of CD33-expressing
hematological malignancies wherein the
CAR is comprised of the CD33-binding
domain referenced as Hu195 or hP67.6,
is delivered via lentiviral transduction,
and the T cells are:
1. Derived autologously (meaning
cells derived from one individual who
is both the donor and the recipient) in
the first-line or relapsed/refractory
setting, or
2. derived allogeneically (meaning
cells derived from a matched healthy
donor), in the post-transplant setting.
This technology discloses a CAR
therapy that targets CD33 by utilizing
the anti-CD33 binder known as Hu195
or hP67.6 for the treatment of
hematological malignancies. CD33 is a
validated immunotherapeutic target that
is expressed on the surface of the vast
majority of acute myelogenous leukemia
(AML) blasts and cells in chronic
myeloid leukemia-blast crisis (CML–
BC).
This Notice is made in accordance
with 35 U.S.C. 209 and 37 CFR part 404.
The prospective exclusive license will
be royalty bearing, and the prospective
exclusive license may be granted unless
within thirty (30) days from the date of
this published Notice, the National
Cancer Institute receives written
PO 00000
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Fmt 4703
Sfmt 4703
evidence and argument that establishes
that the grant of the license would not
be consistent with the requirements of
35 U.S.C. 209 and 37 CFR part 404.
In response to this Notice, the public
may file comments or objections.
Comments and objections, other than
those in the form of a license
application, will not be treated
confidentially, and may be made
publicly available.
License applications submitted in
response to this Notice will be
presumed to contain business
confidential information and any release
of information from these license
applications will be made only as
required and upon a request under the
Freedom of Information Act, 5 U.S.C.
552.
Dated: May 7, 2020.
Richard U. Rodriguez,
Associate Director, Technology Transfer
Center, National Cancer Institute.
[FR Doc. 2020–10304 Filed 5–13–20; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive
Patent License: Development and
Commercialization of Logic-Gated
Chimeric Antigen Receptor (CAR)
Therapies for the Treatment of Cluster
of Differentiation 33 (CD33) Expressing
Cancers
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The National Cancer Institute,
an institute of the National Institutes of
Health, Department of Health and
Human Services, is contemplating the
grant of an Exclusive Patent License to
practice the inventions embodied in the
Patents and Patent Applications listed
in the Supplementary Information
section of this Notice to Senti Bio
(‘‘Senti’’), located in South San
Francisco, CA.
DATES: Only written comments and/or
applications for a license which are
received by the National Cancer
Institute’s Technology Transfer Center
on or before June 15, 2020 will be
considered.
ADDRESSES: Requests for copies of the
patent applications, inquiries, and
comments relating to the contemplated
Exclusive Patent License should be
directed to: Jim Knabb, Senior
Technology Transfer Manager, NCI
Technology Transfer Center, 9609
SUMMARY:
E:\FR\FM\14MYN1.SGM
14MYN1
]]>Agencies
[Federal Register Volume 85, Number 94 (Thursday, May 14, 2020)]
[Notices]
[Pages 28965-28966]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-10323]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Advisory Committee on Children and Disasters:
Establishment
AGENCY: Office of the Assistant Secretary for Preparedness and Response
(ASPR), Department of Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Office of the Assistant Secretary for Preparedness and
Response (ASPR), in the Department of Health and Human Services (HHS)
Office of the Secretary announces establishment of the National
Advisory Committee on Children and Disasters (NACCD). The Advisory
Committee will provide advice and consultation to the HHS Secretary on
pediatric medical disaster planning, preparedness, response, and
recovery with respect to the medical and public health needs of
children in relation to disasters. The Office of the Assistant
Secretary for Preparedness and Response (ASPR) shall provide management
and administrative oversight to support the activities of the Advisory
Committee. The Office of the Secretary is accepting application
submissions from qualified individuals who wish to be considered for
membership on the NACCD. Up to 13 new voting members with expertise in
pediatric medical disaster planning, preparedness, response, or
recovery will be selected for the Committee. Please visit the NACCD
website at www.phe.gov/naccd for all application submission information
and instructions. Application submissions will be accepted for 30
calendar days from the date this posting is published in the Federal
Register.
Application Period: The application period is from midnight
(Eastern Time) May 27th-June 27th.
FOR FURTHER INFORMATION CONTACT: Maxine Kellman, DVM, Ph.D., PMP,
Alternate Designated Federal Official for National Advisory Committees,
Washington, DC, Office (202) 260-0447 or email [email protected].
SUPPLEMENTARY INFORMATION: Pursuant to the Federal Advisory Committee
Act (FACA) of 1972, the HHS Secretary, in consultation with the
Secretary of the U.S. Department of Homeland Security, established the
National Advisory Committee on Children and Disasters (NACCD). Section
2811A of the Public Health Service Act, as amended by Pandemic and All
Hazard Preparedness and Advancing Innovation Act of 2019 (42 U.S.C.
300hh-10b) requires that the Secretary for Health and Human Services
(HHS) establish the National Advisory Committee on Children and
Disasters (NACCD) to provide advice and consultation to the HHS
Secretary with respect to the medical and public health needs of
children in relation to disasters. The purpose of the NACCD is to
provide advice and consultation to the HHS Secretary with respect to
the medical and public health needs of children in relation to
disasters. The Office of the Assistant Secretary for Preparedness and
Response provides management and administrative oversight to support
the activities of the NACCD.
Description of Duties: The NACCD: (1) Provides advice and
consultation with respect to the activities addressing at-risk
individuals carried out as applicable and appropriate (2) evaluates and
provides input with respect to the medical and public health needs of
children as they relate to preparation for, response to, and recovery
from all-hazards emergencies; (3) provides advice and consultation with
respect to state emergency preparedness and response activities and
children, including related drills and exercises pursuant to the
preparedness goals under the National Health Security Strategy; and (4)
provides advice and recommendations to the HHS Secretary with respect
to children and the medical and public health grants and cooperative
agreements implementing the Public Health Emergency Preparedness and
Hospital Preparedness Programs and other activities, as applicable to
preparedness and response activities.
Structure: The Advisory Committee consists of not more than 13
voting members, including the Chairperson. Members will be appointed by
the HHS Secretary, in consultation with such other Secretaries as may
be appropriate, from among the nation's preeminent scientific, public
health, and medical experts in areas consistent with the purpose and
functions of the NACCD. Section 2811A(d)(2) of the Public Health
Services (PHS) Act States:
(2) REQUIRED NON-FEDERAL MEMBERS.--The Secretary, in consultation
with such other heads of Federal agencies as may be appropriate, shall
appoint to the Advisory Committee under paragraph (1) at least 13
individuals, including--
(A) at least 2 non-Federal professionals with expertise in
pediatric medical disaster planning, preparedness, response, or
recovery;
(B) at least 2 representatives from State, local, Tribal, or
territorial agencies with expertise in pediatric disaster planning,
preparedness, response, or recovery;
(C) at least 4 members representing health care professionals,
which may include members with expertise in pediatric emergency
medicine; pediatric trauma, critical care, or surgery; the treatment of
pediatric patients affected by chemical, biological, radiological, or
nuclear agents, including emerging infectious diseases; pediatric
mental or behavioral health related to children affected by a public
health emergency; or pediatric primary care; and
(D) other members as the Secretary determines appropriate, of
whom--
(i) at least one such member shall represent a children's hospital;
(ii) at least one such member shall be an individual with expertise
in schools or child care settings;
(iii) at least one such member shall be an individual with
expertise in children and youth with special health care needs; and
(iv) at least one such member shall be an individual with expertise
in the needs of parents or family caregivers, including the parents or
caregivers of children with disabilities in the following categories:
Non-federal health care professionals and representatives from state,
local, territorial, or tribal agencies.
The NACCD shall also have up to 12 federal, non-voting members (ex
officio), including the following officials or their designees:
A. The Assistant Secretary for Preparedness and Response;
B. The Director of the Biomedical Advanced Research and Development
Authority;
C. The Director of the Centers for Disease Control and Prevention;
D. The Commissioner of Food and Drugs;
E. The Director of the National Institutes of Health;
F. The Assistant Secretary of the Administration for Children and
Families;
G. The Administrator of the Health Resources and Services
Administration;
H. The Administrator of the Federal Emergency Management Agency;
I. The Administrator of the Administration for Community Living;
J. The Secretary of Education;
K. The Assistant Secretary for Mental Health and Substance Use; and
L. The Administrator of the Environmental Protection Agency.
A voting member of the NACCD shall serve for a term of three years,
except
[[Page 28966]]
that the Secretary may adjust the terms of appointees who are initially
appointed after the date of enacted of the Pandemic and All-Hazards
Preparedness and Advancing Innovation Act of 2019 (June 24, 2019) in
order to provide for a staggered term of appointment for all members. A
voting member may serve not more than three terms on the NACCD, and not
more than two of such terms may be served consecutively. Voting members
shall not be full-time or permanent part-time federal employees but
shall be appointed by the Secretary as Special Government Employees (5
U.S.C. 3109). A member may serve after the expiration of his/her term
until a successor has been appointed. Members whose term expires after
this charter's renewal date will have a term length contingent upon
renewal of the advisory committee. Vacancies will be filled as members
rotate out or resign using the same procedures as the initial selection
process.
Robert P. Kadlec,
Assistant Secretary for Preparedness and Response.
[FR Doc. 2020-10323 Filed 5-13-20; 8:45 am]
BILLING CODE 4150-37-P
