Advisory Committee; Vaccines and Related Biological Products Advisory Committee; Renewal, 5964-5965 [2020-01988]
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Federal Register / Vol. 85, No. 22 / Monday, February 3, 2020 / Notices
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, and the Determination of
the Director, Strategic Business
Initiatives Unit, Office of the Chief
Operating Officer, CDC, pursuant to
Public Law 92–463. 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: Disease, Disability,
and Injury Prevention and Control Special
Emphasis Panel (SEP)–DD15–
0030601SUPP20, Using Longitudinal Data to
Characterize the Natural History of Fragile X
Syndrome to Improve Service.
Date: April 2, 2020.
Time: 11:00 a.m.–5:00 p.m., EDT.
Place: Teleconference.
Agenda: To review and evaluate grant
applications.
For Further Information Contact: Jaya
Raman Ph.D., Scientific Review Officer, CDC,
4770 Buford Highway, Mailstop F80, Atlanta,
Georgia 30341, Telephone: (770) 488–6511,
kva5@cdc.gov.
The Director, Strategic Business Initiatives
Unit, Office of the Chief Operating Officer,
Centers for Disease Control and Prevention,
has been delegated the authority to sign
Federal Register notices pertaining to
announcements of meetings and other
committee management activities, for both
the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Kalwant Smagh,
Director, Strategic Business Initiatives Unit,
Office of the Chief Operating Officer, Centers
for Disease Control and Prevention.
[FR Doc. 2020–01962 Filed 1–31–20; 8:45 am]
BILLING CODE 4163–18–P
Notice of Closed Meeting
lotter on DSKBCFDHB2PROD with NOTICES
Kalwant Smagh,
Director, Strategic Business Initiatives Unit,
Office of the Chief Operating Officer, Centers
for Disease Control and Prevention.
[FR Doc. 2020–01963 Filed 1–31–20; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Notice of Closed Meeting
Centers for Disease Control and
Prevention
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, and the Determination of
16:47 Jan 31, 2020
Name of Committee: Disease, Disability,
and Injury Prevention and Control Special
Emphasis Panel (SEP)–SIP20–004, Effect of
Survivorship Care Plans on Cancer Mortality
and SIP20–005, Validity and Reliability of
Survey Measures for Lung, Cervical, Breast,
and Colorectal Cancer Screening in the
Redesigned National Health Interview
Survey.
Date: April 29, 2020.
Time: 10:00 a.m.–6:00 p.m., EDT.
Place: Teleconference.
Agenda: To review and evaluate grant
applications.
For Further Information Contact: Jaya
Raman, Ph.D., Scientific Review Officer,
CDC, 4770 Buford Highway, Mailstop F80,
Atlanta, Georgia 30341, Telephone: (770)
488–6511, kva5@cdc.gov.
The Director, Strategic Business Initiatives
Unit, Office of the Chief Operating Officer,
Centers for Disease Control and Prevention,
has been delegated the authority to sign
Federal Register notices pertaining to
announcements of meetings and other
committee management activities, for both
the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Centers for Disease Control and
Prevention
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
VerDate Sep<11>2014
the Director, Strategic Business
Initiatives Unit, Office of the Chief
Operating Officer, CDC, pursuant to
Public Law 92–463. 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.
Jkt 250001
Frm 00038
Fmt 4703
Sfmt 4703
Name of Committee: Disease, Disability,
and Injury Prevention and Control Special
Emphasis Panel (SEP)–SIP20–006,
Coordinating Community-Clinical Linkages
With Community Health Workers to Improve
Health and Social Outcomes for Adults With
Epilepsy and SIP20–007, Building Capacity
to Describe Epilepsy Burden by Using
Underutilized National and State Data
Systems.
Date: May 6, 2020.
Time: 10:00 a.m.–6:00 p.m., EDT.
Place: Teleconference.
Agenda: To review and evaluate grant
applications.
For Further Information Contact: Jaya
Raman Ph.D., Scientific Review Officer, CDC,
4770 Buford Highway, Mailstop F80, Atlanta,
Georgia 30341, Telephone: (770) 488–6511,
kva5@cdc.gov.
The Director, Strategic Business Initiatives
Unit, Office of the Chief Operating Officer,
Centers for Disease Control and Prevention,
has been delegated the authority to sign
Federal Register notices pertaining to
announcements of meetings and other
committee management activities, for both
the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Kalwant Smagh,
Director, Strategic Business Initiatives Unit,
Office of the Chief Operating Officer, Centers
for Disease Control and Prevention.
[FR Doc. 2020–01965 Filed 1–31–20; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–0008]
Advisory Committee; Vaccines and
Related Biological Products Advisory
Committee; Renewal
AGENCY:
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, and the Determination of
the Director, Strategic Business
Initiatives Unit, Office of the Chief
Operating Officer, CDC, pursuant to
Public Law 92–463. The grant
applications and the discussions could
PO 00000
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.
Food and Drug Administration,
HHS.
Notice; renewal of advisory
committee.
ACTION:
The Food and Drug
Administration (FDA) is announcing the
renewal of the Vaccines and Related
Biological Products Advisory
Committee by the Commissioner of
Food and Drugs (the Commissioner).
The Commissioner has determined that
it is in the public interest to renew the
Vaccines and Related Biological
Products Advisory Committee for an
SUMMARY:
E:\FR\FM\03FEN1.SGM
03FEN1
lotter on DSKBCFDHB2PROD with NOTICES
Federal Register / Vol. 85, No. 22 / Monday, February 3, 2020 / Notices
additional 2 years beyond the charter
expiration date. The new charter will be
in effect until December 31, 2021.
DATES: Authority for the Vaccines and
Related Biological Products Advisory
Committee will expire on December 31,
2021, unless the Commissioner formally
determines that renewal is in the public
interest.
FOR FURTHER INFORMATION CONTACT:
Prabhakara Atreya, Division of
Scientific Advisors and Consultants,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
6306, Silver Spring, MD 20993–0002,
240–402–8006, Prabhakara.Atreya@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant
to 41 CFR 102–3, FDA is announcing
the renewal of the Vaccines and Related
Biological Products Advisory
Committee (the Committee). The
Committee is a discretionary Federal
advisory committee established to
provide advice to the Commissioner.
The Committee advises the
Commissioner or designee in
discharging responsibilities as they
relate to helping to ensure safe and
effective vaccines and related biological
products for human use and, as
required, any other product for which
FDA has regulatory responsibility.
The Committee reviews and evaluates
data concerning the safety,
effectiveness, and appropriate use of
vaccines and related biological products
that are intended for use in the
prevention, treatment, or diagnosis of
human diseases and, as required, any
other products for which FDA has
regulatory responsibility. The
Committee also considers the quality
and relevance of FDA’s research
program, which provides scientific
support for the regulation of these
products and makes appropriate
recommendations to the Commissioner.
Pursuant to its Charter, the Committee
shall consist of a core of 15 voting
members, including the Chairperson
(the Chair). Members and the Chair are
selected by the Commissioner or
designee from among authorities
knowledgeable in the fields of
immunology, molecular biology, rDNA,
virology, bacteriology, epidemiology or
biostatistics, vaccine policy, vaccine
safety science, Federal immunization
activities, vaccine development
including translational and clinical
evaluation programs, allergy, preventive
medicine, infectious diseases,
pediatrics, microbiology, and
biochemistry. Members will be invited
to serve for overlapping terms of up to
4 years. Almost all non-Federal
members of this Committee serve as
VerDate Sep<11>2014
16:47 Jan 31, 2020
Jkt 250001
Special Government Employees. Ex
Officio voting members, one each from
the Department of Health and Human
Services, the Centers for Disease Control
and Prevention, and the National
Institutes of Health, may be included.
The core of voting members may
include one technically qualified
member, selected by the Commissioner
or designee, who is identified with
consumer interests and is recommended
by either a consortium of consumeroriented organizations or other
interested persons. In addition to the
voting members, the Committee may
include one non-voting member who is
identified with industry interests. There
may also be an alternate industry
representative.
The Commissioner or designee shall
have the authority to select members of
other scientific and technical FDA
advisory committees (normally not to
exceed 10 members) to serve
temporarily as voting members and to
designate consultants to serve
temporarily as voting members when:
(1) Expertise is required that is not
available among current voting standing
members of the Committee (when
additional voting members are added to
the Committee to provide needed
expertise, a quorum will be based on the
combined total of regular and added
members) or (2) to comprise a quorum
when, because of unforeseen
circumstances, a quorum is or will be
lacking. Because of the size of the
Committee and the variety in the types
of issues that it will consider, FDA may,
in connection with a particular
Committee meeting, specify a quorum
that is less than a majority of the current
voting members. The Agency’s
regulations (21 CFR 14.22(d)) authorize
a Committee charter to specify quorum
requirements.
If functioning as a medical device
panel, a non-voting representative of
consumer interests and a non-voting
representative of industry interests will
be included in addition to the voting
members.
Further information regarding the
most recent charter and other
information can be found at https://
www.fda.gov/AdvisoryCommittees/
CommitteesMeetingMaterials/Blood
VaccinesandOtherBiologics/
VaccinesandRelatedBiologicalProducts
AdvisoryCommittee/ucm129571.htm or
by contacting the Designated Federal
Officer (see FOR FURTHER INFORMATION
CONTACT). In light of the fact that no
change has been made to the Committee
name or description of duties, no
amendment will be made to 21 CFR
14.100.
PO 00000
Frm 00039
Fmt 4703
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5965
This document is issued under the
Federal Advisory Committee Act (5
U.S.C. app.). For general information
related to FDA advisory committees,
please check https://www.fda.gov/
AdvisoryCommittees/default.htm.
Dated: January 29, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–01988 Filed 1–31–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0719]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Planning for the
Effects of High Absenteeism To
Ensure Availability of Medically
Necessary Drug Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) 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.
DATES: Fax written comments on the
collection of information by March 4,
2020.
SUMMARY:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0675. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
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:
E:\FR\FM\03FEN1.SGM
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]]>Agencies
[Federal Register Volume 85, Number 22 (Monday, February 3, 2020)]
[Notices]
[Pages 5964-5965]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-01988]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-0008]
Advisory Committee; Vaccines and Related Biological Products
Advisory Committee; Renewal
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; renewal of advisory committee.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
renewal of the Vaccines and Related Biological Products Advisory
Committee by the Commissioner of Food and Drugs (the Commissioner). The
Commissioner has determined that it is in the public interest to renew
the Vaccines and Related Biological Products Advisory Committee for an
[[Page 5965]]
additional 2 years beyond the charter expiration date. The new charter
will be in effect until December 31, 2021.
DATES: Authority for the Vaccines and Related Biological Products
Advisory Committee will expire on December 31, 2021, unless the
Commissioner formally determines that renewal is in the public
interest.
FOR FURTHER INFORMATION CONTACT: Prabhakara Atreya, Division of
Scientific Advisors and Consultants, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 71, Rm. 6306, Silver Spring, MD 20993-
0002, 240-402-8006, [email protected].
SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3, FDA is announcing
the renewal of the Vaccines and Related Biological Products Advisory
Committee (the Committee). The Committee is a discretionary Federal
advisory committee established to provide advice to the Commissioner.
The Committee advises the Commissioner or designee in discharging
responsibilities as they relate to helping to ensure safe and effective
vaccines and related biological products for human use and, as
required, any other product for which FDA has regulatory
responsibility.
The Committee reviews and evaluates data concerning the safety,
effectiveness, and appropriate use of vaccines and related biological
products that are intended for use in the prevention, treatment, or
diagnosis of human diseases and, as required, any other products for
which FDA has regulatory responsibility. The Committee also considers
the quality and relevance of FDA's research program, which provides
scientific support for the regulation of these products and makes
appropriate recommendations to the Commissioner.
Pursuant to its Charter, the Committee shall consist of a core of
15 voting members, including the Chairperson (the Chair). Members and
the Chair are selected by the Commissioner or designee from among
authorities knowledgeable in the fields of immunology, molecular
biology, rDNA, virology, bacteriology, epidemiology or biostatistics,
vaccine policy, vaccine safety science, Federal immunization
activities, vaccine development including translational and clinical
evaluation programs, allergy, preventive medicine, infectious diseases,
pediatrics, microbiology, and biochemistry. Members will be invited to
serve for overlapping terms of up to 4 years. Almost all non-Federal
members of this Committee serve as Special Government Employees. Ex
Officio voting members, one each from the Department of Health and
Human Services, the Centers for Disease Control and Prevention, and the
National Institutes of Health, may be included. The core of voting
members may include one technically qualified member, selected by the
Commissioner or designee, who is identified with consumer interests and
is recommended by either a consortium of consumer-oriented
organizations or other interested persons. In addition to the voting
members, the Committee may include one non-voting member who is
identified with industry interests. There may also be an alternate
industry representative.
The Commissioner or designee shall have the authority to select
members of other scientific and technical FDA advisory committees
(normally not to exceed 10 members) to serve temporarily as voting
members and to designate consultants to serve temporarily as voting
members when: (1) Expertise is required that is not available among
current voting standing members of the Committee (when additional
voting members are added to the Committee to provide needed expertise,
a quorum will be based on the combined total of regular and added
members) or (2) to comprise a quorum when, because of unforeseen
circumstances, a quorum is or will be lacking. Because of the size of
the Committee and the variety in the types of issues that it will
consider, FDA may, in connection with a particular Committee meeting,
specify a quorum that is less than a majority of the current voting
members. The Agency's regulations (21 CFR 14.22(d)) authorize a
Committee charter to specify quorum requirements.
If functioning as a medical device panel, a non-voting
representative of consumer interests and a non-voting representative of
industry interests will be included in addition to the voting members.
Further information regarding the most recent charter and other
information can be found at https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/VaccinesandRelatedBiologicalProductsAdvisoryCommittee/ucm129571.htm or
by contacting the Designated Federal Officer (see FOR FURTHER
INFORMATION CONTACT). In light of the fact that no change has been made
to the Committee name or description of duties, no amendment will be
made to 21 CFR 14.100.
This document is issued under the Federal Advisory Committee Act (5
U.S.C. app.). For general information related to FDA advisory
committees, please check https://www.fda.gov/AdvisoryCommittees/default.htm.
Dated: January 29, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-01988 Filed 1-31-20; 8:45 am]
BILLING CODE 4164-01-P
