Advisory Committee; Vaccines and Related Biological Products Advisory Committee; Renewal, 4897-4898 [2022-01858]
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Federal Register / Vol. 87, No. 20 / Monday, January 31, 2022 / Notices
khammond on DSKJM1Z7X2PROD with NOTICES
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Principles of
Premarket Pathways for Combination
Products.’’ It does not establish any
rights for any person and is not binding
on FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations.
II. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. Therefore, clearance by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required for this guidance.
The previously approved collections of
information are subject to review by
OMB under the PRA. The collections of
information in 21 CFR part 3 and in the
guidance ‘‘How to Prepare a Pre-Request
for Designation (Pre-RFD)’’ have been
approved under OMB control number
0910–0523. The collections of
information for applications for FDA
approval to market a new drug (certain
provisions of 21 CFR part 314) have
been approved under OMB control
number 0910–0001; the collections of
information in 21 CFR part 601 have
been approved under 0910–0338; and
the collections of information in section
351(k) of the Public Health Service Act
(42 U.S.C. 262) have been approved
under 0910–0719. The collections of
information in 21 CFR part 807, subpart
E, have been approved under OMB
control number 0910–0120; the
collections of information in 21 CFR
part 814, subparts A through E, have
been approved under OMB control
number 0910–0231; the collections of
information in 21 CFR part 860,
subparts A through C, have been
approved under OMB control number
0910–0138; the collections of
information in the guidance document
‘‘Requests for Feedback and Meetings
for Medical Device Submissions: The QSubmission Program’’ have been
approved under OMB control number
0910–0756; and the collections of
information in 21 CFR part 860, subpart
D, for De Novo classifications have been
approved under OMB control number
0910–0844.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at https://
www.fda.gov/combination-products/
guidance-regulatory-information/
combination-products-guidance-
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17:38 Jan 28, 2022
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documents, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: January 26, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–01925 Filed 1–28–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–0008]
Advisory Committee; Vaccines and
Related Biological Products Advisory
Committee; Renewal
AGENCY:
Food and Drug Administration,
HHS.
Notice; renewal of Federal
advisory committee.
ACTION:
The Food and Drug
Administration (FDA or the Agency) 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 additional 2 years
beyond the charter expiration date. The
new charter will be in effect until the
December 31, 2023, expiration date.
DATES: Authority for the Vaccines and
Related Biological Products Advisory
Committee will expire on December 31,
2023, unless the Commissioner formally
determines that renewal is in the public
interest.
FOR FURTHER INFORMATION CONTACT:
Prabhakara Atreya, Division of
Scientific Advisors and Consultants,
Center for Biologics Evaluation and
Research, 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 102–3.65 and approval by the
Department of Health and Human
Services and by the General Services
Administration, 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
SUMMARY:
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4897
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
which 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.
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 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
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4898
Federal Register / Vol. 87, No. 20 / Monday, January 31, 2022 / Notices
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/advisory-committees/
vaccines-and-related-biologicalproducts-advisory-committee/chartervaccines-and-related-biologicalproducts-advisory-committee 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 visit us at https://www.fda.gov/
AdvisoryCommittees/default.htm.
Dated: January 24, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–01858 Filed 1–28–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
khammond on DSKJM1Z7X2PROD with NOTICES
Meeting of the Advisory Committee on
Childhood Vaccines
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
In accordance with the
Federal Advisory Committee Act, this
notice announces that the Advisory
SUMMARY:
VerDate Sep<11>2014
17:38 Jan 28, 2022
Jkt 256001
Commission on Childhood Vaccines
(ACCV) will hold public meetings for
the 2022 calendar year (CY).
Information about the ACCV, agendas,
and materials for these meetings can be
found on the ACCV website at https://
www.hrsa.gov/advisory-committees/
vaccines/.
DATES: ACCV meetings will be held on:
• March 3, 2022, 10:00 a.m. Eastern
Time (ET)–4:00 p.m. ET;
• June 2, 2022, 10:00 a.m. ET–4:00
p.m. ET;
• September 1, 2022, 10:00 a.m. ET–
4:00 p.m. ET; and
• December 1, 2022, 10:00 a.m. ET–
4:00 p.m. ET.
ADDRESSES: Meetings may be held inperson or virtually. For updates on how
the meeting will be held, visit the ACCV
website 30 business days before the
meeting date, where instructions for
joining meetings either in-person or
remotely will be posted. In-person
ACCV meetings will be held at 5600
Fishers Lane, Rockville, Maryland
20857. For meeting information
updates, go to the ACCV website
meeting page at https://www.hrsa.gov/
advisory-committees/vaccines/
meetings.html.
FOR FURTHER INFORMATION CONTACT:
Annie Herzog, Division of Injury
Compensation Programs, HRSA, 5600
Fishers Lane, 08N186B, Rockville,
Maryland 20857; 301–443–6634; or
ACCV@HRSA.gov.
SUPPLEMENTARY INFORMATION: The ACCV
provides advice and recommendations
to the Secretary of HHS on policy,
program development, and other issues
related to the implementation of the
National Vaccine Injury Compensation
Program and concerning other matters
as described under section 2119 of the
Public Health Service Act (42 U.S.C.
300aa–19).
Since priorities dictate meeting times,
be advised that times and agenda items
are subject to change. Refer to the ACCV
website listed above for any meeting
updates that may occur. For CY 2022
meetings, agenda items may include,
but are not limited to: Updates from the
Division of Injury Compensation
Programs, Department of Justice, Office
of Infectious Disease and HIV/AIDS
Policy (HHS), Immunization Safety
Office (Centers for Disease Control and
Prevention), National Institute of
Allergy and Infectious Diseases
(National Institutes of Health) and
Center for Biologics, Evaluation and
Research (Food and Drug
Administration). Refer to the ACCV
website listed above for all current and
updated information concerning the CY
2022 ACCV meetings, including draft
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agendas and meeting materials posted 5
calendar days before the meeting(s).
Members of the public will have the
opportunity to provide comments.
Public participants may submit written
statements in advance of the scheduled
meeting(s). Oral comments will be
honored in the requested order and may
be limited as time allows. Requests to
submit a written statement or make oral
comments to ACCV should be sent to
Annie Herzog using the contact
information above at least 5 business
days before the meeting date(s).
Individuals who need special
assistance or another reasonable
accommodation should notify Annie
Herzog using the contact information
listed above at least 10 business days
before the meeting(s) they wish to
attend. If in-person meetings occur, they
will be held in a federal government
building and attendees must go through
a security check to enter the building.
Non-U.S. Citizen attendees must notify
HRSA of their planned attendance at
least 20 business days before the
meeting to facilitate their entry into the
building. All attendees are required to
present government-issued
identification before entry.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2022–01848 Filed 1–28–22; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings 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: Biobehavioral and
Behavioral Processes Integrated Review
Group; Biobehavioral Mechanisms of
Emotion, Stress and Health Study Section.
Date: February 24–25, 2022.
Time: 10:00 a.m. to 8:00 p.m.
E:\FR\FM\31JAN1.SGM
31JAN1
]]>Agencies
[Federal Register Volume 87, Number 20 (Monday, January 31, 2022)]
[Notices]
[Pages 4897-4898]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-01858]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-0008]
Advisory Committee; Vaccines and Related Biological Products
Advisory Committee; Renewal
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; renewal of Federal advisory committee.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or the Agency) 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 additional 2 years beyond the charter expiration date.
The new charter will be in effect until the December 31, 2023,
expiration date.
DATES: Authority for the Vaccines and Related Biological Products
Advisory Committee will expire on December 31, 2023, unless the
Commissioner formally determines that renewal is in the public
interest.
FOR FURTHER INFORMATION CONTACT: Prabhakara Atreya, Division of
Scientific Advisors and Consultants, Center for Biologics Evaluation
and Research, 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 102-3.65 and approval by
the Department of Health and Human Services and by the General Services
Administration, 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 which 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.
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
[[Page 4898]]
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/advisory-committees/vaccines-and-related-biological-products-advisory-committee/charter-vaccines-and-related-biological-products-advisory-committee 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 visit us at https://www.fda.gov/AdvisoryCommittees/default.htm.
Dated: January 24, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-01858 Filed 1-28-22; 8:45 am]
BILLING CODE 4164-01-P
