Advisory Committee; Vaccines and Related Biological Products Advisory Committee, Renewal, 5243-5244 [2024-01585]
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Federal Register / Vol. 89, No. 18 / Friday, January 26, 2024 / Notices
from cattle, as well as, with regard to
§§ 189.5(e) and 700.27(e), foreign
governments seeking designation under
those regulations.
In the Federal Register of August 11,
2023 (88 FR 54617), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. We received one comment
5243
that was not related to the PRA and
therefore will not be addressed in this
document.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
189.5(c)(6) and 700.27(c)(6); affirmation of
compliance.
189.5(e) and 700.27(e); request for designation.
189.5(e) and 700.27(e); response to request
for review by FDA.
Total ...........................................................
1 There
Number of
responses per
respondent
Number of
respondents
21 CFR section; activity
Total annual
responses
Average burden per
response
Total hours
54,825
1
54,825
0.033 (2 minutes) .............
1,809
1
1
1
80 ......................................
80
1
1
1
26 ......................................
26
........................
........................
........................
...........................................
1,915
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
Type of respondent
Total annual
records
Average burden per
recordkeeper
Total hours
Domestic Facilities ............................................
Foreign Facilities ...............................................
697
916
52
52
36,244
47,632
0.25 (15 minutes) .............
0.25 (15 minutes) .............
9,061
11,908
Total ...........................................................
........................
........................
........................
...........................................
20,969
1 There
are no capital or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
Dated: January 18, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–01586 Filed 1–25–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–6827]
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
SUMMARY:
lotter on DSK11XQN23PROD with NOTICES1
Number of
records per
recordkeeper
VerDate Sep<11>2014
18:02 Jan 25, 2024
Jkt 262001
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, 2025, expiration date.
DATES: Authority for the Vaccines and
Related Biological Products Advisory
Committee will expire on December 31,
2025, unless the Commissioner formally
determines that renewal is in the public
interest.
FOR FURTHER INFORMATION CONTACT:
Sussan Paydar, Division of Scientific
Advisors and Consultants, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Silver Spring,
MD 20993–0002, 202–657–8533,
Sussan.Paydar@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
discharging responsibilities as they
relate to helping to ensure safe and
effective vaccines and related biological
products for human use, and as
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
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.
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, hypersensitivity
reactions to the vaccines, preventive
medicine, infectious diseases,
pediatrics, microbiology, and
biochemistry. Members will be invited
E:\FR\FM\26JAN1.SGM
26JAN1
lotter on DSK11XQN23PROD with NOTICES1
5244
Federal Register / Vol. 89, No. 18 / Friday, January 26, 2024 / Notices
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 nonvoting 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, an additional nonvoting
representative of consumer interests and
a nonvoting 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
VerDate Sep<11>2014
18:02 Jan 25, 2024
Jkt 262001
amendment will be made to 21 CFR
14.100.
This notice 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 23, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–01585 Filed 1–25–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–D–0810]
Conducting Remote Regulatory
Assessments—Questions and
Answers; Revised Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability for
comment of a revised draft guidance for
industry entitled ‘‘Conducting Remote
Regulatory Assessments—Question and
Answers.’’ FDA has revised and is
reissuing the draft guidance in response
to public comments and recent
amendments to the Federal Food, Drug,
and Cosmetic Act (FD&C Act). When
finalized, this guidance will describe
FDA’s current thinking regarding its use
of remote regulatory assessments
(RRAs). FDA has used RRAs to conduct
oversight, mitigate risk, meet critical
public health needs, and help maximize
compliance of FDA-regulated products.
This revised draft guidance provides
answers to frequently asked questions
regarding RRAs.
DATES: Submit either electronic or
written comments on the draft guidance
by March 26, 2024 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2022–D–0810 for ‘‘Conducting Remote
Regulatory Assessments; Questions and
Answers; Guidance for Industry.’’
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
E:\FR\FM\26JAN1.SGM
26JAN1
]]>Agencies
[Federal Register Volume 89, Number 18 (Friday, January 26, 2024)]
[Notices]
[Pages 5243-5244]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-01585]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-6827]
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, 2025,
expiration date.
DATES: Authority for the Vaccines and Related Biological Products
Advisory Committee will expire on December 31, 2025, unless the
Commissioner formally determines that renewal is in the public
interest.
FOR FURTHER INFORMATION CONTACT: Sussan Paydar, Division of Scientific
Advisors and Consultants, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Silver Spring, MD 20993-0002, 202-657-8533,
[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.
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, hypersensitivity reactions to the vaccines,
preventive medicine, infectious diseases, pediatrics, microbiology, and
biochemistry. Members will be invited
[[Page 5244]]
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 nonvoting 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, an additional nonvoting
representative of consumer interests and a nonvoting 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 notice 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 23, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-01585 Filed 1-25-24; 8:45 am]
BILLING CODE 4164-01-P
