Advisory Committee; Arthritis Advisory Committee; Renewal, 48652-48653 [2024-12525]
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Federal Register / Vol. 89, No. 111 / Friday, June 7, 2024 / Notices
irradiation in the production,
processing, and handling of food are
found in part 179 (21 CFR part 179). To
ensure safe use of a radiation source,
§ 179.21(b)(1) requires that the label of
sources bear appropriate and accurate
information identifying the source of
radiation and the maximum (or
minimum and maximum) energy of the
emitted radiation. Section 179.21(b)(2)
requires that the label or accompanying
labeling bear adequate directions for
installation and use and a statement
supplied by us that indicates maximum
dose of radiation allowed. Section
179.26(c) requires that the label or
accompanying labeling bear a logo and
a radiation disclosure statement. Section
179.25(e) requires that food processors
who treat food with radiation make and
retain, for 1 year past the expected shelf
life of the products up to a maximum of
3 years, specified records relating to the
irradiation process (e.g., the food
treated, lot identification, scheduled
process, etc.). The records required by
§ 179.25(e) are used by our inspectors to
assess compliance with the regulation
that establishes limits within which
radiation may be safely used to treat
food. We cannot ensure safe use without
a method to assess compliance with the
dose limits, and there are no practicable
methods for analyzing most foods to
determine whether they have been
treated with ionizing radiation and are
within the limitations set forth in part
179. Records inspection is the only way
to determine whether firms are
complying with the regulations for
treatment of foods with ionizing
radiation.
Description of Respondents:
Respondents to the information
collection are businesses engaged in the
irradiation of food.
In the Federal Register of January 23,
2024 (89 FR 4311), FDA published a 60day notice requesting public comment
on the proposed collection of
information. One comment related to
the PRA was received which suggested
that FDA could enhance and improve
the information received in this
collection of information by clarifying
reporting requirements, detailing
consistent guidelines, conducting
training and educational programs to
increase understanding, and integrating
technology into the process. The
comment also indicated that regular
audits and checks should be instituted,
and the implementation of these
suggestions will increase the quality of
the information being collected.
FDA strives to protect the public
health and safety in irradiated food and
packaging. FDA’s website at https://
www.fda.gov/food/food-ingredientspackaging/irradiation-food-packaging
provides a discussion of FDA’s
regulation of irradiated food as well as
information about the history, science,
and regulations of irradiated food and
packaging. In addition, FDA offers
educational webinars, such as the joint
CFSAN/JIFSAN webinar on Food
Packaging and Irradiation. This webinar
can be found on YouTube at https://
www.youtube.com/watch?v=
X3rYqwHx_KU. This webinar provides
some clarification on food processing
and handling of irradiated food. FDA
also conducts inspections on an asneeded basis to check on the accuracy
of the records being maintained by food
processors and to ensure the safety of
irradiated food and packaging.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
recordkeepers
21 CFR section
Total annual
records
Average
burden per
recordkeeping
Total hours
179.25(e), large processors .................................................
179.25(e), small processors ................................................
4
4
300
30
1,200
120
1
1
1,200
120
Total ..............................................................................
........................
........................
........................
........................
1,320
1 There
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Number of
records per
recordkeeper
are no capital costs 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. Our
estimate of the recordkeeping burden
under § 179.25(e) is based on our
experience regulating the safe use of
radiation as a direct food additive. The
number of firms who process food using
irradiation is extremely limited. We
estimate that there are four irradiation
plants whose business is devoted
primarily (i.e., approximately 100
percent) to irradiation of food and other
agricultural products. Four other firms
also irradiate small quantities of food.
We estimate that this irradiation
accounts for no more than 10 percent of
the business for each of these firms.
Therefore, the average estimated burden
is based on four facilities devoting 100
percent of their business to food
irradiation, and four facilities devoting
10 percent of their business to food
irradiation.
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No burden has been estimated for the
labeling requirements in §§ 179.21(b)(1),
179.21(b)(2), and 179.26(c) because the
disclosures are supplied by FDA. Under
5 CFR 1320.3(c)(2), the public
disclosure of information originally
supplied by the Federal Government to
the recipient for the purpose of
disclosure to the public is not subject to
review by OMB under the PRA.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: June 4, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
ACTION:
[FR Doc. 2024–12536 Filed 6–6–24; 8:45 am]
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Food and Drug Administration
[Docket No. FDA–2024–N–0008]
Advisory Committee; Arthritis
Advisory Committee; Renewal
AGENCY:
Food and Drug Administration,
HHS.
Notice; renewal of Federal
advisory committee.
The Food and Drug
Administration (FDA or the Agency) is
announcing the renewal of the Arthritis
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 Arthritis Advisory
Committee for an additional 2 years
beyond the charter expiration date. The
new charter will be in effect until the
April 5, 2026, expiration date.
SUMMARY:
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Federal Register / Vol. 89, No. 111 / Friday, June 7, 2024 / Notices
Authority for the Arthritis
Advisory Committee will expire on
April 5, 2026, unless the Commissioner
formally determines that renewal is in
the public interest.
FOR FURTHER INFORMATION CONTACT:
Jessica Seo, Center for Drug Evaluation
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 31, Rm. 2417, Silver Spring,
MD 20993–0002, 301–796–9001, AAC@
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 Arthritis 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 drugs for human use and, as
required, any other product for which
FDA has regulatory responsibility.
The Committee reviews and evaluates
data concerning the safety and
effectiveness of marketed and
investigational human drug products for
use in the treatment of arthritis,
rheumatism, and related diseases, and
makes appropriate recommendations to
the Commissioner.
Pursuant to its Charter, the Committee
shall consist of a core of 11 voting
members including the Chair. Members
and the Chair are selected by the
Commissioner or designee from among
authorities knowledgeable in the fields
of arthritis, rheumatology, orthopedics,
epidemiology or statistics, analgesics,
and related specialties. Members will be
invited to serve for overlapping terms of
up to 4 years. Non-Federal members of
this committee will serve as Special
Government Employees,
representatives, or Ex-Officio members.
Federal members will serve as Regular
Government Employees or Ex-Officios.
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 representative
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
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DATES:
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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 non-voting
representative member of consumer
interests and an additional non-voting
representative member 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/
human-drug-advisory-committees/
arthritis-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 as
amended (5 U.S.C. 1001 et seq). For
general information related to FDA
advisory committees, please visit us at
https://www.fda.gov/
AdvisoryCommittees/default.htm.
Dated: June 4, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–12525 Filed 6–6–24; 8:45 am]
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48653
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–0335]
Advisory Committee; Obstetrics,
Reproductive and Urologic Drugs
Advisory; 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
Obstetrics, Reproductive and Urologic
Drugs 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 Obstetrics,
Reproductive and Urologic Drugs
Advisory Committee for an additional 2
years beyond the charter expiration
date. The new charter will be in effect
until the March 23, 2026, expiration
date.
SUMMARY:
Authority for the Obstetrics,
Reproductive and Urologic Drugs
Advisory Committee will expire on
March 23, 2026, unless the
Commissioner formally determines that
renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT:
Joyce Frimpong, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–7973, email: ORUDAC@
fda.hhs.gov.
DATES:
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 Obstetrics, Reproductive
and Urologic Drugs 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 drugs for human use and, as
required, any other product for which
FDA has regulatory responsibility.
The Committee reviews and evaluates
data on the safety and effectiveness of
marketed and investigational human
drug products for use in the practice of
obstetrics, gynecology, urology, and
related specialties, and makes
SUPPLEMENTARY INFORMATION:
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]]>Agencies
[Federal Register Volume 89, Number 111 (Friday, June 7, 2024)]
[Notices]
[Pages 48652-48653]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-12525]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-0008]
Advisory Committee; Arthritis 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 Arthritis 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 Arthritis
Advisory Committee for an additional 2 years beyond the charter
expiration date. The new charter will be in effect until the April 5,
2026, expiration date.
[[Page 48653]]
DATES: Authority for the Arthritis Advisory Committee will expire on
April 5, 2026, unless the Commissioner formally determines that renewal
is in the public interest.
FOR FURTHER INFORMATION CONTACT: Jessica Seo, Center for Drug
Evaluation Research, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001,
[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 Arthritis 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
drugs for human use and, as required, any other product for which FDA
has regulatory responsibility.
The Committee reviews and evaluates data concerning the safety and
effectiveness of marketed and investigational human drug products for
use in the treatment of arthritis, rheumatism, and related diseases,
and makes appropriate recommendations to the Commissioner.
Pursuant to its Charter, the Committee shall consist of a core of
11 voting members including the Chair. Members and the Chair are
selected by the Commissioner or designee from among authorities
knowledgeable in the fields of arthritis, rheumatology, orthopedics,
epidemiology or statistics, analgesics, and related specialties.
Members will be invited to serve for overlapping terms of up to 4
years. Non-Federal members of this committee will serve as Special
Government Employees, representatives, or Ex-Officio members. Federal
members will serve as Regular Government Employees or Ex-Officios. 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 representative 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 non-voting
representative member of consumer interests and an additional non-
voting representative member 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/human-drug-advisory-committees/arthritis-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 as
amended (5 U.S.C. 1001 et seq). For general information related to FDA
advisory committees, please visit us at https://www.fda.gov/AdvisoryCommittees/default.htm.
Dated: June 4, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-12525 Filed 6-6-24; 8:45 am]
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