Advisory Committee; Allergenic Products Advisory Committee, Renewal, 48486 [2022-17052]
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48486
Federal Register / Vol. 87, No. 152 / Tuesday, August 9, 2022 / Notices
Application No.
Drug name
Active ingredient(s)
Strength(s)
Dosage form/route
ANDA 083082 ..
CHLOROQUINE PHOSPHATE.
ZORVOLEX .......................
Chloroquine Phosphate .....
250 mg; 500 mg ................
Tablet; Oral ........................
Hikma Pharms.
Diclofenac ..........................
18 mg .................................
Capsule; Oral .....................
Zyla.
NDA 204592 .....
FDA has reviewed its records and,
under § 314.161, has determined that
the drug products listed were not
withdrawn from sale for reasons of
safety or effectiveness. Accordingly, the
Agency will continue to list the drug
products in the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book. The ‘‘Discontinued Drug Product
List’’ identifies, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness.
Approved ANDAs that refer to the
drug products listed are unaffected by
the discontinued marketing of the
products subject to these applications.
Additional ANDAs that refer to these
products may also be approved by the
Agency if they comply with relevant
legal and regulatory requirements. If
FDA determines that labeling for these
drug products should be revised to meet
current standards, the Agency will
advise ANDA applicants to submit such
labeling.
Dated: August 2, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–17056 Filed 8–8–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–2475]
Advisory Committee; Allergenic
Products Advisory Committee,
Renewal
AGENCY:
Food and Drug Administration,
HHS.
Notice; renewal of Federal
advisory committee.
ACTION:
The Food and Drug
Administration (FDA) is announcing the
renewal of the Allergenic 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 Allergenic
Products Advisory Committee for an
additional 2 years beyond the charter
expiration date. The new charter will be
in effect until the July 9, 2024,
expiration date.
jspears on DSK121TN23PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:04 Aug 08, 2022
Jkt 256001
Authority for the Allergenic
Products Advisory Committee will
expire on July 9, 2024, unless the
Commissioner formally determines that
renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT:
Sussan Paydar, Division of Scientific
Advisors and Consultants, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10993
New Hampshire Ave., Bldg. 71, Rm.
1333A, Silver Spring, MD 20993–0002,
301–796–4897, 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 Allergenic 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 drugs for human use and, as
required, any other product for which
FDA has regulatory responsibility.
The Committee shall consist of a core
of nine voting members including the
Chair. Members and the Chair are
selected by the Commissioner or
designee from among authorities
knowledgeable in the fields of allergy,
immunology, pediatrics, internal
medicine, biochemistry, and related
specialties. 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. 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.
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
DATES:
PO 00000
Frm 00036
Fmt 4703
Sfmt 9990
Applicant
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/advisory-committees/
allergenic-products-advisory-committee/
charter-allergenic-products-advisorycommittee 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: August 2, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–17052 Filed 8–8–22; 8:45 am]
BILLING CODE 4164–01–P
E:\FR\FM\09AUN1.SGM
09AUN1
]]>Agencies
[Federal Register Volume 87, Number 152 (Tuesday, August 9, 2022)]
[Notices]
[Page 48486]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-17052]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-2475]
Advisory Committee; Allergenic Products Advisory Committee,
Renewal
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; renewal of Federal advisory committee.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
renewal of the Allergenic 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 Allergenic
Products Advisory Committee for an additional 2 years beyond the
charter expiration date. The new charter will be in effect until the
July 9, 2024, expiration date.
DATES: Authority for the Allergenic Products Advisory Committee will
expire on July 9, 2024, unless the Commissioner formally determines
that renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT: Sussan Paydar, Division of Scientific
Advisors and Consultants, Center for Biologics Evaluation and Research,
Food and Drug Administration, 10993 New Hampshire Ave., Bldg. 71, Rm.
1333A, Silver Spring, MD 20993-0002, 301-796-4897,
[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 Allergenic
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 drugs for human use and, as required, any other
product for which FDA has regulatory responsibility.
The Committee shall consist of a core of nine voting members
including the Chair. Members and the Chair are selected by the
Commissioner or designee from among authorities knowledgeable in the
fields of allergy, immunology, pediatrics, internal medicine,
biochemistry, and related specialties. 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. 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.
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/advisory-committees/allergenic-products-advisory-committee/charter-allergenic-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: August 2, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-17052 Filed 8-8-22; 8:45 am]
BILLING CODE 4164-01-P
