Advisory Committee; Pulmonary-Allergy Drugs Advisory Committee, Renewal, 26481 [2018-12219]
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26481
Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Notices
TABLE 5—ESTIMATED ANNUAL REPORTING BURDEN FOR TOBACCO PRODUCTS 1
Number of
respondents
21 CFR section
25.40(a) and (c) ...................................................................
1 There
Dated: June 1, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–12221 Filed 6–6–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–1860]
Advisory Committee; PulmonaryAllergy Drugs Advisory Committee,
Renewal
Food and Drug Administration,
HHS.
Notice; renewal of advisory
committee.
ACTION:
The Food and Drug
Administration (FDA) is announcing the
renewal of the Pulmonary-Allergy 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 Pulmonary-Allergy
Drugs Advisory Committee for an
additional 2 years beyond the charter
expiration date. The new charter will be
in effect until May 30, 2020.
DATES: Authority for the PulmonaryAllergy Drugs Advisory Committee will
expire on May 30, 2020, unless the
Commissioner formally determines that
renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT:
Cindy Chee, Center for Drug Evaluation
and Research, Food and Drug
SUMMARY:
sradovich on DSK3GMQ082PROD with NOTICES
5,832
Total annual
responses
1
Average
burden per
response
5,832
Total hours
80
466,560
are no capital costs or operating and maintenance costs associated with this collection of information.
The Estimated Annual Reporting
Burden for Human Foods is no longer a
part of this information collection. The
burden has now been incorporated into
OMB control number 0910–0541.
Our estimated burden for the
information collection reflects an
overall increase of 453,834 hours
(currently approved 231,224) and a
corresponding increase of 7,108 annual
responses (currently approved 15,527).
The new estimated totals are 685,058
hours and 22,635 annual responses. We
attribute this adjustment to an increase
in the number of EA submissions we
received since the last extension.
AGENCY:
Number of
responses per
respondent
VerDate Sep<11>2014
17:19 Jun 06, 2018
Jkt 244001
Administration, 10903 New Hampshire
Ave., Bldg. 31, Rm. 2417, Silver Spring,
MD 20993–0002; 301–796–9001, email:
PADAC@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant
to 41 CFR 102–3.65 and approval by the
Department of Health and Human
Services pursuant to 45 CFR part 11 and
by the General Services Administration,
FDA is announcing the renewal of the
Pulmonary-Allergy 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
available data concerning the safety and
effectiveness of marketed and
investigational human drug products for
use in the treatment of pulmonary
disease and diseases with allergic and/
or immunologic mechanisms and makes
appropriate recommendations to the
Commissioner of Food and Drugs.
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
pulmonary medicine, allergy, clinical
immunology, and epidemiology or
statistics. 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.
Further information regarding the
most recent charter and other
information can be found at https://
www.fda.gov/AdvisoryCommittees/
PO 00000
Frm 00072
Fmt 4703
Sfmt 4703
CommitteesMeetingMaterials/Drugs/
Pulmonary-AllergyDrugsAdvisory
Committee/ucm107567.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: June 1, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–12219 Filed 6–6–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–0478]
Sebela Ireland, Ltd. et al.; Withdrawal
of Approval of 24 Abbreviated New
Drug Applications; Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register on February 23, 2018. The
notice announced the voluntary
withdrawal of approval of 24
abbreviated new drug applications
(ANDAs) from multiple applicants,
effective March 26, 2018. The notice
indicated that FDA was withdrawing
approval of the following ANDA after
receiving a withdrawal request from
Sun Pharmaceutical Industries, Ltd., c/
o Sun Pharmaceutical Industries, Inc.
(Sun Pharmaceutical), 2 Independence
Way, Princeton, NJ 08540: ANDA
077483, Benazepril Hydrochloride and
Hydrochlorothiazide Tablets, 5
milligrams (mg)/6.25 mg, 10 mg/12.5
mg, 20 mg/12.5 mg, and 20 mg/25 mg.
Before withdrawal of this ANDA
became effective, however, Sun
SUMMARY:
E:\FR\FM\07JNN1.SGM
07JNN1
]]>Agencies
[Federal Register Volume 83, Number 110 (Thursday, June 7, 2018)]
[Notices]
[Page 26481]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12219]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-1860]
Advisory Committee; Pulmonary-Allergy Drugs 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 Pulmonary-Allergy 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 Pulmonary-
Allergy Drugs Advisory Committee for an additional 2 years beyond the
charter expiration date. The new charter will be in effect until May
30, 2020.
DATES: Authority for the Pulmonary-Allergy Drugs Advisory Committee
will expire on May 30, 2020, unless the Commissioner formally
determines that renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT: Cindy Chee, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002; 301-796-9001, email:
[email protected].
SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by
the Department of Health and Human Services pursuant to 45 CFR part 11
and by the General Services Administration, FDA is announcing the
renewal of the Pulmonary-Allergy 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 available data concerning the
safety and effectiveness of marketed and investigational human drug
products for use in the treatment of pulmonary disease and diseases
with allergic and/or immunologic mechanisms and makes appropriate
recommendations to the Commissioner of Food and Drugs.
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 pulmonary medicine, allergy, clinical immunology, and
epidemiology or statistics. 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.
Further information regarding the most recent charter and other
information can be found at https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Pulmonary-AllergyDrugsAdvisoryCommittee/ucm107567.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: June 1, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12219 Filed 6-6-18; 8:45 am]
BILLING CODE 4164-01-P
