Notice2022-22700
Pulmonary-Allergy Drugs Advisory Committee; Amendment of Notice
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
October 19, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Pulmonary-Allergy Drugs Advisory Committee. This meeting was announced in the Federal Register of September 8, 2022. The amendment is being made to reflect changes in the DATES, ADDRESSES, and SUPPLEMENTARY INFORMATION portions of the document. The meeting was rescheduled to allow time for FDA to review new information submitted to the application. There are no other changes.
Full Text
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<title>Federal Register, Volume 87 Issue 201 (Wednesday, October 19, 2022)</title>
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[Federal Register Volume 87, Number 201 (Wednesday, October 19, 2022)]
[Notices]
[Pages 63500-63501]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-22700]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-2107]
Pulmonary-Allergy Drugs Advisory Committee; Amendment of Notice
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing an
amendment to the notice of meeting of the Pulmonary-Allergy Drugs
Advisory Committee. This meeting was announced in the Federal Register
of September 8, 2022. The amendment is being made to reflect changes in
the DATES, ADDRESSES, and SUPPLEMENTARY INFORMATION portions of the
document. The meeting was rescheduled to allow time for FDA to review
new information submitted to the application. There are no other
changes.
FOR FURTHER INFORMATION CONTACT: Takyiah Stevenson, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 240-
402-2507, email: <a href="/cdn-cgi/l/email-protection#b5e5f4f1f4f6f5d3d1d49bddddc69bd2dac3"><span class="__cf_email__" data-cfemail="4b1b0a0f0a080b2d2f2a65232338652c243d">[email protected]</span></a>, or FDA Advisory Committee
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC
area). Please call the Information Line for up-to-date information on
this meeting.
SUPPLEMENTARY INFORMATION: In the Federal Register of September 8,
2022, 87 FR 55008, FDA announced that a meeting of the Pulmonary-
Allergy Drugs Advisory Committee would be held on October 6, 2022. The
following changes are being made.
(1) On page 55008, in the third column, the DATES portion of the
document is changed to read as follows:
DATES: The meeting will be held virtually on November 9, 2022, from
9 a.m. to 5 p.m. Eastern Time.
(2) On page 55008, in the third column, the second paragraph and
the first sentence of the third paragraph of the ADDRESSES portion of
the document are changed to read as follows:
FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2022-N-2107. Please note that late, untimely
filed comments will not be considered. The docket will close on
November 8, 2022. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing
system will accept comments until 11:59 p.m. Eastern Time at the end of
November 8, 2022.
[[Page 63501]]
Comments received by mail/hand delivery/courier (for written/paper
submissions) will be considered timely if they are received on or
before that date.
Comments received on or before October 26, 2022, will be provided
to the committee.
(3) On page 55009, in the third column, the first paragraph of the
Procedure section of the SUPPLEMENTARY INFORMATION portion of the
document is changed to read as follows:
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
All electronic and written submissions submitted to the Docket (see
ADDRESSES) on or before October 26, 2022, will be provided to the
committee. Oral presentations from the public will be scheduled between
approximately 1:30 p.m. and 2:30 p.m. Eastern Time. Those individuals
interested in making formal oral presentations should notify the
contact person and submit a brief statement of the general nature of
the evidence or arguments they wish to present, the names and addresses
of proposed participants, and an indication of the approximate time
requested to make their presentation on or before October 26, 2022.
Time allotted for each presentation may be limited. If the number of
registrants requesting to speak is greater than can be reasonably
accommodated during the scheduled open public hearing session, FDA may
conduct a lottery to determine the speakers for the scheduled open
public hearing session. The contact person will notify interested
persons regarding their request to speak by October 27, 2022.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.
Dated: October 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-22700 Filed 10-18-22; 8:45 am]
BILLING CODE 4164-01-P
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