Document ID: FDA-2022-N-2107-0063
Agency: fda
Document Type: Notice
Title: Pulmonary-Allergy Drugs Advisory Committee; Amendment of Notice
Posted Date: 2022-10-19T04:00Z

[Federal Register Volume 87, Number 201 (Wednesday, October 19, 2022)]
[Notices]
[Pages 63500-63501]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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: [email protected], 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 https://www.regulations.gov 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]
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