- November 8, 2022
10:00 a.m. – 4:30 p.m. ET
The end time of the November 8, 2022 meeting has been changed to 4:30 p.m. ET.
All other information remains the same.
|CDER||Please note that due to the impact of this COVID-19 pandemic, all meeting participants will join this Advisory Committee meeting via an online teleconference platform|
Presentations from the meeting will be listened to, viewed, captioned and recorded via an online teleconferencing platform. The committee will discuss new drug application 214070, for a fixed dose combination of budesonide and albuterol sulfate metered dose inhaler, submitted by AstraZeneca and Bond Avillion 2 Development LP. The proposed indication is the treatment as needed or the prevention of bronchoconstriction and the prevention of exacerbations in asthmatic patients aged 4 years and older.
FDA intends to make the background materials, pre-recorded presentations, and link to the live webcast available to the public no later than two (2) business days prior to the meeting in the Materials section of the event. of this webpage. Pre-recorded presentations will be viewed by the committee prior to the meeting and will not be replayed on the day of the meeting. If FDA is unable to post the background materials and/or pre-recorded presentations on its website prior to the meeting, the background materials and/or pre-recorded presentations will be made publicly available on the website. of the FDA at the time of the advisory committee meeting. . The meeting will include brief summaries of the pre-recorded presentations. Pre-recorded presentations and brief summaries will include slide presentations with audio components to enable presentation of materials in a manner that most closely resembles an in-person advisory committee meeting.
Information on public participation
Interested persons may submit data, information or opinions, orally or in writing, on matters pending before the committee.
The FDA is compiling a public comment package on this meeting. The file number is FDA-2022-N-1946. The case will close on November 7, 2022. Submit electronic or written comments on this public meeting by November 7, 2022. Please note that comments submitted late and after the deadline will not be considered. Electronic comments must be submitted no later than November 7, 2022. The electronic filing system https://www.regulations.gov will accept comments until 11:59 p.m. Eastern Time at the end of November 7. 2022. Comments received by courier/hand delivery/courier (for written/paper submissions) will be considered timely if postmarked or delivery service acceptance receipt is no later than this date.
Comments received by October 25, 2022 will be provided to the committee. Comments received after this date but before November 7, 2022 will be considered by the FDA. In the event that the meeting is canceled, FDA will continue to evaluate all relevant requests or information and consider comments submitted on the record, as appropriate. You can submit comments as follows:
Submit electronic comments as follows:
- Federal Online Rulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted on file without modification. Since your comment will be made public, you are solely responsible for ensuring that your comment does not contain any confidential information that you or a third party would not wish to be published, such as medical information, your social security number or that of someone else. another, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.
- If you wish to submit a comment containing confidential information that you do not wish to make available to the public, submit the comment in the form of a written/hard copy submission and in detail (see “Written/hard copy submissions” and “Instructions”).
Submit written/paper submissions as follows:
- Mail/hand delivery/courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
- For written/paper comments submitted to the Division of Records Management, FDA will release your comment, along with any attachments, except information submitted, marked and identified as confidential, if submitted as set forth in the instructions “.
Instructions: All submissions received must include the file number. FDA-2022-N-1946 for “Pulmonary Allergy Drug Advisory Committee”; Notice of Meeting ; Establishment of a public role; Request for Comments.” Comments received, those filed in a timely manner, will be placed on file and, except for those submitted as “Confidential Submissions”, publicly viewable at https://www.regulations.gov or to Case Management staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
- Confidential Submissions–To submit a comment containing confidential information that you do not wish to be made public, submit your comments only as a written/hard copy submission. You must submit two copies in total. A copy will include the information you claim to be confidential with a title or cover note stating “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION”. The FDA will consider this copy, including the claimed confidential information, when considering comments. The second copy, in which the claimed confidential information will be redacted/blacked out, will be available for public viewing and posted at https://www.regulations.gov. Submit both copies to records management staff. If you do not want your name and contact information made public, you may provide this information on the cover page and not in the body of your comments and you must identify the information as “confidential”. Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure laws. For more information on the publication of comments by the FDA in public records, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015 -09-18/pdf/2015-23389.pdf.
Role: To access the file to read reference materials or electronic and written/paper comments received, go to https://www.regulations.gov and insert the file number, found in parentheses in the header of this document, in the” and follow the prompts and/or contact Records Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.
Public oral presentations will take place between approximately 1:00 p.m. and 2:00 p.m. Eastern Time. Persons interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or argument they wish to present, the names and addresses of the proposed participants, and a indication of the approximate time required to make their presentation no later than October 17, 2022.
The time allotted to each presentation may be limited. If the number of registrants requesting to speak is greater than can reasonably be accommodated at the scheduled open public hearing session, FDA may conduct a lottery to determine speakers for the scheduled open public hearing session. The resource person will inform interested persons of their request to speak by October 18, 2022.
CDER plans to provide a free, live webcast of the November 8, 2022 meeting of the Pulmonary Allergy Drug Advisory Committee. If there are instances where the webcast transmission is not successful, the staff will endeavor to restore the transmission as soon as possible. Further information regarding the webcast, including the webcast web address, will be made available no later than two (2) business days prior to the meeting in the Event Materials section of this web page.
CDER plans to post archived webcasts after the meeting, however, in cases where transmission was not successful, archived webcasts will not be available.
- FDA Advisory Committee Information Line
(301-443-0572 in the Washington DC area)
Please call the information line for up-to-date information on this meeting.
A notice in the Federal Register of last-minute changes that impact a previously announced advisory committee meeting may not always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s website or call the committee’s Designated Federal Officer (see Contact Information) for possible changes before coming to the meeting.
People attending FDA advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. The FDA welcomes public participation in its advisory committee meetings and will make every effort to accommodate people with disabilities. If you require accommodations due to a disability, please contact the Committee’s Designated Federal Officer (see Contact Information) at least 7 days prior to the meeting.
Answers to frequently asked questions, including information regarding special accommodations due to disability, can be found at: Common Questions and Answers About FDA Advisory Committee Meetings.
The FDA is committed to ensuring the smooth running of its advisory committee meetings. Please visit our website at Public Conduct During FDA Advisory Committee Meetings for procedures regarding public conduct during advisory committee meetings.
Notice of this meeting is given pursuant to the Federal Advisory Committee Act (5 USC app.2).