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UPDATED INFORMATION (as of October 19, 2022):

The start time for October 19, 2022 (Day 3) has changed to 8:30 a.m. Eastern Time.

All other information remains the same.

UPDATED INFORMATION (as of October 16, 2022):

The start time for October 18, 2022 (Day 2) has changed to 8:20 a.m. Eastern Time.

All other information remains the same.

UPDATED INFORMATION (as of August 29, 2022):

Public Participation Information:
The deadline for submitting requests to make a formal presentation or present oral comments during the session for public participation has been extended to September 14, 2022.

Oral presentations from the public will be scheduled between approximately 2 p.m. to 4 p.m. Eastern Time on the first day of the hearing and from 8 a.m. to 10 a.m. on the second day. Persons interested in participating in the hearing by making an oral presentation during the 4 hours currently reserved for such presentations must submit requests by 11:59 p.m. Eastern Time on September 14, 2022, as further described below.

If you wish to make a formal presentation or present oral comments during the session for public participation, you must register at the following link by 5 p.m. Eastern Time on September 14, 2022: https://www.surveymonkey.com/r/B72THCF. When registering, please provide complete contact information, including name, title, affiliation, address, email, and telephone number. To complete your request for an opportunity to make a presentation at the hearing, you must also submit a comment to the docket for this hearing matter (see ADDRESSES) by 11:59 p.m. Eastern Time on September 14, 2022, and clearly indicate in the heading and/or cover page that your comment is a “Request for Oral Presentation.”

In the “Request for Oral Presentation” submitted to the public docket, you must identify yourself and others who will join you for your presentation, list the affiliation (if any) of each individual participating in your presentation (including your own), and request a specific amount of time for your presentation. You must also include a summary of what you plan to present at the hearing and a copy of any slide deck, along with any data or information on which you intend to rely at the hearing that is not already referenced or included in the public docket for this hearing matter. No commercial or promotional material will be permitted to be presented or distributed at the public hearing.

We urge organizations with common interests to consolidate or coordinate their presentations. In accordance with 21 CFR 15.21(c), the presiding officer may require joint presentations by persons with common interests.

The presiding officer will determine the amount of time allotted to each presenter and the approximate time each presentation is to begin and will select and notify participants by September 30, 2022. If you are notified that you will be a presenter, we encourage you to be online well in advance of the approximate time provided in the notice. Actual presentation times may vary based on how the hearing progresses.

All other information remains the same.

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ORIGINAL INFORMATION:

Agenda

The presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. The Office of the Commissioner is conducting a hearing under 21 CFR 314.530 on the Center of Drug Evaluation and Research's proposal to withdraw accelerated approval of Makena (hydroxyprogesterone caproate injection, 250 milligrams (mg) per milliliter (mL)). As part of the hearing process, the Obstetrics, Reproductive and Urologic Drugs Advisory Committee (the Committee) will discuss whether a confirmatory trial verified the clinical benefit of Makena and whether available evidence demonstrates that Makena is effective for its approved indication, which is to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. The Committee will also discuss whether FDA should allow Makena to remain on the market while an appropriate confirmatory study is designed and conducted.

Meeting Materials

FDA intends to make background material and the link to the live webcast available to the public no later than two (2) business days before the hearing in the Event Materials section of this web page. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available on FDA’s website at the time of the hearing. The hearing will include slide presentations with audio components to allow the presentation of materials in a manner that most closely resembles an in-person 21 CFR Part 15 hearing.

Public Participation Information

Interested persons may present data, information, or views, orally or in writing, on issues pending before the presiding officer and the committee.

FDA established a docket for public comment on this meeting. The docket number is FDA-2020-N-2029. The docket will close on November 3, 2022. Submit either electronic or written comments on this public meeting by November 3, 2022. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted by November 3, 2022. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of November 3, 2022. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

Comments received on or before October 11, 2022 will be provided to the presiding officer and the committee. In the event that the hearing is cancelled, FDA will continue to evaluate any relevant applications or information, and consider any comments submitted to the docket, as appropriate. You may submit comments as follows:

Electronic Submissions

Submit electronic comments in the following way:

• Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, 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 want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions

Submit written/paper submissions as follows:

• Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.


• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

Instructions: All submissions received must include the Docket No. FDA-2020-N-2029 for “Proposal to Withdraw Marketing Approval; Hearing.” Received comments, those filed in a timely manner, will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.

• Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” FDA will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information be made publicly available, you can provide this information on the cover sheet 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 law. For more information about FDA’s posting of comments to public dockets, 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.

Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.

Oral presentations from the public will be scheduled between approximately 2 p.m. to 4 p.m. Eastern Time on the first day of the hearing and from 8 a.m. to 10 a.m. on the second day. Persons interested in participating in the hearing by making an oral presentation during the 4 hours currently reserved for such presentations must submit requests by 11:59 p.m. Eastern Time on September 6, 2022, as further described below.

If you wish to make a formal presentation or present oral comments during the session for public participation, you must register at the following link by 5 p.m. Eastern Time on September 6, 2022: https://www.surveymonkey.com/r/B72THCF. When registering, please provide complete contact information, including name, title, affiliation, address, email, and telephone number. To complete your request for an opportunity to make a presentation at the hearing, you must also submit a comment to the docket for this hearing matter (see ADDRESSES) by 11:59 p.m. Eastern Time on September 6, 2022, and clearly indicate in the heading and/or cover page that your comment is a “Request for Oral Presentation.”

In the “Request for Oral Presentation” submitted to the public docket, you must identify yourself and others who will join you for your presentation, list the affiliation (if any) of each individual participating in your presentation (including your own), and request a specific amount of time for your presentation. You must also include a summary of what you plan to present at the hearing and a copy of any slide deck, along with any data or information on which you intend to rely at the hearing that is not already referenced or included in the public docket for this hearing matter. No commercial or promotional material will be permitted to be presented or distributed at the public hearing.

We urge organizations with common interests to consolidate or coordinate their presentations. In accordance with 21 CFR 15.21(c), the presiding officer may require joint presentations by persons with common interests.

The presiding officer will determine the amount of time allotted to each presenter and the approximate time each presentation is to begin and will select and notify participants by September 30, 2022. If you are notified that you will be a presenter, we encourage you to be online well in advance of the approximate time provided in the notice. Actual presentation times may vary based on how the hearing progresses.

Webcast Information

Persons wishing to view the hearing may access the webcast at the following separate links on the respective days of the hearing:
Day 1: https://youtu.be/EEm7pM_LgsM
Day 2: https://youtu.be/Nt2bcDVgpag
Day 3: https://youtu.be/Dal27hktzcg

If there are instances where the webcast transmission is not successful, staff will work to re-establish the transmission as soon as possible. CDER plans to post archived webcasts after the meeting, however, in cases where transmission was not successful, archived webcasts will not be available.

Contact Information

• Rachael Vieder Linowes
  Office of Scientific Integrity
  Food and Drug Administration
  10903 New Hampshire Avenue
  WO1-4206
  Silver Spring, MD 20993-0002
  
  Phone: 240-402-5931
  
  Email: [email protected]

• 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 hearing.

• For press inquiries:
  • Office of the Commissioner: Shannon Hatch – email: [email protected] or (202) 510-1973
  • Center for Drug Evaluation and Research: April Grant – email: [email protected] or (202) 657-8179