Date: Time:

Center Date Time Location CDER December 7, 2017 8:00 a.m. to 5:00 p.m.

FDA White Oak Campus

10903 New Hampshire Avenue

Building 31 Conference Center

The Great Room (Rm. 1503)

Silver Spring, Maryland

Agenda

The committee will discuss appropriate patient selection criteria and clinical trial design features, including acceptable endpoints, for demonstrating clinical benefit for drugs intended to treat interstitial cystitis and bladder pain syndrome. The committee will also discuss whether bladder pain syndrome and interstitial cystitis reflect overlapping or different populations, and whether it is appropriate to assess efficacy in the same way for both conditions.

Meeting Materials

FDA intends to make background material available to the public no later than two (2) business days before the meeting. If FDA is unable to post the background material on its web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at: http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm

Public Participation Information

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

FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2017-N-4561. The docket will close on December 6, 2017. Submit either electronic or written comments on this public meeting by that date. Late, untimely filed comments will not be considered. Electronic comments must be submitted on or before December 6, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of December 6, 2017. 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 November 22, 2017, will be provided to the committee. Comments received after that date but by December 6, 2017 will be taken into consideration by the Agency.

Interested persons may submit either electronic or written comments regarding this meeting. 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): 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 Dockets Management, 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-2017-N-4561 for “Bone, Reproductive and Urologic Drugs Advisory Committee; Notice of Meeting; Request for Comments.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

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.” The Agency 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 Division of Dockets Management. If you do not wish your name and contact information to 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 this 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

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 Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

Oral presentations from the public will be scheduled between approximately 1:00 p.m. and 2:00 p.m. on December 7, 2017. 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 November 14, 2017.

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 November 15, 2017.

Webcast Information

CDER plans to provide a free of charge, live webcast of the December 7, 2017 Bone, Reproductive and Urologic Drugs Advisory Committee meeting. While CDER is making a webcast available to the public for this meeting, there are instances where the webcast transmission is not successful; staff will work to re-establish the transmission as soon as possible. Further information regarding the webcast, including the web address for the webcast, will be made available at least 2 days in advance of the meeting at the following website: http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm

Contact Information

Kalyani Bhatt

Center for Drug Evaluation and Research

Food and Drug Administration

10903 New Hampshire Avenue

WO31-2417

Silver Spring, MD 20993-0002



Phone: 301-796-9001

Fax: 301-847-8533

E-mail: BRUDAC@fda.hhs.gov

FDA Advisory Committee Information Line

1-800-741-8138

(301-443-0572 in the Washington DC area)- follow the prompts to the desired center or product area

Please call the Information Line for up-to-date information on this meeting.

A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s web site and call the FDA Advisory Committee Information Line to learn about possible modifications before coming to the meeting.

Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Kalyani Bhatt at (301) 796-9001 at least seven (7) days in advance of the meeting.

Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: Common Questions and Answers about FDA Advisory Committee Meetings.

FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website at Public Conduct During FDA Advisory Committee Meetings for procedures on public conduct during advisory committee meetings.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app.2).