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How You Can Participate in the Ataluren Ad Comm

The Duchenne community is now preparing for the September 28 Advisory Committee Meeting for PTC’s therapy ataluren. Whether submitting written testimony and/or attending the Ad Comm in person, there are multiple ways for Duchenne community members in the U.S. and abroad to have an impact and share your personal experience with the Advisory Committee reviewing this product.

Details

 

  • Contact Person
    • Moon Hee V. Choi, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, rm. 2417, Silver Spring, MD 20993-0002
    • Phone: 301-796-9001
    • FAX: 301-847-8533
    • Email: PCNS@fda.hhs.gov
    • FDA Advisory Committee Information Line: 1-800-741-8138 (301-443-0572 in the Washington, DC area).

How to Request to Speak at Ad Comm

  • We are working to organize our public testimony in order to avoid requiring the FDA to implement a 'lottery system' for the open public hearing. For those interested in collaborating to ensure messages are not duplicated and are most impactful please considering contacting us to speak about the Open public hearing.
  • Those individuals interested in making formal oral presentations should notify the contact person (Moon Hee V. Choi) 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 September 6, 2017.
  • Oral presentations from the public will be scheduled between approximately 1:15 p.m. and 2:15 p.m. 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 September 7, 2017.
  • For those community members planning on participating in the Open Public Hearing, please contact Ryan Fischer at ryan@parentprojectmd.org to learn more about available travel support.
  • If you require accessible accommodations while attending this meeting, contact Moon Hee V. Choi prior to September 21, 2017.

How to Submit Written Testimony 

  • Written submissions may be submitted to the docket either electronically or by mail on or before September 27, 2017. Comments submitted to the docket by September 14 will be shared with the Advisory Committee, after that comments will be considered by the Agency.
  • Everyone has a chance to participate in Ad Comm via a written testimony. That includes those chosen to speak during the OPH. Click here for more details and guidance on writing testimonies.
  • To submit Written Testimony Electronically (encouraged):
    • Submit using FDA’s electronic filing system. Comments will be accepted until 12 midnight eastern at the end of September 27 (note that comments received by September 14 will be shared with the Committee; those submitted between September 15 and September 17 will be considered by the Agency)
    • 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 wish for your comment to remain confidential, you must submit it by mail.
    • All submissions received must include the Docket No. FDA-2017-N-4835 for “Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments.” 
  • To submit written Testimony by Mail/ Hand Delivery/ Courier:
    • Address to: 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.”
    • All submissions received must include the Docket No. FDA-2017-N-4835 for “Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments.” 
  • 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 Dockets Management Staff. 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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
  • Please also consider emailing your written submission (whether electronic or mailed) to ryan@parentprojectmd.org -- we are compiling all submissions into a printed piece to submit to the FDA. 

How to Access Background Materials

  • FDA intends to make background material available to the public no later than 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. Scroll down to the appropriate advisory committee meeting link.

Learn more

For more information about the FDA Ad Comms, please visit the links and resources that we at PPMD have compiled with the assistance of our community members, regulatory advisors, and federal agency partners:

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