[Federal Register Volume 81, Number 127 (Friday, July 1, 2016)]
[Notices]
[Pages 43207-43209]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-15662]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-N-2016-1493]


Erythropoietic Protoporphyria; Scientific Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
a public workshop and an opportunity for public comment on 
Erythropoietic Protoporphyria (EPP).

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The public workshop is intended to discuss how best to facilitate and 
expedite the development of safe and effective drug therapies to treat 
signs and symptoms related to EPP. FDA will provide information for, 
and gain perspective from, patients and patient advocacy organizations, 
health care providers, academic experts, and industry on disease 
symptoms and its impact on daily life, experience with current 
treatment regimens for EPP, and various aspects of clinical development 
of products intended to treat EPP. The input from this public workshop 
will help in developing topics for further discussion.

DATES: The public workshop will be held on October 24, 2016, from 10 
a.m. to 4 p.m. Submit electronic or written comments to the public 
docket by December 24, 2016. See the SUPPLEMENTARY INFORMATION section 
for registration date and information.

ADDRESSES: The workshop will be held at the FDA White Oak Campus, 10903 
New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 
1503), Silver Spring, MD 20993-0002. Participants must enter through 
Bldg. 1 and undergo security screening. For more information on parking 
and security procedures, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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-N-2016-1493. Received comments will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at http://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 http://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 http://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.
    FDA will post the agenda approximately 5 days before the workshop 
at: http://www.fda.gov/Drugs/NewsEvents/ucm501389.htm.

FOR FURTHER INFORMATION CONTACT: Meghana Chalasani, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 1146, Silver Spring, MD 20993-0002, 240-
402-6525, FAX: 301-847-8443, [email protected].

SUPPLEMENTARY INFORMATION:

I. Public Workshop Information

A. Purpose and Scope of the Workshop

    FDA is announcing a public workshop and an opportunity for public 
comment on Erythropoietic Protoporphyria (EPP). EPP is a group of 
genetic disorders that is characterized by photosensitivity that often 
manifests as severe pain, swelling and/or burning. Treatment for EPP 
focuses on minimizing sun exposure. Other treatments may include 
dietary management, over-the-counter and prescription sunscreen, and 
phototherapy. The purpose of the workshop is to discuss issues that may 
affect the development of products for the treatments of EPP, and to 
provide a scientific and technical forum to consider issues related to 
clinical trial designs (including eligible populations and trial 
feasibility) and clinical trial endpoints. FDA will provide information 
on current review considerations for new products in the United States, 
and gain perspective from patients and patient advocacy organizations, 
health care providers, academic experts, and industry on the most 
significant disease symptoms and its impact on daily life and 
experience with current treatment regimens for EPP. The input from this 
public workshop will help in developing topics for further discussion.

B. Workshop Attendance and Participation

    Registration: If you wish to attend this workshop, visit https://eppscientificworkshop.eventbrite.com. Please register by October 17, 
2016. If you are unable to attend the workshop in person, you can 
register to view a live Webcast of the workshop. You will be asked to

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indicate in your registration if you plan to attend in person or via 
the Webcast. Seating will be limited, so early registration is 
recommended. Registration is free and will be on a first-come, first-
served basis. However, FDA may limit the number of participants from 
each organization based on space limitations. Registrants will receive 
confirmation once they have been accepted. Onsite registration on the 
day of the workshop will be based on space availability. If you need 
special accommodations because of a disability, please contact Meghana 
Chalasani (see FOR FURTHER INFORMATION CONTACT) at least 7 days before 
the workshop.
    FDA will hold an open public comment period to give the public an 
opportunity to comment. Registration for open public comment will occur 
at the registration desk on the day of the workshop on a first-come, 
first-served basis.
    Docket Comments: Regardless of if you attend the public workshop, 
you can submit electronic or written responses for consideration to the 
public docket (see ADDRESSES) by December 24, 2016. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.
    Transcripts: As soon as a transcript is available, FDA will post it 
at http://www.fda.gov/Drugs/NewsEvents/ucm501389.htm.

    Dated: June 27, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-15662 Filed 6-30-16; 8:45 am]
 BILLING CODE 4164-01-P