Erythropoietic Protoporphyria; Scientific Workshop, 43207-43209 [2016-15662]
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asabaliauskas on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Notices
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: https://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.
Submit written requests for single
copies of the guidance to the Office of
Communication, Outreach and
Development, Center for Biologics
Evaluation and Research (CBER), Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist the office in processing your
requests. The guidance may also be
obtained by mail by calling CBER at 1–
800–835–4709 or 240–402–8010. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
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Jkt 238001
FOR FURTHER INFORMATION CONTACT:
Jessica T. Walker, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a document entitled ‘‘Early Clinical
Trials With Live Biotherapeutic
Products: Chemistry, Manufacturing,
and Control Information; Guidance for
Industry.’’ The guidance provides IND
sponsors with recommendations
regarding IND submissions for early
clinical trials for LBPs in the United
States, including LBPs lawfully
marketed as conventional foods and
dietary supplements in the United
States and proposed for clinical uses
regulated under section 351 of the
Public Health Service (PHS) Act (42
U.S.C. 262). The guidance focuses on
the CMC information that should be
provided in an IND for early clinical
trials evaluating LBPs. The guidance is
applicable to INDs of LBPs, whether
clinical trials are conducted
commercially, in an academic setting, or
otherwise under part 312 (21 CFR part
312).
In the Federal Register of February
21, 2012 (77 FR 9947), FDA announced
the availability of the final guidance of
the same title dated February 2012. In
the Federal Register of March 31, 2015
(80 FR 17050), FDA published a notice
requesting additional comments on the
CMC information that a sponsor of an
IND should provide in its IND in order
to meet regulatory requirements when
commercially available conventional
foods or dietary supplements containing
LBPs are used as investigational new
drugs in early phase clinical trials. FDA
received a few comments on the notice
and in response to the comments, FDA
is updating the February 2012 guidance
by adding a section to address when the
label on commercially available
products will be considered adequate to
satisfy the purpose of the CMC
requirements for INDs under
§ 312.23(a)(7)(iv)(a)–(b). In addition,
editorial changes were made to improve
clarity. The guidance announced in this
notice updates the guidance of the same
title dated February 2012.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
FDA is issuing this guidance for
immediate implementation in
accordance with 21 CFR 10.115(g)(2)
without seeking additional comments
after determining that prior public
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43207
participation is not feasible or
appropriate. FDA notes that we already
sought comments on the issues
addressed by the revisions in this
guidance in the Federal Register of
March 31, 2015 under Docket No. FDA–
2010–D–0500. Further delay in
implementing these revisions could
impede the progress of certain
investigations of drug use of
commercially marketed foods or dietary
supplements that are of low risk and
may be of benefit to the public health.
The guidance represents the current
thinking of FDA on ‘‘Early Clinical
Trials with Live Biotherapeutic
Products: Chemistry, Manufacturing,
and Control Information.’’ It does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
The guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
part 312 have been approved under
OMB control number 0910–0014.
III. Electronic Access
Persons with access to the Internet
may obtain the guidance at either https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm or
https://www.regulations.gov.
Dated: June 27, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–15664 Filed 6–30–16; 8:45 am]
BILLING CODE 4164–01–P
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.
Notice of public workshop;
request for comments.
ACTION:
The Food and Drug
Administration (FDA or Agency) is
announcing a public workshop and an
opportunity for public comment on
Erythropoietic Protoporphyria (EPP).
SUMMARY:
E:\FR\FM\01JYN1.SGM
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43208
Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Notices
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.
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
https://www.fda.gov/AboutFDA/Working
atFDA/BuildingsandFacilities/White
OakCampusInformation/
ucm241740.htm.
You may submit comments as
follows:
asabaliauskas on DSK3SPTVN1PROD with NOTICES
DATES:
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
VerDate Sep<11>2014
19:05 Jun 30, 2016
Jkt 238001
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
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: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
PO 00000
Frm 00027
Fmt 4703
Sfmt 4703
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.
FDA will post the agenda
approximately 5 days before the
workshop at: https://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,
Meghana.Chalasani@fda.hhs.gov.
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://eppscientific
workshop.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
E:\FR\FM\01JYN1.SGM
01JYN1
Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Notices
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 firstcome, 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 https://
www.regulations.gov.
Transcripts: As soon as a transcript is
available, FDA will post it at https://
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2007–D–0369]
Bioequivalence Recommendations for
Paliperidone Palmitate; Draft Guidance
for Industry; Availability
Food and Drug Administration,
asabaliauskas on DSK3SPTVN1PROD with NOTICES
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA) is announcing the
availability of a revised draft guidance
for industry on generic paliperidone
palmitate extended-release injectable
suspension, entitled ‘‘Draft Guidance on
Paliperidone Palmitate.’’ The
recommendations provide specific
SUMMARY:
VerDate Sep<11>2014
19:05 Jun 30, 2016
Jkt 238001
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
Food and Drug Administration
AGENCY:
guidance on the design of
bioequivalence (BE) studies to support
abbreviated new drug applications
(ANDAs) for paliperidone palmitate
extended-release injectable suspension.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by September 6,
2016.
ADDRESSES: You may submit comments
as follows:
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–
2007–D–0369 for ‘‘Draft Guidance on
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
43209
Paliperidone Palmitate.’’ 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: https://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.
Submit written requests for single
copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
E:\FR\FM\01JYN1.SGM
01JYN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
a public workshop and an opportunity for public comment on
Erythropoietic Protoporphyria (EPP).
[[Page 43208]]
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 https://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: 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-N-2016-1493. 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: https://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.
FDA will post the agenda approximately 5 days before the workshop
at: https://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, Meghana.Chalasani@fda.hhs.gov.
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
[[Page 43209]]
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 https://www.regulations.gov.
Transcripts: As soon as a transcript is available, FDA will post it
at https://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
