Human Dermal (Skin) Safety Testing for Topical Drug Products: Regulatory Utility and Evaluation; Public Workshop; Request for Comments, 39761-39763 [2018-17130]
Download as PDF
<![CDATA[
39761
Federal Register / Vol. 83, No. 155 / Friday, August 10, 2018 / Notices
Desk Officer for the Administration for
Children and Families.
Emily B. Jabbour,
ACF/OPRE Certifying Officer.
[FR Doc. 2018–17121 Filed 8–9–18; 8:45 am]
BILLING CODE 4184–74–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Proposed Projects
Title: Supplemental Nutrition
Assistance Program (SNAP) Matching
Program Performance Outcomes.
OMB No. 0970–0464.
Description: State agencies
administering the Supplemental
Nutrition Assistance Program (SNAP)
are mandated to participate in a
computer matching program with the
federal Office of Child Support
Enforcement (OCSE). The matching
program compares SNAP applicant and
recipient information with employment
and wage information maintained in the
National Directory of New Hires
(NDNH). The outcomes of the compared
information help state SNAP agencies
with administering the program and
verifying and determining an
individual’s benefit eligibility. To
receive NDNH information, state
agencies enter into a computer matching
agreement and adhere to its terms and
conditions, including providing OCSE
with annual performance outcomes
attributable to the use of NDNH
information.
The Office of Management and Budget
(OMB) requires OCSE to periodically
report performance measurements
demonstrating how the use of
information in the NDNH supports
OCSE’s strategic mission, goals, and
objectives. OCSE will provide the
annual SNAP performance outcomes to
OMB.
The information collection activities
for the SNAP performance outcomes
reports are authorized by: (1) Subsection
453(j)(10) of the Social Security Act (42
U.S.C. 653(j)(10)), which allows the
Secretary of the U.S. Department of
Health and Human Services to disclose
information maintained in the NDNH to
state agencies administering SNAP
under the Nutrition Act of 2008, as
amended by the Agriculture Act of
2014; (2) the Privacy Act of 1974, as
amended by the Computer Matching
and Privacy Protection Act of 1988 (5
U.S.C. 552a), which sets forth the terms
and conditions of a computer matching
program; and, (3) the Government
Performance and Results Modernization
Act of 2010 (Pub. L. 111–352), which
requires agencies to report program
performance outcomes to the Office of
Management and Budget and for the
reports to be available to the public.
Respondents: State SNAP Agencies.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total
burden hours
SNAP Matching Program Performance Outcomes .........................................
daltland on DSKBBV9HB2PROD with NOTICES
Information collection title
53
1
1.92
101.76
Estimated Total Annual Burden
Hours: 101.76.
Additional Information: Copies of the
proposed collection may be obtained by
writing to The Administration for
Children and Families, Office of
Information Services, 330 C Street SW,
Washington, DC 20447, Attn: ACF
Reports Clearance Officer.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Email: OIRA_
SUBMISSION@OMB.EOP.GOV, Attn:
Desk Officer for the Administration for
Children and Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2018–17152 Filed 8–9–18; 8:45 am]
BILLING CODE 4184–41–P
VerDate Sep<11>2014
19:03 Aug 09, 2018
Jkt 244001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–2582]
Human Dermal (Skin) Safety Testing
for Topical Drug Products: Regulatory
Utility and Evaluation; Public
Workshop; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public workshop;
request for comments.
ACTION:
The Food and Drug
Administration (FDA, Agency, or we) is
announcing the following 1-day public
workshop entitled ‘‘Human Dermal
(Skin) Safety Testing for Topical Drug
Products: Regulatory Utility and
Evaluation.’’ The purpose of the public
workshop is to provide a forum to
discuss the current state and future
directions of the collection of human
data on the potential skin toxicity with
the use of medications applied
topically. The workshop will review
current approaches to the collection of
human data during the clinical
development of topical drug products.
The workshop will also address the
SUMMARY:
PO 00000
Frm 00105
Fmt 4703
Sfmt 4703
impact of human skin toxicity studies
on drug labeling and consider
alternative approaches to providing
information about skin toxicity.
DATES: The public workshop will be
held on September 10, 2018, from 8:30
a.m. to 4 p.m. Eastern Time. Submit
either electronic or written comments
on this public workshop by October 10,
2018. See the SUPPLEMENTARY
INFORMATION section for registration date
and information.
ADDRESSES: The public workshop will
be held at the FDA White Oak Campus,
10903 New Hampshire Ave., Building
31 Conference Center, the Great Room
(Rm. 1503, Section A), Silver Spring,
MD 20993–0002. Entrance for the public
workshop participants (non-FDA
employees) is through Building 1, where
routine security check procedures will
be performed. For parking and security
information, please refer to https://
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
You may submit comments as
follows. Please note that late, untimely
filed comments will not be considered.
Electronic comments must be submitted
on or before October 10, 2018. The
E:\FR\FM\10AUN1.SGM
10AUN1
39762
Federal Register / Vol. 83, No. 155 / Friday, August 10, 2018 / Notices
https://www.regulations.gov electronic
filing system will accept comments
until midnight Eastern Time at the end
of October 10, 2018. 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.
daltland on DSKBBV9HB2PROD with NOTICES
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–
2018–N–2582 for ‘‘Human Dermal
(Skin) Safety Testing for Topical Drug
Products: Regulatory Utility and
Evaluation; Public Workshop; Request
for Comments.’’ Received comments,
those filed in a timely manner (see
ADDRESSES), will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
VerDate Sep<11>2014
19:03 Aug 09, 2018
Jkt 244001
viewable at https://www.regulations.gov
or at the Dockets Management Staff
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 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/201523389.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.
FOR FURTHER INFORMATION CONTACT:
Tisha Washington, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993–0002, 301–796–1019,
tisha.washington@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing a public
workshop entitled ‘‘Human Dermal
(Skin) Safety Testing for Topical Drug
Products: Regulatory Utility and
Evaluation’’ to discuss the current state
and future directions of the collection of
human data on the potential skin risks
PO 00000
Frm 00106
Fmt 4703
Sfmt 4703
from use of topical drug products,
including irritancy, sensitization,
phototoxicity, and photoallergenicity.
II. Topics for Discussion at the Public
Workshop
The morning session of the workshop
will focus on review and discussion of
current approaches for the collection of
human skin toxicity data, limitations of
these approaches, and their impact on
labeling of topical drug products. The
afternoon session of the workshop will
be a panel discussion by individuals
with different perspectives about
alternative approaches to provide
information about skin toxicity. Thirty
minutes of the afternoon session will be
allocated to an open public hearing. The
Agency encourages health care
providers, industry representatives, and
other interested persons to attend this
public workshop.
III. Participating in the Public
Workshop
Registration: To register for the public
workshop, please visit the following
website by September 4, 2018: https://
www.eventbrite.com/e/fda-publicworkshop-human-dermal-safety-testingfor-topical-drug-products-tickets47483161414. Please provide complete
contact information for each attendee,
including name, title, affiliation,
address, email, and telephone, and
intended attendance method—in person
or by webcast. You may also indicate if
you wish to present at the public
comment session (see Requests for Oral
Presentations). For those unable to
attend in person, FDA will provide a
live webcast of the workshop.
Registration is free and based on
space availability, with priority given to
early registrants. Persons interested in
attending this public workshop must
register by 5 p.m. Eastern Time,
September 4, 2018. Early registration is
recommended because seating is
limited; therefore, FDA may limit the
number of participants from each
organization. Registrants will receive
confirmation when they have been
accepted. Seating will be available on a
first-come, first-served basis. If time and
space permit, onsite registration on the
day of the workshop will be provided
beginning at 8:15 a.m. Eastern Time;
FDA will let the public know whether
onsite registration is available before the
day of the public workshop.
An agenda for the workshop and any
other background materials will be
made available 5 days before the
workshop at https://www.fda.gov/
Drugs/NewsEvents/ucm611203.htm.
If you need special accommodations
due to a disability, please contact Tisha
E:\FR\FM\10AUN1.SGM
10AUN1
daltland on DSKBBV9HB2PROD with NOTICES
Federal Register / Vol. 83, No. 155 / Friday, August 10, 2018 / Notices
Washington, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–1019, tisha.washington@
fda.hhs.gov no later than September 4,
2018.
Requests for Oral Presentations:
During online registration you may
indicate if you wish to present at the
public comment session, and which
topic(s) you wish to address. We will do
our best to accommodate requests to
make public comments. Individuals and
organizations with common interests are
urged to consolidate or coordinate their
presentations, and request time for a
joint presentation. Following the close
of registration, we will determine the
amount of time allotted to each
presenter and the approximate time
each oral presentation is to begin, and
will select and notify participants by
September 5, 2018. All requests to make
oral presentations must be received by
the close of registration on September 4,
2018. If selected for presentation, any
presentation materials must be emailed
to Tisha Washington (see FOR FURTHER
INFORMATION CONTACT) no later than
close of business, September 6, 2018. No
commercial or promotional material
will be permitted to be presented or
distributed at the public workshop.
Streaming Webcast of the Public
Workshop: This public workshop will
also be webcast. The webcast link will
be available on the following web page
5 days before the workshop at: https://
www.fda.gov/Drugs/NewsEvents/
ucm611203.htm.
If you have never attended a Connect
Pro event before, test your connection at
https://collaboration.fda.gov/common/
help/en/support/meeting_test.htm. To
get a quick overview of the Connect Pro
program, visit https://www.adobe.com/
go/connectpro_overview. FDA has
verified the website addresses in this
document, as of the date this document
publishes in the Federal Register, but
websites are subject to change over time.
Transcripts: Please be advised that as
soon as a transcript of the public
workshop is available, it will be
accessible at https://
www.regulations.gov. It may be viewed
at the Dockets Management Staff (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852. A link to the transcript will
also be available on the internet at
https://www.fda.gov/Drugs/NewsEvents/
ucm611203.htm.
VerDate Sep<11>2014
19:03 Aug 09, 2018
Jkt 244001
Dated: August 6, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–17130 Filed 8–9–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
HHS Approval of Entities That Certify
Medical Review Officers
Substance Abuse and Mental
Health Services Administration, HHS.
ACTION: Notice.
AGENCY:
This notice publishes a list of
the Department of Health and Human
Services (HHS) approved Medical
Review Officers certification entities.
The HHS Mandatory Guidelines for
Federal Workplace Drug Testing
Programs (Mandatory Guidelines),
applicable on October 1, 2017,
addresses the role and qualifications of
Medical Review Officers (MROs) and
HHS approval of entities that certify
MROs.
FOR FURTHER INFORMATION CONTACT:
Sean J. Belouin, Pharm.D., CAPT,
United States Public Health Service,
Senior Pharmacology and Regulatory
Policy Advisor, Substance Abuse and
Mental Health Services Administration,
5600 Fishers Lane, Room 16N06D,
Rockville, Maryland 20857; Telephone:
(240) 276–2716; Email: sean.belouin@
samhsa.hhs.gov.
SUPPLEMENTARY INFORMATION: Subpart
M—Medical Review Officer (MRO),
Section 13.2 of the Mandatory
Guidelines, ‘‘How are nationally
recognized entities or subspecialty
boards that certify MROs approved?’’
states as follows: ‘‘All nationally
recognized entities or subspecialty
boards which seek approval by the
Secretary to certify physicians as MROs
for federal workplace drug testing
programs must submit their
qualifications, a sample examination,
and other necessary supporting
examination materials (e.g., answers,
previous examination statistics or other
background examination information, if
requested) (OMB Control No.: 0930–
0158). Approval will be based on an
objective review of qualifications that
include a copy of the MRO applicant
application form, documentation that
the continuing education courses are
accredited by a professional
organization, and the delivery method
and content of the examination. Each
approved MRO certification entity must
SUMMARY:
PO 00000
Frm 00107
Fmt 4703
Sfmt 4703
39763
resubmit their qualifications for
approval every two years. The Secretary
shall publish at least every two years a
notice in the Federal Register listing
those entities and subspecialty boards
that have been approved. This notice is
also available on the internet at https://
www.samhsa.gov/workplace/drugtesting.’’
HHS has completed its review of
entities that certify MROs, in
accordance with requests submitted by
such entities to HHS.
The HHS Secretary approves the
following MRO certifying entities that
offer MRO certification through
examination:
American Association of Medical
Review Officers (AAMRO), P.O. Box
12873, Research Triangle Park, NC
27709, Phone: (919) 489–5407, Fax:
(919) 490–1010, Email: bbrandon@
aamro.com, website: https://
www.aamro.com/.
Medical Review Officer Certification
Council (MROCC), 3231 S. Halsted St,
#167, Chicago, IL 60608, Phone: (847)
631–0599, Fax: (847) 483–1282,
Email: mrocc@mrocc.org, website:
https://www.mrocc.org/.
DATES: HHS approval is effective July
31, 2018.
Alex M. Azar II,
Secretary.
[FR Doc. 2018–17184 Filed 8–9–18; 8:45 am]
BILLING CODE 4162–20–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Alcohol Abuse
and Alcoholism; Notice of Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the National Advisory
Council on Alcohol Abuse and
Alcoholism.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
E:\FR\FM\10AUN1.SGM
10AUN1
]]>Agencies
[Federal Register Volume 83, Number 155 (Friday, August 10, 2018)]
[Notices]
[Pages 39761-39763]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-17130]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-2582]
Human Dermal (Skin) Safety Testing for Topical Drug Products:
Regulatory Utility and Evaluation; Public Workshop; Request for
Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing the following 1-day public workshop entitled ``Human Dermal
(Skin) Safety Testing for Topical Drug Products: Regulatory Utility and
Evaluation.'' The purpose of the public workshop is to provide a forum
to discuss the current state and future directions of the collection of
human data on the potential skin toxicity with the use of medications
applied topically. The workshop will review current approaches to the
collection of human data during the clinical development of topical
drug products. The workshop will also address the impact of human skin
toxicity studies on drug labeling and consider alternative approaches
to providing information about skin toxicity.
DATES: The public workshop will be held on September 10, 2018, from
8:30 a.m. to 4 p.m. Eastern Time. Submit either electronic or written
comments on this public workshop by October 10, 2018. See the
SUPPLEMENTARY INFORMATION section for registration date and
information.
ADDRESSES: The public workshop will be held at the FDA White Oak
Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the
Great Room (Rm. 1503, Section A), Silver Spring, MD 20993-0002.
Entrance for the public workshop participants (non-FDA employees) is
through Building 1, where routine security check procedures will be
performed. For parking and security information, please refer to
https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
You may submit comments as follows. Please note that late, untimely
filed comments will not be considered. Electronic comments must be
submitted on or before October 10, 2018. The
[[Page 39762]]
https://www.regulations.gov electronic filing system will accept
comments until midnight Eastern Time at the end of October 10, 2018.
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.
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-2018-N-2582 for ``Human Dermal (Skin) Safety Testing for Topical
Drug Products: Regulatory Utility and Evaluation; Public Workshop;
Request for Comments.'' Received comments, those filed in a timely
manner (see ADDRESSES), 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.
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.
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.
FOR FURTHER INFORMATION CONTACT: Tisha Washington, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-1019,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing a public workshop entitled ``Human Dermal (Skin)
Safety Testing for Topical Drug Products: Regulatory Utility and
Evaluation'' to discuss the current state and future directions of the
collection of human data on the potential skin risks from use of
topical drug products, including irritancy, sensitization,
phototoxicity, and photoallergenicity.
II. Topics for Discussion at the Public Workshop
The morning session of the workshop will focus on review and
discussion of current approaches for the collection of human skin
toxicity data, limitations of these approaches, and their impact on
labeling of topical drug products. The afternoon session of the
workshop will be a panel discussion by individuals with different
perspectives about alternative approaches to provide information about
skin toxicity. Thirty minutes of the afternoon session will be
allocated to an open public hearing. The Agency encourages health care
providers, industry representatives, and other interested persons to
attend this public workshop.
III. Participating in the Public Workshop
Registration: To register for the public workshop, please visit the
following website by September 4, 2018: https://www.eventbrite.com/e/fda-public-workshop-human-dermal-safety-testing-for-topical-drug-products-tickets-47483161414. Please provide complete contact
information for each attendee, including name, title, affiliation,
address, email, and telephone, and intended attendance method--in
person or by webcast. You may also indicate if you wish to present at
the public comment session (see Requests for Oral Presentations). For
those unable to attend in person, FDA will provide a live webcast of
the workshop.
Registration is free and based on space availability, with priority
given to early registrants. Persons interested in attending this public
workshop must register by 5 p.m. Eastern Time, September 4, 2018. Early
registration is recommended because seating is limited; therefore, FDA
may limit the number of participants from each organization.
Registrants will receive confirmation when they have been accepted.
Seating will be available on a first-come, first-served basis. If time
and space permit, onsite registration on the day of the workshop will
be provided beginning at 8:15 a.m. Eastern Time; FDA will let the
public know whether onsite registration is available before the day of
the public workshop.
An agenda for the workshop and any other background materials will
be made available 5 days before the workshop at https://www.fda.gov/Drugs/NewsEvents/ucm611203.htm.
If you need special accommodations due to a disability, please
contact Tisha
[[Page 39763]]
Washington, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002,
301-796-1019, [email protected] no later than September 4,
2018.
Requests for Oral Presentations: During online registration you may
indicate if you wish to present at the public comment session, and
which topic(s) you wish to address. We will do our best to accommodate
requests to make public comments. Individuals and organizations with
common interests are urged to consolidate or coordinate their
presentations, and request time for a joint presentation. Following the
close of registration, we will determine the amount of time allotted to
each presenter and the approximate time each oral presentation is to
begin, and will select and notify participants by September 5, 2018.
All requests to make oral presentations must be received by the close
of registration on September 4, 2018. If selected for presentation, any
presentation materials must be emailed to Tisha Washington (see FOR
FURTHER INFORMATION CONTACT) no later than close of business, September
6, 2018. No commercial or promotional material will be permitted to be
presented or distributed at the public workshop.
Streaming Webcast of the Public Workshop: This public workshop will
also be webcast. The webcast link will be available on the following
web page 5 days before the workshop at: https://www.fda.gov/Drugs/NewsEvents/ucm611203.htm.
If you have never attended a Connect Pro event before, test your
connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program,
visit https://www.adobe.com/go/connectpro_overview. FDA has verified
the website addresses in this document, as of the date this document
publishes in the Federal Register, but websites are subject to change
over time.
Transcripts: Please be advised that as soon as a transcript of the
public workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. A link to the transcript will also be available on
the internet at https://www.fda.gov/Drugs/NewsEvents/ucm611203.htm.
Dated: August 6, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-17130 Filed 8-9-18; 8:45 am]
BILLING CODE 4164-01-P
