Evaluation of the Safety of Drugs and Biological Products Used During Lactation; Public Workshop; Request for Comments, 7809-7810 [2016-02967]
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Federal Register / Vol. 81, No. 30 / Tuesday, February 16, 2016 / Notices
enhance the safety and security of the
pharmaceutical distribution supply
chain. Stakeholders may comment on
utilizing the product identifier for
product tracing and the technical
capabilities of the pharmaceutical
distribution supply chain and the
system attributes that are necessary to
implement the requirements under
section 582. The information gathered
from the workshop participants and
from the comments submitted to the
docket for the public workshop will
further inform FDA’s development of its
pilot project program under section
582(j) of the FD&C Act.
Dated: February 9, 2016.
Leslie Kux,
Associate Commissioner for Policy.
III. Registration for the Public
Workshop
AGENCY:
To request registration for the public
workshop, provide your information
including name, company or
organization, address, telephone
number, and email address to FDA at
https://www.fda.gov/Drugs/NewsEvents/
ucm481767.htm. Registration requests
should be received by March 11, 2016.
FDA is limiting workshop attendance
due to limited space. FDA may limit the
number of participants from each
organization based on space limitations.
FDA recommends that each
organization determine who should
register for the workshop to represent
his/her organization. This will help
ensure that the workshop will have
broad and varied representation across
the pharmaceutical distribution supply
chain. Registrants will receive
confirmation of participation for the
workshop from FDA by March 18, 2016.
There is no registration fee for the
public workshop. There will be no
onsite registration. If registration
reaches maximum capacity, FDA will
post a notice closing registration for the
workshop on FDA’s Web site at https://
www.fda.gov/Drugs/NewsEvents/
ucm481767.htm. If you need special
accommodations due to a disability,
please contact Daniel Bellingham (see
FOR FURTHER INFORMATION CONTACT) at
least 7 days in advance of the public
workshop.
ACTION:
mstockstill on DSK4VPTVN1PROD with NOTICES
Portions of this public workshop will
be recorded and Webcasted on the day
of the workshop. Information for how to
access the Webcast will be available at
https://www.fda.gov/Drugs/NewsEvents/
ucm481767.htm by March 29, 2016. The
Webcast will be conducted in listeningmode only.
22:15 Feb 12, 2016
Jkt 238001
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0437]
Evaluation of the Safety of Drugs and
Biological Products Used During
Lactation; Public Workshop; Request
for Comments
Food and Drug Administration,
HHS.
IV. Webcasting of the Public Workshop
VerDate Sep<11>2014
[FR Doc. 2016–02977 Filed 2–12–16; 8:45 am]
Notice of public workshop;
request for comments.
The Food and Drug
Administration (FDA) is announcing a
public workshop entitled ‘‘Evaluation of
the Safety of Drugs and Biological
Products used during Lactation.’’ The
purpose of this workshop is to provide
a forum to discuss the current state and
future directions of the collection of
data on the potential risks to breastfed
infants with maternal use of
medications during lactation. The
workshop will review current
approaches to the collection of data
when drugs are used or expected to be
used during lactation. The workshop
will also discuss and consider novel
approaches to improve the quality and
quantity of data, to inform of the
potential risks of medication use during
lactation, and to raise awareness and
engage stakeholders about
communication of safety information
related to maternal use of medications
during lactation.
DATES: The public workshop will be
held on April 27, 2016, from 8 a.m. to
5 p.m.; and April 28, 2016, from 8 a.m.
to 1 p.m. Registration closes on April 8,
2016. Submit electronic or written
comments to the public docket by May
28, 2016.
ADDRESSES: The public workshop will
be held at FDA’s White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503A), 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.
SUMMARY:
PO 00000
Frm 00068
Fmt 4703
Sfmt 4703
7809
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–
2016–N–0437 for ‘‘Evaluation of the
Safety of Drugs and Biological Products
used during Lactation; Public
Workshop; 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
E:\FR\FM\16FEN1.SGM
16FEN1
mstockstill on DSK4VPTVN1PROD with NOTICES
7810
Federal Register / Vol. 81, No. 30 / Tuesday, February 16, 2016 / Notices
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.
FOR FURTHER INFORMATION CONTACT: For
questions regarding the workshop,
contact Denise Pica-Branco, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993–0002, 301–796–1732, FAX: 301–
796–9858, denise.picabranco@
fda.hhs.gov; or Denise Johnson-Lyles,
Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–6169; FAX: 301–796–9858,
denise.johnson-lyles@fda.hhs.gov.
Registration: Participation can be
either in person attendance or by
Webcast. There is no fee to attend the
public workshop, but attendees must
register in advance. Space is limited,
and registration will be on a first-come,
first-served basis. Persons interested in
attending this workshop must register
online at lactation@fda.hhs.gov. Please
VerDate Sep<11>2014
22:15 Feb 12, 2016
Jkt 238001
include: (1) First and last name, (2)
contact phone or email address, (2) live
attendance or via Webcast, (4) indicate
if you plan to attend day 1, day 2, or
both days. Registration closes on April
8, 2016. For those without Internet
access, please contact Denise PicaBranco or Denise Johnson-Lyles (see FOR
FURTHER INFORMATION CONTACT) to
register. Onsite registration will not be
available.
If you need special accommodations
due to a disability, please contact
Denise Pica-Branco or Denise JohnsonLyles (see FOR FURTHER INFORMATION
CONTACT) at least 7 days in advance.
SUPPLEMENTARY INFORMATION:
I. Background
FDA has engaged with regulatory,
academic, and industry experts to
discuss the current state and future
directions of the collection of data on
the potential risks to breastfed infants
with maternal use of medications during
lactation. The first day of the workshop
will focus on review and discussion of
current approaches for the collection of
data, and review and discussion of gaps
in our present knowledge. The second
day of the workshop will focus on
consideration of novel approaches to
improve the quality and quantity of data
available to assess the safety of
medications used during lactation as
well as a review and discussion of
strategies to communicate safety
information related to maternal use of
medications during lactation.
This workshop includes a public
comment session. If you would like to
present during this session, please
identify the topic(s) you will address
during the registration. FDA will do its
best accommodate requests to speak.
FDA urges individuals and
organizations with common interests to
coordinate and give a joint, consolidated
presentation. Following the close of
registration, FDA will allot time for each
presentation and notify presenters by
April 21, 2016. Do not present or
distribute commercial or promotional
material during the workshop.
Registered presenters should check in
before the workshop begins.
II. Transcripts
Please be advised that as soon as a
transcript is available, it will be
accessible at https://
www.regulations.gov. It may be viewed
at the Division of Dockets Management,
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20857. A transcript will also be
available in either hardcopy or on CD–
ROM, after submission of a Freedom of
Information request. The Freedom of
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
Information office address is available
on the Agency’s Web site at https://
www.fda.gov.
Dated: February 9, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–02967 Filed 2–12–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–D–0369]
Bioequivalence Recommendations for
Cyclosporine; Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry on cyclosporine ophthalmic
emulsion entitled ‘‘Draft Guidance on
Cyclosporine.’’ The recommendations
provide specific guidance on the design
of bioequivalence (BE) studies to
support abbreviated new drug
applications (ANDAs) for cyclosporine
ophthalmic emulsion. This draft
guidance is a revised version of a
previously issued draft guidance on the
same subject.
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 comments 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 April 18, 2016.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
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
E:\FR\FM\16FEN1.SGM
16FEN1
]]>Agencies
[Federal Register Volume 81, Number 30 (Tuesday, February 16, 2016)]
[Notices]
[Pages 7809-7810]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-02967]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0437]
Evaluation of the Safety of Drugs and Biological Products Used
During Lactation; 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) is announcing a public
workshop entitled ``Evaluation of the Safety of Drugs and Biological
Products used during Lactation.'' The purpose of this workshop is to
provide a forum to discuss the current state and future directions of
the collection of data on the potential risks to breastfed infants with
maternal use of medications during lactation. The workshop will review
current approaches to the collection of data when drugs are used or
expected to be used during lactation. The workshop will also discuss
and consider novel approaches to improve the quality and quantity of
data, to inform of the potential risks of medication use during
lactation, and to raise awareness and engage stakeholders about
communication of safety information related to maternal use of
medications during lactation.
DATES: The public workshop will be held on April 27, 2016, from 8 a.m.
to 5 p.m.; and April 28, 2016, from 8 a.m. to 1 p.m. Registration
closes on April 8, 2016. Submit electronic or written comments to the
public docket by May 28, 2016.
ADDRESSES: The public workshop will be held at FDA's White Oak Campus,
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room
(Rm. 1503A), 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:
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-2016-N-0437 for ``Evaluation of the Safety of Drugs and Biological
Products used during Lactation; Public Workshop; 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
[[Page 7810]]
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.
FOR FURTHER INFORMATION CONTACT: For questions regarding the workshop,
contact Denise Pica-Branco, Center for Drug Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring,
MD 20993-0002, 301-796-1732, FAX: 301-796-9858,
denise.picabranco@fda.hhs.gov; or Denise Johnson-Lyles, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-6169; FAX: 301-
796-9858, denise.johnson-lyles@fda.hhs.gov.
Registration: Participation can be either in person attendance or
by Webcast. There is no fee to attend the public workshop, but
attendees must register in advance. Space is limited, and registration
will be on a first-come, first-served basis. Persons interested in
attending this workshop must register online at lactation@fda.hhs.gov.
Please include: (1) First and last name, (2) contact phone or email
address, (2) live attendance or via Webcast, (4) indicate if you plan
to attend day 1, day 2, or both days. Registration closes on April 8,
2016. For those without Internet access, please contact Denise Pica-
Branco or Denise Johnson-Lyles (see FOR FURTHER INFORMATION CONTACT) to
register. Onsite registration will not be available.
If you need special accommodations due to a disability, please
contact Denise Pica-Branco or Denise Johnson-Lyles (see FOR FURTHER
INFORMATION CONTACT) at least 7 days in advance.
SUPPLEMENTARY INFORMATION:
I. Background
FDA has engaged with regulatory, academic, and industry experts to
discuss the current state and future directions of the collection of
data on the potential risks to breastfed infants with maternal use of
medications during lactation. The first day of the workshop will focus
on review and discussion of current approaches for the collection of
data, and review and discussion of gaps in our present knowledge. The
second day of the workshop will focus on consideration of novel
approaches to improve the quality and quantity of data available to
assess the safety of medications used during lactation as well as a
review and discussion of strategies to communicate safety information
related to maternal use of medications during lactation.
This workshop includes a public comment session. If you would like
to present during this session, please identify the topic(s) you will
address during the registration. FDA will do its best accommodate
requests to speak. FDA urges individuals and organizations with common
interests to coordinate and give a joint, consolidated presentation.
Following the close of registration, FDA will allot time for each
presentation and notify presenters by April 21, 2016. Do not present or
distribute commercial or promotional material during the workshop.
Registered presenters should check in before the workshop begins.
II. Transcripts
Please be advised that as soon as a transcript is available, it
will be accessible at https://www.regulations.gov. It may be viewed at
the Division of Dockets Management, Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20857. A transcript will also be
available in either hardcopy or on CD-ROM, after submission of a
Freedom of Information request. The Freedom of Information office
address is available on the Agency's Web site at https://www.fda.gov.
Dated: February 9, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-02967 Filed 2-12-16; 8:45 am]
BILLING CODE 4164-01-P
