[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]
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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.
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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 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-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 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
[[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 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.
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,
[email protected]; 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, [email protected].
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 [email protected].
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 http://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 http://www.fda.gov.
Dated: February 9, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-02967 Filed 2-12-16; 8:45 am]
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