[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 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]
BILLING CODE 4164-01-P