[Federal Register Volume 81, Number 35 (Tuesday, February 23, 2016)]
[Notices]
[Pages 8967-8969]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-03712]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0173]


Waterpipes and Waterpipe Tobacco; Public Workshop; Establishment 
of a Public Docket

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; establishment of docket; request for 
comments.

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SUMMARY: The Food and Drug Administration (FDA), Center for Tobacco 
Products (CTP), is announcing a public workshop to gather scientific 
information on waterpipes and waterpipe tobacco and to identify areas 
of research that may inform CTP's regulation of these tobacco products. 
The workshop will include presentations and panel discussions about the 
current state of the science, and will focus on product use and design, 
smoke constituents, environmental impacts, and the impact of marketing 
these products on population health, including on both users and 
nonusers. FDA is also opening a public docket to receive data, 
information, and comments on this topic.

DATES: The public workshop will be held on March 17, 2016, from 8:30 
a.m. to 5 p.m. and on March 18, 2016, from 8:30 a.m. to 4 p.m. 
Individuals who wish to attend the public workshop must register by 
February 25, 2016. Submit written or electronic comments to Docket No. 
FDA-2016-N-0173 by April 29, 2016.

ADDRESSES: The public workshop will be held at the FDA White Oak 
Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great 
Room (Rm. 1503A), Silver Spring, MD 20993. Entrance for the public 
workshop participants (non-FDA employees) is

[[Page 8968]]

through Building 1 where routine security check procedures will be 
performed. For parking, transportation, security, and information 
regarding special accommodations due to a disability, 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-0173 for ``Waterpipes and Waterpipe Tobacco; Public 
Workshop; Establishment of a Public Docket.'' 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 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: Caryn Cohen, Office of Science, Center 
for Tobacco Products, Food and Drug Administration, Document Control 
Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 
20993-0002, 1-877-287-1373, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing a public workshop to gather scientific 
information and stimulate discussion among scientists about waterpipes 
and waterpipe tobacco. The workshop will focus on waterpipe tobacco 
product toxic emissions and exposure to harmful and potentially harmful 
constituents including: Second hand exposure, design and environmental 
concerns, prevalence, perception, use pattern, addiction, individual 
and population health. FDA is interested in gathering scientific 
information from individuals with a broad range of backgrounds on the 
scientific topics to be discussed at the workshop. Information related 
to workshop presentations and discussion topics, including specific 
questions to be addressed at the workshop, can be found at http://www.fda.gov/TobaccoProducts/NewsEvents/ucm238308.htm.

II. Registration To Attend the Workshop

    If you wish to attend the workshop in person or by Webcast, you 
must register by submitting either an electronic or written request no 
later than February 25, 2016. Please submit electronic requests at 
https://www.surveymonkey.com/r/Waterpipes2016. Persons without Internet 
access may send written requests for registration to Caryn Cohen (see 
FOR FURTHER INFORMATION CONTACT). Requests for registration must 
include the prospective attendee's name, title, affiliation, address, 
email address if available, and telephone number. Registration is free 
and you may register to either attend in-person or view the live 
Webcast. Both seating and viewership are limited, so early registration 
is recommended. FDA may limit the number of registrants from a single 
organization, as well as the total number of participants, if 
registration reaches full capacity. For those registrants with Internet 
access, confirmation of registration will be emailed to you no later 
March 1, 2016. Onsite registration may be allowed if space is 
available. If registration reaches maximum capacity, FDA will post a 
notice closing registration at http://www.fda.gov/TobaccoProducts/NewsEvents/ucm238308.htm. If you need special accommodations due to a 
disability, please contact Caryn Cohen (see FOR FURTHER INFORMATION 
CONTACT) no later than March 10, 2016.

III. Oral Presentations by Members of the Public

    This workshop includes a public comment session. Persons wishing to 
present during the public comment session must make this request at the 
time of registration and should identify the topic they wish to address 
from among those topics under consideration.

[[Page 8969]]

FDA will do its best to accommodate requests to present. FDA urges 
individuals and organizations with common interests to consolidate or 
coordinate their comments, and request a single time for a joint 
presentation. For those requesters with Internet access, Caryn Cohen 
(see FOR FURTHER INFORMATION CONTACT) will email you regarding your 
request to speak by March 1, 2016.

IV. 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 (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. 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. It will also be available after the workshop at 
http://www.fda.gov/TobaccoProducts/NewsEvents/ucm238308.htm as soon as 
the official transcript is finalized.

    Dated: February 18, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-03712 Filed 2-22-16; 8:45 am]
 BILLING CODE 4164-01-P