[Federal Register Volume 84, Number 119 (Thursday, June 20, 2019)]
[Notices]
[Pages 28822-28823]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-13122]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-1482]


Scientific Data and Information About Products Containing 
Cannabis or Cannabis-Derived Compounds; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA or we) is extending the 
comment period for the notice that appeared in the Federal Register of 
April 3, 2019. The notice announced a public hearing to obtain 
scientific data and information about the safety, manufacturing, 
product quality, marketing, labeling, and sale of products containing 
cannabis or cannabis-derived compounds. In addition, it notified the 
public that FDA was establishing a docket for public comment on this 
hearing and that the docket would close on July 2, 2019. We are 
extending the comment period to give interested parties more time to 
comment.

DATES: FDA is extending the comment period on the notice published in 
the Federal Register of April 3, 2019 (84 FR 12969). Submit either 
electronic or written comments by July 16, 2019.

ADDRESSES: 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 July 16, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of July 16, 2019. 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-2019-N-1482 for ``Scientific Data and Information About Products 
Containing Cannabis or Cannabis-Derived Compounds.'' 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.'' We will review 
this copy, including the claimed confidential information, in our 
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

[[Page 28823]]

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: April Alexandrow, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 32, Room 3147, Silver 
Spring, MD 20993, 301-796-5363.

SUPPLEMENTARY INFORMATION: In the Federal Register of April 3, 2019, 
FDA published a notice announcing a public hearing to obtain scientific 
data and information about the safety, manufacturing, product quality, 
marketing, labeling, and sale of products containing cannabis or 
cannabis-derived compounds. In addition, we notified the public that 
FDA was establishing a docket for public comment on this hearing. The 
information from the hearing and comments provided to the docket will 
inform our regulatory oversight of these products and is an important 
step in our continued evaluation of cannabis and cannabis-derived 
compounds in FDA-regulated products. We asked that comments be 
submitted by July 2, 2019.
    At the public hearing, we received requests for a 30-day extension 
of the comment period for the notice. The requests conveyed concern 
that the current 60-day comment period does not allow sufficient time 
to develop meaningful or thoughtful responses to the questions that 
appeared in the notice requesting data and other evidence in support of 
answers.
    We have considered the requests and are extending the comment 
period for another 14 days, until July 16, 2019. We believe that a 14-
day extension allows adequate time for interested persons to submit 
comments without significantly delaying any potential further action on 
these important issues.

    Dated: June 14, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-13122 Filed 6-19-19; 8:45 am]
 BILLING CODE 4164-01-P


