[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