Document ID: FDA-2019-N-0767-1940
Agency: fda
Document Type: Notice
Title: International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; World Health Organization; Scheduling Recommendations; Dronabinol (delta-9 tetrahydrocannabinol) and Its Stereoisomers; Cannabis, Cannabis Resin, Extracts and Tinctures; Cannabidiol Preparations; and Pharmaceutical Preparations of Cannabis; Reopening of the Comment Period
Posted Date: 2019-08-29T04:00Z

[Federal Register Volume 84, Number 168 (Thursday, August 29, 2019)]
[Notices]
[Pages 45501-45502]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-18714]

[[Page 45501]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-0767]

International Drug Scheduling; Convention on Psychotropic 
Substances; Single Convention on Narcotic Drugs; World Health 
Organization; Scheduling Recommendations; Dronabinol (delta-9 
tetrahydrocannabinol) and Its Stereoisomers; Cannabis, Cannabis Resin, 
Extracts and Tinctures; Cannabidiol Preparations; and Pharmaceutical 
Preparations of Cannabis; Reopening of the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reopening of the comment period.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
reopening the comment period for the notice entitled ``International 
Drug Scheduling; Convention on Psychotropic Substances; Single 
Convention on Narcotic Drugs; World Health Organization; Scheduling 
Recommendations; Dronabinol (delta-9 tetrahydrocannabinol) and its 
Stereoisomers; Cannabis, Cannabis Resin, Extracts and Tinctures; 
Cannabidiol Preparations; and Pharmaceutical Preparations of Cannabis'' 
that appeared in the Federal Register of March 1, 2019. The Agency is 
taking this action to allow interested persons additional time to 
submit comments.

DATES: FDA is reopening the comment period for the notice published on 
March 1, 2019 (84 FR 7064). Submit either electronic or written 
comments by September 30, 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 September 30, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of September 30, 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-0767 for ``International Drug Scheduling; Convention on 
Psychotropic Substances; Single Convention on Narcotic Drugs; World 
Health Organization; Scheduling Recommendations; Dronabinol (delta-9 
tetrahydrocannabinol) and its Stereoisomers; Cannabis, Cannabis Resin, 
Extracts and Tinctures; Cannabidiol Preparations; and Pharmaceutical 
Preparations of Cannabis.'' 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.'' 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 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 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: James Hunter, Center for Drug 
Evaluation and Research, Controlled Substance Staff, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5150, Silver 
Spring, MD 20993-0002, 301-796-3156, james.hunter@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In the Federal Register of March 1, 2019 (84 
FR 7064), FDA published a notice with a 14-day comment period to 
request comments on the notice entitled ``International Drug 
Scheduling; Convention on Psychotropic Substances; Single Convention on 
Narcotic Drugs; World Health Organization; Scheduling Recommendations; 
Dronabinol (delta-9 tetrahydrocannabinol) and its Stereoisomers; 
Cannabis, Cannabis Resin, Extracts and Tinctures; Cannabidiol 
Preparations; and Pharmaceutical Preparations of

[[Page 45502]]

Cannabis.'' FDA is reopening the comment period until September 30, 
2019. The Agency believes that an additional 30 days will allow 
adequate time for interested persons to submit comments.
    When the notice was initially published, FDA noted the need for a 
shortened time period for the submission of comments to ensure that the 
U.S. Department of Health and Human Services may in timely fashion 
carry out the required action and be responsive to the United Nations. 
FDA also noted that if voting on the cannabis-related recommendations 
was deferred to a later date, the comment period would reopen. The 
Bureau of the 62nd Commission on Narcotic Drugs decided to postpone the 
voting on the cannabis-related recommendations by adopting decision 62/
14 (available at: https://www.unodc.org/documents/commissions/CND/Drug_Resolutions/2010-2019/2019/Decisions/CND_Decision_62_14.pdf). 
Therefore, FDA is reopening the comment period to allow interested 
persons an additional 30 days to comment.

    Dated: August 26, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-18714 Filed 8-28-19; 8:45 am]
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