[Federal Register Volume 85, Number 48 (Wednesday, March 11, 2020)]
[Notices]
[Pages 14206-14207]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-04919]


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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; 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, Agency, or we) is 
reopening the comment period for the notice that appeared in the 
Federal Register of April 3, 2019, and extending it indefinitely. 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. On June 20, 2019, a notice 
that appeared in the Federal Register extended the comment period to 
July 16, 2019. To provide a public and transparent way for stakeholders 
to provide new and emerging information to us in real time as it 
becomes available, we are reopening the comment period and extending it 
indefinitely to allow interested parties to continue to comment. We are 
particularly interested in data that may help to address uncertainties 
and data gaps related to the safety of cannabidiol (CBD).

DATES: FDA is reopening the comment period and extending it 
indefinitely on the notice published in the Federal Register of April 
3, 2019 (84 FR 12969).

ADDRESSES: You may submit either electronic or written comments as 
follows.

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 
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.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

[[Page 14207]]

    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: April Alexandrow, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 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 were 
solicited to help inform our regulatory oversight of these products and 
as 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.
    In response to requests for an extension of the comment period to 
provide additional time to develop meaningful and thoughtful responses 
to questions, on June 20, 2019, we published a notice that appeared in 
the Federal Register that extended the comment period for 14 days, 
until July 16, 2019.
    In light of the continued interest and increased research activity 
in this space, as well as the need for additional scientific data on 
this topic, we have decided to reopen the comment period and extend it 
indefinitely to allow interested parties to continue to comment and to 
provide relevant data to the Agency on this subject. If, in the future, 
we decide to close the comment period, we will publish a Federal 
Register notice to that effect. This extension will allow stakeholders 
to continue to provide new and emerging information, in as close to 
real time as possible, as research in this area evolves.
    We are particularly interested in data that may help to address 
uncertainties and data gaps related to the CBD. Studies that may help 
to address such uncertainties and data gaps may include, but are not 
limited to:
     The risk of liver injury from CBD, e.g., clinical studies 
to evaluate potential liver injury following long-term exposure of CBD 
in healthy populations and in people who may be more susceptible to 
CBD-induced liver injury (e.g., due to preexisting liver disease), 
long-term (chronic), repeated dose studies in an appropriate animal 
model to determine the most sensitive liver toxicity endpoint, and to 
establish a no observed effect level (NOAEL), as well as studies to 
investigate the mechanism of liver injury;
     Toxicities of some of the active metabolites of CBD, e.g., 
animal toxicology studies of the major human metabolites such as 7-
COOH-CBD, as well as pharmacology studies to fully characterize the 
binding profile and activity of major metabolites of CBD (e.g., 7-OH-
CBD, 7-COOH-CBD);
     Impact of CBD on the male reproductive system, e.g., long-
term (chronic), repeated dose studies in an appropriate animal model to 
determine the most sensitive male reproductive toxicity endpoint and to 
establish a NOAEL, and studies to characterize the mechanism mediating 
CBD effects on the male reproductive system for the purpose of 
assessing human relevance;
     Effect of CBD co-administration with other medicines, 
alcohol, dietary supplements, tobacco products, and herbal products;
     Impact on neurological development, e.g., 
neurodevelopmental toxicology studies of CBD and 7-COOH-CBD to 
characterize the long-term functional impact of these compounds on the 
developing brain; addition of long-term neurodevelopment adverse 
outcomes in ongoing or future clinical trials of CBD to assess 
learning, cognition, and behavior;
     Sedative effects of CBD, e.g., studies to characterize the 
effect on driving performance and ability to operate heavy machinery 
due to CBD's sedative effects;
     Transdermal penetration and pharmacokinetics of CBD, e.g., 
methods development for the evaluation and assessment of dermal 
penetration of CBD;
     Clinical studies (including real world data/evidence) to 
address safety questions related to long-term sustained or cumulative 
exposure to CBD, including in vulnerable populations such as children, 
the elderly, and women who are pregnant or breastfeeding;
     Long-term (chronic) repeated dose toxicity studies in 
appropriate animal models, evaluating the most relevant toxicological 
end points (e.g., male reproductive toxicity and liver toxicity), to 
better characterize the potential long-term effects of CBD, with 
systematic reporting of relevant parameters including, but not limited 
to, histopathology, hematology and clinical chemistry analyses, 
testosterone and other hormone levels, and urinalysis;
     Clinical studies on the effect of different routes of CBD 
administration (e.g., oral, topical, inhaled) on its safety profile;
     Effect of CBD on pets and food-producing animals, e.g., 
animal studies that demonstrate the effect of CBD exposure in different 
target animal species, breeds, or classes, including information on the 
formation of residues in edible tissues of food-producing animals and 
safety of chronic exposure;
     Studies to characterize the potential for bioaccumulation 
of CBD over long-term exposure, e.g., appropriately designed 
absorption, distribution, metabolism, and elimination studies in 
appropriate animal models; and
     Effect of CBD on the eye, e.g., studies to determine if 
CBD is distributed into the eye following various routes of exposure, 
studies to characterize CBD's potential effect on intraocular pressure, 
and assessment of potential impacts in potentially sensitive 
populations such as patients with glaucoma.

    Dated: March 5, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-04919 Filed 3-10-20; 8:45 am]
 BILLING CODE 4164-01-P


