[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