Scientific Data and Information About Products Containing Cannabis or Cannabis-Derived Compounds; Reopening of the Comment Period, 14206-14207 [2020-04919]
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Federal Register / Vol. 85, No. 48 / Wednesday, March 11, 2020 / Notices
Hampshire Ave., Bldg. 51, Rm. 1117,
Silver Spring, MD 20993–0002, 301–
796–0035, email: cderdatastandards@
fda.hhs.gov.
Notice; reopening of the
comment period.
ACTION:
SUPPLEMENTARY INFORMATION:
I. Background
On December 17, 2014, FDA
published final guidance for industry
entitled ‘‘Providing Regulatory
Submissions in Electronic Format—
Standardized Study Data’’ (eStudy Data
guidance), posted on FDA’s Study Data
Standards Resources web page at
https://www.fda.gov/forindustry/
datastandards/studydatastandards/
default.htm. The eStudy Data guidance
implements the electronic submission
requirements of section 745A(a) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 379k–1(a)) for study data
contained in new drug applications,
abbreviated new drug applications,
biologics license applications, and
investigational new drug applications
submitted to CDER or the Center for
Biologics Evaluation and Research by
specifying the format for electronic
submissions. The eStudy Data guidance
states that a Federal Register notice will
specify any new standard version
updates that will be added to the
Catalog and will specify when support
for the new standard begins or ends, and
when the requirement to submit data
using the new standard begins or ends.
FDA will begin supporting SDTM v1.8
and SENDIG–AR v1.0 on March 15,
2020, and such Animal Rule 1
submissions will be required to use the
new standard effective March 15, 2022.
Dated: March 5, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–04898 Filed 3–10–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–1482]
lotter on DSKBCFDHB2PROD with NOTICES
Scientific Data and Information About
Products Containing Cannabis or
Cannabis-Derived Compounds;
Reopening of the Comment Period
AGENCY:
Food and Drug Administration,
HHS.
1 The Animal Rule refers to FDA’s regulations for
the approval of new drugs and biological products
when human efficacy studies are not ethical or
feasible (see 21 CFR 314.600–650 for drugs and 21
CFR 601.90–95 for biologics).
VerDate Sep<11>2014
16:37 Mar 10, 2020
Jkt 250001
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.
SUMMARY:
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
PO 00000
Frm 00023
Fmt 4703
Sfmt 4703
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-201509-18/pdf/2015-23389.pdf.
E:\FR\FM\11MRN1.SGM
11MRN1
lotter on DSKBCFDHB2PROD with NOTICES
Federal Register / Vol. 85, No. 48 / Wednesday, March 11, 2020 / Notices
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 FDAregulated 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:
VerDate Sep<11>2014
16:37 Mar 10, 2020
Jkt 250001
• The risk of liver injury from CBD,
e.g., clinical studies to evaluate
potential liver injury following longterm 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 longterm 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
PO 00000
Frm 00024
Fmt 4703
Sfmt 4703
14207
reproductive toxicity and liver toxicity),
to better characterize the potential longterm 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 foodproducing 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 longterm 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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–0001]
Scientific and Ethical Considerations
for the Inclusion of Pregnant Women in
Clinical Trials
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public meeting.
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing the following public
meeting entitled ‘‘Scientific and Ethical
Considerations for the Inclusion of
Pregnant Women in Clinical Trials.’’
The meeting will be convened by Duke
University’s Robert J. Margolis, Center
for Health Policy (Duke-Margolis) and
supported by a cooperative agreement
with FDA. The meeting is intended to
gather industry, patient, clinician,
SUMMARY:
E:\FR\FM\11MRN1.SGM
11MRN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
