Request for Information on Vaping Products Associated With Lung Injuries, 8875-8877 [2020-03160]
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Federal Register / Vol. 85, No. 32 / Tuesday, February 18, 2020 / Notices
§ 488.5(e)(2)(i) require AOs to reapply
for continued approval of its
accreditation program every 6 years or
sooner as determined by CMS.
The Joint Commission’s current term
of approval for their hospital
accreditation program expires July 15,
2020.
II. Approval of Deeming Organizations
Section 1865(a)(2) of the Act and our
regulations at § 488.5 require that our
findings concerning review and
approval of a national AO’s
requirements consider, among other
factors, the applying AO’s requirements
for accreditation; survey procedures;
resources for conducting required
surveys; capacity to furnish information
for use in enforcement activities;
monitoring procedures for provider
entities found not in compliance with
the conditions or requirements; and
ability to provide CMS with the
necessary data for validation.
Section 1865(a)(3)(A) of the Act
further requires that we publish, within
60 days of receipt of an organization’s
complete application, a notice
identifying the national accrediting
body making the request, describing the
nature of the request, and providing at
least a 30-day public comment period.
We have 210 days from the receipt of a
complete application to publish notice
of approval or denial of the application.
The purpose of this proposed notice
is to inform the public of the Joint
Commission’s request for continued
approval of its hospital accreditation
program. This notice also solicits public
comment on whether the Joint
Commission’s requirements meet or
exceed the Medicare conditions of
participation (CoPs) for hospitals.
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III. Evaluation of Deeming Authority
Request
The Joint Commission submitted all
the necessary materials to enable us to
make a determination concerning its
request for continued approval of its
hospital accreditation program. This
application was determined to be
complete on December 18, 2019. Under
section 1865(a)(2) of the Act and our
regulations at § 488.5 (Application and
re-application procedures for national
accrediting organizations), our review
and evaluation of the Joint Commission
will be conducted in accordance with,
but not necessarily limited to, the
following factors:
• The equivalency of the Joint
Commission’s standards for hospitals as
compared with CMS’ hospital CoPs.
• The Joint Commission’s survey
process to determine the following:
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++ The composition of the survey
team, surveyor qualifications, and the
ability of the organization to provide
continuing surveyor training.
++ The comparability of the Joint
Commission’s processes to those of state
agencies, including survey frequency,
and the ability to investigate and
respond appropriately to complaints
against accredited facilities.
++ The Joint Commission’s processes
and procedures for monitoring a
hospital found out of compliance with
the Joint Commission’s program
requirements. These monitoring
procedures are used only when the Joint
Commission identifies noncompliance.
If noncompliance is identified through
validation reviews or complaint
surveys, the SA monitors corrections as
specified at § 488.9.
++ The Joint Commission’s capacity
to report deficiencies to the surveyed
facilities and respond to the facility’s
plan of correction in a timely manner.
++ The Joint Commission’s capacity
to provide CMS with electronic data and
reports necessary for effective validation
and assessment of the organization’s
survey process.
++ The adequacy of the Joint
Commission’s staff and other resources,
and its financial viability.
++ The Joint Commission’s capacity
to adequately fund required surveys.
++ The Joint Commission’s policies
with respect to whether surveys are
announced or unannounced, to assure
that surveys are unannounced.
++ The Joint Commission’s policies
and procedures to avoid conflicts of
interest, including the appearance of
conflicts of interest, involving
individuals who conduct surveys or
participate in accreditation decisions.
++ The Joint Commission’s
agreement to provide CMS with a copy
of the most current accreditation survey
together with any other information
related to the survey as we may require
(including corrective action plans).
IV. Collection of Information
Requirements
This document does not impose
information collection requirements,
that is, reporting, recordkeeping or third
party disclosure requirements.
Consequently, there is no need for
review by the Office of Management and
Budget under the authority of the
Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.).
V. Response to Public Comments
Because of the large number of public
comments we normally receive on
Federal Register documents, we are not
able to acknowledge or respond to them
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8875
individually. We will consider all
comments we receive by the date and
time specified in the DATES section of
this preamble, and, when we proceed
with a subsequent document, we will
respond to the comments in the
preamble to that document.
Dated: February 6, 2020.
Seema Verma,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2020–03082 Filed 2–14–20; 8:45 am]
BILLING CODE P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–0597]
Request for Information on Vaping
Products Associated With Lung
Injuries
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; request for information.
The Food and Drug
Administration (FDA) is opening a
docket to obtain data and information
related to the use of vaping products
that are associated with recent lung
injuries. This request for information
(RFI) responds to direction from
Congress to gather information from the
public that could help identify and
evaluate additional steps the Agency
could take to ‘‘address the recent
pulmonary illnesses reported to be
associated with the use of e-cigarettes
and vaping products.’’ FDA is seeking
information on product design and
potential ways to prevent consumers
from modifying or adding substances to
these products that are not intended by
the manufacturers. In particular, FDA is
seeking data and information in the
form of reports and manuscripts that are
unpublished or not available through
indexed bibliographic databases. FDA
has searched the publicly available
scientific literature and is now seeking
to supplement that with information not
included in the published scientific
literature.
SUMMARY:
Submit either electronic or
written comments or information by
April 20, 2020.
ADDRESSES: You may submit either
electronic or written comments as
follows:
DATES:
Electronic Submissions
Submit electronic comments in the
following way:
E:\FR\FM\18FEN1.SGM
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8876
Federal Register / Vol. 85, No. 32 / Tuesday, February 18, 2020 / Notices
lotter on DSKBCFDHB2PROD with NOTICES
• 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–
2020–N–0597 for ‘‘Request for
Information on Vaping Products
Associated With Lung Injuries.’’
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.’’ The
Agency will review this copy, including
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17:48 Feb 14, 2020
Jkt 250001
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.govinfo.gov/content/pkg/FR-201509-18/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:
Samantha LohCollado, Center for
Tobacco Products, Food and Drug
Administration, Document Control
Center, 10903 New Hampshire Ave.,
Bldg. 71, Rm. G335, Silver Spring, MD
20993–0002, email: CTPRegulations@
fda.hhs.gov, 1–877–287–1373.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the opening of a
docket entitled ‘‘Request for Information
on Vaping Products Associated With
Lung Injuries.’’
FDA remains deeply concerned about
the recent lung injuries and deaths and
is working closely with other agencies,
as well as State and local public health
partners, to investigate these incidents.
To help gather and analyze as much
information as possible, FDA is working
closely with Federal and State partners
to identify the vaping products or other
substances that may be causing the
injuries. Specifically, FDA is analyzing
samples submitted by a number of
States for the presence of a broad range
of chemicals, including nicotine,
tetrahydrocannabinol (THC) and other
cannabinoids, along with cutting agents/
diluents and other additives, pesticides,
opioids, poisons, heavy metals, and
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toxins. As of February 3, 2020, FDA has
received over 1,300 samples from 31
States and 1 territory with roughly 1,070
of these samples connected to patients.1
These samples have been collected
directly from consumers, hospitals, and
State offices. They have included vaping
devices and products containing varied
levels of liquid as well as packaging and
other documentation. FDA has not
found one product or substance that is
implicated in all of the cases; however,
we do know that THC is present in most
of the samples being tested and many of
these samples have vitamin E acetate as
a diluent. FDA is following all potential
leads and is committed to taking
appropriate actions as additional facts
emerge.
On December 20, 2019, the President
signed the ‘‘Further Consolidated
Appropriations Act, 2020’’ which
directs FDA to issue a RFI to solicit
information regarding ‘‘the recent
pulmonary illnesses reported to be
associated with the use of e-cigarettes
and vaping products.’’ 2 To further this
goal, FDA is seeking information related
to the use of vaping products that are
associated with the recent lung injuries,
including public comment on product
design and ways to prevent the public
from modifying or adding substances to
these products that are not intended by
the manufacturer. This information may
be used by FDA to inform future
rulemaking and review of industry
premarket application submissions, or
in taking other regulatory actions.
II. Request for Information
FDA seeks to obtain data and
information related to the use of vaping
products that are associated with recent
lung injuries. FDA has searched the
publicly available scientific literature
and is now seeking to supplement that
search with information from other
sources, specifically unpublished data
or other information. If the work is not
directly conducted in tobacco products,
1 For more information regarding FDA’s current
efforts to identify and address lung injuries related
to the use of vaping products, please see https://
www.fda.gov/news-events/public-health-focus/lungillnesses-associated-use-vaping-products.
2 Further Consolidated Appropriations Act, 2020,
Public Law 116–94, § 785. FDA uses the term
‘‘vaping products’’ for purposes of this RFI. ‘‘Vaping
products’’ include e-cigarettes as well as other
electronic nicotine delivery systems (ENDS). See
‘‘Guidance for Industry: Enforcement Priorities for
Electronic Nicotine Delivery Systems (ENDS) and
Other Deemed Products on the Market Without
Premarket Authorization,’’ available at https://
www.fda.gov/industry/fda-basics-industry/
guidances (defining ‘‘ENDS’’ as including ‘‘include
devices, components, and/or parts that deliver
aerosolized e-liquid when inhaled. For example,
FDA considers vapes or vape pens, personal
vaporizers, e-cigarettes, cigalikes, e-pens, ehookahs, e-cigars, and e-pipes to be ENDS.’’)
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Federal Register / Vol. 85, No. 32 / Tuesday, February 18, 2020 / Notices
responses should include a discussion
of how the information or data can be
applied specifically to tobacco products
or to lung injuries associated with the
use of vaping products.
For this RFI, FDA is requesting: (1)
Unpublished data or information
(summarized); (2) unpublished or
prepublication copies of manuscripts,
conference presentations, and/or
posters; (3) dissertations and/or theses;
and (4) white papers or other
unpublished reports. FDA is requesting
data and information from all interested
parties, including, but not limited to,
academic and government researchers,
industry, and any other sources.
Specifically, FDA is requesting
unpublished data or information on the
following:
• Specific chemicals, compounds,
ingredients or combinations of
ingredients that when inhaled or
aerosolized, may be associated with the
symptoms observed in ‘‘e-cigarette, or
vaping, product use-associated lung
injury’’ (EVALI) patients; e.g., cough,
chest pain, shortness of breath,
abdominal pain, nausea, vomiting,
diarrhea, fever, chills; 3
• nature of pulmonary pathological
changes associated with inhaling the
specific chemicals, compounds,
ingredients, or combinations of
ingredients that elicit the symptoms
observed in EVALI;
• methods or sources for obtaining
chemicals, compounds, ingredients, or
combinations of ingredients, other than
those intended by the manufacturer,
that are added to vaping products;
• in what ways and how frequently
consumers add chemicals, compounds,
ingredients or combinations of
ingredients, other than those intended
by the manufacturer, to vaping products
and how these changes affect the health
impacts, frequency, and patterns of
consumer use of the products;
• methods for identifying and
detecting materials added or
modifications to vaping products after
the manufacturing process and not
intended by the manufacturer; and
• methods of changing the
manufacturing process or product
design features for vaping products that
will reduce or prevent consumers from
modifying products after the
manufacturing process.
Data may come from studies outside
of the United States; however, FDA
prefers that reports be submitted in
English.
3 For more information concerning the symptoms
observed in EVALI patients, please see https://
www.cdc.gov/tobacco/basic_information/ecigarettes/severe-lung-disease/need-to-know/index.
html#symptoms.
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17:48 Feb 14, 2020
Jkt 250001
When submitting information, please
include details about how the data were
collected, including the sample
composition, year(s) of data collection,
and a detailed summary of the methods
and measures used. For data summaries,
please include both point estimates and
measures of variance, as well as effect
sizes (if available).
Please also note that when submitting
information and data to the docket,
certain compressed file formats (e.g., zip
files) are not allowed. Acceptable file
formats include: .doc, .docx, .pdf, .ppt,
.pptx, .rtf, .txt, .xls, .xlsx, .xlsm, .xlsb,
and .wpd.
Dated: February 12, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–03160 Filed 2–14–20; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–0259]
Patient-Focused Drug Development for
Stimulant Use Disorder; Public
Meeting; Request for Comments
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ACTION:
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing the following public
meeting entitled ‘‘Patient-Focused Drug
Development for Stimulant Use
Disorder.’’ The purpose of the public
meeting is to allow FDA to obtain
stakeholder perspectives on the impact
of stimulant use disorder and views on
treatment approaches for stimulant use
disorder.
DATES: The public meeting will be held
on March 10, 2020, from 12:30 p.m. to
5 p.m. Submit either electronic or
written comments on this public
meeting by May 11, 2020. See the
SUPPLEMENTARY INFORMATION section for
registration date and information.
ADDRESSES: The public meeting will be
held at the Silver Spring Civic Building,
1 Veterans Pl., Silver Spring, MD 20910.
The building is located at Veterans
Plaza in downtown Silver Spring and is
accessible via the Silver Spring Metro
Station on the Red Line. Paid public
parking is also available at the Town
Square Garage (Garage 61), 801
Ellsworth Dr., Silver Spring, MD 20910,
and the Wayne-Ellsworth Garage
(Garage 60), 921 Wayne Ave., Silver
SUMMARY:
PO 00000
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Spring, MD 20910. For more
information regarding parking, Metro
access, and the meeting location, please
refer to https://
www.montgomerycountymd.gov/cupf/
info-reservation/SSCB.html.
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 May 11, 2020. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
May 11, 2020. 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
BILLING CODE 4164–01–P
AGENCY:
8877
Sfmt 4703
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.’’
E:\FR\FM\18FEN1.SGM
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]]>Agencies
[Federal Register Volume 85, Number 32 (Tuesday, February 18, 2020)]
[Notices]
[Pages 8875-8877]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-03160]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-0597]
Request for Information on Vaping Products Associated With Lung
Injuries
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for information.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is opening a docket to
obtain data and information related to the use of vaping products that
are associated with recent lung injuries. This request for information
(RFI) responds to direction from Congress to gather information from
the public that could help identify and evaluate additional steps the
Agency could take to ``address the recent pulmonary illnesses reported
to be associated with the use of e-cigarettes and vaping products.''
FDA is seeking information on product design and potential ways to
prevent consumers from modifying or adding substances to these products
that are not intended by the manufacturers. In particular, FDA is
seeking data and information in the form of reports and manuscripts
that are unpublished or not available through indexed bibliographic
databases. FDA has searched the publicly available scientific
literature and is now seeking to supplement that with information not
included in the published scientific literature.
DATES: Submit either electronic or written comments or information by
April 20, 2020.
ADDRESSES: You may submit either electronic or written comments as
follows:
Electronic Submissions
Submit electronic comments in the following way:
[[Page 8876]]
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-2020-N-0597 for ``Request for Information on Vaping Products
Associated With Lung Injuries.'' 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.'' 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.govinfo.gov/content/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: Samantha LohCollado, Center for
Tobacco Products, Food and Drug Administration, Document Control
Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD
20993-0002, email: [email protected], 1-877-287-1373.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the opening of a docket entitled ``Request for
Information on Vaping Products Associated With Lung Injuries.''
FDA remains deeply concerned about the recent lung injuries and
deaths and is working closely with other agencies, as well as State and
local public health partners, to investigate these incidents. To help
gather and analyze as much information as possible, FDA is working
closely with Federal and State partners to identify the vaping products
or other substances that may be causing the injuries. Specifically, FDA
is analyzing samples submitted by a number of States for the presence
of a broad range of chemicals, including nicotine, tetrahydrocannabinol
(THC) and other cannabinoids, along with cutting agents/diluents and
other additives, pesticides, opioids, poisons, heavy metals, and
toxins. As of February 3, 2020, FDA has received over 1,300 samples
from 31 States and 1 territory with roughly 1,070 of these samples
connected to patients.\1\ These samples have been collected directly
from consumers, hospitals, and State offices. They have included vaping
devices and products containing varied levels of liquid as well as
packaging and other documentation. FDA has not found one product or
substance that is implicated in all of the cases; however, we do know
that THC is present in most of the samples being tested and many of
these samples have vitamin E acetate as a diluent. FDA is following all
potential leads and is committed to taking appropriate actions as
additional facts emerge.
---------------------------------------------------------------------------
\1\ For more information regarding FDA's current efforts to
identify and address lung injuries related to the use of vaping
products, please see https://www.fda.gov/news-events/public-health-focus/lung-illnesses-associated-use-vaping-products.
---------------------------------------------------------------------------
On December 20, 2019, the President signed the ``Further
Consolidated Appropriations Act, 2020'' which directs FDA to issue a
RFI to solicit information regarding ``the recent pulmonary illnesses
reported to be associated with the use of e-cigarettes and vaping
products.'' \2\ To further this goal, FDA is seeking information
related to the use of vaping products that are associated with the
recent lung injuries, including public comment on product design and
ways to prevent the public from modifying or adding substances to these
products that are not intended by the manufacturer. This information
may be used by FDA to inform future rulemaking and review of industry
premarket application submissions, or in taking other regulatory
actions.
---------------------------------------------------------------------------
\2\ Further Consolidated Appropriations Act, 2020, Public Law
116-94, Sec. 785. FDA uses the term ``vaping products'' for
purposes of this RFI. ``Vaping products'' include e-cigarettes as
well as other electronic nicotine delivery systems (ENDS). See
``Guidance for Industry: Enforcement Priorities for Electronic
Nicotine Delivery Systems (ENDS) and Other Deemed Products on the
Market Without Premarket Authorization,'' available at https://www.fda.gov/industry/fda-basics-industry/guidances (defining
``ENDS'' as including ``include devices, components, and/or parts
that deliver aerosolized e-liquid when inhaled. For example, FDA
considers vapes or vape pens, personal vaporizers, e-cigarettes,
cigalikes, e-pens, e-hookahs, e-cigars, and e-pipes to be ENDS.'')
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II. Request for Information
FDA seeks to obtain data and information related to the use of
vaping products that are associated with recent lung injuries. FDA has
searched the publicly available scientific literature and is now
seeking to supplement that search with information from other sources,
specifically unpublished data or other information. If the work is not
directly conducted in tobacco products,
[[Page 8877]]
responses should include a discussion of how the information or data
can be applied specifically to tobacco products or to lung injuries
associated with the use of vaping products.
For this RFI, FDA is requesting: (1) Unpublished data or
information (summarized); (2) unpublished or prepublication copies of
manuscripts, conference presentations, and/or posters; (3)
dissertations and/or theses; and (4) white papers or other unpublished
reports. FDA is requesting data and information from all interested
parties, including, but not limited to, academic and government
researchers, industry, and any other sources.
Specifically, FDA is requesting unpublished data or information on
the following:
Specific chemicals, compounds, ingredients or combinations
of ingredients that when inhaled or aerosolized, may be associated with
the symptoms observed in ``e-cigarette, or vaping, product use-
associated lung injury'' (EVALI) patients; e.g., cough, chest pain,
shortness of breath, abdominal pain, nausea, vomiting, diarrhea, fever,
chills; \3\
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\3\ For more information concerning the symptoms observed in
EVALI patients, please see https://www.cdc.gov/tobacco/basic_information/e-cigarettes/severe-lung-disease/need-to-know/#symptoms.
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nature of pulmonary pathological changes associated with
inhaling the specific chemicals, compounds, ingredients, or
combinations of ingredients that elicit the symptoms observed in EVALI;
methods or sources for obtaining chemicals, compounds,
ingredients, or combinations of ingredients, other than those intended
by the manufacturer, that are added to vaping products;
in what ways and how frequently consumers add chemicals,
compounds, ingredients or combinations of ingredients, other than those
intended by the manufacturer, to vaping products and how these changes
affect the health impacts, frequency, and patterns of consumer use of
the products;
methods for identifying and detecting materials added or
modifications to vaping products after the manufacturing process and
not intended by the manufacturer; and
methods of changing the manufacturing process or product
design features for vaping products that will reduce or prevent
consumers from modifying products after the manufacturing process.
Data may come from studies outside of the United States; however,
FDA prefers that reports be submitted in English.
When submitting information, please include details about how the
data were collected, including the sample composition, year(s) of data
collection, and a detailed summary of the methods and measures used.
For data summaries, please include both point estimates and measures of
variance, as well as effect sizes (if available).
Please also note that when submitting information and data to the
docket, certain compressed file formats (e.g., zip files) are not
allowed. Acceptable file formats include: .doc, .docx, .pdf, .ppt,
.pptx, .rtf, .txt, .xls, .xlsx, .xlsm, .xlsb, and .wpd.
Dated: February 12, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-03160 Filed 2-14-20; 8:45 am]
BILLING CODE 4164-01-P
