[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]


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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.

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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that are unpublished or not available through indexed bibliographic 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: 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 
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.
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    \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.
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    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.
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    \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/index.html#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


