Electronic Nicotine Delivery System Device and E-Liquid Manufacturer Site Tours Program, 24157-24158 [2019-10898]
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Federal Register / Vol. 84, No. 101 / Friday, May 24, 2019 / Notices
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) the quality, utility,
and clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Consideration will be given
to comments and suggestions submitted
within 60 days of this publication.
Authority: Pub. L. 105–285, [42 U.S.C. 604
note].
Mary B. Jones,
ACF/OPRE Certifying Officer.
column, in the DATES section, the
sentence ‘‘The meeting will be held on
May 30, 2019, from 10 a.m. to 4 p.m.
and on May 31, 2019, from 8 a.m. to 4
p.m.’’ is changed to read as follows:
The meeting will be held on May 30,
2019, from 9 a.m. to 4 p.m. and on May
31, 2019, from 8 a.m. to 4 p.m.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to the advisory committees.
Dated: May 21, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–10900 Filed 5–23–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2019–10863 Filed 5–23–19; 8:45 am]
BILLING CODE 4184–24–P
Food and Drug Administration
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2019–N–2037]
Electronic Nicotine Delivery System
Device and E-Liquid Manufacturer Site
Tours Program
Food and Drug Administration
[Docket No. FDA–2019–N–1281]
General and Plastic Surgery Devices
Panel of the Medical Devices Advisory
Committee; Amendment of Notice
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
amendment to the notice of meeting of
the General and Plastic Surgery Devices
Panel of the Medical Devices Advisory
Committee. This meeting was
announced in the Federal Register of
April 24, 2019. The amendment is being
made to reflect a change in the DATES
portion of the document. There are no
other changes.
FOR FURTHER INFORMATION CONTACT:
Patricio Garcia, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G610, Silver Spring,
MD 20993, 301–796–6875,
Patricio.garcia@fda.hhs.gov; or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area). Please call the
Information Line for up-to-date
information on this meeting.
SUPPLEMENTARY INFORMATION: In the
Federal Register of April 24, 2019 (84
FR 17173), FDA announced that a
meeting of the General and Plastic
Surgery Devices Panel of the Medical
Devices Advisory Committee would be
held on May 30, 2019, from 10 a.m. to
4 p.m. On page 17173, in the third
khammond on DSKBBV9HB2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:10 May 23, 2019
Jkt 247001
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA), Center for
Tobacco Products (CTP), is announcing
an invitation for participation in its
voluntary Electronic Nicotine Delivery
System (ENDS) Device and E-Liquid
Manufacturer Site Tours Program. This
program is intended to give CTP staff an
opportunity to visit facilities that
develop, manufacture, or test ENDS
devices or e-liquids (including pods or
cartridges) to gain a better
understanding of the processes involved
in the development, manufacturing, and
testing of ENDS devices and e-liquids.
The site tours in this program are not
intended as regulatory inspections. The
purpose of this document is to invite
ENDS device or e-liquid manufacturers
that can demonstrate assembly process
and present supply chain information,
and laboratories that conduct ENDS
aerosol and e-liquid testing, that are
interested in participating in the ENDS
Device and E-Liquid Manufacturer Site
Tours Program to submit requests to
CTP.
DATES: Submit either an electronic or
written request for participation in this
program by July 23, 2019. See section IV
of this document for information on
requests for participation.
ADDRESSES: If your facility is interested
in participating in a facility visit, please
submit a request either electronically to
SUMMARY:
PO 00000
Frm 00083
Fmt 4703
Sfmt 4703
24157
https://www.regulations.gov or in
writing to the Dockets Management Staff
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Karla Price, Office of Science, Center for
Tobacco Products, Food and Drug
Administration, Document Control
Center, 10903 New Hampshire Ave.,
Bldg. 71, Rm. G335, Silver Spring, MD
20993–0002, 1–877–287–1373, email:
AskCTP@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
On June 22, 2009, the Family
Smoking Prevention and Tobacco
Control Act (Pub. L. 111–31) (Tobacco
Control Act) was signed into law,
amending the Federal Food, Drug, and
Cosmetic Act (FD&C Act) by, among
other things, adding a new chapter
(chapter IX) granting FDA the authority
to regulate tobacco product
manufacturing, distribution, and
marketing. The Tobacco Control Act
provides FDA authority to regulate
cigarettes, cigarette tobacco, roll-yourown tobacco, smokeless tobacco, and
any other tobacco products that the
Agency by regulation deems to be
subject to the law.
On May 10, 2016, FDA published a
final rule entitled ‘‘Deeming Tobacco
Products To Be Subject to the Federal
Food, Drug, and Cosmetic Act, as
Amended by the Family Smoking
Prevention and Tobacco Control Act;
Restrictions on the Sale and Distribution
of Tobacco Products and Required
Warning Statements for Tobacco
Products’’ (81 FR 28974), which became
effective on August 8, 2016. Under this
rule, all products, such as ENDS, that
meet the statutory definition of ‘‘tobacco
product’’ set forth in section 201(rr) of
the FD&C Act (21 U.S.C. 321(rr)),
including components and parts, but
excluding accessories of newly deemed
products, are now subject to chapter IX
of the FD&C Act.
CTP’s Office of Science is conducting
the ENDS Device and E-Liquid
Manufacturer Site Tours Program to
provide its staff an opportunity to visit
facilities that develop, manufacture, or
test ENDS devices or e-liquids
(including pods or cartridges). The
ENDS device and e-liquid facilities are
regulated by FDA if they, among other
things, manufacture products that meet
the statutory definition of a ‘‘tobacco
product’’ set forth in section 201(rr) of
the FD&C Act. The site tours will aid the
Agency in gaining a better
understanding of the processes involved
in developing, manufacturing, and
E:\FR\FM\24MYN1.SGM
24MYN1
24158
Federal Register / Vol. 84, No. 101 / Friday, May 24, 2019 / Notices
testing ENDS devices and e-liquids
(including pods or cartridges).
ADDRESSES) between 9 a.m. and 4 p.m.,
Monday through Friday.
II. Description of ENDS Device and ELiquid Manufacturer Site Tours
Program
Dated: May 20, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
In the ENDS Device and E-Liquid
Manufacturer Site Tours Program, CTP
staff will observe the operations of
ENDS device and e-liquid
manufacturers, including the
development, manufacturing, and
testing of ENDS devices and e-liquids.
The site tours in this program are not
intended as regulatory inspections;
rather, the program is meant to educate
CTP staff and improve their
understanding of ENDS devices and eliquids. It is anticipated that the site
tours will take place in 2020.
[FR Doc. 2019–10898 Filed 5–23–19; 8:45 am]
III. Site Selection
CTP hopes to be able to tour the
facilities of different size manufacturers
of ENDS devices, as well as facilities
that develop or manufacture e-liquids
(including pods and cartridges). This
includes laboratories that test e-liquids
or aerosols. Final site selections will be
based on the availability of funds and
resources for the relevant fiscal year as
well as the desire to visit a wide variety
of ENDS device and e-liquid
manufacturers. FDA plans on visiting
five or fewer ENDS device or e-liquid
manufacturers. All travel expenses
associated with the ENDS Device and ELiquid Manufacturer site tours will be
the responsibility of FDA.
khammond on DSKBBV9HB2PROD with NOTICES
To aid in site selection, your request
for participation should include the
following information:
• A description of your company,
including the size of the organization;
• A list of the ENDS devices and eliquids your company develops or
manufactures, including whether the
company performs e-liquid and aerosol
testing;
• The name and contact information
(including address, phone number, and
email) of your point of contact for the
request;
• The physical address(es) of the
site(s) for which you are submitting a
request; and
• A proposed 1-day agenda that will
aid with planning travel, indicating start
and end times and provides addresses of
all sites during the tour.
Identify requests for participation
with the docket number found in
brackets in the heading of this
document. Received requests are
available for public examination in the
Dockets Management Staff (see
18:10 May 23, 2019
Jkt 247001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–E–5055]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; EDWARDS INTUITY ELITE
AORTIC VALVE
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for EDWARDS INTUITY ELITE AORTIC
VALVE and is publishing this notice of
that determination as required by law.
FDA has made the determination
because of the submission of an
application to the Director of the U.S.
Patent and Trademark Office (USPTO),
Department of Commerce, for the
extension of a patent which claims that
medical device.
SUMMARY:
Anyone with knowledge that any
of the dates as published (in the
SUPPLEMENTARY INFORMATION section) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by July 23, 2019.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
November 20, 2019. See ‘‘Petitions’’ in
the SUPPLEMENTARY INFORMATION section
for more information.
DATES:
IV. Requests for Participation
VerDate Sep<11>2014
BILLING CODE 4164–01–P
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 July 23, 2019.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of November 20, 2019.
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.
ADDRESSES:
PO 00000
Frm 00084
Fmt 4703
Sfmt 4703
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–
2017–E–5055 for ‘‘Determination of
Regulatory Review Period for Purposes
of Patent Extension; EDWARDS
INTUITY ELITE AORTIC VALVE.’’
Received comments, those filed in a
timely manner (see ADDRESSES), 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
E:\FR\FM\24MYN1.SGM
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]]>Agencies
[Federal Register Volume 84, Number 101 (Friday, May 24, 2019)]
[Notices]
[Pages 24157-24158]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-10898]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-2037]
Electronic Nicotine Delivery System Device and E-Liquid
Manufacturer Site Tours Program
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA), Center for Tobacco
Products (CTP), is announcing an invitation for participation in its
voluntary Electronic Nicotine Delivery System (ENDS) Device and E-
Liquid Manufacturer Site Tours Program. This program is intended to
give CTP staff an opportunity to visit facilities that develop,
manufacture, or test ENDS devices or e-liquids (including pods or
cartridges) to gain a better understanding of the processes involved in
the development, manufacturing, and testing of ENDS devices and e-
liquids. The site tours in this program are not intended as regulatory
inspections. The purpose of this document is to invite ENDS device or
e-liquid manufacturers that can demonstrate assembly process and
present supply chain information, and laboratories that conduct ENDS
aerosol and e-liquid testing, that are interested in participating in
the ENDS Device and E-Liquid Manufacturer Site Tours Program to submit
requests to CTP.
DATES: Submit either an electronic or written request for participation
in this program by July 23, 2019. See section IV of this document for
information on requests for participation.
ADDRESSES: If your facility is interested in participating in a
facility visit, please submit a request either electronically to
https://www.regulations.gov or in writing to the Dockets Management
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Karla Price, Office of Science, Center
for Tobacco Products, Food and Drug Administration, Document Control
Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD
20993-0002, 1-877-287-1373, email: [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
On June 22, 2009, the Family Smoking Prevention and Tobacco Control
Act (Pub. L. 111-31) (Tobacco Control Act) was signed into law,
amending the Federal Food, Drug, and Cosmetic Act (FD&C Act) by, among
other things, adding a new chapter (chapter IX) granting FDA the
authority to regulate tobacco product manufacturing, distribution, and
marketing. The Tobacco Control Act provides FDA authority to regulate
cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless
tobacco, and any other tobacco products that the Agency by regulation
deems to be subject to the law.
On May 10, 2016, FDA published a final rule entitled ``Deeming
Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic
Act, as Amended by the Family Smoking Prevention and Tobacco Control
Act; Restrictions on the Sale and Distribution of Tobacco Products and
Required Warning Statements for Tobacco Products'' (81 FR 28974), which
became effective on August 8, 2016. Under this rule, all products, such
as ENDS, that meet the statutory definition of ``tobacco product'' set
forth in section 201(rr) of the FD&C Act (21 U.S.C. 321(rr)), including
components and parts, but excluding accessories of newly deemed
products, are now subject to chapter IX of the FD&C Act.
CTP's Office of Science is conducting the ENDS Device and E-Liquid
Manufacturer Site Tours Program to provide its staff an opportunity to
visit facilities that develop, manufacture, or test ENDS devices or e-
liquids (including pods or cartridges). The ENDS device and e-liquid
facilities are regulated by FDA if they, among other things,
manufacture products that meet the statutory definition of a ``tobacco
product'' set forth in section 201(rr) of the FD&C Act. The site tours
will aid the Agency in gaining a better understanding of the processes
involved in developing, manufacturing, and
[[Page 24158]]
testing ENDS devices and e-liquids (including pods or cartridges).
II. Description of ENDS Device and E-Liquid Manufacturer Site Tours
Program
In the ENDS Device and E-Liquid Manufacturer Site Tours Program,
CTP staff will observe the operations of ENDS device and e-liquid
manufacturers, including the development, manufacturing, and testing of
ENDS devices and e-liquids. The site tours in this program are not
intended as regulatory inspections; rather, the program is meant to
educate CTP staff and improve their understanding of ENDS devices and
e-liquids. It is anticipated that the site tours will take place in
2020.
III. Site Selection
CTP hopes to be able to tour the facilities of different size
manufacturers of ENDS devices, as well as facilities that develop or
manufacture e-liquids (including pods and cartridges). This includes
laboratories that test e-liquids or aerosols. Final site selections
will be based on the availability of funds and resources for the
relevant fiscal year as well as the desire to visit a wide variety of
ENDS device and e-liquid manufacturers. FDA plans on visiting five or
fewer ENDS device or e-liquid manufacturers. All travel expenses
associated with the ENDS Device and E-Liquid Manufacturer site tours
will be the responsibility of FDA.
IV. Requests for Participation
To aid in site selection, your request for participation should
include the following information:
A description of your company, including the size of the
organization;
A list of the ENDS devices and e-liquids your company
develops or manufactures, including whether the company performs e-
liquid and aerosol testing;
The name and contact information (including address, phone
number, and email) of your point of contact for the request;
The physical address(es) of the site(s) for which you are
submitting a request; and
A proposed 1-day agenda that will aid with planning
travel, indicating start and end times and provides addresses of all
sites during the tour.
Identify requests for participation with the docket number found in
brackets in the heading of this document. Received requests are
available for public examination in the Dockets Management Staff (see
ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday.
Dated: May 20, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-10898 Filed 5-23-19; 8:45 am]
BILLING CODE 4164-01-P
