General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice, 24157 [2019-10900]
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Federal Register / Vol. 84, No. 101 / Friday, May 24, 2019 / Notices
performance of the functions of the
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(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
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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]
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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:
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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
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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
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[Federal Register Volume 84, Number 101 (Friday, May 24, 2019)]
[Notices]
[Page 24157]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-10900]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
-----------------------------------------------------------------------
SUMMARY: 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, [email protected]; 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 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
