Enforcement Policy for Certain Marketed Tobacco Products; Draft Guidance for Industry; Availability, 7084-7085 [2019-03657]
Download as PDF
jbell on DSK30RV082PROD with NOTICES
7084
Federal Register / Vol. 84, No. 41 / Friday, March 1, 2019 / Notices
limited; therefore, FDA may limit the
number of participants from each
organization. Registrants will receive
confirmation when their registration has
been received. If time and space permit,
onsite registration on the day of the
public meeting will be provided
beginning an hour prior to the start of
the meeting.
If you need special accommodations
due to a disability, please contact
Eleanor Dixon-Terry, at 301–796–7634,
or OOPDOrphanEvents@fda.hhs.gov no
later than April 15, 2019.
Requests for Oral Presentations:
Patients and patient representatives who
are interested in presenting comments
as part of the initial panel discussions
will be asked to indicate in their
registration which topic(s) they wish to
address. These patients and patient
representatives also must send to
Eleanor Dixon-Terry
(OOPDOrphanEvents@fda.hhs.gov or
301–796–7634) a brief summary of
responses to the meeting topics by April
1, 2019. Details regarding the meeting
agenda and topics will be available at
https://www.fda.gov/NewsEvents/
MeetingsConferencesWorkshops/
ucm628352.htm.
FDA will hold an open public
comment period to give the public an
opportunity to comment. Registration
for open public comment will occur in
the meeting registration and at the
registration desk on the day of the
meeting on a first-come, first-served
basis.
Panelists and open public comment
period speakers will be notified of their
selection approximately 7 days before
the public meeting. We will try to
accommodate all patients and patient
representatives who wish to speak,
either through the panel discussion, an
open public comment period, or
audience participation; however, the
duration of comments may be limited by
time constraints.
Streaming Webcast of the Public
Meeting: For those unable to attend in
person, FDA will provide a live webcast
of the meeting. To register for the
streaming webcast of the public
meeting, please visit the following
website by April 28, 2019: https://
www.fda.gov/NewsEvents/
MeetingsConferencesWorkshops/
ucm628352.htm.
If you have never attended a Connect
Pro event before, test your connection at
https://collaboration.fda.gov/common/
help/en/support/meeting_test.htm. To
get a quick overview of the Connect Pro
program, visit https://www.adobe.com/
go/connectpro_overview. FDA has
verified the website addresses in this
document, as of the date this document
VerDate Sep<11>2014
18:13 Feb 28, 2019
Jkt 247001
publishes in the Federal Register, but
websites are subject to change over time.
Transcripts: Please be advised that as
soon as a transcript of the public
meeting is available, it will be accessible
at https://www.regulations.gov. It may
be viewed at the Dockets Management
Staff (see ADDRESSES). A link to the
transcript will also be available on the
internet at https://www.fda.gov/News
Events/MeetingsConferencesWorkshops/
ucm628352.htm.
Dated: February 26, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019–03675 Filed 2–28–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–3244]
Enforcement Policy for Certain
Marketed Tobacco Products; Draft
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Enforcement Policy
for Certain Marketed Tobacco
Products.’’ FDA is issuing this draft
guidance to provide information
regarding FDA’s enforcement policy for
certain marketed tobacco products that
become the subject of a not substantially
equivalent (NSE) order. This policy
primarily involves ‘‘provisional’’
tobacco products that become subject to
NSE orders issued under the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) (provisional tobacco products are
tobacco products that were first
introduced or delivered for introduction
into interstate commerce for commercial
distribution after February 15, 2007, and
prior to March 22, 2011, and for which
a substantial equivalence report (SE
Report) was submitted no later than
March 22, 2011). The draft guidance
also provides information on FDA’s
enforcement policy when an applicant
files a request for supervisory review of
an NSE order.
DATES: Submit either electronic or
written comments on the draft guidance
by April 30, 2019 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
You may submit comments
on any guidance at any time as follows:
ADDRESSES:
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–
2018–D–3244 for ‘‘Enforcement Policy
for Certain Marketed Tobacco
Products.’’ 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
E:\FR\FM\01MRN1.SGM
01MRN1
jbell on DSK30RV082PROD with NOTICES
Federal Register / Vol. 84, No. 41 / Friday, March 1, 2019 / Notices
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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of this draft guidance to the
Center for Tobacco Products, Food and
Drug Administration, Document Control
Center, 10903 New Hampshire Ave.,
Bldg. 71, Rm. G335, Silver Spring, MD
20993–0002. Send one self-addressed
adhesive label to assist that office in
processing your request or include a fax
number to which the draft guidance
may be sent. See the SUPPLEMENTARY
INFORMATION section for information on
electronic access to the draft guidance.
FOR FURTHER INFORMATION CONTACT:
Annette Marthaler, 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:
CTPRegulations@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
VerDate Sep<11>2014
18:13 Feb 28, 2019
Jkt 247001
‘‘Enforcement Policy for Certain
Marketed Tobacco Products.’’ FDA is
issuing this draft guidance to provide
information regarding FDA’s
enforcement policy for certain marketed
tobacco products that become the
subject of an NSE order. This policy
primarily involves provisional tobacco
products that become subject to NSE
orders issued under section 910(a)(2)(B)
of the FD&C Act (21 U.S.C.
387j(a)(2)(B)). This policy extends to
new tobacco products created by
modifying the quantity of a provisional
tobacco product in a pending SE Report
that become subject to NSE orders. The
draft guidance also provides
information on FDA’s enforcement
policy for when FDA receives from an
applicant a request for supervisory
review under 21 CFR 10.75 within 30
calendar days of the issue date of the
NSE order. The draft guidance provides
that for these new tobacco products,
FDA intends to offer copies of those
final scientific reviews that supported
the basis of the Agency’s decision to the
applicant concurrent with the NSE
order for provisional tobacco products.
II. Significance of Draft Guidance
FDA is issuing this draft guidance
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘Enforcement Policy for Certain
Marketed Tobacco Products,’’ and will
supersede ‘‘Enforcement Policy for
Certain (Provisional) Tobacco Products
That the Food and Drug Administration
Finds Not Substantially Equivalent;
Guidance for Industry and Tobacco
Retailers’’ (the availability of which was
announced in the Federal Register (80
FR 55124, September 14, 2015)). It does
not establish any rights for any person
and is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations. This
guidance is not subject to Executive
Order 12866.
III. Electronic Access
Persons with access to the internet
may obtain an electronic version of the
draft guidance at either https://
www.regulations.gov or https://
www.fda.gov/TobaccoProducts/
GuidanceComplianceRegulatory
Information/default.htm.
Dated: February 25, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019–03657 Filed 2–28–19; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
Frm 00070
Fmt 4703
Sfmt 4703
7085
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Retail Pharmacy Interest in Utilization
of Innovative Educational Technology
To Increase Human Papillomavirus
(HPV) Vaccination Rates in Rural
Areas; Correction
National Vaccine Program
Office, Office of the Assistant Secretary
for Health, Office of the Secretary,
Department of Health and Human
Services.
ACTION: Notice; correction.
AGENCY:
SUMMARY: The Department of Health and
Human Services published a document
in the Federal Register of February 15,
2019, concerning a request for
information (RFI) for informational and
planning purposes only. We would like
to extend the deadline in order to
provide more time to the public to
submit their response.
FOR FURTHER INFORMATION CONTACT: Kara
Elam, National Vaccine Program Office,
Office of the Assistant Secretary for
Health, Department of Health and
Human Services; telephone (202) 690–
5566; email: nvpo@hhs.gov.
SUPPLEMENTARY INFORMATION:
Correction
In the Federal of February 15, 2019,
in FR Doc. 2019–02548, on page 4483,
in the first column, correct the DATES
caption to read:
DATES: Information from retail
pharmacies with greater than 100 stores
in geographic areas considered to be
rural by the census definition (<50,000
population) should submit responses to
this RFI as described in the addresses
section below no later than midnight,
12:00 a.m. EDT on March 15, 2019.
Dated: February 25, 2019.
Tammy Beckham,
Acting Director, National Vaccine Program
Office.
[FR Doc. 2019–03698 Filed 2–28–19; 8:45 am]
BILLING CODE 4150–44–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Drug Abuse;
Notice of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
E:\FR\FM\01MRN1.SGM
01MRN1
Agencies
[Federal Register Volume 84, Number 41 (Friday, March 1, 2019)]
[Notices]
[Pages 7084-7085]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-03657]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-D-3244]
Enforcement Policy for Certain Marketed Tobacco Products; Draft
Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Enforcement
Policy for Certain Marketed Tobacco Products.'' FDA is issuing this
draft guidance to provide information regarding FDA's enforcement
policy for certain marketed tobacco products that become the subject of
a not substantially equivalent (NSE) order. This policy primarily
involves ``provisional'' tobacco products that become subject to NSE
orders issued under the Federal Food, Drug, and Cosmetic Act (FD&C Act)
(provisional tobacco products are tobacco products that were first
introduced or delivered for introduction into interstate commerce for
commercial distribution after February 15, 2007, and prior to March 22,
2011, and for which a substantial equivalence report (SE Report) was
submitted no later than March 22, 2011). The draft guidance also
provides information on FDA's enforcement policy when an applicant
files a request for supervisory review of an NSE order.
DATES: Submit either electronic or written comments on the draft
guidance by April 30, 2019 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments on any guidance at any time 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-2018-D-3244 for ``Enforcement Policy for Certain Marketed Tobacco
Products.'' 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
[[Page 7085]]
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.gpo.gov/fdsys/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.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of this draft guidance to
the Center for Tobacco Products, Food and Drug Administration, Document
Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request or include a fax number to which
the draft guidance may be sent. See the SUPPLEMENTARY INFORMATION
section for information on electronic access to the draft guidance.
FOR FURTHER INFORMATION CONTACT: Annette Marthaler, 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: CTPRegulations@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Enforcement Policy for Certain Marketed Tobacco Products.''
FDA is issuing this draft guidance to provide information regarding
FDA's enforcement policy for certain marketed tobacco products that
become the subject of an NSE order. This policy primarily involves
provisional tobacco products that become subject to NSE orders issued
under section 910(a)(2)(B) of the FD&C Act (21 U.S.C. 387j(a)(2)(B)).
This policy extends to new tobacco products created by modifying the
quantity of a provisional tobacco product in a pending SE Report that
become subject to NSE orders. The draft guidance also provides
information on FDA's enforcement policy for when FDA receives from an
applicant a request for supervisory review under 21 CFR 10.75 within 30
calendar days of the issue date of the NSE order. The draft guidance
provides that for these new tobacco products, FDA intends to offer
copies of those final scientific reviews that supported the basis of
the Agency's decision to the applicant concurrent with the NSE order
for provisional tobacco products.
II. Significance of Draft Guidance
FDA is issuing this draft guidance consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Enforcement
Policy for Certain Marketed Tobacco Products,'' and will supersede
``Enforcement Policy for Certain (Provisional) Tobacco Products That
the Food and Drug Administration Finds Not Substantially Equivalent;
Guidance for Industry and Tobacco Retailers'' (the availability of
which was announced in the Federal Register (80 FR 55124, September 14,
2015)). It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.
This guidance is not subject to Executive Order 12866.
III. Electronic Access
Persons with access to the internet may obtain an electronic
version of the draft guidance at either https://www.regulations.gov or
https://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm.
Dated: February 25, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-03657 Filed 2-28-19; 8:45 am]
BILLING CODE 4164-01-P