Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Establishing That a Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007, 26120-26121 [2019-11659]
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Federal Register / Vol. 84, No. 108 / Wednesday, June 5, 2019 / Notices
B. Request and Submission of the Panel
Nominations
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
The Request for Nominations to the
Advisory Panel on Hospital Outpatient
Payment notice (83 FR 3715) provides
for nominations to be accepted on a
continuous basis to fill upcoming panel
vacancies. CMS encourages additional
submissions. Any interested person or
organization may nominate qualified
individuals. Self-nominations from
qualified individuals are also accepted.
Additional information including
criteria for nominees as well as
submission requirements are available
in the notice, which is accessible from
the CMS website at: https://
www.govinfo.gov/content/pkg/FR-201801-26/pdf/2018-01474.pdf.
As a result of that notice, we are
announcing 6 new members to the
Panel. These 6 new Panel member
appointments will assure that we
continue to have a Chair and up to 15
members available to attend our
scheduled meeting.
Food and Drug Administration
New Appointments to the Panel
• Terry Bohlke, CPA, CMA, MHA,
CASC
• Carmen Cooper-Oguz, PT, DPT, MBA,
CWS, WCC
• Paul Courtney, M.D.
• Peter Duffy, M.D.
• Lisa Gangarosa, M.D.
• Michael Kuettel, M.D., MBA, Ph.D.
IV. Collection of Information
Requirements
jbell on DSK3GLQ082PROD with NOTICES
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.).
[FR Doc. 2019–11756 Filed 6–4–19; 8:45 am]
BILLING CODE 4120–01–P
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Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance for
Industry on Establishing That a
Tobacco Product Was Commercially
Marketed in the United States as of
February 15, 2007
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by July 5,
2019.
SUMMARY:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0775. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
New members of the Panel will have
terms beginning on March 1, 2019 and
continuing through February 28, 2023.
The new members of the Panel are as
follows:
Dated: May 31, 2019.
Paul Mango,
Chief Principal Deputy Administrator and
Chief of Staff, Centers for Medicare &
Medicaid Services.
[Docket No. FDA–2011–D–0125]
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Guidance for Industry on Establishing
That a Tobacco Product Was
Commercially Marketed in the United
States as of February 15, 2007
OMB Control Number 0910–0775—
Extension
On June 22, 2009, the Family
Smoking Prevention and Tobacco
Control Act (Tobacco Control Act) (Pub.
L. 111–31) was signed into law. The
Tobacco Control Act amended the
Federal Food, Drug, and Cosmetic Act
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
(FD&C Act) by adding, among other
things, a chapter granting FDA authority
to regulate the manufacture, marketing,
and distribution of tobacco products to
protect the public health generally and
to reduce tobacco use by minors.
Section 201(rr) of the FD&C Act (21
U.S.C.321(rr)), as amended, defines a
tobacco product as any product made or
derived from tobacco that is intended
for human consumption, including any
component, part, or accessory of a
tobacco product (except for raw
materials other than tobacco used in
manufacturing a component, part, or
accessory of a tobacco product). Section
910 of the FD&C Act (21 U.S.C. 387j)
sets out premarket requirements for new
tobacco products. The term new tobacco
product is defined as any tobacco
product (including those products in
test markets) that was not commercially
marketed in the United States as of
February 15, 2007, or any modification
(including a change in design, any
component, any part, or any constituent,
including a smoke constituent, or in the
content, delivery, or form of nicotine, or
any other additive or ingredient) of a
tobacco product where the modified
product was commercially marketed in
the United States after February 15,
2007 (section 910(a)(1) of the FD&C
Act).
The Tobacco Control Act also gave
FDA the authority to issue a regulation
deeming all other products that meet the
statutory definition of a tobacco product
to be subject to chapter IX of the FD&C
Act (section 901(b) (21 U.S.C. 387a(b))
of the FD&C Act). On May 10, 2016,
FDA issued that rule, extending FDA’s
tobacco product authority to all
products that meet the definition of
tobacco product in the law (except for
accessories of newly regulated tobacco
products), including electronic nicotine
delivery systems, cigars, hookah, pipe
tobacco, nicotine gels, dissolvables that
were not already subject to the FD&C
Act, and other tobacco products that
may be developed in the future (81 FR
28974 at 28976).
FDA refers to tobacco products that
were commercially marketed (other than
exclusively in test markets) in the
United States as of February 15, 2007,
as grandfathered tobacco products.
Grandfathered tobacco products are not
considered new tobacco products and
are not subject to the premarket
requirements of section 910 of the FD&C
Act. The guidance document associated
with this information collection
provides information on how a
manufacturer may establish that a
tobacco product was commercially
marketed in the United States as of
February 15, 2007. A grandfathered
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26121
Federal Register / Vol. 84, No. 108 / Wednesday, June 5, 2019 / Notices
tobacco product may also serve as the
predicate tobacco product in a section
905(j) report (intended to be used
toward demonstrating substantial
equivalence) for a new tobacco product
(section 905(j)(1)A)(i) of the FD&C Act
(21 U.S.C. 387e(j)(1)(A)(i))).
The guidance recommends that the
manufacturer submit information
adequate to demonstrate that the
tobacco product was commercially
marketed in the United States as of
February 15, 2007. Examples of such
information may include, but are not
limited to, the following: dated copies of
advertisements, dated catalog pages,
dated promotional material, and dated
bills of lading.
In the Federal Register of October 17,
2018 (83 FR 52488), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. Two comments were
received; however, they were not PRA
related.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
FD&C Act sections or action
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
(in hours)
Total hours
Submit evidence of commercial marketing in the United
States as of February 15, 2007 .......................................
1,000
1
1,000
5
5,000
jbell on DSK3GLQ082PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA’s estimate of the number of
respondents is based on the fact that
requesting an Agency determination of
the grandfathered status of a tobacco
product under the guidance is not
required and also on the number of
grandfathered submissions received
from 2011 to June 2018. We estimate
submissions have increased due to the
effective date of the deeming rule. FDA
has stated that, for deemed combustible
products that were on the market as of
August 8, 2016, it does not intend to
initiate enforcement for failure to have
premarket authorization until August 8,
2021. FDA has also stated that, for
deemed noncombustible products that
were on the market as of August 8, 2016,
it does not intend to initiate
enforcement for failure to have
premarket authorization until August 8,
2022. Because interested persons are
seeking information on the
grandfathered status of tobacco products
in advance of these dates, FDA expects
a drop in the number of grandfathered
submissions following those dates. The
number of hours to gather the evidence
is FDA’s estimate of how long it might
take a manufacturer to review, gather,
and submit dated information if making
a request for Agency determination.
FDA further estimates it would take a
manufacturer approximately 5 hours to
put together this collection of evidence
and to submit the package to FDA for
review. FDA estimates that it would
take approximately 5,000 hours
annually to respond to this collection of
information.
Our estimated burden for the
information collection reflects an
overall increase of 4,235 hours. We
attribute this adjustment to an updated
number of submissions received
through this approval and the number of
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19:03 Jun 04, 2019
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submissions expected in the next 3
years.
Dated: May 30, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–11659 Filed 6–4–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0147]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance for
Industry and Food and Drug
Administration Staff; Section 905(j)
Reports: Demonstrating Substantial
Equivalence for Tobacco Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995
(PRA).
DATES: Fax written comments on the
collection of information by July 5,
2019.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
SUMMARY:
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
comments should be identified with the
OMB control number 0910–0673. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Guidance for Industry and Food and
Drug Administration Staff; Section
905(j) Reports: Demonstrating
Substantial Equivalence for Tobacco
Products
OMB Control Number 0910–0673—
Extension
On June 22, 2009, the Family
Smoking Prevention and Tobacco
Control Act (Tobacco Control Act) (Pub.
L. 111–31) was signed into law. The
Tobacco Control Act amended the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) by adding, among other
things, a chapter granting FDA authority
to regulate the manufacture, marketing,
and distribution of tobacco products to
protect the public health generally and
to reduce tobacco use by minors.
The FD&C Act, as amended by the
Tobacco Control Act, generally requires
that before a new tobacco product may
be introduced or delivered for
introduction into interstate commerce,
the new tobacco product must undergo
premarket review by FDA. FDA must
issue an order authorizing the
commercial distribution of the new
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05JNN1
]]>Agencies
[Federal Register Volume 84, Number 108 (Wednesday, June 5, 2019)]
[Notices]
[Pages 26120-26121]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-11659]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-D-0125]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance for Industry
on Establishing That a Tobacco Product Was Commercially Marketed in the
United States as of February 15, 2007
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by July 5,
2019.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax: 202-395-7285, or emailed to [email protected]. All
comments should be identified with the OMB control number 0910-0775.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
[email protected].
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Guidance for Industry on Establishing That a Tobacco Product Was
Commercially Marketed in the United States as of February 15, 2007
OMB Control Number 0910-0775--Extension
On June 22, 2009, the Family Smoking Prevention and Tobacco Control
Act (Tobacco Control Act) (Pub. L. 111-31) was signed into law. The
Tobacco Control Act amended the Federal Food, Drug, and Cosmetic Act
(FD&C Act) by adding, among other things, a chapter granting FDA
authority to regulate the manufacture, marketing, and distribution of
tobacco products to protect the public health generally and to reduce
tobacco use by minors.
Section 201(rr) of the FD&C Act (21 U.S.C.321(rr)), as amended,
defines a tobacco product as any product made or derived from tobacco
that is intended for human consumption, including any component, part,
or accessory of a tobacco product (except for raw materials other than
tobacco used in manufacturing a component, part, or accessory of a
tobacco product). Section 910 of the FD&C Act (21 U.S.C. 387j) sets out
premarket requirements for new tobacco products. The term new tobacco
product is defined as any tobacco product (including those products in
test markets) that was not commercially marketed in the United States
as of February 15, 2007, or any modification (including a change in
design, any component, any part, or any constituent, including a smoke
constituent, or in the content, delivery, or form of nicotine, or any
other additive or ingredient) of a tobacco product where the modified
product was commercially marketed in the United States after February
15, 2007 (section 910(a)(1) of the FD&C Act).
The Tobacco Control Act also gave FDA the authority to issue a
regulation deeming all other products that meet the statutory
definition of a tobacco product to be subject to chapter IX of the FD&C
Act (section 901(b) (21 U.S.C. 387a(b)) of the FD&C Act). On May 10,
2016, FDA issued that rule, extending FDA's tobacco product authority
to all products that meet the definition of tobacco product in the law
(except for accessories of newly regulated tobacco products), including
electronic nicotine delivery systems, cigars, hookah, pipe tobacco,
nicotine gels, dissolvables that were not already subject to the FD&C
Act, and other tobacco products that may be developed in the future (81
FR 28974 at 28976).
FDA refers to tobacco products that were commercially marketed
(other than exclusively in test markets) in the United States as of
February 15, 2007, as grandfathered tobacco products. Grandfathered
tobacco products are not considered new tobacco products and are not
subject to the premarket requirements of section 910 of the FD&C Act.
The guidance document associated with this information collection
provides information on how a manufacturer may establish that a tobacco
product was commercially marketed in the United States as of February
15, 2007. A grandfathered
[[Page 26121]]
tobacco product may also serve as the predicate tobacco product in a
section 905(j) report (intended to be used toward demonstrating
substantial equivalence) for a new tobacco product (section
905(j)(1)A)(i) of the FD&C Act (21 U.S.C. 387e(j)(1)(A)(i))).
The guidance recommends that the manufacturer submit information
adequate to demonstrate that the tobacco product was commercially
marketed in the United States as of February 15, 2007. Examples of such
information may include, but are not limited to, the following: dated
copies of advertisements, dated catalog pages, dated promotional
material, and dated bills of lading.
In the Federal Register of October 17, 2018 (83 FR 52488), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Two comments were received; however, they
were not PRA related.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
FD&C Act sections or action Number of responses per Total annual per response Total hours
respondents respondent responses (in hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submit evidence of commercial marketing in the United States as of 1,000 1 1,000 5 5,000
February 15, 2007.................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA's estimate of the number of respondents is based on the fact
that requesting an Agency determination of the grandfathered status of
a tobacco product under the guidance is not required and also on the
number of grandfathered submissions received from 2011 to June 2018. We
estimate submissions have increased due to the effective date of the
deeming rule. FDA has stated that, for deemed combustible products that
were on the market as of August 8, 2016, it does not intend to initiate
enforcement for failure to have premarket authorization until August 8,
2021. FDA has also stated that, for deemed noncombustible products that
were on the market as of August 8, 2016, it does not intend to initiate
enforcement for failure to have premarket authorization until August 8,
2022. Because interested persons are seeking information on the
grandfathered status of tobacco products in advance of these dates, FDA
expects a drop in the number of grandfathered submissions following
those dates. The number of hours to gather the evidence is FDA's
estimate of how long it might take a manufacturer to review, gather,
and submit dated information if making a request for Agency
determination.
FDA further estimates it would take a manufacturer approximately 5
hours to put together this collection of evidence and to submit the
package to FDA for review. FDA estimates that it would take
approximately 5,000 hours annually to respond to this collection of
information.
Our estimated burden for the information collection reflects an
overall increase of 4,235 hours. We attribute this adjustment to an
updated number of submissions received through this approval and the
number of submissions expected in the next 3 years.
Dated: May 30, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-11659 Filed 6-4-19; 8:45 am]
BILLING CODE 4164-01-P
