Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Establishing That a Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007, 52488-52490 [2018-22578]
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52488
Federal Register / Vol. 83, No. 201 / Wednesday, October 17, 2018 / Notices
Medicare beneficiaries to falsify weekly
visit/time record sheets indicating that
she provided skilled nursing services
twice a day, 7 days a week, when she
did not provide those services with such
frequency. Gil falsified daily blood
sugar/insulin log sheets stating that she
administered insulin injections and
provided other medical services to
Medicare beneficiaries when she did not
provide those services. Lastly, Gil
created false weekly visit/time records
claiming that she provided skilled
nursing services to two separate
Medicare beneficiaries at the same time
and she caused local home health
agencies to submit false and fraudulent
claims that falsely represented that she
provided home health services to
eligible Medicare beneficiaries.
By letter dated March 18, 2014, FDA’s
Office of Regulatory Affairs (ORA)
notified Gil of a proposal to debar her
for 6 years from providing services in
any capacity to a person that has an
approved or pending drug product
application. The proposal explained
that the proposed debarment period was
based on her 12 felony convictions. The
proposal stated that maximum
debarment period for each offense is 5
years and that FDA may determine
whether debarment periods for multiple
offenses should run concurrently or
consecutively.
The proposal outlined findings
regarding the four applicable factors
ORA considered in determining the
appropriateness and period of
debarment, as provided in section
306(c)(3) of the FD&C Act: (1) The
nature and seriousness of the offense,
(2) the nature and extent of management
participation in any offense, (3) the
nature and extent of voluntary steps to
mitigate the impact on the public, and
(4) prior convictions under the FD&C
Act or other acts involving matters
within FDA’s jurisdiction. ORA found
that the nature and seriousness of the
offenses and her failure to take
voluntary steps to mitigate the impact of
her offenses were unfavorable factors for
Gil. ORA found that her lack of prior
convictions was a favorable factor for
Gil. Finally, ORA found that the
management participation factor was
not applicable based on the information
in the record. ORA concluded that ‘‘the
unfavorable factors cumulatively
outweigh the favorable factors and that
debarment is appropriate.’’ ORA
proposed that each felony offense
should have a 3-year debarment period.
ORA further proposed that the 3-year
debarment period for each healthcare
fraud conviction should run
concurrently and that the 3-year
debarment period for each false
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statement conviction should run
concurrently, for a total debarment
period of 6 years.
The proposal offered Gil the
opportunity to request a hearing,
providing her 30 days from the date of
receipt of the letter to file the request
and 60 days from the date of receipt of
the letter to support her request with
information sufficient to justify a
hearing. In a letter dated May 9, 2014,
through counsel, Gil filed a request for
hearing and indicated that she had not
received the proposal until April 10,
2014. She also stated that the
information justifying the hearing
request would be forthcoming. More
than 60 days have passed from the date
Gil represents she received FDA’s letter,
and she has not filed any information,
or any legal or policy arguments, to
support her request.
Under the authority delegated to him
by the Commissioner of Food and
Drugs, the Acting Director of the Office
of Scientific Integrity (OSI) has
considered Gil’s request for a hearing.
Hearings will not be granted on issues
of policy or law, on mere allegations,
denials, or general descriptions of
positions and contentions, or on data
and information insufficient to justify
the factual determination urged (see 21
CFR 21.24(b)).
Inasmuch as Gil has not presented
any information to support her hearing
request, OSI concludes that Gil has
failed to raise a genuine and substantial
issue of fact requiring a hearing.
Therefore, OSI denies Gil’s request for a
hearing. Further, Gil has not presented
any arguments concerning whether
debarment is appropriate for each of her
felony convictions or whether the
proposed debarment periods are
appropriate. Based on the factual
findings in the proposal to debar, OSI
finds that a 3-year debarment period for
each felony offense is appropriate and
that the 3-year debarment period for
each healthcare fraud conviction should
run concurrently and that the 3-year
debarment period for each false
statement conviction should run
concurrently, for a resulting total
debarment of 6 years.
II. Findings and Order
Therefore, the Director of OSI, under
section 306(b)(2)(B)(i)(I) of the FD&C
Act and authority delegated to him by
the Commissioner of Food and Drugs,
finds that: (1) Gil was convicted of a
felony that involves bribery, payment of
illegal gratuities, fraud, perjury, false
statement, racketeering, blackmail,
extortion, falsification or destruction of
records, or interference with,
obstruction of an investigation into, or
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prosecution of, any criminal offense and
(2) based on the conviction and other
information, Gil demonstrated a pattern
of conduct giving reason to believe that
she may violate requirements under the
FD&C Act relating to drug products.
FDA considered the applicable factors
listed in section 306(c)(3) of the FD&C
Act and determined that a 6-year
debarment is appropriate.
As a result of the foregoing findings,
Isachi Gil is debarred for 6 years from
providing services in any capacity to a
person with an approved or pending
drug product application under sections
505, 512, or 802 of the FD&C Act (21
U.S.C. 355, 360b, or 382), or under
section 351 of the Public Health Service
Act (42 U.S.C. 262), effective (see
DATES), (see 21 U.S.C. 335a(c)(1)(B) and
(c)(2)(A)(iii) and 21 U.S.C. 321(dd)).
Any person with an approved or
pending drug application who
knowingly uses the services of Gil, in
any capacity during her debarment, will
be subject to civil money penalties
(section 307(a)(6) of the FD&C Act (21
U.S.C. 335b(a)(6))). If Gil, during her
period of debarment, provides services
in any capacity to a person with an
approved or pending drug product
application, she will be subject to civil
money penalties (section 307(a)(7) of the
FD&C Act). In addition, FDA will not
accept or review any abbreviated new
drug applications submitted by or with
the assistance of Gil during her period
of debarment (section 306(c)(1)(B) of the
FD&C Act).
Dated: October 10, 2018.
George M. Warren,
Director, Office of Scientific Integrity.
[FR Doc. 2018–22581 Filed 10–16–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0125]
Agency Information Collection
Activities; Proposed Collection;
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 or Agency) is
announcing an opportunity for public
comment on the proposed collection of
SUMMARY:
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Federal Register / Vol. 83, No. 201 / Wednesday, October 17, 2018 / Notices
daltland on DSKBBV9HB2PROD with NOTICES
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the guidance for
industry entitled ‘‘Establishing That a
Tobacco Product Was Commercially
Marketed in the United States as of
February 15, 2007.’’
DATES: Submit either electronic or
written comments on the collection of
information by December 17, 2018.
ADDRESSES: 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 December 17,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of December 17, 2018.
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.
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:
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• 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–
2011–D–0125 for the guidance for
industry entitled ‘‘Establishing That a
Tobacco Product Was Commercially
Marketed in the United States as of
February 15, 2007.’’ 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
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.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
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52489
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:
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.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
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 President
signed the Family Smoking Prevention
and Tobacco Control Act (Tobacco
Control Act) (Pub. L. 111–31) into law.
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Federal Register / Vol. 83, No. 201 / Wednesday, October 17, 2018 / Notices
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 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 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.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
FD&C Act sections or action
Submit evidence of commercial marketing in the United
States as of February 15, 2007 .......................................
daltland on DSKBBV9HB2PROD with NOTICES
1 There
Number of
responses per
respondent
1,000
Average
burden per
response
(in hours)
Total
annual
responses
1
1,000
Total hours
5
5,000
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 2, 2016,
it does not intend to initiate
enforcement for failure to have
premarket authorization until August 8,
2022. When these compliance periods
end, FDA expects a drop in the number
of grandfathered submissions. The
number of hours to gather the evidence
is FDA’s estimate of how long it might
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take one 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 should
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: October 11, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–22578 Filed 10–16–18; 8:45 am]
BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–3163]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Physician
Interpretation of Information About
Prescription Drugs in Scientific
Publications Versus Promotional
Pieces
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
SUMMARY:
E:\FR\FM\17OCN1.SGM
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]]>Agencies
[Federal Register Volume 83, Number 201 (Wednesday, October 17, 2018)]
[Notices]
[Pages 52488-52490]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-22578]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-D-0125]
Agency Information Collection Activities; Proposed Collection;
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 or Agency) is announcing
an opportunity for public comment on the proposed collection of
[[Page 52489]]
certain information by the Agency. Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the guidance for industry
entitled ``Establishing That a Tobacco Product Was Commercially
Marketed in the United States as of February 15, 2007.''
DATES: Submit either electronic or written comments on the collection
of information by December 17, 2018.
ADDRESSES: 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 December 17, 2018. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of December 17, 2018. 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.
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-2011-D-0125 for the guidance for industry entitled ``Establishing
That a Tobacco Product Was Commercially Marketed in the United States
as of February 15, 2007.'' 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 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.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.
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: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
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 President signed the Family Smoking
Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. L. 111-
31) into law.
[[Page 52490]]
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 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 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.
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 1,000 1 1,000 5 5,000
marketing in the United States
as of 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 2, 2016, it does not intend to initiate
enforcement for failure to have premarket authorization until August 8,
2022. When these compliance periods end, FDA expects a drop in the
number of grandfathered submissions. The number of hours to gather the
evidence is FDA's estimate of how long it might take one 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 should 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: October 11, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-22578 Filed 10-16-18; 8:45 am]
BILLING CODE 4164-01-P
