83 FR 52488 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 201 (October 17, 2018)

Page Range		52488-52490
FR Document		2018-22578

The Food and Drug Administration (FDA or Agency) 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 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.''

Federal Register, Volume 83 Issue 201 (Wednesday, October 17, 2018)

[Federal Register Volume 83, Number 201 (Wednesday, October 17, 2018)]
[Notices]
[Pages 52488-52490]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-22578]

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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.thefederalregister.org/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,
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.

[[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

52488 Federal Register / Vol. 83, No. 201 / Wednesday, October 17, 2018 / Notices

Medicare beneficiaries to falsify weekly statement conviction should run prosecution of, any criminal offense and
visit/time record sheets indicating that concurrently, for a total debarment (2) based on the conviction and other
she provided skilled nursing services period of 6 years. information, Gil demonstrated a pattern
twice a day, 7 days a week, when she The proposal offered Gil the of conduct giving reason to believe that
did not provide those services with such opportunity to request a hearing, she may violate requirements under the
frequency. Gil falsified daily blood providing her 30 days from the date of FD&C Act relating to drug products.
sugar/insulin log sheets stating that she receipt of the letter to file the request FDA considered the applicable factors
administered insulin injections and and 60 days from the date of receipt of listed in section 306(c)(3) of the FD&C
provided other medical services to the letter to support her request with Act and determined that a 6-year
Medicare beneficiaries when she did not information sufficient to justify a debarment is appropriate.
provide those services. Lastly, Gil hearing. In a letter dated May 9, 2014, As a result of the foregoing findings,
created false weekly visit/time records through counsel, Gil filed a request for Isachi Gil is debarred for 6 years from
claiming that she provided skilled hearing and indicated that she had not providing services in any capacity to a
nursing services to two separate received the proposal until April 10, person with an approved or pending
Medicare beneficiaries at the same time 2014. She also stated that the drug product application under sections
and she caused local home health information justifying the hearing 505, 512, or 802 of the FD&C Act (21
agencies to submit false and fraudulent request would be forthcoming. More U.S.C. 355, 360b, or 382), or under
claims that falsely represented that she than 60 days have passed from the date section 351 of the Public Health Service
provided home health services to Gil represents she received FDA’s letter, Act (42 U.S.C. 262), effective (see
eligible Medicare beneficiaries. and she has not filed any information, DATES), (see 21 U.S.C. 335a(c)(1)(B) and
By letter dated March 18, 2014, FDA’s or any legal or policy arguments, to (c)(2)(A)(iii) and 21 U.S.C. 321(dd)).
Office of Regulatory Affairs (ORA) support her request. Any person with an approved or
notified Gil of a proposal to debar her Under the authority delegated to him pending drug application who
for 6 years from providing services in by the Commissioner of Food and knowingly uses the services of Gil, in
any capacity to a person that has an Drugs, the Acting Director of the Office any capacity during her debarment, will
approved or pending drug product of Scientific Integrity (OSI) has be subject to civil money penalties
application. The proposal explained considered Gil’s request for a hearing. (section 307(a)(6) of the FD&C Act (21
that the proposed debarment period was Hearings will not be granted on issues U.S.C. 335b(a)(6))). If Gil, during her
based on her 12 felony convictions. The of policy or law, on mere allegations, period of debarment, provides services
proposal stated that maximum denials, or general descriptions of in any capacity to a person with an
debarment period for each offense is 5 positions and contentions, or on data approved or pending drug product
years and that FDA may determine and information insufficient to justify
application, she will be subject to civil
whether debarment periods for multiple the factual determination urged (see 21
money penalties (section 307(a)(7) of the
offenses should run concurrently or CFR 21.24(b)).
Inasmuch as Gil has not presented FD&C Act). In addition, FDA will not
consecutively. accept or review any abbreviated new
The proposal outlined findings any information to support her hearing
request, OSI concludes that Gil has drug applications submitted by or with
regarding the four applicable factors
failed to raise a genuine and substantial the assistance of Gil during her period
ORA considered in determining the
issue of fact requiring a hearing. of debarment (section 306(c)(1)(B) of the
appropriateness and period of
Therefore, OSI denies Gil’s request for a FD&C Act).
debarment, as provided in section
306(c)(3) of the FD&C Act: (1) The hearing. Further, Gil has not presented Dated: October 10, 2018.
nature and seriousness of the offense, any arguments concerning whether George M. Warren,
(2) the nature and extent of management debarment is appropriate for each of her Director, Office of Scientific Integrity.
participation in any offense, (3) the felony convictions or whether the [FR Doc. 2018–22581 Filed 10–16–18; 8:45 am]
nature and extent of voluntary steps to proposed debarment periods are BILLING CODE 4164–01–P
mitigate the impact on the public, and appropriate. Based on the factual
(4) prior convictions under the FD&C findings in the proposal to debar, OSI
Act or other acts involving matters finds that a 3-year debarment period for DEPARTMENT OF HEALTH AND
within FDA’s jurisdiction. ORA found each felony offense is appropriate and HUMAN SERVICES
that the nature and seriousness of the that the 3-year debarment period for
offenses and her failure to take each healthcare fraud conviction should Food and Drug Administration
voluntary steps to mitigate the impact of run concurrently and that the 3-year
[Docket No. FDA–2011–D–0125]
her offenses were unfavorable factors for debarment period for each false
Gil. ORA found that her lack of prior statement conviction should run Agency Information Collection
convictions was a favorable factor for concurrently, for a resulting total Activities; Proposed Collection;
Gil. Finally, ORA found that the debarment of 6 years. Comment Request; Guidance for
management participation factor was Industry on Establishing That a
not applicable based on the information II. Findings and Order
Tobacco Product Was Commercially
in the record. ORA concluded that ‘‘the Therefore, the Director of OSI, under
Marketed in the United States as of
unfavorable factors cumulatively section 306(b)(2)(B)(i)(I) of the FD&C
February 15, 2007
outweigh the favorable factors and that Act and authority delegated to him by
debarment is appropriate.’’ ORA the Commissioner of Food and Drugs, AGENCY: Food and Drug Administration,
daltland on DSKBBV9HB2PROD with NOTICES

proposed that each felony offense finds that: (1) Gil was convicted of a HHS.
should have a 3-year debarment period. felony that involves bribery, payment of ACTION: Notice.
ORA further proposed that the 3-year illegal gratuities, fraud, perjury, false
debarment period for each healthcare statement, racketeering, blackmail, SUMMARY: The Food and Drug
fraud conviction should run extortion, falsification or destruction of Administration (FDA or Agency) is
concurrently and that the 3-year records, or interference with, announcing an opportunity for public
debarment period for each false obstruction of an investigation into, or comment on the proposed collection of

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52490 Federal Register / Vol. 83, No. 201 / Wednesday, October 17, 2018 / Notices

The Tobacco Control Act amended the any other additive or ingredient) of a Grandfathered tobacco products are not
Federal Food, Drug, and Cosmetic Act tobacco product where the modified considered new tobacco products and
(FD&C Act) by adding, among other product was commercially marketed in are not subject to the premarket
things, a chapter granting FDA authority the United States after February 15, requirements of section 910 of the FD&C
to regulate the manufacture, marketing, 2007 (section 910(a)(1) of the FD&C Act. The guidance document provides
and distribution of tobacco products to Act). information on how a manufacturer may
protect the public health generally and The Tobacco Control Act also gave establish that a tobacco product was
to reduce tobacco use by minors. FDA the authority to issue a regulation commercially marketed in the United
Section 201(rr) of the FD&C Act (21 deeming all other products that meet the States as of February 15, 2007. A
U.S.C.321(rr)), as amended, defines a statutory definition of a tobacco product grandfathered tobacco product may also
tobacco product as any product made or to be subject to chapter IX of the FD&C serve as the predicate tobacco product
derived from tobacco that is intended Act (section 901(b) (21 U.S.C. 387a(b)) in a section 905(j) report (intended to be
for human consumption, including any of the FD&C Act). On May 10, 2016, used toward demonstrating substantial
component, part, or accessory of a FDA issued that rule, extending FDA’s equivalence) for a new tobacco product
tobacco product (except for raw tobacco product authority to all (section 905(j)(1)A)(i) of the FD&C Act
materials other than tobacco used in products that meet the definition of (21 U.S.C. 387e(j)(1)(A)(i))).
manufacturing a component, part, or tobacco product in the law (except for
accessory of a tobacco product). Section accessories of newly regulated tobacco The guidance recommends that the
910 of the FD&C Act (21 U.S.C. 387j) products), including electronic nicotine manufacturer submit information
sets out premarket requirements for new delivery systems, cigars, hookah, pipe adequate to demonstrate that the
tobacco products. The term new tobacco tobacco, nicotine gels, dissolvables that tobacco product was commercially
product is defined as any tobacco were not already subject to the FD&C marketed in the United States as of
product (including those products in Act, and other tobacco products that February 15, 2007. Examples of such
test markets) that was not commercially may be developed in the future (81 FR information may include, but are not
marketed in the United States as of 28974 at 28976). limited to, the following: Dated copies
February 15, 2007, or any modification FDA refers to tobacco products that of advertisements, dated catalog pages,
(including a change in design, any were commercially marketed (other than dated promotional material, and dated
component, any part, or any constituent, exclusively in test markets) in the bills of lading.
including a smoke constituent, or in the United States as of February 15, 2007, FDA estimates the burden of this
content, delivery, or form of nicotine, or as grandfathered tobacco products. collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Average
Number of Total
Number of burden per
FD&C Act sections or action responses per annual Total hours
respondents response
respondent responses (in hours)

Submit evidence of commercial marketing in the United
States as of February 15, 2007 ....................................... 1,000 1 1,000 5 5,000
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

FDA’s estimate of the number of take one to review, gather, and submit DEPARTMENT OF HEALTH AND
respondents is based on the fact that dated information if making a request HUMAN SERVICES
requesting an Agency determination of for Agency determination.
the grandfathered status of a tobacco Food and Drug Administration
FDA further estimates it would take a
product under the guidance is not manufacturer approximately 5 hours to [Docket No. FDA–2018–N–3163]
required and also on the number of put together this collection of evidence
grandfathered submissions received and to submit the package to FDA for Agency Information Collection
from 2011 to June 2018. We estimate review. FDA estimates that it should Activities; Proposed Collection;
submissions have increased due to the Comment Request; Physician
take approximately 5,000 hours
effective date of the deeming rule. FDA Interpretation of Information About
annually to respond to this collection of
has stated that, for deemed combustible Prescription Drugs in Scientific
information.
products that were on the market as of Publications Versus Promotional
August 8, 2016, it does not intend to Our estimated burden for the Pieces
initiate enforcement for failure to have information collection reflects an
overall increase of 4,235 hours. We AGENCY: Food and Drug Administration,
premarket authorization until August 8, HHS.
2021. FDA has also stated that, for attribute this adjustment to an updated
number of submissions received ACTION: Notice.
deemed noncombustible products that
were on the market as of August 2, 2016, through this approval and the number of SUMMARY: The Food and Drug
it does not intend to initiate submissions expected in the next 3 Administration (FDA) is announcing an
daltland on DSKBBV9HB2PROD with NOTICES

enforcement for failure to have years. opportunity for public comment on the
premarket authorization until August 8, Dated: October 11, 2018. proposed collection of certain
2022. When these compliance periods Leslie Kux, information by the Agency. Under the
end, FDA expects a drop in the number Paperwork Reduction Act of 1995
Associate Commissioner for Policy.
of grandfathered submissions. The (PRA), Federal Agencies are required to
[FR Doc. 2018–22578 Filed 10–16–18; 8:45 am]
number of hours to gather the evidence publish notice in the Federal Register
is FDA’s estimate of how long it might BILLING CODE 4164–01–P concerning each proposed collection of

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Document Created: 2018-10-17 01:46:42
Document Modified: 2018-10-17 01:46:42

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Submit either electronic or written comments on the collection of information by December 17, 2018.
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]
FR Citation		83 FR 52488

83 FR 52488 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 201 (October 17, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration