Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Tobacco Health Document Submission, 22860-22862 [2019-10402]
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Federal Register / Vol. 84, No. 97 / Monday, May 20, 2019 / Notices
not licensed by the owner of the patent
engaged in the manufacture, use, or sale
of the drug product (§ 314.53(b)). Such
patents claim the drug substance (active
ingredient), drug product (formulation
and composition), or method(s) of use.
If a patent is issued after the application
is filed with FDA, but before the
application is approved, the applicant
must submit the required patent
information on Form FDA 3542a as an
amendment to the application, within
30 days of the date of issuance of the
patent.
Within 30 days after the date of
approval of an application, the
applicant must submit Form FDA 3542
for each patent that claims the drug
substance (active ingredient), drug
product (formulation and composition),
or approved method(s) of use of the
product for listing in the Orange Book.
For patents issued after the date of
approval of an application, Form FDA
3542 must be submitted within 30 days
of the date of issuance of the patent. In
addition, an NDA applicant’s
amendment to the description of the
approved method(s) of use claimed by
the patent must be submitted within the
timeframes described in §§ 314.50(i)(4)
and 314.94(a)(12)(vi) (21 CFR
314.94(a)(12)(vi)) to be considered
timely filed.
Description of Respondents: The
respondents to this collection of
information are NDA applicants for
original applications, amendments, or
supplements to an NDA or NDA
applicants submitting information on a
patent after approval of the NDA or
supplement.
The final rule ‘‘Abbreviated New Drug
Applications and 505(b)(2)
Applications,’’ implemented portions of
Title XI of the Medicare Prescription
Drug, Improvement and Modernization
Act of 2003 (MMA) and also amended
certain regulations regarding 505(b)(2)
applications and abbreviated new drug
applications (ANDAs) to facilitate
compliance with and efficient
enforcement of the FD&C Act (81 FR
69580; October 6, 2016) (MMA Final
Rule). In the MMA Final Rule, we
estimated that the burden for Form FDA
3542a would be reduced by 5 hours
from 20 hours to 15 hours per response;
we further estimated that the burden for
Form FDA 3542 would increase by 5
hours from 5 to 10 hours per response.
The burden hours were adjusted to shift
a portion of the time spent preparing
Form FDA 3542a to the estimated time
spent preparing Form FDA 3542 to
reflect the additional time spent by the
NDA holder to develop the use code in
accordance with FDA’s revised
regulations and identify the specific
section(s) and subsection(s) of labeling
that describe the specific approved
method of use claimed by the patent.
The burden hours of Forms FDA 3542
and 3542a in this notice reflect the
reporting burden approved by OMB
under OMB control number 0910–0786
in connection with the MMA Final
Rule. The effective date of the MMA
Final Rule was December 5, 2016.
Consequently, the annual reporting
burden estimated below is based on
calendar year 2017 data only to reflect
the post-MMA Final Rule regulatory
requirements and reporting burden
estimate.
FDA requests OMB approval for the
following information collection:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN
21 CFR 314.50
(citing § 314.53)
Number of
responses per
respondent
Total annual
responses
CY 2017
Hours per
response
Total hours
Form FDA 3542 ...................................................................
Form FDA 3542a .................................................................
281
310
2.875
2.084
808
646
10
15
8,080
9,690
Total ..............................................................................
........................
........................
........................
........................
17,770
1 There
khammond on DSKBBV9HB2PROD with NOTICES
Number of
respondents
are no capital costs or operating and maintenance costs associated with this collection of information.
For purposes of this analysis, we
consider the number of respondents to
correspond to the number of NDAs and
efficacy supplements submitted or
approved, respectively, in calendar year
(CY) 2017, even though one company
may submit or hold multiple NDAs or
may submit multiple efficacy
supplements to one or more NDAs. FDA
approved 127 NDAs and 154 efficacy
supplements to NDAs during CY 2017,
which corresponds to 281 respondents.
Based on information provided by the
Orange Book staff, approximately 623
patent records were created in CY 2017,
which corresponds to an estimated 513
Forms FDA 3542 submitted to FDA for
listing of patent information in the
Orange Book for NDAs approved in CY
2017 and an estimated 110 Forms FDA
3542 submitted to FDA for listing of
patent information in the Orange Book
for efficacy supplements approved in
CY 2017. In addition, based on
information provided by the Orange
Book staff and FDA’s experience, we
VerDate Sep<11>2014
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Jkt 247001
estimate that approximately 185 Forms
FDA 3542 were submitted in CY 2017
to modify patent information, which
results in an estimated total of 808
Forms FDA 3542 submitted in CY 2017.
During calendar year 2017, FDA
received 141 original NDAs and 169
efficacy supplements to NDAs for FDA
review and approval. We estimate that
applicants submitted approximately 405
Forms FDA 3542a for the original NDAs
submitted during CY 2017. In addition,
based on a review of the submitted
efficacy supplements, FDA received 241
Forms FDA 3542a with the efficacy
supplements received during CY 2017,
resulting in a total of 646 Forms FDA
3542a submitted in CY 2017.
Our estimated burden for the
information collection reflects an
overall decrease. We attribute this
adjustment to a decrease in the number
of duplicative submissions of Forms
FDA 3542a and 3542 in connection with
supplements submitted or approved
after the effective date of the MMA final
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
rule, and improved data collection from
upgraded data software tools.
Dated: May 14, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–10421 Filed 5–17–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0377]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Tobacco Health
Document Submission
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
E:\FR\FM\20MYN1.SGM
Notice.
20MYN1
Federal Register / Vol. 84, No. 97 / Monday, May 20, 2019 / Notices
The Food and Drug
Administration (FDA or Agency) 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 June 19,
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 0910–0654. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
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:
Tobacco Health Document Submission
khammond on DSKBBV9HB2PROD with NOTICES
OMB Control Number 0910–0654—
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.
The Tobacco Control Act amended the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) by adding, among other
things, a new chapter granting FDA
important authority to regulate the
manufacture, marketing, and
distribution of tobacco products to
protect the public health generally and
to reduce tobacco use by minors.
Additionally, section 101 of the Tobacco
Control Act amended the FD&C Act by
adding, among other things, new section
904(a)(4) (21 U.S.C. 387d(a)(4)).
Section 904(a)(4) of the FD&C Act
requires each tobacco product
manufacturer or importer, or agent
thereof, to submit all documents
developed after June 22, 2009, ‘‘that
relate to health, toxicological,
behavioral, or physiologic effects of
current or future tobacco products, their
constituents (including smoke
constituents), ingredients, components,
VerDate Sep<11>2014
16:41 May 17, 2019
Jkt 247001
and additives’’ (herein referred to as
‘‘tobacco health documents’’).
FDA announced the availability of a
guidance on this collection in the
Federal Register of April 4, 2010, (75 FR
20606) (revised December 5, 2016, (81
FR 87565) and August 10, 2017, (82 FR
37459) (extending compliance dates))
and requested health documents that
were created during the period of June
23, 2009, through December 31, 2009,
based on the statutory requirements.
The guidance stated that information
required under section 904(a)(4) of the
FD&C Act must be submitted to FDA
beginning December 22, 2009. However,
FDA also explained that it did not
intend to enforce the December 22,
2009, deadline provided that the
documents were submitted by April 30,
2010, for all health documents
developed between June 23, 2009, and
December 31, 2009. Further, FDA stated
it would publish a revised guidance
specifying the timing of subsequent
reporting.
FDA has been collecting the
information submitted pursuant to
section 904(a)(4) of the FD&C Act
through a facilitative electronic form
and through a paper form (Form FDA
3743) for those individuals who choose
not to use the electronic method. On
both forms, FDA is requesting the
following information from firms that
have not already reported or still have
documents to report:
• Submitter identification
• Submitter type, company name,
address, country, company
headquarter’s Dun and Bradstreet
D–U–N–S number, and FDA
assigned Facility Establishment
Identifier number
• Submitter point of contact
• Contact name, title, position title,
email, telephone, and fax
• Submission format and contents (as
applicable)
• Electronic documents: Media type,
media quantity, size of submission,
quantity of documents, file type,
and file software
• Paper documents: Quantity of
documents, quantity of volumes,
and quantity of boxes
• Whether or not a submission is being
provided
• Confirmation statement
• Identification and signature of
submitter including name, company
name, address, position title, email,
telephone, and Fax
• Document categorization (as
applicable): relationship of the
document or set of documents to
the following:
Æ Health, behavioral, toxicological, or
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
22861
physiological effects
Æ Uniquely identified current or
future tobacco product(s)
Æ Category of current or future
tobacco product(s)
Æ Specific ingredient(s),
constituent(s), component(s), or
additive(s)
Æ Class of ingredient(s),
constituent(s), component(s), or
additive(s)
• Document readability and
accessibility: Keywords; glossary or
explanation of any abbreviations,
jargon, or internal (e.g., code)
names; special instructions for
loading or compiling submission.
• Document metadata: Date document
was created, document author(s),
document recipient(s), document
custodian, document title or
identification number, beginning
and ending Bates numbers, Bates
number ranges for documents
attached to a submitted email,
document type, and whether the
document is present in the
University of California San
Francisco’s Truth Tobacco
Documents database.
In addition to the electronic and
paper forms, FDA issued guidance
documents intended to assist persons
making tobacco health document
submissions (draft guidance: December
28, 2009 (74 FR 68629); final guidance:
April 20, 2010 (75 FR 20606); revised
December 5, 2016 (81 FR 87565); and
August 10, 2017 (82 FR 37459)
(extending compliance dates)). For
further assistance, FDA is providing a
technical guide, embedded hints, and a
web tutorial on the electronic portal.
FDA issued a final rule on May 10,
2016 (81 FR 28973), which became
effective on August 8, 2016, to deem
products meeting the statutory
definition of ‘‘tobacco product’’ to be
subject to the FD&C Act. The FD&C Act
provides FDA authority to regulate
cigarettes, cigarette tobacco, roll-yourown tobacco (RYO), smokeless tobacco,
and any other tobacco products that the
Agency by regulation deems to be
subject to the law. This final rule
extends the Agency’s ‘‘tobacco product’’
authorities to all other categories of
products that meet the statutory
definition of ‘‘tobacco product’’ in the
FD&C Act, except accessories of such
deemed tobacco products.
For tobacco products subject to the
deeming rule, FDA understands
‘‘current or future tobacco products’’ to
refer to products commercially
distributed on or after August 8, 2016,
or products in any stage of research or
development at any time after August 8,
E:\FR\FM\20MYN1.SGM
20MYN1
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Federal Register / Vol. 84, No. 97 / Monday, May 20, 2019 / Notices
2016, including experimental products
and developmental products intended
for introduction into the market for
consumer use. For cigarettes, cigarette
tobacco, RYO, and smokeless tobacco,
FDA understands ‘‘current or future
tobacco products’’ to refer to products
commercially distributed on or after
June 23, 2009, or products in any stage
of research or development at any time
after June 23, 2009, including
experimental products and
developmental products intended for
introduction into the market for
consumer use.
All manufacturers and importers of
tobacco products are now subject to the
FD&C Act and are required to comply
with section 904(a)(4), which requires
immediate and ongoing submission of
health documents developed after June
22, 2009 (the date of enactment of the
Tobacco Control Act). However, FDA
generally does not intend to enforce the
requirement at this time with respect to
all such health documents relating to
the deemed tobacco products, so long as
a specified set of documents, those
developed between June 23, 2009, and
December 31, 2009, were submitted by
February 8, 2017, or in the case of smallscale deemed tobacco product
manufacturers (small-scale
manufacturers), by November 8, 2017
(81 FR 28974 at 29008–09).
Additionally, FDA extended the
compliance deadlines by an additional
6 months to May 8, 2018, for small-scale
manufacturers in the areas impacted by
recent natural disasters. Thereafter,
FDA’s compliance plan requests
deemed manufacturers provide tobacco
health document submissions from the
specified period at least 90 days prior to
the delivery for introduction into
interstate commerce of tobacco products
to which the health documents relate.
Manufacturers or importers of cigarettes,
cigarette tobacco, RYO, or smokeless
tobacco products must provide all
health documents developed between
June 23, 2009, and December 31, 2009,
at least 90 days prior to the delivery for
introduction of tobacco products into
interstate commerce.
In the Federal Register of August 23,
2018 (83 FR 42664), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. One comment was received
that was PRA related.
(Comment) FDA received one
comment requesting that FDA exercise
enforcement discretion by suspending
the collection and utilizing the Agency’s
other authorities to inform regulatory
decisions due to the associated burden
of manufacturers to retain documents
for future submission to FDA.
Additionally, the commenter requests
FDA to narrow the scope of the
collection by defining key terms.
(Response) At this time, FDA does not
intend to suspend the collection as
respondents have the option to submit
documents directly to FDA independent
of the compliance policy. Additionally,
at this time, FDA believes narrowly
defining health effects could potentially
exclude relevant scientific information
from being retained by industry and
subsequently submitted as part of future
health document submissions.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Tobacco Health Document Submissions and Form FDA
3743 ..................................................................................
10
3.2
32
50
1,600
khammond on DSKBBV9HB2PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The number of documents received
each year since the original collection
period has fallen to less than 5 percent
of what was received in the original
collection period. FDA expects this is
because documents created within the
specified period should have already
been submitted. The Agency bases this
estimate on the total number of tobacco
firms it is aware of and its experience
with document production and the
number of additional documents that
have been reported each year since the
original estimate of the reporting
burden.
FDA estimates that a tobacco health
document submission for cigars, pipe
and waterpipe tobacco, electronic
nicotine delivery systems (ENDS), and
other tobacco products as required by
section 904(a)(4) of the FD&C Act, will
take approximately 50 hours per
submission based on the existing
collection that applies to tobacco
products currently subject to the FD&C
Act and FDA experience. To derive the
number of respondents for this
provision, FDA assumes that very few
VerDate Sep<11>2014
16:41 May 17, 2019
Jkt 247001
manufacturers or importers of deemed
tobacco products, or agents thereof,
would have health documents to
submit. In addition to the existing 4
respondents, the Agency estimates that
approximately 6 submissions (2 for cigar
manufacturers, 1 for pipe and waterpipe
tobacco manufacturers, 1 for other
tobacco product manufacturers, 1 for
tobacco importers, and 1 for importers
of ENDS that are considered
manufacturers) will be submitted on an
annual basis for a total of 10
respondents. FDA estimates the total
annual reporting burden to be 1,600
hours.
Based on a review of the information
collection of our current OMB approval,
we have made no adjustments to our
burden estimate.
Dated: May 14, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–10402 Filed 5–17–19; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
Frm 00057
Fmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1533]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; National Panel of
Tobacco Consumer Studies
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) 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 June 19,
2019.
SUMMARY:
To ensure that comments on
the information collection are received,
ADDRESSES:
Sfmt 4703
E:\FR\FM\20MYN1.SGM
20MYN1
]]>Agencies
[Federal Register Volume 84, Number 97 (Monday, May 20, 2019)]
[Notices]
[Pages 22860-22862]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-10402]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0377]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Tobacco Health
Document Submission
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
[[Page 22861]]
SUMMARY: The Food and Drug Administration (FDA or Agency) 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 June
19, 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 0910-0654.
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.
Tobacco Health Document Submission
OMB Control Number 0910-0654--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. The Tobacco Control Act amended the Federal Food, Drug,
and Cosmetic Act (FD&C Act) by adding, among other things, a new
chapter granting FDA important authority to regulate the manufacture,
marketing, and distribution of tobacco products to protect the public
health generally and to reduce tobacco use by minors. Additionally,
section 101 of the Tobacco Control Act amended the FD&C Act by adding,
among other things, new section 904(a)(4) (21 U.S.C. 387d(a)(4)).
Section 904(a)(4) of the FD&C Act requires each tobacco product
manufacturer or importer, or agent thereof, to submit all documents
developed after June 22, 2009, ``that relate to health, toxicological,
behavioral, or physiologic effects of current or future tobacco
products, their constituents (including smoke constituents),
ingredients, components, and additives'' (herein referred to as
``tobacco health documents'').
FDA announced the availability of a guidance on this collection in
the Federal Register of April 4, 2010, (75 FR 20606) (revised December
5, 2016, (81 FR 87565) and August 10, 2017, (82 FR 37459) (extending
compliance dates)) and requested health documents that were created
during the period of June 23, 2009, through December 31, 2009, based on
the statutory requirements. The guidance stated that information
required under section 904(a)(4) of the FD&C Act must be submitted to
FDA beginning December 22, 2009. However, FDA also explained that it
did not intend to enforce the December 22, 2009, deadline provided that
the documents were submitted by April 30, 2010, for all health
documents developed between June 23, 2009, and December 31, 2009.
Further, FDA stated it would publish a revised guidance specifying the
timing of subsequent reporting.
FDA has been collecting the information submitted pursuant to
section 904(a)(4) of the FD&C Act through a facilitative electronic
form and through a paper form (Form FDA 3743) for those individuals who
choose not to use the electronic method. On both forms, FDA is
requesting the following information from firms that have not already
reported or still have documents to report:
Submitter identification
Submitter type, company name, address, country, company
headquarter's Dun and Bradstreet D-U-N-S number, and FDA assigned
Facility Establishment Identifier number
Submitter point of contact
Contact name, title, position title, email, telephone, and fax
Submission format and contents (as applicable)
Electronic documents: Media type, media quantity, size of
submission, quantity of documents, file type, and file software
Paper documents: Quantity of documents, quantity of volumes,
and quantity of boxes
Whether or not a submission is being provided
Confirmation statement
Identification and signature of submitter including name,
company name, address, position title, email, telephone, and Fax
Document categorization (as applicable): relationship of the
document or set of documents to the following:
[cir] Health, behavioral, toxicological, or physiological effects
[cir] Uniquely identified current or future tobacco product(s)
[cir] Category of current or future tobacco product(s)
[cir] Specific ingredient(s), constituent(s), component(s), or
additive(s)
[cir] Class of ingredient(s), constituent(s), component(s), or
additive(s)
Document readability and accessibility: Keywords; glossary or
explanation of any abbreviations, jargon, or internal (e.g., code)
names; special instructions for loading or compiling submission.
Document metadata: Date document was created, document
author(s), document recipient(s), document custodian, document title or
identification number, beginning and ending Bates numbers, Bates number
ranges for documents attached to a submitted email, document type, and
whether the document is present in the University of California San
Francisco's Truth Tobacco Documents database.
In addition to the electronic and paper forms, FDA issued guidance
documents intended to assist persons making tobacco health document
submissions (draft guidance: December 28, 2009 (74 FR 68629); final
guidance: April 20, 2010 (75 FR 20606); revised December 5, 2016 (81 FR
87565); and August 10, 2017 (82 FR 37459) (extending compliance
dates)). For further assistance, FDA is providing a technical guide,
embedded hints, and a web tutorial on the electronic portal.
FDA issued a final rule on May 10, 2016 (81 FR 28973), which became
effective on August 8, 2016, to deem products meeting the statutory
definition of ``tobacco product'' to be subject to the FD&C Act. The
FD&C Act provides FDA authority to regulate cigarettes, cigarette
tobacco, roll-your-own tobacco (RYO), smokeless tobacco, and any other
tobacco products that the Agency by regulation deems to be subject to
the law. This final rule extends the Agency's ``tobacco product''
authorities to all other categories of products that meet the statutory
definition of ``tobacco product'' in the FD&C Act, except accessories
of such deemed tobacco products.
For tobacco products subject to the deeming rule, FDA understands
``current or future tobacco products'' to refer to products
commercially distributed on or after August 8, 2016, or products in any
stage of research or development at any time after August 8,
[[Page 22862]]
2016, including experimental products and developmental products
intended for introduction into the market for consumer use. For
cigarettes, cigarette tobacco, RYO, and smokeless tobacco, FDA
understands ``current or future tobacco products'' to refer to products
commercially distributed on or after June 23, 2009, or products in any
stage of research or development at any time after June 23, 2009,
including experimental products and developmental products intended for
introduction into the market for consumer use.
All manufacturers and importers of tobacco products are now subject
to the FD&C Act and are required to comply with section 904(a)(4),
which requires immediate and ongoing submission of health documents
developed after June 22, 2009 (the date of enactment of the Tobacco
Control Act). However, FDA generally does not intend to enforce the
requirement at this time with respect to all such health documents
relating to the deemed tobacco products, so long as a specified set of
documents, those developed between June 23, 2009, and December 31,
2009, were submitted by February 8, 2017, or in the case of small-scale
deemed tobacco product manufacturers (small-scale manufacturers), by
November 8, 2017 (81 FR 28974 at 29008-09). Additionally, FDA extended
the compliance deadlines by an additional 6 months to May 8, 2018, for
small-scale manufacturers in the areas impacted by recent natural
disasters. Thereafter, FDA's compliance plan requests deemed
manufacturers provide tobacco health document submissions from the
specified period at least 90 days prior to the delivery for
introduction into interstate commerce of tobacco products to which the
health documents relate. Manufacturers or importers of cigarettes,
cigarette tobacco, RYO, or smokeless tobacco products must provide all
health documents developed between June 23, 2009, and December 31,
2009, at least 90 days prior to the delivery for introduction of
tobacco products into interstate commerce.
In the Federal Register of August 23, 2018 (83 FR 42664), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. One comment was received that was PRA
related.
(Comment) FDA received one comment requesting that FDA exercise
enforcement discretion by suspending the collection and utilizing the
Agency's other authorities to inform regulatory decisions due to the
associated burden of manufacturers to retain documents for future
submission to FDA. Additionally, the commenter requests FDA to narrow
the scope of the collection by defining key terms.
(Response) At this time, FDA does not intend to suspend the
collection as respondents have the option to submit documents directly
to FDA independent of the compliance policy. Additionally, at this
time, FDA believes narrowly defining health effects could potentially
exclude relevant scientific information from being retained by industry
and subsequently submitted as part of future health document
submissions.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tobacco Health Document Submissions and Form FDA 3743.............. 10 3.2 32 50 1,600
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
The number of documents received each year since the original
collection period has fallen to less than 5 percent of what was
received in the original collection period. FDA expects this is because
documents created within the specified period should have already been
submitted. The Agency bases this estimate on the total number of
tobacco firms it is aware of and its experience with document
production and the number of additional documents that have been
reported each year since the original estimate of the reporting burden.
FDA estimates that a tobacco health document submission for cigars,
pipe and waterpipe tobacco, electronic nicotine delivery systems
(ENDS), and other tobacco products as required by section 904(a)(4) of
the FD&C Act, will take approximately 50 hours per submission based on
the existing collection that applies to tobacco products currently
subject to the FD&C Act and FDA experience. To derive the number of
respondents for this provision, FDA assumes that very few manufacturers
or importers of deemed tobacco products, or agents thereof, would have
health documents to submit. In addition to the existing 4 respondents,
the Agency estimates that approximately 6 submissions (2 for cigar
manufacturers, 1 for pipe and waterpipe tobacco manufacturers, 1 for
other tobacco product manufacturers, 1 for tobacco importers, and 1 for
importers of ENDS that are considered manufacturers) will be submitted
on an annual basis for a total of 10 respondents. FDA estimates the
total annual reporting burden to be 1,600 hours.
Based on a review of the information collection of our current OMB
approval, we have made no adjustments to our burden estimate.
Dated: May 14, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-10402 Filed 5-17-19; 8:45 am]
BILLING CODE 4164-01-P
