Agency Information Collection Activities; Proposed Collection; Comment Request; Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments and Listing of Ingredients in Tobacco Products, 53478-53481 [2018-23056]
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53478
Federal Register / Vol. 83, No. 205 / Tuesday, October 23, 2018 / Notices
product. Thereafter, the USPTO
requested that FDA determine the
product’s regulatory review period.
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II. Determination of Regulatory Review
Period
FDA has determined that the
applicable regulatory review period for
SILIQ is 3,101 days. Of this time, 2,643
days occurred during the testing phase
of the regulatory review period, while
458 days occurred during the approval
phase. These periods of time were
derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(i))
became effective: August 22, 2008. The
applicant claims September 26, 2009, as
the date the investigational new drug
application (IND) became effective.
However, FDA records indicate that the
IND effective date was August 22, 2008,
which was 30 days after FDA receipt of
an earlier IND.
2. The date the application was
initially submitted with respect to the
human biological product under section
351 of the Public Health Service Act (42
U.S.C. 262): November 16, 2015. FDA
has verified the applicant’s claim that
the biologics license application (BLA)
for SILIQ (BLA 761032) was initially
submitted on November 16, 2015.
3. The date the application was
approved: February 15, 2017. FDA has
verified the applicant’s claim that BLA
761032 was approved on February 15,
2017.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its applications for patent extension,
this applicant seeks 1,156 days, 906
days, or 847 days of patent term
extension.
III. Petitions
Anyone with knowledge that any of
the dates as published are incorrect may
submit either electronic or written
comments and, under 21 CFR 60.24, ask
for a redetermination (see DATES).
Furthermore, as specified in § 60.30 (21
CFR 60.30), any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period. To
meet its burden, the petition must
comply with all the requirements of
§ 60.30, including but not limited to:
must be timely (see DATES), must be
filed in accordance with § 10.20, must
contain sufficient facts to merit an FDA
investigation, and must certify that a
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true and complete copy of the petition
has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th
Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
Dated: October 17, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–23058 Filed 10–22–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0386]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Registration and
Product Listing for Owners and
Operators of Domestic Tobacco
Product Establishments and Listing of
Ingredients in Tobacco Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) 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 ‘‘Registration and
Product Listing for Owners and
Operators of Domestic Tobacco Product
Establishments and Listing of
Ingredients in Tobacco Products.’’
DATES: Submit either electronic or
written comments on the collection of
information by December 24, 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 24,
2018. The https://www.regulations.gov
electronic filing system will accept
SUMMARY:
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comments until 11:59 p.m. Eastern Time
at the end of December 24, 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–
2012–N–0386 for ‘‘Registration and
Product Listing for Owners and
Operators of Domestic Tobacco Product
Establishments and Listing of
Ingredients in Tobacco Products.’’
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
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Federal Register / Vol. 83, No. 205 / Tuesday, October 23, 2018 / Notices
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
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
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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.
Registration and Product Listing for
Owners and Operators of Domestic
Tobacco Product Establishments and
Listing of Ingredients in Tobacco
Products
OMB Control Number 0910–0650—
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 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. The
Tobacco Control Act created new
requirements for the tobacco industry.
Section 101 of the Tobacco Control Act
amended the FD&C Act by adding
sections 905 and 904 (21 U.S.C. 387e
and 387d).
Section 905 of the FD&C Act requires
the annual registration of any
‘‘establishment in any State engaged in
the manufacture, preparation,
compounding, or processing of a
tobacco product or tobacco products.’’
Section 905 requires this registration be
completed by December 31 of each year.
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The Secretary of Health and Human
Services (Secretary) has delegated to the
Commissioner of Food and Drugs the
responsibility for administering the
FD&C Act, including section 905.
Section 905 of the FD&C Act requires
owners or operators of each
establishment to register: (1) Their
name; (2) places of business; (3) a list of
all tobacco products which are
manufactured by that person; (4) a copy
of all labeling and a reference to the
authority for the marketing of any
tobacco product subject to a tobacco
product standard under section 907 of
the FD&C Act (21 U.S.C. 387g) or to
premarket review under section 910 of
the FD&C Act (21 U.S.C. 387j); (5) a
copy of all consumer information and
other labeling; (6) a representative
sampling of advertisements; (7) upon
request made by the Secretary for good
cause, a copy of all advertisements for
a particular tobacco product; and (8)
upon request made by the Secretary, if
the registrant has determined that a
tobacco product contained in the
product list is not subject to a tobacco
product standard established under
section 907 of the FD&C Act, a brief
statement of the basis upon which the
registrant made such determination.
FDA collects the information
submitted pursuant to section 905 of the
FD&C Act through an electronic portal,
and through paper forms (Forms FDA
3741 and FDA 3741a) for those
individuals who choose not to use the
electronic portal.
FDA has also published a guidance
for industry entitled ‘‘Registration and
Product Listing for Owners and
Operators of Domestic Tobacco Product
Establishments’’ (https://www.fda.gov/
downloads/TobaccoProducts/Labeling/
RulesRegulationsGuidance/
UCM191940.pdf). This guidance is
intended to assist persons making
tobacco product establishment
registration and product listing
submissions to FDA.
Section 904(a)(1) of the FD&C Act
requires that each tobacco product
manufacturer or importer submit ‘‘a
listing of all ingredients, including
tobacco, substances, compounds, and
additives that are, as of such date, added
by the manufacturer to the tobacco,
paper, filter, or other part of each
tobacco product by brand and by
quantity in each brand and subbrand’’
by December 22, 2009. This section
applies only to those tobacco products
manufactured and distributed before
June 22, 2009, and which are still
manufactured as of the date of the
ingredient listing submission.
Section 904(c) of the FD&C Act
requires that a tobacco product
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manufacturer: (1) Provide all
information required under section
904(a) of the FD&C Act to FDA ‘‘at least
90 days prior to the delivery for
introduction into interstate commerce of
a tobacco product not on the market on
the date of enactment’’ of the Tobacco
Control Act; (2) advise FDA in writing
at least 90 days prior to adding any new
tobacco additive or increasing in
quantity an existing tobacco additive,
except for those additives that have
been designated by FDA through
regulation as not a human or animal
carcinogen, or otherwise harmful to
health under intended conditions of
use; and (3) advise FDA in writing at
least 60 days prior to eliminating or
decreasing an existing additive, or
adding or increasing an additive that
has been designated by FDA through
regulation as not a human or animal
carcinogen, or otherwise harmful to
health under intended conditions of
use.
FDA collects the information
submitted pursuant to sections 904(a)(1)
and 904(c) of the FD&C Act through an
electronic portal, and through a paper
form (Form FDA 3742) for those
individuals who choose not to use the
electronic portal.
In addition to the development of the
electronic portal and paper form, FDA
published a guidance entitled ‘‘Listing
of Ingredients in Tobacco Products.’’
This guidance is intended to assist
persons making tobacco product
ingredient listing submissions. FDA also
provides a technical guide, embedded
hints, and a web tutorial to the
electronic portal.
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 9 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) (‘‘the final deeming
rule’’)).
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
FDA form/activity/TCA section
Tobacco Product Establishment Initial Registration
and Listing; Form FDA 3741 Registration and
Product Listing for Owners and Operators of Domestic Establishments (Electronic and Paper
submissions); Sections 905(b), 905(c), 905(d),
905(h), or 905(i).
Tobacco Product Establishment Renewal Registration and Listing; Form FDA 3741 Registration
and Product Listing for Owners and Operators of
Domestic Establishments (Electronic and Paper
submissions); Sections 905(b), 905(c), 905(d),
905(h), or 905(i).
Tobacco Product Listing; Form FDA 3742 Listing
of Ingredients (Electronic and Paper submissions); Section 904(a)(1).
Tobacco Product Listing; Form FDA 3742 Listing
of Ingredients (Electronic and Paper submissions); Section 904(c).
Obtaining a Dun and Bradstreet D–U–N–S Number
Total ..................................................................
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1 There
Number of
responses per
respondent
Total annual
responses
Hours per response
Total hours
100
1
100
1.6 .............................
160
3,578
1
3,578
.16 (10 minutes) ........
572
10
1
10
2 ................................
20
35
2
70
0.40 (24 minutes) ......
28
100
1
100
0.5 (30 minutes) ........
50
........................
........................
........................
....................................
830
are no capital costs or operating and maintenance costs associated with this collection of information.
The PRA burden estimates have been
updated to fully incorporate the use of
an electronic system known as FURLS
for submitting registration and product
listing information to FDA. With the
FURLS, manufacturers can enter
information quickly and easily. For
example, product label pictures can be
uploaded directly. We anticipate that
most, if not all companies, already have
electronic versions of their labels for
printing, sales, or marketing purposes.
Product listing information is
provided at the time of registration.
Currently, registration and listing
requirements only apply to domestic
establishments engaged in the
manufacture, preparation,
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compounding, or processing of a
tobacco product. This includes
importers to the extent that they engage
in the manufacture, preparation,
compounding, or processing of a
tobacco product, including repackaging
or otherwise changing the container,
wrapper, or labeling of any tobacco
product package. Foreign
establishments are not required to
register and list until FDA issues
regulations establishing such
requirements in accordance with section
905(h) of the FD&C Act. To account for
the foregoing, we include both domestic
manufacturing establishments and
importers in our estimates.
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As the deadline for initial
establishment registration and product
listing for both statutorily regulated and
deemed products has passed, FDA
estimates that few (up to 100) new
establishments will submit one initial
establishment registration and product
listing report each year. Such new
establishments potentially include new
vape shop locations that mix or
assemble products on the market as of
the final deeming rule effective date.
The Agency estimates that up to 100
tobacco establishments will each submit
1 initial establishment registration and
product listing report each year, which
is expected to take 1.6 hours, for a total
160 burden hours.
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FDA estimates that the confirmation
or updating of establishment registration
and product listing information as
required by section 905 of the FD&C Act
will take 10 minutes annually per
confirmation or update per
establishment. Based on FDA’s
experience with current establishment
registration and product listings
submitted to the Agency, the Agency
estimates that on average 3,578
establishments will each submit one
confirmation or updated report each
year, which is expected to take 0.16
hour (10 minutes) for a total 572 burden
hours.
FDA estimates that we have received
most tobacco product ingredient
submissions for large manufacturers of
deemed products. Small manufacturers’
deadline for ingredient submissions is
November 2018. This is based on the
counts we have to date (July 2018),
including statutorily regulated products
(based on information in our tracking
system).
FDA estimates that the submission of
ingredient listings required by section
904(a)(1) of the FD&C Act for each
establishment will take 2 hours initially.
Because this burden estimate covers a
timeframe of 3 years, we anticipate
almost all section 904(a)(1) tobacco
ingredient submissions to have been
received before the expiration of the
current approval (prior to 11/8/2018 for
small manufacturers and large
manufacturers, 5/8/18). We are
estimating approximately 30
manufacturers may miss their deadline.
This is based on estimates of how many
large manufacturers we are aware of that
have missed their deadline. Because this
burden estimate covers 3 years, we are
dividing by 3, to yield 10 respondents
as a yearly average for this estimate.
Therefore, FDA estimates that 10
establishments will initially submit one
report annually at 2 hours per report, for
a total of 20 hours.
Submissions under 904(c) of the
FD&C Act are for any new product that
is not yet on the market (e.g., if on the
market due to deeming compliance
period), newly deemed product
manufacturers should have submitted
under section 904(a)(1) of the FD&C Act.
This includes any statutorily regulated
product that would receive a marketing
authorization and any new deemed
product not subject to the deeming
compliance period. For deemed product
categories, while we anticipate receiving
a large number of premarket
applications, there is a portion of these
applicants who will have reported their
ingredients under section 904(a)(1) as
most of these submissions are expected
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to be for products subject to the
deeming compliance period.
Based on FDA’s experience and the
actual number of product ingredient
listings submitted over the past 3 years,
FDA estimates that 35 establishments
will each submit two reports (one every
6 months). FDA also estimates that the
confirmation or updating of product
(ingredient) listing information required
by section 904(c) of the FD&C Act is
expected to take 0.40 hour (24 minutes)
and will take 48 minutes annually for
two confirmations or updates per
establishment, for a total 28 burden
hours. FDA estimates that obtaining a
DUNS (data universal numbering
system) number will take 30 minutes.
FDA assumes that all new establishment
facilities that will be required to
initially register under section 905 of
the FD&C Act would obtain a DUNS
number. FDA estimates that up to 100
establishments that would need to
obtain this number each year. The total
industry burden to obtain a DUNS
number is 50 hours.
FDA estimates the total burden for
this collection to be 830 hours. We have
adjusted our burden estimate, which has
resulted in a decrease of 93,086 hours to
the currently approved burden. Based
on data we reviewed from the past 3
years and projecting the number of
remaining establishments that have not
registered and submitted product
ingredient listings, we revised the
number of respondents and burden
hours in this information collection.
Dated: October 17, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–23056 Filed 10–22–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2017–E–3617, FDA–
2017–E–3619, and FDA–2017–E–3618]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; NUPLAZID
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for NUPLAZID and is publishing this
notice of that determination as required
by law. FDA has made the
determination because of the
submission of applications to the
SUMMARY:
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53481
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that human drug
product.
Anyone with knowledge that any
of the dates as published (see the
SUPPLEMENTARY INFORMATION section) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by December 24, 2018.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
April 22, 2019. See ‘‘Petitions’’ in the
SUPPLEMENTARY INFORMATION section for
more information.
DATES:
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 24,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of December 24, 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.
ADDRESSES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
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]]>Agencies
[Federal Register Volume 83, Number 205 (Tuesday, October 23, 2018)]
[Notices]
[Pages 53478-53481]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-23056]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0386]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Registration and Product Listing for Owners and
Operators of Domestic Tobacco Product Establishments and Listing of
Ingredients in Tobacco Products
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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 ``Registration and Product
Listing for Owners and Operators of Domestic Tobacco Product
Establishments and Listing of Ingredients in Tobacco Products.''
DATES: Submit either electronic or written comments on the collection
of information by December 24, 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 24, 2018. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of December 24, 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-2012-N-0386 for ``Registration and Product Listing for Owners and
Operators of Domestic Tobacco Product Establishments and Listing of
Ingredients in Tobacco Products.'' 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
[[Page 53479]]
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.
Registration and Product Listing for Owners and Operators of Domestic
Tobacco Product Establishments and Listing of Ingredients in Tobacco
Products
OMB Control Number 0910-0650--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 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. The Tobacco
Control Act created new requirements for the tobacco industry. Section
101 of the Tobacco Control Act amended the FD&C Act by adding sections
905 and 904 (21 U.S.C. 387e and 387d).
Section 905 of the FD&C Act requires the annual registration of any
``establishment in any State engaged in the manufacture, preparation,
compounding, or processing of a tobacco product or tobacco products.''
Section 905 requires this registration be completed by December 31 of
each year. The Secretary of Health and Human Services (Secretary) has
delegated to the Commissioner of Food and Drugs the responsibility for
administering the FD&C Act, including section 905. Section 905 of the
FD&C Act requires owners or operators of each establishment to
register: (1) Their name; (2) places of business; (3) a list of all
tobacco products which are manufactured by that person; (4) a copy of
all labeling and a reference to the authority for the marketing of any
tobacco product subject to a tobacco product standard under section 907
of the FD&C Act (21 U.S.C. 387g) or to premarket review under section
910 of the FD&C Act (21 U.S.C. 387j); (5) a copy of all consumer
information and other labeling; (6) a representative sampling of
advertisements; (7) upon request made by the Secretary for good cause,
a copy of all advertisements for a particular tobacco product; and (8)
upon request made by the Secretary, if the registrant has determined
that a tobacco product contained in the product list is not subject to
a tobacco product standard established under section 907 of the FD&C
Act, a brief statement of the basis upon which the registrant made such
determination.
FDA collects the information submitted pursuant to section 905 of
the FD&C Act through an electronic portal, and through paper forms
(Forms FDA 3741 and FDA 3741a) for those individuals who choose not to
use the electronic portal.
FDA has also published a guidance for industry entitled
``Registration and Product Listing for Owners and Operators of Domestic
Tobacco Product Establishments'' (https://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM191940.pdf). This
guidance is intended to assist persons making tobacco product
establishment registration and product listing submissions to FDA.
Section 904(a)(1) of the FD&C Act requires that each tobacco
product manufacturer or importer submit ``a listing of all ingredients,
including tobacco, substances, compounds, and additives that are, as of
such date, added by the manufacturer to the tobacco, paper, filter, or
other part of each tobacco product by brand and by quantity in each
brand and subbrand'' by December 22, 2009. This section applies only to
those tobacco products manufactured and distributed before June 22,
2009, and which are still manufactured as of the date of the ingredient
listing submission.
Section 904(c) of the FD&C Act requires that a tobacco product
[[Page 53480]]
manufacturer: (1) Provide all information required under section 904(a)
of the FD&C Act to FDA ``at least 90 days prior to the delivery for
introduction into interstate commerce of a tobacco product not on the
market on the date of enactment'' of the Tobacco Control Act; (2)
advise FDA in writing at least 90 days prior to adding any new tobacco
additive or increasing in quantity an existing tobacco additive, except
for those additives that have been designated by FDA through regulation
as not a human or animal carcinogen, or otherwise harmful to health
under intended conditions of use; and (3) advise FDA in writing at
least 60 days prior to eliminating or decreasing an existing additive,
or adding or increasing an additive that has been designated by FDA
through regulation as not a human or animal carcinogen, or otherwise
harmful to health under intended conditions of use.
FDA collects the information submitted pursuant to sections
904(a)(1) and 904(c) of the FD&C Act through an electronic portal, and
through a paper form (Form FDA 3742) for those individuals who choose
not to use the electronic portal.
In addition to the development of the electronic portal and paper
form, FDA published a guidance entitled ``Listing of Ingredients in
Tobacco Products.'' This guidance is intended to assist persons making
tobacco product ingredient listing submissions. FDA also provides a
technical guide, embedded hints, and a web tutorial to the electronic
portal.
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 9 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) (``the final deeming rule'')).
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
FDA form/activity/TCA section Number of responses per Total annual Hours per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tobacco Product Establishment Initial 100 1 100 1.6....................................... 160
Registration and Listing; Form FDA 3741
Registration and Product Listing for Owners
and Operators of Domestic Establishments
(Electronic and Paper submissions);
Sections 905(b), 905(c), 905(d), 905(h), or
905(i).
Tobacco Product Establishment Renewal 3,578 1 3,578 .16 (10 minutes).......................... 572
Registration and Listing; Form FDA 3741
Registration and Product Listing for Owners
and Operators of Domestic Establishments
(Electronic and Paper submissions);
Sections 905(b), 905(c), 905(d), 905(h), or
905(i).
Tobacco Product Listing; Form FDA 3742 10 1 10 2......................................... 20
Listing of Ingredients (Electronic and
Paper submissions); Section 904(a)(1).
Tobacco Product Listing; Form FDA 3742 35 2 70 0.40 (24 minutes)......................... 28
Listing of Ingredients (Electronic and
Paper submissions); Section 904(c).
Obtaining a Dun and Bradstreet D-U-N-S 100 1 100 0.5 (30 minutes).......................... 50
Number.
-----------------------------------------------------------------------------------------------------------
Total................................... .............. .............. .............. .......................................... 830
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
The PRA burden estimates have been updated to fully incorporate the
use of an electronic system known as FURLS for submitting registration
and product listing information to FDA. With the FURLS, manufacturers
can enter information quickly and easily. For example, product label
pictures can be uploaded directly. We anticipate that most, if not all
companies, already have electronic versions of their labels for
printing, sales, or marketing purposes.
Product listing information is provided at the time of
registration. Currently, registration and listing requirements only
apply to domestic establishments engaged in the manufacture,
preparation, compounding, or processing of a tobacco product. This
includes importers to the extent that they engage in the manufacture,
preparation, compounding, or processing of a tobacco product, including
repackaging or otherwise changing the container, wrapper, or labeling
of any tobacco product package. Foreign establishments are not required
to register and list until FDA issues regulations establishing such
requirements in accordance with section 905(h) of the FD&C Act. To
account for the foregoing, we include both domestic manufacturing
establishments and importers in our estimates.
As the deadline for initial establishment registration and product
listing for both statutorily regulated and deemed products has passed,
FDA estimates that few (up to 100) new establishments will submit one
initial establishment registration and product listing report each
year. Such new establishments potentially include new vape shop
locations that mix or assemble products on the market as of the final
deeming rule effective date. The Agency estimates that up to 100
tobacco establishments will each submit 1 initial establishment
registration and product listing report each year, which is expected to
take 1.6 hours, for a total 160 burden hours.
[[Page 53481]]
FDA estimates that the confirmation or updating of establishment
registration and product listing information as required by section 905
of the FD&C Act will take 10 minutes annually per confirmation or
update per establishment. Based on FDA's experience with current
establishment registration and product listings submitted to the
Agency, the Agency estimates that on average 3,578 establishments will
each submit one confirmation or updated report each year, which is
expected to take 0.16 hour (10 minutes) for a total 572 burden hours.
FDA estimates that we have received most tobacco product ingredient
submissions for large manufacturers of deemed products. Small
manufacturers' deadline for ingredient submissions is November 2018.
This is based on the counts we have to date (July 2018), including
statutorily regulated products (based on information in our tracking
system).
FDA estimates that the submission of ingredient listings required
by section 904(a)(1) of the FD&C Act for each establishment will take 2
hours initially. Because this burden estimate covers a timeframe of 3
years, we anticipate almost all section 904(a)(1) tobacco ingredient
submissions to have been received before the expiration of the current
approval (prior to 11/8/2018 for small manufacturers and large
manufacturers, 5/8/18). We are estimating approximately 30
manufacturers may miss their deadline. This is based on estimates of
how many large manufacturers we are aware of that have missed their
deadline. Because this burden estimate covers 3 years, we are dividing
by 3, to yield 10 respondents as a yearly average for this estimate.
Therefore, FDA estimates that 10 establishments will initially submit
one report annually at 2 hours per report, for a total of 20 hours.
Submissions under 904(c) of the FD&C Act are for any new product
that is not yet on the market (e.g., if on the market due to deeming
compliance period), newly deemed product manufacturers should have
submitted under section 904(a)(1) of the FD&C Act. This includes any
statutorily regulated product that would receive a marketing
authorization and any new deemed product not subject to the deeming
compliance period. For deemed product categories, while we anticipate
receiving a large number of premarket applications, there is a portion
of these applicants who will have reported their ingredients under
section 904(a)(1) as most of these submissions are expected to be for
products subject to the deeming compliance period.
Based on FDA's experience and the actual number of product
ingredient listings submitted over the past 3 years, FDA estimates that
35 establishments will each submit two reports (one every 6 months).
FDA also estimates that the confirmation or updating of product
(ingredient) listing information required by section 904(c) of the FD&C
Act is expected to take 0.40 hour (24 minutes) and will take 48 minutes
annually for two confirmations or updates per establishment, for a
total 28 burden hours. FDA estimates that obtaining a DUNS (data
universal numbering system) number will take 30 minutes. FDA assumes
that all new establishment facilities that will be required to
initially register under section 905 of the FD&C Act would obtain a
DUNS number. FDA estimates that up to 100 establishments that would
need to obtain this number each year. The total industry burden to
obtain a DUNS number is 50 hours.
FDA estimates the total burden for this collection to be 830 hours.
We have adjusted our burden estimate, which has resulted in a decrease
of 93,086 hours to the currently approved burden. Based on data we
reviewed from the past 3 years and projecting the number of remaining
establishments that have not registered and submitted product
ingredient listings, we revised the number of respondents and burden
hours in this information collection.
Dated: October 17, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-23056 Filed 10-22-18; 8:45 am]
BILLING CODE 4164-01-P
