Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments and Listing of Ingredients in Tobacco Products, 44971-44973 [2015-18410]
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Federal Register / Vol. 80, No. 144 / Tuesday, July 28, 2015 / Notices
asabaliauskas on DSK5VPTVN1PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
Lillian A. Sparks Robinson,
Commissioner, Administration for
Native Americans, at 202–401–5590, by
email at Lillian.sparks@acf.hhs.gov, or
by mail at 370 L’Enfant Promenade SW.,
2 West, Washington, DC 20447.
SUPPLEMENTARY INFORMATION: On
November 5, 2009, President Obama
signed the ‘‘Memorandum for the Heads
of Executive Departments and Agencies
on Tribal Consultation.’’ The President
stated that his Administration is
committed to regular and meaningful
consultation and collaboration with
tribal officials in policy decisions that
have tribal implications, including, as
an initial step, through complete and
consistent implementation of Executive
Order 13175.
The United States has a unique legal
and political relationship with Indian
tribal governments, established through
and confirmed by the Constitution of
the United States, treaties, statutes,
executive orders, and judicial decisions.
In recognition of that special
relationship, pursuant to Executive
Order 13175 of November 6, 2000,
executive departments and agencies are
charged with engaging in regular and
meaningful consultation and
collaboration with tribal officials in the
development of federal policies that
have tribal implications and are
responsible for strengthening the
government-to-government relationship
between the United States and Indian
tribes.
HHS has taken its responsibility to
comply with Executive Order 13175
very seriously over the past decade;
including the initial implementation of
a Department-wide policy on tribal
consultation and coordination in 1997,
and through multiple evaluations and
revisions of that policy, most recently in
2010. ACF has developed its own
agency-specific consultation policy that
complements the Department-wide
efforts.
The ACF Tribal Consultation Session
will begin on the morning of September
14, 2015, and continue throughout the
day until all discussions have been
completed. To help both tribal officials
and the ACF Principals prepare for this
consultation, planning teleconference
calls will be held on:
Wednesday, August 19, 2015, 3 p.m.–
3:30 p.m. Eastern Time
Wednesday, August 26, 2015, 3 p.m.–
3:30 p.m. Eastern Time
Wednesday, September 2, 2015, 3 p.m.–
3:30 p.m. Eastern Time
The call-in number is: 866–769–9393.
The passcode is: 4449449#.
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The purpose of the planning calls will
be to identify individuals who will
provide oral testimony to ACF, solicit
for tribal moderators and identify
specific topics of interest so we can
ensure that all appropriate individuals
are present.
Testimonies are to be submitted no
later than September 8, 2015, to: Lillian
Sparks Robinson, Commissioner,
Administration for Native Americans,
370 L’Enfant Promenade SW.,
Washington, DC 20447,
anacommissioner@acf.hhs.gov.
To facilitate the security process
when entering our building, we would
appreciate if participants register for the
session by sending an email to
anacommissoner@acf.hhs.gov with the
names of attendees, titles, and tribe/
organization name. If you plan to
provide testimony, please include the
name of the office(s) you wish to
address. We are also interested in
collecting the same information from
anyone who will be attending by
webinar.
Dated: July 21, 2015.
Mark H. Greenberg,
Acting Assistant Secretary for Children and
Families.
[FR Doc. 2015–18430 Filed 7–27–15; 8:45 am]
BILLING CODE 4184–34–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0386]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
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) 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 August 27,
2015.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
SUMMARY:
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
44971
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 0910–0650. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
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.
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 Tobacco Control Act (Pub. L.
111–31) into law. The Tobacco Control
Act amended the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21
U.S.C. 301 et seq.) by, among other
things, adding 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.
Section 905(b) of the FD&C Act (21
U.S.C. 387e(b)), as amended by the
Tobacco Control Act, requires that
‘‘every person who owns or operates
any establishment in any State engaged
in the manufacture, preparation,
compounding, or processing of a
tobacco product or tobacco products
. . .’’ register with FDA the name,
places of business, and all
establishments owned or operated by
that person. Every person must register
by December 31 of each year. Section
905(c) of the FD&C Act requires that
first-time persons ‘‘engaging in the
manufacture, preparation,
compounding, or processing of a
tobacco product or tobacco products
shall register with the Secretary the
name, places of business, and all such
establishments of that person.’’ Section
905(d) states that persons required to
register under section 905(b) or (c) shall
register any additional establishment
that they own or operate in any State
which begins the manufacture,
preparation, compounding, or
processing of a tobacco product or
tobacco products. Section 905(h)
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44972
Federal Register / Vol. 80, No. 144 / Tuesday, July 28, 2015 / Notices
addresses foreign establishment
registration requirements, which will go
into effect when regulations are issued
by the Secretary. Section 905(i)(1) of the
FD&C Act, as amended by the Tobacco
Control Act, requires that all registrants
‘‘shall, at the time of registration under
any such subsection, file with [FDA] a
list of all tobacco products which are
being manufactured, prepared,
compounded, or processed by that
person for commercial distribution,’’
along with certain accompanying
consumer information, such as all
labeling and a representative sampling
of advertisements. Section 904(a)(1) of
the FD&C Act (21 U.S.C. 387d(a)(1)), as
amended by the Tobacco Control Act,
requires each tobacco product
manufacturer or importer, or agent
thereof, to submit ‘‘a listing of all
ingredients, including tobacco,
substances, compounds, and additives
that are * * * added by the
manufacturer to the tobacco, paper,
filter, or other part of each tobacco
product by brand or by quantity in each
brand and subbrand.’’ Since the
Tobacco Control Act was enacted on
June 22, 2009, the information required
under section 904(a)(1) must be
submitted to FDA by December 22,
2009, and include the ingredients added
as of the date of submission. Section
904(c) of the FD&C Act also requires
submission of information whenever
additives, or the quantities of additives,
are changed.
FDA issued guidance documents on
both: (1) Registration and Product
Listing for Owners and Operators of
Domestic Tobacco Product
Establishments and (2) listing of
Ingredients in Tobacco Products to
assist persons making such submissions
to FDA under the Tobacco Control Act.
While electronic submission of
registration and product listing
information and ingredient listing
information are not required, FDA is
strongly encouraging electronic
submission to facilitate efficiency and
timeliness of data management and
collection. To that end, FDA designed
electronic submission applications to
streamline the data entry process for
registration and product listing and for
ingredient listing. These tools allow for
importation of large quantities of
structured data, attachment of files (e.g.,
in portable document format (PDFs) and
certain media files), and automatic
acknowledgement of FDA’s receipt of
submissions.
FDA also developed paper forms
(Form FDA 3741—Registration and
Listing for Owners and Operators of
Domestic Tobacco Product
Establishments, and Form FDA 3742—
Listing of Ingredients in Tobacco
Products) as an alternative submission
tool. Both the electronic submission
application and the paper forms can be
accessed at https://www.fda.gov/tobacco.
In the Federal Register of April 21,
2015 (80 FR 22202), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN
Number of
respondents
FDA Form/activity/TCA section
Total ...................................................................................................
asabaliauskas on DSK5VPTVN1PROD with NOTICES
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);
Section 905(b), (c), (d), (h), or (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); Section 905(b), (c), (d), (h), or (i).
Tobacco Product Initial Ingredient Listing; Form FDA 3742 Listing of Ingredients (Electronic and Paper submissions); Section 904(a)(1) or
(c).
Tobacco Product Renewal Ingredient Listing; Form FDA 3742 Listing of
Ingredients (Electronic and Paper submissions); Section 904(a)(1) or
(c).
Obtaining a Dun and Bradstreet D–U–N–S Number ...............................
Tobacco Product Ingredient Listing Electronic and Paper submission ...
On April 21, 2015, the FDA published
a 60-day notice (80 FR 22202)
requesting public comments in the
Federal Register. In this notice, the total
amount of burden hours for this
collection was incorrectly listed as
1,354 hours. After an internal review of
burden for this collection, FDA realized
that the burden in the 60-day Federal
Register notice did not take into account
new information from another Federal
Agency (which revised the number of
respondents slightly upward), and the
use of a new electronic registration and
product listing submission system. To
correct this oversight, FDA is revising
the number of respondents upward,
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Number of
responses per
respondent
Total annual
responses
Frm 00049
Total
hours
Total operating
and
maintenance
costs
135
1
135
2 .................
270
$0.66
135
1
135
0.20 (12
minutes).
27
0.66
135
1
135
2 .................
270
0.66
135
2
270
0.40 (24
minutes).
108
1.32
8
135
1
1
8
135
0.5 ..............
3 .................
4
405
........................
0.66
........................
........................
........................
....................
1,084
3.96
from 125 to 135 respondents. FDA also
has incorporated the use of a new
electronic system into this collection, so
the total hours were revised from 1,354
hours to 1,084 hours in table 1.
The burden estimates have been
updated to fully incorporate the use of
FDA’s new electronic system known as
FURLS for submitting registration and
product listing information to FDA. This
system allows companies to enter
information quickly and easily. For
example, product label pictures can be
uploaded directly into the system and
FDA anticipates that most, if not all
companies already have electronic
versions of their labels for printing,
sales, or marketing purposes. FDA
PO 00000
Hours per
response
Fmt 4703
Sfmt 4703
anticipates that the initial entry
registration and initial product listing
will each take 2 hours per entity.
Under section 905, once information
is entered into FURLS, the twice yearly
conformation or updates to product lists
are expected to be simplified as all
information previously entered is
maintained and visible in the system.
Therefore, FDA expects that ongoing
maintenance of the product listing
information will take 30 minutes twice
a year, or a total of 1 hour annually.
This is broken down into 12 minutes for
recurring Registration and Listing each
year, and 24 minutes twice a year for
recurring Product Ingredient Listings, or
a total of 48 minutes annually.
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Federal Register / Vol. 80, No. 144 / Tuesday, July 28, 2015 / Notices
Based on data shared by another
Federal Agency, FDA estimates that 135
establishments will initially submit one
report, and then will submit
confirmation or update reports on a
semiannual basis.
FDA estimates that the confirmation
or updating of registration information
as required by section 905 will take 12
minutes annually per confirmation or
update per establishment.
FDA estimates that the submission of
product listings required by section 905
for each establishment will take 2 hours
initially. FDA also estimates that the
confirmation or updating of product
listing information required by section
905 will take 48 minutes annually for
two confirmations or updates per
establishment.
FDA estimates that obtaining an
optional Dun and Bradstreet D–U–N–S
number will take 0.5 hours, and that 8
respondents (1 percent × 135 = 1.35 of
establishments required to register
under section 905, and 5 percent × 135
= 6.75 of submitters required to list
ingredients under section 904) will not
already have a Dun and Bradstreet D–U–
N–S number.
FDA estimates that the submission of
ingredient listing information as
required by section 904 of the act will
take 3 hours per tobacco product.
Dated: July 22, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–18410 Filed 7–27–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–2537]
Request for Quality Metrics; Notice of
Draft Guidance Availability and Public
Meeting; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of meeting; notice of
draft guidance availability, request for
comments.
ACTION:
The Food and Drug
Administration (FDA), Center for Drug
Evaluation and Research (CDER) and
Center for Biologics Evaluation and
Research (CBER), is announcing the
availability of a draft guidance for
industry entitled ‘‘Request for Quality
Metrics’’ and a public meeting regarding
the Agency’s plans associated with a
quality metrics reporting program. The
draft guidance and public meeting are
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SUMMARY:
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19:17 Jul 27, 2015
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intended to gain stakeholders’
perspectives on various aspects of the
development and planned
implementation of a quality metrics
program launched under the authority
of the Food, Drug, and Cosmetic Act
(the FD&C Act). The guidance includes
an explanation of how FDA intends to
use quality metrics data to further
develop the FDA’s risk-based inspection
scheduling, to identify situations in
which there may be a risk for drug
supply disruption, to improve the
efficiency and effectiveness of
establishment inspections, and to
improve FDA’s evaluation of drug
manufacturing and control operations.
FDA expects that the initial use of the
metrics will be to consider a decreased
surveillance inspection frequency for
certain establishments. For example,
establishments that have highly
controlled manufacturing processes
have the potential to be inspected less
often (as a lower priority for inspection)
than similar establishments that
demonstrate uncontrolled processes (as
a higher priority for inspection). In
addition, FDA intends to consider
whether these metrics may provide a
basis for FDA to use improved riskbased principles to determine the
appropriate reporting category for
postapproval manufacturing changes.
FDA intends to consider the input from
this public meeting as we finalize this
guidance and the planned
implementation of this program,
including FDA’s initial set of requests
for quality metrics data.
DATES: The meeting will be held on
August 24, 2015, from 8:30 a.m. to 5
p.m. The meeting may be extended or
end early depending on the level of
public participation. Register to attend
or present at the meeting by August 7,
2015, (see section V.C. for information
on how to register or make a
presentation at the meeting). If you
cannot attend in person, information
about how you can access a live Web
cast will be located at https://
www.fda.gov/Drugs/NewsEvents/
ucm451529.htm.
Submit either electronic or written
comments concerning the draft
guidance and collection of information
proposed in the draft guidance by
September 28, 2015.
ADDRESSES: The meeting will be held at
FDA White Oak Campus, 10903 New
Hampshire Ave., Bldg. 31 Conference
Center, the Great Room (Rm. 1503
Section B/C), Silver Spring, MD 20993–
0002. Entrance for the public meeting
participants (non-FDA employees) is
through Building 1, where routine
security check procedures will be
PO 00000
Frm 00050
Fmt 4703
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44973
performed. For parking and security
information, please refer to https://
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
Submit written requests for single
copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002, or Center for Biologics Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 71, Rm. 7301, Silver Spring,
MD 20993–0002, 240–402–7911. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
The draft guidance may also be obtained
by mail by calling CBER at 1–800–835–
4709 or 240–402–7800.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Althea Cuff, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–4061, email: Althea.Cuff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
More than a decade ago, FDA
launched an initiative to encourage the
implementation of a modern, risk-based
pharmaceutical quality assessment
system. As part of this initiative, and in
recognition of the increasing complexity
of pharmaceutical manufacturing, FDA
developed a 21st century vision for
manufacturing and quality with input
from academia and industry. The
desired state was described as follows:
‘‘A maximally efficient, agile, flexible
pharmaceutical manufacturing sector
that reliably produces high-quality drug
products without extensive regulatory
oversight.’’ 1
There has been significant progress
toward this vision in the intervening
1 See ‘‘FDA Pharmaceutical Quality Oversight:
One Quality Voice’’ at https://www.fda.gov/
downloads/AboutFDA/CentersOffices/
OfficeofMedicalProductsandTobacco/CDER/
UCM442666.pdf.
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]]>Agencies
[Federal Register Volume 80, Number 144 (Tuesday, July 28, 2015)]
[Notices]
[Pages 44971-44973]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-18410]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0386]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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) 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 August
27, 2015.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0650.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.
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.
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 Tobacco Control Act
(Pub. L. 111-31) into law. The Tobacco Control Act amended the Federal
Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 301 et seq.) by,
among other things, adding 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.
Section 905(b) of the FD&C Act (21 U.S.C. 387e(b)), as amended by
the Tobacco Control Act, requires that ``every person who owns or
operates any establishment in any State engaged in the manufacture,
preparation, compounding, or processing of a tobacco product or tobacco
products . . .'' register with FDA the name, places of business, and
all establishments owned or operated by that person. Every person must
register by December 31 of each year. Section 905(c) of the FD&C Act
requires that first-time persons ``engaging in the manufacture,
preparation, compounding, or processing of a tobacco product or tobacco
products shall register with the Secretary the name, places of
business, and all such establishments of that person.'' Section 905(d)
states that persons required to register under section 905(b) or (c)
shall register any additional establishment that they own or operate in
any State which begins the manufacture, preparation, compounding, or
processing of a tobacco product or tobacco products. Section 905(h)
[[Page 44972]]
addresses foreign establishment registration requirements, which will
go into effect when regulations are issued by the Secretary. Section
905(i)(1) of the FD&C Act, as amended by the Tobacco Control Act,
requires that all registrants ``shall, at the time of registration
under any such subsection, file with [FDA] a list of all tobacco
products which are being manufactured, prepared, compounded, or
processed by that person for commercial distribution,'' along with
certain accompanying consumer information, such as all labeling and a
representative sampling of advertisements. Section 904(a)(1) of the
FD&C Act (21 U.S.C. 387d(a)(1)), as amended by the Tobacco Control Act,
requires each tobacco product manufacturer or importer, or agent
thereof, to submit ``a listing of all ingredients, including tobacco,
substances, compounds, and additives that are * * * added by the
manufacturer to the tobacco, paper, filter, or other part of each
tobacco product by brand or by quantity in each brand and subbrand.''
Since the Tobacco Control Act was enacted on June 22, 2009, the
information required under section 904(a)(1) must be submitted to FDA
by December 22, 2009, and include the ingredients added as of the date
of submission. Section 904(c) of the FD&C Act also requires submission
of information whenever additives, or the quantities of additives, are
changed.
FDA issued guidance documents on both: (1) Registration and Product
Listing for Owners and Operators of Domestic Tobacco Product
Establishments and (2) listing of Ingredients in Tobacco Products to
assist persons making such submissions to FDA under the Tobacco Control
Act. While electronic submission of registration and product listing
information and ingredient listing information are not required, FDA is
strongly encouraging electronic submission to facilitate efficiency and
timeliness of data management and collection. To that end, FDA designed
electronic submission applications to streamline the data entry process
for registration and product listing and for ingredient listing. These
tools allow for importation of large quantities of structured data,
attachment of files (e.g., in portable document format (PDFs) and
certain media files), and automatic acknowledgement of FDA's receipt of
submissions.
FDA also developed paper forms (Form FDA 3741--Registration and
Listing for Owners and Operators of Domestic Tobacco Product
Establishments, and Form FDA 3742--Listing of Ingredients in Tobacco
Products) as an alternative submission tool. Both the electronic
submission application and the paper forms can be accessed at https://www.fda.gov/tobacco.
In the Federal Register of April 21, 2015 (80 FR 22202), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total
Number of Number of Total annual Total operating and
FDA Form/activity/TCA section respondents responses per responses Hours per response hours maintenance
respondent costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tobacco Product Establishment Initial 135 1 135 2.............................. 270 $0.66
Registration and Listing; Form FDA 3741
Registration and Product Listing for Owners
and Operators of Domestic Establishments
(Electronic and Paper submissions); Section
905(b), (c), (d), (h), or (i).
Tobacco Product Establishment Renewal 135 1 135 0.20 (12 minutes).............. 27 0.66
Registration and Listing; Form FDA 3741
Registration and Product Listing for Owners
and Operators of Domestic Establishments
(Electronic and Paper submissions); Section
905(b), (c), (d), (h), or (i).
Tobacco Product Initial Ingredient Listing; 135 1 135 2.............................. 270 0.66
Form FDA 3742 Listing of Ingredients
(Electronic and Paper submissions); Section
904(a)(1) or (c).
Tobacco Product Renewal Ingredient Listing; 135 2 270 0.40 (24 minutes).............. 108 1.32
Form FDA 3742 Listing of Ingredients
(Electronic and Paper submissions); Section
904(a)(1) or (c).
Obtaining a Dun and Bradstreet D-U-N-S Number. 8 1 8 0.5............................ 4 ..............
Tobacco Product Ingredient Listing Electronic 135 1 135 3.............................. 405 0.66
and Paper submission.
---------------------------------------------------------------------------------------------------------
Total..................................... .............. .............. .............. ............................... 1,084 3.96
--------------------------------------------------------------------------------------------------------------------------------------------------------
On April 21, 2015, the FDA published a 60-day notice (80 FR 22202)
requesting public comments in the Federal Register. In this notice, the
total amount of burden hours for this collection was incorrectly listed
as 1,354 hours. After an internal review of burden for this collection,
FDA realized that the burden in the 60-day Federal Register notice did
not take into account new information from another Federal Agency
(which revised the number of respondents slightly upward), and the use
of a new electronic registration and product listing submission system.
To correct this oversight, FDA is revising the number of respondents
upward, from 125 to 135 respondents. FDA also has incorporated the use
of a new electronic system into this collection, so the total hours
were revised from 1,354 hours to 1,084 hours in table 1.
The burden estimates have been updated to fully incorporate the use
of FDA's new electronic system known as FURLS for submitting
registration and product listing information to FDA. This system allows
companies to enter information quickly and easily. For example, product
label pictures can be uploaded directly into the system and FDA
anticipates that most, if not all companies already have electronic
versions of their labels for printing, sales, or marketing purposes.
FDA anticipates that the initial entry registration and initial product
listing will each take 2 hours per entity.
Under section 905, once information is entered into FURLS, the
twice yearly conformation or updates to product lists are expected to
be simplified as all information previously entered is maintained and
visible in the system. Therefore, FDA expects that ongoing maintenance
of the product listing information will take 30 minutes twice a year,
or a total of 1 hour annually. This is broken down into 12 minutes for
recurring Registration and Listing each year, and 24 minutes twice a
year for recurring Product Ingredient Listings, or a total of 48
minutes annually.
[[Page 44973]]
Based on data shared by another Federal Agency, FDA estimates that
135 establishments will initially submit one report, and then will
submit confirmation or update reports on a semiannual basis.
FDA estimates that the confirmation or updating of registration
information as required by section 905 will take 12 minutes annually
per confirmation or update per establishment.
FDA estimates that the submission of product listings required by
section 905 for each establishment will take 2 hours initially. FDA
also estimates that the confirmation or updating of product listing
information required by section 905 will take 48 minutes annually for
two confirmations or updates per establishment.
FDA estimates that obtaining an optional Dun and Bradstreet D-U-N-S
number will take 0.5 hours, and that 8 respondents (1 percent x 135 =
1.35 of establishments required to register under section 905, and 5
percent x 135 = 6.75 of submitters required to list ingredients under
section 904) will not already have a Dun and Bradstreet D-U-N-S number.
FDA estimates that the submission of ingredient listing information
as required by section 904 of the act will take 3 hours per tobacco
product.
Dated: July 22, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-18410 Filed 7-27-15; 8:45 am]
BILLING CODE 4164-01-P
