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, 22202-22204 [2015-09092]
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II. Selection Procedure
Any industry organization interested
in participating in the selection of an
appropriate nonvoting member to
represent industry interests should send
a letter stating that interest to the FDA
contact (see FOR FURTHER INFORMATION
CONTACT) within 30 days of publication
of this document (see DATES). Within the
subsequent 30 days, FDA will send a
letter to each organization that has
expressed an interest, attaching a
complete list of all such organizations;
and a list of all nominees along with
their current resumes. The letter will
also state that it is the responsibility of
the interested organizations to confer
with one another and to select a
candidate, within 60 days after the
receipt of the FDA letter, to serve as the
nonvoting member to represent industry
interests for the committee. The
interested organizations are not bound
by the list of nominees in selecting a
candidate. However, if no individual is
selected within 60 days, the
Commissioner will select the nonvoting
member to represent industry interests.
tkelley on DSK3SPTVN1PROD with NOTICES
III. Application Procedure
Individuals may self-nominate and/or
an organization may nominate one or
more individuals to serve as a nonvoting
industry representative. Contact
information, current curriculum vitae,
and the name of the committee of
interest should be sent to the FDA
Advisory Committee Membership
Nomination Portal (see ADDRESSES)
within 30 days of publication of this
document (see DATES). FDA will forward
all nominations to the organizations
expressing interest in participating in
the selection process for the committee.
(Persons who nominate themselves as
nonvoting industry representatives will
not participate in the selection process).
FDA seeks to include the views of
women, and men, members of all racial
and ethnic groups and individuals with
and without disabilities on its advisory
committees and, therefore encourages
nominations of appropriately qualified
candidates from these groups.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to advisory committees.
Dated: April 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–09082 Filed 4–20–15; 8:45 am]
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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) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the proposed extension of an existing
collection of information pertaining to
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 June 22, 2015.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information 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: 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: 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
SUMMARY:
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
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 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) 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
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Federal Register / Vol. 80, No. 76 / Tuesday, April 21, 2015 / Notices
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 905(c) of
the FD&C Act 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) of the FD&C Act
addresses foreign establishment
registration requirements, which will go
into effect when regulations are
promulgated 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 sub-brand.
Since the Tobacco Control Act was
enacted on June 22, 2009, the
information required under section
904(a)(1) of the FD&C Act 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 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.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN
Number of
responses per
respondent
Number of
respondents
Activity
Average
burden per
response
Total annual
responses
Total operating
and maintenance costs
Total hours
125
1.6
200
3.75
750
$0.98
125
1.6
200
3
600
0.98
8
.5 (30
minutes)
4
........................
Total ................................................
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Form FDA 3741: Registration and Product Listing for Owners and Operators
of Domestic Establishments (Electronic and Paper Submission)/Section
905(b), 905(c), 905(d) 905(h), or
905(i) of the FD&C Act .......................
Form FDA 3742: Listing of Ingredients
(Electronic and Paper Submissions)/
Section 904(a)(1) or 904(c) of the
FD&C Act ...........................................
Obtaining a DUNS Number (10% of
Total Respondents) ............................
........................
........................
........................
1,354
1.96
8
Since this collection of information
was last approved by OMB on October
15, 2012, its burden has remained the
same at 1,354 reporting hours. This
burden estimate was determined as a
result of FDA experience over the past
3 years in the regulation of tobacco
products and is based on the actual
number of establishment registration
and product listings and product
ingredient submissions received during
this time period. FDA estimates that the
submission of registration information
as required by section 905 of the FD&C
Act will remain at 3.75 hours per
establishment and, based on the actual
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1
..........................
number of registration information
submitted in the past 3 years and its
experience, the Agency estimates that
approximately 200 registrations will be
submitted from 125 tobacco product
establishments annually, for a total of
750 reporting burden hours. FDA
estimates that the submission of
ingredient listing information as
required by section 904 of the FD&C Act
will remain at 3 hours per tobacco
product and, based on the actual
number of product ingredient listings
submitted over the past 3 years and its
experience, the Agency estimates that
approximately 200 ingredient listings
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will be submitted from 125 tobacco
establishments, for a total of 600
reporting burden hours.
FDA also estimates that obtaining a
Dun and Bradstreet (DUNS) number will
take 0.5 hours, and that 8 respondents
(1 percent (1.25) of establishments
required to register under section 905
and 5 percent (6.25) of submitters
required to list ingredients under
section 904) will not already have a
DUNS number. The total burden is
estimated to be 4 hours. Total burden
hours for this collection, therefore is
1,354 hours.
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Dated: April 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
information, refer to https://
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
[FR Doc. 2015–09092 Filed 4–20–15; 8:45 am]
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FOR FURTHER INFORMATION CONTACT:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0882]
Generic Drug User Fees; Public
Meeting; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ACTION:
The Food and Drug
Administration (FDA) is announcing a
public meeting on the Generic Drug
User Fee Amendments of 2012
(GDUFA). The legislative authority for
GDUFA expires at the end of September
2017. At that time, new legislation will
be required for FDA to continue to
collect generic drug user fees for future
fiscal years. The Federal Food, Drug,
and Cosmetic Act (the FD&C Act)
requires that before FDA begins
negotiations with the regulated industry
on GDUFA reauthorization; we publish
a notice in the Federal Register
requesting public input on the
reauthorization, hold a public meeting
at which the public may present its
views on the reauthorization, including
specific suggestions for changes to the
goals referred to in the Generic Drug
User Fee Act Program Performance
Goals and Procedures (i.e., the
Commitment Letter), provide a period of
30 days after the public meeting to
obtain written comments from the
public, and publish the comments on
FDA’s Web site. FDA invites public
comment on the GDUFA program and
suggestions regarding the features FDA
should propose for the next GDUFA
program.
SUMMARY:
The public meeting will be held
on June 15, 2015, from 9 a.m. to 5 p.m.
The public meeting may be extended or
may end early depending on the level of
public participation.
ADDRESSES: The public meeting will be
held at the FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), 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
performed. For parking and security
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DATES:
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Connie Wisner, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1718,
Silver Spring, MD 20993, 240–402–
7946, Connie.Wisner@fda.hhs.gov; or
Kimberly Giordano, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1611,
Silver Spring, MD 20993, 301–796–
1071, Kimberly.Giordano@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
On July 9, 2012, the Food and Drug
Administration Safety and Innovation
Act, which included GDUFA (Pub. L.
112–144, title III), was signed into law
by the President. GDUFA authorizes
FDA to collect fees from drug
companies that submit marketing
applications for certain generic human
drug applications, certain drug master
files, and certain facilities. Designed to
speed access to safe and effective
generic drugs to the public, GDUFA
requires that generic drug manufacturers
pay user fees to finance critical and
measurable generic drug program
enhancements. GDUFA also requires
that generic drug facilities around the
world provide identification
information annually to FDA.
Additional information concerning
GDUFA, including the text of the law,
the Commitment Letter, key Federal
Register documents, GDUFA-related
guidances, performance reports, and
financial reports may be found on the
FDA Web site at https://www.fda.gov/
gdufa.
II. Purpose of Public Meeting
FDA is announcing a public meeting
on GDUFA. The authority for GDUFA
expires at the end of September 2017.
Without new legislation, FDA will no
longer be able to collect user fees to
fund the human generic drug review
process. Section 744(C)(d)(2) (21 U.S.C.
379j–43(d)(2)) of the FD&C Act requires
that before FDA begins negotiations
with the regulated industry on GDUFA
reauthorization, we do the following: (1)
Publish a notice in the Federal Register
requesting public input on the
reauthorization, (2) hold a public
meeting at which the public may
present its views on the reauthorization,
including specific suggestions for
changes to the goals referred to in the
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Commitment Letter, (3) provide a period
of 30 days after the public meeting to
obtain written comments from the
public, and (4) publish the comments on
the FDA Web site. This notice, the
public meeting, the 30-day comment
period after the meeting, and the posting
of the comments on the FDA Web site
will satisfy these requirements. The
purpose of the public meeting is to
receive public input on the
reauthorization of GDUFA, including
specific suggestions for changes to the
goals referred to in the Commitment
Letter. FDA is interested in responses to
the following two general questions and
welcomes any other relevant
information the public would like to
share:
• What is your assessment of the
overall performance of the GDUFA
program to date?
• What aspects of GDUFA should be
retained, changed, or discontinued to
further strengthen and improve the
program?
In general, the meeting format will
include presentations by FDA, scientific
and academic experts, health care
professionals, representatives of patient
and consumer advocacy groups, the
generic drug industry, and the general
public. The amount of time available for
public testimony will be determined by
the number of persons who register to
present at the meeting. A draft agenda
and other background information for
the public meeting will be posted at
https://www.fda.gov/gdufa by June 8,
2015.
III. Meeting Attendance and
Participation
FDA is seeking participation (i.e.,
attendance and oral presentations) at the
public meeting by all interested parties,
including but not limited to scientific
and academic experts, health care
professionals, representatives of patient
and consumer advocacy groups, the
generic drug industry, and the general
public. If you wish to attend the
meeting, please email your registration
information to GenericDrugPolicy@
fda.hhs.gov by June 1, 2015. Your email
should contain complete contact
information for each attendee, including
name, title, affiliation, address, email
address, and telephone number.
Registration is free and is on a firstcome, first-served basis. Early
registration is recommended because
seating is limited. Registrants will
receive confirmation once they have
been accepted. If registration becomes
full prior to the meeting, FDA will place
a notice on https://www.fda.gov/gdufa.
Onsite registration on the day of the
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[Federal Register Volume 80, Number 76 (Tuesday, April 21, 2015)]
[Notices]
[Pages 22202-22204]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-09092]
-----------------------------------------------------------------------
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) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the proposed extension of an
existing collection of information pertaining to 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 June 22, 2015.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information 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: 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: 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 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) 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
[[Page 22203]]
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 905(c) of the FD&C Act 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) of the FD&C Act addresses
foreign establishment registration requirements, which will go into
effect when regulations are promulgated 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 sub-brand. Since the Tobacco Control
Act was enacted on June 22, 2009, the information required under
section 904(a)(1) of the FD&C Act 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 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. FDA estimates the burden of this collection of
information as follows:
Table 1--Estimated Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total
Number of Number of Total annual Average operating and
Activity respondents responses per responses burden per Total hours maintenance
respondent response costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Form FDA 3741: Registration and Product Listing for 125 1.6 200 3.75 750 $0.98
Owners and Operators of Domestic Establishments
(Electronic and Paper Submission)/Section 905(b),
905(c), 905(d) 905(h), or 905(i) of the FD&C Act......
Form FDA 3742: Listing of Ingredients (Electronic and 125 1.6 200 3 600 0.98
Paper Submissions)/Section 904(a)(1) or 904(c) of the
FD&C Act..............................................
Obtaining a DUNS Number (10% of Total Respondents)..... 8 1 8 .5 (30 4 ..............
minutes)
------------------------------------------------------------------------------------------------
Total.............................................. .............. ............... .............. .............. 1,354 1.96
--------------------------------------------------------------------------------------------------------------------------------------------------------
Since this collection of information was last approved by OMB on
October 15, 2012, its burden has remained the same at 1,354 reporting
hours. This burden estimate was determined as a result of FDA
experience over the past 3 years in the regulation of tobacco products
and is based on the actual number of establishment registration and
product listings and product ingredient submissions received during
this time period. FDA estimates that the submission of registration
information as required by section 905 of the FD&C Act will remain at
3.75 hours per establishment and, based on the actual number of
registration information submitted in the past 3 years and its
experience, the Agency estimates that approximately 200 registrations
will be submitted from 125 tobacco product establishments annually, for
a total of 750 reporting burden hours. FDA estimates that the
submission of ingredient listing information as required by section 904
of the FD&C Act will remain at 3 hours per tobacco product and, based
on the actual number of product ingredient listings submitted over the
past 3 years and its experience, the Agency estimates that
approximately 200 ingredient listings will be submitted from 125
tobacco establishments, for a total of 600 reporting burden hours.
FDA also estimates that obtaining a Dun and Bradstreet (DUNS)
number will take 0.5 hours, and that 8 respondents (1 percent (1.25) of
establishments required to register under section 905 and 5 percent
(6.25) of submitters required to list ingredients under section 904)
will not already have a DUNS number. The total burden is estimated to
be 4 hours. Total burden hours for this collection, therefore is 1,354
hours.
[[Page 22204]]
Dated: April 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-09092 Filed 4-20-15; 8:45 am]
BILLING CODE 4164-01-P
