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, 7269-7270 [2010-3031]
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7269
Federal Register / Vol. 75, No. 32 / Thursday, February 18, 2010 / Notices
ESTIMATED ANNUALIZED BURDEN TABLE
Forms
(if necessary)
Type of
respondent
Self-administered questionnaire .......
Medicare beneficiaries .....................
Seleda Perryman,
Office of the Secretary, Paperwork Reduction
Act Reports Clearance Officer.
[FR Doc. 2010–3071 Filed 2–17–10; 8:45 am]
BILLING CODE 4150–05–P
Food and Drug Administration
[Docket No. FDA–2010–N–0074]
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
Food and Drug Administration,
HHS.
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
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 to
listing of ingredients in tobacco
products under the Family Smoking
Prevention and Tobacco Control Act
(the Tobacco Control Act).
DATES: Submit written or electronic
comments on the collection of
information by April 19, 2010.
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
VerDate Nov<24>2008
16:37 Feb 17, 2010
Jkt 220001
Total burden
hours
500
1
25/60
208
........................
........................
208
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:
Jonna Capezzuto, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3794,
Jonnalynn.Capezzuto@fda.hhs.gov.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
ACTION:
Average
burden hours
per response
500
Total ...........................................
AGENCY:
Number of
responses per
respondent
Number of
respondents
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.
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
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 (Public
Law 111–31) into law. The Tobacco
Control Act amended the Federal Food,
Drug, and Cosmetic Act (the act) (21
U.S.C. 301 et seq.) by, among other
things, adding a new chapter granting
FDA important new 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 act (21 U.S.C.
395(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(i)(1) of the 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 act, 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 and 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,
E:\FR\FM\18FEN1.SGM
18FEN1
7270
Federal Register / Vol. 75, No. 32 / Thursday, February 18, 2010 / Notices
2009, and include the ingredients added
as of the date of submission. Section
904(c) of the 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
(November 12, 2009, 74 FR 58298) and
(2) Listing of Ingredients in Tobacco
Products (December 1, 2009, 74 FR
62795) 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
the eSubmitter application to streamline
the data entry process for registration
and product listing and for ingredient
listing. This tool allows for importation
of large quantities of structured data,
attachments 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 (FDA Form 3742—Registration
and Listing for Owners and Operators of
Domestic Tobacco Product
Establishments and FDA Form 3743—
Listing of Ingredients in Tobacco
Products) as an alternative submission
tool. Both the eSubmitter application
and the paper forms can be accessed at
https://www.fda.gov/tobacco.
On September 1, 2009 (74 FR 45219),
FDA published notice in the Federal
Register announcing that a proposed
collection of information had been
submitted to OMB for emergency
processing under the Paperwork
Reduction Act of 1995. On September
15, 2009 (74 FR 47257), FDA published
a notice correcting the length of the
comment period, keeping it open until
October 1, 2009. On October 13, 2009
(74 FR 52495), FDA published a notice
reopening the comment period until
October 26, 2009. Based on comments
indicating that the burden estimates
were too low, FDA has adjusted its
original burden estimates. FDA has
adjusted its burden estimate for
registration and product listing for
owners and operators of domestic
establishments under section 905 of the
act from 0.75 hours per response to 3.75
hours per response. FDA has adjusted
its burden estimate for listing of
ingredients under section 904 of the act
from 0.75 hours per response to 3.0
hours per response. FDA also decreased
the number of respondents for listing of
ingredients under section 904 from
100,000 to 11,000 in response to
comments that this estimate was too
high. FDA also added the activity of
applying for a Dun and Bradstreet D-UN-S number to the burden of this
information collection for those who
chose to use eSubmitter.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Activity
No. of
Respondents
Registration and Product
Listing for Owners and
Operators of Domestic
Establishments
Annual Frequency
per Response
Total Annual
Respondents
Hours per
Response
Total Hours
100,000
1
100,000
3.75
375,000
Listing of Ingredients
11,000
1
11,000
3.0
33,000
Obtaining a Dun and
Bradstreet D-U-N-S
Number
1,550
1
1,550
0.5
775
Total
1 There
112,550
408,775
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: February 4, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–3031 Filed 2–17–10; 8:45 am]
BILLING CODE 4160–01–S
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
112,550
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0434]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance for
Humanitarian Device Exemption
Holders, Institutional Review Boards,
Clinical Investigators, and Food and
Drug Administration Staff:
Humanitarian Device Exemption
Regulation: Questions and Answers;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
VerDate Nov<24>2008
14:39 Feb 17, 2010
Jkt 220001
PO 00000
Notice.
Frm 00040
Fmt 4703
Sfmt 4703
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 March 22,
2010.
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 e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–NEW and
title Guidance for Humanitarian Device
Exemption Holders, Institutional
E:\FR\FM\18FEN1.SGM
18FEN1
]]>Agencies
[Federal Register Volume 75, Number 32 (Thursday, February 18, 2010)]
[Notices]
[Pages 7269-7270]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-3031]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0074]
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 to listing of ingredients in tobacco products under
the Family Smoking Prevention and Tobacco Control Act (the Tobacco
Control Act).
DATES: Submit written or electronic comments on the collection of
information by April 19, 2010.
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: Jonna Capezzuto, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850, 301-796-3794, Jonnalynn.Capezzuto@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
(Public Law 111-31) into law. The Tobacco Control Act amended the
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 301 et seq.)
by, among other things, adding a new chapter granting FDA important new
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 act (21 U.S.C. 395(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(i)(1) of the 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 act, 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 and 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,
[[Page 7270]]
2009, and include the ingredients added as of the date of submission.
Section 904(c) of the 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 (November 12, 2009, 74 FR 58298) and (2) Listing of
Ingredients in Tobacco Products (December 1, 2009, 74 FR 62795) 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
the eSubmitter application to streamline the data entry process for
registration and product listing and for ingredient listing. This tool
allows for importation of large quantities of structured data,
attachments 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 (FDA Form 3742--
Registration and Listing for Owners and Operators of Domestic Tobacco
Product Establishments and FDA Form 3743--Listing of Ingredients in
Tobacco Products) as an alternative submission tool. Both the
eSubmitter application and the paper forms can be accessed at https://www.fda.gov/tobacco.
On September 1, 2009 (74 FR 45219), FDA published notice in the
Federal Register announcing that a proposed collection of information
had been submitted to OMB for emergency processing under the Paperwork
Reduction Act of 1995. On September 15, 2009 (74 FR 47257), FDA
published a notice correcting the length of the comment period, keeping
it open until October 1, 2009. On October 13, 2009 (74 FR 52495), FDA
published a notice reopening the comment period until October 26, 2009.
Based on comments indicating that the burden estimates were too low,
FDA has adjusted its original burden estimates. FDA has adjusted its
burden estimate for registration and product listing for owners and
operators of domestic establishments under section 905 of the act from
0.75 hours per response to 3.75 hours per response. FDA has adjusted
its burden estimate for listing of ingredients under section 904 of the
act from 0.75 hours per response to 3.0 hours per response. FDA also
decreased the number of respondents for listing of ingredients under
section 904 from 100,000 to 11,000 in response to comments that this
estimate was too high. FDA also added the activity of applying for a
Dun and Bradstreet D-U-N-S number to the burden of this information
collection for those who chose to use eSubmitter.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual Frequency Total Annual
Activity No. of Respondents per Response Respondents Hours per Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Registration and Product Listing for Owners 100,000 1 100,000 3.75 375,000
and Operators of Domestic Establishments
--------------------------------------------------------------------------------------------------------------------------------------------------------
Listing of Ingredients 11,000 1 11,000 3.0 33,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Obtaining a Dun and Bradstreet D-U-N-S 1,550 1 1,550 0.5 775
Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 112,550 ................. 112,550 .................... 408,775
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: February 4, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-3031 Filed 2-17-10; 8:45 am]
BILLING CODE 4160-01-S
