Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Tobacco Health Document Submission, 41210-41211 [2010-17230]
Download as PDF
<![CDATA[
41210
Federal Register / Vol. 75, No. 135 / Thursday, July 15, 2010 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued
21 CFR Section and Part/Form
No.
No. of Respondents
101.79(c)(2)(iv)
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
100
0.25
25
1
1,000
1
1,000
25,000
1.03
25,750
0.5
12,875
1
101.105 and 101.100(h)
100
1,000
101.100(d)
1
1
1
40
40
101.108
Total
1,109,873
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
21 CFR Section
No. of Recordkeepers
101.12(e)
Annual Frequency
per Recordkeeping
Total Annual
Records
Hours per Record
Total Hours
25
1
25
1
25
101.13(q)(5)
300,000
1.5
450,000
0.75
337,500
101.14(d)(2)
300,000
1.5
450,000
0.75
337,500
101.22(i)(4)
25
1
25
1
25
1,000
1
1,000
1
1,000
100
1
100
1
100
101.100(d)(2)
101.105(t)
Total
srobinson on DSKHWCL6B1PROD with NOTICES
1 There
676,150
are no capital costs or operating and maintenance costs associated with this collection of information.
The estimated annual reporting and
recordkeeping burdens are based on
agency communications with industry
and FDA’s knowledge of and experience
with food labeling and the submission
of petitions and requests to the agency.
Where an agency regulation implements
an information collection requirement
in the act or the FPLA, only any
additional burden attributable to the
regulation has been included in FDA’s
burden estimate.
No burden has been estimated for
those requirements where the
information to be disclosed is
information that has been supplied by
FDA. Also, no burden has been
estimated for information that is
disclosed to third parties as a usual and
customary part of a food producer’s
normal business activities. Under 5 CFR
1320.3(c)(2), the public disclosure of
information originally supplied by the
Federal Government to the recipient for
the purpose of disclosure to the public
is not a collection of information. Under
5 CFR 1320.3(b)(2), the time, effort, and
financial resources necessary to comply
with a collection of information are
excluded from the burden estimate if
the reporting, recordkeeping, or
disclosure activities needed to comply
are usual and customary because they
VerDate Mar<15>2010
16:53 Jul 14, 2010
Jkt 220001
would occur in the normal course of
activities.
In this request for extension of OMB
approval under the PRA, FDA is no
longer combining the burden hours
associated with OMB Control Numbers
0910–0395 (collection titled, ‘‘Food
Labeling: Nutrition Labeling of Dietary
Supplements on a ‘Per Day’ Basis’’) and
0910–0515 (collection titled, ‘‘Food
Labeling: Trans Fatty Acids in Nutrition
Labeling’’), with the burden hours
approved under OMB Control Number
0910–0381 (collection titled, ‘‘Food
Labeling Regulations’’) as announced
previously. Such consolidation may
occur in the future.
Dated: July 9, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–17229 Filed 7–14–10; 8:45 am]
BILLING CODE 4160–01–S
PO 00000
Frm 00072
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0185]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Tobacco Health
Document Submission
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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
(the PRA).
DATES: Fax written comments on the
collection of information by August 16,
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
E:\FR\FM\15JYN1.SGM
15JYN1
Federal Register / Vol. 75, No. 135 / Thursday, July 15, 2010 / Notices
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0654. Also
include the FDA docket number found
in brackets in the heading of this
document.
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: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Tobacco Health Document
Submission—(OMB Control Number
0910–0654)—Extension
On June 22, 2009, the President
signed the Tobacco Control Act (Public
Law 111–31) into law. The Tobacco
Control Act granted 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. Among its many provisions, the
Tobacco Control Act added section
904(a)(4) to the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C.
387d(a)(4)), requiring submission of
documents related to certain effects of
tobacco products.
Section 904(a)(4) of the act requires
each tobacco product manufacturer or
importer, or agent thereof, to submit all
documents developed after June 22,
2009, ‘‘that relate to health,
toxicological, behavioral, or physiologic
effects of current or future tobacco
products, their constituents (including
smoke constituents), ingredients,
components, and additives.’’
Information required under section
904(a)(4) of the act must be submitted to
FDA beginning December 22, 2009.
FDA issued a draft guidance
document entitled ‘‘Tobacco Health
Document Submission’’’ on December
28, 2009 (74 FR 68629) to assist persons
making certain document submissions
to FDA under section 904(a)(4) of the
act. The guidance document was
finalized on April 20, 2010 (75 FR
20606). While electronic submission of
tobacco health documents is not
required, FDA designed the eSubmitter
application as an alternative for mailing
documents. This electronic 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 a paper form (FDA Form
3743) as an alternative submission tool.
Both the eSubmitter application and the
paper form 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 PRA. 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. On January 7,
2010, FDA received emergency approval
41211
for this information collection. Based on
comments indicating that the burden
estimate was too low, FDA has adjusted
its original burden estimate from 1.0
hour per response to 200 hours per
response. FDA also increased the annual
frequency per response from 1 to 4
(quarterly).
FDA is maintaining the original
estimate of the number of respondents
at 10. FDA is basing its estimates on the
total number of tobacco firms it is aware
of, its experience with document
production, and comments received in
response to the draft guidance
document published on December 28,
2009.
In the Federal Register of April 20,
2010 (75 FR 20603), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. FDA received one
comment in response to the 60-day
notice soliciting public comment on the
extension of OMB approval for this
information collection. The comment
stated that the classification/coding
recommendations will impose burdens
that significantly exceed the burden
estimate of 200 hours and will likely
inundate FDA with information with
little incremental value. The estimated
200 hours per response burden is based
on the average burden estimate among
all 10 respondents. Therefore, on an
individual basis, the actual burden per
respondent may be higher or lower than
the 200 hours estimate since it is an
average value. FDA currently is
evaluating the classification/coding
recommendations and will revisit this
issue in future guidance.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Activity
No. of
Respondents
Tobacco Health Document
Submission and Form FDA
3743
1 There
10
Total Annual
Responses
4
Hours per
Response
40
200
Total
Hours
8,000
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: July 9, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–17230 Filed 7–14–10; 8:45 am]
srobinson on DSKHWCL6B1PROD with NOTICES
Annual Frequency
per Response
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Office of the Director; Notice of
Establishment
Pursuant to the Federal Advisory
Committee Act, as amended (5 U.S.C.
Appendix 2), the Director, Office of
Federal Advisory Committee Policy,
National Institutes of Health (NIH),
VerDate Mar<15>2010
16:53 Jul 14, 2010
Jkt 220001
PO 00000
Frm 00073
Fmt 4703
Sfmt 4703
announces the establishment of the
Interagency Pain Research Coordinating
Committee.
Public Law 111–148 (‘‘Patient
Protection and Affordable Care Act’’),
Title IV, as it amends Part B of Title IV
of the Public Health Service Act (42
USC 284 et seq.) requires the committee
to: (a) Develop a summary of advances
in pain care research supported or
conducted by Federal agencies relevant
to the diagnosis, prevention, and
E:\FR\FM\15JYN1.SGM
15JYN1
]]>Agencies
[Federal Register Volume 75, Number 135 (Thursday, July 15, 2010)]
[Notices]
[Pages 41210-41211]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-17230]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0185]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Tobacco Health
Document Submission
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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 (the PRA).
DATES: Fax written comments on the collection of information by August
16, 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
[[Page 41211]]
oira_submission@omb.eop.gov. All comments should be identified with
the OMB control number 0910-0654. Also include the FDA docket number
found in brackets in the heading of this document.
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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Tobacco Health Document Submission--(OMB Control Number 0910-0654)--
Extension
On June 22, 2009, the President signed the Tobacco Control Act
(Public Law 111-31) into law. The Tobacco Control Act granted 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. Among its many provisions, the
Tobacco Control Act added section 904(a)(4) to the Federal Food, Drug,
and Cosmetic Act (the act) (21 U.S.C. 387d(a)(4)), requiring submission
of documents related to certain effects of tobacco products.
Section 904(a)(4) of the act requires each tobacco product
manufacturer or importer, or agent thereof, to submit all documents
developed after June 22, 2009, ``that relate to health, toxicological,
behavioral, or physiologic effects of current or future tobacco
products, their constituents (including smoke constituents),
ingredients, components, and additives.'' Information required under
section 904(a)(4) of the act must be submitted to FDA beginning
December 22, 2009.
FDA issued a draft guidance document entitled ``Tobacco Health
Document Submission''' on December 28, 2009 (74 FR 68629) to assist
persons making certain document submissions to FDA under section
904(a)(4) of the act. The guidance document was finalized on April 20,
2010 (75 FR 20606). While electronic submission of tobacco health
documents is not required, FDA designed the eSubmitter application as
an alternative for mailing documents. This electronic 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 a paper form (FDA Form 3743) as an alternative
submission tool. Both the eSubmitter application and the paper form 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 PRA. 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. On January 7, 2010, FDA received
emergency approval for this information collection. Based on comments
indicating that the burden estimate was too low, FDA has adjusted its
original burden estimate from 1.0 hour per response to 200 hours per
response. FDA also increased the annual frequency per response from 1
to 4 (quarterly).
FDA is maintaining the original estimate of the number of
respondents at 10. FDA is basing its estimates on the total number of
tobacco firms it is aware of, its experience with document production,
and comments received in response to the draft guidance document
published on December 28, 2009.
In the Federal Register of April 20, 2010 (75 FR 20603), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received one comment in response to the
60-day notice soliciting public comment on the extension of OMB
approval for this information collection. The comment stated that the
classification/coding recommendations will impose burdens that
significantly exceed the burden estimate of 200 hours and will likely
inundate FDA with information with little incremental value. The
estimated 200 hours per response burden is based on the average burden
estimate among all 10 respondents. Therefore, on an individual basis,
the actual burden per respondent may be higher or lower than the 200
hours estimate since it is an average value. FDA currently is
evaluating the classification/coding recommendations and will revisit
this issue in future guidance.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
Activity Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
Tobacco 10 4 40 200 8,000
Health
Document
Submissio
n and
Form FDA
3743
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: July 9, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-17230 Filed 7-14-10; 8:45 am]
BILLING CODE 4160-01-S
