Agency Information Collection Activities; Proposed Collection; Comment Request; Information Request Regarding Dissolvable Tobacco Products, 65490-65491 [2010-26830]
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65490
Federal Register / Vol. 75, No. 205 / Monday, October 25, 2010 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Type of
respondent
Form name
Selected women for exploratory focus groups
Selected women for message testing focus
groups.
Exploratory Focus Group Guide ....................
Message Testing Focus Group Guide ...........
Dated: October 19, 2010.
Carol E. Walker,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. 2010–26878 Filed 10–22–10; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0542]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Information
Request Regarding Dissolvable
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 and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
an information request regarding the use
of dissolvable tobacco products.
DATES: Submit either electronic or
written comments on the collection of
information by December 27, 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–
emcdonald on DSK2BSOYB1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
16:05 Oct 22, 2010
Jkt 223001
Number of
respondents
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
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.
Information Request Regarding
Dissolvable Tobacco Products
On June 22, 2009, the President
signed the Family Smoking Prevention
and Tobacco Control Act (Tobacco
Control Act) (Pub. L. 111–31) into law.
The Tobacco Control Act amended the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) by adding a new chapter
granting FDA important new authority
to regulate the manufacture, marketing,
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
72
54
Average
burden per
response
(in hours)
Responses
per
respondent
1
1
2
2
and distribution of tobacco products to
protect the public health generally and
to reduce tobacco use by minors.
Section 917 of the Tobacco Control
Act required the Secretary of Health and
Human Services (the Secretary) to
establish a Tobacco Products Scientific
Advisory Committee (TPSAC). Section
907(f) of the Tobacco Control Act
requires the TPSAC to submit a report
and recommendations to the Secretary
on the impact of the use of dissolvable
tobacco products on the public health,
including such use among children. To
ensure a comprehensive review of this
issue, FDA is requesting tobacco
industry documents and information to
support the work of TPSAC. Under
section 907(f), TPSAC must submit its
report and recommendations to the
Secretary within 2 years of its
formation, or March 23, 2012.
In order to provide TPSAC with the
information it needs to carry out its
statutory obligation, FDA is requesting
that tobacco companies submit
information under section 904(b) of the
Tobacco Control Act pertaining to
documents and underlying scientific
and financial information relating to
research, and research findings,
conducted, supported, or possessed by
the manufacturer (or agents thereof) on
a specified set of topics. For the
purposes of this request, ‘‘research’’ may
include, but is not limited to, focus
groups, surveys, experimental clinical
studies, post-marketing surveillance,
toxicological and biochemical assays,
taste panels, and assessments of the
effectiveness of product marketing
practices. Topics for which information
relating to dissolvable tobacco products
is requested are marketing research;
marketing practices; effectiveness of
marketing practices; and health,
toxicological, behavioral, and
physiological effects. FDA’s request for
documents related to dissolvable
tobacco products includes, but is not
limited to products for research,
investigational use, developmental
studies, test marketing, and/or
commercial marketing, and also to the
components, parts, or accessories of
such products.
E:\FR\FM\25OCN1.SGM
25OCN1
65491
Federal Register / Vol. 75, No. 205 / Monday, October 25, 2010 / Notices
FDA estimates the burden for this
collection of information as follows:
TABLE 1—ESTIMATE OF ONE-TIME REPORTING BURDEN1
Annual
frequency
per response
Number of
respondents
Activity
Total
average
annual
responses
Hours per response
Total hours
Providing negative response to request for dissolvable
tobacco product documents ...........................................
Submission of dissolvable tobacco products .....................
110
10
1
1
110
10
0.50
230
55
2,300
Total ............................................................................
120
........................
120
..........................
2,355
emcdonald on DSK2BSOYB1PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
These burden estimates were derived
by taking into consideration FDA’s
experience with document production,
experience with submissions pertaining
to other tobacco product-related
information collections, and comments
received in response to other tobacco
product-related information collections.
FDA is limiting the burden on
respondents by only requesting
documents on specific topics that will
have utility for FDA. FDA is requesting
the final version of documents or the
most recent draft in the absence of a
final document. Also, publically
available published abstracts, editorials,
letters, and manuscripts are not being
requested, although FDA would
appreciate a list of such publications.
Information responsive to this section
904(b) information request that has been
previously provided to FDA under the
FD&C Act or other letter requests does
not have to be resubmitted as long as the
document is fully referenced. FDA
believes that the number of documents
being requested in this information
collection will be limited due to the
estimated small number of respondents
and the relatively shorter amount of
time these tobacco products have been
in existence compared to other tobacco
products.
FDA estimates that there are
approximately 120 tobacco product
manufacturers who may be affected by
this collection of information. Of the
total number of manufacturers, FDA
estimates that most manufacturers (110)
will not have documents which will be
responsive to this section 904(b) request
and that they will only need to send a
letter notifying the FDA’s Center for
Tobacco Products that they have no
documents to report. FDA anticipates it
should take no longer than 30 minutes
to draft such a response and send to
FDA. The total one-time hourly burden
to submit this letter to FDA is estimated
to be 55 hours (30 minutes × 110
manufacturers).
VerDate Mar<15>2010
16:05 Oct 22, 2010
Jkt 223001
FDA estimates that there are
approximately 10 tobacco product
manufacturers who may have
documents meeting the criteria of this
information collection request. Because
the volume of responsive documents
each of these respondents may have will
likely vary, the corresponding time
burden for each respondent to satisfy
this information collection request will
also vary. Therefore, FDA estimates that
these 10 respondents will average
approximately 230 hours each to satisfy
the requirements of this section 904(b)
request. The total one-time hourly
burden to locate and send documents
meeting the requirements of this request
is estimated to be 2,300 hours (230
hours × 10 manufacturers). The total
one-time hourly burden for this
collection of information is 2,355 hours
(55 hours + 2,300 hours).
Dated: October 19, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–26830 Filed 10–22–10; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0411]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guide To Minimize
Microbial Food Safety Hazards of
Fresh-Cut Fruits and Vegetables
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
SUMMARY:
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by November
24, 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 emailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0609. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Denver Presley Jr., Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3793.
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.
Guide To Minimize Microbial Food
Safety Hazards of Fresh-Cut Fruits and
Vegetables—(OMB Control Number
0910–0609)—Extension
Fresh-cut fruits and vegetables are
fruits and vegetables that have been
processed by peeling, slicing, chopping,
shredding, coring, trimming, or
mashing, with or without washing or
other treatment, prior to being packaged
for consumption. The methods by
which produce is grown, harvested, and
processed may contribute to its
contamination with pathogens and,
consequently, the role of the produce in
transmitting foodborne illness. Factors
such as the high degree of handling and
mixing of the product, the release of
cellular fluids during cutting or
mashing, the high moisture content of
the product, the absence of a step lethal
E:\FR\FM\25OCN1.SGM
25OCN1
]]>Agencies
[Federal Register Volume 75, Number 205 (Monday, October 25, 2010)]
[Notices]
[Pages 65490-65491]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-26830]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0542]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Information Request Regarding Dissolvable 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 and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on an information request regarding the use of
dissolvable tobacco products.
DATES: Submit either electronic or written comments on the collection
of information by December 27, 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 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.
Information Request Regarding Dissolvable Tobacco Products
On June 22, 2009, the President signed the Family Smoking
Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. L. 111-
31) into law. The Tobacco Control Act amended the Federal Food, Drug,
and Cosmetic Act (FD&C Act) by adding 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 917 of the Tobacco Control Act required the Secretary of
Health and Human Services (the Secretary) to establish a Tobacco
Products Scientific Advisory Committee (TPSAC). Section 907(f) of the
Tobacco Control Act requires the TPSAC to submit a report and
recommendations to the Secretary on the impact of the use of
dissolvable tobacco products on the public health, including such use
among children. To ensure a comprehensive review of this issue, FDA is
requesting tobacco industry documents and information to support the
work of TPSAC. Under section 907(f), TPSAC must submit its report and
recommendations to the Secretary within 2 years of its formation, or
March 23, 2012.
In order to provide TPSAC with the information it needs to carry
out its statutory obligation, FDA is requesting that tobacco companies
submit information under section 904(b) of the Tobacco Control Act
pertaining to documents and underlying scientific and financial
information relating to research, and research findings, conducted,
supported, or possessed by the manufacturer (or agents thereof) on a
specified set of topics. For the purposes of this request, ``research''
may include, but is not limited to, focus groups, surveys, experimental
clinical studies, post-marketing surveillance, toxicological and
biochemical assays, taste panels, and assessments of the effectiveness
of product marketing practices. Topics for which information relating
to dissolvable tobacco products is requested are marketing research;
marketing practices; effectiveness of marketing practices; and health,
toxicological, behavioral, and physiological effects. FDA's request for
documents related to dissolvable tobacco products includes, but is not
limited to products for research, investigational use, developmental
studies, test marketing, and/or commercial marketing, and also to the
components, parts, or accessories of such products.
[[Page 65491]]
FDA estimates the burden for this collection of information as
follows:
Table 1--Estimate of One-Time Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
Annual Total average
Activity Number of frequency per annual Hours per Total hours
respondents response responses response
----------------------------------------------------------------------------------------------------------------
Providing negative response to 110 1 110 0.50 55
request for dissolvable tobacco
product documents..............
Submission of dissolvable 10 1 10 230 2,300
tobacco products...............
-------------------------------------------------------------------------------
Total....................... 120 .............. 120 .............. 2,355
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
These burden estimates were derived by taking into consideration
FDA's experience with document production, experience with submissions
pertaining to other tobacco product-related information collections,
and comments received in response to other tobacco product-related
information collections. FDA is limiting the burden on respondents by
only requesting documents on specific topics that will have utility for
FDA. FDA is requesting the final version of documents or the most
recent draft in the absence of a final document. Also, publically
available published abstracts, editorials, letters, and manuscripts are
not being requested, although FDA would appreciate a list of such
publications. Information responsive to this section 904(b) information
request that has been previously provided to FDA under the FD&C Act or
other letter requests does not have to be resubmitted as long as the
document is fully referenced. FDA believes that the number of documents
being requested in this information collection will be limited due to
the estimated small number of respondents and the relatively shorter
amount of time these tobacco products have been in existence compared
to other tobacco products.
FDA estimates that there are approximately 120 tobacco product
manufacturers who may be affected by this collection of information. Of
the total number of manufacturers, FDA estimates that most
manufacturers (110) will not have documents which will be responsive to
this section 904(b) request and that they will only need to send a
letter notifying the FDA's Center for Tobacco Products that they have
no documents to report. FDA anticipates it should take no longer than
30 minutes to draft such a response and send to FDA. The total one-time
hourly burden to submit this letter to FDA is estimated to be 55 hours
(30 minutes x 110 manufacturers).
FDA estimates that there are approximately 10 tobacco product
manufacturers who may have documents meeting the criteria of this
information collection request. Because the volume of responsive
documents each of these respondents may have will likely vary, the
corresponding time burden for each respondent to satisfy this
information collection request will also vary. Therefore, FDA estimates
that these 10 respondents will average approximately 230 hours each to
satisfy the requirements of this section 904(b) request. The total one-
time hourly burden to locate and send documents meeting the
requirements of this request is estimated to be 2,300 hours (230 hours
x 10 manufacturers). The total one-time hourly burden for this
collection of information is 2,355 hours (55 hours + 2,300 hours).
Dated: October 19, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-26830 Filed 10-22-10; 8:45 am]
BILLING CODE 4160-01-P
