Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study on the Public Display of Lists of Harmful and Potentially Harmful Tobacco Constituents, 77837-77838 [2011-32026]
Download as PDF
<![CDATA[
Federal Register / Vol. 76, No. 240 / Wednesday, December 14, 2011 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0867]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Experimental
Study on the Public Display of Lists of
Harmful and Potentially Harmful
Tobacco Constituents
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 a 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
the Experimental Study on the Public
Display of the List of Harmful and
Potentially Harmful Tobacco
Constituents. This study is being
conducted in support of the provision of
the Family Smoking Prevention and
Tobacco Control Act (the Tobacco
Control Act) that requires FDA to
publish in a format that is
understandable and not misleading to a
lay person and to place on public
display the list of harmful and
potentially harmful constituents
(HPHCs) in tobacco products and
tobacco smoke.
DATES: Submit either electronic or
written comments on the collection of
information by February 13, 2012.
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:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, (301) 796–
5156, daniel.gittleson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
15:14 Dec 13, 2011
Jkt 226001
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.
Experimental Study on the Public
Display of the List of Harmful and
Potentially Harmful Tobacco
Constituents (OMB Control Number—
0910–New)
The Tobacco Control Act (Pub. L.
111–31) amends the Federal Food, Drug,
and Cosmetic Act (FD&C Act) to grant
FDA authority to regulate the
manufacture, marketing, and
distribution of tobacco products to
protect the public health and to reduce
tobacco use by minors. Section 904(d)(1)
of the FD&C Act states, ‘‘Not later than
3 years after the date of enactment of the
Family Smoking Prevention and
Tobacco Control Act, and annually
thereafter, the Secretary shall publish in
a format that is understandable and not
misleading to a lay person, and place on
public display (in a manner determined
by the Secretary) the list [of harmful or
potentially harmful constituents]
established under [section 904(e)]’’ of
the FD&C Act. Section 904(e) of the
FD&C Act directs FDA to establish ‘‘a
list of harmful and potentially harmful
constituents, including smoke
constituents, to health in each tobacco
PO 00000
Frm 00072
Fmt 4703
Sfmt 4703
77837
product by brand, and by quantity in
each brand and subbrand.’’ On January
31, 2011, FDA announced the
availability of a final guidance
representing the Agency’s current
thinking on the meaning of the term
‘‘harmful and potentially harmful
constituent’’ (see 76 FR 5387). On
August 12, 2011, FDA published a
notice in the Federal Register
requesting comment issues related to
the establishment of the HPHC list (see
76 FR 50226).
FDA intends to conduct research with
consumers to help inform decisions
about how to implement section
904(d)(1) of the FD&C Act and to
provide information about how
consumers understand information
about HPHCs. The research goals are to
evaluate the impact of different list
formats on the public’s ability to
understand HPHC information, and to
assess the potential for certain
unintended consequences resulting
from exposure to the lists. The impact
of different list formats will be
measured by evaluating respondents’
understanding of the following
concepts: (1) There are more than 4,000
chemicals in tobacco products and
tobacco smoke; (2) the chemicals come
from the tobacco leaf itself, how it is
processed, and different parts of a
tobacco product such as the tobacco
smoke, glues, inks, paper, or additives;
(3) for smokeless products, many of the
chemicals come from the tobacco leaf
itself; for smoked products, many of the
chemicals come from burning the
tobacco leaf; (4) Federal law requires
tobacco companies to test their tobacco
products and smoke for the chemicals
on this list; (5) each tobacco product
brand and subbrand has its own
separate list of chemicals; (6) science
has linked the chemicals on these lists
to health problems or potential health
problems; (7) these lists do not include
necessarily all of the health problems
that may be caused by the tobacco
product; (8) these lists do not
necessarily include all of the chemicals
in the tobacco product that may be
harmful; (9) the amount of a chemical
listed for a specific tobacco product
does not necessarily indicate the
likelihood of experiencing a health
problem; (10) the number of chemicals
listed for a specific tobacco product
does not necessarily indicate the
likelihood of experiencing a health
problem; (11) the number of possible
health outcomes listed for a tobacco
product does not necessarily indicate
the likelihood of experiencing a health
problem; (13) the number of chemicals
listed for a specific health problem does
E:\FR\FM\14DEN1.SGM
14DEN1
77838
Federal Register / Vol. 76, No. 240 / Wednesday, December 14, 2011 / Notices
not necessarily indicate the likelihood
of experiencing a health problem; (13)
when a chemical is listed without a
quantity it may mean that a
manufacturer has not yet tested its
products for that chemical; and/or that
a test was conducted but it was not
sensitive enough to measure the amount
of chemical in the product; and/or that
a way to test for that chemical is still
being developed. Unintended
consequences will be assessed by
measuring respondents’ susceptibility to
initiation of tobacco use, motivation and
confidence to quit tobacco use, risk
perceptions about tobacco use, and
emotional reactivity.
understood and not misleading to a lay
person, and is expected to provide
information that may inform Agency
communications about HPHCs. The data
obtained from this study is one factor
that will be used to inform FDA’s
decisionmaking regarding the public
display of the list of HPHCs required
under section 904(d)(1) of the FD&C
Act. By evaluating respondents’
understanding of the concepts listed
previously in this document we do not
intend to imply that consumer
understanding of all concepts is needed
to comply with these requirements.
FDA estimates the burden of this
collection of information as follows:
FDA proposes to conduct an
experimental study with current
smokers aged 15 years and older, former
smokers aged 15 years and older, and
nonsmokers aged between 13 and 25
years who may be susceptible to
initiation of smoking. Data will be
collected from members of an Internet
panel. The study will include an
oversampling of subjects with limited
health literacy. Participation in the
experimental study is voluntary. The
information collected from the study is
necessary to inform the Agency’s efforts
to implement the requirement of the
FD&C Act to place on public display a
list of HPHCs in tobacco products and
tobacco smoke in a format that is
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Number of
responses
per
respondent
Total annual
responses
Average
burden per
response
Total hours
Pretest ..................................................................................
Screener ...............................................................................
Experimental Survey ............................................................
60
10,000
3,000
1
1
1
60
10,000
3,000
0.5
0.0167
0.5
30
167
1,500
Total ..............................................................................
13,060
........................
........................
........................
1,697
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA’s burden estimate is based on
prior experience with Internet panel
experiments similar to the study
proposed here. Sixty panel members
will take part in a pretest of the study,
estimated to last 30 minutes (0.5 hours),
for a total of 30 hours. Approximately
10,000 respondents will complete a
screener to determine eligibility for
participation in the study, estimated to
take 1 minute (0.0167 hours), for a total
of 167 hours. Three thousand
respondents will complete the full
study, estimated to last 30 minutes (0.5
hours), for a total of 1,500 hours. The
total estimated burden is 1,697 hours.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: December 8, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
ACTION:
[FR Doc. 2011–32026 Filed 12–13–11; 8:45 am]
mstockstill on DSK4VPTVN1PROD with NOTICES
BILLING CODE 4160–01–P
VerDate Mar<15>2010
15:14 Dec 13, 2011
Jkt 226001
Food and Drug Administration
[Docket No. FDA–2011–N–0535]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance for
Industry: Notification of a Health Claim
or Nutrient Content Claim Based on an
Authoritative Statement of a Scientific
Body
AGENCY:
Food and Drug Administration,
HHS.
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by January 13,
2012.
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
SUMMARY:
PO 00000
Frm 00073
Fmt 4703
Sfmt 4703
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0374. 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.
Guidance for Industry: Notification of a
Health Claim or Nutrient Content Claim
Based on an Authoritative Statement of
a Scientific Body—(OMB Control
Number 0910–0374)—Extension
Section 403(r)(2)(G) and (r)(3)(C) of
the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C.
343(r)(2)(G) and (r)(3)(C)), as amended
by the FDA Modernization Act of 1997,
provides that any person may market a
food product whose label bears a
nutrient content claim or a health claim
that is based on an authoritative
statement of a scientific body of the U.S.
Government or the National Academy of
Sciences (NAS). Under this section of
E:\FR\FM\14DEN1.SGM
14DEN1
]]>Agencies
[Federal Register Volume 76, Number 240 (Wednesday, December 14, 2011)]
[Notices]
[Pages 77837-77838]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-32026]
[[Page 77837]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0867]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Experimental Study on the Public Display of Lists of
Harmful and Potentially Harmful Tobacco Constituents
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 a 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 the Experimental Study on the Public
Display of the List of Harmful and Potentially Harmful Tobacco
Constituents. This study is being conducted in support of the provision
of the Family Smoking Prevention and Tobacco Control Act (the Tobacco
Control Act) that requires FDA to publish in a format that is
understandable and not misleading to a lay person and to place on
public display the list of harmful and potentially harmful constituents
(HPHCs) in tobacco products and tobacco smoke.
DATES: Submit either electronic or written comments on the collection
of information by February 13, 2012.
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: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, (301) 796-5156,
daniel.gittleson@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.
Experimental Study on the Public Display of the List of Harmful and
Potentially Harmful Tobacco Constituents (OMB Control Number--0910-New)
The Tobacco Control Act (Pub. L. 111-31) amends the Federal Food,
Drug, and Cosmetic Act (FD&C Act) to grant FDA authority to regulate
the manufacture, marketing, and distribution of tobacco products to
protect the public health and to reduce tobacco use by minors. Section
904(d)(1) of the FD&C Act states, ``Not later than 3 years after the
date of enactment of the Family Smoking Prevention and Tobacco Control
Act, and annually thereafter, the Secretary shall publish in a format
that is understandable and not misleading to a lay person, and place on
public display (in a manner determined by the Secretary) the list [of
harmful or potentially harmful constituents] established under [section
904(e)]'' of the FD&C Act. Section 904(e) of the FD&C Act directs FDA
to establish ``a list of harmful and potentially harmful constituents,
including smoke constituents, to health in each tobacco product by
brand, and by quantity in each brand and subbrand.'' On January 31,
2011, FDA announced the availability of a final guidance representing
the Agency's current thinking on the meaning of the term ``harmful and
potentially harmful constituent'' (see 76 FR 5387). On August 12, 2011,
FDA published a notice in the Federal Register requesting comment
issues related to the establishment of the HPHC list (see 76 FR 50226).
FDA intends to conduct research with consumers to help inform
decisions about how to implement section 904(d)(1) of the FD&C Act and
to provide information about how consumers understand information about
HPHCs. The research goals are to evaluate the impact of different list
formats on the public's ability to understand HPHC information, and to
assess the potential for certain unintended consequences resulting from
exposure to the lists. The impact of different list formats will be
measured by evaluating respondents' understanding of the following
concepts: (1) There are more than 4,000 chemicals in tobacco products
and tobacco smoke; (2) the chemicals come from the tobacco leaf itself,
how it is processed, and different parts of a tobacco product such as
the tobacco smoke, glues, inks, paper, or additives; (3) for smokeless
products, many of the chemicals come from the tobacco leaf itself; for
smoked products, many of the chemicals come from burning the tobacco
leaf; (4) Federal law requires tobacco companies to test their tobacco
products and smoke for the chemicals on this list; (5) each tobacco
product brand and subbrand has its own separate list of chemicals; (6)
science has linked the chemicals on these lists to health problems or
potential health problems; (7) these lists do not include necessarily
all of the health problems that may be caused by the tobacco product;
(8) these lists do not necessarily include all of the chemicals in the
tobacco product that may be harmful; (9) the amount of a chemical
listed for a specific tobacco product does not necessarily indicate the
likelihood of experiencing a health problem; (10) the number of
chemicals listed for a specific tobacco product does not necessarily
indicate the likelihood of experiencing a health problem; (11) the
number of possible health outcomes listed for a tobacco product does
not necessarily indicate the likelihood of experiencing a health
problem; (13) the number of chemicals listed for a specific health
problem does
[[Page 77838]]
not necessarily indicate the likelihood of experiencing a health
problem; (13) when a chemical is listed without a quantity it may mean
that a manufacturer has not yet tested its products for that chemical;
and/or that a test was conducted but it was not sensitive enough to
measure the amount of chemical in the product; and/or that a way to
test for that chemical is still being developed. Unintended
consequences will be assessed by measuring respondents' susceptibility
to initiation of tobacco use, motivation and confidence to quit tobacco
use, risk perceptions about tobacco use, and emotional reactivity.
FDA proposes to conduct an experimental study with current smokers
aged 15 years and older, former smokers aged 15 years and older, and
nonsmokers aged between 13 and 25 years who may be susceptible to
initiation of smoking. Data will be collected from members of an
Internet panel. The study will include an oversampling of subjects with
limited health literacy. Participation in the experimental study is
voluntary. The information collected from the study is necessary to
inform the Agency's efforts to implement the requirement of the FD&C
Act to place on public display a list of HPHCs in tobacco products and
tobacco smoke in a format that is understood and not misleading to a
lay person, and is expected to provide information that may inform
Agency communications about HPHCs. The data obtained from this study is
one factor that will be used to inform FDA's decisionmaking regarding
the public display of the list of HPHCs required under section
904(d)(1) of the FD&C Act. By evaluating respondents' understanding of
the concepts listed previously in this document we do not intend to
imply that consumer understanding of all concepts is needed to comply
with these requirements.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Pretest......................... 60 1 60 0.5 30
Screener........................ 10,000 1 10,000 0.0167 167
Experimental Survey............. 3,000 1 3,000 0.5 1,500
-------------------------------------------------------------------------------
Total....................... 13,060 .............. .............. .............. 1,697
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
FDA's burden estimate is based on prior experience with Internet
panel experiments similar to the study proposed here. Sixty panel
members will take part in a pretest of the study, estimated to last 30
minutes (0.5 hours), for a total of 30 hours. Approximately 10,000
respondents will complete a screener to determine eligibility for
participation in the study, estimated to take 1 minute (0.0167 hours),
for a total of 167 hours. Three thousand respondents will complete the
full study, estimated to last 30 minutes (0.5 hours), for a total of
1,500 hours. The total estimated burden is 1,697 hours.
Dated: December 8, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-32026 Filed 12-13-11; 8:45 am]
BILLING CODE 4160-01-P
