Submission for OMB Review; Comment Request; Next Series of Tobacco Use Supplements to the Current Population Survey (TUS-CPS) (NCI), 4080-4081 [2010-1425]
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4080
Federal Register / Vol. 75, No. 16 / Tuesday, January 26, 2010 / Notices
section 403(r)(6) of the act. Section
403(r)(6) of the act requires that the
agency be notified, with a submission
about such statements, no later than 30
days after the first marketing of the
dietary supplement. Information that is
required in the submission includes the
following items: (1) The name and
address of the manufacturer, packer, or
distributor of the dietary supplement
product; (2) the text of the statement
that is being made; (3) the name of the
dietary ingredient or supplement that is
the subject of the statement; (4) the
name of the dietary supplement
(including the brand name); and (5) a
signature of a responsible individual
who can certify the accuracy of the
information presented, and who must
certify that the information contained in
the notice is complete and accurate, and
that the notifying firm has
substantiation that the statement is
truthful and not misleading.
The agency established § 101.93 (21
CFR 101.93) as the procedural
regulation for this program. Section
101.93 provides details of the
procedures associated with the
submission and identifies the
information that must be included in
order to meet the requirements of
section 403 of the act.
In the Federal Register of June 2, 2009
(74 FR 26406), FDA published a 60-day
notice requesting public comment on
the proposed collection of information.
FDA received two letters in response,
each containing one or more comments.
One of these letters was received several
months after the close of the comment
period. The comments that were timely
filed were outside the scope of the
comment request.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
21 CFR Section
101.93
1 There
2,200
Total Annual
Responses
1
2,200
Hours per
Response
Total Hours
0.75
1,650
are no capital costs or operating and maintenance costs associated with this collection of information.
The agency believes that there will be
minimal burden on the industry to
generate information to meet the
requirements of section 403 of the act in
submitting information regarding
section 403(r)(6) statements on labels or
in labeling of dietary supplements. The
agency is requesting only information
that is immediately available to the
manufacturer, packer, or distributor of
the dietary supplement that bears such
a statement on its label or in its labeling.
FDA estimates that, each year,
approximately 2,200 firms will submit
the information required by section 403
of the act. We estimate that a firm will
require 0.75 hours to gather the
information needed and prepare a
communication to FDA, for a total of
1,650 hours (2,200 x 0.75). This estimate
is based on the average number of
notification submissions received by the
agency in the preceding 2 years.
Dated: January 20, 2010.
David Dorsey
Acting Deputy Commissioner for Policy,
Planning and Budget.
[FR Doc. 2010–1435 Filed 1–25–10; 8:45 am]
BILLING CODE 4160–01–S
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
Annual Frequency
per Response
VerDate Nov<24>2008
14:10 Jan 25, 2010
Jkt 220001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review;
Comment Request; Next Series of
Tobacco Use Supplements to the
Current Population Survey (TUS–CPS)
(NCI)
Summary: Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Cancer Institute (NCI), the National
Institutes of Health (NIH), has submitted
to the Office of Management and Budget
(OMB) a request to review and approve
the information collection listed below.
This proposed information collection
was previously published in the Federal
Register on November 6, 2009, (Vol. 74,
No. 214, pp. 57496–97) and allowed 60
days for public comment. One request
for information was received on
November 6, 2009. A copy of the 2010–
2011 TUS–CPS was e-mailed to the
requestor reiterating our data collection
plans as stated in the 60-day Federal
Register Notice. Another comment was
received on December 16, 2009
complimenting our inclusion in the
2010–2011 TUS–CPS of critically
needed information on details about the
types of cigars (especially small cigars)
used by smokers and new and valuable
information on menthol cigarette
smoking. We thanked the requestor for
the endorsement and agreed that we
thought that was valuable and timely as
well and that is why we have included
the information in the proposed data
collection. The purpose of this notice is
to allow an additional 30 days for public
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
comment. The National Institutes of
Health may not conduct or sponsor, and
the respondent is not required to
respond to, an information collection
that has been extended, revised, or
implemented on or after October 1,
1995, unless it displays a currently valid
OMB control number.
Proposed Collection: Title: Next Series
of Tobacco Use Supplements to the
Current Population Survey (TUS–CPS)
(NCI). Type of information request:
REINSTATEMENT WITH CHANGE of
OMB #0925–0368, Expiration 4/30/
2009. Need and Use of Information
Collection: The 2010–2011 Tobacco Use
Supplement to the Current Population
Survey conducted by the Census Bureau
will collect data from the U.S. civilian
non-institutionalized population on
smoking, other tobacco use, and
attempts at cessation; policy
information such as home and
workplace smoking policies; health
professional advice to stop smoking;
and changes in smoking norms and
attitudes. The TUS–CPS will be and has
been in the past a key source of
national, State, and some local-level
data on these topics in U.S. households
because it uses a large, nationally
representative sample. This survey is
part of a continuing series of surveys
(OMB #0925–0368) that were sponsored
by NCI and has been administered
triennially as part of the U.S. Census
Bureau’s and the Bureau of Labor
Statistics CPS. The TUS–CPS has been
fielded since 1992, most recently in
2006–07, and its data are available for
public use. Government agencies, other
researchers and the public can use the
data to monitor progress in the control
E:\FR\FM\26JAN1.SGM
26JAN1
4081
Federal Register / Vol. 75, No. 16 / Tuesday, January 26, 2010 / Notices
of tobacco use, conduct tobacco-related
research, evaluate tobacco control
programs, examine tobacco-use-related
health disparities, and use this data to
help determine policies and services
that need to be provided. A unique
feature is the ability to link other social
and economic Census Bureau and
Bureau of Labor Statistics data and other
sponsor-supported supplement data to
the TUS–CPS data. Much of this data
can also be linked to cancer and other
cause-specific mortality data through
the National Longitudinal Mortality
Study (co-sponsored by three NIH
agencies, the National Center for Health
Statistics/Centers for Disease Control
and Prevention (CDC), and the Census
Bureau). This survey has in the past and
the 2010–2011 survey will provide in
the future invaluable information to
measure progress toward tobacco
control as part of the NCI’s Cancer
Trend Progress Report, and the
Department of Health and Human
Services’ Healthy People 2010 and 2020
Goals. This data will also provide a
basis for the National Human Genome
Research Institute’s PhenX Alcohol,
Tobacco, and Other Substances Toolkit,
provide long-term trend data for CDC
and other State and local public health
staff, and support the research of
extramural scientists. The 2010–2011
TUS–CPS is also relevant to several NCI
tobacco control initiatives. The main
2010–2011 survey will allow State and
sub-State-specific estimates to be made
as do all the previous surveys. The May
2011 Follow-Up questionnaire will
consist of an abbreviated version of the
main 2010–2011 questionnaire. Data
will be collected in May 2010, August
2010, January 2011, and May 2011 from
approximately 315,000 respondents
(270,000 unique respondents, 45,000 of
these in the May 2011 Follow-Up). The
2010–2011 TUS–CPS, complemented by
the Follow-Up questionnaire, will be
useful for researchers interested in
measuring the impact on tobacco
cessation of new FDA regulation (the
Family Smoking Prevention and
Tobacco Control Act) as it is
implemented, and will complement
Federal tobacco research and policy
efforts. Frequency of Response: Onetime study for the main 2010–2011
survey; One-time study for the May
2011 Follow-Up. Affected Public:
Individuals or households. Type of
Respondents: Persons 18 years of age or
older. The annualized cost to
respondents is estimated at $285,000.
There are no Capital Costs, Operating
Costs, and/or Maintenance Costs to
report. The annual reporting burden is
presented in the table below.
TABLE—ESTIMATES OF ANNUAL BURDEN HOURS
Number of
respondents
(annualized)
Type of respondent per survey period
Average time per
response
(minutes/hour)
Responses per
respondent
30,000
30,000
30,000
15,000
1
1
1
1
Totals ............................................................................................
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
May 2010: Individuals ......................................................................
August 2010: Individuals .................................................................
January 2011: Individuals ................................................................
May 2011 Follow-Up: Individuals ....................................................
105,000
............................
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies should
address one or more of the following
points: (1) Evaluate whether the
proposed collection of information is
necessary for the proper performance of
the function of the agency, including
whether the information will have
practical utility; (2) Evaluate the
accuracy of the agency’s estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and (4) Minimize the burden
of the collection of information on those
who are to respond, including the use
of appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the
Attention: NIH Desk Officer, Office of
Management and Budget, at
VerDate Nov<24>2008
14:10 Jan 25, 2010
Jkt 220001
OIRA_submission@omb.eop.gov or by
fax to 202–395–6974. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and instruments, contact Anne
Hartman, M.S., M.A., Health
Statistician, National Cancer Institute,
6130 Executive Blvd—MSC 7344,
Executive Plaza North, Suite 4005,
Bethesda, Maryland 20892–7344, or call
non-toll free (301) 496–4970, or FAX
your request to (301) 435–3710, or email your request, including your
address, to ah42t@nih.gov or
hartmana@mail.nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30 days of the date of
this publication.
Dated: January 15, 2010.
Kristine Miller,
NCI Project Clearance Liaison, National
Institutes of Health.
[FR Doc. 2010–1425 Filed 1–25–10; 8:45 am]
BILLING CODE 4140–01–P
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
9/60
9/60
9/60
6/60
Annual burden
hours
(0.15)
(0.15)
(0.15)
(0.10)
4,500
4,500
4,500
1,500
............................
15,000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0019]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; General Licensing
Provisions: Biologics License
Application, Changes to an Approved
Application, Labeling, Revocation and
Suspension, Postmarketing Studies
Status Reports, and Forms FDA 356h
and 2567
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
E:\FR\FM\26JAN1.SGM
26JAN1
]]>Agencies
[Federal Register Volume 75, Number 16 (Tuesday, January 26, 2010)]
[Notices]
[Pages 4080-4081]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-1425]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; Comment Request; Next Series of
Tobacco Use Supplements to the Current Population Survey (TUS-CPS)
(NCI)
Summary: Under the provisions of Section 3507(a)(1)(D) of the
Paperwork Reduction Act of 1995, the National Cancer Institute (NCI),
the National Institutes of Health (NIH), has submitted to the Office of
Management and Budget (OMB) a request to review and approve the
information collection listed below. This proposed information
collection was previously published in the Federal Register on November
6, 2009, (Vol. 74, No. 214, pp. 57496-97) and allowed 60 days for
public comment. One request for information was received on November 6,
2009. A copy of the 2010-2011 TUS-CPS was e-mailed to the requestor
reiterating our data collection plans as stated in the 60-day Federal
Register Notice. Another comment was received on December 16, 2009
complimenting our inclusion in the 2010-2011 TUS-CPS of critically
needed information on details about the types of cigars (especially
small cigars) used by smokers and new and valuable information on
menthol cigarette smoking. We thanked the requestor for the endorsement
and agreed that we thought that was valuable and timely as well and
that is why we have included the information in the proposed data
collection. The purpose of this notice is to allow an additional 30
days for public comment. The National Institutes of Health may not
conduct or sponsor, and the respondent is not required to respond to,
an information collection that has been extended, revised, or
implemented on or after October 1, 1995, unless it displays a currently
valid OMB control number.
Proposed Collection: Title: Next Series of Tobacco Use Supplements
to the Current Population Survey (TUS-CPS) (NCI). Type of information
request: REINSTATEMENT WITH CHANGE of OMB 0925-0368,
Expiration 4/30/2009. Need and Use of Information Collection: The 2010-
2011 Tobacco Use Supplement to the Current Population Survey conducted
by the Census Bureau will collect data from the U.S. civilian non-
institutionalized population on smoking, other tobacco use, and
attempts at cessation; policy information such as home and workplace
smoking policies; health professional advice to stop smoking; and
changes in smoking norms and attitudes. The TUS-CPS will be and has
been in the past a key source of national, State, and some local-level
data on these topics in U.S. households because it uses a large,
nationally representative sample. This survey is part of a continuing
series of surveys (OMB 0925-0368) that were sponsored by NCI
and has been administered triennially as part of the U.S. Census
Bureau's and the Bureau of Labor Statistics CPS. The TUS-CPS has been
fielded since 1992, most recently in 2006-07, and its data are
available for public use. Government agencies, other researchers and
the public can use the data to monitor progress in the control
[[Page 4081]]
of tobacco use, conduct tobacco-related research, evaluate tobacco
control programs, examine tobacco-use-related health disparities, and
use this data to help determine policies and services that need to be
provided. A unique feature is the ability to link other social and
economic Census Bureau and Bureau of Labor Statistics data and other
sponsor-supported supplement data to the TUS-CPS data. Much of this
data can also be linked to cancer and other cause-specific mortality
data through the National Longitudinal Mortality Study (co-sponsored by
three NIH agencies, the National Center for Health Statistics/Centers
for Disease Control and Prevention (CDC), and the Census Bureau). This
survey has in the past and the 2010-2011 survey will provide in the
future invaluable information to measure progress toward tobacco
control as part of the NCI's Cancer Trend Progress Report, and the
Department of Health and Human Services' Healthy People 2010 and 2020
Goals. This data will also provide a basis for the National Human
Genome Research Institute's PhenX Alcohol, Tobacco, and Other
Substances Toolkit, provide long-term trend data for CDC and other
State and local public health staff, and support the research of
extramural scientists. The 2010-2011 TUS-CPS is also relevant to
several NCI tobacco control initiatives. The main 2010-2011 survey will
allow State and sub-State-specific estimates to be made as do all the
previous surveys. The May 2011 Follow-Up questionnaire will consist of
an abbreviated version of the main 2010-2011 questionnaire. Data will
be collected in May 2010, August 2010, January 2011, and May 2011 from
approximately 315,000 respondents (270,000 unique respondents, 45,000
of these in the May 2011 Follow-Up). The 2010-2011 TUS-CPS,
complemented by the Follow-Up questionnaire, will be useful for
researchers interested in measuring the impact on tobacco cessation of
new FDA regulation (the Family Smoking Prevention and Tobacco Control
Act) as it is implemented, and will complement Federal tobacco research
and policy efforts. Frequency of Response: One-time study for the main
2010-2011 survey; One-time study for the May 2011 Follow-Up. Affected
Public: Individuals or households. Type of Respondents: Persons 18
years of age or older. The annualized cost to respondents is estimated
at $285,000. There are no Capital Costs, Operating Costs, and/or
Maintenance Costs to report. The annual reporting burden is presented
in the table below.
Table--Estimates of Annual Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average time per
Type of respondent per survey period respondents Responses per response Annual burden
(annualized) respondent (minutes/hour) hours
----------------------------------------------------------------------------------------------------------------
May 2010: Individuals................... 30,000 1 9/60 (0.15) 4,500
August 2010: Individuals................ 30,000 1 9/60 (0.15) 4,500
January 2011: Individuals............... 30,000 1 9/60 (0.15) 4,500
May 2011 Follow-Up: Individuals......... 15,000 1 6/60 (0.10) 1,500
-----------------------------------------------------------------------
Totals................................ 105,000 ................ ................ 15,000
----------------------------------------------------------------------------------------------------------------
Request for Comments: Written comments and/or suggestions from the
public and affected agencies should address one or more of the
following points: (1) Evaluate whether the proposed collection of
information is necessary for the proper performance of the function of
the agency, including whether the information will have practical
utility; (2) Evaluate the accuracy of the agency's estimate of the
burden of the proposed collection of information, including the
validity of the methodology and assumptions used; (3) Enhance the
quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collection of information on those who
are to respond, including the use of appropriate automated, electronic,
mechanical, or other technological collection techniques or other forms
of information technology.
Direct Comments to OMB: Written comments and/or suggestions
regarding the item(s) contained in this notice, especially regarding
the estimated public burden and associated response time, should be
directed to the Attention: NIH Desk Officer, Office of Management and
Budget, at OIRA_submission@omb.eop.gov or by fax to 202-395-6974. To
request more information on the proposed project or to obtain a copy of
the data collection plans and instruments, contact Anne Hartman, M.S.,
M.A., Health Statistician, National Cancer Institute, 6130 Executive
Blvd--MSC 7344, Executive Plaza North, Suite 4005, Bethesda, Maryland
20892-7344, or call non-toll free (301) 496-4970, or FAX your request
to (301) 435-3710, or e-mail your request, including your address, to
ah42t@nih.gov or hartmana@mail.nih.gov.
Comments Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 30 days
of the date of this publication.
Dated: January 15, 2010.
Kristine Miller,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2010-1425 Filed 1-25-10; 8:45 am]
BILLING CODE 4140-01-P
