Proposed Collection; Comment Request; Next Series of Tobacco Use Supplements to the Current Population Survey (TUS-CPS) (NCI), 57496-57497 [E9-26848]
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57496
Federal Register / Vol. 74, No. 214 / Friday, November 6, 2009 / Notices
Bar Code Label Requirement for
Human Drug and Biological Products
(21 CFR Part 314) (OMB Control
Number 0910–0537) Extension
In the Federal Register of February
26, 2004 (69 FR 9120), we issued new
regulations that required human drug
product and biological product labels to
have bar codes. The rule required bar
codes on most human prescription drug
products and on over-the-counter (OTC)
drug products that are dispensed
pursuant to an order and commonly
used in health care facilities. The rule
also required machine-readable
information on blood and blood
components. For human prescription
drug products and OTC drug products
that are dispensed pursuant to an order
and commonly used in health care
facilities, the bar code must contain the
National Drug Code number for the
product. For blood and blood
components, the rule specifies the
minimum contents of the machinereadable information in a format
approved by the Director, Center for
Biologics Evaluation and Research as
blood centers have generally agreed
upon the information to be encoded on
the label. The rule is intended to help
reduce the number of medication errors
in hospitals and other health care
settings by allowing health care
professionals to use bar code scanning
equipment to verify that the right drug
(in the right dose and right route of
administration) is being given to the
right patient at the right time.
Most of the information collection
burden resulting from the final rule, as
calculated in table 1 of the final rule (69
FR 9120 at 9149), was a one-time
burden that does not occur after the
rule’s compliance date of April 26,
2006. In addition, some of the
information collection burden estimated
in the final rule is now covered in other
OMB-approved information collection
packages for FDA. However, parties may
continue to seek an exemption from the
bar code requirement under certain,
limited circumstances. Section
201.25(d) (21 CFR 201.25(d)) requires
submission of a written request for an
exemption and describes the contents of
such requests. Based on the number of
exemption requests we have received,
we estimate that approximately two
exemption requests may be submitted
annually, and that each exemption
request will require 24 hours to
complete. This would result in an
annual reporting burden of 48 hours.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
21 CFR Section
201.25(d)
1 There
No. of Responses
per Respodent
2
1
Hours per
Response
2
Total Hours
24
48
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: November 2, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–26850 Filed 11–5–09; 8:45 am]
mstockstill on DSKH9S0YB1PROD with NOTICES6
Total Annual
Responses
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
BILLING CODE 4160–01–S
information such as home and
workplace smoking policies; health
DEPARTMENT OF HEALTH AND
professional advice to stop smoking;
HUMAN SERVICES
and changes in smoking norms and
attitudes. The TUS–CPS will be and has
National Institutes of Health
been in the past a key source of
national, State, and some local-level
Proposed Collection; Comment
data on these topics in U.S. households
Request; Next Series of Tobacco Use
because it uses a large, nationally
Supplements to the Current Population
representative sample. This survey is
Survey (TUS–CPS) (NCI)
part of a continuing series of surveys
(OMB# 0925–0368) that were sponsored
SUMMARY: In compliance with the
by National Cancer Institute (NCI) and
requirement of Section 3506(c)(2)(A) of
has been administered triennially as
the Paperwork Reduction Act of 1995,
part of the U.S. Census Bureau’s and the
for opportunity for public comment on
Bureau of Labor Statistics CPS. The
proposed data collection projects, the
TUS–CPS has been fielded since 1992,
National Cancer Institute (NCI), the
most recently in 2006–07, and its data
National Institutes of Health (NIH) will
publish periodic summaries of proposed are available for public use. Government
agencies, other researchers and the
projects to be submitted to the Office of
Management and Budget (OMB) for
public can use the data to monitor
review and approval.
progress in the control of tobacco use,
Proposed Collection: Title: Next Series conduct tobacco-related research,
evaluate tobacco control programs,
of Tobacco Use Supplements to the
examine tobacco-use-related health
Current Population Survey (TUS–CPS).
disparities, and use this data to help
Type of information request:
determine policies and services that
REINSTATEMENT WITH CHANGE of
need to be provided. A unique feature
OMB #0925–0368, Expiration 4/30/
is the ability to link other social and
2009. Need and Use of Information
Collection: The 2010–2011 Tobacco Use economic Census Bureau and Bureau of
Labor Statistics data and other sponsorSupplement to the Current Population
VerDate Nov<24>2008
18:23 Nov 05, 2009
Jkt 220001
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
supported supplement data to the TUS–
CPS data. Much of this data can also be
linked to cancer and other causespecific 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
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
E:\FR\FM\06NON1.SGM
06NON1
57497
Federal Register / Vol. 74, No. 214 / Friday, November 6, 2009 / Notices
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)
Responses
per respondent
May 2010: Individuals ..........................................................................................
August 2010: Individuals .....................................................................................
January 2011: Individuals ....................................................................................
May 2011 Follow-Up: Individuals ........................................................................
30,000
30,000
30,000
15,000
1
1
1
1
Totals ............................................................................................................
105,000
Type of respondent per survey period
mstockstill on DSKH9S0YB1PROD with NOTICES6
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.
FOR FURTHER INFORMATION CONTACT: 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 60 days of the date of
this publication.
VerDate Nov<24>2008
18:23 Nov 05, 2009
Jkt 220001
Dated: November 2, 2009.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National
Institutes of Health.
[FR Doc. E9–26848 Filed 11–5–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS 10198 and CMS–
10296]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
AGENCY: Centers for Medicare &
Medicaid Services, HHS.
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Centers for Medicare & Medicaid
Services (CMS), Department of Health
and Human Services, is publishing the
following summary of proposed
collections for public comment.
Interested persons are invited to send
comments regarding this burden
estimate or any other aspect of this
collection of information, including any
of the following subjects: (1) The
necessity and utility of the proposed
information collection for the proper
performance of the Agency’s function;
(2) the accuracy of the estimated
burden; (3) ways to enhance the quality,
utility, and clarity of the information to
be collected; and (4) the use of
automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
Average time
per response
(minutes/hour)
9/60
9/60
9/60
6/60
(0.15)
(0.15)
(0.15)
(0.10)
Annual burden
hours
4,500
4,500
4,500
1,500
15,000
1. Type of Information Collection
Request: Extension without change of a
currently approved collection; Title of
Information Collection: Creditable
Coverage Disclosure to CMS On-Line
Form and Instructions; Use: Most
entities that currently provide
prescription drug benefits to any
Medicare Part D eligible individual
must disclose to the CMS whether the
prescription drug benefit that they offer
is creditable. The disclosure is required
to be provided annually and upon any
change that affects whether the coverage
is creditable prescription drug coverage.
CMS released a Disclosure to CMS
Guidance Paper and a disclosure to
CMS notification on-line form in
January 2006.
Section 1860D–1 of the Medicare
Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA) and
implementing regulations at 42 CFR
423.56 require that entities that offer
prescription drug benefits under any of
the types of coverage described in 42
CFR 423.56 (b) provide a disclosure of
creditable coverage to CMS informing us
whether such coverage meets the
actuarial requirements specified in
guidelines provided by CMS. Form
Number: CMS–10198 (OMB#: 0938–
1013); Frequency: Reporting—Yearly
and Semi-annually; Affected Public:
Federal Government, Business or other
for-profits and not-for-profit
institutions, and State, Local, or Tribal
Governments; Number of Respondents:
87,500; Total Annual Responses:
87,500; Total Annual Hours: 7,291.7.
(For policy questions regarding this
collection contact Louis Blank at 410–
786–5511. For all other issues call 410–
786–1326.)
2. Type of Information Collection
Request: New collection; Title of
Information Collection: Electronic
E:\FR\FM\06NON1.SGM
06NON1
]]>Agencies
[Federal Register Volume 74, Number 214 (Friday, November 6, 2009)]
[Notices]
[Pages 57496-57497]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-26848]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment Request; Next Series of Tobacco Use
Supplements to the Current Population Survey (TUS-CPS) (NCI)
SUMMARY: In compliance with the requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995, for opportunity for public comment
on proposed data collection projects, the National Cancer Institute
(NCI), the National Institutes of Health (NIH) will publish periodic
summaries of proposed projects to be submitted to the Office of
Management and Budget (OMB) for review and approval.
Proposed Collection: Title: Next Series of Tobacco Use Supplements
to the Current Population Survey (TUS-CPS). 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
National Cancer Institute (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 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 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
[[Page 57497]]
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 Responses Average time
Type of respondent per survey period respondents per 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.
FOR FURTHER INFORMATION CONTACT: 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 60 days
of the date of this publication.
Dated: November 2, 2009.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. E9-26848 Filed 11-5-09; 8:45 am]
BILLING CODE 4140-01-P
