Agency Information Collection Activities: Submission for OMB Review; Comment Request, 34959 [2012-14197]
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34959
Federal Register / Vol. 77, No. 113 / Tuesday, June 12, 2012 / Notices
OMB control number 0910–0078. In
accordance with the PRA, prior to
publication of any final guidance
document, FDA intends to solicit public
comment and obtain OMB approval for
any information collections
recommended in this draft guidance
that are new or that would represent
material modifications to these
previously approved collections of
information found in FDA regulations.
III. Comments
The draft guidance is being
distributed for comment purposes only
and is not intended for implementation
at this time. Interested persons may
submit to the Division of Dockets
Management (see ADDRESSES) either
electronic or written comments
regarding this document. It is only
necessary to send one set of comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
IV. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/ScienceResearch/
SpecialTopics/RunningClinicalTrials/
ProposedRegulationsandDraft
Guidances/default.htm or https://
www.regulations.gov.
Dated: June 6, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–14295 Filed 6–11–12; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Periodically, the Substance Abuse and
Mental Health Services Administration
(SAMHSA) will publish a summary of
information collection requests under
OMB review, in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
documents, call the SAMHSA Reports
Clearance Officer on (240) 276–1243.
Project: 2013 National Survey on Drug
Use and Health—(OMB No. 0930–0110)
—Revision
The National Survey on Drug Use and
Health (NSDUH) is a survey of the
civilian, non-institutionalized
population of the United States 12 years
old and older. The data are used to
determine the prevalence of use of
tobacco products, alcohol, illicit
substances, and illicit use of
prescription drugs. The results are used
by SAMHSA, ONDCP, Federal
government agencies, and other
organizations and researchers to
establish policy, direct program
activities, and better allocate resources.
Data from clinical interviews
completed in 2008 were combined with
the main interview short scale data to
develop a predictive model that was
applied to the full main sample to
estimate SMI. Follow-up clinical
interviews continued to be conducted
with NSDUH respondents from 2009 to
2012. Data from these interviews were
analyzed annually to update the
calibration of the screening measure. To
maximize trend validity, this model has
been applied to 2009–2011 data. With
the completion of 1500 clinical
interviews in 2012, SAMHSA will have
accumulated a large enough sample
(4,500) to update and improve the
models. Therefore, the MHSS clinical
interviewing will be discontinued in
2013.
For the 2013 NSDUH, a few
questionnaire changes are proposed.
The instrument has been updated to
include new questions on military
service, medical marijuana, physician
substance use screening, and
respondent characteristics.
As with all NSDUH/NHSDA surveys
conducted since 1999, the sample size
of the survey for 2013 will be sufficient
to permit prevalence estimates for each
of the fifty states and the District of
Columbia. The total annual burden
estimate is shown below:
ESTIMATED BURDEN FOR 2013 NSDUH
Responses
per
respondent
Number of
respondents
Instrument
Hours per
response
Total burden
hours
Hourly wage
rate
Annualized
costs
145,474
67,500
5,400
10,125
1
1
1
1
0.083
1.000
0.067
0.067
12,074
67,500
362
678
$14.45
14.45
14.45
14.45
$174,469
975,375
5,231
9,797
Total ..................................................
srobinson on DSK4SPTVN1PROD with NOTICES
Household Screening ...............................
Interview ...................................................
Screening Verification ..............................
Interview Verification ................................
145,474
........................
........................
80,614
........................
1,164,872
Written comments and
recommendations concerning the
proposed information collection should
be sent by July 12, 2012 to the SAMHSA
Desk Officer at the Office of Information
and Regulatory Affairs, Office of
Management and Budget (OMB). To
ensure timely receipt of comments, and
to avoid potential delays in OMB’s
receipt and processing of mail sent
through the U.S. Postal Service,
commenters are encouraged to submit
their comments to OMB via email to:
OIRA_Submission@omb.eop.gov.
Although commenters are encouraged to
VerDate Mar<15>2010
22:42 Jun 11, 2012
Jkt 226001
send their comments via email,
commenters may also fax their
comments to: 202–395–7285.
Commenters may also mail them to:
Office of Management and Budget,
Office of Information and Regulatory
Affairs, New Executive Office Building,
Room 10102, Washington, DC 20503.
Summer King,
Statistician.
[FR Doc. 2012–14197 Filed 6–11–12; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Proposed Collection;
Comment Request
In compliance with Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 concerning
opportunity for public comment on
proposed collections of information, the
Substance Abuse and Mental Health
E:\FR\FM\12JNN1.SGM
12JNN1
]]>Agencies
[Federal Register Volume 77, Number 113 (Tuesday, June 12, 2012)]
[Notices]
[Page 34959]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-14197]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
Periodically, the Substance Abuse and Mental Health Services
Administration (SAMHSA) will publish a summary of information
collection requests under OMB review, in compliance with the Paperwork
Reduction Act (44 U.S.C. Chapter 35). To request a copy of these
documents, call the SAMHSA Reports Clearance Officer on (240) 276-1243.
Project: 2013 National Survey on Drug Use and Health--(OMB No. 0930-
0110) --Revision
The National Survey on Drug Use and Health (NSDUH) is a survey of
the civilian, non-institutionalized population of the United States 12
years old and older. The data are used to determine the prevalence of
use of tobacco products, alcohol, illicit substances, and illicit use
of prescription drugs. The results are used by SAMHSA, ONDCP, Federal
government agencies, and other organizations and researchers to
establish policy, direct program activities, and better allocate
resources.
Data from clinical interviews completed in 2008 were combined with
the main interview short scale data to develop a predictive model that
was applied to the full main sample to estimate SMI. Follow-up clinical
interviews continued to be conducted with NSDUH respondents from 2009
to 2012. Data from these interviews were analyzed annually to update
the calibration of the screening measure. To maximize trend validity,
this model has been applied to 2009-2011 data. With the completion of
1500 clinical interviews in 2012, SAMHSA will have accumulated a large
enough sample (4,500) to update and improve the models. Therefore, the
MHSS clinical interviewing will be discontinued in 2013.
For the 2013 NSDUH, a few questionnaire changes are proposed. The
instrument has been updated to include new questions on military
service, medical marijuana, physician substance use screening, and
respondent characteristics.
As with all NSDUH/NHSDA surveys conducted since 1999, the sample
size of the survey for 2013 will be sufficient to permit prevalence
estimates for each of the fifty states and the District of Columbia.
The total annual burden estimate is shown below:
Estimated Burden for 2013 NSDUH
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Responses per Hours per Total burden Hourly wage Annualized
Instrument respondents respondent response hours rate costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Household Screening..................................... 145,474 1 0.083 12,074 $14.45 $174,469
Interview............................................... 67,500 1 1.000 67,500 14.45 975,375
Screening Verification.................................. 5,400 1 0.067 362 14.45 5,231
Interview Verification.................................. 10,125 1 0.067 678 14.45 9,797
-----------------------------------------------------------------------------------------------
Total............................................... 145,474 .............. .............. 80,614 .............. 1,164,872
--------------------------------------------------------------------------------------------------------------------------------------------------------
Written comments and recommendations concerning the proposed
information collection should be sent by July 12, 2012 to the SAMHSA
Desk Officer at the Office of Information and Regulatory Affairs,
Office of Management and Budget (OMB). To ensure timely receipt of
comments, and to avoid potential delays in OMB's receipt and processing
of mail sent through the U.S. Postal Service, commenters are encouraged
to submit their comments to OMB via email to: OIRA_Submission@omb.eop.gov. Although commenters are encouraged to send
their comments via email, commenters may also fax their comments to:
202-395-7285. Commenters may also mail them to: Office of Management
and Budget, Office of Information and Regulatory Affairs, New Executive
Office Building, Room 10102, Washington, DC 20503.
Summer King,
Statistician.
[FR Doc. 2012-14197 Filed 6-11-12; 8:45 am]
BILLING CODE 4162-20-P
