Agency Forms Undergoing Paperwork Reduction Act Review, 22552-22553 [2013-08861]
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22552
Federal Register / Vol. 78, No. 73 / Tuesday, April 16, 2013 / Notices
and text message surveys by feature
phone (cell phones that do not have
Web access), the outcomes of the
surveys, and the value of the surveys.
The universe for this study is Englishspeaking U.S. residents aged 18–65. The
sample frame will consist of a national
random digit dial sample of telephone
numbers from a frame of known cell
phone exchanges. Respondents reached
on their cell phones will be asked to
complete an initial CATI survey
consisting of a short series of simple
demographic questions, general health
questions, and questions about tobacco
and alcohol use. At the conclusion of
this brief survey, respondents who have
smartphones will be asked to participate
in the feasibility study, which consists
of a first follow-up survey and, a week
later, a second follow-up survey. Those
who agree will receive invitations to
participate by text message, which will
include a link to the survey. A sample
of respondents who have feature phones
will be asked to participate in a text
message pilot, which also consists of a
first follow-up survey and a second
follow-up survey. Text message
respondents will receive a text message
inviting them to participate;
respondents who opt in will receive text
messages with one survey question at a
time. Before initiating the feasibility
study, CDC will conduct a brief pre-test
of information collection forms and
procedures.
This study will evaluate: (1) Response
bias of a smartphone health survey by
comparing data collected via CATI to
data collected via smartphones/text
messages, and data collected via
smartphones to data collected via text
messages, (2) relative cost-effectiveness
of data collected via CATI to data
collected via smartphones/text
messages; (3) coverage bias associated
with restricting the sample to
smartphone users; and (4) the utility of
smartphones for completing frequent,
short interviews (e.g., diary studies to
track activities or events).
OMB approval is requested for one
year. Participation is voluntary. There
are no costs to respondents other than
their time. The total estimated
annualized burden hours are 306.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Form name
Adults Aged 18 to 65, All cell phone users ....
Pre-test (CATI Screener/CATI Recruitment ...
Screener/CATI Recruitment ...........................
Initial CATI Survey .........................................
First Web Survey Follow-up for Smartphone
Users.
Second
Web
Survey
Follow-up
for
Smartphone Users.
First Text Message Survey Follow-up for
non-Smartphone Users.
Second Text Message Survey Follow-up for
non-Smartphone Users.
Adults Aged 18 to 65, Smartphone Users ......
Adults Aged 18 to 65, Non-smartphone Users
Ron A. Otten,
Director, Office of Scientific Integrity, Office
of the Associate Director for Science, Office
of the Director, Centers for Disease Control
and Prevention.
DC 20503 or by fax to (202) 395–5806.
Written comments should be received
within 30 days of this notice.
[FR Doc. 2013–08862 Filed 4–15–13; 8:45 am]
CDC Model Performance Evaluation
Program (MPEP) for Mycobacterium
tuberculosis and Nontuberculous
Mycobacteria Drug Susceptibility
Testing OMB # 0920–0600 (exp. 5/31/
2013),—Revision—National Center for
HIV/AIDS, Viral Hepatitis, STD, and TB
Prevention (NCHHSTP), Centers for
Disease Control and Prevention (CDC).
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–13–0600]
Background and Brief Description
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Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) publishes a list of
information collection requests under
review by the Office of Management and
Budget (OMB) in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
requests, call (404) 639–7570 or send an
email to omb@cdc.gov. Send written
comments to CDC Desk Officer, Office of
Management and Budget, Washington,
VerDate Mar<15>2010
17:58 Apr 15, 2013
Proposed Project
Jkt 229001
As part of the continuing effort to
support domestic public health
objectives for treatment of tuberculosis
(TB), prevention of multi- drug
resistance, and surveillance programs,
CDC is requesting approval from the
Office of Management and Budget to
continue data collection from
participants in the Model Performance
Evaluation Program for Mycobacterium
tuberculosis and Non-tuberculous
Mycobacterium Drug Susceptibility
Testing. This request includes (a)
PO 00000
Frm 00042
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Number of
responses per
respondent
Average
burden per
response
(in hr)
20
1,990
1,590
700
1
1
1
1
8/60
1/60
7/60
3/60
595
1
3/60
200
1
3/60
170
1
3/60
changing the title of the data collection
to ‘‘CDC Model Performance Evaluation
(MPEP) for Mycobacterium tuberculosis
Drug Susceptibility Testing’’ to reflect
that nontuberculous mycobacteria are
no longer included in the test package;
(b) replacement of Laboratory
Enrollment Form with a Participant
Biosafety Compliance Letter of
Agreement; (c) revision of the Preshipment Email; (d) addition of
Instructions to Participants Letter; (e)
revision of the MPEP M. tuberculosis
Results Worksheet; (f) entering survey
results online using a modified data
collection instrument; (g) modification
of Reminder Email; (h) modification of
Reminder Telephone Script; and (i)
modification of the Aggregate Report
Letter.
While the overall number of cases of
TB in the U.S. has decreased, rates still
remain high among foreign-born
persons, prisoners, homeless
populations, and individuals infected
with HIV in major metropolitan areas.
To reach the goal of eliminating TB, the
Model Performance Evaluation Program
for Mycobacterium tuberculosis and
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16APN1
22553
Federal Register / Vol. 78, No. 73 / Tuesday, April 16, 2013 / Notices
Non-tuberculous Mycobacterium Drug
Susceptibility Testing is used to monitor
and evaluate performance and practices
among national laboratories performing
M. tuberculosis susceptibility testing.
Participation in this program is one way
laboratories can ensure high-quality
laboratory testing, resulting in accurate
and reliable testing results.
By providing an evaluation program
to assess the ability of the laboratories
to test for drug resistant M. tuberculosis
strains, laboratories also have a selfassessment tool to aid in optimizing
their skills in susceptibility testing. The
information obtained from the
laboratories on susceptibility practices
and procedures is used to establish
variables related to good performance,
assessing training needs, and aid with
the development of practice standards.
Participants in this program include
domestic clinical and public health
laboratories. Data collection from
laboratory participants occurs twice per
year. The data collected in this program
will include the susceptibility test
results of primary and secondary drugs,
drug concentrations, and test methods
performed by laboratories on a set of
performance evaluation (PE) samples.
The PE samples are sent to participants
twice a year. Participants also report
demographic data such as laboratory
type and the number of tests performed
annually.
There is no cost to respondents to
participate other than their time. The
total estimated annual burden hours are
156.
ESTIMATED ANNUALIZED BURDEN HOURS
Type of
respondent
Form name
Domestic Laboratory ...............
MPEP
Participant Biosafety Compliance Letter of Agreement .........
Mycobacterium tuberculosis Results Worksheet ...................
Online Survey Instrument .......................................................
Ron A. Otten,
Director, Office of Scientific Integrity, Office
of the Associate Director for Science, Office
of the Director, Centers for Disease Control
and Prevention.
[FR Doc. 2013–08861 Filed 4–15–13; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0876]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Pretesting of Tobacco
Communications
AGENCY:
Dated: April 11, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–08860 Filed 4–15–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Pretesting of Tobacco
Communications’’ has been approved by
the Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995.
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: On
January 28, 2013, the Agency submitted
a proposed collection of information
entitled ‘‘Pretesting of Tobacco
SUMMARY:
mstockstill on DSK4VPTVN1PROD with NOTICES
Communications’’ to OMB for review
and clearance under 44 U.S.C. 3507. An
Agency may not conduct or sponsor,
and a person is not required to respond
to, a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0674. The
approval expires on March 31, 2016. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
Food and Drug Administration,
HHS.
ACTION:
Number of
respondents
VerDate Mar<15>2010
17:58 Apr 15, 2013
Jkt 229001
Food and Drug Administration
[Docket No. FDA–2013–N–0391]
Generic Drug Facilities, Sites, and
Organizations
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that the generic drug facility selfidentification reporting period for fiscal
year (FY) 2014 will begin on May 1,
2013, and close on June 1, 2013. Generic
drug facilities, certain sites, and
organizations identified in a generic
drug submission are required by the
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Frm 00043
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93
93
93
Number of
responses per
respondent
Average
burden per
response
(in hours)
2
2
2
5/60
30/60
15/60
Generic Drug User Fee Amendments of
2012 (GDUFA) to submit, update, or
reconfirm identification information to
FDA annually.
DATES: For FY 2014, identification
information must be submitted,
updated, or reconfirmed between May 1,
2013, and June 1, 2013.
ADDRESSES: Electronic tools for
submitting the required information
may be found on FDA’s Web site at the
following addresses:
• eSubmitter tool: https://
www.fda.gov/ForIndustry/
FDAeSubmitter/ucm108165.htm.
• Structured Product Labeling (SPL)
Xforms: https://www.fda.gov/
ForIndustry/DataStandards/
StructuredProductLabeling/
ucm189651.htm.
Other applications are available
commercially.
FOR FURTHER INFORMATION CONTACT:
Jaewon Hong, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10001 New
Hampshire Ave., Rm. 4145, Silver
Spring, MD 20993, 301–796–6707,
AskGDUFA@fda.hhs.gov.
GDUFA
(Pub. L. 112–144, Title III) was signed
into law by the President on July 9,
2012, as part of the Food and Drug
Administration Safety and Innovation
Act. GDUFA is designed to speed the
delivery of safe and effective generic
drugs to the public and reduce costs to
industry. GDUFA enables FDA to assess
user fees to fund critical and measurable
enhancements to FDA’s generic drugs
program. GDUFA will also significantly
SUPPLEMENTARY INFORMATION:
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16APN1
]]>Agencies
[Federal Register Volume 78, Number 73 (Tuesday, April 16, 2013)]
[Notices]
[Pages 22552-22553]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-08861]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-13-0600]
Agency Forms Undergoing Paperwork Reduction Act Review
The Centers for Disease Control and Prevention (CDC) publishes a
list of information collection requests under review by the Office of
Management and Budget (OMB) in compliance with the Paperwork Reduction
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call
(404) 639-7570 or send an email to omb@cdc.gov. Send written comments
to CDC Desk Officer, Office of Management and Budget, Washington, DC
20503 or by fax to (202) 395-5806. Written comments should be received
within 30 days of this notice.
Proposed Project
CDC Model Performance Evaluation Program (MPEP) for Mycobacterium
tuberculosis and Nontuberculous Mycobacteria Drug Susceptibility
Testing OMB 0920-0600 (exp. 5/31/2013),--Revision--National
Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP),
Centers for Disease Control and Prevention (CDC).
Background and Brief Description
As part of the continuing effort to support domestic public health
objectives for treatment of tuberculosis (TB), prevention of multi-
drug resistance, and surveillance programs, CDC is requesting approval
from the Office of Management and Budget to continue data collection
from participants in the Model Performance Evaluation Program for
Mycobacterium tuberculosis and Non-tuberculous Mycobacterium Drug
Susceptibility Testing. This request includes (a) changing the title of
the data collection to ``CDC Model Performance Evaluation (MPEP) for
Mycobacterium tuberculosis Drug Susceptibility Testing'' to reflect
that nontuberculous mycobacteria are no longer included in the test
package; (b) replacement of Laboratory Enrollment Form with a
Participant Biosafety Compliance Letter of Agreement; (c) revision of
the Pre-shipment Email; (d) addition of Instructions to Participants
Letter; (e) revision of the MPEP M. tuberculosis Results Worksheet; (f)
entering survey results online using a modified data collection
instrument; (g) modification of Reminder Email; (h) modification of
Reminder Telephone Script; and (i) modification of the Aggregate Report
Letter.
While the overall number of cases of TB in the U.S. has decreased,
rates still remain high among foreign-born persons, prisoners, homeless
populations, and individuals infected with HIV in major metropolitan
areas. To reach the goal of eliminating TB, the Model Performance
Evaluation Program for Mycobacterium tuberculosis and
[[Page 22553]]
Non-tuberculous Mycobacterium Drug Susceptibility Testing is used to
monitor and evaluate performance and practices among national
laboratories performing M. tuberculosis susceptibility testing.
Participation in this program is one way laboratories can ensure high-
quality laboratory testing, resulting in accurate and reliable testing
results.
By providing an evaluation program to assess the ability of the
laboratories to test for drug resistant M. tuberculosis strains,
laboratories also have a self-assessment tool to aid in optimizing
their skills in susceptibility testing. The information obtained from
the laboratories on susceptibility practices and procedures is used to
establish variables related to good performance, assessing training
needs, and aid with the development of practice standards.
Participants in this program include domestic clinical and public
health laboratories. Data collection from laboratory participants
occurs twice per year. The data collected in this program will include
the susceptibility test results of primary and secondary drugs, drug
concentrations, and test methods performed by laboratories on a set of
performance evaluation (PE) samples. The PE samples are sent to
participants twice a year. Participants also report demographic data
such as laboratory type and the number of tests performed annually.
There is no cost to respondents to participate other than their
time. The total estimated annual burden hours are 156.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per
Type of respondent Form name respondents responses per response (in
respondent hours)
----------------------------------------------------------------------------------------------------------------
Domestic Laboratory................ Participant Biosafety 93 2 5/60
Compliance Letter of
Agreement.
MPEP Mycobacterium tuberculosis 93 2 30/60
Results Worksheet.
Online Survey Instrument... 93 2 15/60
----------------------------------------------------------------------------------------------------------------
Ron A. Otten,
Director, Office of Scientific Integrity, Office of the Associate
Director for Science, Office of the Director, Centers for Disease
Control and Prevention.
[FR Doc. 2013-08861 Filed 4-15-13; 8:45 am]
BILLING CODE 4163-18-P
