Proposed Data Collection Submitted for Public Comment and Recommendations, 46536-46537 [2019-19017]
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46536
Federal Register / Vol. 84, No. 171 / Wednesday, September 4, 2019 / Notices
undetermined agents, undetermined
sources, undetermined transmission, or
undetermined risk factors annually. The
projected average number of
respondents is 200 per EEI, for a total
of 12,000 respondents. CDC estimates
performed during the previous two
years. OMB approval is requested for
three years. There are no costs to
respondents.
the average burden per response is 0.5
hours and each respondent will be
asked to respond once. Therefore, the
total estimated annual burden hours are
6,000. These estimates are based on the
reported burden for EEIs that have been
ESTIMATED ANNUALIZED BURDEN HOURS
Average
burden per
response
(in hours)
Total
burden hours
(in hours)
Form name
Emergency Epidemic Investigation
Participants.
Emergency Epidemic Investigation
Data Collection Instruments.
12,000
1
30/60
6,000
Total ...........................................
...........................................................
........................
........................
........................
6,000
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2019–19019 Filed 9–3–19; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–19–19BOI; Docket No. CDC–2019–
0074]
Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:
The Centers for Disease
Control and Prevention (CDC), as part of
its continuing effort to reduce public
burden and maximize the utility of
government information, invites the
general public and other Federal
agencies the opportunity to comment on
a proposed and/or continuing
information collection, as required by
the Paperwork Reduction Act of 1995.
This notice invites comment on a
proposed information collection project
titled National Diabetes Prevention
Program (DPP) Introductory Session
Project. This information collection
aims to help CDC determine the
prevalence and types of introductory
sessions being offered as a recruitment
strategy to increase enrollment in the
National Diabetes Prevention Program
lifestyle change program (National DPP
LCP) (Phase 1: Introductory Session
Landscape Assessment) and to evaluate
a behaviorally-focused intervention
known as Be Your Best (BYB) Discovery
SUMMARY:
jbell on DSK3GLQ082PROD with NOTICES
Number of
responses per
respondent
Number of
respondents
Type of respondent
VerDate Sep<11>2014
19:08 Sep 03, 2019
Jkt 247001
Session compared with other already
occurring introductory sessions.
DATES: CDC must receive written
comments on or before November 4,
2019.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2019–
0074 by any of the following methods:
• Federal eRulemaking Portal:
Regulations.gov. Follow the instructions
for submitting comments.
• Mail: Jeffrey M. Zirger, Information
Collection Review Office, Centers for
Disease Control and Prevention, 1600
Clifton Road NE, MS–D74, Atlanta,
Georgia 30329.
Instructions: All submissions received
must include the agency name and
Docket Number. CDC will post, without
change, all relevant comments to
Regulations.gov.
Please note: Submit all comments through
the Federal eRulemaking portal
(regulations.gov) or by U.S. mail to the
address listed above.
To
request more information on the
proposed project or to obtain a copy of
the information collection plan and
instruments, contact Jeffrey M. Zirger,
Information Collection Review Office,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE, MS–
D74, Atlanta, Georgia 30329; phone:
404–639–7118; Email: omb@cdc.gov.
SUPPLEMENTARY INFORMATION: Under the
Paperwork Reduction Act of 1995 (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. In addition, the PRA also
requires Federal agencies to provide a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each new
proposed collection, each proposed
extension of existing collection of
information, and each reinstatement of
FOR FURTHER INFORMATION CONTACT:
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
previously approved information
collection before submitting the
collection to the OMB for approval. To
comply with this requirement, we are
publishing this notice of a proposed
data collection as described below.
The OMB is particularly interested in
comments that will help:
1. Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions 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 through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submissions
of responses.
5. Assess information collection costs.
Proposed Project
National Diabetes Prevention Program
(DPP) Introductory Session Project—
New—National Center for Chronic
Disease Prevention and Health
Promotion (NCCDPHP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
The Centers for Disease Control and
Prevention’s (CDC) National Diabetes
Prevention Program Lifestyle Change
Program (National DPP LCP) is focused
on helping participants adopt healthier
behaviors (e.g., improving diet,
increasing physical activity, reducing
stress) to prevent or delay the
E:\FR\FM\04SEN1.SGM
04SEN1
Federal Register / Vol. 84, No. 171 / Wednesday, September 4, 2019 / Notices
development of type 2 diabetes. This
proposed project’s primary purposes are
to (1) increase knowledge of recruitment
strategies, specifically introductory
sessions, used by CDC-recognized
organizations to increase enrollment in
the National DPP LCP (Phase 1), and (2)
evaluate introductory sessions,
specifically a CDC-developed
behaviorally-informed introductory
session known as the Be Your Best
(BYB) Discovery Session, on enrollment
compared with other types of
introductory sessions that organizations
currently use (Phase 2).
CDC is requesting OMB approval to
collect information needed for this
evaluation. For Phase 1 of this project,
the Introductory Session Landscape
Assessment, CDC is seeking approval to
disseminate a brief Landscape
Assessment (survey) to all National DPP
CDC-recognized organizations
(approximately 1,700) and their affiliate
class locations (up to 540). The survey
will initially be disseminated
electronically (web-based survey), and
then a hard copy will be mailed to nonrespondents. The overall evaluation
46537
hard copies to introductory session
attendees. The BYB Discovery Session
Implementation Fidelity Checklist and
the Registration and Attendance
Tracking Form will be designed in
Microsoft Excel and distributed to
participating LCP staff using secure FTP
upload for LCP personnel to complete
electronically.
Information collected will be
analyzed to evaluate the effectiveness of
the BYB Discovery Session intervention
in increasing enrollment in the National
DPP LCP compared with already
occurring introductory sessions (i.e.,
standard care), with a secondary aim of
better understanding how it is
implemented and the context of its
implementation. This data collection is
important because if the BYB Discovery
Session is determined to be an effective
recruitment strategy compared with
other existing introductory sessions, it
should be promoted to maximize the
National DPP’s potential to reduce type
2 diabetes incidence. CDC requests
approval for 1,572 Burden Hours
annually. There are no costs to
respondents other than their time.
objectives of the Introductory Session
Landscape Assessment are to increase
knowledge of recruitment strategies
(specifically introductory sessions) used
by CDC-recognized organizations to
increase enrollment in LCPs;
understand how CDC-recognized
organizations are using introductory
sessions (including session content and
delivery); and inform the subsequent
Phase 2 Introductory Session Evaluation
that will evaluate the BYB Discovery
Session compared with other types of
introductory sessions.
For the Phase 2 Introductory Session
Evaluation, CDC is seeking approval to
disseminate the following data
collection tools: (1) Pre-Session Survey
(to be completed by up to 2,640
introductory session attendees), (2) PostSession Survey (to be completed by up
to 2,640 introductory session attendees),
(3) Registration and Attendance
Tracking Form (to be completed by up
to 132 LCP staff), and (4) Discovery
Session Implementation Fidelity
Checklist (to be completed by up to 66
LCP staff). The Pre-Session and PostSession Surveys will be distributed as
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Average
burden per
response
(in hours)
Total
burden
(in hours)
Form name
LCP Staff ...........................................
Introductory Session Attendees (Individuals).
Introductory Session Attendees (Individuals).
LCP Staff ...........................................
Landscape Assessment ...................
Pre-Session Survey .........................
2,240
2,640
1
1
15/60
10/60
560
440
Post-Session Survey ........................
2,640
1
10/60
440
Registration Attendance and Tracking Form.
BYB Discovery Session Implementation Fidelity Checklist.
132
1
15/60
33
66
1
90/60
99
...........................................................
........................
........................
........................
1,572
LCP Staff ...........................................
Total ...........................................
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2019–19017 Filed 9–3–19; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0242]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Current Good
Manufacturing Practices for Positron
Emission Tomography Drugs
jbell on DSK3GLQ082PROD with NOTICES
Number of
responses per
respondent
Type of respondents
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
SUMMARY:
VerDate Sep<11>2014
19:08 Sep 03, 2019
Jkt 247001
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
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 October 4,
2019.
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 oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0667. Also
include the FDA docket number found
in brackets in the heading of this
document.
E:\FR\FM\04SEN1.SGM
04SEN1
]]>Agencies
[Federal Register Volume 84, Number 171 (Wednesday, September 4, 2019)]
[Notices]
[Pages 46536-46537]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-19017]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-19-19BOI; Docket No. CDC-2019-0074]
Proposed Data Collection Submitted for Public Comment and
Recommendations
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice with comment period.
-----------------------------------------------------------------------
SUMMARY: The Centers for Disease Control and Prevention (CDC), as part
of its continuing effort to reduce public burden and maximize the
utility of government information, invites the general public and other
Federal agencies the opportunity to comment on a proposed and/or
continuing information collection, as required by the Paperwork
Reduction Act of 1995. This notice invites comment on a proposed
information collection project titled National Diabetes Prevention
Program (DPP) Introductory Session Project. This information collection
aims to help CDC determine the prevalence and types of introductory
sessions being offered as a recruitment strategy to increase enrollment
in the National Diabetes Prevention Program lifestyle change program
(National DPP LCP) (Phase 1: Introductory Session Landscape Assessment)
and to evaluate a behaviorally-focused intervention known as Be Your
Best (BYB) Discovery Session compared with other already occurring
introductory sessions.
DATES: CDC must receive written comments on or before November 4, 2019.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2019-
0074 by any of the following methods:
Federal eRulemaking Portal: Regulations.gov. Follow the
instructions for submitting comments.
Mail: Jeffrey M. Zirger, Information Collection Review
Office, Centers for Disease Control and Prevention, 1600 Clifton Road
NE, MS-D74, Atlanta, Georgia 30329.
Instructions: All submissions received must include the agency name
and Docket Number. CDC will post, without change, all relevant comments
to Regulations.gov.
Please note: Submit all comments through the Federal
eRulemaking portal (regulations.gov) or by U.S. mail to the address
listed above.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the information collection plan
and instruments, contact Jeffrey M. Zirger, Information Collection
Review Office, Centers for Disease Control and Prevention, 1600 Clifton
Road NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7118; Email:
[email protected].
SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995
(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. In addition, the PRA also requires
Federal agencies to provide a 60-day notice in the Federal Register
concerning each proposed collection of information, including each new
proposed collection, each proposed extension of existing collection of
information, and each reinstatement of previously approved information
collection before submitting the collection to the OMB for approval. To
comply with this requirement, we are publishing this notice of a
proposed data collection as described below.
The OMB is particularly interested in comments that will help:
1. Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions 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 through the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submissions of responses.
5. Assess information collection costs.
Proposed Project
National Diabetes Prevention Program (DPP) Introductory Session
Project--New--National Center for Chronic Disease Prevention and Health
Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
The Centers for Disease Control and Prevention's (CDC) National
Diabetes Prevention Program Lifestyle Change Program (National DPP LCP)
is focused on helping participants adopt healthier behaviors (e.g.,
improving diet, increasing physical activity, reducing stress) to
prevent or delay the
[[Page 46537]]
development of type 2 diabetes. This proposed project's primary
purposes are to (1) increase knowledge of recruitment strategies,
specifically introductory sessions, used by CDC-recognized
organizations to increase enrollment in the National DPP LCP (Phase 1),
and (2) evaluate introductory sessions, specifically a CDC-developed
behaviorally-informed introductory session known as the Be Your Best
(BYB) Discovery Session, on enrollment compared with other types of
introductory sessions that organizations currently use (Phase 2).
CDC is requesting OMB approval to collect information needed for
this evaluation. For Phase 1 of this project, the Introductory Session
Landscape Assessment, CDC is seeking approval to disseminate a brief
Landscape Assessment (survey) to all National DPP CDC-recognized
organizations (approximately 1,700) and their affiliate class locations
(up to 540). The survey will initially be disseminated electronically
(web-based survey), and then a hard copy will be mailed to non-
respondents. The overall evaluation objectives of the Introductory
Session Landscape Assessment are to increase knowledge of recruitment
strategies (specifically introductory sessions) used by CDC-recognized
organizations to increase enrollment in LCPs; understand how CDC-
recognized organizations are using introductory sessions (including
session content and delivery); and inform the subsequent Phase 2
Introductory Session Evaluation that will evaluate the BYB Discovery
Session compared with other types of introductory sessions.
For the Phase 2 Introductory Session Evaluation, CDC is seeking
approval to disseminate the following data collection tools: (1) Pre-
Session Survey (to be completed by up to 2,640 introductory session
attendees), (2) Post-Session Survey (to be completed by up to 2,640
introductory session attendees), (3) Registration and Attendance
Tracking Form (to be completed by up to 132 LCP staff), and (4)
Discovery Session Implementation Fidelity Checklist (to be completed by
up to 66 LCP staff). The Pre-Session and Post-Session Surveys will be
distributed as hard copies to introductory session attendees. The BYB
Discovery Session Implementation Fidelity Checklist and the
Registration and Attendance Tracking Form will be designed in Microsoft
Excel and distributed to participating LCP staff using secure FTP
upload for LCP personnel to complete electronically.
Information collected will be analyzed to evaluate the
effectiveness of the BYB Discovery Session intervention in increasing
enrollment in the National DPP LCP compared with already occurring
introductory sessions (i.e., standard care), with a secondary aim of
better understanding how it is implemented and the context of its
implementation. This data collection is important because if the BYB
Discovery Session is determined to be an effective recruitment strategy
compared with other existing introductory sessions, it should be
promoted to maximize the National DPP's potential to reduce type 2
diabetes incidence. CDC requests approval for 1,572 Burden Hours
annually. There are no costs to respondents other than their time.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per Total burden
Type of respondents Form name respondents responses per response (in (in hours)
respondent hours)
----------------------------------------------------------------------------------------------------------------
LCP Staff..................... Landscape 2,240 1 15/60 560
Assessment.
Introductory Session Attendees Pre-Session 2,640 1 10/60 440
(Individuals). Survey.
Introductory Session Attendees Post-Session 2,640 1 10/60 440
(Individuals). Survey.
LCP Staff..................... Registration 132 1 15/60 33
Attendance and
Tracking Form.
LCP Staff..................... BYB Discovery 66 1 90/60 99
Session
Implementation
Fidelity
Checklist.
---------------------------------------------------------------
Total..................... ................ .............. .............. .............. 1,572
----------------------------------------------------------------------------------------------------------------
Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2019-19017 Filed 9-3-19; 8:45 am]
BILLING CODE 4163-18-P
