Published 60 day FRN

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: [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
FOR FURTHER INFORMATION CONTACT:

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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

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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:

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19:08 Sep 03, 2019

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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_
[email protected]. 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.

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