60 Day FRN

Att 2a - 60-day FRN.pdf

Laboratory Response Network

60 Day FRN

OMB: 0920-0850

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50096

Federal Register / Vol. 83, No. 193 / Thursday, October 4, 2018 / Notices
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
respondents/
POCs

Form name

Total burden
hours

Average hourly
wage rate *

Total cost
burden

Registration Form .....................................................................................
Data Use Agreement ................................................................................
Data Files Submission ..............................................................................

11
86
11

1
22
110

a 40.95
b 93.44

..................
..................
c 40.95 ..................

$41
2,056
4,505

Total ...................................................................................................

108

133

NA ........................

6,602

* National Compensation Survey: Occupational wages in the United States May 2016, ‘‘U.S. Department of Labor, Bureau of Labor Statistics.’’
(a) and (c) Based on the mean hourly wages for Computer Programmer (15–1131). (b) Based on the mean hourly wage for Chief Executives
(11–1011). https://www.bls.gov/oes/current/oes_nat.htm.

Request for Comments
In accordance with the Paperwork
Reduction Act, comments on AHRQ’s
information collection are requested
with regard to any of the following: (a)
Whether the proposed collection of
information is necessary for the proper
performance of AHRQ’s health care
research and health care information
dissemination functions, including
whether the information will have
practical utility; (b) the accuracy of
AHRQ’s estimate of burden (including
hours and costs) of the proposed
collection(s) of information; (c) ways to
enhance the quality, utility and clarity
of the information to be collected; and
(d) ways to minimize the burden of the
collection of information upon the
respondents, including the use of
automated collection techniques or
other forms of information technology.
Comments submitted in response to
this notice will be summarized and
included in the Agency’s subsequent
request for OMB approval of the
proposed information collection. All
comments will become a matter of
public record.
Francis D. Chesley, Jr.,
Acting Deputy Director.
[FR Doc. 2018–21618 Filed 10–3–18; 8:45 am]
BILLING CODE 4160–90–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention

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[60Day–18–0850; Docket No. CDC–2018–
0088]

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:

VerDate Sep<11>2014

17:43 Oct 03, 2018

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 Laboratory Response Network to
maintain an integrated national and
international network of laboratories
that can respond to suspected acts of
biological, chemical, or radiological
terrorism and other public health
emergencies.

SUMMARY:

Jkt 247001

CDC must receive written
comments on or before December 3,
2018.

DATES:

You may submit comments,
identified by Docket No. CDC–2018–
0088 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:
404–639–7570; Email: [email protected].
ADDRESSES:

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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.

SUPPLEMENTARY INFORMATION:

Proposed Project
Laboratory Response Network
Information Collection (OMB Control
No. 0920–0850, Exp. Date: 4/30/2019)—
Extension—National Center for
Emerging and Zoonotic Infectious

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50097

Federal Register / Vol. 83, No. 193 / Thursday, October 4, 2018 / Notices
Diseases (NCEZID), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
CDC is requesting a 3-year extension
without change to the data collection
plan or tools for Laboratory Response
Network (OMB Control No. 0920–0850,
Exp. Date: April 30, 2019). The only
change is a decrease in the estimated
burden from 2,382,300 to 2,064,660
annual hours. The decrease is due to a
decrease in the number of LRN member
laboratories from 150 to 130
laboratories.
The Laboratory Response Network
(LRN) was established by the
Department of Health and Human
Services (HHS), Centers for Disease
Control and Prevention (CDC) in
accordance with Presidential Decision
Directive 39, which outlined national
anti-terrorism policies and assigned
specific missions to federal departments
and agencies. The LRN’s mission is to
maintain an integrated national and
international network of laboratories
that can respond to suspected acts of
biological, chemical, or radiological
terrorism and other public health
emergencies.
Federal, state and local public health
laboratories join the LRN voluntarily.
When laboratories join, they assume
specific responsibilities and are
required to provide information to the
LRN Program Office at CDC. Each
laboratory must submit and maintain
complete information regarding the
testing capabilities of the laboratory.
Biennially, laboratories are required to
review, verify and update their testing
capability information. This information
is needed so that the LRN Program
Office can determine the ability of the
Network to respond to a biological or
chemical terrorism event. The
sensitivity of all information associated
with the LRN requires that CDC obtain
personal information about all
individuals accessing the LRN website.
Since CDC must be able to contact all
laboratory personnel during an event,
each laboratory staff member who
obtains access to the restricted LRN
website must provide his or her contact
information to the LRN Program Office.

belonging to the Laboratory Response
Network utilize the CDC developed
software tool LRN Results Messenger to
submit testing results to CDC. Data
Integration through the Laboratory
Information Management System
Integration (LIMSi) is an effort parallel
to the LRN Results Messenger, which
will ultimately allow laboratories to
submit data to CDC using their own data
collection systems. Results include
details about the type and source of
samples as well as the tests performed
and the numerical and empirical results
of those tests. The LRN website is used
by laboratories to provide their
complete testing capabilities to CDC. All
individuals who use the LRN website
must provide their contact information
to the LRN Program Office during
registration.
An LRN laboratory must provide its
testing capabilities, physical and
shipping addresses, United States
Department of Agriculture (USDA) and
Select Agent Permits, and specified
responsible individuals’ names, phone
numbers and email addresses. After
registering with the LRN website, a user
must provide his/her first and last
name, work phone number, alternate
phone number, email address, and
month and day of birth. During
reporting of results, sample details, tests
performed, results obtained, and
conclusions of tests are required.
Accomplishments during the last
three years include the requalification of
labs. The requalification occurred
between October 24, 2014 and
November 7, 2016 and December 12,
2016. We had 130 domestic LRN labs
tasked with completing the
requalification. We had a 96% response
rate. The LRN website has remained the
same, and has only undergone routine
maintenance since 2015 to keep it in
working order. This data collection is
authorized under the Public Health
Service Act, (42 U.S.C. 241) Section 301.
CDC has estimated the annualized
burden for this project to be 2,064,660
hours, a decrease of 317,640 hours per
year. There is no cost to respondents
other than the time to participate.

As a requirement of membership, LRN
laboratories must report all biological
and chemical testing results to the LRN
Program using a CDC developed
software tool called the LRN Results
Messenger, or through the laboratory
information management system (LIMS)
which CDC refers to as Data Integration.
CDC supplies this software to LRN
laboratories at no charge. This
information obtained from LRN
laboratories is essential for surveillance
of anomalies, to support response to an
event that may involve multiple
agencies, and to manage limited
resources.
LRN laboratories are also required to
participate in Proficiency Testing
Challenges or Validation Studies and
report their results to CDC. LRN
laboratories participate in multiple
Proficiency Testing Challenges,
Exercises and/or Validation Studies
every year. These activities consist of
5–500 simulated samples provided by
CDC. These challenges are necessary to
verify the testing capability of the LRN
laboratories. Because biological or
chemical agents perceived to be of
bioterrorism concern can occur rarely,
some LRN laboratories may not be
maintaining proficiency in certain
testing methods as a result of day-to-day
testing. Thus, simulated samples are
distributed to ensure proficiency across
LRN member laboratories. LRN
laboratories also enter the results of
these simulated samples into the LRN
Results Messenger or through Data
Integration for evaluation by CDC.
During a surge event resulting from a
bioterrorism or chemical terrorism
attack, or during an emerging infectious
disease outbreak, LRN Laboratories
must submit all testing results using
LRN Results Messenger or through Data
Integration. CDC uses these results in
order to track the progression of a
bioterrorism event, responds in the most
efficient and effective way possible, and
shares this data with other Federal
partners involved in the response.
Data is collected via two primary
avenues, the program LRN Results
Messenger or through Data Integration
and the LRN website. Laboratories

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ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Respondents

Forms

Public Health Laboratories ................

Biennial Requalification ....................
General Surveillance Testing Results.
Proficiency Testing/Validation Testing Results.

VerDate Sep<11>2014

17:43 Oct 03, 2018

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Average
number of
responses per
respondent

Average
burden per
response
(hours)

Total burden
hours

130
130

1
25

2
24

260
78,000

130

5

56

36,400

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50098

Federal Register / Vol. 83, No. 193 / Thursday, October 4, 2018 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Respondents

Total ...........................................

625

24

1,950,000

...........................................................

........................

........................

........................

2,064,660

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60 Day–18–1090; Docket No. CDC–2018–
0089]

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 revision of information
collection project titled Formative and
Summative Evaluation of Scaling the
National Diabetes Prevention Program
(National DPP) in Underserved Areas.
This revision is to allow CDC to
continue collecting the information
needed to assess the effectiveness of its
program, ‘‘Scaling the National DPP in
Underserved Areas’’, and to collect
more targeted information on CDC
grantees’ success in reaching both
general and priority populations in
underserved areas.
DATES: CDC must receive written
comments on or before December 3,
2018.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2018–
0089 by any of the following methods:
SUMMARY:

daltland on DSKBBV9HB2PROD with NOTICES

Total burden
hours

130

[FR Doc. 2018–21570 Filed 10–3–18; 8:45 am]

17:43 Oct 03, 2018

Average
burden per
response
(hours)

Surge Event Testing Results ...........

Jeffrey M. Zirger,
Acting Chief, Information Collection Review
Office, Office of Scientific Integrity, Office
of the Associate Director for Science, Office
of the Director, Centers for Disease Control
and Prevention.

VerDate Sep<11>2014

Average
number of
responses per
respondent

Number of
respondents

Forms

Jkt 247001

• 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:
404–639–7570; 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

PO 00000

Frm 00036

Fmt 4703

Sfmt 4703

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
Formative and Summative Evaluation
of Scaling the National Diabetes
Prevention Program in Underserved
Areas (OMB No. 0920–1090, exp.
12/31/2018)—Revision—National
Center for Chronic Disease Prevention
and Health Promotion (NCCDPHP),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
The CDC-led National Diabetes
Prevention Program (National DPP) is a
partnership of public and private
organizations working collectively to
build the infrastructure for nationwide
delivery of an evidence-based lifestyle
change program to prevent or delay
Type 2 diabetes among adults with
prediabetes. The National DPP lifestyle
change program is founded on the
science of the Diabetes Prevention
Program research study, and several
translation studies that followed, which
showed that making modest behavior
changes helped people with prediabetes
lose 5% to 7% of their body weight and
reduce their risk of developing Type 2
diabetes by 58% (71% for people over
60 years old). From 2012 to 2017, CDC
funded six national organizations
through a cooperative agreement to
establish and expand multistate
networks of over 200 program delivery
organizations that are able to meet
national standards and achieve the
outcomes proven to prevent or delay
onset of Type 2 diabetes. CDC has
conducted a formative and summative
evaluation of this program and used the

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