60 Day FRN

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Federal Register / Vol. 84, No. 129 / Friday, July 5, 2019 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Average
burden
per response
(in hours)

Total burden
(in hrs.)

Form name

Petitioners .........................................

Form A, 42 CFR 83.9 ......................
Form B, 42 CFR 83.9 ......................
42 CFR 83.9 .....................................

2
5
1

1
1
1

3/60
5
6

6/60
25
6

42 CFR 83.18 ...................................

2

1

5

10

Authorization Form, 42 CFR 83.7 ....

3

1

3/60

9/60

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

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

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

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

41

Petitioners using a submission format other than Form B (as permitted by rule).
Petitioners Appealing final HHS decision (no specific form is required).
Claimant authorizing a party to submit petition on his/her behalf.
Total ...........................................

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2019–14304 Filed 7–3–19; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60 Day–19–19AYV; Docket No. CDC–2019–
0048]

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 State and Local Public Health
Laboratory Antibiotic Resistance
Testing. This collection will assist
public health laboratories to improve
detection and characterization of two
urgent antibiotic resistant threats in
healthcare-associated infections,
carbapenem-resistant Enterobacteriaceae
(CRE) and carbapenem-resistant
Pseudomonas aeruginosa (CRPA).
DATES: CDC must receive written
comments on or before September 3,
2019.
SUMMARY:

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Number of
responses per
respondent

Number of
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Type of respondents

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You may submit comments,
identified by Docket No. CDC–2019–
0048 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, of
the 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.
ADDRESSES:

PO 00000

Frm 00064

Fmt 4703

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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
State and Local Public Health
Laboratory Antibiotic Resistance
Testing—Existing Collection in use
without an OMB Control Number—
National Center for Emerging and
Zoonotic Infectious Diseases (NCEZID),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
This state and local laboratory testing
capacity collection is being
implemented by the Department of
Health and Human Services (HHS),
Centers for Disease Control and
Prevention (CDC) in response to
Executive Order 13676, with the
National Strategy of September 2014,
and to implement sub-objective 2.1.1 of
the National Action Plan of March 2015
for Combating Antibiotic Resistant
Bacteria. Data collected throughout this
network is also authorized by Section

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32183

Federal Register / Vol. 84, No. 129 / Friday, July 5, 2019 / Notices
301 of the Public Health Service Act (42
U.S.C. 241).
The Antibiotic Resistance Laboratory
Network (AR Lab Network) is made up
of 56 jurisdictional public health
laboratories (i.e., all 50 states, five large
cities, and Puerto Rico). These 56
laboratories will be equipped to detect
and characterize carbapenem-resistant
Enterobacteriaceae (CRE) and
Pseudomonas aeruginosa (CRPA). These
resistant bacteria are becoming more
and more prevalent, particularly in
healthcare settings, and are typically
identified in clinical laboratories.
However, characterization is often
limited. The laboratory testing will
allow for additional testing and
characterization, including use of goldstandard methods. Characterization
includes organism identification,
antimicrobial susceptibility testing
(AST) to confirm carbapenem resistance
and determine susceptibility to new
drugs of therapeutic and
epidemiological importance, a
phenotypic method to detect
carbapenemase enzyme production, and
molecular testing to identify the
resistance mechanism(s). Results from
this laboratory testing will be used to (1)
identify targets for infection control, (2)
detect new types of resistance, (2)
characterize geographical distribution of
resistance, (3) determine whether
resistance mechanisms are spreading
among organisms, people, and facilities,
and (4) provide data that informs state
and local public health surveillance and
prevention activities and priorities.
CDC’s AR Lab Network supports
nationwide lab capacity to rapidly
detect antibiotic resistance and inform
local public health responses to prevent
spread and protect people. It closes the
gap between local capabilities and the
data needed to combat antibiotic
resistance by providing comprehensive
lab capacity and infrastructure for
detecting antibiotic-resistant pathogens
(germs), cutting-edge technology, like

was evaluated to be approximately six
minutes. The average burden per
response for the Annual Evaluation and
Performance Measurement Report was
evaluated to be four hours per report.
Based on previous laboratory
experience in analyzing CRE/CRPA
isolates, the estimated time for each
participating public health laboratory
for Monthly Testing Results Report is
four hours per response. Because of the
need to add more data collection points
as new drugs are developed, new
susceptibility testing methods are made
available, new resistance mechanisms
emerge, and new pathogens are
prioritized as threats, the Monthly Data
Report includes some placeholder
elements in expectation of evolving
needs.
The use of ARLN Alerts encompass
targeted AR threats that include new
and rare plasmid-mediated (‘‘jumping’’)
carbapenemase genes, isolates that are
non-susceptible to all drugs tested, and
detection of novel resistance
mechanisms. These alerts must be sent
within one working day of detection.
The elements of these messages include
the unique public health laboratory
specimen ID and a summary of
specimen testing results generated to
date. With the conversion to HL7
messaging of these data will be
transmitted in real-time, thus
eliminating the need to send alerts.
Until that time, REDCap will be utilized
to communicate alerts. CDC estimates
that public health laboratories send an
average of 34 ARLN Alerts per lab each
year, with an estimated burden per
response of 0.1 hours.
The total estimated annualized
burden across all AR Lab Network labs
and activities for DHQP is 3108 hours.
Public Health laboratories receive
federal funds through CDC’s
Epidemiology and Laboratory Capacity
for Infectious Diseases (ELC) mechanism
to participate in this project.

DNA sequencing, and rapid sharing of
actionable data to drive infection
control responses and help treat
infections. This infrastructure allows
the public health community to rapidly
detect emerging antibiotic-resistant
threats in healthcare and the
community, mount a comprehensive
local response, and better understand
these deadly threats to quickly contain
them.
Funded state and local public health
laboratories will provide the following
information to the Program Office at
CDC—Division of Healthcare Quality
Promotion (DHQP):
1. A summary report describing
testing methods and volume. These
reports will be submitted by email to
[email protected].
2. Evaluation and Performance
Measurement Reports to CDC via email
to [email protected].
3. A report for all testing results to
CDC using an online web-portal
transmission. For messaging to CDC,
these messaging protocols will be
provided by the Association of Public
Health Laboratories (APHL) Informatics
Messaging Services (AIMS) platform.
4. Detection of targeted resistant
organisms and resistance mechanisms
that pose an immediate threat to patient
safety and require rapid infection
control, facility assessments, and/or
additional diagnostics, and an
immediate communication to the local
healthcare-associated infection program
in the jurisdictional public health
department and CDC.
The estimated annualized burden
hours were determined as follows.
There are 56 laboratories within this
framework. A ‘‘respondent’’ refers to a
single participating testing laboratory. A
‘‘response’’ is defined as the data
collection/processing and laboratory
processing associated with an
individual isolate from an individual
patient.
The average burden per response for
the Annual Summary of testing methods

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ESTIMATED ANNUALIZED BURDEN HOURS
Average
burden per
response
(in hours)

Form name

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

56
56

1
1

6/60
4

6
224

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

Annual Report of Testing Methods ..
Annual Evaluation and Performance
Measurement Report.
Monthly Testing Results Reports .....
ARLN Alerts .....................................

56
56

12
34

4
6/60

2,688
190

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

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

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

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

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

3,108

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respondents

Average
number of
responses per
respondent

Type of
respondents

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Total burden
(in hours)

32184

Federal Register / Vol. 84, No. 129 / Friday, July 5, 2019 / Notices

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2019–14299 Filed 7–3–19; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–19–0770; Docket No. CDC–2019–
0054]

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 HIV Behavioral
Surveillance System (NHBS). CDC is
requesting approval for a revision to the
previously approved project to continue
collecting standardized HIV-related
behavioral data from persons at risk for
HIV, selected from up to 25
Metropolitan Statistical Areas (MSAs)
throughout the United States.
DATES: CDC must receive written
comments on or before September 3,
2019.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2019–
0054 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.

jbell on DSK3GLQ082PROD with NOTICES

SUMMARY:

VerDate Sep<11>2014

17:54 Jul 03, 2019

Jkt 247001

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
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.
FOR FURTHER INFORMATION CONTACT:

Proposed Project
National HIV Behavioral Surveillance
System (NHBS)—(OMB Control No.
0920–0770, Exp. 05/31/2020)—
Revision—National Center for HIV/
AIDS, Viral Hepatitis, STD, and TB
Prevention (NCHHSTP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
The purpose of this data collection is
to monitor behaviors of persons at high

PO 00000

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Fmt 4703

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risk for infection that are related to
Human Immunodeficiency Virus (HIV)
transmission and prevention in the
United States. The primary objectives of
the NHBS are to obtain data from
samples of persons at risk to: (a)
Describe the prevalence and trends in
risk behaviors; (b) describe the
prevalence of and trends in HIV testing
and HIV infection; (c) describe the
prevalence of and trends in use of HIV
prevention services; (d) identify met and
unmet needs for HIV prevention
services in order to inform health
departments, community based
organizations, community planning
groups and other stakeholders.
By describing and monitoring the HIV
risk behaviors, HIV seroprevalence and
incidence, and HIV prevention
experiences of persons at highest risk
for HIV infection, NHBS provides an
important data source for evaluating
progress towards national public health
goals, such as reducing new infections,
increasing the use of condoms, and
targeting high-risk groups.
The Centers for Disease Control and
Prevention requests approval for a threeyear revision of this information
collection. Data are collected through
anonymous, in-person interviews
conducted with persons systematically
selected from up to 25 Metropolitan
Statistical Areas (MSAs) throughout the
United States; these 25 MSAs are
chosen based on having high HIV
prevalence. Persons at risk for HIV
infection to be interviewed for NHBS
include men who have sex with men
(MSM), persons who inject drugs (IDU),
and heterosexually active persons at
increased risk of HIV infection (HET). A
brief screening interview will be used to
determine eligibility for participation in
the behavioral assessment.
The data from the behavioral
assessment will provide estimates of (1)
behavior related to the risk of HIV and
other sexually transmitted diseases, (2)
prior testing for HIV, (3) and use of HIV
prevention services.
All persons interviewed will also be
offered an HIV test, and will participate
in a pre-test counseling session. No
other federal agency systematically
collects this type of information from
persons at risk for HIV infection. These
data have substantial impact on
prevention program development and
monitoring at the local, state, and
national levels.
CDC estimates that NHBS will
involve, per year in up to 25 MSAs,
eligibility screening for 100 persons and
eligibility screening plus the behavioral
assessment with 500 eligible
respondents, resulting in a total of
37,500 eligible survey respondents and

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