60 Day FRN

71802

Federal Register / Vol. 80, No. 221 / Tuesday, November 17, 2015 / Notices

renewed for a 2-year period through
November 5, 2017.
For information, contact Samuel L.
Groseclose D.V.M., M.P.H., Designated
Federal Officer, Board of Scientific
Counselors, Office of Public Health
Preparedness and Response, CDC, HHS,
1600 Clifton Road NE., Mailstop D44,
Atlanta, Georgia 30329–4027,
Telephone 404/639–0637, Fax 404/639–
7977.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2015–29259 Filed 11–16–15; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–16–0600; Docket No. CDC–2015–
0103]

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 efforts to reduce public
burden and maximize the utility of
government information, invites the
general public and other Federal
agencies to take this opportunity to
comment on proposed and/or
continuing information collections, as
required by the Paperwork Reduction
Act of 1995. This notice invites
comment on CDC Model Performance
Evaluation Program (MPEP) for
Mycobacterium tuberculosis
Susceptibility Testing information
collection. CDC is requesting a threeyear approval for extension to the
previously approved project used to
collect data from participants 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

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SUMMARY:

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laboratory testing, resulting in accurate
and reliable testing results.
DATES: Written comments must be
received on or before January 19, 2016.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2015–
0103 by any of the following methods:
• Federal eRulemaking Portal:
Regulation.gov. Follow the instructions
for submitting comments.
• Mail: Leroy A. Richardson,
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. All relevant comments
received will be posted without change
to Regulations.gov, including any
personal information provided. For
access to the docket to read background
documents or comments received, go to
Regulations.gov.
Please note: All public comment
should be submitted 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 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 OMB for approval. To
comply with this requirement, we are
publishing this notice of a proposed
data collection as described below.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and

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clarity of the information to be
collected; (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology; and (e) estimates of capital
or start-up costs and costs of operation,
maintenance, and purchase of services
to provide information. Burden means
the total time, effort, or financial
resources expended by persons to
generate, maintain, retain, disclose or
provide information to or for a Federal
agency. This includes the time needed
to review instructions; to develop,
acquire, install and utilize technology
and systems for the purpose of
collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information, to search
data sources, to complete and review
the collection of information; and to
transmit or otherwise disclose the
information.
Proposed Project
CDC Model Performance Evaluation
Program (MPEP) for Mycobacterium
tuberculosis Susceptibility Testing
(OMB #0920–0600, expiration. 5/31/
2016)—Extension—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 the Office of
Management and Budget to extend
approval of data collection from
participants in the Model Performance
Evaluation Program (MPEP) for
Mycobacterium tuberculosis Drug
Susceptibility Testing. There are no
changes requested for approval to
number of respondents, information
collection forms, burden, and other
methodology to collect data from
participants.
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 Drug
Susceptibility Testing is used to monitor
and evaluate performance and practices
among national laboratories performing

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71803

Federal Register / Vol. 80, No. 221 / Tuesday, November 17, 2015 / Notices
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.
The data collected over the previous
three-year period enabled CDC to
correlate testing practices with
performance and to use this information
to design training modules targeted to
participants encouraging the adaptation
of advanced testing methods. Extension
of data collection will allow CDC to
evaluate the effectiveness of these
training modules by continually
monitoring laboratory performance.
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.

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent

Average
burden per
response
(in hours)

Total burden hours

Form name

Domestic Laboratory

Participant Biosafety Compliance Letter of Agreement ...
MPEP Mycobacterium tuberculosis Results Worksheet ..
Online Survey Instrument ................................................

93
93
93

2
2
2

5/60
30/60
15/60

16
93
47

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

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

93

6

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

156

Leroy A. Richardson,
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.
[FR Doc. 2015–29272 Filed 11–16–15; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Advisory Council for the Elimination of
Tuberculosis Meeting (ACET)
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC),
announces the following meeting of the
aforementioned committee:

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Number of
respondents

Type of respondent

Times and Dates:
8:30 a.m.–5:00 p.m., EST, December 15, 2015
8:30 a.m.–12:00 p.m., EST, December 16,
2015
Place: Corporate Square, Corporate
Boulevard, Building 8, 1st Floor Conference
Room, Atlanta, Georgia 30329, telephone
(404) 639–8317.
This meeting is also accessible by Webinar:
December 15, 2015
For Participants:
URL: https://www.mymeetings.com/nc/join/
Conference number: PW1126536
Audience passcode: 6816256
Participants can join the event directly at:

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https://www.mymeetings.com/nc/join.php?i=
PW1126536&p=6816256&t=c
USA Toll-free +1 (888) 947–9021, Participant
code: 6816256
December 16, 2015
For Participants:
URL: https://www.mymeetings.com/nc/join/
Conference number: PW5803596
Audience passcode: 6816256
Participants can join the event directly at:
https://www.mymeetings.com/nc/join.php?i=
PW5803596&p=6816256&t=c
USA Toll-free +1 (888) 947–9021, Participant
code: 6816256
Status: Open to the public, limited only by
the space available. The meeting room
accommodates approximately 100 people.
Purpose: This Council advises and makes
recommendations to the Secretary of Health
and Human Services, the Assistant Secretary
for Health, and the Director, CDC, regarding
the elimination of tuberculosis. Specifically,
the Council makes recommendations
regarding policies, strategies, objectives, and
priorities; addresses the development and
application of new technologies; and reviews
the extent to which progress has been made
toward eliminating tuberculosis.
Matters for Discussion: Agenda items
include the following topics: (1) Overview of
Biomedical Advanced Research and
Development Authority (BARDA); (2)
Tuberculosis in Congregate Settings; (3)
Updates from Workgroups; and (4) other
tuberculosis-related issues.
Agenda items are subject to change as
priorities dictate.
Contact Person for More Information:
Margie Scott-Cseh, Centers for Disease
Control and Prevention, 1600 Clifton Road
NE., M/S E–07, Atlanta, Georgia 30333,
telephone (404) 639–8317 Email: zkr7@
cdc.gov.

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The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register Notices
pertaining to announcements of meetings and
other committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2015–29260 Filed 11–16–15; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Statement of Organization, Functions,
and Delegations of Authority
Part C (Centers for Disease Control
and Prevention) of the Statement of
Organization, Functions, and
Delegations of Authority of the
Department of Health and Human
Services (45 FR 67772–76, dated
October 14, 1980, and corrected at 45 FR
69296, October 20, 1980, as amended
most recently at 80 FR 58479–58485,
dated September 29, 2015) is amended
to reflect the reorganization of the
National Center for Immunization and
Respiratory Diseases, and the Office of
Infectious Diseases, Centers for Disease
Control and Prevention.

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