Proposed Data Collection Submitted for Public Comment and Recommendations, 71802-71803 [2015-29272]

Download as PDF 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 mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 18:14 Nov 16, 2015 Jkt 238001 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: 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 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 PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 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 E:\FR\FM\17NON1.SGM 17NON1 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 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 ........................................................................................... 93 6 ........................ 156 Form name Domestic Laboratory Total ................. 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) mstockstill on DSK4VPTVN1PROD with NOTICES 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: 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: VerDate Sep<11>2014 Average burden per response (in hours) Number of respondents Type of respondent 18:14 Nov 16, 2015 Jkt 238001 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. PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 Total burden hours 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. E:\FR\FM\17NON1.SGM 17NON1

Agencies

[Federal Register Volume 80, Number 221 (Tuesday, November 17, 2015)]
[Notices]
[Pages 71802-71803]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-29272]


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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

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 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 
three-year 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 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: 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 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 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

[[Page 71803]]

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 self-assessment 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    Average burden     Total
      Type of respondent              Form name          Number of    responses per   per response      burden
                                                        respondents    respondent      (in hours)       hours
----------------------------------------------------------------------------------------------------------------
Domestic Laboratory...........  Participant Biosafety            93               2            5/60           16
                                 Compliance Letter of
                                 Agreement.
                                MPEP Mycobacterium               93               2           30/60           93
                                 tuberculosis Results
                                 Worksheet.
                                Online Survey                    93               2           15/60           47
                                 Instrument.
                                                      ----------------------------------------------------------
    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
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