80 FR 71802 - Proposed Data Collection Submitted for Public Comment and Recommendations
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 80, Issue 221 (November 17, 2015)
Centers for Disease Control and Prevention
Federal Register Volume 80, Issue 221 (November 17, 2015)
| Page Range | 71802-71803 | |
| FR Document | 2015-29272 |
[Federal Register Volume 80, Number 221 (Tuesday, November 17, 2015)] [Notices] [Pages 71802-71803] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-29272] ----------------------------------------------------------------------- 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: [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 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
![71802 Federal Register / Vol. 80, No. 221 / Tuesday, November 17, 2015 / Notices
renewed for a 2-year period through laboratory testing, resulting in accurate clarity of the information to be
November 5, 2017. and reliable testing results. collected; (d) ways to minimize the
For information, contact Samuel L. DATES: Written comments must be burden of the collection of information
Groseclose D.V.M., M.P.H., Designated received on or before January 19, 2016. on respondents, including through the
Federal Officer, Board of Scientific ADDRESSES: You may submit comments, use of automated collection techniques
Counselors, Office of Public Health identified by Docket No. CDC–2015– or other forms of information
Preparedness and Response, CDC, HHS, 0103 by any of the following methods: technology; and (e) estimates of capital
1600 Clifton Road NE., Mailstop D44, • Federal eRulemaking Portal: or start-up costs and costs of operation,
Atlanta, Georgia 30329–4027, Regulation.gov. Follow the instructions maintenance, and purchase of services
Telephone 404/639–0637, Fax 404/639– for submitting comments. to provide information. Burden means
7977. • Mail: Leroy A. Richardson, the total time, effort, or financial
The Director, Management Analysis Information Collection Review Office, resources expended by persons to
and Services Office, has been delegated Centers for Disease Control and generate, maintain, retain, disclose or
the authority to sign Federal Register Prevention, 1600 Clifton Road NE., MS– provide information to or for a Federal
notices pertaining to announcements of D74, Atlanta, Georgia 30329. agency. This includes the time needed
meetings and other committee Instructions: All submissions received to review instructions; to develop,
management activities, for both the must include the agency name and acquire, install and utilize technology
Centers for Disease Control and Docket Number. All relevant comments and systems for the purpose of
Prevention and the Agency for Toxic received will be posted without change collecting, validating and verifying
Substances and Disease Registry. to Regulations.gov, including any information, processing and
Elaine L. Baker, personal information provided. For maintaining information, and disclosing
access to the docket to read background and providing information; to train
Director, Management Analysis and Services
Office, Centers for Disease Control and documents or comments received, go to personnel and to be able to respond to
Prevention. Regulations.gov. a collection of information, to search
[FR Doc. 2015–29259 Filed 11–16–15; 8:45 am] Please note: All public comment data sources, to complete and review
should be submitted through the the collection of information; and to
BILLING CODE 4163–18–P
Federal eRulemaking portal transmit or otherwise disclose the
(Regulations.gov) or by U.S. mail to the information.
DEPARTMENT OF HEALTH AND address listed above. Proposed Project
HUMAN SERVICES FOR FURTHER INFORMATION CONTACT: To CDC Model Performance Evaluation
request more information on the Program (MPEP) for Mycobacterium
Centers for Disease Control and proposed project or to obtain a copy of
Prevention tuberculosis Susceptibility Testing
the information collection plan and (OMB #0920–0600, expiration. 5/31/
[60Day–16–0600; Docket No. CDC–2015– instruments, contact the Information 2016)—Extension—National Center for
0103] Collection Review Office, Centers for HIV/AIDS, Viral Hepatitis, STD, and TB
Disease Control and Prevention, 1600 Prevention (NCHHSTP), Centers for
Proposed Data Collection Submitted Clifton Road NE., MS–D74, Atlanta, Disease Control and Prevention (CDC).
for Public Comment and Georgia 30329; phone: 404–639–7570;
Recommendations Email: omb@cdc.gov. Background and Brief Description
AGENCY: Centers for Disease Control and SUPPLEMENTARY INFORMATION: Under the As part of the continuing effort to
Prevention (CDC), Department of Health Paperwork Reduction Act of 1995 (PRA) support domestic public health
and Human Services (HHS). (44 U.S.C. 3501–3520), Federal agencies objectives for treatment of tuberculosis
ACTION: Notice with comment period. must obtain approval from the Office of (TB), prevention of multi-drug
Management and Budget (OMB) for each resistance, and surveillance programs,
SUMMARY: The Centers for Disease collection of information they conduct CDC is requesting the Office of
Control and Prevention (CDC), as part of or sponsor. In addition, the PRA also Management and Budget to extend
its continuing efforts to reduce public requires Federal agencies to provide a approval of data collection from
burden and maximize the utility of 60-day notice in the Federal Register participants in the Model Performance
government information, invites the concerning each proposed collection of Evaluation Program (MPEP) for
general public and other Federal information, including each new Mycobacterium tuberculosis Drug
agencies to take this opportunity to proposed collection, each proposed Susceptibility Testing. There are no
comment on proposed and/or extension of existing collection of changes requested for approval to
continuing information collections, as information, and each reinstatement of number of respondents, information
required by the Paperwork Reduction previously approved information collection forms, burden, and other
Act of 1995. This notice invites collection before submitting the methodology to collect data from
comment on CDC Model Performance collection to OMB for approval. To participants.
Evaluation Program (MPEP) for comply with this requirement, we are While the overall number of cases of
Mycobacterium tuberculosis publishing this notice of a proposed TB in the U.S. has decreased, rates still
Susceptibility Testing information data collection as described below. remain high among foreign-born
collection. CDC is requesting a three- Comments are invited on: (a) Whether persons, prisoners, homeless
mstockstill on DSK4VPTVN1PROD with NOTICES
year approval for extension to the the proposed collection of information populations, and individuals infected
previously approved project used to is necessary for the proper performance with HIV in major metropolitan areas.
collect data from participants to monitor of the functions of the agency, including To reach the goal of eliminating TB, the
and evaluate performance and practices whether the information shall have Model Performance Evaluation Program
among national laboratories performing practical utility; (b) the accuracy of the for Mycobacterium tuberculosis Drug
M. tuberculosis susceptibility testing. agency’s estimate of the burden of the Susceptibility Testing is used to monitor
Participation in this program is one way proposed collection of information; (c) and evaluate performance and practices
laboratories can ensure high-quality ways to enhance the quality, utility, and among national laboratories performing
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![Federal Register / Vol. 80, No. 221 / Tuesday, November 17, 2015 / Notices 71803
M. tuberculosis susceptibility testing. assessing training needs, and aid with laboratories. Data collection from
Participation in this program is one way the development of practice standards. laboratory participants occurs twice per
laboratories can ensure high-quality The data collected over the previous year. The data collected in this program
laboratory testing, resulting in accurate three-year period enabled CDC to will include the susceptibility test
and reliable testing results. correlate testing practices with results of primary and secondary drugs,
By providing an evaluation program performance and to use this information drug concentrations, and test methods
to assess the ability of the laboratories to design training modules targeted to performed by laboratories on a set of
to test for drug resistant M. tuberculosis participants encouraging the adaptation performance evaluation (PE) samples.
strains, laboratories also have a self- of advanced testing methods. Extension The PE samples are sent to participants
assessment tool to aid in optimizing of data collection will allow CDC to twice a year. Participants also report
their skills in susceptibility testing. The evaluate the effectiveness of these demographic data such as laboratory
information obtained from the training modules by continually type and the number of tests performed
laboratories on susceptibility practices monitoring laboratory performance. annually.
and procedures is used to establish Participants in this program include There is no cost to respondents to
variables related to good performance, domestic clinical and public health participate other than their time.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per Total bur-
Type of respondent Form name responses per
respondents response den hours
respondent (in hours)
Domestic Laboratory Participant Biosafety Compliance Letter of Agreement ... 93 2 5/60 16
MPEP Mycobacterium tuberculosis Results Worksheet .. 93 2 30/60 93
Online Survey Instrument ................................................ 93 2 15/60 47
Total ................. ........................................................................................... 93 6 ........................ 156
Leroy A. Richardson, https://www.mymeetings.com/nc/join.php?i= The Director, Management Analysis and
Chief, Information Collection Review Office, PW1126536&p=6816256&t=c Services Office, has been delegated the
Office of Scientific Integrity, Office of the USA Toll-free +1 (888) 947–9021, Participant authority to sign Federal Register Notices
Associate Director for Science, Office of the code: 6816256 pertaining to announcements of meetings and
Director, Centers for Disease Control and December 16, 2015 other committee management activities, for
Prevention. For Participants: both the Centers for Disease Control and
[FR Doc. 2015–29272 Filed 11–16–15; 8:45 am] URL: https://www.mymeetings.com/nc/join/ Prevention and the Agency for Toxic
Conference number: PW5803596 Substances and Disease Registry.
BILLING CODE 4163–18–P
Audience passcode: 6816256
Elaine L. Baker,
Participants can join the event directly at:
Director, Management Analysis and Services
DEPARTMENT OF HEALTH AND https://www.mymeetings.com/nc/join.php?i= Office, Centers for Disease Control and
HUMAN SERVICES PW5803596&p=6816256&t=c Prevention.
USA Toll-free +1 (888) 947–9021, Participant
code: 6816256 [FR Doc. 2015–29260 Filed 11–16–15; 8:45 am]
Centers for Disease Control and
Status: Open to the public, limited only by BILLING CODE 4163–18–P
Prevention
the space available. The meeting room
Advisory Council for the Elimination of accommodates approximately 100 people.
Tuberculosis Meeting (ACET) Purpose: This Council advises and makes DEPARTMENT OF HEALTH AND
recommendations to the Secretary of Health HUMAN SERVICES
and Human Services, the Assistant Secretary
In accordance with section 10(a)(2) of
for Health, and the Director, CDC, regarding Centers for Disease Control and
the Federal Advisory Committee Act the elimination of tuberculosis. Specifically, Prevention
(Pub. L. 92–463), the Centers for Disease the Council makes recommendations
Control and Prevention (CDC), regarding policies, strategies, objectives, and Statement of Organization, Functions,
announces the following meeting of the priorities; addresses the development and and Delegations of Authority
aforementioned committee: application of new technologies; and reviews
the extent to which progress has been made
Times and Dates: Part C (Centers for Disease Control
toward eliminating tuberculosis.
8:30 a.m.–5:00 p.m., EST, December 15, 2015 Matters for Discussion: Agenda items and Prevention) of the Statement of
8:30 a.m.–12:00 p.m., EST, December 16, include the following topics: (1) Overview of Organization, Functions, and
2015 Biomedical Advanced Research and Delegations of Authority of the
Place: Corporate Square, Corporate Development Authority (BARDA); (2) Department of Health and Human
Boulevard, Building 8, 1st Floor Conference Tuberculosis in Congregate Settings; (3) Services (45 FR 67772–76, dated
Room, Atlanta, Georgia 30329, telephone Updates from Workgroups; and (4) other October 14, 1980, and corrected at 45 FR
(404) 639–8317. tuberculosis-related issues.
mstockstill on DSK4VPTVN1PROD with NOTICES
69296, October 20, 1980, as amended
This meeting is also accessible by Webinar: Agenda items are subject to change as most recently at 80 FR 58479–58485,
December 15, 2015 priorities dictate.
dated September 29, 2015) is amended
Contact Person for More Information:
For Participants:
Margie Scott-Cseh, Centers for Disease to reflect the reorganization of the
URL: https://www.mymeetings.com/nc/join/ Control and Prevention, 1600 Clifton Road National Center for Immunization and
Conference number: PW1126536 NE., M/S E–07, Atlanta, Georgia 30333, Respiratory Diseases, and the Office of
Audience passcode: 6816256 telephone (404) 639–8317 Email: zkr7@ Infectious Diseases, Centers for Disease
Participants can join the event directly at: cdc.gov. Control and Prevention.
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Document Created: 2015-12-14 14:00:24
Document Modified: 2015-12-14 14:00:24
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice with comment period. | |
| Dates | Written comments must be received on or before January 19, 2016. | |
| 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] | |
| FR Citation | 80 FR 71802 |
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