90 FR 114 pgs. 25295-25296 - Proposed Data Collection Submitted for Public Comment and Recommendations
Type: NOTICEVolume: 90Number: 114Pages: 25295 - 25296
Pages: 25295, 25296Docket number: [60Day-25-0600; Docket No. CDC-2025-0015]
FR document: [FR Doc. 2025-10860 Filed 6-13-25; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Centers for Disease Control and Prevention
Official PDF Version: PDF Version
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-25-0600; Docket No. CDC-2025-0015]
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 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 continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled, CDC Model Performance Evaluation Program (MPEP) for Mycobacterium tuberculosis Drug Susceptibility Testing. CDC is requesting a three-year approval for extension of the currently approved project used to monitor and evaluate performances and practices among national laboratories' M. tuberculosis susceptibility testing.
DATES:
CDC must receive written comments on or before August 15, 2025.
ADDRESSES:
You may submit comments, identified by Docket No. CDC-2025-0015 by either of the following methods:
• Federal eRulemaking Portal: www.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 H21-8, Atlanta, Georgia 30329.
Instructions: All submissions received must include the agency name and Docket Number. CDC will post, without change, all relevant comments to www.regulations.gov.
Please note: Submit all comments through the Federal eRulemaking portal ( www.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 H21-8, Atlanta, Georgia 30329; Telephone: 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 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;
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; and
5. Assess information collection costs.
Proposed Project
CDC Model Performance Evaluation Program (MPEP) for Mycobacterium tuberculosis Drug Susceptibility Testing (OMB Control No. 0920-0600, Exp. 9/30/2025)-Extension-National Center for HIV, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
The CDC is requesting an Extension of a currently approved information collection request (ICR) titled CDC Model Performance Evaluation Program (MPEP) for Mycobacterium tuberculosis (TB) Drug Susceptibility Testing for a period of three years. The Extension submitted for this ICR will not require changes in the scope of the project.
As part of the Extension, CDC is requesting a non-substantive change to the title of the data collection to CDC Model Performance Evaluation (MPEP) for Mycobacterium tuberculosis Drug Susceptibility Testing to reflect that nontuberculous mycobacteria are no longer included in the program.
[top] While the overall number of cases of TB in the U.S. has remained fairly stable, rates still remain high among foreign-born persons, persons in correctional facilities, 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 U.S. laboratories performing M. tuberculosis susceptibility testing. Participation in this program is one way
Providing an evaluation program to assess the ability of laboratories to test for drug resistant M. tuberculosis strains, gives laboratories 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 inform continuous program improvement related to good performance, training needs, and the development of practice standards. 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) isolates. The PE isolates are sent to participating laboratories twice a year. Participants also report laboratory demographic data such as laboratory type and the number of drug susceptibility tests performed annually.
Over the past three years, six final MPEP reports have been distributed and published with an average of 58 participants per MPEP isolate shipment. All state public health laboratories that perform Mycobacterium tuberculosis drug susceptibility testing participated in MPEP, along with approximately seven hospital, seven independent/reference, and two federal laboratories; these participating laboratories represent geographical and laboratory type variation. Drug susceptibility testing results met consensus for 73% or 22 isolates of the six panels with five isolates each (30) for first-line drugs, highlighting challenges that laboratories experience with current testing practices and methods. MPEP continues to select isolates with both common and challenging resistance patterns for educational value.
CDC is requesting approval for 113 burden hours, a reduction of 16 burden hours due to the reduction in the number of respondents. There is no cost to respondents to participate other than their time.
| Type of respondent | Form name | Number of respondents | Number of responses per respondent | Average burden per response (hours) | Total burden (hours) |
|---|---|---|---|---|---|
| Domestic Laboratory | Participant Biosafety Compliance Agreement | 70 | 1 | 5/60 | 6 |
| MPEP Mycobacterium tuberculosis Results Worksheet | 70 | 2 | 30/60 | 70 | |
| Online Survey Instrument | 70 | 2 | 15/60 | 35 | |
| MPEP Mycobacterium tuberculosis Minimum Inhibitory Concentration (MIC) Results Form | 4 | 2 | 15/60 | 2 | |
| Total | 113 |
Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Public Health Ethics and Regulations, Office of Science, Centers for Disease Control and Prevention.
[FR Doc. 2025-10860 Filed 6-13-25; 8:45 am]
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