90 FR 152 pgs. 38652-38654 - Proposed Data Collection Submitted for Public Comment and Recommendations
Type: NOTICEVolume: 90Number: 152Pages: 38652 - 38654
Pages: 38652, 38653, 38654Docket number: [60Day-25-0850; Docket No. CDC-2025-0255]
FR document: [FR Doc. 2025-15215 Filed 8-8-25; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Centers for Disease Control and Prevention
Official PDF Version: PDF Version
[top]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-25-0850; Docket No. CDC-2025-0255]
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 to take this 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 Laboratory Response Network. This collection will allow CDC to continue to track laboratory testing capacity, capability, and distribution to ensure all areas of the nation are protected during a public health emergency response.
DATES:
CDC must receive written comments on or before October 10, 2025.
ADDRESSES:
You may submit comments, identified by Docket No. CDC-2025-0255 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.
[top]
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
Laboratory Response Network (OMB Control No. 0920-0850, Exp. 4/30/2026)-Revision-Office of Laboratory Systems and Response (OLSR), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
The Laboratory Response Network (LRN) was established by the Department of Health and Human Services (HHS), Centers for Disease Control and Prevention (CDC) in accordance with Presidential Decision Directive 39, which outlined national anti-terrorism policies and assigned specific missions to federal departments and agencies. The LRN's mission is to maintain an integrated national and international network of laboratories that can respond to suspected biological, chemical, or radiological threats and other public health emergencies. To ensure fulfillment of that mission, CDC collects data from the LRN member laboratories related to laboratory capability, capacity, and distribution as well as laboratory test results.
Upon volunteering to join the LRN, laboratories are required to submit qualification information to the LRN Program Office at CDC, to include first and last names, work addresses, work email addresses, work phone numbers, and alternative phone numbers of personnel trained in LRN procedures. This information is needed to contact laboratory personnel in the case of a public health emergency, to ship reagents, test kits, or supplies, and determine laboratory testing capacity. Laboratories are also required to provide additional qualification information related to testing capability and capacity including available testing equipment, safety equipment, facilities, reagents, test kits, and validated tests. This information is used by CDC to ensure that laboratory testing capability is distributed across the country and the network has adequate testing capacity to provide adequate public health emergency response. Qualification information is collected in the LRN Secure Information Hub (SIH) accessed through the CDC Secure Access Management System (SAMS). Laboratories are required to update their capability and capacity information whenever changes occur such as personnel changes, the addition of new tests, or the addition of new equipment. For laboratories that hold United States Department of Agriculture (USDA) or Select Agent permits, copies of the permits are also collected. This information is used to inform CDC of additional laboratory capability. These permits are not required for LRN membership.
LRN laboratories are also required to report certain laboratory test results to CDC as described below. The test results include details about the type and source of samples as well as the tests performed, results obtained, and conclusions. CDC collects test results related to validation studies and proficiency testing to verify that laboratories continue to properly perform the tests they have validated. CDC collects test data related to emergency response exercises to verify laboratory performance in a simulated emergency response situation. CDC collects test results related to routine testing of known biological and chemical threat agents. These results are used to monitor emerging threat situations. CDC also collects test results for samples analyzed during a public health threat response to monitor threat levels and determine procurement, allocation, and distribution of response resources.
Laboratory test results are reported to CDC using either a CSV file upload into a cloud-based web page (DataLink) or using their laboratory information management system (LIMS) to send an electronic Health Level Seven (HL7) message. DataLink is accessed by the LRN laboratories through SAMS and can be rapidly modified for a new or emerging threat, with the burden of maintenance removed from the member laboratory.
[top] There have been some improvements to the LRN SIH: The LRN SIH migrated to CDC Secure Access Management Services (SAMS) servers to provide a more secured login and user authentication. A new CDC template was implemented to support 508 compliance and responsive designs. Additionally, there is a decrease in the estimated burden from 422,716 to 59,024 annual hours. This decrease in burden is due to several factors. Burden has been reduced by the continued expansion of LRN laboratories implementing HL7 reporting and decreasing the need for manual entry to Results Messenger. The number of data elements collected for the LRN Data Exchange has also been reduced. Numerical test results ( e.g., Ct values) or a sample conclusion are no longer collected. Burden was further reduced by reevaluating the burden calculation based upon requirements LRN places upon the member laboratories versus the requirements of the Clinical Laboratory Improvement Amendments (CLIA) regulations and other quality management programs place upon the laboratories. In the instance of proficiency tests and challenge panels, the analysis of these samples is required by CLIA and/or other quality management systems implemented locally. Therefore, the only burden the LRN is placing on the laboratory is the
This data collection is vital to the continued support of the national public health system in its efforts to respond to chemical and biological threats. The state, local, and federal public health laboratories participating in this program generate the data in this collection as part of their individual emergency response duties. By merging this data into a single collection, a local perspective of an emerging threat becomes a broader national perspective with greater depth and detail for more efficient and effective decision making. There is no cost to respondents other than their time to participate.
Estimated Annualized Burden Hours
| Respondent type | Form | Number of responders | Average number of responses per responder | Average burden per response (hours) | Total burden hours |
|---|---|---|---|---|---|
| Public Health Laboratories | Laboratory Qualification | 136 | 1 | 2 | 272 |
| Routine Testing Results | 136 | 25 | 0.5 | 1,700 | |
| Challenge Panel/Validation Testing Results | 136 | 2 | 12 | 3,264 | |
| Public Health Surge Response Testing Results | 136 | 625 | 0.5 | 42,500 | |
| Proficiency Testing/Characterization Results (LRN-C) | 44 | 35 | 2 | 3,080 | |
| Surge Event Testing Results/Exercises (LRN-C: SPaSE, Surge, ERE) | 57 | 6 | 24 | 8,208 | |
| Total | 59,024 |
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. 2025-15215 Filed 8-8-25; 8:45 am]
BILLING CODE 4163-18-P