Federal Register #2026-13204

NIH Request for Comment on Genetic Testing Registry Information Collection

This notice from the National Institutes of Health (NIH), part of the Department of Health and Human Services, seeks public comment on a proposed information collection for the Genetic Testing Registry (GTR). - Government Buyer: - Department of Health and Human Services (HHS) - National Institutes of Health (NIH) - Purpose: - Collect information to support the Genetic Testing Registry (GTR), a centralized online resource for genetic test information - Registry covers clinical laboratory tests for over 18,000 genetic conditions and includes tests for microbes such as SARS-CoV-2 - Stakeholders: - Test developers, manufacturers, and researchers are invited to voluntarily submit detailed information about genetic tests - Scope of Information: - Includes test availability, scientific basis, accuracy, validity, and clinical usefulness - Aims to help clinicians assess genetic tests and identify evidence gaps for further research - Administrative Details: - No specific OEMs or vendors are named - No products or services are being procured; this is a request for information and comment - Estimated annualized burden for respondents is 5,217 hours - OMB approval is requested for a three-year period

Description

The National Institutes of Health Office of the Director (OD) is proposing a collection of information to support the Genetic Testing Registry (GTR). The GTR provides a centralized online location for test developers, manufacturers, and researchers to voluntarily submit detailed information about genetic tests, including their availability and scientific basis. This registry is valuable to clinicians by providing information about the accuracy, validity, and usefulness of genetic tests, and it also highlights evidence gaps where additional research is needed. The collection includes data on clinical laboratory tests for more than 18,000 genetic conditions and tests for microbes such as SARS-CoV-2. The proposed collection seeks public comment and requests approval from the Office of Management and Budget (OMB) for three years, with an estimated annual burden of 5,217 hours.

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