Proposed Collection; 30-Day Comment Request; NIH Information Collection Forms to Support the Genetic Testing Registry (OD)
Health and Human Services Department, National Institutes of Health
Key Details
- Posted Date
- Response Deadline
- NAICS Code
- 541715
- Source
- Federal Register
- Contract Type
- regulation
Description
DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; 30-Day Comment Request; NIH Information Collection Forms to Support the Genetic Testing Registry (OD) AGENCY: National Institutes of Health, HHS. ACTION: Notice. SUMMARY: In compliance with the requirement of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institutes of Health Office of the Director (OD) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. DATES: Comments regarding this information collection are best assured of having their full effect if received by July 30, 2026. ADDRESSES: Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting âCurrently under 30-day ReviewâOpen for Public Commentsâ or by using the search function. FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Dr. Ellen Wann, Acting Director, Division of Scientific Data Sharing Policy, Office of Science Policy, Office of the Director, NIH, 6705 Rockledge Dr., Suite 631, Bethesda, MD 20892, non-toll-free number (301) 496-9838; SciencePolicy@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing. SUPPLEMENTARY INFORMATION: Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires: written comments and/or suggestions from the public and affected agencies are invited to address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) 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) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimizes the burden of the collection of information from those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Proposed Collection Title: NIH Information Collection Forms to Support the Genetic Testing Registryâ0925-0651âExpiration Date January 31, 2025âREINSTATEMENT WITHOUT CHANGEâOffice of the Director (OD), National Institutes of Health (NIH). Need and Use of Information Collection: Clinical laboratory tests are available for more than 18,000 genetic conditions. The Genetic Testing Registry (GTR) provides a centralized, online location for test developers, manufacturers, and researchers to voluntarily submit detailed information about the availability and scientific basis of their genetic tests. The GTR is of value to clinicians by providing information about the accuracy, validity, and usefulness of genetic tests. The GTR also highlights evidence gaps where additional research is needed. The GTR also has tests for microbes like for SARS-CoV-2 to diagnose COVID-19. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 5,217 hours. Estimated Annualized Burden Hours Type of respondent Type of form Estimated annual number of respondents Number of responses per respondent Average time per response (in hours) Total annual burden hours Laboratory Personnel Using Bulk Submission (new tests) Minimal Fields 16 67 18/60 322 â Optional Fields 16 67 17/60 304 Laboratory Personnel Not Using Bulk Submission (new tests) Minimal Fields 51 67 30/60 1,709 â Optional Fields 47 67 29/60 1,522 Laboratory Personnel (updated tests) Annual Review 340 24 10/60 1,360 Total 470 16, 870 5,217 Dated: June 25, 2026. Matthew J. Memoli, Principal Deputy Director, National Institutes of Health. [FR Doc. 2026-13204 Filed 6-29-26; 8:45 am] BILLING CODE 4167-05-P
Key Dates
Frequently Asked Questions
Is this regulation still open?+
How do I apply for this regulation?+
Track This Regulation
Get alerts and track updates with Bureauify.
Track in BureauifyView on Federal RegisterIntelligence
- Win probability analysis
- Competitive landscape
- Incumbent analysis
- Price-to-win estimate
- Similar awards history
Data sourced from Federal Register