{"abstract":"Regulations at 42 CFR 493.15 and 493.17, implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA), Pub. L. 100- 578 (codified at 42 U.S.C. 263a), require that the Secretary provide for the categorization of specific laboratory test systems, assays, and examinations by level of complexity. The criteria for such categorizations also are set forth in those regulations. This Notice announces the addition of approximately 5,700 test systems, assays, and examinations that have been categorized with categorization notification to manufacturers between January 1, 1997 and September 3, 1999. These categorizations were effective on the issue date of the notification letter sent to the manufacturer. CDC invites comments on the tests initially categorized in this Notice and reserves the right to reevaluate and recategorize tests based on the comments received in response to this Notice. CDC, The Food and Drug Administration (FDA) and the Health Care Financing Administration have agreed to the transfer of the test categorization responsibility to the FDA, and the transfer is in process. When the transfer is completed, manufacturers will be able to submit premarket applications for products and requests for complexity categorization of these products under CLIA to one agency. FDA is expected to assume test categorization responsibilities on or about January 31, 2000. Until FDA assumes responsibility for test categorization, CDC will continue to perform complexity determinations and categorization requests should be sent to the CDC.","action":"Notice with comment period.","agencies":[{"raw_name":"Notice of Specific List for Categorization of Laboratory Test Systems,"},{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Disease Control and Prevention","name":"Centers for Disease Control and Prevention","id":44,"url":"https://www.federalregister.gov/agencies/centers-for-disease-control-and-prevention","json_url":"https://www.federalregister.gov/api/v1/agencies/44","parent_id":221,"slug":"centers-for-disease-control-and-prevention"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/1999/09/23/99-24638.html","cfr_references":[],"citation":"64 FR 51590","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":null,"disposition_notes":null,"docket_ids":[],"dockets":[],"document_number":"99-24638","effective_on":null,"end_page":51654,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":null,"html_url":"https://www.federalregister.gov/documents/1999/09/23/99-24638/notice-of-specific-list-for-categorization-of-laboratory-test-systems-assays-and-examinations-by","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/99-24638?publication_date=1999-09-23","mods_url":"https://www.govinfo.gov/metadata/granule/FR-1999-09-23/99-24638/mods.xml","not_received_for_publication":null,"page_length":65,"page_views":{"count":365,"last_updated":"2026-04-04 14:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-1999-09-23/pdf/99-24638.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"1999-09-23","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/1999/09/23/99-24638.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2011-09-21T10:07:31Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":51590,"subtype":null,"title":"Notice of Specific List for Categorization of Laboratory Test Systems, Assays, and Examinations by Complexity","toc_doc":null,"toc_subject":null,"topics":[],"type":"Notice","volume":64}