51590 Federal Register / Vol. 64, No. 184 / Thursday, September 23, 1999 / Notices DEPARTMENT OF HEALTH AND 1999. CDC reserves the right to required for waiver approval must be HUMAN SERVICES reevaluate and recategorize tests based incorporated into those existing test on the comments received in response systems for use of such test systems to Centers for Disease Control and to this Notice. be considered waived. (Pending such Prevention ADDRESSES: Comments on the modifications, the particular test system categorization of tests in this Notice already in use by a laboratory will retain Notice of Specific List for should be addressed to CLIA Federal its prior test categorization.) Categorization of Laboratory Test Register Notice, Centers for Disease Systems, Assays, and Examinations Waived Tests Marketed Under Control and Prevention, Public Health by Complexity Alternate Product Names Practice Program Office, Mail Stop F± Frequently, products which have been AGENCY: Centers for Disease Control and 11, 4770 Buford Highway, NE, Atlanta, granted waived status are later Prevention (CDC),Department of Health Georgia 30341±3724. repackaged and marketed under and Human Services (HHS). Requests for test complexity alternate product names. In these cases, ACTION: Notice with comment period. categorization should be submitted to: Attention: Test Categorization/CLIA, it is the responsibility of the SUMMARY: Regulations at 42 CFR 493.15 Centers for Disease Control and manufacturer to notify CDC and to send and 493.17, implementing the Clinical Prevention, Public Health Practice the package insert demonstrating the Laboratory Improvement Amendments Program Office, Mail Stop F±11, 4770 new labeling along with all sets of of 1988 (CLIA), Pub. L. 100±578 Buford Highway, NE, Atlanta, Georgia instructions that apply (e.g., if separate (codified at 42 U.S.C. 263a), require that 30341±3724. instructions for home use and for the Secretary provide for the Requests for waiver status should be professional use exist, send a copy of categorization of specific laboratory test submitted to: Attention: Request for both sets of instructions). Even though systems, assays, and examinations by Waiver Status/CLIA, Centers for Disease a test may be waived under one product level of complexity. The criteria for Control and Prevention, Public Health name, it is not considered waived under such categorizations also are set forth in Practice Program Office, Mail Stop F± an alternate name until it is reviewed by those regulations. 11, 4770 Buford Highway, NE, Atlanta, CDC and the manufacturer is notified of This Notice announces the addition of GA 30341±3724. the waived status. approximately 5,700 test systems, Due to staffing and resource Comments and Responses assays, and examinations that have been limitations, we cannot accept facsimile On April 11, 1997, a test list of categorized with categorization (FAX) copies of comments. Nor can we approximately 1,300 additional test notification to manufacturers between accept comments by telephone. systems, assays, and examinations January 1, 1997 and September 3, 1999. FOR FURTHER INFORMATION CONTACT: categorized by level of complexity was These categorizations were effective on Sharon Granade, (770) 488±8155. published in the Federal Register (62 the issue date of the notification letter SUPPLEMENTARY INFORMATION: All FR 17832) with a 30 day comment sent to the manufacturer. CDC invites requests for test categorization should period. CDC received no comment comments on the tests initially be submitted to CDC. Manufacturers are letters in regard to this Notice. categorized in this Notice and reserves requested to submit the package insert the right to reevaluate and recategorize and/or an Operator's Manual along with Analyte Clarification tests based on the comments received in the 510(k) or Pre-Market Approval A new analyte name, ``D-Dimer'' response to this Notice. (PMA) number for the product, if (Analyte code 1320), was created for the CDC, The Food and Drug applicable, to CDC when requesting measurement of this specific fibrin Administration (FDA) and the Health categorization. Although some products degradation product. Test systems Care Financing Administration have may now be exempt from FDA's 510(k) measuring D-Dimer, but previously agreed to the transfer of the test review process, they continue to need categorized under the broader analyte categorization responsibility to the FDA, evaluation for complexity categorization name (1904) Fibrin(ogen) Split/ and the transfer is in process. When the under CLIA. For products undergoing Degradation Products (FSP/FDP), are transfer is completed, manufacturers the 510(k) or PMA review process, CDC now listed under the new analyte name. will be able to submit premarket will not be able to issue the test The analyte name Fibrin(ogen) Split/ applications for products and requests categorization until the FDA has Degradation Products (FSP/FDP) will for complexity categorization of these completed its review process and has continue to be used for measurements products under CLIA to one agency. notified CDC of the clearance date. Test not specific to a particular degradation FDA is expected to assume test categorizations are effective as of the product. categorization responsibilities on or date of notification by CDC to the The analyte (5828) Streptococcus, about January 31, 2000. Until FDA applicant. Updates and revisions to the group A (from throat only) was deleted assumes responsibility for test CLIA test categorization list are and the test systems categorized for this categorization, CDC will continue to periodically published in the Federal analyte are now listed under the analyte perform complexity determinations and Register with an opportunity for public (5810) Streptococcus, group A. The test categorization requests should be sent to comment. CDC also maintains an system qualifier ``Direct Antigen/ the CDC. electronic list of categorized tests which Visual'', associated with this analyte, DATES: Effective date: All is available via the Internet (http:// was replaced with ``Direct from throat categorizations in this Notice were www.phppo.cdc.gov/DLS/clia/ swab.'' effective on the date of the test testcat.asp). For consistency with the listing of categorization notification letter sent to other autoantibodies, the analyte (6135) the manufacturer. Written comments on Effect of Waiver on Tests Already in Thyroid Peroxidase Autoantibodies the tests initially categorized in this Use (TPO) was replaced with (0527) Anti- Notice will be considered if they are For test systems in use prior to waiver Thyroid Peroxidase (TPO) Antibodies. received at the address indicated below, approval, any modifications to the The analyte (0708) ``Blood gases with by no later than 5 p.m. on October 25, device or instructions that were pH'' was modified to accommodate the VerDate 18-JUN-99 13:25 Sep 22, 1999 Jkt 183247 PO 00000 Frm 00002 Fmt 4701 Sfmt 4703 E:\FR\FM\A23SE3.002 pfrm01 PsN: 23SEN2 Federal Register / Vol. 64, No. 184 / Thursday, September 23, 1999 / Notices 51591 technological advances that allow direct From (6148) T11/B4 positive Orion Diagnostica Dentocult LB measurement of analytes that previously Lymphocytes to (3773) Lymphocytes, Culture Paddles (46299) were calculated. The analyte code CD2/CD19; ANALYTE: Clostridium difficile (1022) (0708) now refers to the analyte name From (6151) T4/T8 positive ``Blood gases'' and the analytes for pH, Lymphocytes to (3774) Lymphocytes, Test System, Assay, Examination: pCO2, and pO2 were assigned CD4/CD8. Becton Dickinson ColorPAC Toxin A Test (direct Ag/visual) (08170) individual analyte codes: (4982) pH, Manufacturer Listing (4983) pCO2, (4984) pO2. To avoid Biosite Triage Clostridium difficile confusion, the analyte (0731) All Body For data entry reasons, the Panel (08111) manufacturer Reference Diagnostics, Fluids (other than blood) pH was ANALYTE: Escherichia coli (1604) deleted, and the test system (04542) All Inc. is now denoted in the Test Qualitative Dipstick Color Comparison Categorization list as RDI and the Test System, Assay, Examination: pH Testing, categorized under the manufacturer International Technidyne Universal HealthWatch Quix Rapid E. deleted analyte, was reassigned to the Corp. is denoted as ITC. coli 0157 Strip Test (64043) new analyte (4982) pH. Correction ANALYTE: Gardnerella vaginalis (2212) For clarity and consistency and to Due to a data entry error, an incorrect reflect current nomenclature, the Test System, Assay, Examination: categorization for the analyte (6404) following analyte names and codes were Becton Dickinson Affirm VPIII Uric Acid on the test system (04036) changed: Microbial Identification Test Abbott Bichromatic ABA 200 was (07852) From (0735) B1 positive Lymphocytes to published as moderate complexity in Litmus Concepts Indicard Test (from (3758) Lymphocytes, CD20; the April 11, 1997 Federal Register (62 vaginal swab) (37110) From (0736) B4 positive Lymphocytes to FR 17832). The correct categorization (3759) Lymphocytes, CD19; for Uric Acid on this instrument is high ANALYTE: Helicobacter pylori (2512) From (1111) CD3(IgG1)positive complexity. Test System, Assay, Examination: Lymphocytes, (1110) CD3 positive Medical Instruments Pronto Dry Lymphocytes, and (6149) T3 positive Dated: September 16, 1999. Joseph R. Carter, (40331) Lymphocytes to (3760) Lymphocytes, Remel Selective Rapid Urea (55238) CD3; Associate Director for Management and From (1116) CD4 positive Lymphocytes Operations,