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At least 793 records · Page 44Linked to original sources
PubMed1997

Site registration fee schedule and related matters for facilities transferring or receiving select agents--CDC. Notice.

The Centers for Disease Control and Prevention is announcing its site registration fee schedule for facilities registered under 42 CFR 72.6. This notice includes the total fee for facilities in three categories, small, medium, and large. The fee is broken down into subtotals that illustrate how the agency derived the total fee. In return for the fee, the facility receives a 3 year site registration and is subject to inspection during that time period. Also included in this notice is clarification of the exemption of certain toxins, as well as clarification of biosafety levels for certain viruses in the regulation.

Centers for Disease Control and Prevention, U.S.↗
PubMed1997

Notice of specific list for categorization of laboratory test systems, assays, and examinations by complexity--CDC. Notice with comment period.

Regulations codified at 42 CFR 493.17, implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA), Public Law 100-578, 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 1,300 test systems, assays, and examinations that have been categorized and notified between June 7, 1996 and December 31, 1996. These categorizations were effective on the issue date of the notification letter sent to the manufacturer and are subject to the 30 day comment period for this Notice.

Centers for Disease Control and Prevention, U.S.↗
PubMed1997

Medicare, Medicaid, and CLIA programs; clinical laboratory requirements--extension of certain effective dates for clinical laboratory requirements under CLIA--CDC, HCFA. Final rule with comment period.

This final rule extends certain effective dates for clinical laboratory requirements in regulations published on February 28, 1992, and subsequently revised December 6, 1994, that implemented provisions of the Clinical Laboratory Improvement Amendments of 1988 (CLIA). This rule extends the phase-in date of the quality control requirements applicable to moderate and high complexity tests and extends the date by which an individual with a doctoral degree must possess board certification to qualify as a director of a laboratory that performs high complexity testing. These effective dates are extended to allow the Department additional time to issue revised quality control requirements and to ensure laboratory directors are able to complete certification requirements. These effective date extensions do not reduce the current requirements for quality test performance.

Centers for Disease Control and Prevention, U.S.↗