federal_register: 00-11093
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
This data as json
| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 00-11093 | Notice of Intent; Genetic Testing Under the Clinical Laboratory Improvement Amendments | Notice | The Centers for Disease Control and Prevention (CDC) acts as a scientific advisor to the Health Care Financing Administration (HCFA) in development of requirements for clinical laboratories under the Clinical Laboratory Improvement Amendments (CLIA). The CDC is issuing this notice to advise the public that the Department of Health and Human Services (HHS) will be preparing a Notice of Proposed Rule Making (NPRM) to revise the CLIA regulations applicable to laboratories performing human genetic testing. Before issuing the NPRM, comments are being solicited on the recommendations of the Clinical Laboratory Improvement Advisory Committee (CLIAC) to change current CLIA requirements to specifically recognize a genetic testing specialty. This new speciality area will address unique testing issues in the pre- analytic, analytic, and post-analytic phases of testing that could affect the accuracy and reliability of test results, and related issues such as informed consent, confidentiality, counseling, and the clinical appropriateness of a genetic test. To ensure that a full range of issues relating to this proposed action are addressed and potential impacts are identified, comments and suggestions are invited from all interested parties. Comments or questions regarding this proposed action should be directed to CDC at the address below. The Department has also established a Secretary's Advisory Committee on Genetic Testing (SACGT) to advise the Department on the medical, scientific, ethical, legal, and social issues raised by the development and use of genetic testing. The SACGT is currently addressing, in consultation with the public, broad questions related to the adequacy of oversight of genetic testing. If, after public consultation and analysis, SACGT finds that further oversight measures are warranted, it will recommend options for such oversight. The public comment for the SACGT issues is being conducted separately (See the December 1, 1999 Federal Register, 64 FR 67273). The reason for independent solicitations is that the SACGT is addressing more general aspects of genetic testing, such as the criteria that should be used to assess the benefits and risks of genetic tests. That purpose differs from this solicitation that deals specifically with the application of CLIA to genetic laboratory testing. The two requests for public comments thus solicit complementary information: the SACGT comments will guide development of recommendations to the Secretary on policy and oversight issues, whereas comments on the CLIAC recommendations will guide development of appropriate genetic testing laboratory requirements for revision of the CLIA regulations. | 2000-05-04 | 2000 | 5 | https://www.federalregister.gov/documents/2000/05/04/00-11093/notice-of-intent-genetic-testing-under-the-clinical-laboratory-improvement-amendments | https://www.govinfo.gov/content/pkg/FR-2000-05-04/pdf/00-11093.pdf | Health and Human Services Department; Centers for Disease Control and Prevention | 221,44 | The Centers for Disease Control and Prevention (CDC) acts as a scientific advisor to the Health Care Financing Administration (HCFA) in development of requirements for clinical laboratories under the Clinical Laboratory Improvement Amendments (CLIA).... |