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Code of Federal Regulations (Last Updated: July 5, 2024) |
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Title 42 - Public Health |
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Chapter IV—Centers for Medicare & Medicaid Services, Department of Health and Human Services |
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SubChapter G—Standards and Certification |
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Part 493 - Laboratory Requirements |
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Subpart F - General Administration |
§ 493.639 - Fees for revised and replacement certificates.
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§ 493.639 Fee Fees for revised certificate.
and replacement certificates.
(a) If, after a laboratory is issued a registration certificate, it changes its name or locationrequests a revised certificate, the laboratory must pay a fee to cover the cost of issuing a revised registration certificate. The fee for the a revised registration certificate is based on the cost to issue the revised certificate to the laboratory.
(b) A laboratory must pay a fee to cover the cost of issuing a revised certificate in any of the following circumstances:
(2) A(1) The fee for issuing an appropriate revised certificate is based on the cost to issue the revised certificate to the laboratory as follows:
(i) If a laboratory with a certificate of waiver wishes to perform tests in addition to those listed in § 493.15(c) as waived tests, it must, as set forth in § 493.638, pay an additional fee for the appropriate certificate to cover the additional testing.
(ii) If a laboratory with a certificate for PPM procedures wishes to perform tests in addition to those specified as PPM procedures or listed in § 493.15(c) as waived tests, it must, as set forth in § 493.638, pay an additional fee for the appropriate certificate to cover the additional testing.
The fee must be paid in full before the revised certificate will be issued.
(1) If laboratory services are added to a certificate of compliance, the laboratory must pay an additional fee if required under § 493.643(d)(2).
(2) [Reserved]
[57 FR 7213, Feb. 28, 1992, as amended at 60 FR 20047, Apr. 24, 1995(b) If, after a laboratory is issued a certificate, it requests a replacement certificate, the laboratory must pay a fee to cover the cost of issuing a
revised certificate when—(i) A laboratory changes its name, location, or its director; or
(ii) A laboratory deletes services or wishes to add services and requests that its certificate be changed. (An additional fee is also required under § 493.643(d) if it is necessary to determine compliance with additional requirements.)
replacement certificate. The fee for a replacement certificate is based on the cost of issuing the replacement certificate to the laboratory. The fee must be paid in full before issuing the replacement certificate.
[88 FR 90036, Dec. 28, 2023]