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Title 42 Part 493 → Subpart F → §493.639

Title 42 → Chapter IV → Subchapter G → Part 493 → Subpart F → §493.639

Electronic Code of Federal Regulations e-CFR

Title 42 Part 493 → Subpart F → §493.639

e-CFR data is current as of January 16, 2020

Title 42Chapter IVSubchapter GPart 493Subpart F → §493.639


Title 42: Public Health
PART 493—LABORATORY REQUIREMENTS
Subpart F—General Administration


§493.639   Fee for revised certificate.

(a) If, after a laboratory is issued a registration certificate, it changes its name or location, the laboratory must pay a fee to cover the cost of issuing a revised registration certificate. The fee for the 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:

(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.

(2) A 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.)

[57 FR 7213, Feb. 28, 1992, as amended at 60 FR 20047, Apr. 24, 1995]