CFR > Title 42 - Public Health > CHAPTER IV—CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER G—STANDARDS AND CERTIFICATION (parts 482 to 498) > PART 493—LABORATORY REQUIREMENTS > SUBPART F—General Administration (§493.602 to §493.649) > 493.639—Fee for revised certificate.

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]