42 U.S. Code § 263a–3 - Accreditation organizations

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(a) Approval of accreditation organizations
Not later than 2 years after October 24, 1992, the Secretary, through the Centers for Disease Control, shall promulgate criteria and procedures for the approval of accreditation organizations to inspect and certify embryo laboratories. The procedures shall require an application to the Secretary by an accreditation organization for approval. An accreditation organization which has received such an approval—
(1) may be used by States in the certification program under section 263a–2 of this title to inspect and certify embryo laboratories, or
(2) may certify embryo laboratories in States which have not adopted such a certification program.
(b) Criteria and procedures
The criteria and procedures promulgated under subsection (a) of this section shall include—
(1) requirements for submission of such reports and the maintenance of such records as the Secretary or a State may require, and
(2) requirements for the conduct of inspections under section 263a–2 (h)  [1] of this title.
(c) Evaluations
The Secretary shall evaluate annually the performance of each accreditation organization approved by the Secretary by—
(1) inspecting under section 263a–2 (i)  [2] of this title a sufficient number of embryo laboratories accredited by such an organization to allow a reasonable estimate of the performance of such organization, and
(2) such other means as the Secretary determines to be appropriate.
(d) Transition
If the Secretary revokes approval under section 263a–2 (i)(3)(D)  [3] of this title of an accreditation organization after an evaluation under subsection (c) of this section, the certification of any embryo laboratory accredited by the organization shall continue in effect for 60 days after the laboratory is notified by the Secretary of the withdrawal of approval, except that the Secretary may extend the period during which the certification shall remain in effect if the Secretary determines that the laboratory submitted an application to another approved accreditation organization for certification after receipt of such notice in a timely manner.


[1]  So in original. Probably should be section “263a–2(g)”.

[2]  So in original. Probably should be section “263a–2(h)”.

[3]  So in original. Probably should be section “263a–2(h)(3)(D)”.

Source

(Pub. L. 102–493, § 4,Oct. 24, 1992, 106 Stat. 3150.)
Codification

Section was enacted as part of the Fertility Clinic Success Rate and Certification Act of 1992, and not as part of the Public Health Service Act which comprises this chapter.
Change of Name

Centers for Disease Control changed to Centers for Disease Control and Prevention by Pub. L. 102–531, title III, § 312,Oct. 27, 1992, 106 Stat. 3504.
Effective Date

Section effective upon expiration of 2 years after Oct. 24, 1992, see section 9 ofPub. L. 102–493, set out as a note under section 263a–1 of this title.

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21 CFR - Food and Drugs

21 CFR Part 4 - REGULATION OF COMBINATION PRODUCTS

21 CFR Part 210 - CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL

21 CFR Part 211 - CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS

21 CFR Part 600 - BIOLOGICAL PRODUCTS: GENERAL

21 CFR Part 606 - CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS

21 CFR Part 610 - GENERAL BIOLOGICAL PRODUCTS STANDARDS

21 CFR Part 660 - ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS

42 CFR - Public Health

42 CFR Part 416 - AMBULATORY SURGICAL SERVICES

42 CFR Part 418 - HOSPICE CARE

42 CFR Part 491 - CERTIFICATION OF CERTAIN HEALTH FACILITIES

42 CFR Part 493 - LABORATORY REQUIREMENTS

 

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