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Code · U.S. Code · Title 42 - THE PUBLIC HEALTH AND WELFARE · CHAPTER 6A— PUBLIC HEALTH SERVICE · Part F— Licensing of Biological Products and Clinical Laboratories · § 263a–3

§ 263a–3. Accreditation organizations

403 words·~2 min read·/usc/title-42/section-263a-3

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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— may be used by States in the certification program under section 263a–2 of this title to inspect and certify embryo laboratories, or may certify embryo laboratories in States which have not adopted such a certification program. The criteria and procedures promulgated under subsection
(a)shall include— requirements for submission of such reports and the maintenance of such records as the Secretary or a State may require, and requirements for the conduct of inspections under section 263a–2(h) 1 of this title. The Secretary shall evaluate annually the performance of each accreditation organization approved by the Secretary by— 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 such other means as the Secretary determines to be appropriate. 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), 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. ( Pub. L. 102–493, § 4 , Oct. 24, 1992 , 106 Stat. 3150 .)
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  • Pub. L. 102-493
  • 106 Stat. 3150
  • Pub. L. 102-531
  • 106 Stat. 3504
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cites case law
§ 263a–3
Accreditation organizations
Pub. L.Pub. L. 102-493
Stat.106 Stat. 3150
Pub. L.Pub. L. 102-531
Stat.106 Stat. 3504
Cites 4Cited by 0 across 0 sources
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