View all text of Subpart 2 [§ 263a - § 263a-7]

§ 263a–3.
Accreditation organizations
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.
Criteria and procedures
The criteria and procedures promulgated under subsection (a) 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
1 So in original. Probably should be section “263a–2(g)”.
of this title.
The Secretary shall evaluate annually the performance of each accreditation organization approved by the Secretary by—
(1) inspecting under section 263a–2(i) 2
2 So in original. Probably should be section “263a–2(h)”.
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.

If the Secretary revokes approval under section 263a–2(i)(3)(D) 3

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