Page:United States Statutes at Large Volume 106 Part 4.djvu/414

 106 STAT. 3150 PUBLIC LAW 102-493—OCT. 24, 1992 42 USC 263a-3. SEC. 4. ACCREDITATION ORGANIZATIONS. (a) APPROVAL OF ACCREDITATION ORGANIZATIONS.—Not later than 2 years after the date of the enactment of this Act 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 3 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 tmder 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 3(h). (c) EVALUATIONS. — The Secretary shall evaluate annually the gerformance of each accreditation organization approved by the ecretary by— (1) inspecting under section 3(i) a sufficient number of embryo laboratories accredited by such an organization to allow a reasonable estimate of the peiformance of such organization, and (2) such other means as the Secretary determines to be appropriate. (d) TRANSITION.— If the Secretary revokes approval under section 3(i)(3)(D) 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. 42 USC 263a-4. SEC. 6. CERTIFICATION REVOCATION AND SUSPENSION. (a) IN GENERAL.— ^A certification issued by a State or an accreditation organization for an embryo laboratory shall be revoked or suspended if the State or organization finds, on the basis of inspections and sifter reasonable notice and opportunity for hearing to the owner or operator of the laboratory, that the owner or operator or any employee of the laboratory— (1) has been guilty of misrepresentation in obtaining the certification, (2) has failed to comply with any standards under section 3 applicable to the certification, or (3) has refused a request of the State or accreditation organization for permission to inspect the laboratory, its operations, and records. (b) EFFECT. —If the certification of an embryo laboratory is revoked or suspended, the certification of the laboratory shall con-

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