§263a–3 — Title 42 The Public Health and Welfare | U.S. Code

§263a–3 Accreditation organizations

Title 42 › Chapter CHAPTER 6A— - PUBLIC HEALTH SERVICE › Subchapter SUBCHAPTER II— - GENERAL POWERS AND DUTIES › Part Part F— - Licensing of Biological Products and Clinical Laboratories › Subpart subpart 2— - clinical laboratories › § 263a–3

Last updated Apr 6, 2026|Official source

Summary

Create rules, within 2 years after October 24, 1992, by the Secretary using the Centers for Disease Control, for approving groups that inspect and certify embryo laboratories. Those groups must apply for approval. Once approved, a group can be used by States in their lab-certification programs or can certify labs in States without such programs. The rules must say what reports and records are needed and how inspections must be carried out. The Secretary must check each approved group every year by inspecting enough of the labs they accredited to judge how well the group is doing, and by other ways the Secretary chooses. If the Secretary removes a group’s approval, labs it certified keep their certification for 60 days after they are told. The Secretary can extend that time if a lab promptly applies to another approved group after getting the notice.

Title 42, §263a–3

The Public Health and Welfare — Source: USLM XML via OLRC

(a)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)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) 11 So in original. Probably should be section “263a–2(g)”. of this title.

(c)The Secretary shall evaluate annually the performance of each accreditation organization approved by the Secretary by—

(1)inspecting under section 263a–2(i) 22 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.

(d)If the Secretary revokes approval under section 263a–2(i)(3)(D) 33 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.

Notes & Related Subsidiaries

Editorial Notes

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.

Statutory Notes and Related Subsidiaries

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 of Pub. L. 102–493, set out as a note under section 263a–1 of this title.