---
kind: "section"
citation: "42 U.S.C. § 263a–3"
title: "42"
title_heading: "The Public Health and Welfare"
number: "263a–3"
heading: "Accreditation organizations"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/42/263a-3"
units:
  - "Chapter 6A — Public Health Service"
  - "Subchapter II — General Powers and Duties"
  - "Part F — Licensing of Biological Products and Clinical Laboratories"
  - "Subpart 2 — clinical laboratories"
---

# §263a–3. Accreditation organizations

- (a) **Approval of accreditation organizations—** Not later than 2 years after October 24, 1992, the [Secretary](/usc/42/201.md?p=c), through the Centers for Disease Control, shall promulgate criteria and procedures for the approval of accreditation organizations to inspect and certify [embryo laboratories](/usc/42/263a–7.md?p=2). The procedures shall require an application to the [Secretary](/usc/42/201.md?p=c) by an accreditation organization for approval. An accreditation organization which has received such an approval—
  - (1) may be used by [States](/usc/42/201.md?p=f) in the certification [program](/usc/42/274l–1.md?p=4) under [section 263a–2 of this title](/usc/42/263a–2.md) to inspect and certify [embryo laboratories](/usc/42/263a–7.md?p=2), or
  - (2) may certify [embryo laboratories](/usc/42/263a–7.md?p=2) in [States](/usc/42/201.md?p=f) which have not adopted such a certification [program](/usc/42/274l–1.md?p=4).
- (b) **Criteria and procedures—** The criteria and procedures promulgated under [subsection (a)](#a) shall include—
  - (1) requirements for submission of such reports and the maintenance of such records as the [Secretary](/usc/42/201.md?p=c) or a [State](/usc/42/201.md?p=f) may require, and
  - (2) requirements for the conduct of inspections under [section 263a–2(h)](/usc/42/263a–2.md?p=h)[^1] of this title.
- (c) **Evaluations—** The [Secretary](/usc/42/201.md?p=c) shall evaluate annually the performance of each accreditation organization approved by the [Secretary](/usc/42/201.md?p=c) by—
  - (1) inspecting under [section 263a–2(i)](/usc/42/263a–2.md?p=i)[^2] of this title a sufficient number of [embryo laboratories](/usc/42/263a–7.md?p=2) accredited by such an organization to allow a reasonable estimate of the performance of such organization, and
  - (2) such other means as the [Secretary](/usc/42/201.md?p=c) determines to be appropriate.
- (d) **Transition—** If the [Secretary](/usc/42/201.md?p=c) revokes approval under [section 263a–2(i)(3)(D)](/usc/42/263a–2.md)[^3] of this title of an accreditation organization after an evaluation under [subsection (c)](#c), the certification of any [embryo laboratory](/usc/42/263a–7.md?p=2) accredited by the organization shall continue in effect for 60 days after the laboratory is notified by the [Secretary](/usc/42/201.md?p=c) of the withdrawal of approval, except that the [Secretary](/usc/42/201.md?p=c) may extend the period during which the certification shall remain in effect if the [Secretary](/usc/42/201.md?p=c) determines that the laboratory submitted an application to another approved accreditation organization for certification after receipt of such notice in a timely manner.

## Footnotes

[^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 credit

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

## Notes

### 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.