
From the U.S. Code Online via GPO Access
[wais.access.gpo.gov]
[Laws in effect as of January 23, 2000]
[Document not affected by Public Laws enacted between
  January 23, 2000 and December 4, 2001]
[CITE: 42USC263a-3]

 
                 TITLE 42--THE PUBLIC HEALTH AND WELFARE
 
                    CHAPTER 6A--PUBLIC HEALTH SERVICE
 
                SUBCHAPTER II--GENERAL POWERS AND DUTIES
 
   Part F--Licensing of Biological Products and Clinical Laboratories
 
                    subpart 2--clinical laboratories
 
Sec. 263a-3. Accreditation organizations


(a) 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.

(b) Criteria and procedures

    The criteria and procedures promulgated under subsection (a) of this 
section 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\ of this title.
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    \1\ So in original. Probably should be section ``263a-2(g)''.
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(c) Evaluations

    The Secretary shall evaluate annually the performance of each 
accreditation organization approved by the Secretary by--
        (1) 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
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    \2\ So in original. Probably should be section ``263a-2(h)''.
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        (2) such other means as the Secretary determines to be 
    appropriate.

(d) Transition

    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) of this section, 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.
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    \3\ So in original. Probably should be section ``263a-2(h)(3)(D)''.
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(Pub. L. 102-493, Sec. 4, Oct. 24, 1992, 106 Stat. 3150.)

                          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.

                         Change of Name

    Centers for Disease Control changed to Centers for Disease Control 
and Prevention by Pub. L. 102-531, title III, Sec. 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.

                  Section Referred to in Other Sections

    This section is referred to in sections 263a-2, 263a-5, 263a-6, 
263a-7 of this title.
