---
kind: "range"
citation: "42 U.S.C. §§ 263a–1–263a–7"
title: "42"
from: "263a–1"
to: "263a–7"
count: 7
release: "119-102"
url: "https://uscodex.org/usc/42/263a-1..263a-7"
---

# §263a–1. Assisted reproductive technology programs

- (a) **In general—** Effective 2 years after October 24, 1992, each [assisted reproductive technology](/usc/42/263a–7.md?p=1) (as defined in [section 263a–7](/usc/42/263a–7.md)[^1] of this title) [program](/usc/42/274l–1.md?p=4) shall annually report to the [Secretary](/usc/42/201.md?p=c) through the Centers for Disease Control—
  - (1) pregnancy success rates achieved by such [program](/usc/42/274l–1.md?p=4) through each [assisted reproductive technology](/usc/42/263a–7.md?p=1), and
  - (2) the identity of each [embryo laboratory](/usc/42/263a–7.md?p=2) (as defined in [section 263a–7](/usc/42/263a–7.md)[^1] of this title) used by such [program](/usc/42/274l–1.md?p=4) and whether the [laboratory](/usc/42/300jj.md?p=10) is certified under [section 263a–2 of this title](/usc/42/263a–2.md) or has applied for such certification.
- (b) **Pregnancy success rates—**
  - (1) **In general—** For purposes of [subsection (a)(1)](#a-1), the [Secretary](/usc/42/201.md?p=c) shall, in consultation with the organizations referenced in [subsection (c)](#c), define pregnancy success rates and shall make public any proposed definition in such manner as to facilitate comment from any [person](/usc/42/1320a–7k.md?p=d-4-C-i) (including any Federal or other [public agency](/usc/42/11851.md?p=8)) during its development.
  - (2) **Definition—** In developing the definition of pregnancy success rates, the [Secretary](/usc/42/201.md?p=c) shall take into account the effect on success rates of age, diagnosis, and other significant factors and shall include in such rates—
    - (A) the basic live birth rate calculated for each [assisted reproductive technology](/usc/42/263a–7.md?p=1) performed by an [assisted reproductive technology](/usc/42/263a–7.md?p=1) [program](/usc/42/274l–1.md?p=4) by dividing the number of pregnancies which result in live births by the number of ovarian stimulation procedures attempted by such [program](/usc/42/274l–1.md?p=4), and
    - (B) the live birth rate per successful oocyte retrieval procedure calculated for each [assisted reproductive technology](/usc/42/263a–7.md?p=1) performed by an [assisted reproductive technology](/usc/42/263a–7.md?p=1) [program](/usc/42/274l–1.md?p=4) by dividing the number of pregnancies which result in live births by the number of successful oocyte retrieval procedures performed by such [program](/usc/42/274l–1.md?p=4).
- (c) **Consultation—** In developing the definition under [subsection (b)](#b), the [Secretary](/usc/42/201.md?p=c) shall consult with appropriate consumer and professional organizations with expertise in using, providing, and evaluating professional [services](/usc/42/201.md?p=a) and [embryo laboratories](/usc/42/263a–7.md?p=2) associated with [assisted reproductive technologies](/usc/42/263a–7.md?p=1).

# §263a–2. Certification of embryo laboratories

- (a) **In general—**
  - (1) **Development—** Not later than 2 years after October 24, 1992, the [Secretary](/usc/42/201.md?p=c), through the Centers for Disease Control, shall develop a model [program](/usc/42/274l–1.md?p=4) for the certification of [embryo laboratories](/usc/42/263a–7.md?p=2) (referred to in this section as a “certification [program](/usc/42/274l–1.md?p=4)”) to be carried out by the [States](/usc/42/300gg–91.md?p=d-14).
  - (2) **Consultation—** In developing the certification [program](/usc/42/274l–1.md?p=4) under [paragraph (1)](#a-1), the [Secretary](/usc/42/201.md?p=c) shall consult with appropriate consumer and professional organizations with expertise in using, providing, and evaluating professional [services](/usc/42/201.md?p=a) and [embryo laboratories](/usc/42/263a–7.md?p=2) associated with the [assisted reproductive technology](/usc/42/263a–7.md?p=1) [programs](/usc/42/274l–1.md?p=4).
- (b) **Distribution—** The [Secretary](/usc/42/201.md?p=c) shall distribute a description of the certification [program](/usc/42/274l–1.md?p=4) to—
  - (1) the [Governor](/usc/42/6372.md?p=1) of each [State](/usc/42/300gg–91.md?p=d-14),
  - (2) the presiding officers of each [State](/usc/42/300gg–91.md?p=d-14) legislature,
  - (3) the public health official of each [State](/usc/42/300gg–91.md?p=d-14), and
  - (4) the official responsible in each [State](/usc/42/300gg–91.md?p=d-14) for the operation of the [State](/usc/42/300gg–91.md?p=d-14)’s contract with the [Secretary](/usc/42/201.md?p=c) under [section 1395aa of this title](/usc/42/1395aa.md),

  and shall encourage such officials to assist in the [State](/usc/42/300gg–91.md?p=d-14) adopting such [program](/usc/42/274l–1.md?p=4).

- (c) **Requirements—** The certification [program](/usc/42/274l–1.md?p=4) shall include the following requirements:
  - (1) **Administration—** The certification [program](/usc/42/274l–1.md?p=4) shall be administered by the [State](/usc/42/300gg–91.md?p=d-14) and shall provide for the [inspection](/usc/42/4851b.md?p=12) and certification of [embryo laboratories](/usc/42/263a–7.md?p=2) in the [State](/usc/42/300gg–91.md?p=d-14) by the [State](/usc/42/300gg–91.md?p=d-14) or by approved accreditation organizations.
  - (2) **Application requirements—** The certification [program](/usc/42/274l–1.md?p=4) shall provide for the submission of an application to a [State](/usc/42/300gg–91.md?p=d-14) by an [embryo laboratory](/usc/42/263a–7.md?p=2) for certification, in such form as may be specified by the [State](/usc/42/300gg–91.md?p=d-14). Such an application shall include—
    - (A) assurances satisfactory to the [State](/usc/42/300gg–91.md?p=d-14) that the [embryo laboratory](/usc/42/263a–7.md?p=2) will be operated in accordance with the [standards](/usc/42/1320d.md?p=7) under [subsection (d)](#d),
    - (B) a report to the [State](/usc/42/300gg–91.md?p=d-14) identifying the [assisted reproductive technology](/usc/42/263a–7.md?p=1) [programs](/usc/42/274l–1.md?p=4) with which the [laboratory](/usc/42/300jj.md?p=10) is associated, and
    - (C) such other information as the [State](/usc/42/300gg–91.md?p=d-14) finds necessary.

    An [embryo laboratory](/usc/42/263a–7.md?p=2) which meets the requirements of [section 263a of this title](/usc/42/263a.md) shall, for the purposes of [subparagraph (A)](#c-2-A) be considered in compliance with the [standards](/usc/42/1320d.md?p=7) referred to in such subparagraph which are the same as the [standards](/usc/42/1320d.md?p=7) in effect under [section 263a of this title](/usc/42/263a.md).

- (d) **Standards—** The certification [program](/usc/42/274l–1.md?p=4) shall include the following [standards](/usc/42/1320d.md?p=7) developed by the [Secretary](/usc/42/201.md?p=c):
  - (1) A [standard](/usc/42/1320d.md?p=7) to assure consistent performance of procedures by each [embryo laboratory](/usc/42/263a–7.md?p=2) certified under the certification [program](/usc/42/274l–1.md?p=4) or by an approved accreditation organization in a [State](/usc/42/300gg–91.md?p=d-14) which has not adopted the certification [program](/usc/42/274l–1.md?p=4).
  - (2) A [standard](/usc/42/1320d.md?p=7) for a quality assurance and a quality control [program](/usc/42/274l–1.md?p=4) to assure valid, reliable, and reproduceable[^1] procedures in the [laboratory](/usc/42/300jj.md?p=10).
  - (3) A [standard](/usc/42/1320d.md?p=7) for the maintenance of records (on a [program](/usc/42/274l–1.md?p=4) by [program](/usc/42/274l–1.md?p=4) basis) on [laboratory](/usc/42/300jj.md?p=10) tests and procedures performed, including the scientific basis of, and the methodology used for, the tests, procedures, and preparation of any [standards](/usc/42/1320d.md?p=7) or controls, criteria for acceptable and unacceptable outcomes, criteria for sample rejection, and procedures for safe sample [disposal](/usc/42/2021b.md?p=7).
  - (4) A [standard](/usc/42/1320d.md?p=7) for the maintenance of written records on personnel and [facilities](/usc/42/11049.md?p=4) necessary for proper and effective operation of the [laboratory](/usc/42/300jj.md?p=10), schedules of preventive maintenance, function verification for equipment, and the [release](/usc/42/9601.md?p=22) of such records to the [State](/usc/42/300gg–91.md?p=d-14) upon demand.
  - (5) A [standard](/usc/42/1320d.md?p=7) for the use of such personnel who meet such qualifications as the [Secretary](/usc/42/201.md?p=c) may develop.
- (e) **Certification under State programs—** A [State](/usc/42/300gg–91.md?p=d-14) may qualify to adopt the certification [program](/usc/42/274l–1.md?p=4) if the [State](/usc/42/300gg–91.md?p=d-14) has submitted an application to the [Secretary](/usc/42/201.md?p=c) to adopt such [program](/usc/42/274l–1.md?p=4) and the [Secretary](/usc/42/201.md?p=c) has approved the application. Such an application shall include—
  - (1) assurances by the [State](/usc/42/300gg–91.md?p=d-14) satisfactory to the [Secretary](/usc/42/201.md?p=c) that the certification [program](/usc/42/274l–1.md?p=4) within the [State](/usc/42/300gg–91.md?p=d-14) meets the requirements of this section,
  - (2) an [agreement](/usc/42/1320b–8.md?p=a-3-A) to make such reports as the [Secretary](/usc/42/201.md?p=c) may require, and
  - (3) information about any proposed use of accreditation organizations under [subsection (g)](#g).[^2]
- (f) **Use of accreditation organizations—** A [State](/usc/42/300gg–91.md?p=d-14) which has adopted the certification [program](/usc/42/274l–1.md?p=4) may use accreditation organizations approved under [section 263a–3 of this title](/usc/42/263a–3.md) to inspect and certify [embryo laboratories](/usc/42/263a–7.md?p=2).
- (g) **Inspections—**
  - (1) **In general—** A [State](/usc/42/300gg–91.md?p=d-14) which qualifies to adopt the certification [program](/usc/42/274l–1.md?p=4) within the [State](/usc/42/300gg–91.md?p=d-14) shall conduct [inspections](/usc/42/4851b.md?p=12) in accordance with [paragraph (2)](#g-2) to determine if [laboratories](/usc/42/300jj.md?p=10) in the [State](/usc/42/300gg–91.md?p=d-14) meet the requirements of such [program](/usc/42/274l–1.md?p=4). Such [inspections](/usc/42/4851b.md?p=12) shall be carried out by the [State](/usc/42/300gg–91.md?p=d-14) or by accreditation organizations used by the [State](/usc/42/300gg–91.md?p=d-14) under [subsection (g)](#g).[^2]
  - (2) **Requirements—** [Inspections](/usc/42/4851b.md?p=12) carried out under [paragraph (1)](#g-1) shall—
    - (A) be periodic and unannounced, or
    - (B) be announced in such circumstances as the [Secretary](/usc/42/201.md?p=c) determines will not diminish the likelihood of discovering deficiencies in the operations of a [laboratory](/usc/42/300jj.md?p=10).

    Before making a determination under [subparagraph (B)](#g-2-B), the [Secretary](/usc/42/201.md?p=c) shall make public, in such manner as to facilitate comment from any [person](/usc/42/1320a–7k.md?p=d-4-C-i) (including any Federal or other [public agency](/usc/42/11851.md?p=8)), a proposal indicating the circumstances under which announced [inspections](/usc/42/4851b.md?p=12) would be permitted.

  - (3) **Results—** The specific findings, including deficiencies, identified in an [inspection](/usc/42/4851b.md?p=12) carried out under [paragraph (1)](#g-1) and any subsequent corrections to those deficiencies shall be announced and made available to the public upon request beginning no later than 60 days after the date of the [inspection](/usc/42/4851b.md?p=12).
- (h) **Validation inspections—**
  - (1) **In general—** The [Secretary](/usc/42/201.md?p=c) may enter and inspect, during regular hours of operation, [embryo laboratories](/usc/42/263a–7.md?p=2)—
    - (A) which have been certified by a [State](/usc/42/300gg–91.md?p=d-14) under the certification [program](/usc/42/274l–1.md?p=4), or
    - (B) which have been certified by an accreditation organization approved by the [Secretary](/usc/42/201.md?p=c) under [section 263a–3 of this title](/usc/42/263a–3.md),

    for the purpose of determining whether the [laboratory](/usc/42/300jj.md?p=10) is being operated in accordance with the [standards](/usc/42/1320d.md?p=7) in [subsection (d)](#d).

  - (2) **Access to facilities and records—** In conducting an [inspection](/usc/42/4851b.md?p=12) of an [embryo laboratory](/usc/42/263a–7.md?p=2) under [paragraph (1)](#h-1), the [Secretary](/usc/42/201.md?p=c) shall have access to all [facilities](/usc/42/11049.md?p=4), equipment, materials, records, and information which the [Secretary](/usc/42/201.md?p=c) determines is necessary to determine if such [laboratory](/usc/42/300jj.md?p=10) is being operated in accordance with the [standards](/usc/42/1320d.md?p=7) in [subsection (d)](#d). As part of such an [inspection](/usc/42/4851b.md?p=12), the [Secretary](/usc/42/201.md?p=c) may copy any material, record, or information inspected or require it to be submitted to the [Secretary](/usc/42/201.md?p=c). Such an [inspection](/usc/42/4851b.md?p=12) may be made only upon the presentation of identification to the [owner](/usc/42/13641.md?p=4), operator, or agent in charge of the [laboratory](/usc/42/300jj.md?p=10) being inspected.
  - (3) **Failure to comply—** If the [Secretary](/usc/42/201.md?p=c) determines as a result of an [inspection](/usc/42/4851b.md?p=12) under [paragraph (1)](#h-1) that the [embryo laboratory](/usc/42/263a–7.md?p=2) is not in compliance with the [standards](/usc/42/1320d.md?p=7) in [subsection (d)](#d), the [Secretary](/usc/42/201.md?p=c) shall—
    - (A) notify the [State](/usc/42/300gg–91.md?p=d-14) in which the [laboratory](/usc/42/300jj.md?p=10) is located and, if appropriate, the accreditation organization which certified the [laboratory](/usc/42/300jj.md?p=10),
    - (B) make available to the public the results of the [inspection](/usc/42/4851b.md?p=12),
    - (C) conduct additional [inspections](/usc/42/4851b.md?p=12) of other [embryo laboratories](/usc/42/263a–7.md?p=2) under [paragraph (1)](#h-1) to determine if—
      - (i) such [State](/usc/42/300gg–91.md?p=d-14) in carrying out the certification [program](/usc/42/274l–1.md?p=4) is reliably identifying the deficiencies of such [laboratory](/usc/42/300jj.md?p=10), or
      - (ii) the accreditation organization which certified such [laboratories](/usc/42/300jj.md?p=10) is reliably identifying such deficencies,[^3] and
    - (D) if the [Secretary](/usc/42/201.md?p=c) determines—
      - (i) that such [State](/usc/42/300gg–91.md?p=d-14) in carrying out the certification [program](/usc/42/274l–1.md?p=4) has not met the requirements applicable to such [program](/usc/42/274l–1.md?p=4), or
      - (ii) the accreditation organization which certified such [laboratory](/usc/42/300jj.md?p=10) has not met the requirements of [section 263a–3 of this title](/usc/42/263a–3.md),

    the [Secretary](/usc/42/201.md?p=c) may revoke the approval of the [State](/usc/42/300gg–91.md?p=d-14) certification [program](/usc/42/274l–1.md?p=4) or revoke the approval of such accreditation organization.

- (i) **Limitation—**
  - (1) **Secretary—** In developing the certification [program](/usc/42/274l–1.md?p=4), the [Secretary](/usc/42/201.md?p=c) may not establish any regulation, [standard](/usc/42/1320d.md?p=7), or requirement which has the effect of exercising supervision or control over the practice of medicine in [assisted reproductive technology](/usc/42/263a–7.md?p=1) [programs](/usc/42/274l–1.md?p=4).
  - (2) **State—** In adopting the certification [program](/usc/42/274l–1.md?p=4), a [State](/usc/42/300gg–91.md?p=d-14) may not establish any regulation, [standard](/usc/42/1320d.md?p=7), or requirement which has the effect of exercising supervision or control over the practice of medicine in [assisted reproductive technology](/usc/42/263a–7.md?p=1) [programs](/usc/42/274l–1.md?p=4).
- (j) **Term—** The term of a certification issued by a [State](/usc/42/300gg–91.md?p=d-14) or an accreditation organization in a [State](/usc/42/300gg–91.md?p=d-14) shall be prescribed by the [Secretary](/usc/42/201.md?p=c) in the certification [program](/usc/42/274l–1.md?p=4) and shall be valid for a period of time to be defined by the [Secretary](/usc/42/201.md?p=c) through the public comment process described in [subsection (h)(2)](#h-2).[^4] The [Secretary](/usc/42/201.md?p=c) shall provide an application for recertification to be submitted at the time of changes in the ownership of a certified [laboratory](/usc/42/300jj.md?p=10) or changes in the administration of such a [laboratory](/usc/42/300jj.md?p=10).

# §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/42/300gg–91.md?p=d-14) 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/42/300gg–91.md?p=d-14) 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/42/300gg–91.md?p=d-14) may require, and
  - (2) requirements for the conduct of [inspections](/usc/42/4851b.md?p=12) 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](/usc/42/300w–9.md?p=c-2) 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](/usc/42/300w–9.md?p=c-2) by the organization shall continue in effect for 60 days after the [laboratory](/usc/42/300jj.md?p=10) 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](/usc/42/300jj.md?p=10) submitted an application to another approved accreditation organization for certification after receipt of such notice in a timely manner.

# §263a–4. Certification revocation and suspension

- (a) **In general—** A certification issued by a [State](/usc/42/300gg–91.md?p=d-14) or an accreditation organization for an [embryo laboratory](/usc/42/263a–7.md?p=2) shall be revoked or suspended if the [State](/usc/42/300gg–91.md?p=d-14) or organization finds, on the basis of [inspections](/usc/42/4851b.md?p=12) and after reasonable notice and opportunity for hearing to the [owner or operator](/usc/42/9601.md?p=20-B) of the [laboratory](/usc/42/300jj.md?p=10), that the [owner or operator](/usc/42/9601.md?p=20-B) or any [employee](/usc/42/300gg–91.md?p=d-5) of the [laboratory](/usc/42/300jj.md?p=10)—
  - (1) has been guilty of misrepresentation in obtaining the certification,
  - (2) has failed to comply with any [standards](/usc/42/1320d.md?p=7) under [section 263a–2 of this title](/usc/42/263a–2.md) applicable to the certification, or
  - (3) has refused a request of the [State](/usc/42/300gg–91.md?p=d-14) or accreditation organization for permission to inspect the [laboratory](/usc/42/300jj.md?p=10), its operations, and records.
- (b) **Effect—** If the certification of an [embryo laboratory](/usc/42/263a–7.md?p=2) is revoked or suspended, the certification of the [laboratory](/usc/42/300jj.md?p=10) shall continue in effect for 60 days after the [laboratory](/usc/42/300jj.md?p=10) receives notice of the revocation or suspension. If the certification of an [embryo laboratory](/usc/42/263a–7.md?p=2) is revoked or suspended, the [laboratory](/usc/42/300jj.md?p=10) may apply for recertification after one year after the date of the revocation or suspension.

# §263a–5. Publication


The [Secretary](/usc/42/201.md?p=c), through the Centers for Disease Control, shall not later than 3 years after October 24, 1992, and annually thereafter publish and distribute to the [States](/usc/42/300gg–91.md?p=d-14) and the public—

- (1)
  - (A) [^1] pregnancy success rates reported to the [Secretary](/usc/42/201.md?p=c) under [section 263a–1(a)(1) of this title](/usc/42/263a–1.md?p=a-1) and, in the case of an [assisted reproductive technology](/usc/42/263a–7.md?p=1) [program](/usc/42/274l–1.md?p=4) which failed to report one or more success rates as required under such section, the name of each such [program](/usc/42/274l–1.md?p=4) and each pregnancy success rate which the [program](/usc/42/274l–1.md?p=4) failed to report, and
  - (B) from information reported under [section 263a–1(a)(2) of this title](/usc/42/263a–1.md?p=a-2)—
    - (i) the identity of each [embryo laboratory](/usc/42/263a–7.md?p=2) in a [State](/usc/42/300gg–91.md?p=d-14) which has adopted the certification [program](/usc/42/274l–1.md?p=4) under such [program](/usc/42/274l–1.md?p=4) and whether such [laboratory](/usc/42/300jj.md?p=10) is certified under [section 263a–2 of this title](/usc/42/263a–2.md),
    - (ii) the identity of each [embryo laboratory](/usc/42/263a–7.md?p=2) in a [State](/usc/42/300gg–91.md?p=d-14) which has not adopted such certification [program](/usc/42/274l–1.md?p=4) and which has been certified by an accreditation organization approved by the [Secretary](/usc/42/201.md?p=c) under [section 263a–3 of this title](/usc/42/263a–3.md), and
    - (iii) in the case of an [embryo laboratory](/usc/42/263a–7.md?p=2) which is not certified under [section 263a–2 of this title](/usc/42/263a–2.md) or certified by an accreditation organization approved by the [Secretary](/usc/42/201.md?p=c) under [section 263a–3 of this title](/usc/42/263a–3.md), whether the [laboratory](/usc/42/300jj.md?p=10) applied for certification.

# §263a–6. Fees


The [Secretary](/usc/42/201.md?p=c) may require the payment of fees for the purpose of, and in an amount sufficient to cover the cost of, administering [sections 263a–1 to 263a–7](/usc/42/263a–1..263a–7.md) of this title. A [State](/usc/42/300gg–91.md?p=d-14) operating a [program](/usc/42/274l–1.md?p=4) under [section 263a–2 of this title](/usc/42/263a–2.md) may require the payment of fees for the purpose of, and in an amount sufficient to cover the costs of, administering its [program](/usc/42/274l–1.md?p=4).


# §263a–7. Definitions


For purposes of [sections 263a–1 to 263a–7](/usc/42/263a–1..263a–7.md) of this title:

- (1) **Assisted reproductive technology—** The term “assisted reproductive technology” means all [treatments](/usc/42/11851.md?p=11) or procedures which include the handling of human oocytes or embryos, including in vitro fertilization, gamete intrafallopian transfer, zygote intrafallopian transfer, and such other specific technologies as the [Secretary](/usc/42/201.md?p=c) may include in this definition, after making public any proposed definition in such manner as to facilitate comment from any [person](/usc/42/1320a–7k.md?p=d-4-C-i) (including any Federal or other [public agency](/usc/42/11851.md?p=8)).
- (2) **Embryo laboratory—** The term “embryo laboratory” means a [facility](/usc/42/11049.md?p=4) in which human oocytes are subject to [assisted reproductive technology](#1) [treatment](/usc/42/11851.md?p=11) or procedures based on manipulation of oocytes or embryos which are subject to implantation.
- (3) **Secretary—** The term “[Secretary](/usc/42/201.md?p=c)” means the [Secretary](/usc/42/201.md?p=c) of Health and Human [Services](/usc/42/201.md?p=a).