---
kind: "section"
citation: "42 U.S.C. § 263b"
title: "42"
title_heading: "The Public Health and Welfare"
number: "263b"
heading: "Certification of mammography facilities"
release: "119-102"
url: "https://uscodex.org/usc/42/263b"
units:
  - "Chapter 6A — Public Health Service"
  - "Subchapter II — General Powers and Duties"
  - "Part F — Licensing of Biological Products and Clinical Laboratories"
  - "Subpart 3 — mammography facilities"
---

# §263b. Certification of mammography facilities

- (a) **Definitions—** As used in this section:
  - (1) **Accreditation body—** The term “accreditation body” means a body that has been approved by the [Secretary](/usc/42/201.md?p=c) under [subsection (e)(1)(A)](#e-1-A) to accredit [mammography](#a-6) [facilities](#a-3-A).
  - (2) **Certificate—** The term “certificate” means the certificate described in [subsection (b)(1)](#b-1).
  - (3) **Facility—**
    - (A) **In general—** The term “facility” means a [hospital](/usc/42/1395dd.md?p=e-5), outpatient department, clinic, radiology practice, or mobile [unit](/usc/42/1395w–114b.md?p=g-2), an [office](/usc/42/3058f.md?p=1) of a [physician](/usc/42/1320a–7h.md?p=e-11), or other facility as determined by the [Secretary](/usc/42/201.md?p=c), that conducts breast cancer screening or diagnosis through [mammography](#a-6) activities. Such term does not include a facility of the Department of Veterans Affairs.
    - (B) **Activities—** For the purposes of this section, the activities of a [facility](#a-3-A) include the operation of equipment to produce the [mammogram](#a-5), the processing of the film, the initial interpretation of the [mammogram](#a-5) and the viewing conditions for that interpretation. Where procedures such as the film processing, or the interpretation of the [mammogram](#a-5) are performed in a location different from where the [mammogram](#a-5) is performed, the [facility](#a-3-A) performing the [mammogram](#a-5) shall be responsible for meeting the quality [standards](/usc/42/1320d.md?p=7) described in [subsection (f)](#f).
  - (4) **Inspection—** The term “inspection” means an onsite evaluation of the [facility](#a-3-A) by the [Secretary](/usc/42/201.md?p=c), or [State](/usc/42/300gg–91.md?p=d-14) or local agency on behalf of the [Secretary](/usc/42/201.md?p=c).
  - (5) **Mammogram—** The term “mammogram” means a radiographic image produced through [mammography](#a-6).
  - (6) **Mammography—** The term “mammography” means radiography of the breast.
  - (7) **Survey—** The term “survey” means an onsite physics consultation and evaluation performed by a medical physicist as described in [subsection (f)(1)(E)](#f-1-E).
  - (8) **Review physician—** The term “review physician” means a [physician](/usc/42/1320a–7h.md?p=e-11) as prescribed by the [Secretary](/usc/42/201.md?p=c) under [subsection (f)(1)(D)](#f-1-D) who meets such additional requirements as may be established by an [accreditation body](#a-1) under [subsection (e)](#e) and approved by the [Secretary](/usc/42/201.md?p=c) to review clinical images under [subsection (e)(1)(B)(i)](#e-1-B-i) on behalf of the [accreditation body](#a-1).
- (b) **Certificate requirement—**
  - (1) **Certificate—** No [facility](#a-3-A) may conduct an examination or procedure described in [paragraph (2)](#b-2) involving [mammography](#a-6) after October 1, 1994, unless the [facility](#a-3-A) obtains—
    - (A) a [certificate](#a-2) or a temporary renewal [certificate](#a-2)—
      - (i) that is issued, and, if applicable, renewed, by the [Secretary](/usc/42/201.md?p=c) in accordance with paragraphs[^1] (1) or (2) of [subsection (c)](#c);
      - (ii) that is applicable to the examination or procedure to be conducted; and
      - (iii) that is displayed prominently in such [facility](#a-3-A); or
    - (B) a provisional [certificate](#a-2) or a limited provisional [certificate](#a-2)—
      - (i) that is issued by the [Secretary](/usc/42/201.md?p=c) in accordance with paragraphs [(3)](#c-3) and [(4)](#c-4) of subsection (c);
      - (ii) that is applicable to the examination or procedure to be conducted; and
      - (iii) that is displayed prominently in such [facility](#a-3-A).

    The reference to a [certificate](#a-2) in this section includes a temporary renewal [certificate](#a-2), provisional [certificate](#a-2), or a limited provisional [certificate](#a-2).

  - (2) **Examination or procedure—** A [facility](#a-3-A) shall obtain a [certificate](#a-2) in order to—
    - (A) operate radiological equipment that is used to image the breast;
    - (B) provide for the interpretation of a [mammogram](#a-5) produced by such equipment at the [facility](#a-3-A) or under arrangements with a [qualified individual](/usc/42/18032.md?p=f-1-A) at a [facility](#a-3-A) different from where the [mammography](#a-6) examination is performed; and
    - (C) provide for the processing of film produced by such equipment at the [facility](#a-3-A) or under arrangements with a [qualified individual](/usc/42/18032.md?p=f-1-A) at a [facility](#a-3-A) different from where the [mammography](#a-6) examination is performed.
- (c) **Issuance and renewal of certificates—**
  - (1) **In general—** The [Secretary](/usc/42/201.md?p=c) may issue or renew a certificate for a [facility](#a-3-A) if the [person](/usc/42/1320a–7k.md?p=d-4-C-i) or agent described in [subsection (d)(1)(A)](#d-1-A) meets the applicable requirements of [subsection (d)(1)](#d-1) with respect to the [facility](#a-3-A). The [Secretary](/usc/42/201.md?p=c) may issue or renew a certificate under this paragraph for not more than 3 years.
  - (2) **Temporary renewal certificate—** The [Secretary](/usc/42/201.md?p=c) may issue a temporary renewal certificate, for a period of not to exceed 45 days, to a [facility](#a-3-A) seeking reaccreditation if the [accreditation body](#a-1) has issued an accreditation extension, for a period of not to exceed 45 days, for any of the following:
    - (A) The [facility](#a-3-A) has submitted the required materials to the [accreditation body](#a-1) within the established time frames for the submission of such materials but the [accreditation body](#a-1) is unable to complete the reaccreditation process before the certification expires.
    - (B) The [facility](#a-3-A) has acquired additional or replacement equipment, or has had significant personnel changes or other unforeseen situations that have caused the [facility](#a-3-A) to be unable to meet reaccreditation timeframes, but in the opinion of the [accreditation body](#a-1) have not compromised the quality of [mammography](#a-6).
  - (3) **Limited provisional certificate—** The [Secretary](/usc/42/201.md?p=c) may, upon the request of an [accreditation body](#a-1), issue a limited provisional certificate to an entity to enable the entity to conduct examinations for educational purposes while an onsite visit from an [accreditation body](#a-1) is in progress. Such certificate shall be valid only during the time the site visit team from the [accreditation body](#a-1) is physically in the [facility](#a-3-A), and in no case shall be valid for longer than 72 hours. The issuance of a certificate under this paragraph, shall not preclude the entity from qualifying for a provisional certificate under [paragraph (4)](#c-4).
  - (4) **Provisional certificate—** The [Secretary](/usc/42/201.md?p=c) may issue a provisional certificate for an entity to enable the entity to qualify as a [facility](#a-3-A). The applicant for a provisional certificate shall meet the requirements of [subsection (d)(1)](#d-1), except providing information required by clauses [(iii)](#d-1-A-iii) and [(iv)](#d-1-A-iv) of subsection (d)(1)(A). A provisional certificate may be in effect no longer than 6 months from the date it is issued, except that it may be extended once for a period of not more than 90 days if the [owner](/usc/42/13641.md?p=4), lessor, or agent of the [facility](#a-3-A) demonstrates to the [Secretary](/usc/42/201.md?p=c) that without such extension access to [mammography](#a-6) in the [geographic area](/usc/42/11360.md?p=9) served by the [facility](#a-3-A) would be significantly reduced and if the [owner](/usc/42/13641.md?p=4), lessor, or agent of the [facility](#a-3-A) will describe in a report to the [Secretary](/usc/42/201.md?p=c) steps that will be taken to qualify the [facility](#a-3-A) for certification under [subsection (b)(1)](#b-1).
- (d) **Application for certificate—**
  - (1) **Submission—** The [Secretary](/usc/42/201.md?p=c) may issue or renew a certificate for a [facility](#a-3-A) if—
    - (A) the [person](/usc/42/1320a–7k.md?p=d-4-C-i) who owns or leases the [facility](#a-3-A) or an authorized agent of the [person](/usc/42/1320a–7k.md?p=d-4-C-i), submits to the [Secretary](/usc/42/201.md?p=c), in such form and manner as the [Secretary](/usc/42/201.md?p=c) shall prescribe, an application that contains at a minimum—
      - (i) a description of the [manufacturer](/usc/42/300aa–33.md?p=3), model, and type of each x-ray machine, image receptor, and processor operated in the performance of [mammography](#a-6) by the [facility](#a-3-A);
      - (ii) a description of the procedures currently used to provide [mammography](#a-6) at the [facility](#a-3-A), including—
        - (I) the types of procedures performed and the number of such procedures performed in the prior 12 months;
        - (II) the methodologies for [mammography](#a-6); and
        - (III) the names and qualifications (educational background, [training](/usc/42/285e–2.md?p=b-2), and experience) of the personnel performing [mammography](#a-6) and the [physicians](/usc/42/1395cc–4.md?p=a-2-E) reading and interpreting the results from the procedures;
      - (iii) proof of on-site survey by a qualified medical physicist as described in [subsection (f)(1)(E)](#f-1-E); and
      - (iv) proof of accreditation in such manner as the [Secretary](/usc/42/201.md?p=c) shall prescribe; and
    - (B) the [person](/usc/42/1320a–7k.md?p=d-4-C-i) or agent submits to the [Secretary](/usc/42/201.md?p=c)—
      - (i) a satisfactory assurance that the [facility](#a-3-A) will be operated in accordance with [standards](/usc/42/1320d.md?p=7) established by the [Secretary](/usc/42/201.md?p=c) under [subsection (f)](#f) to assure the safety and accuracy of [mammography](#a-6);
      - (ii) a satisfactory assurance that the [facility](#a-3-A) will—
        - (I) permit [inspections](#a-4) under [subsection (g)](#g);
        - (II) make such records and information available, and submit such reports, to the [Secretary](/usc/42/201.md?p=c) as the [Secretary](/usc/42/201.md?p=c) may require; and
        - (III) update the information submitted under [subparagraph (A)](#d-1-A) or assurances submitted under this subparagraph on a timely basis as required by the [Secretary](/usc/42/201.md?p=c); and
      - (iii) such other information as the [Secretary](/usc/42/201.md?p=c) may require.

    An applicant shall not be required to provide in an application under [subparagraph (A)](#d-1-A) any information which the applicant has supplied to the [accreditation body](#a-1) which [accredited](/usc/42/300w–9.md?p=c-2) the applicant, except as required by the [Secretary](/usc/42/201.md?p=c).

  - (2) **Appeal—** If the [Secretary](/usc/42/201.md?p=c) denies an application for the certification of a [facility](#a-3-A) submitted under [paragraph (1)(A)](#d-1-A), the [Secretary](/usc/42/201.md?p=c) shall provide the [owner](/usc/42/13641.md?p=4) or lessor of the [facility](#a-3-A) or the agent of the [owner](/usc/42/13641.md?p=4) or lessor who submitted such application—
    - (A) a statement of the grounds on which the denial is based, and
    - (B) an opportunity for an appeal in accordance with the procedures set forth in [regulations](/usc/42/201.md?p=d) of the [Secretary](/usc/42/201.md?p=c) published at [part 498 of title 42, Code of Federal Regulations](/cfr/42/part498.md).
  - (3) **Effect of denial—** If the application for the certification of a [facility](#a-3-A) is denied, the [facility](#a-3-A) may not operate unless the denial of the application is overturned at the conclusion of the administrative appeals process provided in the [regulations](/usc/42/201.md?p=d) referred to in [paragraph (2)(B)](#d-2-B).
- (e) **Accreditation—**
  - (1) **Approval of accreditation bodies—**
    - (A) **In general—** The [Secretary](/usc/42/201.md?p=c) may approve a private nonprofit organization or [State agency](/usc/42/1396r–8.md?p=k-9) to accredit [facilities](#a-3-A) for purposes of [subsection (d)(1)(A)(iv)](#d-1-A-iv) if the [accreditation body](#a-1) meets the [standards](/usc/42/1320d.md?p=7) for accreditation established by the [Secretary](/usc/42/201.md?p=c) as described in [subparagraph (B)](#e-1-B) and provides the assurances required by [subparagraph (C)](#e-1-C).
    - (B) **Standards—** The [Secretary](/usc/42/201.md?p=c) shall establish [standards](/usc/42/1320d.md?p=7) for [accreditation bodies](#a-1), including—
      - (i) [standards](/usc/42/1320d.md?p=7) that require an [accreditation body](#a-1) to perform—
        - (I) a review of clinical images from each [facility](#a-3-A) [accredited](/usc/42/300w–9.md?p=c-2) by such body not less often than every 3 years which review will be made by qualified [review physicians](#a-8); and
        - (II) a review of a random sample of clinical images from such [facilities](#a-3-A) in each 3-year period beginning October 1, 1994, which review will be made by qualified [review physicians](#a-8);
      - (ii) [standards](/usc/42/1320d.md?p=7) that prohibit individuals conducting the reviews described in [clause (i)](#e-1-B-i) from maintaining any relationship to the [facility](#a-3-A) undergoing review which would constitute a conflict of interest;
      - (iii) [standards](/usc/42/1320d.md?p=7) that limit the imposition of fees for accreditation to reasonable amounts;
      - (iv) [standards](/usc/42/1320d.md?p=7) that require as a condition of accreditation that each [facility](#a-3-A) undergo a survey at least annually by a medical physicist as described in [subsection (f)(1)(E)](#f-1-E) to ensure that the [facility](#a-3-A) meets the [standards](/usc/42/1320d.md?p=7) described in subparagraphs [(A)](#f-1-A) and [(B)](#f-1-B) of subsection (f)(1);
      - (v) [standards](/usc/42/1320d.md?p=7) that require monitoring and evaluation of such survey, as prescribed by the [Secretary](/usc/42/201.md?p=c);
      - (vi) [standards](/usc/42/1320d.md?p=7) that are equal to [standards](/usc/42/1320d.md?p=7) established under [subsection (f)](#f) which are relevant to accreditation as determined by the [Secretary](/usc/42/201.md?p=c); and
      - (vii) such additional [standards](/usc/42/1320d.md?p=7) as the [Secretary](/usc/42/201.md?p=c) may require.
    - (C) **Assurances—** The accrediting body shall provide the [Secretary](/usc/42/201.md?p=c) satisfactory assurances that the body will—
      - (i) comply with the [standards](/usc/42/1320d.md?p=7) as described in [subparagraph (B)](#e-1-B);
      - (ii) comply with the requirements described in [paragraph (4)](#e-4);
      - (iii) submit to the [Secretary](/usc/42/201.md?p=c) the name of any [facility](#a-3-A) for which the [accreditation body](#a-1) denies, suspends, or revokes accreditation;
      - (iv) notify the [Secretary](/usc/42/201.md?p=c) in a timely manner before the [accreditation body](#a-1) changes the [standards](/usc/42/1320d.md?p=7) of the body;
      - (v) notify each [facility](#a-3-A) [accredited](/usc/42/300w–9.md?p=c-2) by the [accreditation body](#a-1) if the [Secretary](/usc/42/201.md?p=c) withdraws approval of the [accreditation body](#a-1) under [paragraph (2)](#e-2) in a timely manner; and
      - (vi) provide such other additional information as the [Secretary](/usc/42/201.md?p=c) may require.
    - (D) **Regulations—** Not later than 9 months after October 27, 1992, the [Secretary](/usc/42/201.md?p=c) shall promulgate [regulations](/usc/42/201.md?p=d) under which the [Secretary](/usc/42/201.md?p=c) may approve an [accreditation body](#a-1).
  - (2) **Withdrawal of approval—**
    - (A) **In general—** The [Secretary](/usc/42/201.md?p=c) shall promulgate [regulations](/usc/42/201.md?p=d) under which the [Secretary](/usc/42/201.md?p=c) may withdraw the approval of an [accreditation body](#a-1) if the [Secretary](/usc/42/201.md?p=c) determines that the [accreditation body](#a-1) does not meet the [standards](/usc/42/1320d.md?p=7) under [subparagraph (B)](#e-1-B) of paragraph (1), the requirements of [clauses (i) through (vi)](#e-2-C-i..e-2-C-vi) of subparagraph (C) of [paragraph (1)](#e-1), or the requirements of [paragraph (4)](#e-4).
    - (B) **Effect of withdrawal—** If the [Secretary](/usc/42/201.md?p=c) withdraws the approval of an [accreditation body](#a-1) under [subparagraph (A)](#e-2-A), the certificate of any [facility](#a-3-A) [accredited](/usc/42/300w–9.md?p=c-2) by the body shall continue in effect until the expiration of a reasonable period, as determined by the [Secretary](/usc/42/201.md?p=c), for such [facility](#a-3-A) to obtain another accreditation.
  - (3) **Accreditation—** To be [accredited](/usc/42/300w–9.md?p=c-2) by an approved [accreditation body](#a-1) a [facility](#a-3-A) shall meet—
    - (A) the [standards](/usc/42/1320d.md?p=7) described in [paragraph (1)(B)](#e-1-B) which the [Secretary](/usc/42/201.md?p=c) determines are applicable to the [facility](#a-3-A), and
    - (B) such other [standards](/usc/42/1320d.md?p=7) which the [accreditation body](#a-1) may require.
  - (4) **Compliance—** To ensure that [facilities](#a-3-A) [accredited](/usc/42/300w–9.md?p=c-2) by an [accreditation body](#a-1) will continue to meet the [standards](/usc/42/1320d.md?p=7) of the [accreditation body](#a-1), the [accreditation body](#a-1) shall—
    - (A) make onsite visits on an annual basis of a sufficient number of the [facilities](#a-3-A) [accredited](/usc/42/300w–9.md?p=c-2) by the body to allow a reasonable estimate of the performance of the body; and
    - (B) take such additional measures as the [Secretary](/usc/42/201.md?p=c) determines to be appropriate.

    Visits made under [subparagraph (A)](#e-4-A) shall be made after providing such notice as the [Secretary](/usc/42/201.md?p=c) may require.

  - (5) **Revocation of accreditation—** If an [accreditation body](#a-1) revokes the accreditation of a [facility](#a-3-A), the certificate of the [facility](#a-3-A) shall continue in effect until such time as may be determined by the [Secretary](/usc/42/201.md?p=c).
  - (6) **Evaluation and report—**
    - (A) **Evaluation—** The [Secretary](/usc/42/201.md?p=c) shall evaluate annually the performance of each approved [accreditation body](#a-1) by—
      - (i) inspecting under [subsection (g)(2)](#g-2) a sufficient number of the [facilities](#a-3-A) [accredited](/usc/42/300w–9.md?p=c-2) by the body to allow a reasonable estimate of the performance of the body; and
      - (ii) such additional means as the [Secretary](/usc/42/201.md?p=c) determines to be appropriate.
    - (B) **Report—** The [Secretary](/usc/42/201.md?p=c) shall annually prepare and submit to the Committee on Labor and Human Resources of the Senate and the Committee on [Energy](/usc/42/6311.md?p=7) and [Commerce](/usc/42/6311.md?p=7) of the House of [Representatives](/usc/42/3058f.md?p=5) a report that describes the results of the evaluation conducted in accordance with [subparagraph (A)](#e-6-A).
- (f) **Quality standards—**
  - (1) **In general—** The [standards](/usc/42/1320d.md?p=7) referred to in [subsection (d)(1)(B)(i)](#d-1-B-i) are [standards](/usc/42/1320d.md?p=7) established by the [Secretary](/usc/42/201.md?p=c) which include—
    - (A) [standards](/usc/42/1320d.md?p=7) that require establishment and maintenance of a quality assurance and quality control [program](/usc/42/274l–1.md?p=4) at each [facility](#a-3-A) that is adequate and appropriate to ensure the reliability, clarity, and accuracy of interpretation of [mammograms](#a-5) and [standards](/usc/42/1320d.md?p=7) for appropriate radiation dose;
    - (B) [standards](/usc/42/1320d.md?p=7) that require use of radiological equipment specifically designed for [mammography](#a-6), including radiologic [standards](/usc/42/1320d.md?p=7) and [standards](/usc/42/1320d.md?p=7) for other equipment and materials used in conjunction with such equipment;
    - (C) a requirement that personnel who perform [mammography](#a-6)—
      - (i)
        - (I) be licensed by a [State](/usc/42/300gg–91.md?p=d-14) to perform radiological procedures; or
        - (II) be certified as qualified to perform radiological procedures by an organization described in [paragraph (2)(A)](#f-2-A); and
      - (ii) during the 2-year period beginning October 1, 1994, meet [training](/usc/42/285e–2.md?p=b-2) [standards](/usc/42/1320d.md?p=7) for personnel who perform [mammography](#a-6) or meet experience requirements which shall at a minimum include 1 year of experience in the performance of [mammography](#a-6); and
      - (iii) upon the expiration of such 2-year period meet minimum [training](/usc/42/285e–2.md?p=b-2) [standards](/usc/42/1320d.md?p=7) for personnel who perform [mammograms](#a-5);
    - (D) a requirement that [mammograms](#a-5) be interpreted by a [physician](/usc/42/1320a–7h.md?p=e-11) who is certified as qualified to interpret radiological procedures, including [mammography](#a-6)—
      - (i)
        - (I) by a [board](/usc/42/10261.md?p=2) described in [paragraph (2)(B)](#f-2-B); or
        - (II) by a [program](/usc/42/274l–1.md?p=4) that complies with the [standards](/usc/42/1320d.md?p=7) described in [paragraph (2)(C)](#f-2-C); and
      - (ii) who meets [training](/usc/42/285e–2.md?p=b-2) and continuing medical education requirements as established by the [Secretary](/usc/42/201.md?p=c);
    - (E) a requirement that individuals who [survey](#a-7) [mammography](#a-6) [facilities](#a-3-A) be medical physicists—
      - (i) licensed or approved by a [State](/usc/42/300gg–91.md?p=d-14) to perform such [surveys](#a-7), reviews, or [inspections](#a-4) for [mammography](#a-6) [facilities](#a-3-A);
      - (ii) certified in diagnostic radiological physics or certified as qualified to perform such [surveys](#a-7) by a [board](/usc/42/10261.md?p=2) as described in [paragraph (2)(D)](#f-2-D); or
      - (iii) in the first 5 years after October 27, 1992, who meet other criteria established by the [Secretary](/usc/42/201.md?p=c) which are comparable to the criteria described in clause [(i)](#f-1-E-i) or [(ii)](#f-1-E-ii);
    - (F) a requirement that a medical physicist who is qualified in [mammography](#a-6) as described in [subparagraph (E)](#f-1-E) [survey](#a-7) [mammography](#a-6) equipment and oversee quality assurance [practices](/usc/42/17061.md?p=19) at each [facility](#a-3-A);
    - (G) a requirement that—
      - (i) a [facility](#a-3-A) that performs any [mammogram](#a-5)—
        - (I) except as provided in [subclause (II)](#f-1-G-i-II), maintain the [mammogram](#a-5) in the permanent medical records of the patient for a period of not less than 5 years, or not less than 10 years if no subsequent [mammograms](#a-5) of such patient are performed at the [facility](#a-3-A), or longer if mandated by [State](/usc/42/300gg–91.md?p=d-14) law; and
        - (II) upon the request of or on behalf of the patient, transfer the [mammogram](#a-5) to a medical institution, to a [physician](/usc/42/1320a–7h.md?p=e-11) of the patient, or to the patient directly; and
      - (ii)
        - (I) a [facility](#a-3-A) must assure the preparation of a written report of the results of any [mammography](#a-6) examination signed by the interpreting [physician](/usc/42/1320a–7h.md?p=e-11);
        - (II) such written report shall be provided to the patient’s [physicians](/usc/42/1395cc–4.md?p=a-2-E) (if any);
        - (III) if such a [physician](/usc/42/1320a–7h.md?p=e-11) is not available or if there is no such [physician](/usc/42/1320a–7h.md?p=e-11), the written report shall be sent directly to the patient; and
        - (IV) whether or not such a [physician](/usc/42/1320a–7h.md?p=e-11) is available or there is no such [physician](/usc/42/1320a–7h.md?p=e-11), a summary of the written report shall be sent directly to the patient in terms easily understood by a lay [person](/usc/42/1320a–7k.md?p=d-4-C-i); and
    - (H) [standards](/usc/42/1320d.md?p=7) relating to special techniques for [mammography](#a-6) of patients with breast implants.

    [Subparagraph (G)](#f-1-G) shall not be construed to limit a patient’s access to the patient’s medical records.

  - (2) **Certification of personnel—** The [Secretary](/usc/42/201.md?p=c) shall by regulation—
    - (A) specify organizations eligible to certify individuals to perform radiological procedures as required by [paragraph (1)(C)](#f-1-C);
    - (B) specify [boards](/usc/42/10261.md?p=2) eligible to certify [physicians](/usc/42/1395cc–4.md?p=a-2-E) to interpret radiological procedures, including [mammography](#a-6), as required by [paragraph (1)(D)](#f-1-D);
    - (C) establish [standards](/usc/42/1320d.md?p=7) for a [program](/usc/42/274l–1.md?p=4) to certify [physicians](/usc/42/1395cc–4.md?p=a-2-E) described in [paragraph (1)(D)](#f-1-D); and
    - (D) specify [boards](/usc/42/10261.md?p=2) eligible to certify medical physicists who are qualified to [survey](#a-7) [mammography](#a-6) equipment and to oversee quality assurance [practices](/usc/42/17061.md?p=19) at [mammography](#a-6) [facilities](#a-3-A).
- (g) **Inspections—**
  - (1) **Annual inspections—**
    - (A) **In general—** The [Secretary](/usc/42/201.md?p=c) may enter and inspect [facilities](#a-3-A) to determine compliance with the certification requirements under [subsection (b)](#b) and the [standards](/usc/42/1320d.md?p=7) established under [subsection (f)](#f). The [Secretary](/usc/42/201.md?p=c) shall, if feasible, delegate to a [State](/usc/42/300gg–91.md?p=d-14) or local agency the authority to make such [inspections](#a-4).
    - (B) **Identification—** The [Secretary](/usc/42/201.md?p=c), or [State](/usc/42/300gg–91.md?p=d-14) or local agency acting on behalf of the [Secretary](/usc/42/201.md?p=c), may conduct [inspections](#a-4) only on presenting identification to the [owner](/usc/42/13641.md?p=4), operator, or agent in charge of the [facility](#a-3-A) to be inspected.
    - (C) **Scope of inspection—** In conducting [inspections](#a-4), the [Secretary](/usc/42/201.md?p=c) or [State](/usc/42/300gg–91.md?p=d-14) or local agency acting on behalf of the [Secretary](/usc/42/201.md?p=c)—
      - (i) shall have access to all equipment, materials, records, and information that the [Secretary](/usc/42/201.md?p=c) or [State](/usc/42/300gg–91.md?p=d-14) or local agency considers necessary to determine whether the [facility](#a-3-A) is being operated in accordance with this section; and
      - (ii) may copy, or require the [facility](#a-3-A) to submit to the [Secretary](/usc/42/201.md?p=c) or the [State](/usc/42/300gg–91.md?p=d-14) or local agency, any of the materials, records, or information.
    - (D) **Qualifications of inspectors—** [Qualified individuals](/usc/42/18032.md?p=f-1-A), as determined by the [Secretary](/usc/42/201.md?p=c), shall conduct all [inspections](#a-4). The [Secretary](/usc/42/201.md?p=c) may request that a [State](/usc/42/300gg–91.md?p=d-14) or local agency acting on behalf of the [Secretary](/usc/42/201.md?p=c) designate a qualified officer or [employee](/usc/42/300gg–91.md?p=d-5) to conduct the [inspections](#a-4), or designate a qualified Federal officer or [employee](/usc/42/300gg–91.md?p=d-5) to conduct [inspections](#a-4). The [Secretary](/usc/42/201.md?p=c) shall establish minimum qualifications and appropriate [training](/usc/42/285e–2.md?p=b-2) for inspectors and criteria for certification of inspectors in order to inspect [facilities](#a-3-A) for compliance with [subsection (f)](#f).
    - (E) **Frequency—** The [Secretary](/usc/42/201.md?p=c) or [State](/usc/42/300gg–91.md?p=d-14) or local agency acting on behalf of the [Secretary](/usc/42/201.md?p=c) shall conduct [inspections](#a-4) under this paragraph of each [facility](#a-3-A) not less often than annually, subject to [paragraph (6)](#g-6).
    - (F) **Records and annual reports—** The [Secretary](/usc/42/201.md?p=c) or a [State](/usc/42/300gg–91.md?p=d-14) or local agency acting on behalf of the [Secretary](/usc/42/201.md?p=c) which is responsible for inspecting [mammography](#a-6) [facilities](#a-3-A) shall maintain records of annual [inspections](#a-4) required under this paragraph for a period as prescribed by the [Secretary](/usc/42/201.md?p=c). Such a [State](/usc/42/300gg–91.md?p=d-14) or local agency shall annually prepare and submit to the [Secretary](/usc/42/201.md?p=c) a report concerning the [inspections](#a-4) carried out under this paragraph. Such reports shall include a description of the [facilities](#a-3-A) inspected and the results of such [inspections](#a-4).
  - (2) **Inspection of accredited facilities—** The [Secretary](/usc/42/201.md?p=c) shall inspect annually a sufficient number of the [facilities](#a-3-A) [accredited](/usc/42/300w–9.md?p=c-2) by an [accreditation body](#a-1) to provide the [Secretary](/usc/42/201.md?p=c) with a reasonable estimate of the performance of such body.
  - (3) **Inspection of facilities inspected by State or local agencies—** The [Secretary](/usc/42/201.md?p=c) shall inspect annually [facilities](#a-3-A) inspected by [State](/usc/42/300gg–91.md?p=d-14) or local agencies acting on behalf of the [Secretary](/usc/42/201.md?p=c) to assure a reasonable performance by such [State](/usc/42/300gg–91.md?p=d-14) or local agencies.
  - (4) **Timing—** The [Secretary](/usc/42/201.md?p=c), or [State](/usc/42/300gg–91.md?p=d-14) or local agency, may conduct [inspections](#a-4) under paragraphs [(1)](#g-1), [(2)](#g-2), and [(3)](#g-3), during regular business hours or at a mutually agreeable time and after providing such notice as the [Secretary](/usc/42/201.md?p=c) may prescribe, except that the [Secretary](/usc/42/201.md?p=c) may waive such requirements if the continued performance of [mammography](#a-6) at such [facility](#a-3-A) threatens the public health.
  - (5) **Limited reinspection—** Nothing in this section limits the authority of the [Secretary](/usc/42/201.md?p=c) to conduct limited reinspections of [facilities](#a-3-A) found not to be in compliance with this section.
  - (6) **Demonstration program—**
    - (A) **In general—** The [Secretary](/usc/42/201.md?p=c) may establish a demonstration [program](/usc/42/274l–1.md?p=4) under which [inspections](#a-4) under [paragraph (1)](#g-1) of selected [facilities](#a-3-A) are conducted less frequently by the [Secretary](/usc/42/201.md?p=c) (or as applicable, by [State](/usc/42/300gg–91.md?p=d-14) or local agencies acting on behalf of the [Secretary](/usc/42/201.md?p=c)) than the interval specified in [subparagraph (E)](#g-1-E) of such paragraph.
    - (B) **Requirements—** Any demonstration [program](/usc/42/274l–1.md?p=4) under [subparagraph (A)](#g-6-A) shall be carried out in accordance with the following:
      - (i) The [program](/usc/42/274l–1.md?p=4) may not be implemented before April 1, 2001. Preparations for the [program](/usc/42/274l–1.md?p=4) may be carried out prior to such date.
      - (ii) In carrying out the [program](/usc/42/274l–1.md?p=4), the [Secretary](/usc/42/201.md?p=c) may not select a [facility](#a-3-A) for inclusion in the [program](/usc/42/274l–1.md?p=4) unless the [facility](#a-3-A) is substantially free of incidents of noncompliance with the [standards](/usc/42/1320d.md?p=7) under [subsection (f)](#f). The [Secretary](/usc/42/201.md?p=c) may at any time provide that a [facility](#a-3-A) will no longer be included in the [program](/usc/42/274l–1.md?p=4).
      - (iii) The number of [facilities](#a-3-A) selected for inclusion in the [program](/usc/42/274l–1.md?p=4) shall be sufficient to provide a statistically significant sample, subject to compliance with [clause (ii)](#g-6-B-ii).
      - (iv) [Facilities](#a-3-A) that are selected for inclusion in the [program](/usc/42/274l–1.md?p=4) shall be inspected at such intervals as the [Secretary](/usc/42/201.md?p=c) determines will reasonably ensure that the [facilities](#a-3-A) are maintaining compliance with such [standards](/usc/42/1320d.md?p=7).
- (h) **Sanctions—**
  - (1) **In general—** In order to promote voluntary compliance with this section, the [Secretary](/usc/42/201.md?p=c) may, in lieu of taking the actions authorized by [subsection (i)](#i), impose one or more of the following sanctions:
    - (A) Directed plans of correction which afford a [facility](#a-3-A) an opportunity to correct [violations](/usc/42/2000e–16a.md?p=c) in a timely manner.
    - (B) Payment for the cost of onsite monitoring.
  - (2) **Patient information—** If the [Secretary](/usc/42/201.md?p=c) determines that the quality of [mammography](#a-6) performed by a [facility](#a-3-A) (whether or not certified pursuant to [subsection (c)](#c)) was so inconsistent with the quality [standards](/usc/42/1320d.md?p=7) established pursuant to [subsection (f)](#f) as to present a significant risk to individual or public health, the [Secretary](/usc/42/201.md?p=c) may require such [facility](#a-3-A) to notify patients who received [mammograms](#a-5) at such [facility](#a-3-A), and their referring [physicians](/usc/42/1395cc–4.md?p=a-2-E), of the deficiencies presenting such risk, the potential harm resulting, appropriate remedial measures, and such other relevant information as the [Secretary](/usc/42/201.md?p=c) may require.
  - (3) **Civil money penalties—** The [Secretary](/usc/42/201.md?p=c) may assess civil money penalties in an amount not to exceed $10,000 for—
    - (A) failure to obtain a certificate as required by [subsection (b)](#b),
    - (B) each failure by a [facility](#a-3-A) to substantially comply with, or each day on which a [facility](#a-3-A) fails to substantially comply with, the [standards](/usc/42/1320d.md?p=7) established under [subsection (f)](#f) or the requirements described in [subclauses (I) through (III)](#d-1-B-ii-I..d-1-B-ii-III) of subsection (d)(1)(B)(ii),
    - (C) each failure to notify a patient of risk as required by the [Secretary](/usc/42/201.md?p=c) pursuant to [paragraph (2)](#h-2), and
    - (D) each [violation](/usc/42/2000e–16a.md?p=c), or for each aiding and abetting in a [violation](/usc/42/2000e–16a.md?p=c) of, any provision of, or regulation promulgated under, this section by an [owner](/usc/42/13641.md?p=4), operator, or any [employee](/usc/42/300gg–91.md?p=d-5) of a [facility](#a-3-A) required to have a certificate.
  - (4) **Procedures—** The [Secretary](/usc/42/201.md?p=c) shall develop and implement procedures with respect to when and how each of the sanctions is to be imposed under [paragraphs (1) through (3)](#h-1..h-3). Such procedures shall provide for notice to the [owner or operator](/usc/42/9601.md?p=20-B) of the [facility](#a-3-A) and a reasonable opportunity for the [owner or operator](/usc/42/9601.md?p=20-B) to respond to the proposed sanctions and appropriate procedures for appealing determinations relating to the imposition of sanctions.
- (i) **Suspension and revocation—**
  - (1) **In general—** The certificate of a [facility](#a-3-A) issued under [subsection (c)](#c) may be suspended or revoked if the [Secretary](/usc/42/201.md?p=c) finds, after providing, except as provided in [paragraph (2)](#i-2), reasonable notice and an opportunity for a hearing to the [owner or operator](/usc/42/9601.md?p=20-B) of the [facility](#a-3-A), that the [owner](/usc/42/13641.md?p=4), operator, or any [employee](/usc/42/300gg–91.md?p=d-5) of the [facility](#a-3-A)—
    - (A) has been guilty of misrepresentation in obtaining the certificate;
    - (B) has failed to comply with the requirements of [subsection (d)(1)(B)(ii)(III)](#d-1-B-ii-III) or the [standards](/usc/42/1320d.md?p=7) established by the [Secretary](/usc/42/201.md?p=c) under [subsection (f)](#f);
    - (C) has failed to comply with reasonable requests of the [Secretary](/usc/42/201.md?p=c) (or of an [accreditation body](#a-1) approved pursuant to [subsection (e)](#e)) for any record, information, report, or material that the [Secretary](/usc/42/201.md?p=c) (or such [accreditation body](#a-1) or [State](/usc/42/300gg–91.md?p=d-14) carrying out certification [program](/usc/42/274l–1.md?p=4) requirements pursuant to [subsection (q)](#q)) concludes is necessary to determine the continued eligibility of the [facility](#a-3-A) for a certificate or continued compliance with the [standards](/usc/42/1320d.md?p=7) established under [subsection (f)](#f);
    - (D) has refused a reasonable request of the [Secretary](/usc/42/201.md?p=c), any Federal officer or [employee](/usc/42/300gg–91.md?p=d-5) duly designated by the [Secretary](/usc/42/201.md?p=c), or any [State](/usc/42/300gg–91.md?p=d-14) or local officer or [employee](/usc/42/300gg–91.md?p=d-5) duly designated by the [State](/usc/42/300gg–91.md?p=d-14) or local agency, for permission to inspect the [facility](#a-3-A) or the operations and pertinent records of the [facility](#a-3-A) in accordance with [subsection (g)](#g);
    - (E) has violated or aided and abetted in the [violation](/usc/42/2000e–16a.md?p=c) of any provision of, or regulation promulgated under, this section; or
    - (F) has failed to comply with a sanction imposed under [subsection (h)](#h).
  - (2) **Action before a hearing—**
    - (A) **In general—** The [Secretary](/usc/42/201.md?p=c) may suspend the certificate of the [facility](#a-3-A) before holding a hearing required by [paragraph (1)](#i-1) if the [Secretary](/usc/42/201.md?p=c) has reason to believe that the circumstance of the case will support one or more of the findings described in [paragraph (1)](#i-1) and that—
      - (i) the failure or [violation](/usc/42/2000e–16a.md?p=c) was intentional; or
      - (ii) the failure or [violation](/usc/42/2000e–16a.md?p=c) presents a serious risk to human health.
    - (B) **Hearing—** If the [Secretary](/usc/42/201.md?p=c) suspends a certificate under [subparagraph (A)](#i-2-A), the [Secretary](/usc/42/201.md?p=c) shall provide an opportunity for a hearing to the [owner or operator](/usc/42/9601.md?p=20-B) of the [facility](#a-3-A) not later than 60 days from the effective date of the suspension. The suspension shall remain in effect until the decision of the [Secretary](/usc/42/201.md?p=c) made after the hearing.
  - (3) **Ineligibility to own or operate facilities after revocation—** If the [Secretary](/usc/42/201.md?p=c) revokes the certificate of a [facility](#a-3-A) on the basis of an act described in [paragraph (1)](#i-1), no [person](/usc/42/1320a–7k.md?p=d-4-C-i) who owned or operated the [facility](#a-3-A) at the time of the act may, within 2 years of the revocation of the certificate, own or operate a [facility](#a-3-A) that requires a certificate under this section.
- (j) **Injunctions—** If the [Secretary](/usc/42/201.md?p=c) determines that—
  - (1) continuation of any activity related to the provision of [mammography](#a-6) by a [facility](#a-3-A) would constitute a serious risk to human health, the [Secretary](/usc/42/201.md?p=c) may bring suit in the district court of the [United States](/usc/42/403.md?p=k) for the district in which the [facility](#a-3-A) is situated to enjoin continuation of the activity; and
  - (2) a [facility](#a-3-A) is operating without a certificate as required by [subsection (b)](#b), the [Secretary](/usc/42/201.md?p=c) may bring suit in the district court of the [United States](/usc/42/403.md?p=k) for the district in which the [facility](#a-3-A) is situated to enjoin the operation of the [facility](#a-3-A).

  Upon a proper showing, the district court shall grant a temporary injunction or restraining order against continuation of the activity or against operation of a [facility](#a-3-A), as the case may be, without requiring the [Secretary](/usc/42/201.md?p=c) to post a bond, pending issuance of a final order under this subsection.

- (k) **Judicial review—**
  - (1) **Petition—** If the [Secretary](/usc/42/201.md?p=c) imposes a sanction on a [facility](#a-3-A) under [subsection (h)](#h) or suspends or revokes the certificate of a [facility](#a-3-A) under [subsection (i)](#i), the [owner or operator](/usc/42/9601.md?p=20-B) of the [facility](#a-3-A) may, not later than 60 days after the date the action of the [Secretary](/usc/42/201.md?p=c) becomes final, file a petition with the [United States](/usc/42/403.md?p=k) court of appeals for the circuit in which the [facility](#a-3-A) is situated for judicial review of the action. As soon as practicable after receipt of the petition, the clerk of the court shall transmit a copy of the petition to the [Secretary](/usc/42/201.md?p=c) or other officer designated by the [Secretary](/usc/42/201.md?p=c). As soon as practicable after receipt of the copy, the [Secretary](/usc/42/201.md?p=c) shall file in the court the record on which the action of the [Secretary](/usc/42/201.md?p=c) is based, as provided in [section 2112 of title 28](/usc/28/2112.md).
  - (2) **Additional evidence—** If the petitioner applies to the court for leave to adduce additional evidence, and shows to the satisfaction of the court that the additional evidence is material and that there were reasonable grounds for the failure to adduce such evidence in the proceeding before the [Secretary](/usc/42/201.md?p=c), the court may order the additional evidence (and evidence in rebuttal of the additional evidence) to be taken before the [Secretary](/usc/42/201.md?p=c), and to be adduced upon the hearing in such manner and upon such terms and conditions as the court may determine to be proper. The [Secretary](/usc/42/201.md?p=c) may modify the findings of the [Secretary](/usc/42/201.md?p=c) as to the facts, or make new findings, by reason of the additional evidence so taken, and the [Secretary](/usc/42/201.md?p=c) shall file the [modified](/usc/42/7501.md?p=4) or new findings, and the recommendations of the [Secretary](/usc/42/201.md?p=c), if any, for the [modification](/usc/42/7501.md?p=4) or setting aside of the original action of the [Secretary](/usc/42/201.md?p=c) with the return of the additional evidence.
  - (3) **Judgment of court—** Upon the filing of the petition referred to in [paragraph (1)](#k-1), the court shall have jurisdiction to affirm the action, or to set the action aside in whole or in part, temporarily or permanently. The findings of the [Secretary](/usc/42/201.md?p=c) as to the facts, if supported by substantial evidence, shall be conclusive.
  - (4) **Finality of judgment—** The judgment of the court affirming or setting aside, in whole or in part, any action of the [Secretary](/usc/42/201.md?p=c) shall be final, subject to review by the Supreme Court of the [United States](/usc/42/403.md?p=k) upon certiorari or certification, as provided in [section 1254 of title 28](/usc/28/1254.md).
- (l) **Information—**
  - (1) **In general—** Not later than October 1, 1996, and annually thereafter, the [Secretary](/usc/42/201.md?p=c) shall compile and make available to [physicians](/usc/42/1395cc–4.md?p=a-2-E) and the general public information that the [Secretary](/usc/42/201.md?p=c) determines is useful in evaluating the performance of [facilities](#a-3-A), including a list of [facilities](#a-3-A)—
    - (A) that have been convicted under Federal or [State](/usc/42/300gg–91.md?p=d-14) laws relating to fraud and abuse, false billings, or kickbacks;
    - (B) that have been subject to sanctions under [subsection (h)](#h), together with a statement of the reasons for the sanctions;
    - (C) that have had certificates revoked or suspended under [subsection (i)](#i), together with a statement of the reasons for the revocation or suspension;
    - (D) against which the [Secretary](/usc/42/201.md?p=c) has taken action under [subsection (j)](#j), together with a statement of the reasons for the action;
    - (E) whose accreditation has been revoked, together with a statement of the reasons of the revocation;
    - (F) against which a [State](/usc/42/300gg–91.md?p=d-14) has taken adverse action; and
    - (G) that meets such other measures of performance as the [Secretary](/usc/42/201.md?p=c) may develop.
  - (2) **Date—** The information to be compiled under [paragraph (1)](#l-1) shall be information for the calendar year preceding the date the information is to be made available to the public.
  - (3) **Explanatory information—** The information to be compiled under [paragraph (1)](#l-1) shall be accompanied by such explanatory information as may be appropriate to assist in the interpretation of the information compiled under such paragraph.
- (m) **State laws—** Nothing in this section shall be construed to limit the authority of any [State](/usc/42/300gg–91.md?p=d-14) to enact and enforce laws relating to the matters covered by this section that are at least as stringent as this section or the [regulations](/usc/42/201.md?p=d) issued under this section.
- (n) **National Advisory Committee—**
  - (1) **Establishment—** In carrying out this section, the [Secretary](/usc/42/201.md?p=c) shall establish an [advisory committee](/usc/42/7703.md?p=9) to be known as the National [Mammography](#a-6) Quality Assurance [Advisory Committee](/usc/42/7703.md?p=9) (hereafter in this subsection referred to as the “[Advisory Committee](/usc/42/7703.md?p=9)”).
  - (2) **Composition—** The [Advisory Committee](/usc/42/7703.md?p=9) shall be composed of not fewer than 13, nor more than 19 individuals, who are not officers or [employees](/usc/42/300gg–91.md?p=d-5) of the Federal Government. The [Secretary](/usc/42/201.md?p=c) shall make appointments to the [Advisory Committee](/usc/42/7703.md?p=9) from among—
    - (A) [physicians](/usc/42/1395cc–4.md?p=a-2-E),
    - (B) [practitioners](/usc/42/1395a.md?p=b-6-C), and
    - (C) other health professionals,

    whose clinical practice, research specialization, or professional expertise include a significant focus on [mammography](#a-6). The [Secretary](/usc/42/201.md?p=c) shall appoint at least 4 individuals from among national breast cancer or consumer health organizations with expertise in [mammography](#a-6), at least 2 industry [representatives](/usc/42/3058f.md?p=5) with expertise in [mammography](#a-6) equipment, and at least 2 practicing [physicians](/usc/42/1395cc–4.md?p=a-2-E) who provide [mammography](#a-6) [services](/usc/42/201.md?p=a).

  - (3) **Functions and duties—** The [Advisory Committee](/usc/42/7703.md?p=9) shall—
    - (A) advise the [Secretary](/usc/42/201.md?p=c) on appropriate quality [standards](/usc/42/1320d.md?p=7) and [regulations](/usc/42/201.md?p=d) for [mammography](#a-6) [facilities](#a-3-A);
    - (B) advise the [Secretary](/usc/42/201.md?p=c) on appropriate [standards](/usc/42/1320d.md?p=7) and [regulations](/usc/42/201.md?p=d) for [accreditation bodies](#a-1);
    - (C) advise the [Secretary](/usc/42/201.md?p=c) in the development of [regulations](/usc/42/201.md?p=d) with respect to sanctions;
    - (D) assist in developing procedures for monitoring compliance with [standards](/usc/42/1320d.md?p=7) under [subsection (f)](#f);
    - (E) make recommendations and assist in the establishment of a mechanism to investigate consumer complaints;
    - (F) report on new developments concerning breast imaging that should be considered in the oversight of [mammography](#a-6) [facilities](#a-3-A);
    - (G) determine whether there exists a shortage of [mammography](#a-6) [facilities](#a-3-A) in rural and [health professional shortage areas](/usc/42/254c.md?p=b-3) and determine the effects of personnel or other requirements of [subsection (f)](#f) on access to the [services](/usc/42/201.md?p=a) of such [facilities](#a-3-A) in such areas;
    - (H) determine whether there will exist a sufficient number of medical physicists after October 1, 1999, to assure compliance with the requirements of [subsection (f)(1)(E)](#f-1-E);
    - (I) determine the costs and benefits of compliance with the requirements of this section (including the requirements of [regulations](/usc/42/201.md?p=d) promulgated under this section); and
    - (J) perform other activities that the [Secretary](/usc/42/201.md?p=c) may require.

    The [Advisory Committee](/usc/42/7703.md?p=9) shall report the findings made under subparagraphs [(G)](#n-3-G) and [(I)](#n-3-I) to the [Secretary](/usc/42/201.md?p=c) and the Congress no later than October 1, 1993.

  - (4) **Meetings—** The [Advisory Committee](/usc/42/7703.md?p=9) shall meet not less than quarterly for the first 3 years of the [program](/usc/42/274l–1.md?p=4) and thereafter, at least annually.
  - (5) **Chairperson—** The [Secretary](/usc/42/201.md?p=c) shall appoint a chairperson of the [Advisory Committee](/usc/42/7703.md?p=9).
- (o) **Consultations—** In carrying out this section, the [Secretary](/usc/42/201.md?p=c) shall consult with appropriate [Federal agencies](/usc/42/300j–6.md?p=d-2) within the Department of Health and Human [Services](/usc/42/201.md?p=a) for the purposes of developing [standards](/usc/42/1320d.md?p=7), [regulations](/usc/42/201.md?p=d), evaluations, and procedures for compliance and oversight.
- (p) **Breast cancer screening surveillance research grants—**
  - (1) **Research—**
    - (A) **Grants—** The [Secretary](/usc/42/201.md?p=c) shall award grants to such entities as the [Secretary](/usc/42/201.md?p=c) may determine to be appropriate to establish surveillance systems in selected [geographic areas](/usc/42/11360.md?p=9) to provide data to evaluate the functioning and effectiveness of breast cancer screening [programs](/usc/42/274l–1.md?p=4) in the [United States](/usc/42/403.md?p=k), including assessments of participation rates in screening [mammography](#a-6), diagnostic procedures, incidence of breast cancer, mode of detection ([mammography](#a-6) screening or other methods), outcome and follow up information, and such related epidemiologic analyses that may improve early cancer detection and contribute to reduction in breast cancer mortality. Grants may be awarded for further research on breast cancer surveillance systems upon the [Secretary](/usc/42/201.md?p=c)’s review of the evaluation of the [program](/usc/42/274l–1.md?p=4).
    - (B) **Use of funds—** Grants awarded under [subparagraph (A)](#p-1-A) may be used—
      - (i) to study—
        - (I) methods to link [mammography](#a-6) and clinical breast examination records with population-based cancer [registry](/usc/42/6341.md?p=6) data;
        - (II) methods to provide diagnostic outcome data, or facilitate the communication of diagnostic outcome data, to radiology [facilities](#a-3-A) for purposes of evaluating patterns of [mammography](#a-6) interpretation; and
        - (III) mechanisms for limiting access and maintaining confidentiality of all stored data; and
      - (ii) to conduct pilot testing of the methods and mechanisms described in subclauses [(I)](#p-1-B-i-I), [(II)](#p-1-B-i-II), and [(III)](#p-1-B-i-III) of clause (i) on a limited basis.
    - (C) **Grant application—** To be eligible to receive [funds](/usc/42/12854.md?p=3) under this paragraph, an entity shall submit an application to the [Secretary](/usc/42/201.md?p=c) at such time, in such manner, and containing such information as the [Secretary](/usc/42/201.md?p=c) may require.
    - (D) **Report—** A [recipient](/usc/42/2996a.md?p=6) of a grant under this paragraph shall submit a report to the [Secretary](/usc/42/201.md?p=c) containing the results of the study and testing conducted under clauses [(i)](#p-1-B-i) and [(ii)](#p-1-B-ii) of subparagraph (B), along with recommendations for methods of establishing a breast cancer screening surveillance system.
  - (2) **Establishment—** The [Secretary](/usc/42/201.md?p=c) shall establish a breast cancer screening surveillance system based on the recommendations contained in the report described in [paragraph (1)(D)](#p-1-D).
  - (3) **Standards and procedures—** The [Secretary](/usc/42/201.md?p=c) shall establish [standards](/usc/42/1320d.md?p=7) and procedures for the operation of the breast cancer screening surveillance system, including procedures to maintain confidentiality of patient records.
  - (4) **Information—** The [Secretary](/usc/42/201.md?p=c) shall recruit [facilities](#a-3-A) to provide to the breast cancer screening surveillance system relevant data that could help in the research of the [causes](/usc/42/9908.md?p=c-2), characteristics, and prevalence of, and potential [treatments](/usc/42/11851.md?p=11) for, breast cancer and benign breast conditions, if the information may be disclosed under [section 552 of title 5](/usc/5/552.md).
- (q) **State program—**
  - (1) **In general—** The [Secretary](/usc/42/201.md?p=c) may, upon application, authorize a [State](/usc/42/300gg–91.md?p=d-14)—
    - (A) to carry out, subject to [paragraph (2)](#q-2), the certification [program](/usc/42/274l–1.md?p=4) requirements under subsections [(b)](#b), [(c)](#c), [(d)](#d), [(g)(1)](#g-1), [(h)](#h), [(i)](#i), and [(j)](#j) (including the requirements under [regulations](/usc/42/201.md?p=d) promulgated pursuant to such subsections), and
    - (B) to implement the [standards](/usc/42/1320d.md?p=7) established by the [Secretary](/usc/42/201.md?p=c) under [subsection (f)](#f),

    with respect to [mammography](#a-6) [facilities](#a-3-A) operating within the [State](/usc/42/300gg–91.md?p=d-14).

  - (2) **Approval—** The [Secretary](/usc/42/201.md?p=c) may approve an application under [paragraph (1)](#q-1) if the [Secretary](/usc/42/201.md?p=c) determines that—
    - (A) the [State](/usc/42/300gg–91.md?p=d-14) has enacted laws and issued [regulations](/usc/42/201.md?p=d) relating to [mammography](#a-6) [facilities](#a-3-A) which are the requirements of this section (including the requirements under [regulations](/usc/42/201.md?p=d) promulgated pursuant to such subsections), and
    - (B) the [State](/usc/42/300gg–91.md?p=d-14) has provided satisfactory assurances that the [State](/usc/42/300gg–91.md?p=d-14)—
      - (i) has the legal authority and qualified personnel necessary to enforce the requirements of and the [regulations](/usc/42/201.md?p=d) promulgated pursuant to this section (including the requirements under [regulations](/usc/42/201.md?p=d) promulgated pursuant to such subsections),
      - (ii) will devote adequate [funds](/usc/42/12854.md?p=3) to the administration and enforcement of such requirements, and
      - (iii) will provide the [Secretary](/usc/42/201.md?p=c) with such information and reports as the [Secretary](/usc/42/201.md?p=c) may require.
  - (3) **Authority of Secretary—** In a [State](/usc/42/300gg–91.md?p=d-14) with an approved application—
    - (A) the [Secretary](/usc/42/201.md?p=c) shall carry out the [Secretary](/usc/42/201.md?p=c)’s functions under subsections [(e)](#e) and [(f)](#f);
    - (B) the [Secretary](/usc/42/201.md?p=c) may take action under subsections [(h)](#h), [(i)](#i), and [(j)](#j); and
    - (C) the [Secretary](/usc/42/201.md?p=c) shall conduct oversight functions under subsections [(g)(2)](#g-2) and [(g)(3)](#g-3).
  - (4) **Withdrawal of approval—**
    - (A) **In general—** The [Secretary](/usc/42/201.md?p=c) may, after providing notice and opportunity for corrective action, withdraw the approval of a [State](/usc/42/300gg–91.md?p=d-14)’s authority under [paragraph (1)](#q-1) if the [Secretary](/usc/42/201.md?p=c) determines that the [State](/usc/42/300gg–91.md?p=d-14) does not meet the requirements of such paragraph. The [Secretary](/usc/42/201.md?p=c) shall promulgate [regulations](/usc/42/201.md?p=d) for the implementation of this subparagraph.
    - (B) **Effect of withdrawal—** If the [Secretary](/usc/42/201.md?p=c) withdraws the approval of a [State](/usc/42/300gg–91.md?p=d-14) under [subparagraph (A)](#q-4-A), the certificate of any [facility](#a-3-A) certified by the [State](/usc/42/300gg–91.md?p=d-14) shall continue in effect until the expiration of a reasonable period, as determined by the [Secretary](/usc/42/201.md?p=c), for such [facility](#a-3-A) to obtain certification by the [Secretary](/usc/42/201.md?p=c).
- (r) **Funding—**
  - (1) **Fees—**
    - (A) **In general—** The [Secretary](/usc/42/201.md?p=c) shall, in accordance with this paragraph assess and collect fees from [persons](/usc/42/1320a–7k.md?p=d-4-C-i) described in [subsection (d)(1)(A)](#d-1-A) (other than [persons](/usc/42/1320a–7k.md?p=d-4-C-i) who are governmental entities, as determined by the [Secretary](/usc/42/201.md?p=c)) to cover the costs of [inspections](#a-4) conducted under [subsection (g)(1)](#g-1) by the [Secretary](/usc/42/201.md?p=c) or a [State](/usc/42/300gg–91.md?p=d-14) acting under a delegation under [subparagraph (A)](#r-1-A) of such subsection. Fees may be assessed and collected under this paragraph only in such manner as would result in an aggregate amount of fees collected during any fiscal year which equals the aggregate amount of costs for such fiscal year for [inspections](#a-4) of [facilities](#a-3-A) of such [persons](/usc/42/1320a–7k.md?p=d-4-C-i) under [subsection (g)(1)](#g-1). A [person](/usc/42/1320a–7k.md?p=d-4-C-i)’s liability for fees shall be reasonably based on the proportion of the [inspection](#a-4) costs which relate to such [person](/usc/42/1320a–7k.md?p=d-4-C-i).
    - (B) **Deposit and appropriations—**
      - (i) **Deposit and availability—** Fees collected under [subparagraph (A)](#r-1-A) shall be deposited as an offsetting collection to the appropriations for the Department of Health and Human [Services](/usc/42/201.md?p=a) as provided in appropriation Acts and shall remain available without fiscal year limitation.
      - (ii) **Appropriations—** Fees collected under [subparagraph (A)](#r-1-A) shall be collected and available only to the extent provided in advance in appropriation Acts.
  - (2) **Authorization of appropriations—** There are authorized to be appropriated to carry out this section—
    - (A) to award research grants under [subsection (p)](#p), such sums as may be necessary for each of the fiscal years 1993 through 2007; and
    - (B) for the [Secretary](/usc/42/201.md?p=c) to carry out other activities which are not supported by fees authorized and collected under [paragraph (1)](#r-1), such sums as may be necessary for fiscal years 1993 through 2007.

## Footnotes

[^1]: So in original. Probably should be “paragraph”.

## Source credit

(July 1, 1944, ch. 373, title III, § 354, as added Pub. L. 102–539, § 2, Oct. 27, 1992, 106 Stat. 3547; amended Pub. L. 105–248, §§ 2–13, Oct. 9, 1998, 112 Stat. 1864–1867; Pub. L. 108–365, §§ 2–4, Oct. 25, 2004, 118 Stat. 1738–1740.)

## Notes

### Editorial Notes

### Prior Provisions

A prior section 263b, act July 1, 1944, ch. 373, title III, § 354, as added Oct. 18, 1968, Pub. L. 90–602, § 2(3), 82 Stat. 1173; amended Nov. 28, 1990, Pub. L. 101–629, § 19(a)(1)(B), 104 Stat. 4529; Aug. 13, 1993, Pub. L. 103–80, § 4(a)(2), 107 Stat. 779, set forth Congressional declaration of purpose, prior to repeal by Pub. L. 101–629, § 19(a)(3), Nov. 28, 1990, 104 Stat. 4530.

Sections 263c to 263n, act July 1, 1944, ch. 373, title III, §§ 355–360F, as added Oct. 18, 1968, Pub. L. 90–602, § 2(3), 82 Stat. 1174, and amended, which related to electronic product radiation control, were renumbered sections 531 to 542, respectively, of the Federal Food, Drug, and Cosmetic Act by Pub. L. 101–629, § 19(a)(4), Nov. 28, 1990, 104 Stat. 4530, and are classified to sections 360hh to 360ss, respectively, of Title 21, Food and Drugs.

### Amendments

2004—Subsec. (b)(1). Pub. L. 108–365, § 2(1)(C), substituted “temporary renewal certificate, provisional certificate, or a limited provisional certificate” for “provisional certificate” in concluding provisions.

Subsec. (b)(1)(A). Pub. L. 108–365, § 2(1)(A), inserted “or a temporary renewal certificate” after “certificate” in introductory provisions and substituted “paragraphs (1) or (2) of subsection (c)” for “subsection (c)(1)” in cl. (i).

Subsec. (b)(1)(B). Pub. L. 108–365, § 2(1)(B), inserted “or a limited provisional certificate” after “certificate” in introductory provisions and substituted “paragraphs (3) and (4) of subsection (c)” for “subsection (c)(2)” in cl. (i).

Subsec. (c)(2) to (4). Pub. L. 108–365, § 2(2), added pars. (2) and (3) and redesignated former par. (2) as (4).

Subsec. (n)(2). Pub. L. 108–365, § 3(1), reenacted subpar. (C) without change, added concluding provisions, and struck out former concluding provisions which read as follows: “whose clinical practice, research specialization, or professional expertise include a significant focus on mammography. The Secretary shall appoint at least 4 individuals from among national breast cancer or consumer health organizations with expertise in mammography and at least 2 practicing physicians who provide mammography services.”

Subsec. (n)(4). Pub. L. 108–365, § 3(2), substituted “annually” for “biannually”.

Subsec. (r)(2). Pub. L. 108–365, § 4, substituted “2007” for “2002” in subpars. (A) and (B).

1998—Subsec. (a)(4). Pub. L. 105–248, § 9(1), inserted “or local” after “State”.

Subsec. (a)(8). Pub. L. 105–248, § 4(b), added par. (8).

Subsec. (d)(2)(B). Pub. L. 105–248, § 3, substituted “part 498 of title 42, Code of Federal Regulations” for “42 C.F.R. 498 and in effect on October 27, 1992”.

Subsec. (e)(1)(B)(i)(I), (II). Pub. L. 105–248, § 4(a)(1), substituted “review physicians” for “practicing physicians”.

Subsec. (e)(1)(B)(ii). Pub. L. 105–248, § 4(a)(2), substituted “relationship” for “financial relationship”.

Subsec. (f)(1)(G)(i). Pub. L. 105–248, § 5, added cl. (i) and struck out former cl. (i) which read as follows: “a facility that performs any mammogram maintain the mammogram in the permanent medical records of the patient—

“(I) for a period of not less than 5 years, or not less than 10 years if no additional mammograms of such patient are performed at the facility, or longer if mandated by State law; or

“(II) until such time as the patient should request that the patient’s medical records be forwarded to a medical institution or a physician of the patient;

whichever is longer; and”.

Subsec. (f)(1)(G)(ii)(IV). Pub. L. 105–248, § 6, added subcl. (IV) and struck out former subcl. (IV) which read as follows: “if such report is sent to the patient, the report shall include a summary written in terms easily understood by a lay person; and”.

Subsec. (g)(1). Pub. L. 105–248, § 9(1), inserted “or local” after “State” wherever appearing.

Subsec. (g)(1)(A). Pub. L. 105–248, § 7, in first sentence, struck out “certified” before “facilities” and inserted “the certification requirements under subsection (b) and” after “compliance with”.

Subsec. (g)(1)(E). Pub. L. 105–248, § 8(1), inserted “, subject to paragraph (6)” before period at end.

Subsec. (g)(3). Pub. L. 105–248, § 9(1), (2), inserted “or local” after “State” in heading and in two places in text.

Subsec. (g)(4). Pub. L. 105–248, § 9(1), inserted “or local” after “State”.

Subsec. (g)(6). Pub. L. 105–248, § 8(2), added par. (6).

Subsec. (h)(2). Pub. L. 105–248, § 10(a), added par. (2) and redesignated former par. (2) as (3).

Subsec. (h)(3). Pub. L. 105–248, § 10(a)(1), (b), redesignated par. (2) as (3), added subpar. (C), and redesignated former subpar. (C) as (D). Former par. (3) redesignated (4).

Subsec. (h)(4). Pub. L. 105–248, § 10(a)(1), (c), redesignated par. (3) as (4) and substituted “paragraphs (1) through (3)” for “paragraphs (1) and (2)”.

Subsec. (i)(1)(C). Pub. L. 105–248, § 11, inserted “(or of an accreditation body approved pursuant to subsection (e))” after “of the Secretary” and inserted “(or such accreditation body or State carrying out certification program requirements pursuant to subsection (q))” after “that the Secretary”.

Subsec. (i)(1)(D). Pub. L. 105–248, § 9(3), inserted “or local” after “any State” and “or local agency” after “by the State”.

Subsec. (i)(2)(A). Pub. L. 105–248, § 12, substituted “has reason to believe that the circumstance of the case will support one or more of the findings described in paragraph (1) and that—” and cls. (i) and (ii) for “makes the finding described in paragraph (1) and determines that—

“(i) the failure of a facility to comply with the standards established by the Secretary under subsection (f) of this section presents a serious risk to human health; or

“(ii) a facility has engaged in an action described in subparagraph (D) or (E) of paragraph (1).”

Subsec. (q)(4)(B). Pub. L. 105–248, § 13, substituted “certified” for “accredited”.

Subsec. (r)(2)(A). Pub. L. 105–248, § 2, substituted “subsection (p)” for “subsection (q)” and “2002” for “1997”.

Subsec. (r)(2)(B). Pub. L. 105–248, § 2, substituted “fiscal years” for “fiscal year” and “2002” for “1997”.

### Statutory Notes and Related Subsidiaries

### Change of Name

Committee on Labor and Human Resources of Senate changed to Committee on Health, Education, Labor, and Pensions of Senate by Senate Resolution No. 20, One Hundred Sixth Congress, Jan. 19, 1999.

Committee on Energy and Commerce of House of Representatives treated as referring to Committee on Commerce of House of Representatives by section 1(a) of Pub. L. 104–14, set out as a note preceding section 21 of Title 2, The Congress. Committee on Commerce of House of Representatives changed to Committee on Energy and Commerce of House of Representatives, and jurisdiction over matters relating to securities and exchanges and insurance generally transferred to Committee on Financial Services of House of Representatives by House Resolution No. 5, One Hundred Seventh Congress, Jan. 3, 2001.

### Termination of Advisory Committees

Advisory committees established after Jan. 5, 1973, to terminate not later than the expiration of the 2-year period beginning on the date of their establishment, unless, in the case of a committee established by the President or an officer of the Federal Government, such committee is renewed by appropriate action prior to the expiration of such 2-year period, or in the case of a committee established by Congress, its duration is otherwise provided for by law. See section 1013 of Title 5, Government Organization and Employees.

Pub. L. 93–641, § 6, Jan. 4, 1975, 88 Stat. 2275, set out as a note under section 217a of this title, provided that an advisory committee established pursuant to the Public Health Service Act shall terminate at such time as may be specifically prescribed by an Act of Congress enacted after Jan. 4, 1975.

### Regulations

Pub. L. 103–183, title VII, § 707, Dec. 14, 1993, 107 Stat. 2241, provided that: “The Secretary of Health and Human Services is authorized to issue interim final regulations— under which the Secretary may approve accreditation bodies under section 354(e) of the Public Health Service Act (42 U.S.C. 263b(e)); and establishing quality standards under section 354(f) of the Public Health Service Act (42 U.S.C. 263b(f)).”

### Study

Section 3 of Pub. L. 102–539 directed Comptroller General of United States to conduct a study of the certification program authorized by this section to determine if the program has resulted in improvement of quality and accessibility of mammography services, and if the program has reduced the frequency of poor quality mammography and improved early detection of breast cancer, with Comptroller General, not later than 3 years from Oct. 27, 1992, submit to Congress an interim report of results of study and, not later than 5 years from such date to submit a final report.