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From the U.S. Code Online via GPO Access
[wais.access.gpo.gov]
[Laws in effect as of January 16, 1996]
[Document not affected by Public Laws enacted between
  January 16, 1996 and August 28, 1996]
[CITE: 42USC263b]

 
                 TITLE 42--THE PUBLIC HEALTH AND WELFARE
 
                    CHAPTER 6A--PUBLIC HEALTH SERVICE
 
                SUBCHAPTER II--GENERAL POWERS AND DUTIES
 
   Part F--Licensing of Biological Products and Clinical Laboratories
 
                    subpart 3--mammography facilities
 
Sec. 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 under subsection (e)(1)(A) of this section 
    to accredit mammography facilities.

                           (2) Certificate

        The term ``certificate'' means the certificate described in 
    subsection (b)(1) of this section.

                            (3) Facility

        (A) In general

            The term ``facility'' means a hospital, outpatient 
        department, clinic, radiology practice, or mobile unit, an 
        office of a physician, or other facility as determined by the 
        Secretary, that conducts breast cancer screening or diagnosis 
        through mammography 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 include the operation of equipment to produce the 
        mammogram, the processing of the film, the initial 
        interpretation of the mammogram and the viewing conditions for 
        that interpretation. Where procedures such as the film 
        processing, or the interpretation of the mammogram are performed 
        in a location different from where the mammogram is performed, 
        the facility performing the mammogram shall be responsible for 
        meeting the quality standards described in subsection (f) of 
        this section.

                           (4) Inspection

        The term ``inspection'' means an onsite evaluation of the 
    facility by the Secretary, or State agency on behalf of the 
    Secretary.

                            (5) Mammogram

        The term ``mammogram'' means a radiographic image produced 
    through mammography.

                           (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) of this section.

(b) Certificate requirement

                           (1) Certificate

        No facility may conduct an examination or procedure described in 
    paragraph (2) involving mammography after October 1, 1994, unless 
    the facility obtains--
            (A) a certificate--
                (i) that is issued, and, if applicable, renewed, by the 
            Secretary in accordance with subsection (c)(1) of this 
            section;
                (ii) that is applicable to the examination or procedure 
            to be conducted; and
                (iii) that is displayed prominently in such facility; or

            (B) a provisional certificate--
                (i) that is issued by the Secretary in accordance with 
            subsection (c)(2) of this section;
                (ii) that is applicable to the examination or procedure 
            to be conducted; and
                (iii) that is displayed prominently in such facility.

    The reference to a certificate in this section includes a 
    provisional certificate.

                    (2) Examination or procedure

        A facility shall obtain a certificate in order to--
            (A) operate radiological equipment that is used to image the 
        breast;
            (B) provide for the interpretation of a mammogram produced 
        by such equipment at the facility or under arrangements with a 
        qualified individual at a facility different from where the 
        mammography examination is performed; and
            (C) provide for the processing of film produced by such 
        equipment at the facility or under arrangements with a qualified 
        individual at a facility different from where the mammography 
        examination is performed.

(c) Issuance and renewal of certificates

                           (1) In general

        The Secretary may issue or renew a certificate for a facility if 
    the person or agent described in subsection (d)(1)(A) of this 
    section meets the applicable requirements of subsection (d)(1) of 
    this section with respect to the facility. The Secretary may issue 
    or renew a certificate under this paragraph for not more than 3 
    years.

                     (2) Provisional certificate

        The Secretary may issue a provisional certificate for an entity 
    to enable the entity to qualify as a facility. The applicant for a 
    provisional certificate shall meet the requirements of subsection 
    (d)(1) of this section, except providing information required by 
    clauses (iii) and (iv) of subsection (d)(1)(A) of this section. 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, lessor, or agent of 
    the facility demonstrates to the Secretary that without such 
    extension access to mammography in the geographic area served by the 
    facility would be significantly reduced and if the owner, lessor, or 
    agent of the facility will describe in a report to the Secretary 
    steps that will be taken to qualify the facility for certification 
    under subsection (b)(1) of this section.

(d) Application for certificate

                           (1) Submission

        The Secretary may issue or renew a certificate for a facility 
    if--
            (A) the person who owns or leases the facility or an 
        authorized agent of the person, submits to the Secretary, in 
        such form and manner as the Secretary shall prescribe, an 
        application that contains at a minimum--
                (i) a description of the manufacturer, model, and type 
            of each x-ray machine, image receptor, and processor 
            operated in the performance of mammography by the facility;
                (ii) a description of the procedures currently used to 
            provide mammography at the facility, including--
                    (I) the types of procedures performed and the number 
                of such procedures performed in the prior 12 months;
                    (II) the methodologies for mammography; and
                    (III) the names and qualifications (educational 
                background, training, and experience) of the personnel 
                performing mammography and the physicians 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) of this 
            section; and
                (iv) proof of accreditation in such manner as the 
            Secretary shall prescribe; and

            (B) the person or agent submits to the Secretary--
                (i) a satisfactory assurance that the facility will be 
            operated in accordance with standards established by the 
            Secretary under subsection (f) of this section to assure the 
            safety and accuracy of mammography;
                (ii) a satisfactory assurance that the facility will--
                    (I) permit inspections under subsection (g) of this 
                section;
                    (II) make such records and information available, 
                and submit such reports, to the Secretary as the 
                Secretary may require; and
                    (III) update the information submitted under 
                subparagraph (A) or assurances submitted under this 
                subparagraph on a timely basis as required by the 
                Secretary; and

                (iii) such other information as the Secretary may 
            require.

    An applicant shall not be required to provide in an application 
    under subparagraph (A) any information which the applicant has 
    supplied to the accreditation body which accredited the applicant, 
    except as required by the Secretary.

                             (2) Appeal

        If the Secretary denies an application for the certification of 
    a facility submitted under paragraph (1)(A), the Secretary shall 
    provide the owner or lessor of the facility or the agent of the 
    owner 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 of the Secretary published 
        at 42 C.F.R. 498 and in effect on October 27, 1992.

                        (3) Effect of denial

        If the application for the certification of a facility is 
    denied, the facility may not operate unless the denial of the 
    application is overturned at the conclusion of the administrative 
    appeals process provided in the regulations referred to in paragraph 
    (2)(B).

(e) Accreditation

                (1) Approval of accreditation bodies

        (A) In general

            The Secretary may approve a private nonprofit organization 
        or State agency to accredit facilities for purposes of 
        subsection (d)(1)(A)(iv) of this section if the accreditation 
        body meets the standards for accreditation established by the 
        Secretary as described in subparagraph (B) and provides the 
        assurances required by subparagraph (C).

        (B) Standards

            The Secretary shall establish standards for accreditation 
        bodies, including--
                (i) standards that require an accreditation body to 
            perform--
                    (I) a review of clinical images from each facility 
                accredited by such body not less often than every 3 
                years which review will be made by qualified practicing 
                physicians; and
                    (II) a review of a random sample of clinical images 
                from such facilities in each 3-year period beginning 
                October 1, 1994, which review will be made by qualified 
                practicing physicians;

                (ii) standards that prohibit individuals conducting the 
            reviews described in clause (i) from maintaining any 
            financial relationship to the facility undergoing review 
            which would constitute a conflict of interest;
                (iii) standards that limit the imposition of fees for 
            accreditation to reasonable amounts;
                (iv) standards that require as a condition of 
            accreditation that each facility undergo a survey at least 
            annually by a medical physicist as described in subsection 
            (f)(1)(E) of this section to ensure that the facility meets 
            the standards described in subparagraphs (A) and (B) of 
            subsection (f)(1) of this section;
                (v) standards that require monitoring and evaluation of 
            such survey, as prescribed by the Secretary;
                (vi) standards that are equal to standards established 
            under subsection (f) of this section which are relevant to 
            accreditation as determined by the Secretary; and
                (vii) such additional standards as the Secretary may 
            require.

        (C) Assurances

            The accrediting body shall provide the Secretary 
        satisfactory assurances that the body will--
                (i) comply with the standards as described in 
            subparagraph (B);
                (ii) comply with the requirements described in paragraph 
            (4);
                (iii) submit to the Secretary the name of any facility 
            for which the accreditation body denies, suspends, or 
            revokes accreditation;
                (iv) notify the Secretary in a timely manner before the 
            accreditation body changes the standards of the body;
                (v) notify each facility accredited by the accreditation 
            body if the Secretary withdraws approval of the 
            accreditation body under paragraph (2) in a timely manner; 
            and
                (vi) provide such other additional information as the 
            Secretary may require.

        (D) Regulations

            Not later than 9 months after October 27, 1992, the 
        Secretary shall promulgate regulations under which the Secretary 
        may approve an accreditation body.

                     (2) Withdrawal of approval

        (A) In general

            The Secretary shall promulgate regulations under which the 
        Secretary may withdraw the approval of an accreditation body if 
        the Secretary determines that the accreditation body does not 
        meet the standards under subparagraph (B) of paragraph (1), the 
        requirements of clauses (i) through (vi) of subparagraph (C) of 
        paragraph (1), or the requirements of paragraph (4).

        (B) Effect of withdrawal

            If the Secretary withdraws the approval of an accreditation 
        body under subparagraph (A), the certificate of any facility 
        accredited by the body shall continue in effect until the 
        expiration of a reasonable period, as determined by the 
        Secretary, for such facility to obtain another accreditation.

                          (3) Accreditation

        To be accredited by an approved accreditation body a facility 
    shall meet--
            (A) the standards described in paragraph (1)(B) which the 
        Secretary determines are applicable to the facility, and
            (B) such other standards which the accreditation body may 
        require.

                           (4) Compliance

        To ensure that facilities accredited by an accreditation body 
    will continue to meet the standards of the accreditation body, the 
    accreditation body shall--
            (A) make onsite visits on an annual basis of a sufficient 
        number of the facilities accredited by the body to allow a 
        reasonable estimate of the performance of the body; and
            (B) take such additional measures as the Secretary 
        determines to be appropriate.

    Visits made under subparagraph (A) shall be made after providing 
    such notice as the Secretary may require.

                   (5) Revocation of accreditation

        If an accreditation body revokes the accreditation of a 
    facility, the certificate of the facility shall continue in effect 
    until such time as may be determined by the Secretary.

                      (6) Evaluation and report

        (A) Evaluation

            The Secretary shall evaluate annually the performance of 
        each approved accreditation body by--
                (i) inspecting under subsection (g)(2) of this section a 
            sufficient number of the facilities accredited by the body 
            to allow a reasonable estimate of the performance of the 
            body; and
                (ii) such additional means as the Secretary determines 
            to be appropriate.

        (B) Report

            The Secretary shall annually prepare and submit to the 
        Committee on Labor and Human Resources of the Senate and the 
        Committee on Energy and Commerce of the House of Representatives 
        a report that describes the results of the evaluation conducted 
        in accordance with subparagraph (A).

(f) Quality standards

                           (1) In general

        The standards referred to in subsection (d)(1)(B)(i) of this 
    section are standards established by the Secretary which include--
            (A) standards that require establishment and maintenance of 
        a quality assurance and quality control program at each facility 
        that is adequate and appropriate to ensure the reliability, 
        clarity, and accuracy of interpretation of mammograms and 
        standards for appropriate radiation dose;
            (B) standards that require use of radiological equipment 
        specifically designed for mammography, including radiologic 
        standards and standards for other equipment and materials used 
        in conjunction with such equipment;
            (C) a requirement that personnel who perform mammography--
                (i)(I) be licensed by a State to perform radiological 
            procedures; or
                (II) be certified as qualified to perform radiological 
            procedures by an organization described in paragraph (2)(A); 
            and
                (ii) during the 2-year period beginning October 1, 1994, 
            meet training standards for personnel who perform 
            mammography or meet experience requirements which shall at a 
            minimum include 1 year of experience in the performance of 
            mammography; and
                (iii) upon the expiration of such 2-year period meet 
            minimum training standards for personnel who perform 
            mammograms;

            (D) a requirement that mammograms be interpreted by a 
        physician who is certified as qualified to interpret 
        radiological procedures, including mammography--
                (i)(I) by a board described in paragraph (2)(B); or
                (II) by a program that complies with the standards 
            described in paragraph (2)(C); and
                (ii) who meets training and continuing medical education 
            requirements as established by the Secretary;

            (E) a requirement that individuals who survey mammography 
        facilities be medical physicists--
                (i) licensed or approved by a State to perform such 
            surveys, reviews, or inspections for mammography facilities;
                (ii) certified in diagnostic radiological physics or 
            certified as qualified to perform such surveys by a board as 
            described in paragraph (2)(D); or
                (iii) in the first 5 years after October 27, 1992, who 
            meet other criteria established by the Secretary which are 
            comparable to the criteria described in clause (i) or (ii);

            (F) a requirement that a medical physicist who is qualified 
        in mammography as described in subparagraph (E) survey 
        mammography equipment and oversee quality assurance practices at 
        each facility;
            (G) a requirement that--
                (i) 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
                (ii)(I) a facility must assure the preparation of a 
            written report of the results of any mammography examination 
            signed by the interpreting physician;
                (II) such written report shall be provided to the 
            patient's physicians (if any);
                (III) if such a physician is not available or if there 
            is no such physician, the written report shall be sent 
            directly to the patient; and
                (IV) if such report is sent to the patient, the report 
            shall include a summary written in terms easily understood 
            by a lay person; and

            (H) standards relating to special techniques for mammography 
        of patients with breast implants.

    Subparagraph (G) shall not be construed to limit a patient's access 
    to the patient's medical records.

                   (2) Certification of personnel

        The Secretary shall by regulation--
            (A) specify organizations eligible to certify individuals to 
        perform radiological procedures as required by paragraph (1)(C);
            (B) specify boards eligible to certify physicians to 
        interpret radiological procedures, including mammography, as 
        required by paragraph (1)(D);
            (C) establish standards for a program to certify physicians 
        described in paragraph (1)(D); and
            (D) specify boards eligible to certify medical physicists 
        who are qualified to survey mammography equipment and to oversee 
        quality assurance practices at mammography facilities.

(g) Inspections

                       (1) Annual inspections

        (A) In general

            The Secretary may enter and inspect certified facilities to 
        determine compliance with the standards established under 
        subsection (f) of this section. The Secretary shall, if 
        feasible, delegate to a State agency the authority to make such 
        inspections.

        (B) Identification

            The Secretary, or State agency acting on behalf of the 
        Secretary, may conduct inspections only on presenting 
        identification to the owner, operator, or agent in charge of the 
        facility to be inspected.

        (C) Scope of inspection

            In conducting inspections, the Secretary or State agency 
        acting on behalf of the Secretary--
                (i) shall have access to all equipment, materials, 
            records, and information that the Secretary or State agency 
            considers necessary to determine whether the facility is 
            being operated in accordance with this section; and
                (ii) may copy, or require the facility to submit to the 
            Secretary or the State agency, any of the materials, 
            records, or information.

        (D) Qualifications of inspectors

            Qualified individuals, as determined by the Secretary, shall 
        conduct all inspections. The Secretary may request that a State 
        agency acting on behalf of the Secretary designate a qualified 
        officer or employee to conduct the inspections, or designate a 
        qualified Federal officer or employee to conduct inspections. 
        The Secretary shall establish minimum qualifications and 
        appropriate training for inspectors and criteria for 
        certification of inspectors in order to inspect facilities for 
        compliance with subsection (f) of this section.

        (E) Frequency

            The Secretary or State agency acting on behalf of the 
        Secretary shall conduct inspections under this paragraph of each 
        facility not less often than annually.

        (F) Records and annual reports

            The Secretary or a State agency acting on behalf of the 
        Secretary which is responsible for inspecting mammography 
        facilities shall maintain records of annual inspections required 
        under this paragraph for a period as prescribed by the 
        Secretary. Such a State agency shall annually prepare and submit 
        to the Secretary a report concerning the inspections carried out 
        under this paragraph. Such reports shall include a description 
        of the facilities inspected and the results of such inspections.

               (2) Inspection of accredited facilities

        The Secretary shall inspect annually a sufficient number of the 
    facilities accredited by an accreditation body to provide the 
    Secretary with a reasonable estimate of the performance of such 
    body.

      (3) Inspection of facilities inspected by State agencies

        The Secretary shall inspect annually facilities inspected by 
    State agencies acting on behalf of the Secretary to assure a 
    reasonable performance by such State agencies.

                             (4) Timing

        The Secretary, or State agency, may conduct inspections under 
    paragraphs (1), (2), and (3), during regular business hours or at a 
    mutually agreeable time and after providing such notice as the 
    Secretary may prescribe, except that the Secretary may waive such 
    requirements if the continued performance of mammography at such 
    facility threatens the public health.

                      (5) Limited reinspection

        Nothing in this section limits the authority of the Secretary to 
    conduct limited reinspections of facilities found not to be in 
    compliance with this section.

(h) Sanctions

                           (1) In general

        In order to promote voluntary compliance with this section, the 
    Secretary may, in lieu of taking the actions authorized by 
    subsection (i) of this section, impose one or more of the following 
    sanctions:
            (A) Directed plans of correction which afford a facility an 
        opportunity to correct violations in a timely manner.
            (B) Payment for the cost of onsite monitoring.

                      (2) Civil money penalties

        The Secretary 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) of this section,
            (B) each failure by a facility to substantially comply with, 
        or each day on which a facility fails to substantially comply 
        with, the standards established under subsection (f) of this 
        section or the requirements described in subclauses (I) through 
        (III) of subsection (d)(1)(B)(ii) of this section, and
            (C) each violation, or for each aiding and abetting in a 
        violation of, any provision of, or regulation promulgated under, 
        this section by an owner, operator, or any employee of a 
        facility required to have a certificate.

                           (3) Procedures

        The Secretary shall develop and implement procedures with 
    respect to when and how each of the sanctions is to be imposed under 
    paragraphs (1) and (2). Such procedures shall provide for notice to 
    the owner or operator of the facility and a reasonable opportunity 
    for the owner or operator 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 issued under subsection (c) of 
    this section may be suspended or revoked if the Secretary finds, 
    after providing, except as provided in paragraph (2), reasonable 
    notice and an opportunity for a hearing to the owner or operator of 
    the facility, that the owner, operator, or any employee of the 
    facility--
            (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) of this section or the standards established 
        by the Secretary under subsection (f) of this section;
            (C) has failed to comply with reasonable requests of the 
        Secretary for any record, information, report, or material that 
        the Secretary concludes is necessary to determine the continued 
        eligibility of the facility for a certificate or continued 
        compliance with the standards established under subsection (f) 
        of this section;
            (D) has refused a reasonable request of the Secretary, any 
        Federal officer or employee duly designated by the Secretary, or 
        any State officer or employee duly designated by the State, for 
        permission to inspect the facility or the operations and 
        pertinent records of the facility in accordance with subsection 
        (g) of this section;
            (E) has violated or aided and abetted in the violation of 
        any provision of, or regulation promulgated under, this section; 
        or
            (F) has failed to comply with a sanction imposed under 
        subsection (h) of this section.

                     (2) Action before a hearing

        (A) In general

            The Secretary may suspend the certificate of the facility 
        before holding a hearing required by paragraph (1) if the 
        Secretary 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).

        (B) Hearing

            If the Secretary suspends a certificate under subparagraph 
        (A), the Secretary shall provide an opportunity for a hearing to 
        the owner or operator of the facility not later than 60 days 
        from the effective date of the suspension. The suspension shall 
        remain in effect until the decision of the Secretary made after 
        the hearing.

        (3) Ineligibility to own or operate facilities after 
                                 revocation

        If the Secretary revokes the certificate of a facility on the 
    basis of an act described in paragraph (1), no person who owned or 
    operated the facility at the time of the act may, within 2 years of 
    the revocation of the certificate, own or operate a facility that 
    requires a certificate under this section.

(j) Injunctions

    If the Secretary determines that--
        (1) continuation of any activity related to the provision of 
    mammography by a facility would constitute a serious risk to human 
    health, the Secretary may bring suit in the district court of the 
    United States for the district in which the facility is situated to 
    enjoin continuation of the activity; and
        (2) a facility is operating without a certificate as required by 
    subsection (b) of this section, the Secretary may bring suit in the 
    district court of the United States for the district in which the 
    facility is situated to enjoin the operation of the facility.

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, as the case may be, without requiring 
the Secretary to post a bond, pending issuance of a final order under 
this subsection.

(k) Judicial review

                            (1) Petition

        If the Secretary imposes a sanction on a facility under 
    subsection (h) of this section or suspends or revokes the 
    certificate of a facility under subsection (i) of this section, the 
    owner or operator of the facility may, not later than 60 days after 
    the date the action of the Secretary becomes final, file a petition 
    with the United States court of appeals for the circuit in which the 
    facility 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 or other 
    officer designated by the Secretary. As soon as practicable after 
    receipt of the copy, the Secretary shall file in the court the 
    record on which the action of the Secretary is based, as provided in 
    section 2112 of title 28.

                       (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, the court may order the additional evidence 
    (and evidence in rebuttal of the additional evidence) to be taken 
    before the Secretary, 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 may modify the findings of the Secretary 
    as to the facts, or make new findings, by reason of the additional 
    evidence so taken, and the Secretary shall file the modified or new 
    findings, and the recommendations of the Secretary, if any, for the 
    modification or setting aside of the original action of the 
    Secretary with the return of the additional evidence.

                        (3) Judgment of court

        Upon the filing of the petition referred to in paragraph (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 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 shall be final, subject to 
    review by the Supreme Court of the United States upon certiorari or 
    certification, as provided in section 1254 of title 28.

(l) Information

                           (1) In general

        Not later than October 1, 1996, and annually thereafter, the 
    Secretary shall compile and make available to physicians and the 
    general public information that the Secretary determines is useful 
    in evaluating the performance of facilities, including a list of 
    facilities--
            (A) that have been convicted under Federal or State laws 
        relating to fraud and abuse, false billings, or kickbacks;
            (B) that have been subject to sanctions under subsection (h) 
        of this section, together with a statement of the reasons for 
        the sanctions;
            (C) that have had certificates revoked or suspended under 
        subsection (i) of this section, together with a statement of the 
        reasons for the revocation or suspension;
            (D) against which the Secretary has taken action under 
        subsection (j) of this section, 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 has taken adverse action; and
            (G) that meets such other measures of performance as the 
        Secretary may develop.

                              (2) Date

        The information to be compiled under paragraph (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) 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 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 issued under this section.

(n) National Advisory Committee

                          (1) Establishment

        In carrying out this section, the Secretary shall establish an 
    advisory committee to be known as the National Mammography Quality 
    Assurance Advisory Committee (hereafter in this subsection referred 
    to as the ``Advisory Committee'').

                           (2) Composition

        The Advisory Committee shall be composed of not fewer than 13, 
    nor more than 19 individuals, who are not officers or employees of 
    the Federal Government. The Secretary shall make appointments to the 
    Advisory Committee from among--
            (A) physicians,
            (B) practitioners, and
            (C) other health professionals,

    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.

                      (3) Functions and duties

        The Advisory Committee shall--
            (A) advise the Secretary on appropriate quality standards 
        and regulations for mammography facilities;
            (B) advise the Secretary on appropriate standards and 
        regulations for accreditation bodies;
            (C) advise the Secretary in the development of regulations 
        with respect to sanctions;
            (D) assist in developing procedures for monitoring 
        compliance with standards under subsection (f) of this section;
            (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 
        facilities;
            (G) determine whether there exists a shortage of mammography 
        facilities in rural and health professional shortage areas and 
        determine the effects of personnel or other requirements of 
        subsection (f) of this section on access to the services of such 
        facilities 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) of this 
        section;
            (I) determine the costs and benefits of compliance with the 
        requirements of this section (including the requirements of 
        regulations promulgated under this section); and
            (J) perform other activities that the Secretary may require.

    The Advisory Committee shall report the findings made under 
    subparagraphs (G) and (I) to the Secretary and the Congress no later 
    than October 1, 1993.

                            (4) Meetings

        The Advisory Committee shall meet not less than quarterly for 
    the first 3 years of the program and thereafter, at least 
    biannually.

                           (5) Chairperson

        The Secretary shall appoint a chairperson of the Advisory 
    Committee.

(o) Consultations

    In carrying out this section, the Secretary shall consult with 
appropriate Federal agencies within the Department of Health and Human 
Services for the purposes of developing standards, regulations, 
evaluations, and procedures for compliance and oversight.

(p) Breast cancer screening surveillance research grants

                            (1) Research

        (A) Grants

            The Secretary shall award grants to such entities as the 
        Secretary may determine to be appropriate to establish 
        surveillance systems in selected geographic areas to provide 
        data to evaluate the functioning and effectiveness of breast 
        cancer screening programs in the United States, including 
        assessments of participation rates in screening mammography, 
        diagnostic procedures, incidence of breast cancer, mode of 
        detection (mammography 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's review of the evaluation of the program.

        (B) Use of funds

            Grants awarded under subparagraph (A) may be used--
                (i) to study--
                    (I) methods to link mammography and clinical breast 
                examination records with population-based cancer 
                registry data;
                    (II) methods to provide diagnostic outcome data, or 
                facilitate the communication of diagnostic outcome data, 
                to radiology facilities for purposes of evaluating 
                patterns of mammography 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), (II), and (III) of 
            clause (i) on a limited basis.

        (C) Grant application

            To be eligible to receive funds under this paragraph, an 
        entity shall submit an application to the Secretary at such 
        time, in such manner, and containing such information as the 
        Secretary may require.

        (D) Report

            A recipient of a grant under this paragraph shall submit a 
        report to the Secretary containing the results of the study and 
        testing conducted under clauses (i) and (ii) of subparagraph 
        (B), along with recommendations for methods of establishing a 
        breast cancer screening surveillance system.

                          (2) Establishment

        The Secretary shall establish a breast cancer screening 
    surveillance system based on the recommendations contained in the 
    report described in paragraph (1)(D).

                    (3) Standards and procedures

        The Secretary shall establish standards and procedures for the 
    operation of the breast cancer screening surveillance system, 
    including procedures to maintain confidentiality of patient records.

                           (4) Information

        The Secretary shall recruit facilities to provide to the breast 
    cancer screening surveillance system relevant data that could help 
    in the research of the causes, characteristics, and prevalence of, 
    and potential treatments for, breast cancer and benign breast 
    conditions, if the information may be disclosed under section 552 of 
    title 5.

(q) State program

                           (1) In general

        The Secretary may, upon application, authorize a State--
            (A) to carry out, subject to paragraph (2), the 
        certification program requirements under subsections (b), (c), 
        (d), (g)(1), (h), (i), and (j) of this section (including the 
        requirements under regulations promulgated pursuant to such 
        subsections), and
            (B) to implement the standards established by the Secretary 
        under subsection (f) of this section,

    with respect to mammography facilities operating within the State.

                            (2) Approval

        The Secretary may approve an application under paragraph (1) if 
    the Secretary determines that--
            (A) the State has enacted laws and issued regulations 
        relating to mammography facilities which are the requirements of 
        this section (including the requirements under regulations 
        promulgated pursuant to such subsections), and
            (B) the State has provided satisfactory assurances that the 
        State--
                (i) has the legal authority and qualified personnel 
            necessary to enforce the requirements of and the regulations 
            promulgated pursuant to this section (including the 
            requirements under regulations promulgated pursuant to such 
            subsections),
                (ii) will devote adequate funds to the administration 
            and enforcement of such requirements, and
                (iii) will provide the Secretary with such information 
            and reports as the Secretary may require.

                     (3) Authority of Secretary

        In a State with an approved application--
            (A) the Secretary shall carry out the Secretary's functions 
        under subsections (e) and (f) of this section;
            (B) the Secretary may take action under subsections (h), 
        (i), and (j) of this section; and
            (C) the Secretary shall conduct oversight functions under 
        subsections (g)(2) and (g)(3) of this section.

                     (4) Withdrawal of approval

        (A) In general

            The Secretary may, after providing notice and opportunity 
        for corrective action, withdraw the approval of a State's 
        authority under paragraph (1) if the Secretary determines that 
        the State does not meet the requirements of such paragraph. The 
        Secretary shall promulgate regulations for the implementation of 
        this subparagraph.

        (B) Effect of withdrawal

            If the Secretary withdraws the approval of a State under 
        subparagraph (A), the certificate of any facility accredited by 
        the State shall continue in effect until the expiration of a 
        reasonable period, as determined by the Secretary, for such 
        facility to obtain certification by the Secretary.

(r) Funding

                              (1) Fees

        (A) In general

            The Secretary shall, in accordance with this paragraph 
        assess and collect fees from persons described in subsection 
        (d)(1)(A) of this section (other than persons who are 
        governmental entities, as determined by the Secretary) to cover 
        the costs of inspections conducted under subsection (g)(1) of 
        this section by the Secretary or a State acting under a 
        delegation under subparagraph (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 of facilities of such 
        persons under subsection (g)(1) of this section. A person's 
        liability for fees shall be reasonably based on the proportion 
        of the inspection costs which relate to such person.

        (B) Deposit and appropriations

            (i) Deposit and availability

                Fees collected under subparagraph (A) shall be deposited 
            as an offsetting collection to the appropriations for the 
            Department of Health and Human Services as provided in 
            appropriation Acts and shall remain available without fiscal 
            year limitation.
            (ii) Appropriations

                Fees collected under subparagraph (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 (q) of this 
        section, such sums as may be necessary for each of the fiscal 
        years 1993 through 1997; and
            (B) for the Secretary to carry out other activities which 
        are not supported by fees authorized and collected under 
        paragraph (1), such sums as may be necessary for fiscal year \1\ 
        1993 through 1997.
---------------------------------------------------------------------------
    \1\ So in original. Probably should be ``years''.
---------------------------------------------------------------------------

(July 1, 1944, ch. 373, title III, Sec. 354, as added Oct. 27, 1992, 
Pub. L. 102-539, Sec. 2, 106 Stat. 3547.)


                            Prior Provisions

    A prior section 263b, act July 1, 1944, ch. 373, title III, 
Sec. 354, as added Oct. 18, 1968, Pub. L. 90-602, Sec. 2(3), 82 Stat. 
1173; amended Nov. 28, 1990, Pub. L. 101-629, Sec. 19(a)(1)(B), 104 
Stat. 4529; Aug. 13, 1993, Pub. L. 103-80, Sec. 4(a)(2), 107 Stat. 779, 
set forth Congressional declaration of purpose, prior to repeal by Pub. 
L. 101-629, Sec. 19(a)(3), Nov. 28, 1990, 104 Stat. 4530.
    Sections 263c to 263n, act July 1, 1944, ch. 373, title III, 
Secs. 355-360F, as added Oct. 18, 1968, Pub. L. 90-602, Sec. 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, Sec. 19(a)(4), 
Nov. 28, 1990, 104 Stat. 4530, and are classified to sections 360hh to 
360ss, respectively, of Title 21, Food and Drugs.

                         Change of Name

    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.


                   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 14 of Pub. L. 92-
463, Oct. 6, 1972, 86 Stat. 776, set out in the Appendix to Title 5, 
Government Organization and Employees.
    Pub. L. 93-641, Sec. 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, Sec. 707, Dec. 14, 1993, 107 Stat. 2241, 
provided that: ``The Secretary of Health and Human Services is 
authorized to issue interim final regulations--
        ``(1) 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
        ``(2) 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.

                  Section Referred to in Other Sections

    This section is referred to in sections 1395m, 1395x of this title.


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