Return to Public Health Service Act Home |
Climate Change Project |
Table of Contents |
Courses | Search |
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.
Return to Public Health Service Act
The Climate Change and Public Health Law Site
The Best on the WWW Since 1995!
Copyright as to non-public domain materials
See DR-KATE.COM for home hurricane and disaster preparation
See WWW.EPR-ART.COM for photography of southern Louisiana and Hurricane Katrina
Professor Edward P. Richards, III, JD, MPH - Webmaster
Provide Website Feedback - https://www.lsu.edu/feedback
Privacy Statement - https://www.lsu.edu/privacy
Accessibility Statement - https://www.lsu.edu/accessibility