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108th Congress                                                   Report
                        HOUSE OF REPRESENTATIVES
 2d Session                                                     108-694
======================================================================
 
       MAMMOGRAPHY QUALITY STANDARDS REAUTHORIZATION ACT OF 2004

                                _______
                                

 September 22, 2004.--Committed to the Committee of the Whole House on 
            the State of the Union and ordered to be printed

                                _______
                                

    Mr. Barton of Texas, from the Committee on Energy and Commerce, 
                        submitted the following

                              R E P O R T

                        [To accompany H.R. 4555]

      [Including cost estimate of the Congressional Budget Office]

  The Committee on Energy and Commerce, to whom was referred 
the bill (H.R. 4555) to amend the Public Health Service Act to 
revise and extend provisions relating to mammography quality 
standards, having considered the same, report favorably thereon 
with an amendment and recommend that the bill as amended do 
pass.

                                CONTENTS

                                                                   Page
Amendment........................................................     1
Purpose and Summary..............................................     2
Background and Need for Legislation..............................     3
Hearings.........................................................     3
Committee Consideration..........................................     3
Committee Votes..................................................     3
Committee Oversight Findings.....................................     4
Statement of General Performance Goals and Objectives............     4
New Budget Authority, Entitlement Authority, and Tax Expenditures     4
Committee Cost Estimate..........................................     4
Congressional Budget Office Estimate.............................     4
Federal Mandates Statement.......................................     6
Advisory Committee Statement.....................................     6
Constitutional Authority Statement...............................     6
Applicability to Legislative Branch..............................     6
Section-by-Section Analysis of the Legislation...................     6
Changes in Existing Law Made by the Bill, as Reported............     7

                               Amendment

  The amendment is as follows:
  Strike all after the enacting clause and insert the 
following:

SECTION 1. SHORT TITLE.

  This Act may be cited as the ``Mammography Quality Standards 
Reauthorization Act of 2004''.

SEC. 2. TEMPORARY RENEWAL AND LIMITED PROVISIONAL CERTIFICATE.

  Section 354 of the Public Health Service Act (42 U.S.C. 263b) is 
amended--
          (1) in subsection (b)(1)--
                  (A) in subparagraph (A)--
                          (i) in the matter preceding clause (i), by 
                        inserting ``or a temporary renewal 
                        certificate'' after ``certificate''; and
                          (ii) in clause (i), by striking ``subsection 
                        (c)(1)'' and inserting ``paragraphs (1) or (2) 
                        of subsection (c)'';
                  (B) in subparagraph (B)--
                          (i) in the matter preceding clause (i), by 
                        inserting ``or a limited provisional 
                        certificate'' after ``certificate''; and
                          (ii) in clause (i), by striking ``subsection 
                        (c)(2)'' and inserting ``paragraphs (3) and (4) 
                        of subsection (c)''; and
                  (C) in the flush matter at the end, by striking 
                ``provisional certificate'' and inserting ``temporary 
                renewal certificate, provisional certificate, or a 
                limited provisional certificate''; and
          (2) in subsection (c)--
                  (A) by redesignating paragraph (2) as paragraph (4); 
                and
                  (B) by inserting after paragraph (1) the following:
          ``(2) Temporary renewal certificate.--The Secretary may issue 
        a temporary renewal certificate, for a period of not to exceed 
        45 days, to a facility seeking reaccreditation if the 
        accreditation body has issued an accreditation extension, for a 
        period of not to exceed 45 days, for any of the following:
                  ``(A) The facility has submitted the required 
                materials to the accreditation body within the 
                established time frames for the submission of such 
                materials but the accreditation body is unable to 
                complete the reaccreditation process before the 
                certification expires.
                  ``(B) The facility has acquired additional or 
                replacement equipment, or has had significant personnel 
                changes or other unforeseen situations that have caused 
                the facility to be unable to meet reaccreditation 
                timeframes, but in the opinion of the accreditation 
                body have not compromised the quality of mammography.
          ``(3) Limited provisional certificate.--The Secretary may, 
        upon the request of an accreditation body, issue a limited 
        provisional certificate to an entity to enable the entity to 
        conduct examinations for educational purposes while an onsite 
        visit from an accreditation body is in progress. Such 
        certificate shall be valid only during the time the site visit 
        team from the accreditation body is physically in the facility, 
        and in no case shall be valid for longer than 72 hours. The 
        issuance of a certificate under this paragraph, shall not 
        preclude the entity from qualifying for a provisional 
        certificate under paragraph (4).''.

SEC. 3. NATIONAL ADVISORY COMMITTEE.

  Section 354(n) of the Public Health Service Act (42 U.S.C. 263b(n)) 
is amended--
          (1) in paragraph (2), by striking subparagraph (C) and all 
        that follows and inserting the following:
                  ``(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, at least 2 
        industry representatives with expertise in mammography 
        equipment, and at least 2 practicing physicians who provide 
        mammography services.''; and
          (2) in paragraph (4), by striking ``biannually'' and 
        inserting ``annually''.

SEC. 4. AUTHORIZATION OF APPROPRIATIONS.

  Subparagraphs (A) and (B) of section 354(r)(2) of the Public Health 
Service Act (42 U.S.C. 263b(r)(2)(A) and (B)) are amended by striking 
``2002'' each place it appears and inserting ``2007''.

                          Purpose and Summary

    The purpose of H.R. 4555 is to reauthorize the Mammography 
Quality Standards Act (MQSA).

                  Background and Need for Legislation

    In 1992, Congress enacted the Mammography Quality Standards 
Act to ensure that all women have access to quality mammography 
for the detection of breast cancer in its earliest, most 
treatable stages. In 1998, Congress reauthorized MQSA through 
2002 in the Mammography Quality Standards Reauthorization Act 
of 1998.
    The MQSA provides that screening and diagnostic services 
must be accredited and certified by the Food and Drug 
Administration (FDA). When performing this function, the FDA 
also considers the special circumstances required in ensuring 
clear, accurate and reliable mammograms of patients with breast 
implants. As of June 30, 2004, there were 9,039 MQSA-certified 
facilities in the United States and its territories.
    There are four FDA-approved accreditation bodies under 
MQSA. The period of approval for each of the accreditation 
bodies is seven years, after which time they need to apply for 
renewal of their status. The approved bodies are the American 
College of Radiology, and the States of Arkansas, Iowa, and 
Texas. FDA reports annually to the Congress about the 
performance of these accreditation bodies. There is also an 
annual facility inspection component under the program. Under 
MQSA, trained FDA inspectors, with state agencies under 
contract to the FDA, and with states that are certifying 
agencies, perform annual MQSA inspections. Only FDA performs 
annual inspections of Federal facilities. Forty-eight States 
and jurisdictions have contracted with FDA to perform these 
inspections.
    Inspectors perform science-based inspections to (1) 
determine the radiation dose for the standard mammography; (2) 
assess image quality using a standard image quality phantom; 
(3) empirically evaluate the quality of the facility's film 
processing; (4) and, evaluate the facility's equipment. In 
addition to the science-based inspections, the inspectors 
review the facility's medical reports, lay summaries, and 
medical audits to ensure the facility's procedures meet MQSA 
requirements. MQSA requires FDA to collect fees from facilities 
to cover the cost of their annual facility inspections.

                                Hearings

    The Committee on Energy and Commerce has not held hearings 
on the legislation.

                        Committee Consideration

    On June 15, 2004 the Subcommittee on Health met in open 
markup session and approved H.R. 4555 for Full Committee 
consideration by a voice vote. On June 24, 2004, the Committee 
on Energy and Commerce met in open markup session and approved 
H.R. 4555, as amended, by a voice vote.

                            Committee Votes

    There were no record votes taken in connection with 
ordering H.R. 4555 reported. A motion by Mr. Pickering to order 
H.R. 4555 reported to the House, as amended, was agreed to by a 
voice vote.

                      Committee Oversight Findings

    Pursuant to clause 3(c)(1) of rule XIII of the Rules of the 
House of Representatives, the Committee has not held oversight 
or legislative hearings on this legislation.

         Statement of General Performance Goals and Objectives

    The goal of this legislation is to continue the improvement 
in the quality of mammograms nationwide.

   New Budget Authority, Entitlement Authority, and Tax Expenditures

    In compliance with clause 3(c)(2) of rule XIII of the Rules 
of the House of Representatives, the Committee finds that H.R. 
4555, the Mammography Quality Standards Reauthorization Act, 
would result in no new or increased budget authority, 
entitlement authority, or tax expenditures or revenues.

                        Committee Cost Estimate

    The Committee adopts as its own the cost estimate prepared 
by the Director of the Congressional Budget Office pursuant to 
section 402 of the Congressional Budget Act of 1974.

                  Congressional Budget Office Estimate

    Pursuant to clause 3(c)(3) of rule XIII of the Rules of the 
House of Representatives, the following is the cost estimate 
provided by the Congressional Budget Office pursuant to section 
402 of the Congressional Budget Act of 1974:

                                     U.S. Congress,
                               Congressional Budget Office,
                                      Washington, DC, July 7, 2004.
Hon. Joe Barton,
Chairman, Committee on Energy and Commerce,
House of Representatives, Washington, DC.
    Dear Mr. Chairman: The Congressional Budget Office has 
prepared the enclosed cost estimate for H.R. 4555, the 
Mammography Quality Standards Reauthorization Act of 2004.
    If you wish further details on this estimate, we will be 
pleased to provide them. The CBO staff contact is Julia 
Christensen.
            Sincerely,
                                      Elizabeth M. Robinson
                               (For Douglas Holtz-Eakin, Director).
    Enclosure.

H.R. 4555--Mammography Quality Standards Reauthorization Act of 2004

    Summary: H.R. 4555 would reauthorize funding for programs 
carried out under the Mammography Quality Standards Act (MQSA) 
of 1992. (The program was last reauthorized in 1998.) 
Authorizations for the program expired at the end of fiscal 
year 2002 for activities not supported by user fees. The bill 
would authorize the appropriation of such sums as necessary 
through fiscal year 2007. Assuming the appropriation of the 
necessary amounts, CBO estimates that implementing H.R. 4555 
would cost $10 million in 2005 and $51 million over the 2005-
2009 period. Enacting the bill would not affect direct spending 
or receipts.
    H.R. 4555 contains no intergovernmental or private-sector 
mandates as defined in the Unfunded Mandates Reform Act (UMRA) 
and would impose no costs on state, local, or tribal 
governments.
    Estimated cost to the Federal Government: The estimated 
budgetary impact of H.R. 4555 is shown in the following table. 
The costs fall within budget function 550 (health).

----------------------------------------------------------------------------------------------------------------
                                                                     By fiscal year, in millions of dollars--
                                                                 -----------------------------------------------
                                                                   2004    2005    2006    2007    2008    2009
----------------------------------------------------------------------------------------------------------------
                                        SPENDING SUBJECT TO APPROPRIATION
 MQSA spending under current law:
    Estimated budget authority \1\..............................      16       0       0       0       0       0
    Estimated outlays...........................................      16       7       2       0       0       0
Proposed changes:
    Estimated authorization level...............................       0      17      17      18       0       0
    Estimated outlays...........................................       0      10      15      17       7       2
MQSA spending under H.R. 4555:
    Estimated authorization level \1\...........................      16      17      17      18       0       0
    Estimated outlays...........................................      16      17      17      17       7       2
----------------------------------------------------------------------------------------------------------------
\1\ The 2004 level is the amount appropriated in that year for activities authorized under the Mammography
  Quality Standards Act but not supported by user fees.

    Basis of estimate: For this estimate, CBO assumes that the 
bill will be enacted in fiscal year 2004, that the necessary 
appropriations will be provided near the start of each fiscal 
year, and that outlays will not follow historical spending 
patterns for the MQSA program.
    H.R. 4555 would authorize the appropriation of such sums as 
necessary through 2007 for the Food and Drug Administration 
(FDA) to carry out MQSA activities that are not supported by 
user fees. Such activities include establishing and enforcing 
standards for mammography facilities, accreditation bodies, 
equipment, personnel, and quality assurance; inspecting 
facilities run by governmental entities; and providing consumer 
education. The bill also would allow the Secretary of Health 
and Human Services to issue a temporary renewal certificate and 
a limited provisional certificate to facilities seeking 
reaccreditation under certain circumstances. CBO estimates that 
these activities could be carried out with funding set at the 
2004 appropriation level, adjusted for inflation. We estimate 
that these activities would cost $8 million in 2005 and $33 
million over the 2005-2009 period.
    H.R. 4555 would modify composition of the National 
Mammography Quality Assurance Advisory Committee to include two 
industry representatives with expertise in mammography 
equipment. CBO assumes that this requirement would effectively 
add two new members to the committee. The bill also would cut 
back the committee's meeting schedule by directing the 
committee to convene only once each year instead of meeting 
biannually as required under current law. We estimate that 
implementing those changes, on balance, would have a negligible 
effect on FDA's costs associated with the advisory committee.
    In addition, H.R. 4555 would reauthorize the breast cancer 
screening surveillance research grant program, administered by 
the National Cancer Institute. The bill would authorize the 
appropriation of such sums as necessary for that program, at an 
estimated cost of $2 million in 2005 and $18 million over the 
2005-2009 period. The program funds research to determine the 
effectiveness of screening programs in reducing breast cancer 
mortality.
    Intergovernmental and private-sector impact: H.R. 4555 
contains no intergovernmental or private-sector mandates as 
defined in UMRA and would impose no costs on state, local, or 
tribal governments.
    Previous cost estimate: On March 9, 2004, CBO transmitted a 
cost estimate for S. 1879, the Mammography Quality Standards 
Act of 2003, as passed by the Senate on February 2, 2004. The 
main difference between the bills is that H.R. 4555 would 
reauthorize the MQSA program (including the breast cancer 
screening surveillance research grants) through fiscal year 
2007, while S. 1879 would reauthorize MQSA activities through 
2005. H.R. 4555 also would make administrative changes to the 
National Mammography Quality Assurance Advisory Committee; S. 
1879 does not contain a similar provision. Our cost estimates 
reflect those differences.
    Estimate prepared by: Federal Costs: Julia Christenson. 
Impact on State, Local, and Tribal Governments: Leo Lex. Impact 
on Private Sector: Meena Fernandes.
    Estimate approved by: Peter H. Fontaine, Deputy Assistant 
Director for Budget Analysis.

                       Federal Mandates Statement

    The Committee adopts as its own the estimate of Federal 
mandates prepared by the Director of the Congressional Budget 
Office pursuant to section 423 of the Unfunded Mandates Reform 
Act.

                      Advisory Committee Statement

    No advisory committees within the meaning of section 5(b) 
of the Federal Advisory Committee Act were created by this 
legislation.

                   Constitutional Authority Statement

    Pursuant to clause 3(d)(1) of rule XIII of the Rules of the 
House of Representatives, the Committee finds that the 
Constitutional authority for this legislation is provided in 
Article I, section 8, clause 3, which grants Congress the power 
to regulate commerce with foreign nations, among the several 
States, and with the Indian tribes.

                  Applicability to Legislative Branch

    The Committee finds that the legislation does not relate to 
the terms and conditions of employment or access to public 
services or accommodations within the meaning of section 
102(b)(3) of the Congressional Accountability Act.

             Section-by-Section Analysis of the Legislation


Section 1. Short Title

    Section 1 designates the short title of the bill as ``The 
Mammography Quality Standards Reauthorization Act of 2004.''

Section 2. Temporary Renewal and Limited Provisional Certificate

    Section 2 amends section 354 of the Public Health Service 
Act to authorize the Secretary of Health and Human Services 
(HHS) to issue a temporary renewal certificate, for a period 
not to exceed 45 days, to any facility seeking reaccreditation 
under MQSA. In order for a facility to receive a temporary 
renewal certificate from the Secretary, the facility must have 
been issued an accreditation certificate not to exceed 45 days. 
In order to be issued a temporary renewal certificate by the 
Secretary, a facility needs to meet any of the following 
criteria: (1) if the facility has met the established time 
frames for submitting materials to the accreditation body for 
reaccreditation, but the accreditation body is unable to 
complete the process before the certificate expires; (2) if the 
facility acquires additional or replacement equipment, has a 
low volume of mammography, or has significant personnel changes 
which prohibit the facility from meeting the accreditation time 
frames; (3) or, if there are other unforeseen circumstances 
that keep the facility from meeting the reaccreditation time 
frames, but at the same time have not compromised the quality 
of mammography in the opinion of the accreditation body.
    Section 2 also allows the Secretary to issue, upon the 
request of an accreditation body, a limited provisional 
certificate, for a period not to exceed 72 hours, to allow an 
entity to conduct examination for educational purposes while an 
onsite visit from an accreditation body is in progress.
    Finally, section 2 permits the Secretary to appoint 
individuals with expertise in mammography equipment to the 
National Mammography Quality Assurance Advisory Committee and 
grants the Advisory Committee greater flexibility in how many 
times the Committee must meet annually.

Section 3. Authorization of Appropriations

    Section 3 authorizes the appropriations of such sums as 
necessary through fiscal year 2007.

         Changes in Existing Law Made by the Bill, as Reported

  In compliance with clause 3(e) of rule XIII of the Rules of 
the House of Representatives, changes in existing law made by 
the bill, as reported, are shown as follows (existing law 
proposed to be omitted is enclosed in black brackets, new 
matter is printed in italic, existing law in which no change is 
proposed is shown in roman):

              SECTION 354 OF THE PUBLIC HEALTH SERVICE ACT


SEC. 354. CERTIFICATION OF MAMMOGRAPHY FACILITIES.

  (a) * * *
  (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 or a temporary renewal 
                certificate--
                          (i) that is issued, and, if 
                        applicable, renewed, by the Secretary 
                        in accordance with [subsection (c)(1)] 
                        paragraphs (1) or (2) of subsection 
                        (c);

           *       *       *       *       *       *       *

                  (B) a provisional certificate or a limited 
                provisional certificate--
                          (i) that is issued by the Secretary 
                        in accordance with [subsection (c)(2)] 
                        paragraphs (3) and (4) of subsection 
                        (c);

           *       *       *       *       *       *       *

        The reference to a certificate in this section includes 
        a [provisional certificate] temporary renewal 
        certificate, provisional certificate, or a limited 
        provisional certificate.

           *       *       *       *       *       *       *

  (c) Issuance and Renewal of Certificates.--
          (1) * * *
          (2) Temporary renewal certificate.--The Secretary may 
        issue a temporary renewal certificate, for a period of 
        not to exceed 45 days, to a facility seeking 
        reaccreditation if the accreditation body has issued an 
        accreditation extension, for a period of not to exceed 
        45 days, for any of the following:
                  (A) The facility has submitted the required 
                materials to the accreditation body within the 
                established time frames for the submission of 
                such materials but the accreditation body is 
                unable to complete the reaccreditation process 
                before the certification expires.
                  (B) The facility has acquired additional or 
                replacement equipment, or has had significant 
                personnel changes or other unforeseen 
                situations that have caused the facility to be 
                unable to meet reaccreditation timeframes, but 
                in the opinion of the accreditation body have 
                not compromised the quality of mammography.
          (3) Limited provisional certificate.--The Secretary 
        may, upon the request of an accreditation body, issue a 
        limited provisional certificate to an entity to enable 
        the entity to conduct examinations for educational 
        purposes while an onsite visit from an accreditation 
        body is in progress. Such certificate shall be valid 
        only during the time the site visit team from the 
        accreditation body is physically in the facility, and 
        in no case shall be valid for longer than 72 hours. The 
        issuance of a certificate under this paragraph, shall 
        not preclude the entity from qualifying for a 
        provisional certificate under paragraph (4).
          [(2)] (4) 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), except providing information 
        required by clauses (iii) and (iv) of subsection 
        (d)(1)(A). A provisional certificate may be in effect 
        no longer than 6 months from the date it is issued, 
        except that it may be extended once for a period of not 
        more than 90 days if the owner, 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).

           *       *       *       *       *       *       *

  (n) National Advisory Committee.--
          (1) * * *
          (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) * * *

           *       *       *       *       *       *       *

                  [(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.]
                  (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, at least 2 industry representatives with 
        expertise in mammography equipment, and at least 2 
        practicing physicians who provide mammography services.

           *       *       *       *       *       *       *

          (4) Meetings.--The Advisory Committee shall meet not 
        less than quarterly for the first 3 years of the 
        program and thereafter, at least [biannually] annually.

           *       *       *       *       *       *       *

  (r) Funding.--
          (1) * * *
          (2) Authorization of Appropriations.--There are 
        authorized to be appropriated to carry out this 
        section--
                  (A) to award research grants under subsection 
                (p), such sums as may be necessary for each of 
                the fiscal years 1993 through [2002] 2007; 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 years 
                1993 through [2002] 2007.

           *       *       *       *       *       *       *