Mammography Quality Standards Reauthorization Act of 2004
PL 108-365 (H.R.4555), enacted 10/25/2004

118 STAT. 1738
PUBLIC LAW 108–365—OCT. 25, 2004
Public Law 108–365
108th Congress
An Act
To amend the Public Health Service Act to revise and extend provisions relating
to mammography quality standards.
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
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 CERTIFI-
CATE.
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 ‘‘provi-
sional certificate’’ and inserting ‘‘temporary renewal certifi-
cate, provisional certificate, or a limited provisional certifi-
cate’’; 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
Mammography
Quality
Standards
Reauthorization
Act of 2004.
42 USC 201 note.
Oct. 25, 2004
[H.R. 4555]
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118 STAT. 1739
PUBLIC LAW 108–365—OCT. 25, 2004
frames for the submission of such materials but the accredi-
tation 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 con-
duct 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 para-
graph (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’’.
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118 STAT. 1740
PUBLIC LAW 108–365—OCT. 25, 2004
LEGISLATIVE HISTORY—H.R. 4555 (S. 1879):
HOUSE REPORTS: No. 108–694 (Comm. on Energy and Commerce).
SENATE REPORTS: No. 108–220 accompanying S. 1879 (Comm. on Health, Edu-
cation, Labor, and Pensions).
CONGRESSIONAL RECORD, Vol. 150 (2004):
Oct. 5, considered and passed House.
Oct. 9, considered and passed Senate.
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’’.
Approved October 25, 2004.
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