PUBLIC LAW 108–365—OCT. 25, 2004

MAMMOGRAPHY QUALITY STANDARDS

REAUTHORIZATION ACT OF 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 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

Mammography

Quality

Standards

Reauthorization

Act of 2004.

42 USC 201 note.

Oct. 25, 2004

[H.R. 4555]

PUBLIC LAW 108–365—OCT. 25, 2004 118 STAT. 1739

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’’.

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, Education, Labor, and Pensions).

CONGRESSIONAL RECORD, Vol. 150 (2004):

Oct. 5, considered and passed House.

Oct. 9, considered and passed Senate.

Æ

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.