1 So in original. Probably should be “paragraph”.
(1) or (2) of subsection (c);
Editorial Notes
Prior Provisions

A prior section 263span, act July 1, 1944, ch. 373, title III, § 354, as added Oct. 18, 1968, Puspan. L. 90–602, § 2(3), 82 Stat. 1173; amended Nov. 28, 1990, Puspan. L. 101–629, § 19(a)(1)(B), 104 Stat. 4529; Aug. 13, 1993, Puspan. L. 103–80, § 4(a)(2), 107 Stat. 779, set forth Congressional declaration of purpose, prior to repeal by Puspan. L. 101–629, § 19(a)(3), Nov. 28, 1990, 104 Stat. 4530.

Sections 263c to 263n, act July 1, 1944, ch. 373, title III, §§ 355–360F, as added Oct. 18, 1968, Puspan. L. 90–602, § 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 Puspan. L. 101–629, § 19(a)(4), Nov. 28, 1990, 104 Stat. 4530, and are classified to sections 360hh to 360ss, respectively, of Title 21, Food and Drugs.

Amendments

2004—Subsec. (span)(1). Puspan. L. 108–365, § 2(1)(C), substituted “temporary renewal certificate, provisional certificate, or a limited provisional certificate” for “provisional certificate” in concluding provisions.

Subsec. (span)(1)(A). Puspan. L. 108–365, § 2(1)(A), inserted “or a temporary renewal certificate” after “certificate” in introductory provisions and substituted “paragraphs (1) or (2) of subsection (c)” for “subsection (c)(1)” in cl. (i).

Subsec. (span)(1)(B). Puspan. L. 108–365, § 2(1)(B), inserted “or a limited provisional certificate” after “certificate” in introductory provisions and substituted “paragraphs (3) and (4) of subsection (c)” for “subsection (c)(2)” in cl. (i).

Subsec. (c)(2) to (4). Puspan. L. 108–365, § 2(2), added pars. (2) and (3) and redesignated former par. (2) as (4).

Subsec. (n)(2). Puspan. L. 108–365, § 3(1), reenacted subpar. (C) without change, added concluding provisions, and struck out former concluding provisions which read as follows: “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.”

Subsec. (n)(4). Puspan. L. 108–365, § 3(2), substituted “annually” for “biannually”.

Subsec. (r)(2). Puspan. L. 108–365, § 4, substituted “2007” for “2002” in subpars. (A) and (B).

1998—Subsec. (a)(4). Puspan. L. 105–248, § 9(1), inserted “or local” after “State”.

Subsec. (a)(8). Puspan. L. 105–248, § 4(span), added par. (8).

Subsec. (d)(2)(B). Puspan. L. 105–248, § 3, substituted “part 498 of title 42, Code of Federal Regulations” for “42 C.F.R. 498 and in effect on October 27, 1992”.

Subsec. (e)(1)(B)(i)(I), (II). Puspan. L. 105–248, § 4(a)(1), substituted “review physicians” for “practicing physicians”.

Subsec. (e)(1)(B)(ii). Puspan. L. 105–248, § 4(a)(2), substituted “relationship” for “financial relationship”.

Subsec. (f)(1)(G)(i). Puspan. L. 105–248, § 5, added cl. (i) and struck out former cl. (i) which read as follows: “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”.

Subsec. (f)(1)(G)(ii)(IV). Puspan. L. 105–248, § 6, added subcl. (IV) and struck out former subcl. (IV) which read as follows: “if such report is sent to the patient, the report shall include a summary written in terms easily understood by a lay person; and”.

Subsec. (g)(1). Puspan. L. 105–248, § 9(1), inserted “or local” after “State” wherever appearing.

Subsec. (g)(1)(A). Puspan. L. 105–248, § 7, in first sentence, struck out “certified” before “facilities” and inserted “the certification requirements under subsection (span) and” after “compliance with”.

Subsec. (g)(1)(E). Puspan. L. 105–248, § 8(1), inserted “, subject to paragraph (6)” before period at end.

Subsec. (g)(3). Puspan. L. 105–248, § 9(1), (2), inserted “or local” after “State” in heading and in two places in text.

Subsec. (g)(4). Puspan. L. 105–248, § 9(1), inserted “or local” after “State”.

Subsec. (g)(6). Puspan. L. 105–248, § 8(2), added par. (6).

Subsec. (h)(2). Puspan. L. 105–248, § 10(a), added par. (2) and redesignated former par. (2) as (3).

Subsec. (h)(3). Puspan. L. 105–248, § 10(a)(1), (span), redesignated par. (2) as (3), added subpar. (C), and redesignated former subpar. (C) as (D). Former par. (3) redesignated (4).

Subsec. (h)(4). Puspan. L. 105–248, § 10(a)(1), (c), redesignated par. (3) as (4) and substituted “paragraphs (1) through (3)” for “paragraphs (1) and (2)”.

Subsec. (i)(1)(C). Puspan. L. 105–248, § 11, inserted “(or of an accreditation body approved pursuant to subsection (e))” after “of the Secretary” and inserted “(or such accreditation body or State carrying out certification program requirements pursuant to subsection (q))” after “that the Secretary”.

Subsec. (i)(1)(D). Puspan. L. 105–248, § 9(3), inserted “or local” after “any State” and “or local agency” after “by the State”.

Subsec. (i)(2)(A). Puspan. L. 105–248, § 12, substituted “has reason to believe that the circumstance of the case will support one or more of the findings described in paragraph (1) and that—” and cls. (i) and (ii) for “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).”

Subsec. (q)(4)(B). Puspan. L. 105–248, § 13, substituted “certified” for “accredited”.

Subsec. (r)(2)(A). Puspan. L. 105–248, § 2, substituted “subsection (p)” for “subsection (q)” and “2002” for “1997”.

Subsec. (r)(2)(B). Puspan. L. 105–248, § 2, substituted “fiscal years” for “fiscal year” and “2002” for “1997”.

Statutory Notes and Related Subsidiaries
Change of Name

Committee on Labor and Human Resources of Senate changed to Committee on Health, Education, Labor, and Pensions of Senate by Senate Resolution No. 20, One Hundred Sixth Congress, Jan. 19, 1999.

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 Puspan. L. 104–14, set out as a note preceding section 21 of Title 2, The Congress. Committee on Commerce of House of Representatives changed to Committee on Energy and Commerce of House of Representatives, and jurisdiction over matters relating to securities and exchanges and insurance generally transferred to Committee on Financial Services of House of Representatives by House Resolution No. 5, One Hundred Seventh Congress, Jan. 3, 2001.

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 1013 of Title 5, Government Organization and Employees.

Puspan. L. 93–641, § 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

Puspan. L. 103–183, title VII, § 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. 263span(e)); and
“(2) establishing quality standards under section 354(f) of the Public Health Service Act (42 U.S.C. 263span(f)).”

Study

Section 3 of Puspan. 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.