42 U.S.C. 300b-8(a)(1)changedby H.R. 4709 Sec. 2(a)
(1) to enhance, improve orfacilitate, enhance, improve, or expand the ability of State and local public health agencies to provide screening, counseling, or health care services to newborns and children having or at risk for heritable disorders;
The bill says: in paragraph (1), by striking "enhance, improve or" and inserting "facilitate, enhance, improve, or";
Bill text · Current law (42 U.S.C. 300b-8)
42 U.S.C. 300b-8(a)rewrittenby H.R. 4709 Sec. 2(a)
(3) to develop, and deliver to parents, families, and patient advocacy and support groups, educational programs that—(A) address newborn screening counseling, testing (including newborn screening pilot studies), follow-up, treatment, specialty services, and long-term care;(B) assess the target audience’s current knowledge, incorporate health communications strategies, and measure impact; and(C) are at appropriate literacy levels;
The bill says: by amending paragraph (3) to read as follows:
Bill text · Current law (42 U.S.C. 300b-8)
42 U.S.C. 300b-8(a)(4)changedby H.R. 4709 Sec. 2(a)
(4) to establish, maintain, and operate a system to assess and coordinate followupfollow-up and treatment relating to congenital, genetic, and metabolic disorders; and
The bill says: by striking "followup" and inserting "follow-up"; and
Bill text · Current law (42 U.S.C. 300b-8)
42 U.S.C. 300b-8(a)(4)addedby H.R. 4709 Sec. 2(a)
The bill says: by inserting before the semicolon at the end the following: ", including re-engaging patients who have not received recommended follow-up services and supports".
Bill text · Current law (42 U.S.C. 300b-8)
42 U.S.C. 300b-8(c)changedby H.R. 4709 Sec. 2(b)
(c) Approval factors. An application for a grant under this section shall not be approved by the Secretary unless the application contains assurances that the eligible entity has adopted and implemented, is in the process of adopting and implementing, or will usewill use amounts received under such grant to adopt and implement the guidelines and recommendations of the Advisory Committee that are adopted by the Secretary and in effect at the time the grant is awarded or renewed under this section, which shall include the screening of each newborn for the heritable disorders recommended by the Advisory Committee and adopted by the Secretary.
The bill says: by striking "or will use" and inserting "will use"; and
Bill text · Current law (42 U.S.C. 300b-8)
42 U.S.C. 300b-8(c)changedby H.R. 4709 Sec. 2(b)
…by the Secretary unless the application contains assurances that the eligible entity has adopted and implemented, is in the process of adopting and implementing, or will use amounts received under such grant to adopt and implement , or will use amounts received under such grant to enhance capacity and infrastructure to facilitate the adoption of, the guidelines and recommendations of the Advisory Committee that are adopted by the Secretary and in effect at the time the grant is awarded or renewed under this section, which shall include the screening of each newborn for the…
The bill says: by inserting ", or will use amounts received under such grant to enhance capacity and infrastructure to facilitate the adoption of," before "the guidelines and recommendations".
Bill text · Current law (42 U.S.C. 300b-8)
42 U.S.C. 300b-10(b)(5)changedby H.R. 4709 Sec. 3(1)
(5) take appropriate steps and adopt process improvements, at its discretion, to prepare for the review of nominations prior to their submission, including for conditions for which a screening method has been validated but other nomination criteria are not yet met, in order to facilitate timely action by the Advisory Committee once such submission has been received by the Committee;
The bill says: in paragraph (5), by inserting "and adopt process improvements" after "take appropriate steps";
Bill text · Current law (42 U.S.C. 300b-10)
42 U.S.C. 300b-10(b)(7)changedby H.R. 4709 Sec. 3(1)
(7) consider ways to ensure that all States attain the capacity to screen for the conditions described in paragraph (3), and include in such consideration the results of grant funding under section 300b–8 of this title; and
The bill says: in paragraph (7) by striking "and" at the end;
Bill text · Current law (42 U.S.C. 300b-10)
42 U.S.C. 300b-10(b)renumberedby H.R. 4709 Sec. 3(1)
The bill says: by redesignating paragraph (8) as paragraph (9);
Bill text · Current law (42 U.S.C. 300b-10)
42 U.S.C. 300b-10(b)added (8)by H.R. 4709 Sec. 3(1)
(8) develop, maintain, and publish on a publicly accessible website consumer-friendly materials detailing—(A) the uniform screening panel nomination process, including data requirements, standards, and the use of international data in nomination submissions; and(B) the process for obtaining technical assistance for submitting nominations to the uniform screening panel and detailing the instances in which the provision of technical assistance would introduce a conflict of interest for members of the Advisory Committee; and
The bill says: by inserting after paragraph (7) the following:
Bill text · Current law (42 U.S.C. 300b-10)
42 U.S.C. 300b-10(b)(9)renumberedby H.R. 4709 Sec. 3(1)
The bill says: by redesignating subparagraphs (K) and (L) as subparagraphs (L) and (M), respectively; and
Bill text · Current law (42 U.S.C. 300b-10)
42 U.S.C. 300b-10(b)(9)added (K)by H.R. 4709 Sec. 3(1)
(K) the appropriate and recommended use of safe and effective genetic testing by health care professionals in newborns and children with an initial diagnosis of a disease or condition characterized by a variety of genetic causes and manifestations;
The bill says: by inserting after subparagraph (J) the following:
Bill text · Current law (42 U.S.C. 300b-10)
42 U.S.C. 300b-10(g)(1)changedby H.R. 4709 Sec. 3(2)
(1) In general. Notwithstanding section 1013 of title 5, the Advisory Committee shall continue to operate through the end of fiscal year 20192030.
The bill says: in paragraph (1) by striking "2019" and inserting "2030"; and
Bill text · Current law (42 U.S.C. 300b-10)
42 U.S.C. 300b-10(g)(2)changedby H.R. 4709 Sec. 3(2)
(2) Continuation if not reauthorized. If at the end of fiscal year 20192030 the duration of the Advisory Committee has not been extended by statute, the Advisory Committee may be deemed, for purposes of chapter 10 of title 5, an advisory committed 1 established by the President or an officer of the Federal Government under section 1008(a) of title 5.
The bill says: in paragraph (2) by striking "2019" and inserting "2030".
Bill text · Current law (42 U.S.C. 300b-10)
42 U.S.C. 300b-11(c)changedby H.R. 4709 Sec. 4
(c) Nonduplication. In carrying out activities under this section, the Secretary shall ensure that such activities minimize duplication and supplement, not supplant, existing information sharing effortsand complement other Federal newborn screening information sharing activities.
The bill says: Section 1112(c) of the Public Health Service Act (42 U.S.C. 300b–11(c)) is amended by striking "and supplement, not supplant, existing information sharing efforts" and inserting "and complement other Federal newborn screening information sharing activities".
Bill text · Current law (42 U.S.C. 300b-11)
42 U.S.C. 300b-12(a)(1)changedby H.R. 4709 Sec. 5(1)
(1) quality assurance for laboratories involved in screening newborns and children for heritable disorders, including quality assurance for newborn-screening tests, timeliness for processing such tests, performance evaluation services,development of new screening tests, and technical assistance and technology transfer to newborn screening laboratories to ensure analytic validity and utility of screening tests; and
The bill says: by striking "performance evaluation services," and inserting "development of new screening tests,"; and
Bill text · Current law (42 U.S.C. 300b-12)
42 U.S.C. 300b-12(a)(1)changedby H.R. 4709 Sec. 5(1)
(1) quality assurance for laboratories involved in screening newborns and children for heritable disorders, including quality assurance for newborn-screening tests, timeliness for processing such tests, performance evaluation services, and technical assistance and technology transfer to newborn screening laboratories to ensure analytic validity and utility of screening tests; and
The bill says: by striking "and" at the end;
Bill text · Current law (42 U.S.C. 300b-12)
42 U.S.C. 300b-12(a)(2)changedby H.R. 4709 Sec. 5(1)
(2) appropriate quality control and other performance test materialstest performance materials to evaluate the performance of new screening tools.
The bill says: by striking "performance test materials" and inserting "test performance materials"; and
Bill text · Current law (42 U.S.C. 300b-12)
42 U.S.C. 300b-12(a)(2)changedby H.R. 4709 Sec. 5(1)
(2) appropriate quality control and other performance test materials to evaluate the performance of new screening tools.; and
The bill says: by striking the period at the end and inserting "; and"; and
Bill text · Current law (42 U.S.C. 300b-12)
42 U.S.C. 300b-12(a)added (3)by H.R. 4709 Sec. 5(1)
(3) performance evaluation services to enhance disease detection, including the development of tools, resources, and infrastructure to improve data analysis, test result interpretation, data harmonization, and dissemination of laboratory best practices.
The bill says: by adding at the end the following:
Bill text · Current law (42 U.S.C. 300b-12)
42 U.S.C. 300b-12(b)rewrittenby H.R. 4709 Sec. 5(2)
(b) Surveillance activities.— The Secretary, acting through the Director of the Centers for Disease Control and Prevention, and taking into consideration the expertise of the Advisory Committee on Heritable Disorders in Newborns and Children established under section 1111, shall provide for the coordination of national surveillance activities, including—(1) standardizing data collection and reporting through the use of electronic and other forms of health records to achieve real-time data for tracking and monitoring the newborn screening system, from the initial positive screen through diagnosis and long-term care management; and(2) by promoting data sharing linkages between State newborn screening programs and State-based birth defects and developmental disabilities surveillance programs to help families connect with services to assist in evaluating long-term outcomes.
The bill says: in subsection (b) to read as follows:
Bill text · Current law (42 U.S.C. 300b-12)
42 U.S.C. 300b-15(a)(1)changedby H.R. 4709 Sec. 6(1)
(1) In general. The Secretary, in conjunction with the Director of the National Institutes of Health and taking into consideration the recommendations of the Advisory Committee, mayshall continue carrying out, coordinating, and expanding research in newborn screening (to be known as "Hunter Kelly Newborn Screening Research Program") including— (A) identifying, developing, and testing the most promising new screening…
The bill says: by striking "may" and inserting "shall"; and
Bill text · Current law (42 U.S.C. 300b-15)
42 U.S.C. 300b-15(a)(1)(D)changedby H.R. 4709 Sec. 6(1)
(D) conducting pilot studies on conditions recommended by , or with a high probability of being recommended by, the Advisory Committee on Heritable Disorders in Newborns and Children to ensure that screenings are ready for nationwide implementation; and
The bill says: by inserting ", or with a high probability of being recommended by," after "recommended by"; and
Bill text · Current law (42 U.S.C. 300b-15)
42 U.S.C. 300b-15(a)(1)(D)changedby H.R. 4709 Sec. 6(1)
(D) conducting pilot studies on conditions recommended by the Advisory Committee on Heritable Disorders in Newborns and Children to ensure that screenings are ready for nationwide implementationthat reliable newborn screening technologies are piloted and ready for use; and
The bill says: by striking "that screenings are ready for nationwide implementation" and inserting "that reliable newborn screening technologies are piloted and ready for use"; and
Bill text · Current law (42 U.S.C. 300b-15)
42 U.S.C. 300b-15(b)rewrittenby H.R. 4709 Sec. 6(2)
The bill says: in subsection (b) to read as follows:
Bill text · Current law (42 U.S.C. 300b-15)
42 U.S.C. 300b-16(1)changedby H.R. 4709 Sec. 7(1)
(1) to carry out sections 300b–8, 300b–9, 300b–10, and 300b–11 of this title, $11,900,000$20,883,000 for each of fiscal years 2015 through 2019; and
The bill says: by striking "$11,900,000" and inserting "$20,883,000";
Bill text · Current law (42 U.S.C. 300b-16)
42 U.S.C. 300b-16(1)changedby H.R. 4709 Sec. 7(1)
(1) to carry out sections 300b–8, 300b–9, 300b–10, and 300b–11 of this title, $11,900,000 for each of fiscal years 20152026 through 2019; and
The bill says: by striking "2015" and inserting "2026"; and
Bill text · Current law (42 U.S.C. 300b-16)
42 U.S.C. 300b-16(1)changedby H.R. 4709 Sec. 7(1)
(1) to carry out sections 300b–8, 300b–9, 300b–10, and 300b–11 of this title, $11,900,000 for each of fiscal years 2015 through 20192030; and
The bill says: by striking "2019" and inserting "2030"; and
Bill text · Current law (42 U.S.C. 300b-16)
42 U.S.C. 300b-16(2)changedby H.R. 4709 Sec. 7(2)
(2) to carry out section 300b–12 of this title, $8,000,000$22,250,000 for each of fiscal years 2015 through 2019.
The bill says: by striking "$8,000,000" and inserting "$22,250,000";
Bill text · Current law (42 U.S.C. 300b-16)
42 U.S.C. 300b-16(2)changedby H.R. 4709 Sec. 7(2)
(2) to carry out section 300b–12 of this title, $8,000,000 for each of fiscal years 20152026 through 2019.
The bill says: by striking "2015" and inserting "2026"; and
Bill text · Current law (42 U.S.C. 300b-16)
42 U.S.C. 300b-16(2)changedby H.R. 4709 Sec. 7(2)
(2) to carry out section 300b–12 of this title, $8,000,000 for each of fiscal years 2015 through 20192030.
The bill says: by striking "2019" and inserting "2030".
Bill text · Current law (42 U.S.C. 300b-16)
42 U.S.C. 289rewrittenby H.R. 4709 Sec. 8
The bill says: Section 12 of the Newborn Screening Saves Lives Reauthorization Act of 2014 (42 U.S.C. 289 note) is amended to read as follows:
Bill text · Current law (42 U.S.C. 289)