Union Calendar No. 134
116th CONGRESS 1st Session |
[Report No. 116–174]
To amend the Public Health Service Act to reauthorize certain programs under part A of title XI of such Act relating to genetic diseases, and for other purposes.
May 2, 2019
Ms. Roybal-Allard (for herself, Mr. Simpson, Ms. Clark of Massachusetts, and Ms. Herrera Beutler) introduced the following bill; which was referred to the Committee on Energy and Commerce
July 23, 2019
Additional sponsors: Mr. Fitzpatrick, Mrs. Rodgers of Washington, Ms. Norton, Mr. Raskin, Ms. Clarke of New York, Mr. Neguse, Mr. Watkins, Miss Rice of New York, Mr. Stewart, Mrs. Dingell, Mr. Carter of Texas, Mr. Case, Mr. Calvert, Mr. Gallego, Mr. Cole, Mr. Pappas, Mr. Fleischmann, Ms. Castor of Florida, Mr. Lamborn, Ms. Shalala, Mr. Collins of New York, Ms. Blunt Rochester, Mr. Grijalva, Mr. Kennedy, Mr. Ted Lieu of California, Mr. Himes, Mr. Rush, Mr. Hastings, Mr. Higgins of New York, Mr. Soto, Ms. Kuster of New Hampshire, Ms. Kelly of Illinois, Mr. Welch, Mrs. Axne, Mr. Cohen, Mrs. Brooks of Indiana, Mr. Rouda, Ms. Fudge, Mr. Stivers, Ms. DeGette, Mrs. Davis of California, Mr. Hagedorn, Mr. Casten of Illinois, Mr. Guthrie, Ms. Scanlon, Mr. Yarmuth, and Mr. David Scott of Georgia
July 23, 2019
Reported with an amendment, committed to the Committee of the Whole House on the State of the Union, and ordered to be printed
[Strike out all after the enacting clause and insert the part printed in italic]
[For text of introduced bill, see copy of bill as introduced on May 2, 2019]
To amend the Public Health Service Act to reauthorize certain programs under part A of title XI of such Act relating to genetic diseases, and for other purposes.
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,
This Act may be cited as the “Newborn Screening Saves Lives Reauthorization Act of 2019”.
SEC. 2. Improved newborn and child screening and follow-up for heritable disorders.
(a) Purposes.—Section 1109(a) of the Public Health Service Act (42 U.S.C. 300b–8(a)) is amended—
(1) in paragraph (1), by striking “enhance, improve or” and inserting “facilitate, enhance, improve, or”;
(2) by amending paragraph (3) to read as follows:
“(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) Approval factors.—Section 1109(c) of the Public Health Service Act (42 U.S.C. 300b–8(c)) is amended—
SEC. 3. Advisory committee on heritable disorders in newborns and children.
Section 1111 of the Public Health Service Act (42 U.S.C. 300b–10) is amended—
(1) in subsection (b)—
(D) by inserting after paragraph (7) the following:
SEC. 4. Clearinghouse of newborn screening information.
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”.
SEC. 5. Laboratory quality and surveillance.
Section 1113 of the Public Health Service Act (42 U.S.C. 300b–12) is amended—
(1) in subsection (a)—
(A) in paragraph (1)—
(2) in subsection (b) to read as follows:
“(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—
SEC. 6. Hunter Kelly research program.
Section 1116 of the Public Health Service Act (42 U.S.C. 300b–15) is amended—
(2) in subsection (b) to read as follows:
“(b) Funding.—In carrying out the research program under this section, the Secretary and the Director—
SEC. 7. Authorization of appropriations for newborn screening programs and activities.
Section 1117 of the Public Health Service Act (42 U.S.C. 300b–16) is amended—
SEC. 8. Institutional review boards; ethics guidance program.
Section 12 of the Newborn Screening Saves Lives Reauthorization Act of 2014 (42 U.S.C. 289 note) is amended to read as follows:
“SEC. 12. Institutional review boards; ethics guidance program.
“Research on nonidentified newborn dried blood spots shall be considered secondary research (as that term is defined in part 4 of section 46.104 of title 45, Code of Federal Regulations) with nonidentified biospecimens for purposes of federally funded research conducted pursuant to the Public Health Service Act (42 U.S.C. 200 et seq.).”.
SEC. 9. NAM report on the modernization of newborn screening.
(a) Study.—Not later than 60 days after the date of the enactment of this Act, the Secretary of Health and Human Services shall seek to enter into an agreement with the National Academy of Medicine (in this section referred to as “NAM”) (or if NAM declines to enter into such an agreement, another appropriate entity) under which NAM, or such other appropriate entity, agrees to conduct a study on the following:
(1) The uniform screening panel review and recommendation processes to identify factors that impact decisions to add new conditions to the uniform screening panel, to describe challenges posed by newly nominated conditions, including low-incidence diseases, late onset variants, and new treatments without long-term efficacy data.
(2) The barriers that preclude States from adding new uniform screening panel conditions to their State screening panels with recommendations on resources needed to help States implement uniform screening panel recommendations.
(3) The current state of federally and privately funded newborn screening research with recommendations for optimizing the capacity of this research, including piloting multiple prospective conditions at once and addressing rare disease questions.
(4) New and emerging technologies that would permit screening for new categories of disorders, or would make current screening more effective, more efficient, or less expensive.
(5) Technological and other infrastructure needs to improve timeliness of diagnosis and short- and long-term follow-up for infants identified through newborn screening and improve public health surveillance.
(6) Current and future communication and educational needs for priority stakeholders and the public to promote understanding and knowledge of a modernized newborn screening system with an emphasis on evolving communication channels and messaging.
(7) The extent to which newborn screening yields better data on the disease prevalence for screened conditions and improves long-term outcomes for those identified through newborn screening, including existing systems supporting such data collection and recommendations for systems that would allow for improved data collection.
(b) Public stakeholder meeting.—In the course of completing the study described in subsection (a), NAM or such other appropriate entity shall hold not less than one public meeting to obtain stakeholder input on the topics of such study.
(c) Report.—Not later than 18 months after the effective date of the agreement under subsection (a), such agreement shall require NAM, or such other appropriate entity, to submit to the Secretary of Health and Human Services and the appropriate committees of jurisdiction of Congress a report containing—
Union Calendar No. 134 | |||||
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[Report No. 116–174] | |||||
A BILL | |||||
To amend the Public Health Service Act to reauthorize certain programs under part A of title XI of
such Act relating to genetic diseases, and for other purposes. | |||||
July 23, 2019 | |||||
Reported with an amendment, committed to the Committee of the Whole House on the State of the
Union, and ordered to be printed |