89–006 

116TH CONGRESS REPORT " ! HOUSE OF REPRESENTATIVES 1st Session 116–174 

NEWBORN SCREENING SAVES LIVES REAUTHORIZATION 

ACT OF 2019 

JULY 23, 2019.—Committed to the Committee of the Whole House on the State of 

the Union and ordered to be printed 

Mr. PALLONE, from the Committee on Energy and Commerce, 

submitted the following 

R E P O R T 

[To accompany H.R. 2507] 

The Committee on Energy and Commerce, to whom was referred 

the bill (H.R. 2507) 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, having considered the same, report favorably thereon with an amendment and 

recommend that the bill as amended do pass. 

CONTENTS 

Page 

I. Purpose and Summary .................................................................................. 4 

II. Background and Need for the Legislation ................................................... 5 

III. Committee Hearings ...................................................................................... 6 

IV. Committee Consideration .............................................................................. 6 

V. Committee Votes ............................................................................................ 6 

VI. Oversight Findings ........................................................................................ 7 

VII. New Budget Authority, Entitlement Authority, and Tax Expenditures 7 

VIII. Federal Mandates Statement ....................................................................... 7 

IX. Statement of General Performance Goals and Objectives .......................... 7 

X. Duplication of Federal Programs .................................................................. 7 

XI. Committee Cost Estimate ............................................................................. 7 

XII. Earmarks, Limited Tax Benefits, and Limited Tariff Benefits .................. 8 

XIII. Advisory Committee Statement .................................................................... 8 

XIV. Applicability to Legislative Branch .............................................................. 8 

XV. Section-by-Section Analysis of the Legislation ............................................ 8 

XVI. Changes in Existing Law Made by the Bill, as Reported ........................... 10 

The amendment is as follows: 

Strike all after the enacting clause and insert the following: 

SECTION 1. SHORT TITLE. 

This Act may be cited as the ‘‘Newborn Screening Saves Lives Reauthorization 

Act of 2019’’. 


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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 longterm care; 

‘‘(B) assess the target audience’s current knowledge, incorporate health 

communications strategies, and measure impact; and 

‘‘(C) are at appropriate literacy levels;’’; and 

(3) in paragraph (4)— 

(A) by striking ‘‘followup’’ and inserting ‘‘follow-up’’; and 

(B) by inserting before the semicolon at the end the following: ‘‘, including 

re-engaging patients who have not received recommended follow-up services 

and supports’’. 

(b) APPROVAL FACTORS.—Section 1109(c) of the Public Health Service Act (42 

U.S.C. 300b–8(c)) is amended— 

(1) by striking ‘‘or will use’’ and inserting ‘‘will use’’; and 

(2) 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’’. 

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)— 

(A) in paragraph (5), by inserting ‘‘and adopt process improvements’’ after 

‘‘take appropriate steps’’; 

(B) in paragraph (7) by striking ‘‘and’’ at the end; 

(C) by redesignating paragraph (8) as paragraph (9); 

(D) by inserting after paragraph (7) the following: 

‘‘(8) develop, maintain, and publish on a publicly accessible website consumerfriendly 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’’; 

(E) in paragraph (9), as redesignated— 

(i) by redesignating subparagraphs (K) and (L) as subparagraphs (L) 

and (M), respectively; and 

(ii) by inserting after subparagraph (J) the following: 

‘‘(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;’’; and 

(2) in subsection (g)— 

(A) in paragraph (1) by striking ‘‘2019’’ and inserting ‘‘2024’’; and 

(B) in paragraph (2) by striking ‘‘2019’’ and inserting ‘‘2024’’. 

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)— 

(i) by striking ‘‘performance evaluation services,’’ and inserting ‘‘development of new screening tests,’’; and 

(ii) by striking ‘‘and’’ at the end; 

(B) in paragraph (2)— 


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(i) by striking ‘‘performance test materials’’ and inserting ‘‘test performance materials’’; and 

(ii) by striking the period at the end and inserting ‘‘; and’’; and 

(C) by adding at the end the following: 

‘‘(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.’’; and 

(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— 

‘‘(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.’’. 

SEC. 6. HUNTER KELLY RESEARCH PROGRAM. 

Section 1116 of the Public Health Service Act (42 U.S.C. 300b–15) is amended— 

(1) in subsection (a)(1)— 

(A) by striking ‘‘may’’ and inserting ‘‘shall’’; and 

(B) in subparagraph (D)— 

(i) by inserting ‘‘, or with a high probability of being recommended 

by,’’ after ‘‘recommended by’’; and 

(ii) by striking ‘‘that screenings are ready for nationwide implementation’’ and inserting ‘‘that reliable newborn screening technologies are 

evaluated and ready for use’’; and 

(2) in subsection (b) to read as follows: 

‘‘(b) FUNDING.—In carrying out the research program under this section, the Secretary and the Director— 

‘‘(1) shall ensure that entities receiving funding through the program will provide assurances, as practicable, that such entities will work in consultation with 

the appropriate State departments of health; and 

‘‘(2) may accept, use, and dispose of donations and bequests from private forprofit and non-profit entities, in accordance with Federal law.’’. 

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— 

(1) in paragraph (1)— 

(A) by striking ‘‘$11,900,000’’ and inserting ‘‘$31,000,000’’; 

(B) by striking ‘‘2015’’ and inserting ‘‘2020’’; and 

(C) by striking ‘‘2019’’ and inserting ‘‘2024’’; and 

(2) in paragraph (2)— 

(A) by striking ‘‘$8,000,000’’ and inserting ‘‘$29,650,000’’; 

(B) by striking ‘‘2015’’ and inserting ‘‘2020’’; and 

(C) by striking ‘‘2019’’ and inserting ‘‘2024’’. 

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 


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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. 

(8) The impact on newborn morbidity and mortality in States that adopt newborn screening tests included on the uniform panel. 

(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— 

(1) the results of the study conducted under subsection (a); 

(2) recommendations to modernize the processes described in subsection 

(a)(1); and 

(3) recommendations for such legislative and administrative action as NAM, 

or such other appropriate entity, determines appropriate. 

(d) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated 

$2,000,000 for the period of fiscal years 2020 and 2021 to carry out this section. 

I. PURPOSE AND SUMMARY

H.R. 2507, the ‘‘Newborn Screening Saves Lives Reauthorization 

Act of 2019’’, was introduced on May 2, 2019, by Reps. RoybalAllard (D–CA), Simpson (R–ID), Clark (D–MA), and Herrera 

Beutler (R–WA) and referred to the Committee on Energy and 

Commerce. H.R. 2507 would reauthorize newborn screening programs at the U.S. Department of Health and Human Services for 

five years. The bill includes reforms to ensure that the activities of 

the Advisory Committee on Heritable Disorders in Newborns and 

Children (ACHDNC) at the Health Resources and Services Administration (HRSA) are transparent, including requiring the creation 

of a publicly accessible website that details the uniform screening 

panel nomination process. The bill also requires the Centers for 

Disease Control and Prevention (CDC) to standardize data collection and reporting to track and monitor newborn screening in real 

time. Additionally, the bill orders a study on the modernization of 


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1Government Accountability Office, GAO–17–196, Newborn Screening Timeliness (Dec. 15, 

2016). 2 Examining Public Health Legislation to Help Local Communities: Hearing on H.R. 1281 Before the Subcommittee on Health, Committee on Energy & Commerce, 113th Cong. (Nov. 20, 

2013) (statement of Edward R.B. McCabe, Chief Medical Officer, March of Dimes Foundation). 3 Id. 

4S. Rept. No. 110–280, at 2. 

5 Id. 

6Pub. L. No. 110–204. 

7 National Conference of State Legislatures, State Newborn Health Screening Policies, 25 

LegisBrief 14 (Apr. 2017). 8 Health Resources and Services Administration, Recommended Uniform Screening Panel 

(Feb. 2019) (www.hrsa.gov/advisory-committees/heritable-disorders/rusp/index.html). 

newborn screening. The bill authorizes appropriations of $60.65 

million per fiscal year from 2020 through 2024. 

II. BACKGROUND AND NEED FOR LEGISLATION

Every year, more than 12,000 newborns are born with conditions 

that require early detection and treatment.1 Newborn screening 

provides for early identification of certain genetic, metabolic, hormonal, and functional conditions that may be treatable, but not apparent at birth. With proper screening, parents can receive education and children can receive appropriate follow-up treatment. As 

medical and scientific knowledge have advanced since the first 

newborn screening test was developed in the early 1960s, dozens 

more tests and treatments became available. However, a patchwork 

of state requirements for screening led to some newborns being 

screened for many disorders, and others very few.2 In 2004, the 

American College of Medical Genetics recommended that every 

baby born in the United States be screened for a core set of 29 

treatable disorders.3 At that time, only 21 states screened for at 

least nine of the recommended conditions.4 By 2008, significant improvements were made, but still, only 15 states and the District of 

Columbia required that infants be screened for all 29 recommended 

disorders.5

While newborn screening remains a state public health activity, 

Congress passed the Newborn Screening Saves Lives Act in 2008, 

to better standardize and improve state universal newborn screening programs.6 The law codified the Recommended Universal 

Screening Panel (RUSP), which the ACHDNC at HRSA uses to 

make recommendations for conditions for which all newborns 

should be screened. To be considered as a core condition recommended for the RUSP, the condition must: (1) be able to be identified at a stage prior to when it would otherwise be apparent clinically (i.e., the screening must be necessary to identify the condition); (2) have a test with appropriate sensitivity and specificity 

available; and (3) have demonstrated benefits of early detection, 

timely intervention, and efficacious treatment of the condition.7

The law also authorized HRSA to develop a model decision-matrix 

for newborn screening expansion, and consider ways to ensure that 

all states attain the capacity to screen for the recommended conditions. The law also authorized research at the National Institutes 

of Health (NIH) to carry out research on newborn screening. Congress last reauthorized the law in 2014. 

Today, the RUSP includes 35 core conditions.8 While all states 

have caught up to testing for the original 29 recommended condiVerDate Sep 11 2014 18:41 Jul 27, 2019 Jkt 089006 PO 00000 Frm 00005 Fmt 6659 Sfmt 6602 E:\HR\OC\HR174.XXX HR174

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9Scott M. Shone, Newborn Screening Policy Decisions, 80 N.C. Med. J. 1, 43 (Jan. 2019). 

10See note 7. 

tions,9 and some have exceeded the current 35 recommended core 

conditions, others have lagged behind as more tests have been 

added.10 The funding authorized in this legislation is intended to 

help break down those barriers preventing some states from adopting all 35 conditions, ensuring that children across the country are 

screened for all core conditions included on the RUSP. 

III. COMMITTEE HEARINGS

For the purposes of section 103(i) of H. Res. 6 of the 116th Congress the following hearing was used to develop or consider H.R. 

2507: 

The Subcommittee on Health held a legislative hearing on June 

25, 2019 on H.R. 2507, ‘‘Newborn Screening Saves Lives Reauthorization Act of 2019’’ and three other bills. The hearing was entitled 

‘‘Reauthorizing Vital Health Programs for American Families.’’ The 

Subcommittee received testimony from: 

• Amy Hewitt, Ph.D., Director, Institute on Community Integration, University of Minnesota; 

• Joseph Bocchini, M.D., Professor, Department of Pediatrics 

Louisiana State University Health, Shreveport; 

• Patricia Kunz Howard, Ph.D., RN, President, Emergency 

Nurses Association, Director, Emergency Services, University 

of Kentucky Healthcare; and 

• Jill Kagan, Director, ARCH National Respite Network and 

Resource Center. 

IV. COMMITTEE CONSIDERATION

H.R. 2507, the ‘‘Newborn Screening Saves Lives Reauthorization 

Act of 2019’’ was introduced in the House on May 2, 2019, by Reps. 

Roybal-Allard, Simpson, Clark, and Herrera Beutler, and referred 

to the Committee on Energy and Commerce. Subsequently, the bill 

was referred to the Subcommittee on Health on May 3, 2019. Following a legislative hearing, the Subcommittee met in open markup session, pursuant to notice, on July 11, 2019, for consideration 

of the bill H.R. 2507. During consideration of the bill, an amendment offered by Ms. Kelly (D–IL) was agreed to by a voice vote. 

Subsequently, the Subcommittee on Health agreed to a motion by 

Ms. Eshoo, Chairwoman of the Subcommittee, that H.R. 2507 be 

forwarded favorably to the full Committee on Energy and Commerce, amended, by a voice vote. 

On July 17, 2019, the full Committee met in open markup session, pursuant to notice, to consider the bill H.R. 2507, as amended 

by the Subcommittee. At the conclusion of consideration of the bill, 

the full Committee on Energy and Commerce agreed to a motion 

by Mr. Pallone, Chairman of the Committee, that H.R. 2507 be ordered reported favorably to the House, as amended, by a voice vote, 

a quorum being present. 

V. COMMITTEE VOTES

Clause 3(b) of rule XIII of the Rules of the House of Representatives requires the Committee to list each record vote on the motion 


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to report legislation and amendments thereto. The Committee advises that there were no record votes taken on H.R. 2507. 

VI. OVERSIGHT FINDINGS

Pursuant to clause 3(c)(1) of rule XIII and clause 2(b)(1) of rule 

X of the Rules of the House of Representatives, the Committee’s 

oversight findings and recommendations are reflected in the descriptive portion of the report. 

VII. NEW BUDGET AUTHORITY, ENTITLEMENT AUTHORITY, AND TAX

EXPENDITURES

Pursuant to 3(c)(2) of rule XIII of the Rules of the House of Representatives, the Committee adopts as its own the estimate of new 

budget authority, entitlement authority, or tax expenditures or revenues contained in the cost estimate prepared by the Director of 

the Congressional Budget Office pursuant to section 402 of the 

Congressional Budget Act of 1974. 

The Committee has requested but not received from the Director 

of the Congressional Budget Office a statement as to whether this 

bill contains any new budget authority, spending authority, credit 

authority, or an increase or decrease in revenues or tax expenditures. 

VIII. FEDERAL MANDATES STATEMENT

The Committee adopts as its own the estimate of Federal mandates prepared by the Director of the Congressional Budget Office 

pursuant to section 423 of the Unfunded Mandates Reform Act. 

IX. STATEMENT OF GENERAL PERFORMANCE GOALS AND OBJECTIVES

Pursuant to clause 3(c)(4) of rule XIII, the general performance 

goal or objective of this legislation is to reauthorize funding for the 

programs of the Newborn Screen Saves Lives Act, provide for 

transparency at ACHDNC, and authorize reforms to modernize and 

standardize newborn screening programs. 

X. DUPLICATION OF FEDERAL PROGRAMS

Pursuant to clause 3(c)(5) of rule XIII, no provision of H.R. 2507 

is known to be duplicative of another Federal program, including 

any program that was included in a report to Congress pursuant 

to section 21 of Public Law 111–139 or the most recent Catalog of 

Federal Domestic Assistance. 

XI. COMMITTEE COST ESTIMATE

Pursuant to clause 3(d)(1) of rule XIII, the Committee adopts as 

its own the cost estimate prepared by the Director of the Congressional Budget Office pursuant to section 402 of the Congressional 

Budget Act of 1974. 


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XII. EARMARKS, LIMITED TAX BENEFITS, AND LIMITED TARIFF

BENEFITS

Pursuant to clause 9(e), 9(f), and 9(g) of rule XXI, the Committee 

finds that H.R. 2507 contains no earmarks, limited tax benefits, or 

limited tariff benefits. 

XIII. ADVISORY COMMITTEE STATEMENT

No advisory committees within the meaning of section 5(b) of the 

Federal Advisory Committee Act were created by this legislation. 

XIV. APPLICABILITY TO LEGISLATIVE BRANCH

The Committee finds that the legislation does not relate to the 

terms and conditions of employment or access to public services or 

accommodations within the meaning of section 102(b)(3) of the Congressional Accountability Act. 

XV. SECTION-BY-SECTION ANALYSIS OF THE LEGISLATION

Section 1. Short title 

Section 1 designates that the short title may be cited as the 

‘‘Newborn Screening Saves Lives Reauthorization Act of 2019’’. 

Section 2. Improved newborn and child screening and follow-up for 

heritable disorders 

Section 2 amends the authorization terms for the grant program 

established under section 1109 of the Public Health Service Act to 

ensure that educational programs address newborn screening pilot 

studies and assess the target audience’s current knowledge, incorporate health communication strategies, and measure the impact of 

these programs. This Section also authorizes grantees to establish, 

maintain, and operate a system to address and coordinate followup, ‘‘including re-engaging patients who have not received recommended follow-up services and supports.’’ 

Section 3. Advisory Committee on Heritable Disorders in Newborns 

and Children 

Section 3 amends the duties of ACHDNC to include the adoption 

of process improvements and requires the creation of a publicly accessible website which details the uniform screening panel nomination process, the process for obtaining technical assistance for submitting nominations for the uniform screening panel, and the instances in which the provision of technical assistance would introduce a conflict of interest for members of the Advisory Committee. 

The Committee does not intend for this section to necessarily preclude the NIH from providing agency expertise to the ACHDNC. 

Section 4. Clearing house of newborn screening information 

Section 4 clarifies that the Secretary ensure that newborn 

screening activities under this program complement other Federal 

newborn screening information sharing activities. 

Section 5. Laboratory quality and surveillance 

Section 5 amends laboratory quality and surveillance authorization language to instruct the Secretary, acting through the Director 


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of the CDC and taking into consideration the expertise of ACHDNC 

to provide for quality assurance for laboratories involved in screening newborns and children for heritable disorders, including developing new screening tests. This section also instructs the Secretary 

to provide for 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 

Secretary, acting through CDC, is also instructed to provide for the 

coordination of national surveillance activities, including standardizing data collection and reporting through the use of electronic 

and other health records to monitor the newborn screening system 

in real time, and by promoting data sharing between state newborn 

screening programs and developmental disabilities surveillance 

programs. 

Section 6. Hunter Kelly research program 

Section 6 amends the authorizing language for the Hunter Kelly 

Newborn Screening Program at NIH by authorizing the Secretary, 

in conjunction with the NIH Director, to conduct pilot studies on 

conditions recommended by, or with a high probability of being recommended by the ACHDNC to ensure that reliable newborn 

screening technologies are evaluated and ready for use. This section also directs the Secretary and NIH Director to ensure that entities receiving funding through the program will provide reassurances that entities will work in consultation with State departments of health, as appropriate, and clarifies that the Secretary 

and Director may accept, use, and dispose of donations and bequest 

from private for-profit and non-profit entities, in accordance with 

Federal law. 

Section 7. Authorization of appropriations for newborn screening 

programs and activities 

Section 7 extends authorization of appropriations for newborn 

screening programs and activities. 

Paragraph (1) authorizes $31,000,000 to carry out sections 1109, 

1110, 1111, and 1112 for fiscal years 2020 through 2024. 

Paragraph (2) authorizes $29,650,000 to carry out section 1113 

for fiscal years 2020 through 2024. 

Section 8. Institutional review boards; ethics guidance program 

Section 8 clarifies that research on nonidentified newborn dried 

blood spots be considered ‘‘secondary research’’ as defined by part 

4 of subsection d of section 46.104 of title 45 of the Code of Federal 

Regulations, also known as the Common Rule, which governs 

human research and privacy. 

Section 9. NAM report on the modernization of newborn screening 

Section 9 directs the Secretary to enter into an agreement with 

the National Academy of Medicine to conduct a study on certain 

newborn screening activities and issue a report to Congress with 

recommendations to modernize the newborn screening processes. 

This section authorizes $2,000,000 in fiscal years 2020 and 2021 for 

the report. 


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XVI. CHANGES IN EXISTING LAW MADE BY THE BILL, AS REPORTED

In compliance with clause 3(e) of rule XIII of the Rules of the 

House of Representatives, changes in existing law made by the bill, 

as reported, are shown as follows (existing law proposed to be omitted is enclosed in black brackets, new matter is printed in italic, 

and existing law in which no change is proposed is shown in 

roman): 

PUBLIC HEALTH SERVICE ACT 

* * * * * * * 

TITLE XI—GENETIC DISEASES, HEMOPHILIA PROGRAMS, 

AND SUDDEN INFANT DEATH SYNDROME 

PART A—GENETIC DISEASES

* * * * * * * 

SEC. 1109. IMPROVED NEWBORN AND CHILD SCREENING FOR HERITABLE DISORDERS. 

(a) AUTHORIZATION OF GRANT PROGRAM.—From amounts appropriated under section 1117, the Secretary, acting through the Administrator of the Health Resources and Services Administration 

(referred to in this section as the ‘‘Administrator’’) and taking into 

consideration the expertise of the Advisory Committee on Heritable 

Disorders in Newborns and Children (referred to in this section as 

the ‘‘Advisory Committee’’), shall award grants to eligible entities 

to enable such entities— 

(1) to øenhance, improve or¿ facilitate, 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; 

(2) to assist in providing health care professionals and newborn screening laboratory personnel with education in newborn 

screening, counseling, and training in— 

(A) relevant and new technologies in newborn screening 

and congenital, genetic, and metabolic disorders; 

(B) the importance of the timeliness of collection, delivery, receipt, and screening of specimens; and 

(C) sharing of medical and diagnostic information with 

providers and families; 

ø(3) to develop and deliver educational programs (at appropriate literacy levels) about newborn screening counseling, 

testing, follow-up, treatment, and specialty services to parents, 

families, and patient advocacy and support groups; ¿ 

(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; 


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(4) to establish, maintain, and operate a system to assess 

and coordinate øfollowup¿ follow-up and treatment relating to 

congenital, genetic, and metabolic disorders, including re-engaging patients who have not received recommended follow-up 

services and supports; and 

(5) to improve the timeliness of— 

(A) the collection, delivery, receipt, and screening of 

specimens; and 

(B) the diagnosis of heritable disorders in newborns. 

(b) ELIGIBLE ENTITY.—In this section, the term ‘‘eligible entity’’ 

means— 

(1) a State or a political subdivision of a State; 

(2) a consortium of 2 or more States or political subdivisions 

of States; 

(3) a territory; 

(4) a health facility or program operated by or pursuant to 

a contract with or grant from the Indian Health Service; or 

(5) any other entity with appropriate expertise in newborn 

screening, as determined by the Secretary. 

(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, øor 

will use¿ 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 heritable disorders recommended 

by the Advisory Committee and adopted by the Secretary. 

(d) COORDINATION.—The Secretary shall take all necessary steps 

to coordinate programs funded with grants received under this section and to coordinate with existing newborn screening activities. 

(e) LIMITATION.—An eligible entity may not use amounts received 

under this section to— 

(1) provide cash payments to or on behalf of affected individuals; 

(2) provide inpatient services; 

(3) purchase land or make capital improvements to property; 

or 

(4) provide for proprietary research or training. 

(f) VOLUNTARY PARTICIPATION.—The participation by any individual in any program or portion thereof established or operated 

with funds received under this section shall be wholly voluntary 

and shall not be a prerequisite to eligibility for or receipt of any 

other service or assistance from, or to participation in, another Federal or State program. 

(g) SUPPLEMENT NOT SUPPLANT.—Funds appropriated under this 

section shall be used to supplement and not supplant other Federal, State, and local public funds provided for activities of the type 

described in this section. 

(h) PUBLICATION.— 

(1) IN GENERAL.—An application for a grant under this section shall be made public by the State in such a manner as to 


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facilitate comment from any person, including through hearings and other methods used to facilitate comments from the 

public. 

(2) COMMENTS.—Comments received by the State after the 

publication described in paragraph (1) shall be addressed in 

the application for a grant under this section. 

(i) TECHNICAL ASSISTANCE.—The Secretary shall provide to entities receiving grants under subsection (a) such technical assistance 

as may be necessary to ensure the quality of programs conducted 

under this section. 

* * * * * * * 

SEC. 1111. ADVISORY COMMITTEE ON HERITABLE DISORDERS IN 

NEWBORNS AND CHILDREN. 

(a) ESTABLISHMENT.—The Secretary shall establish an advisory 

committee to be known as the ‘‘Advisory Committee on Heritable 

Disorders in Newborns and Children’’ (referred to in this section as 

the ‘‘Advisory Committee’’). 

(b) DUTIES.—The Advisory Committee shall— 

(1) provide advice and recommendations to the Secretary 

concerning grants and projects awarded or funded under section 1109; 

(2) provide technical information to the Secretary for the development of policies and priorities for the administration of 

grants under section 1109; 

(3) make systematic evidence-based and peer-reviewed recommendations that include the heritable disorders that have 

the potential to significantly impact public health for which all 

newborns should be screened, including secondary conditions 

that may be identified as a result of the laboratory methods 

used for screening; 

(4) provide technical assistance, as appropriate, to individuals and organizations regarding the submission of nominations to the uniform screening panel, including prior to the 

submission of such nominations; 

(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; 

(6) develop a model decision-matrix for newborn screening 

expansion, including an evaluation of the potential public 

health impact, including the cost of such expansion, and periodically update the recommended uniform screening panel, as 

appropriate, based on such decision-matrix; 

(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 1109; øand¿ 

(8) develop, maintain, and publish on a publicly accessible 

website consumer-friendly materials detailing— 


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(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 

ø(8)¿ (9) provide such recommendations, advice or information as may be necessary to enhance, expand or improve the 

ability of the Secretary to reduce the mortality or morbidity 

from heritable disorders, which may include recommendations, 

advice, or information dealing with— 

(A) follow-up activities, including those necessary to 

achieve best practices in rapid diagnosis and appropriate 

treatment in the short-term, and those that ascertain longterm case management outcomes and appropriate access to 

related services; 

(B) implementation, monitoring, and evaluation of newborn screening activities, including diagnosis, screening, 

follow-up, and treatment activities; 

(C) diagnostic and other technology used in screening; 

(D) the availability and reporting of testing for conditions for which there is no existing treatment, including 

information on cost and incidence; 

(E) conditions not included in the recommended uniform 

screening panel that are treatable with Food and Drug Administration-approved products or other safe and effective 

treatments, as determined by scientific evidence and peer 

review; 

(F) minimum standards and related policies and procedures used by State newborn screening programs, such as 

language and terminology used by State newborn screening programs to include standardization of case definitions 

and names of disorders for which newborn screening tests 

are performed; 

(G) quality assurance, oversight, and evaluation of State 

newborn screening programs, including ensuring that tests 

and technologies used by each State meet established 

standards for detecting and reporting positive screening 

results; 

(H) public and provider awareness and education; 

(I) the cost and effectiveness of newborn screening and 

medical evaluation systems and intervention programs 

conducted by State-based programs; 

(J) identification of the causes of, public health impacts 

of, and risk factors for heritable disorders; 

(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; 

ø(K)¿ (L) coordination of surveillance activities, including standardized data collection and reporting, harmonization of laboratory definitions for heritable disorders and 


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testing results, and confirmatory testing and verification of 

positive results, in order to assess and enhance monitoring 

of newborn diseases; and 

ø(L)¿ (M) the timeliness of collection, delivery, receipt, 

and screening of specimens to be tested for heritable disorders in newborns in order to ensure rapid diagnosis and 

followup. 

(c) MEMBERSHIP.— (1) IN GENERAL.—The Secretary shall appoint not to exceed 

15 members to the Advisory Committee. In appointing such 

members, the Secretary shall ensure that the total membership of the Advisory Committee is an odd number. 

(2) REQUIRED MEMBERS.—The Secretary shall appoint to the 

Advisory Committee under paragraph (1)— 

(A) the Administrator of the Health Resources and Services Administration; 

(B) the Director of the Centers for Disease Control and 

Prevention; 

(C) the Director of the National Institutes of Health; 

(D) the Director of the Agency for Healthcare Research 

and Quality; 

(E) the Commissioner of the Food and Drug Administration; 

(F) medical, technical, or scientific professionals with 

special expertise in heritable disorders, or in providing 

screening, counseling, testing or specialty services for 

newborns and children at risk for heritable disorders; 

(G) individuals with expertise in ethics and infectious 

diseases who have worked and published material in the 

area of newborn screening; 

(H) members of the public having special expertise about 

or concern with heritable disorders; and 

(I) representatives from such Federal agencies, public 

health constituencies, and medical professional societies as 

determined to be necessary by the Secretary, to fulfill the 

duties of the Advisory Committee, as established under 

subsection (b). 

(d) DECISION ON RECOMMENDATIONS.— (1) IN GENERAL.—Not later than 120 days after the Advisory 

Committee issues a recommendation pursuant to this section, 

the Secretary shall adopt or reject such recommendation. If the 

Secretary is unable to make a determination to adopt or reject 

such recommendation within such 120-day period, the Secretary shall notify the Advisory Committee and the appropriate committees of Congress of such determination together 

with an explanation for why the Secretary was unable to comply within such 120-day period, as well as a plan of action for 

consideration of such pending recommendation. 

(2) DETERMINATIONS TO BE MADE PUBLIC.—The Secretary 

shall publicize any determination on adopting or rejecting a 

recommendation of the Advisory Committee pursuant to this 

subsection, including the justification for the determination. 

(3) DEADLINE FOR REVIEW.—For each condition nominated to 

be added to the recommended uniform screening panel in accordance with the requirements of this section, the Advisory 


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Committee shall review and vote on the nominated condition 

within 9 months of the date on which the Advisory Committee 

referred the nominated condition to the condition review 

workgroup. 

(e) ANNUAL REPORT.—Not later than 3 years after the date of enactment of the Newborn Screening Saves Lives Act of 2008, and 

each fiscal year thereafter, the Advisory Committee shall— 

(1) publish a report on peer-reviewed newborn screening 

guidelines, including follow-up and treatment, in the United 

States; 

(2) submit such report to the appropriate committees of Congress, the Secretary, the Interagency Coordinating Committee 

established under Section 1114, and the State departments of 

health; and 

(3) disseminate such report on as wide a basis as practicable, 

including through posting on the internet clearinghouse established under section 1112. 

(f) MEETINGS.—The Advisory Committee shall meet at least 4 

times each calendar year, or at the discretion of the Designated 

Federal Officer in consultation with the Chair. 

(g) CONTINUATION OF OPERATION OF COMMITTEE.— 

(1) IN GENERAL.—Notwithstanding section 14 of the Federal 

Advisory Committee Act, the Advisory Committee shall continue to operate through the end of fiscal year ø2019¿ 2024. 

(2) CONTINUATION IF NOT REAUTHORIZED.—If at the end of 

fiscal year ø2019¿ 2024 the duration of the Advisory Committee has not been extended by statute, the Advisory Committee may be deemed, for purposes of the Federal Advisory 

Committee Act, an advisory committee established by the 

President or an officer of the Federal Government under section 9(a) of such Act. 

SEC. 1112. CLEARINGHOUSE OF NEWBORN SCREENING INFORMATION. 

(a) IN GENERAL.—The Secretary, acting through the Administrator of the Health Resources and Services Administration (referred to in this part as the ‘‘Administrator’’), in consultation with 

the Director of the Centers for Disease Control and Prevention and 

the Director of the National Institutes of Health, shall establish 

and maintain a central clearinghouse of current educational and 

family support and services information, materials, resources, research, and data on newborn screening to— 

(1) enable parents and family members of newborns, health 

professionals, industry representatives, and other members of 

the public to increase their awareness, knowledge, and understanding of newborn screening; 

(2) increase awareness, knowledge, and understanding of 

newborn diseases and screening services for expectant individuals and families; 

(3) maintain current information on quality indicators to 

measure performance of newborn screening, such as false-positive rates and other quality indicators as determined by the 

Advisory Committee under section 1111; 

(4) maintain current information on the number of conditions 

for which screening is conducted in each State; and 


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(5) disseminate available evidence-based guidelines related 

to diagnosis, counseling, and treatment with respect to conditions detected by newborn screening. 

(b) INTERNET AVAILABILITY.—The Secretary, acting through the 

Administrator, shall ensure that the clearinghouse described under 

subsection (a)— 

(1) is available on the Internet; 

(2) includes an interactive forum; 

(3) is updated on a regular basis, but not less than quarterly; 

and 

(4) provides— 

(A) links to Government-sponsored, non-profit, and other 

Internet websites of laboratories that have demonstrated 

expertise in newborn screening that supply research-based 

information on newborn screening tests currently available 

throughout the United States; 

(B) information about newborn conditions and screening 

services available in each State from laboratories certified 

under subpart 2 of part F of title III, including information 

about supplemental screening that is available but not required, in the State where the infant is born; 

(C) current research on both treatable and not-yet treatable conditions for which newborn screening tests are 

available; 

(D) the availability of Federal funding for newborn and 

child screening for heritable disorders including grants authorized under the Newborn Screening Saves Lives Reauthorization Act of 2014; and 

(E) other relevant information as determined appropriate by the Secretary. 

(c) NONDUPLICATION.—In carrying out activities under this section, the Secretary shall ensure that such activities minimize duplication øand supplement, not supplant, existing information sharing 

efforts¿ and complement other Federal newborn screening information sharing activities. 

SEC. 1113. LABORATORY QUALITY AND SURVEILLANCE. 

(a) IN GENERAL.—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— 

(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, øperformance 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; øand¿ 

(2) appropriate quality control and other øperformance test 

materials¿ test performance materials to evaluate the performance of new screening toolsø.¿; and 

(3) performance evaluation services to enhance disease detection, including the development of tools, resources, and infrastructure to improve data analysis, test result interpretation, 


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data harmonization, and dissemination of laboratory best practices. 

ø(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, may provide, as appropriate, for the coordination of surveillance activities, including— 

ø(1) through standardized data collection and reporting, as 

well as the use of electronic health records; and 

ø(2) by promoting data sharing regarding newborn screening 

with State-based birth defects and developmental disabilities 

monitoring programs.¿ 

(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. 

* * * * * * * 

SEC. 1116. HUNTER KELLY RESEARCH PROGRAM. 

(a) NEWBORN SCREENING ACTIVITIES.— (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, 

ømay¿ shall 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 technologies, in order to improve already existing screening tests, increase the specificity of 

newborn screening, and expand the number of conditions 

for which screening tests are available; 

(B) experimental treatments and disease management 

strategies for additional newborn conditions, and other genetic, metabolic, hormonal, or functional conditions that 

can be detected through newborn screening for which 

treatment is not yet available; 

(C) providing research findings and data for newborn 

conditions under review by the Advisory Committee on 

Heritable Disorders in Newborns and Children to be added 

to the recommended uniform screening panel; 

(D) conducting pilot studies on conditions recommended 

by, or with a high probability of being recommended by, 


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the Advisory Committee on Heritable Disorders in 

Newborns and Children to ensure øthat screenings are 

ready for nationwide implementation¿ that reliable newborn screening technologies are evaluated and ready for 

use; and 

(E) other activities that would improve newborn screening, as identified by the Director. 

(2) ADDITIONAL NEWBORN CONDITION.—For purposes of this 

subsection, the term ‘‘additional newborn condition’’ means any 

condition that is not one of the core conditions recommended 

by the Advisory Committee and adopted by the Secretary. 

ø(b) FUNDING.—In carrying out the research program under this 

section, the Secretary and the Director shall ensure that entities 

receiving funding through the program will provide assurances, as 

practicable, that such entities will work in consultation with the 

appropriate State departments of health, and, as practicable, focus 

their research on screening technology not currently performed in 

the States in which the entities are located, and the conditions on 

the uniform screening panel (or the standard test existing on the 

uniform screening panel).¿ 

(b) FUNDING.—In carrying out the research program under this 

section, the Secretary and the Director— 

(1) shall ensure that entities receiving funding through the 

program will provide assurances, as practicable, that such entities will work in consultation with the appropriate State departments of health; and 

(2) may accept, use, and dispose of donations and bequests 

from private for-profit and non-profit entities, in accordance 

with Federal law. 

(c) REPORTS.—The Director is encouraged to include information 

about the activities carried out under this section in the biennial 

report required under section 403. If such information is included, 

the Director shall make such information available to be included 

on the Internet Clearinghouse established under section 1112. 

(d) NONDUPLICATION.—In carrying out programs under this section, the Secretary shall minimize duplication and supplement, not 

supplant, existing efforts of the type carried out under this section. 

(e) PEER REVIEW.—Nothing in this section shall be construed to 

interfere with the scientific peer-review process at the National Institutes of Health. 

SEC. 1117. AUTHORIZATION OF APPROPRIATIONS FOR NEWBORN 

SCREENING PROGRAMS AND ACTIVITIES. 

There are authorized to be appropriated— 

(1) to carry out sections 1109, 1110, 1111, and 1112, 

ø$11,900,000¿ $31,000,000 for each of fiscal years ø2015¿ 2020 

through ø2019¿ 2024; and 

(2) to carry out section 1113, ø$8,000,000¿ $29,650,000 for 

each of fiscal years ø2015¿ 2020 through ø2019¿ 2024. 

* * * * * * * 

NEWBORN SCREENING SAVES LIVES 

REAUTHORIZATION ACT OF 2014 

* * * * * * * 


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øSEC. 12. INFORMED CONSENT FOR NEWBORN SCREENING RESEARCH. 

ø(a) IN GENERAL.—Research on newborn dried blood spots shall 

be considered research carried out on human subjects meeting the 

definition of section 46.102(f)(2) of title 45, Code of Federal Regulations, for purposes of Federally funded research conducted pursuant to the Public Health Service Act until such time as updates to 

the Federal Policy for the Protection of Human Subjects (the Common Rule) are promulgated pursuant to subsection (c). For purposes of this subsection, sections 46.116(c) and 46.116(d) of title 45, 

Code of Federal Regulations, shall not apply. 

ø(b) EFFECTIVE DATE.—Subsection (a) shall apply only to newborn dried blood spots used for purposes of Federally funded research that were collected not earlier than 90 days after the date 

of enactment of this Act. 

ø(c) REGULATIONS.—Not later than 6 months after the date of enactment of this Act, the Secretary of Health and Human Services 

shall promulgate proposed regulations related to the updating of 

the Federal Policy for the Protection of Human Subjects (the Common Rule), particularly with respect to informed consent. Not later 

than 2 years after such date of enactment, the Secretary shall promulgate final regulations based on such proposed regulations.¿ 

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.). 

Æ 


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