Newborn Screening Saves Lives Reauthorization Act of 2013

Bill: 113-s-1417
Sponsor: Sen. Hagan, Kay R. [D-NC]
Introduced: 2013-08-01 in the Senate
Policy area: Health
Subjects: Advisory bodies
Child health
Congressional oversight
Executive agency funding and structure
Genetics
Health information and medical records
Health programs administration and funding
Health promotion and preventive care
Hereditary and development disorders
Medical research
Medical tests and diagnostic methods
Research administration and funding

Summary:
action_date: 2013-08-01
text: 
Newborn Screening Saves Lives Reauthorization Act of 2013 - Amends the Public Health Service Act to extend and revise a grant program for screening, counseling, and other services related to heritable disorders.
 
Extends a grant program to evaluate the effectiveness of screening, counseling, or health care services in reducing the morbidity and mortality caused by heritable disorders in newborns and children. Expands the program to include evaluation of follow-up care for newborns and their families after screening and diagnosis.
 
Directs the Advisory Committee on Heritable Disorders in Newborns and Children to provide a priority review of a human drug application with respect to a nomination to the recommended uniform screening panel. Requires the Advisory Committee to meet in person at least four times each calendar year with at least two meetings in person.
 
Extends the clearinghouse for newborn screening information. Expands the duties of the clearinghouse to include: (1) maintaining current data on the number of conditions for which screening is conducted in each state; and (2) disseminating available evidence-informed guidelines related to diagnosis, counseling, and treatment with respect to conditions detected by newborn screening.
 
Extends requirements for the Secretary to provide for quality assurance of laboratories involved in screening newborns and children for heritable disorders.
 
Extends the Interagency Coordinating Committee on Newborn and Child Screening.
 
Authorizes the Secretary to have the Hunter Kelly Newborn Screening Research Program to: (1) provide research and data for newborn conditions under review by the Advisory Committee to be added to the Recommended Uniform Screening Panel; and (2) conduct pilot studies on conditions recommended by the Advisory Committee to ensure that screenings are ready for nationwide implementation.

action_date: 2013-12-19
text: 
Newborn Screening Saves Lives Reauthorization Act of 2013 - (Sec. 2) Amends the Public Health Service Act to extend through FY2018 a grant program for newborn and child screening programs for heritable disorders. Includes the improvement of the timely collection, delivery, and receipts, and screening of specimens, and the timely diagnosis of heritable disorders in newborns as a permissible use of grant funds.
 
(Sec. 3) Extends through FY2018 a demonstration program to evaluate the effectiveness of screening, follow-up, counseling or health care services in reducing the morbidity and mortality caused by heritable disorders in newborn and children. Permits the program to also evaluate and assess: (1) methods to improve quality in the diagnosis, treatment, and disease management of heritable disorders based on gaps in services or care; and (2) methods or best practices by which states or political subdivisions of a state, territories, Indian health care facilities or programs, or any entity with appropriate expertise in newborn screening can achieve the timely collection, delivery, receipt, and screening of newborn screening specimens, and the timely diagnosis of heritable disorders in newborns.
 
(Sec. 4) Reauthorizes through FY2018 and extends for five years the operation of the Advisory Committee on Heritable Disorders in Newborns and Children. Expands the duties of the Advisory Committee to include providing technical assistance to individuals and organizations regarding the submission of nominations to the uniform screening panel. Requires the Advisory Committee to give recommendations, advice, or information to the Secretary of Health and Human Services (HHS) on the timely collection, delivery, receipt, and screening of specimens to be tested for heritable disorders in newborns. 
 
Revises the process for the Secretary to consider the Advisory Committee's recommendations.
 
Requires the Advisory Committee to meet at least four times per year.
 
(Sec. 5) Extends through FY2018 the Newborn Screening Clearinghouse of current education and family support and services information, materials, resources, research, and data on newborn screening.
 
(Sec. 6) Extends through FY2018 a quality assurance program requiring the Secretary, acting through the Director of the Centers for Disease Control and Prevention (CDC), to provide for quality assurance of laboratories involved in screening for heritable disorders. Authorizes the Secretary, acting through the Director, to also provide for the coordination of surveillance activities.
 
(Sec. 7) Makes the Interagency Coordinating Committee on Newborn and Child Screening permanent. Includes the Commissioner of Food and Drugs (FDA) as a member of the Interagency Committee.
 
(Sec. 8) Requires the national contingency plan for newborn screening to be updated at least every five years.
 
(Sec. 9) Allows the expansion of the Hunter Kelly Newborn Screening Research Program to include: (1) providing research findings and data for newborn conditions under review by the Advisory Committee to be added to the recommended uniform screening panel, and (2) conducting pilot studies on conditions recommended by the Advisory Committee to ensure that the screenings are ready for nationwide implementation.
 
(Sec. 11) Requires the Comptroller General to report to the relevant congressional committees on the timeliness of screening for heritable disorders in newborns.
 
Requires the Secretary to report to the relevant congressional committees biennially on activities related to newborn screening and screening children who have or are at risk for heritable disorders.

action_date: 2014-01-29
text: 

(This measure has not been amended since it was reported to the Senate on December 19, 2013. The summary of that version is repeated here.)

 
Newborn Screening Saves Lives Reauthorization Act of 2013 - (Sec. 2) Amends the Public Health Service Act to extend through FY2018 a grant program for newborn and child screening programs for heritable disorders. Includes the improvement of the timely collection, delivery, and receipts, and screening of specimens, and the timely diagnosis of heritable disorders in newborns as a permissible use of grant funds.
 
(Sec. 3) Extends through FY2018 a demonstration program to evaluate the effectiveness of screening, follow-up, counseling or health care services in reducing the morbidity and mortality caused by heritable disorders in newborn and children. Permits the program to also evaluate and assess: (1) methods to improve quality in the diagnosis, treatment, and disease management of heritable disorders based on gaps in services or care; and (2) methods or best practices by which states or political subdivisions of a state, territories, Indian health care facilities or programs, or any entity with appropriate expertise in newborn screening can achieve the timely collection, delivery, receipt, and screening of newborn screening specimens, and the timely diagnosis of heritable disorders in newborns.
 
(Sec. 4) Reauthorizes through FY2018 and extends for five years the operation of the Advisory Committee on Heritable Disorders in Newborns and Children. Expands the duties of the Advisory Committee to include providing technical assistance to individuals and organizations regarding the submission of nominations to the uniform screening panel. Requires the Advisory Committee to give recommendations, advice, or information to the Secretary of Health and Human Services (HHS) on the timely collection, delivery, receipt, and screening of specimens to be tested for heritable disorders in newborns. 
 
Revises the process for the Secretary to consider the Advisory Committee's recommendations.
 
Requires the Advisory Committee to meet at least four times per year.
 
(Sec. 5) Extends through FY2018 the Newborn Screening Clearinghouse of current education and family support and services information, materials, resources, research, and data on newborn screening.
 
(Sec. 6) Extends through FY2018 a quality assurance program requiring the Secretary, acting through the Director of the Centers for Disease Control and Prevention (CDC), to provide for quality assurance of laboratories involved in screening for heritable disorders. Authorizes the Secretary, acting through the Director, to also provide for the coordination of surveillance activities.
 
(Sec. 7) Makes the Interagency Coordinating Committee on Newborn and Child Screening permanent. Includes the Commissioner of Food and Drugs (FDA) as a member of the Interagency Committee.
 
(Sec. 8) Requires the national contingency plan for newborn screening to be updated at least every five years.
 
(Sec. 9) Allows the expansion of the Hunter Kelly Newborn Screening Research Program to include: (1) providing research findings and data for newborn conditions under review by the Advisory Committee to be added to the recommended uniform screening panel, and (2) conducting pilot studies on conditions recommended by the Advisory Committee to ensure that the screenings are ready for nationwide implementation.
 
(Sec. 11) Requires the Comptroller General to report to the relevant congressional committees on the timeliness of screening for heritable disorders in newborns.
 
Requires the Secretary to report to the relevant congressional committees biennially on activities related to newborn screening and screening children who have or are at risk for heritable disorders.


Legislative actions:
action_date: 2014-02-07
text: Referred to the Subcommittee on Health.
action_date: 2014-01-31
text: Referred to the House Committee on Energy and Commerce.
action_date: 2014-01-31
text: Received in the House.
action_date: 2014-01-30
text: Message on Senate action sent to the House.
action_date: 2014-01-29
text: Passed Senate with an amendment by Unanimous Consent. (consideration: CR S605-607; text as passed Senate: CR S605-607)
action_date: 2014-01-29
text: Passed/agreed to in Senate: Passed Senate with an amendment by Unanimous Consent.(consideration: CR S605-607; text as passed Senate: CR S605-607)
action_date: 2013-12-19
text: Placed on Senate Legislative Calendar under General Orders. Calendar No. 282.
action_date: 2013-12-19
text: Committee on Health, Education, Labor, and Pensions. Reported with an amendment in the nature of a substitute. Without written report.
action_date: 2013-12-19
text: Committee on Health, Education, Labor, and Pensions. Reported with an amendment in the nature of a substitute. Without written report.
action_date: 2013-12-18
text: Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
action_date: 2013-08-01
text: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
action_date: 2013-08-01
text: Introduced in Senate