Newborn Screening Saves Lives Reauthorization Act of 2014

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. Expands eligible grantees to include a health professional organization and an early childhood health system.

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 treatment and follow-up care for newborns and their families after screening and diagnosis.

Extends for five years the operation of the Advisory Committee on Heritable Disorders in Newborns and Children. Authorizes the Secretary of Health and Human Services (HHS) to continue the Advisory Committee after such time. Requires the Advisory Committee to meet in person at least twice each year.

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) establishing or disseminating guidelines for services and personnel necessary for follow-up, diagnosis, counseling, and treatment of 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.

Directs the Secretary, acting through the Director of the Centers for Disease Control and Prevention (CDC), to award grants to, or enter into cooperative agreements with, eligible entities to develop longitudinal followup and tracking programs for newborn screening.

Newborn Screening Saves Lives Reauthorization Act of 2014 - (Sec. 2) Amends the Public Health Service Act to revise and extend through FY2019 a grant program for screening, counseling, and other services related to heritable disorders that can be detected in newborns. Allows grants to be used to improve timeliness of newborn screening and provide training to health care professionals on the importance of timely screening and on the sharing of medical and diagnostic information with providers and families.

(Sec. 3) Extends through FY2019 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 health outcomes through adolescence and best practices for timely screening of newborns.

(Sec. 4) Extends for five years the operation of the Advisory Committee on Heritable Disorders in Newborns and Children. Authorizes the Secretary of Health and Human Services (HHS) to continue the Advisory Committee after such time.

(Sec. 5) Extends through FY2019 the clearinghouse for newborn screening information. Expands the duties of the clearinghouse to include: (1) maintaining current information on the number of conditions for which screening is conducted in each state; and (2) disseminating guidelines for diagnosis, counseling, and treatment of conditions detected by newborn screening.

(Sec. 6) Extends through FY2019 requirements for the Director of the Centers for Disease Control and Prevention (CDC) to provide for quality assurance of laboratories involved in screening newborns and children for heritable disorders. Authorizes the Director to coordinate surveillance activities, including through standardized data collection and reporting and electronic health records.

(Sec. 7) Makes permanent the Interagency Coordinating Committee on Newborn and Child Screening. Adds the Administrator of the Health Resources and Services Administration and the Commissioner of Food and Drugs (FDA) to this committee.

(Sec. 8) Requires the Director to update the national contingency plan for newborn screening at least every five years.

(Sec. 9) Authorizes the Secretary to expand 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.

(Sec. 11) Requires the Comptroller General (GAO) to report on the timeliness of newborn screening. Requires the Secretary to report on newborn screening activities and expenditures.

(This measure has not been amended since it was reported to the House on June 19, 2014. The summary of that version is repeated here.)

Newborn Screening Saves Lives Reauthorization Act of 2014 - (Sec. 2) Amends the Public Health Service Act to revise and extend through FY2019 a grant program for screening, counseling, and other services related to heritable disorders that can be detected in newborns. Allows grants to be used to improve timeliness of newborn screening and provide training to health care professionals on the importance of timely screening and on the sharing of medical and diagnostic information with providers and families.

(Sec. 3) Extends through FY2019 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 health outcomes through adolescence and best practices for timely screening of newborns.

(Sec. 4) Extends for five years the operation of the Advisory Committee on Heritable Disorders in Newborns and Children. Authorizes the Secretary of Health and Human Services (HHS) to continue the Advisory Committee after such time.

(Sec. 5) Extends through FY2019 the clearinghouse for newborn screening information. Expands the duties of the clearinghouse to include: (1) maintaining current information on the number of conditions for which screening is conducted in each state; and (2) disseminating guidelines for diagnosis, counseling, and treatment of conditions detected by newborn screening.

(Sec. 6) Extends through FY2019 requirements for the Director of the Centers for Disease Control and Prevention (CDC) to provide for quality assurance of laboratories involved in screening newborns and children for heritable disorders. Authorizes the Director to coordinate surveillance activities, including through standardized data collection and reporting and electronic health records.

(Sec. 7) Makes permanent the Interagency Coordinating Committee on Newborn and Child Screening. Adds the Administrator of the Health Resources and Services Administration and the Commissioner of Food and Drugs (FDA) to this committee.

(Sec. 8) Requires the Director to update the national contingency plan for newborn screening at least every five years.

(Sec. 9) Authorizes the Secretary to expand 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.

(Sec. 11) Requires the Comptroller General (GAO) to report on the timeliness of newborn screening. Requires the Secretary to report on newborn screening activities and expenditures.

Newborn Screening Saves Lives Reauthorization Act of 2014 - (Sec. 2) Amends the Public Health Service Act to revise and extend through FY2019 a grant program for screening, counseling, and other services related to heritable disorders that can be detected in newborns. Allows grants to be used to improve timeliness of newborn screening and provide training to health care professionals on the importance of timely screening and on the sharing of medical and diagnostic information with providers and families.

(Sec. 3) Extends through FY2019 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 health outcomes through adolescence and best practices for timely screening of newborns.

(Sec. 4) Extends for five years the operation of the Advisory Committee on Heritable Disorders in Newborns and Children. Authorizes the Secretary of Health and Human Services (HHS) to continue the Advisory Committee after such time.

(Sec. 5) Extends through FY2019 the clearinghouse for newborn screening information. Expands the duties of the clearinghouse to include: (1) maintaining current information on the number of conditions for which screening is conducted in each state; and (2) disseminating guidelines for diagnosis, counseling, and treatment of conditions detected by newborn screening.

(Sec. 6) Extends through FY2019 requirements for the Director of the Centers for Disease Control and Prevention (CDC) to provide for quality assurance of laboratories involved in screening newborns and children for heritable disorders. Authorizes the Director to coordinate surveillance activities, including through standardized data collection and reporting and electronic health records.

(Sec. 7) Makes permanent the Interagency Coordinating Committee on Newborn and Child Screening. Adds the Administrator of the Health Resources and Services Administration and the Commissioner of Food and Drugs (FDA) to this committee.

(Sec. 8) Requires the Director to update the national contingency plan for newborn screening at least every five years.

(Sec. 9) Authorizes the Secretary to expand 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.

(Sec. 11) Requires the Comptroller General (GAO) to report on the timeliness of newborn screening. Requires the Secretary to report on newborn screening activities and expenditures.

(Sec. 12) Directs HHS to update the Federal Policy for the Protection of Human Subjects, also known as the Common Rule, not later than two years after enactment of this Act. Applies the following provisions until HHS updates the Common Rule:

• requires federally funded research on newborn dried blood spots to be considered research on human subjects (which requires the informed consent of the subject), and
• eliminates the ability of an institutional review board to waive informed consent requirements for research on newborn dried blood spots.

(This measure has not been amended since it was passed by the Senate on December 8, 2014. The summary of that version is repeated here.)

Newborn Screening Saves Lives Reauthorization Act of 2014 - (Sec. 2) Amends the Public Health Service Act to revise and extend through FY2019 a grant program for screening, counseling, and other services related to heritable disorders that can be detected in newborns. Allows grants to be used to improve timeliness of newborn screening and provide training to health care professionals on the importance of timely screening and on the sharing of medical and diagnostic information with providers and families.

(Sec. 3) Extends through FY2019 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 health outcomes through adolescence and best practices for timely screening of newborns.

(Sec. 4) Extends for five years the operation of the Advisory Committee on Heritable Disorders in Newborns and Children. Authorizes the Secretary of Health and Human Services (HHS) to continue the Advisory Committee after such time.

(Sec. 5) Extends through FY2019 the clearinghouse for newborn screening information. Expands the duties of the clearinghouse to include: (1) maintaining current information on the number of conditions for which screening is conducted in each state; and (2) disseminating guidelines for diagnosis, counseling, and treatment of conditions detected by newborn screening.

(Sec. 6) Extends through FY2019 requirements for the Director of the Centers for Disease Control and Prevention (CDC) to provide for quality assurance of laboratories involved in screening newborns and children for heritable disorders. Authorizes the Director to coordinate surveillance activities, including through standardized data collection and reporting and electronic health records.

(Sec. 7) Makes permanent the Interagency Coordinating Committee on Newborn and Child Screening. Adds the Administrator of the Health Resources and Services Administration and the Commissioner of Food and Drugs (FDA) to this committee.

(Sec. 8) Requires the Director to update the national contingency plan for newborn screening at least every five years.

(Sec. 9) Authorizes the Secretary to expand 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.

(Sec. 11) Requires the Comptroller General (GAO) to report on the timeliness of newborn screening. Requires the Secretary to report on newborn screening activities and expenditures.

(Sec. 12) Directs HHS to update the Federal Policy for the Protection of Human Subjects, also known as the Common Rule, not later than two years after enactment of this Act. Applies the following provisions until HHS updates the Common Rule:

• requires federally funded research on newborn dried blood spots to be considered research on human subjects (which requires the informed consent of the subject), and
• eliminates the ability of an institutional review board to waive informed consent requirements for research on newborn dried blood spots.