Promoting Biomedical Research and Public Health for Patients Act

Bill: 114-s-2742
Sponsor: Sen. Alexander, Lamar [R-TN]
Introduced: 2016-04-04 in the Senate
Policy area: Health
Subjects: Administrative law and regulatory procedures
Advisory bodies
Animal protection and human-animal relationships
Child health
Congressional oversight
Department of Health and Human Services
Education programs funding
Federal officials
Government ethics and transparency, public corruption
Government information and archives
Government liability
Government studies and investigations
HIV/AIDS
Higher education
Immunology and vaccination
Medical research
National Institutes of Health (NIH)
Public contracts and procurement
Research administration and funding
Student aid and college costs
Women's health
World health

Summary:
action_date: 2016-04-04
text: 

Promoting Biomedical Research and Public Health for Patients Act

 
This bill amends the Public Health Service Act to revise reporting requirements for the National Institutes of Health (NIH) and certain national research institutes.
 
The Department of Health and Human Services (HHS) and the NIH must review and revise policies, including policies on conflicts of interest and laboratory animals, to reduce the administrative burden on researchers while maintaining the integrity and credibility of research findings.
 
The Office of Management and Budget must establish the Research Policy Board to make recommendations to minimize the administrative burden of federal research policies while maintaining responsible oversight.
 
Contractors making substances and living organisms available for research on behalf of HHS may collect payments on behalf of HHS for incurred costs.
 
HHS must revise the Vaccine Injury Table to include information on vaccines recommended by the Centers for Disease Control and Prevention for pregnant women.
 
The bill revises provisions regarding the clinical trial registry data bank to permit earlier publication of certain data and to categorize clinical trials for combination products.
 
The Director of NIH is given the authority to appoint the directors of the national research institutes.
 Additional phases of clinical trials are made eligible for support from the National Center for Advancing Translational Sciences.
action_date: 2016-04-18
text: 

Promoting Biomedical Research and Public Health for Patients Act

 
(Sec. 2) This bill amends the Public Health Service Act to revise reporting requirements for the National Institutes of Health (NIH) and certain national research institutes.
 
(Sec. 3) The Department of Health and Human Services (HHS) must revise policies related to the disclosure of financial conflicts of interest to reduce the administrative burden on researchers while maintaining the integrity and credibility of research findings.
 
The NIH must reduce administrative burdens related to monitoring subrecipients of grants.
 
HHS must revise expenditure reporting policies to avoid duplication and minimize burden for recipients of NIH funding.
 
The NIH, in collaboration with the Department of Agriculture and the Food and Drug Administration (FDA), must revise policies regarding laboratory animals to reduce administrative burdens while maintaining the integrity and credibility of research findings and protection of research animals.
 
HHS must clarify the applicability of regulations regarding documentation of personnel expenses by grant recipients.
 
The Office of Management and Budget must establish the Research Policy Board to make recommendations to minimize the administrative burden of federal research policies while maintaining responsible oversight. The board is terminated at the end of FY2020.
 
(Sec. 4) Contractors making substances and living organisms available for research on behalf of HHS may collect payments on behalf of HHS for incurred costs.
 
(Sec. 6) HHS must revise the Vaccine Injury Table to include information on vaccines recommended by the Centers for Disease Control and Prevention for pregnant women. A mother and child are individually considered for compensation for a vaccine injury from a vaccine administered during pregnancy.
 
(Sec. 7) HHS must report on ways to promote innovation in the development of vaccines.
 
(Sec. 8) The bill revises provisions regarding the clinical trial registry data bank to permit earlier publication of certain data and to categorize clinical trials for combination products.
 
(Sec. 9) The NIH and the FDA must report on information in the clinical trial registry data bank, activities undertaken to encourage compliance with data bank requirements, and actions to enforce compliance.
 
(Sec. 10) The Director of NIH is given the authority to appoint the directors of the national research institutes. The term of office of these directors is set to five years, with no limit on the number of reappointments.
 
(Sec. 11) The National Center for Advancing Translational Sciences may support additional phases of clinical trials.


Legislative actions:
action_date: 2016-04-18
text: Placed on Senate Legislative Calendar under General Orders. Calendar No. 429.
action_date: 2016-04-18
text: Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander with an amendment in the nature of a substitute. Without written report.
action_date: 2016-04-18
text: Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander with an amendment in the nature of a substitute. Without written report.
action_date: 2016-04-06
text: Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
action_date: 2016-04-04
text: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
action_date: 2016-04-04
text: Introduced in Senate