Promoting Biomedical Research and Public Health for Patients Act

3.0.0 2742 2023-01-11T13:31:27Z 2023-01-11T13:31:27Z Senate S 2016-04-04 114 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Reported by 2016-04-18T22:38:51Z Markup by 2016-04-06T14:00:00Z Referred to 2016-04-04T22:05:47Z 2016-04-18 Senate Placed on Senate Legislative Calendar under General Orders. Calendar No. 429. Calendars 2016-04-18 sshr00 Health, Education, Labor, and Pensions Committee Senate Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander with an amendment in the nature of a substitute. Without written report. Committee 2016-04-18 Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander with an amendment in the nature of a substitute. Without written report. Committee 14000 9 Library of Congress sshr00 Health, Education, Labor, and Pensions Committee 2016-04-06 sshr00 Health, Education, Labor, and Pensions Committee Senate Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably. Committee 2016-04-04 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2016-04-04 Introduced in Senate IntroReferral 10000 9 Library of Congress A000360 Sen. Alexander, Lamar [R-TN] Lamar Alexander R TN N M001111 Sen. Murray, Patty [D-WA] Patty Murray D WA 2016-04-04 True K000360 Sen. Kirk, Mark Steven [R-IL] MARK KIRK R IL STEVEN 2016-04-04 True W000817 Sen. Warren, Elizabeth [D-MA] Elizabeth Warren D MA A. 2016-04-04 True Health 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 Health

00 2016-04-04 Introduced in Senate 2016-12-14T14:30:20Z 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.]]>

01 2016-04-18 Reported to Senate with amendment(s) 2017-01-04T16:35:00Z 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.

(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.

]]>

Promoting Biomedical Research and Public Health for Patients Act Display Title Promoting Biomedical Research and Public Health for Patients Act Official Title as Introduced A bill to amend title IV of the Public Health Service Act regarding the national research institutes, and for other purposes. Introduced in Senate IS Short Titles as Introduced Promoting Biomedical Research and Public Health for Patients Act Short Titles as Reported to Senate Promoting Biomedical Research and Public Health for Patients Act S Senate Reported to Senate 2016-04-18T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-114s2742rs/xml/BILLS-114s2742rs.xml Introduced in Senate 2016-04-04T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-114s2742is/xml/BILLS-114s2742is.xml 2016-04-18 Placed on Senate Legislative Calendar under General Orders. Calendar No. 429. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.