Adding Ebola to the FDA Priority Review Voucher Program Act 2014-12-16 Public Law (This measure has not been amended since it was introduced. The expanded summary of the Senate reported version is repeated here.)

Adding Ebola to the FDA Priority Review Voucher Program Act - (Sec. 2) Amends the Federal Food, Drug, and Cosmetic Act to add filoviruses, a family of viruses that includes the Ebola virus, to the list of tropical diseases under the priority review voucher program, which awards vouchers to sponsors of human drug applications that are approved to prevent or treat tropical diseases. (A voucher entitles the holder to have a future human drug application acted upon by the Food and Drug Administration (FDA) within six months.)

Changes the process by which infectious diseases that do not significantly impact developed nations and disproportionately affect poor and marginalized populations can be designated as tropical diseases from rulemaking to order of the Secretary of Health and Human Services (HHS).

Allows priority review vouchers to be transferred between sponsors of human drug applications any number of times.

Reduces from 365 days to 90 days the advance notice required before submitting a human drug application subject to a priority review voucher.]]> 2014-12-03 Passed House without amendment (This measure has not been amended since it was introduced. The expanded summary of the Senate reported version is repeated here.)

Adding Ebola to the FDA Priority Review Voucher Program Act - (Sec. 2) Amends the Federal Food, Drug, and Cosmetic Act to add filoviruses, a family of viruses that includes the Ebola virus, to the list of tropical diseases under the priority review voucher program, which awards vouchers to sponsors of human drug applications that are approved to prevent or treat tropical diseases. (A voucher entitles the holder to have a future human drug application acted upon by the Food and Drug Administration (FDA) within six months.)

Changes the process by which infectious diseases that do not significantly impact developed nations and disproportionately affect poor and marginalized populations can be designated as tropical diseases from rulemaking to order of the Secretary of Health and Human Services (HHS).

Allows priority review vouchers to be transferred between sponsors of human drug applications any number of times.

Reduces from 365 days to 90 days the advance notice required before submitting a human drug application subject to a priority review voucher.]]> 2014-12-02 Passed Senate without amendment (This measure has not been amended since it was introduced. The expanded summary of the Senate reported version is repeated here.)

Adding Ebola to the FDA Priority Review Voucher Program Act - (Sec. 2) Amends the Federal Food, Drug, and Cosmetic Act to add filoviruses, a family of viruses that includes the Ebola virus, to the list of tropical diseases under the priority review voucher program, which awards vouchers to sponsors of human drug applications that are approved to prevent or treat tropical diseases. (A voucher entitles the holder to have a future human drug application acted upon by the Food and Drug Administration (FDA) within six months.)

Changes the process by which infectious diseases that do not significantly impact developed nations and disproportionately affect poor and marginalized populations can be designated as tropical diseases from rulemaking to order of the Secretary of Health and Human Services (HHS).

Allows priority review vouchers to be transferred between sponsors of human drug applications any number of times.

Reduces from 365 days to 90 days the advance notice required before submitting a human drug application subject to a priority review voucher.]]> 2014-11-19 Reported to Senate without amendment (This measure has not been amended since it was introduced. The summary has been expanded because action occurred on the measure.)

Adding Ebola to the FDA Priority Review Voucher Program Act - (Sec. 2) Amends the Federal Food, Drug, and Cosmetic Act to add filoviruses, a family of viruses that includes the Ebola virus, to the list of tropical diseases under the priority review voucher program, which awards vouchers to sponsors of human drug applications that are approved to prevent or treat tropical diseases. (A voucher entitles the holder to have a future human drug application acted upon by the Food and Drug Administration (FDA) within six months.)

Changes the process by which infectious diseases that do not significantly impact developed nations and disproportionately affect poor and marginalized populations can be designated as tropical diseases from rulemaking to order of the Secretary of Health and Human Services (HHS).

Allows priority review vouchers to be transferred between sponsors of human drug applications any number of times.

Reduces from 365 days to 90 days the advance notice required before submitting a human drug application subject to a priority review voucher.]]> 2014-11-12 Introduced in Senate Adding Ebola to the FDA Priority Review Voucher Program Act - Amends the Federal Food, Drug, and Cosmetic Act to add filoviruses, a family of viruses that includes the Ebola virus, to the list of tropical diseases under the priority review voucher program, which awards vouchers to sponsors of human drug applications that are approved to prevent or treat tropical diseases. (A voucher entitles the holder to have a future human drug application acted upon by the Food and Drug Administration (FDA) within six months.)

Changes the process by which infectious diseases that do not significantly impact developed nations and disproportionately affect poor and marginalized populations can be designated as tropical diseases from rulemaking to order of the Secretary of Health and Human Services (HHS).

Allows priority review vouchers to be transferred between sponsors of human drug applications any number of times.

Reduces from 365 days to 90 days the advance notice required before submitting a human drug application subject to a priority review voucher.]]> 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 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.