Adding Ebola to the FDA Priority Review Voucher Program Act

Summary

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.

This text is taken from the official record. PoliticalRepo does not editorialize.

Timeline

1. 18 November 2014

   Introduced

   Introduced in House

   Source: IntroReferral

2. 18 November 2014

   Introduced

   Referred to the House Committee on Energy and Commerce.

   Source: IntroReferral

3. 18 November 2014

   Introduced

   Introduced in House

   Source: IntroReferral

4. 21 November 2014

   Referred

   Referred to the Subcommittee on Health.

   Source: Committee

Votes

No vote records are attached yet.

Versions

• Introduced in House · 18 November 2014 · Download file

Documents

3 official files

• Introduced in House (text)

  Introduced in House · EN · 18 November 2014

  ViewDownloadOpen at official source

• Introduced in House (PDF)

  Introduced in House · EN · 18 November 2014

  ViewDownloadOpen at official source

  Leesvertaling

  Vertaal dit document naar jouw taal. PoliticalRepo bewaart geen aparte kopie per EU-taal.

  Vertaal naarNL · DutchDE · GermanFR · FrenchES · SpanishIT · ItalianPL · PolishPT · PortugueseSV · SwedishDA · DanishFI · FinnishEL · GreekCS · CzechHU · HungarianRO · RomanianBG · BulgarianHR · CroatianSK · SlovakSL · SlovenianLT · LithuanianLV · LatvianET · EstonianGA · IrishMT · Maltese

  Vertaal document

  Documentvertaling op verzoek met downloadbare PDF (logo + link naar de officiële bron). Het bronbestand blijft leidend.

• Introduced in House

  summary · EN · 18 November 2014

  Open at official source

  Leesvertaling

  Vertaal dit document naar jouw taal. PoliticalRepo bewaart geen aparte kopie per EU-taal.

  Vertaal naarNL · DutchDE · GermanFR · FrenchES · SpanishIT · ItalianPL · PolishPT · PortugueseSV · SwedishDA · DanishFI · FinnishEL · GreekCS · CzechHU · HungarianRO · RomanianBG · BulgarianHR · CroatianSK · SlovakSL · SlovenianLT · LithuanianLV · LatvianET · EstonianGA · IrishMT · Maltese

  Vertaal document

  Documentvertaling op verzoek met downloadbare PDF (logo + link naar de officiële bron). Het bronbestand blijft leidend.

Sponsors

• Sen. Blackburn, Marsha [R-TN] · R · Sponsor
• Rep. Green, Gene [D-TX-29] · D · Sponsor
• Rep. Butterfield, G. K. [D-NC-1] · D · Sponsor
• Rep. McCaul, Michael T. [R-TX-10] · R · Sponsor
• Rep. Fleischmann, Charles J. "Chuck" [R-TN-3] · R · Sponsor
• · hsif00 · Standing

Related records

• related to ← Adding Ebola to the FDA Priority Review Voucher Program Act