<billStatus>
 <version>
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  <updateDate>
   2023-03-08T20:26:38Z
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   &lt;pre&gt;[Congressional Record Volume 167, Number 45 (Wednesday, March 10, 2021)][House]From the Congressional Record Online through the Government Publishing Office [&lt;a href="https://www.gpo.gov"&gt;www.gpo.gov&lt;/a&gt;]By Mr. BILIRAKIS:H.R. 1730.Congress has the power to enact this legislation pursuantto the following:This bill is enacted pursuant to Article 1, Section 8,Clause 18 of the Constitution of the United States.[Page H1326]&lt;/pre&gt;
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     Speeding Therapy Access Today Act of 2021
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     Rep. Butterfield, G. K. [D-NC-1]
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     G. K.
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     Butterfield
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     Rep. Soto, Darren [D-FL-9]
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    <firstName>
     Darren
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    <lastName>
     Soto
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     Rep. Hastings, Alcee L. [D-FL-20]
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     HASTINGS
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     Rep. Van Drew, Jefferson [R-NJ-2]
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     Jefferson
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    <lastName>
     Van Drew
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     Rep. Levin, Mike [D-CA-49]
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    <firstName>
     Mike
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    <lastName>
     Levin
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     D
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     Rep. Joyce, John [R-PA-13]
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     John
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    <lastName>
     Joyce
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     R
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    <sponsorshipDate>
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     D000619
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    <fullName>
     Rep. Davis, Rodney [R-IL-13]
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    <firstName>
     Rodney
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    <lastName>
     Davis
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    <party>
     R
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    <state>
     IL
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    <sponsorshipDate>
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    <fullName>
     Rep. Tenney, Claudia [R-NY-22]
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    <firstName>
     Claudia
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    <lastName>
     Tenney
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    <sponsorshipDate>
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     Rep. Lee, Susie [D-NV-3]
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    <firstName>
     Susie
    </firstName>
    <lastName>
     Lee
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     D
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    <state>
     NV
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    <district>
     3
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    <sponsorshipDate>
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     Rep. Wild, Susan [D-PA-7]
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    <firstName>
     Susan
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    <lastName>
     Wild
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     D
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    <state>
     PA
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    <district>
     7
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    <sponsorshipDate>
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     F000466
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    <fullName>
     Rep. Fitzpatrick, Brian K. [R-PA-1]
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    <firstName>
     Brian
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    <lastName>
     Fitzpatrick
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    <state>
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    <fullName>
     Rep. Delgado, Antonio [D-NY-19]
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    <firstName>
     Antonio
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    <lastName>
     Delgado
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     D
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    <state>
     NY
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     19
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    <sponsorshipDate>
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     False
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     L000589
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    <fullName>
     Rep. Lesko, Debbie [R-AZ-8]
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    <firstName>
     Debbie
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    <lastName>
     Lesko
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    <party>
     R
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    <state>
     AZ
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    <district>
     8
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    <sponsorshipDate>
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    <fullName>
     Rep. Napolitano, Grace F. [D-CA-32]
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     GRACE
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    <lastName>
     NAPOLITANO
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    <state>
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    <middleName>
     F.
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    <district>
     32
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    <sponsorshipDate>
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    <isOriginalCosponsor>
     False
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    <fullName>
     Rep. Jacobs, Chris [R-NY-27]
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    <firstName>
     Chris
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    <lastName>
     Jacobs
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     R
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    <state>
     NY
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    <district>
     27
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    <sponsorshipDate>
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    <bioguideId>
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    <fullName>
     Rep. Cole, Tom [R-OK-4]
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    <firstName>
     Tom
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    <lastName>
     Cole
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    <party>
     R
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    <state>
     OK
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    <district>
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    <sponsorshipDate>
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     False
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    <fullName>
     Del. Norton, Eleanor Holmes [D-DC-At Large]
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     ELEANOR
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    <lastName>
     NORTON
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    <middleName>
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    <sponsorshipDate>
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     False
    </isOriginalCosponsor>
   </item>
   <item>
    <bioguideId>
     K000376
    </bioguideId>
    <fullName>
     Rep. Kelly, Mike [R-PA-16]
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    <firstName>
     Mike
    </firstName>
    <lastName>
     Kelly
    </lastName>
    <party>
     R
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    <state>
     PA
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    <district>
     16
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    <sponsorshipDate>
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     False
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    <bioguideId>
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    <fullName>
     Rep. Ross, Deborah K. [D-NC-2]
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    <firstName>
     Deborah
    </firstName>
    <lastName>
     Ross
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    <party>
     D
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    <state>
     NC
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    <middleName>
     K.
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    <district>
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    <sponsorshipDate>
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    <bioguideId>
     K000392
    </bioguideId>
    <fullName>
     Rep. Kustoff, David [R-TN-8]
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    <firstName>
     David
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    <lastName>
     Kustoff
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    <party>
     R
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    <state>
     TN
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    <district>
     8
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    <sponsorshipDate>
     2021-08-03
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     False
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    <bioguideId>
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    <fullName>
     Rep. Gottheimer, Josh [D-NJ-5]
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    <firstName>
     Josh
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    <lastName>
     Gottheimer
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    <state>
     NJ
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    <district>
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    <sponsorshipDate>
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    <fullName>
     Rep. Huffman, Jared [D-CA-2]
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    <firstName>
     Jared
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    <lastName>
     Huffman
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    <district>
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    <sponsorshipDate>
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    <fullName>
     Rep. DeSaulnier, Mark [D-CA-11]
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    <firstName>
     Mark
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    <lastName>
     DeSaulnier
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    <party>
     D
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    <state>
     CA
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    <district>
     11
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    <sponsorshipDate>
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   <item>
    <bioguideId>
     L000562
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    <fullName>
     Rep. Lynch, Stephen F. [D-MA-8]
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    <firstName>
     Stephen
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    <lastName>
     Lynch
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     D
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    <state>
     MA
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    <middleName>
     F.
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    <district>
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    <sponsorshipDate>
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    <fullName>
     Rep. Phillips, Dean [D-MN-3]
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    <firstName>
     Dean
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    <lastName>
     Phillips
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     D
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     MN
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    <sponsorshipDate>
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     False
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    <fullName>
     Rep. Neguse, Joe [D-CO-2]
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    <firstName>
     Joe
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    <lastName>
     Neguse
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     D
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     CO
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    <district>
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    <sponsorshipDate>
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     Resident Commissioner González-Colón, Jenniffer [R-PR-At Large]
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     Jenniffer
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     Gonzalez-Colon
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     Rep. Yarmuth, John A. [D-KY-3]
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    <firstName>
     John
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    <lastName>
     Yarmuth
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     D
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    <state>
     KY
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    <middleName>
     A.
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    <district>
     3
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    <sponsorshipDate>
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     False
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     Rep. Dean, Madeleine [D-PA-4]
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    <firstName>
     Madeleine
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    <lastName>
     Dean
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    <party>
     D
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    <state>
     PA
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    <district>
     4
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    <sponsorshipDate>
     2022-03-09
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    <fullName>
     Rep. Bishop, Sanford D., Jr. [D-GA-2]
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    <firstName>
     SANFORD
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    <lastName>
     BISHOP
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    <party>
     D
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    <state>
     GA
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    <middleName>
     D.
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    <district>
     2
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    <sponsorshipDate>
     2022-03-09
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     False
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    <bioguideId>
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     Eric
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    <lastName>
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     Tom
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     Joe
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    <lastName>
     Wilson
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     Jason
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    <lastName>
     Crow
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    <lastName>
     Hill
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    <firstName>
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    <lastName>
     Matsui
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    <party>
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    <middleName>
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    <sponsorshipDate>
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   <item>
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    <fullName>
     Rep. Mullin, Markwayne [R-OK-2]
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    <firstName>
     Markwayne
    </firstName>
    <lastName>
     Mullin
    </lastName>
    <party>
     R
    </party>
    <state>
     OK
    </state>
    <district>
     2
    </district>
    <sponsorshipDate>
     2022-03-31
    </sponsorshipDate>
    <isOriginalCosponsor>
     False
    </isOriginalCosponsor>
   </item>
   <item>
    <bioguideId>
     B001298
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    <fullName>
     Rep. Bacon, Don [R-NE-2]
    </fullName>
    <firstName>
     Don
    </firstName>
    <lastName>
     Bacon
    </lastName>
    <party>
     R
    </party>
    <state>
     NE
    </state>
    <district>
     2
    </district>
    <sponsorshipDate>
     2022-04-21
    </sponsorshipDate>
    <isOriginalCosponsor>
     False
    </isOriginalCosponsor>
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  <policyArea>
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    Health
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  <subjects>
   <legislativeSubjects>
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      Advisory bodies
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    <item>
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      Department of Health and Human Services
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     <name>
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     <name>
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    <item>
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      Food and Drug Administration (FDA)
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    <item>
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      Research administration and funding
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     Health
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     Introduced in House
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     &lt;p&gt;&lt;strong&gt;Speeding Therapy Access Today Act of 2021&lt;/strong&gt;&lt;/p&gt; &lt;p&gt;This bill requires and authorizes various actions to accelerate the development of therapies for rare diseases. &lt;/p&gt; &lt;p&gt;The Food and Drug Administration (FDA) shall establish the Intercenter Institute on Rare Diseases and Conditions. The institute shall (1) coordinate engagement with relevant stakeholders, (2) build the FDA's expertise in the review of medical products to treat rare diseases, (3) coordinate regulatory science initiatives related to rare diseases, (4) establish and implement a program to make recommendations to address challenges associated with developing medical products to treat rare diseases in an individual or in very small populations, (5) convene a stakeholder meeting to consider potential amendments to labels for medical products to treat rare diseases, and (6) establish and carry out a program to facilitate voluntary communication between the sponsors of such medical products and third-party payers (e.g., insurance companies). &lt;/p&gt; &lt;p&gt;The bill also authorizes the FDA to make grants to assist in developing practices related to the development and production of individualized therapies or therapies to treat very small populations. &lt;/p&gt; &lt;p&gt;The bill also establishes an advisory committee to advise the FDA on issues related to the development of therapies to treat rare diseases.&lt;/p&gt;
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  <title>
   Speeding Therapy Access Today Act of 2021
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     Speeding Therapy Access Today Act of 2021
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     To amend the Federal Food, Drug, and Cosmetic Act to accelerate development of therapies across the spectrum of rare diseases and conditions and facilitate patient access to such therapies, and for other purposes.
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    Referred to the Subcommittee on Health.
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   Congressional Research Service, Library of Congress
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   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.
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2021-03-10
Health Subcommittee
hsif14
1
House committee actions
Referred to the Subcommittee on Health.
Committee
H11100
2021-03-10
Energy and Commerce Committee
hsif00
2
House floor actions
Referred to the House Committee on Energy and Commerce.
IntroReferral
Intro-H
2021-03-10
9
Library of Congress
Introduced in House
IntroReferral
1000
2021-03-10
9
Library of Congress
Introduced in House
IntroReferral
2021-03-10T14:01:40Z
Referred to
House
Energy and Commerce Committee
2021-03-10T14:58:16Z
Referred to
Health Subcommittee
hsif14
hsif00
Standing
B001251
1
G. K.
Rep. Butterfield, G. K. [D-NC-1]
Butterfield
D
2021-03-10
NC
S001200
9
Darren
Rep. Soto, Darren [D-FL-9]
Soto
D
2021-03-16
FL
H000324
20
ALCEE
Rep. Hastings, Alcee L. [D-FL-20]
HASTINGS
L.
D
2021-03-23
FL
V000133
2
Jefferson
Rep. Van Drew, Jefferson [R-NJ-2]
Van Drew
R
2021-04-05
NJ
L000593
49
Mike
Rep. Levin, Mike [D-CA-49]
Levin
D
2021-04-19
CA
J000302
13
John
Rep. Joyce, John [R-PA-13]
Joyce
R
2021-04-26
PA
D000619
13
Rodney
Rep. Davis, Rodney [R-IL-13]
Davis
R
2021-05-11
IL
T000478
22
Claudia
Rep. Tenney, Claudia [R-NY-22]
Tenney
R
2021-05-11
NY
L000590
3
Susie
Rep. Lee, Susie [D-NV-3]
Lee
D
2021-05-12
NV
W000826
7
Susan
Rep. Wild, Susan [D-PA-7]
Wild
D
2021-05-14
PA
F000466
1
Brian
Rep. Fitzpatrick, Brian K. [R-PA-1]
Fitzpatrick
K.
R
2021-05-17
PA
D000630
19
Antonio
Rep. Delgado, Antonio [D-NY-19]
Delgado
D
2021-05-18
NY
L000589
8
Debbie
Rep. Lesko, Debbie [R-AZ-8]
Lesko
R
2021-06-01
AZ
N000179
32
GRACE
Rep. Napolitano, Grace F. [D-CA-32]
NAPOLITANO
F.
D
2021-06-01
CA
J000020
27
Chris
Rep. Jacobs, Chris [R-NY-27]
Jacobs
R
2021-06-11
NY
C001053
4
Tom
Rep. Cole, Tom [R-OK-4]
Cole
R
2021-06-15
OK
N000147
0
ELEANOR
Del. Norton, Eleanor Holmes [D-DC-At Large]
NORTON
HOLMES
D
2021-07-22
DC
K000376
16
Mike
Rep. Kelly, Mike [R-PA-16]
Kelly
R
2021-07-22
PA
R000305
2
Deborah
Rep. Ross, Deborah K. [D-NC-2]
Ross
K.
D
2021-07-22
NC
K000392
8
David
Rep. Kustoff, David [R-TN-8]
Kustoff
R
2021-08-03
TN
G000583
5
Josh
Rep. Gottheimer, Josh [D-NJ-5]
Gottheimer
D
2021-08-03
NJ
H001068
2
Jared
Rep. Huffman, Jared [D-CA-2]
Huffman
D
2021-10-15
CA
D000623
11
Mark
Rep. DeSaulnier, Mark [D-CA-11]
DeSaulnier
D
2021-10-15
CA
L000562
8
Stephen
Rep. Lynch, Stephen F. [D-MA-8]
Lynch
F.
D
2021-10-21
MA
P000616
3
Dean
Rep. Phillips, Dean [D-MN-3]
Phillips
D
2021-12-23
MN
N000191
2
Joe
Rep. Neguse, Joe [D-CO-2]
Neguse
D
2022-02-08
CO
G000582
0
Jenniffer
Resident Commissioner González-Colón, Jenniffer [R-PR-At Large]
Gonzalez-Colon
R
2022-02-25
PR
Y000062
3
John
Rep. Yarmuth, John A. [D-KY-3]
Yarmuth
A.
D
2022-03-09
KY
D000631
4
Madeleine
Rep. Dean, Madeleine [D-PA-4]
Dean
D
2022-03-09
PA
B000490
2
SANFORD
Rep. Bishop, Sanford D., Jr. [D-GA-2]
BISHOP
D.
D
2022-03-09
GA
A000378
3
Cynthia
Rep. Axne, Cynthia [D-IA-3]
Axne
D
2022-03-09
IA
S001193
15
Eric
Rep. Swalwell, Eric [D-CA-15]
Swalwell
D
2022-03-09
CA
S001218
1
Melanie
Rep. Stansbury, Melanie Ann [D-NM-1]
Stansbury
Ann
D
2022-03-11
NM
O000171
1
Tom
Rep. O'Halleran, Tom [D-AZ-1]
O'Halleran
D
2022-03-11
AZ
W000795
2
Joe
Rep. Wilson, Joe [R-SC-2]
Wilson
R
2022-03-15
SC
C001121
6
Jason
Rep. Crow, Jason [D-CO-6]
Crow
D
2022-03-15
CO
H001072
2
J.
Rep. Hill, J. French [R-AR-2]
Hill
French
R
2022-03-18
AR
M001163
6
Doris
Rep. Matsui, Doris O. [D-CA-6]
Matsui
O.
D
2022-03-18
CA
M001190
2
Markwayne
Rep. Mullin, Markwayne [R-OK-2]
Mullin
R
2022-03-31
OK
B001298
2
Don
Rep. Bacon, Don [R-NE-2]
Bacon
R
2022-04-21
NE
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.
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.
2021-03-10
2021-03-10
Referred to the Subcommittee on Health.
House
Health
2021-03-10
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
CRS
Identical bill
Speeding Therapy Access Today Act of 2021
S
B001257
12
Gus
Rep. Bilirakis, Gus M. [R-FL-12]
N
Bilirakis
M.
R
FL
Advisory bodies Department of Health and Human Services Drug safety, medical device, and laboratory regulation Drug therapy Executive agency funding and structure Food and Drug Administration (FDA) Health technology, devices, supplies Manufacturing Medical research Research administration and funding
2021-03-10
Introduced in House
 <p><strong>Speeding Therapy Access Today Act of 2021</strong></p> <p>This bill requires and authorizes various actions to accelerate the development of therapies for rare diseases. </p> <p>The Food and Drug Administration (FDA) shall establish the Intercenter Institute on Rare Diseases and Conditions. The institute shall (1) coordinate engagement with relevant stakeholders, (2) build the FDA's expertise in the review of medical products to treat rare diseases, (3) coordinate regulatory science initiatives related to rare diseases, (4) establish and implement a program to make recommendations to address challenges associated with developing medical products to treat rare diseases in an individual or in very small populations, (5) convene a stakeholder meeting to consider potential amendments to labels for medical products to treat rare diseases, and (6) establish and carry out a program to facilitate voluntary communication between the sponsors of such medical products and third-party payers (e.g., insurance companies). </p> <p>The bill also authorizes the FDA to make grants to assist in developing practices related to the development and production of individualized therapies or therapies to treat very small populations. </p> <p>The bill also establishes an advisory committee to advise the FDA on issues related to the development of therapies to treat rare diseases.</p>
2021-06-24T22:47:44Z
00
2021-03-10T05:00:00Z
Introduced in House
https://www.govinfo.gov/content/pkg/BILLS-117hr1730ih/xml/BILLS-117hr1730ih.xml
Speeding Therapy Access Today Act of 2021
Speeding Therapy Access Today Act of 2021
Display Title
IH
Introduced in House
To amend the Federal Food, Drug, and Cosmetic Act to accelerate development of therapies across the spectrum of rare diseases and conditions and facilitate patient access to such therapies, and for other purposes.
Official Title as Introduced
IH
Introduced in House
Speeding Therapy Access Today Act of 2021
Short Title(s) as Introduced
HR
2023-03-08T20:26:38Z
2023-03-08T20:26:38Z
3.0.0
2021-03-10
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
CRS
Identical bill
Speeding Therapy Access Today Act of 2021
S
2021-03-10
Health Subcommittee
hsif14
1
House committee actions
Referred to the Subcommittee on Health.
Committee
H11100
2021-03-10
Energy and Commerce Committee
hsif00
2
House floor actions
Referred to the House Committee on Energy and Commerce.
IntroReferral
Intro-H
2021-03-10
9
Library of Congress
Introduced in House
IntroReferral
1000
2021-03-10
9
Library of Congress
Introduced in House
IntroReferral
B001257
12
Gus
Rep. Bilirakis, Gus M. [R-FL-12]
N
Bilirakis
M.
R
FL
B001251
1
G. K.
Rep. Butterfield, G. K. [D-NC-1]
Butterfield
D
2021-03-10
NC
S001200
9
Darren
Rep. Soto, Darren [D-FL-9]
Soto
D
2021-03-16
FL
H000324
20
ALCEE
Rep. Hastings, Alcee L. [D-FL-20]
HASTINGS
L.
D
2021-03-23
FL
V000133
2
Jefferson
Rep. Van Drew, Jefferson [R-NJ-2]
Van Drew
R
2021-04-05
NJ
L000593
49
Mike
Rep. Levin, Mike [D-CA-49]
Levin
D
2021-04-19
CA
J000302
13
John
Rep. Joyce, John [R-PA-13]
Joyce
R
2021-04-26
PA
D000619
13
Rodney
Rep. Davis, Rodney [R-IL-13]
Davis
R
2021-05-11
IL
T000478
22
Claudia
Rep. Tenney, Claudia [R-NY-22]
Tenney
R
2021-05-11
NY
L000590
3
Susie
Rep. Lee, Susie [D-NV-3]
Lee
D
2021-05-12
NV
W000826
7
Susan
Rep. Wild, Susan [D-PA-7]
Wild
D
2021-05-14
PA
F000466
1
Brian
Rep. Fitzpatrick, Brian K. [R-PA-1]
Fitzpatrick
K.
R
2021-05-17
PA
D000630
19
Antonio
Rep. Delgado, Antonio [D-NY-19]
Delgado
D
2021-05-18
NY
L000589
8
Debbie
Rep. Lesko, Debbie [R-AZ-8]
Lesko
R
2021-06-01
AZ
N000179
32
GRACE
Rep. Napolitano, Grace F. [D-CA-32]
NAPOLITANO
F.
D
2021-06-01
CA
J000020
27
Chris
Rep. Jacobs, Chris [R-NY-27]
Jacobs
R
2021-06-11
NY
C001053
4
Tom
Rep. Cole, Tom [R-OK-4]
Cole
R
2021-06-15
OK
N000147
0
ELEANOR
Del. Norton, Eleanor Holmes [D-DC-At Large]
NORTON
HOLMES
D
2021-07-22
DC
K000376
16
Mike
Rep. Kelly, Mike [R-PA-16]
Kelly
R
2021-07-22
PA
R000305
2
Deborah
Rep. Ross, Deborah K. [D-NC-2]
Ross
K.
D
2021-07-22
NC
K000392
8
David
Rep. Kustoff, David [R-TN-8]
Kustoff
R
2021-08-03
TN
G000583
5
Josh
Rep. Gottheimer, Josh [D-NJ-5]
Gottheimer
D
2021-08-03
NJ
H001068
2
Jared
Rep. Huffman, Jared [D-CA-2]
Huffman
D
2021-10-15
CA
D000623
11
Mark
Rep. DeSaulnier, Mark [D-CA-11]
DeSaulnier
D
2021-10-15
CA
L000562
8
Stephen
Rep. Lynch, Stephen F. [D-MA-8]
Lynch
F.
D
2021-10-21
MA
P000616
3
Dean
Rep. Phillips, Dean [D-MN-3]
Phillips
D
2021-12-23
MN
N000191
2
Joe
Rep. Neguse, Joe [D-CO-2]
Neguse
D
2022-02-08
CO
G000582
0
Jenniffer
Resident Commissioner González-Colón, Jenniffer [R-PR-At Large]
Gonzalez-Colon
R
2022-02-25
PR
Y000062
3
John
Rep. Yarmuth, John A. [D-KY-3]
Yarmuth
A.
D
2022-03-09
KY
D000631
4
Madeleine
Rep. Dean, Madeleine [D-PA-4]
Dean
D
2022-03-09
PA
B000490
2
SANFORD
Rep. Bishop, Sanford D., Jr. [D-GA-2]
BISHOP
D.
D
2022-03-09
GA
A000378
3
Cynthia
Rep. Axne, Cynthia [D-IA-3]
Axne
D
2022-03-09
IA
S001193
15
Eric
Rep. Swalwell, Eric [D-CA-15]
Swalwell
D
2022-03-09
CA
S001218
1
Melanie
Rep. Stansbury, Melanie Ann [D-NM-1]
Stansbury
Ann
D
2022-03-11
NM
O000171
1
Tom
Rep. O'Halleran, Tom [D-AZ-1]
O'Halleran
D
2022-03-11
AZ
W000795
2
Joe
Rep. Wilson, Joe [R-SC-2]
Wilson
R
2022-03-15
SC
C001121
6
Jason
Rep. Crow, Jason [D-CO-6]
Crow
D
2022-03-15
CO
H001072
2
J.
Rep. Hill, J. French [R-AR-2]
Hill
French
R
2022-03-18
AR
M001163
6
Doris
Rep. Matsui, Doris O. [D-CA-6]
Matsui
O.
D
2022-03-18
CA
M001190
2
Markwayne
Rep. Mullin, Markwayne [R-OK-2]
Mullin
R
2022-03-31
OK
B001298
2
Don
Rep. Bacon, Don [R-NE-2]
Bacon
R
2022-04-21
NE
Advisory bodies Department of Health and Human Services Drug safety, medical device, and laboratory regulation Drug therapy Executive agency funding and structure Food and Drug Administration (FDA) Health technology, devices, supplies Manufacturing Medical research Research administration and funding
2021-03-10
Introduced in House
 <p><strong>Speeding Therapy Access Today Act of 2021</strong></p> <p>This bill requires and authorizes various actions to accelerate the development of therapies for rare diseases. </p> <p>The Food and Drug Administration (FDA) shall establish the Intercenter Institute on Rare Diseases and Conditions. The institute shall (1) coordinate engagement with relevant stakeholders, (2) build the FDA's expertise in the review of medical products to treat rare diseases, (3) coordinate regulatory science initiatives related to rare diseases, (4) establish and implement a program to make recommendations to address challenges associated with developing medical products to treat rare diseases in an individual or in very small populations, (5) convene a stakeholder meeting to consider potential amendments to labels for medical products to treat rare diseases, and (6) establish and carry out a program to facilitate voluntary communication between the sponsors of such medical products and third-party payers (e.g., insurance companies). </p> <p>The bill also authorizes the FDA to make grants to assist in developing practices related to the development and production of individualized therapies or therapies to treat very small populations. </p> <p>The bill also establishes an advisory committee to advise the FDA on issues related to the development of therapies to treat rare diseases.</p>
2021-06-24T22:47:44Z
00
Speeding Therapy Access Today Act of 2021
Speeding Therapy Access Today Act of 2021
Display Title
IH
Introduced in House
To amend the Federal Food, Drug, and Cosmetic Act to accelerate development of therapies across the spectrum of rare diseases and conditions and facilitate patient access to such therapies, and for other purposes.
Official Title as Introduced
IH
Introduced in House
Speeding Therapy Access Today Act of 2021
Short Title(s) as Introduced
2021-03-10
Referred to the Subcommittee on Health.