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Letters, Testimony, & Comments | BIO

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class="mc-cardPlainText__description" ><div class="af-text">Under the 340B program, participating manufacturers must offer 340B pricing on their covered outpatient drugs by covered entities, as a condition of having those drugs federally payable under Medicare Part B and Medicaid. Critically, Congress…</div></div></div><div class="mc-cardPlainText__rgnBottom"><div class="mc-cardPlainText__ctaLink" ><a class="af-link" href="/letters-testimony-comments/bio-letter-hrsa-340b-rebate-model" aria-label="Learn more" >Learn more</a></div></div></div></div></div><div class="oc-widgetPane__rgnCell rowFirst rowLast col-lg-4 col-md-6 col-sm-12"><div class="mc-cardPlainText act-component -styleArticlePromo -hasBottom"><div class="mc-cardPlainText__rgnInner act-component-inner"><div class="mc-cardPlainText__rgnMain"><div class="mc-cardPlainText__title" ><div class="af-text">CSBA Letter to Congressional Leadership on…</div></div></div><div class="mc-cardPlainText__rgnBottom"><div class="mc-cardPlainText__ctaLink" ><a class="af-link" href="/letters-testimony-comments/csba-letter-congressional-leadership-reauthorization-rare-pediatric" aria-label="Learn more" >Learn more</a></div></div></div></div></div><div class="oc-widgetPane__rgnCell rowFirst rowLast col-lg-4 col-md-6 col-sm-12 offset-md-3 offset-lg-0"><div class="mc-cardPlainText act-component -styleArticlePromo -hasBottom"><div class="mc-cardPlainText__rgnInner act-component-inner"><div class="mc-cardPlainText__rgnMain"><div class="mc-cardPlainText__title" ><div class="af-text">BIO Comments to the USPTO’s MAY 10, 2024 Proposed…</div></div><div class="mc-cardPlainText__description" ><div class="af-text">BIO submitted these&nbsp;comments in response to the United States Patent and Trademark Office’s May 10, 2024, Notice of Proposed Rulemaking regarding Terminal Disclaimer Practice to Obviate Nonstatutory Double Patenting. </div></div></div><div class="mc-cardPlainText__rgnBottom"><div class="mc-cardPlainText__ctaLink" ><a class="af-link" href="/letters-testimony-comments/bio-comments-usptos-may-10-2024-proposed-rulemaking-terminal-disclaimer" aria-label="Learn more" >Learn more</a></div></div></div></div></div></div></div></div></div></div><div class="oc-compoList__rgnSection"><div 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class="views-infinite-scroll-content-wrapper clearfix row"><div class="act-pane__region layout__region layout__region--col-1 col-lg-12 col-md-12 col-sm-12"><div class="mc-cardPlainText act-component -styleArticleTeaser"><div class="mc-cardPlainText__rgnInner act-component-inner"><div class="mc-cardPlainText__rgnMain"><div class="mc-cardPlainText__titleLink" ><a class="af-link" href="/letters-testimony-comments/bio-letter-hrsa-340b-rebate-model" aria-label="BIO Letter to HRSA on 340B Rebate Model" >BIO Letter to HRSA on 340B Rebate Model</a></div><div class="mc-cardPlainText__summary" ><div class="af-text">October 10, 2024</div></div><div class="mc-cardPlainText__description" ><div class="af-text">Under the 340B program, participating manufacturers must offer 340B pricing on their covered outpatient drugs by covered entities, as a condition of having those drugs federally payable under Medicare Part B and Medicaid. Critically, Congress…</div></div></div></div></div></div><div class="act-pane__region layout__region layout__region--col-1 col-lg-12 col-md-12 col-sm-12"><div class="mc-cardPlainText act-component -styleArticleTeaser"><div class="mc-cardPlainText__rgnInner act-component-inner"><div class="mc-cardPlainText__rgnMain"><div class="mc-cardPlainText__titleLink" ><a class="af-link" href="/letters-testimony-comments/csba-letter-congressional-leadership-reauthorization-rare-pediatric" aria-label="CSBA Letter to Congressional Leadership on Reauthorization of the Rare Pediatric Disease Priority Review Voucher Program" >CSBA Letter to Congressional Leadership on Reauthorization of the Rare Pediatric Disease Priority Review Voucher Program</a></div><div class="mc-cardPlainText__summary" ><div class="af-text">September 9, 2024</div></div></div></div></div></div><div class="act-pane__region layout__region layout__region--col-1 col-lg-12 col-md-12 col-sm-12"><div class="mc-cardPlainText act-component -styleArticleTeaser"><div class="mc-cardPlainText__rgnInner act-component-inner"><div class="mc-cardPlainText__rgnMain"><div class="mc-cardPlainText__titleLink" ><a class="af-link" href="/letters-testimony-comments/comments-biotechnology-innovation-organization-bio-uspto-february-13" aria-label="Comments of the Biotechnology Innovation Organization (BIO) to The USPTO February 13, 2024 Inventorship Guidance for AI-Assisted Inventions, 89 FR 10043" >Comments of the Biotechnology Innovation Organization (BIO) to The USPTO February 13, 2024 Inventorship Guidance for AI-Assisted Inventions, 89 FR 10043</a></div><div class="mc-cardPlainText__summary" ><div class="af-text">May 15, 2024</div></div><div class="mc-cardPlainText__description" ><div class="af-text">On behalf of its member organizations, Biotechnology Innovation Organization (“BIO”) respectfully submits this Comment in response to the United States Patent and Trademark Office’s (the “Patent Office” or “PTO”) February 13, 2024 Request for…</div></div></div></div></div></div><div class="act-pane__region layout__region layout__region--col-1 col-lg-12 col-md-12 col-sm-12"><div class="mc-cardPlainText act-component -styleArticleTeaser"><div class="mc-cardPlainText__rgnInner act-component-inner"><div class="mc-cardPlainText__rgnMain"><div class="mc-cardPlainText__titleLink" ><a class="af-link" href="/letters-testimony-comments/bio-comments-usptos-may-10-2024-proposed-rulemaking-terminal-disclaimer" aria-label="BIO Comments to the USPTO’s MAY 10, 2024 Proposed Rulemaking on Terminal Disclaimer Practice, 89 Fed. Reg. 40439, Docket No. PTO-P-2024-0003" >BIO Comments to the USPTO’s MAY 10, 2024 Proposed Rulemaking on Terminal Disclaimer Practice, 89 Fed. Reg. 40439, Docket No. PTO-P-2024-0003</a></div><div class="mc-cardPlainText__summary" ><div class="af-text">May 10, 2024</div></div><div class="mc-cardPlainText__description" ><div class="af-text">BIO submitted these&nbsp;comments in response to the United States Patent and Trademark Office’s May 10, 2024, Notice of Proposed Rulemaking regarding Terminal Disclaimer Practice to Obviate Nonstatutory Double Patenting. </div></div></div></div></div></div><div class="act-pane__region layout__region layout__region--col-1 col-lg-12 col-md-12 col-sm-12"><div class="mc-cardPlainText act-component -styleArticleTeaser"><div class="mc-cardPlainText__rgnInner act-component-inner"><div class="mc-cardPlainText__rgnMain"><div class="mc-cardPlainText__titleLink" ><a class="af-link" href="/letters-testimony-comments/bio-comments-fws-use-gmos-national-wildlife-refuge-lands" aria-label="BIO Comments to FWS on Use of GMOs on National Wildlife Refuge Lands" >BIO Comments to FWS on Use of GMOs on National Wildlife Refuge Lands</a></div><div class="mc-cardPlainText__summary" ><div class="af-text">May 9, 2024</div></div><div class="mc-cardPlainText__description" ><div class="af-text">BIO comments on a proposed rule to restrict planting of GE organisms on national wildlife refuge lands.&nbsp; </div></div></div></div></div></div><div class="act-pane__region layout__region layout__region--col-1 col-lg-12 col-md-12 col-sm-12"><div class="mc-cardPlainText act-component -styleArticleTeaser"><div class="mc-cardPlainText__rgnInner act-component-inner"><div class="mc-cardPlainText__rgnMain"><div class="mc-cardPlainText__titleLink" ><a class="af-link" href="/letters-testimony-comments/bio-comments-minnesota-department-health-drugs-substantial-public" aria-label="BIO Comments to the Minnesota Department of Health on Drugs of Substantial Public Interest: Draft Methodology for Public Comment" >BIO Comments to the Minnesota Department of Health on Drugs of Substantial Public Interest: Draft Methodology for Public Comment</a></div><div class="mc-cardPlainText__summary" ><div class="af-text">May 9, 2024</div></div><div class="mc-cardPlainText__description" ><div class="af-text">BIO submits comments on the MDH’s proposed regulations regarding Drugs of Substantial Public Interest: Draft Methodology for Public Comment as required in statute by the Prescription Drug Price Transparency Act. &nbsp; &nbsp; </div></div></div></div></div></div><div class="act-pane__region layout__region layout__region--col-1 col-lg-12 col-md-12 col-sm-12"><div class="mc-cardPlainText act-component -styleArticleTeaser"><div class="mc-cardPlainText__rgnInner act-component-inner"><div class="mc-cardPlainText__rgnMain"><div class="mc-cardPlainText__titleLink" ><a class="af-link" href="/letters-testimony-comments/bio-comments-hhss-centers-medicare-medicaid-services-response-their" aria-label="BIO Comments to HHS&#039;s Centers for Medicare &amp; Medicaid Services in response to their Information Collection Request (ICR) on the Part C and Part D Medicare Prescription Payment Plan" >BIO Comments to HHS's Centers for Medicare & Medicaid Services in response to their Information Collection Request (ICR) on the Part C and Part D Medicare Prescription Payment Plan</a></div><div class="mc-cardPlainText__summary" ><div class="af-text">April 19, 2024</div></div><div class="mc-cardPlainText__description" ><div class="af-text">The Biotechnology Innovation Organization appreciates the opportunity to comment on the Center for Medicare and Medicaid Services’ Information Collection Request on the Part C and Part D Medicare Prescription Payment Plan Model Documents. </div></div></div></div></div></div><div class="act-pane__region layout__region layout__region--col-1 col-lg-12 col-md-12 col-sm-12"><div class="mc-cardPlainText act-component -styleArticleTeaser"><div class="mc-cardPlainText__rgnInner act-component-inner"><div class="mc-cardPlainText__rgnMain"><div class="mc-cardPlainText__titleLink" ><a class="af-link" href="/letters-testimony-comments/bio-comments-department-justice-proposed-regulations-preventing-access" aria-label="BIO Comments to the Department of Justice on proposed regulations “Preventing Access to Americans’ Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern.”" >BIO Comments to the Department of Justice on proposed regulations “Preventing Access to Americans’ Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern.”</a></div><div class="mc-cardPlainText__summary" ><div class="af-text">April 19, 2024</div></div><div class="mc-cardPlainText__description" ><div class="af-text">In response to their advance notice of proposed rulemaking (ANPRM), BIO submitted comments to the DOJ's National Security Division on implementing the White House Executive Order of February 28, 2024, “Preventing Access to Americans’ Bulk Sensitive…</div></div></div></div></div></div><div class="act-pane__region layout__region layout__region--col-1 col-lg-12 col-md-12 col-sm-12"><div class="mc-cardPlainText act-component -styleArticleTeaser"><div class="mc-cardPlainText__rgnInner act-component-inner"><div class="mc-cardPlainText__rgnMain"><div class="mc-cardPlainText__titleLink" ><a class="af-link" href="/letters-testimony-comments/biotech-companies-express-concern-proposed-changes-medicaid-drug-rebate" aria-label="Biotech Companies Express Concern With Proposed Changes to the Medicaid Drug Rebate Program (MDRP) " >Biotech Companies Express Concern With Proposed Changes to the Medicaid Drug Rebate Program (MDRP) </a></div><div class="mc-cardPlainText__summary" ><div class="af-text">April 11, 2024</div></div><div class="mc-cardPlainText__description" ><div class="af-text">We, the undersigned, are writing to express our strong concern with a proposed update to the Medicaid Drug Rebate Program. If finalized in its current form, the proposed rule (CMS-2434-P) would impose significant costs to the government and industry…</div></div></div></div></div></div><div class="act-pane__region layout__region layout__region--col-1 col-lg-12 col-md-12 col-sm-12"><div class="mc-cardPlainText act-component -styleArticleTeaser"><div class="mc-cardPlainText__rgnInner act-component-inner"><div class="mc-cardPlainText__rgnMain"><div class="mc-cardPlainText__titleLink" ><a class="af-link" href="/letters-testimony-comments/bio-statement-senate-340b-bipartisan-working-group-safeguarding-and-0" aria-label="BIO Statement to the Senate 340B Bipartisan Working Group on Safeguarding and Strengthening 340B" >BIO Statement to the Senate 340B Bipartisan Working Group on Safeguarding and Strengthening 340B</a></div><div class="mc-cardPlainText__summary" ><div class="af-text">April 1, 2024</div></div><div class="mc-cardPlainText__description" ><div class="af-text">In response to the 340B Request for Information issued by the Senate 340B Bipartisan Working Group, BIO submits detailed comments. </div></div></div></div></div></div></div></div></div></div></div></div><ul class="js-pager__items pager" data-drupal-views-infinite-scroll-pager><li class="pager__item"><a class="button" href="?page=1" title="Load more items" rel="next">Load More</a></li></ul></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div><div class="act-layout act-pane layout layout--bs-columns layout--bottom -rgnWidth100 paneBottom"><div class="section-inner"><div class="act-pane__content row"><div class="act-pane__region layout__region layout__region--col-1 col-lg-12 col-md-12 col-sm-12"></div></div></div></div></div> </div> </div> </div> </div> </div> <style>.edit__action{padding: 0 5px;}</style> <div id="block-bioorgfooterblock" class="block block-bio-general block-org-footer-block"> <div class="content"> <div class="oc-orgFooter act-component"><div class="oc-orgFooter__rgnInner act-component-inner"><div class="oc-orgFooter__rgnBrand"><div class="oc-orgFooter__siteName" ><div class="af-text">Biotechnology Innovation Organization</div></div></div><div class="oc-orgFooter__rgnMain"><div class="oc-orgFooter__rgnMainCol -linkList"><div class="mc-listLink act-component -typeText"><div class="mc-listLink__rgnInner act-component-inner"><div class="mc-listLink__title" ><div class="af-text">Explore BIO</div></div><div class="mc-listLink__linkList"><div class="mc-listLink__link" ><a class="af-link" href="/policy" aria-label="Policy" >Policy</a></div><div class="mc-listLink__link" ><a class="af-link" href="/events" aria-label="Events" >Events</a></div><div class="mc-listLink__link" ><a class="af-link" href="/about" aria-label="About" >About</a></div><div class="mc-listLink__link" ><a class="af-link" href="/ia-reports" aria-label="Industry Insights" >Industry Insights</a></div><div class="mc-listLink__link" ><a class="af-link" href="/join-today-archive" aria-label="Join Now" >Join Now</a></div><div class="mc-listLink__link" ><a class="af-link" href="/bio-pac" aria-label="BIO PAC" >BIO PAC</a></div></div></div></div></div><div class="oc-orgFooter__rgnMainCol -linkList"><div class="mc-listLink act-component -typeText"><div class="mc-listLink__rgnInner act-component-inner"><div class="mc-listLink__title" ><div class="af-text">For Members</div></div><div class="mc-listLink__linkList"><div class="mc-listLink__link" ><a class="af-link" href="/bio-member-directory" aria-label="Member Directory" >Member Directory</a></div><div class="mc-listLink__link" ><a class="af-link" href="/member/join-committees-have-voice" aria-label="BIO Policy Committees" >BIO Policy Committees</a></div><div class="mc-listLink__link" ><a class="af-link" href="/save" aria-label="Cost-Savings Program" >Cost-Savings Program</a></div></div></div></div></div><div class="oc-orgFooter__rgnMainCol -linkList"><div class="mc-listLink act-component -typeText"><div class="mc-listLink__rgnInner act-component-inner"><div class="mc-listLink__title" ><div class="af-text">BIO Events</div></div><div class="mc-listLink__linkList"><div class="mc-listLink__link" ><a class="af-link" href="/events/bio-international-convention" aria-label="BIO International Convention" >BIO International Convention</a></div><div class="mc-listLink__link" ><a class="af-link" href="https://www.bio.org/events/bio-partnering-jpm" aria-label="BIO Partnering at JPM Week" >BIO Partnering at JPM Week</a></div><div class="mc-listLink__link" ><a class="af-link" href="/events/bio-ceo-investor-conference" aria-label="BIO CEO &amp; 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