Comment Letters

Comment Letters

Biocom California is actively engaged in submitting comments to federal health agencies on draft guidances and proposals. We monitor and engage in important regulatory and reimbursement matters on behalf of the California life science community.

Biocom California Comment Letters

  • Biocom California Letter to COMPETES/USICA – July 21, 2022

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  • NIH Response to Biocom California to March-In Letter

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  • Biocom California March-In Rights Letter – May 17, 2022

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  • Extension of SBIR/STTR Programs Letter – May 9, 2022

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  • Biocom California FY23 FDA Appropriations Letter – May 4, 2022

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  • Biocom California FY23 Labor & HHS Appropriations Letter – May 4, 2022

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  • Biocom California FY23 MilCon VA Appropriations Letter – May 4, 2022

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  • Biocom California OSTP RFI Response – March 31, 2022

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  • Medical Devices EUA Transition Plan Comment Letter – March 23, 2022

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  • Multi-State MedTech R&D Expensing Letter – March 21, 2022

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  • Multi-State QSBS Letter – March 18, 2022

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  • Biocom California’s Response to the Health Future Task Force’s RFI on Wearable Technologies – March 4, 2022

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  • Comments on National Coverage Analysis (NCA) for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease – February 11, 2022

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  • Protect the Orphan Drug Tax Credit – February 4, 2022

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  • Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial – December 21, 2021

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  • Medtech Associations Letter Regarding Semiconductor Shortage – November 19, 2021

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  • Comments on Medicare Coverage of Innovative Technology (MCIT) Pathway Removal – October 15, 2021

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  • Comments on FDA Remanufacturing Guidance – September 22, 2021

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  • Comments in Response to PFS FY22 – September 13, 2021

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  • Response to the Cures 2.0 Discussion Draft – July 16, 2021

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