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Letters, Testimony & Comments

Concerns regarding unilateral actions that the USDA is poised to take in the name of coexistence
December 23, 2010
Dear Mr. Sunstein: The Biotechnology Industry Organization (BIO) wishes to express in the strongest possible terms its concerns regarding unilateral actions that the U.S. Department of Agriculture (USDA or the Department) is poised to take in...
BIO Comments on the Food and Drug Administration Approval Pathway for Biosimilar and Interchangeable Biological Products
December 23, 2010
Re: Docket No. FDA-2010-N-0477, Request for Comments on the Food and Drug Administration Approval Pathway for Biosimilar and Interchangeable Biological Products Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and...
Parallel Review of Medical Products
December 16, 2010
Re: Parallel Review of Medical Products [FDA-2010-N-0308] Dear Dr. Berwick and Dr. Hamburg: The Biotechnology Industry Organization (BIO) is pleased to submit the following comments on the notice and request for comments from the Centers for...
Climate Change and IP: Letter Urges US to Protect Intellectual Property Rights at Conference
December 7, 2010
Re: IPR and Technology discussions at Cancún Climate Change Talks Dear Secretary Clinton and Ambassador Stern: At this very moment, language is circulating at the UNFCCC climate change meeting in Cancún that proposes to continue...
BIO comments submitted to United States Department of Agriculture’s (USDA’s) Animal and Plant Health Inspection Service (APHIS
December 6, 2010
Re: APHIS-2010-0047: Availability of an Environmental Assessment for Supplemental Request for Partial Deregulation of Sugar Beets Genetically Engineered to Be Tolerant to the Herbicide Glyphosate To whom it may concern: These comments are...
Comments to the Institute of Medicine on the Determination of Essential Health Benefits
December 6, 2010
Institute of Medicine Essential Health Benefits BIO Comments 1. What is your interpretation of the word “essential” in the context of an essential benefit package? “Essential” in the context of an essential benefit...
Medicare Program; Request for Information Regarding Accountable Care Organizations and the Medicare Shared Savings Program
December 3, 2010
Re: Medicare Program; Request for Information Regarding Accountable Care Organizations and the Medicare Shared Savings Program [CMS-1345-NC] Dear Administrator Berwick: The Biotechnology Industry Organization (BIO) is pleased to submit the...
Job Creation: Biobased Products Seek Equal Tax Credits
December 1, 2010
Dear Honorable Sander Levin and Honorable Dave Camp, We applaud your ongoing leadership on strengthening U.S. manufacturing and reducing our reliance on imported products. The recently released draft bill, Domestic Manufacturing and Energy Jobs...
BIO comments on the proposed accession of Malaysia to the Trans Pacific Partnership (TPP) negotiations
November 22, 2010
RE: Participation of Malaysia in the Trans-Pacific Partnership Trade Negotiations Dear Ms. Blue: The Biotechnology Industry Organization (BIO) is pleased to have the opportunity to comment on the proposed accession of Malaysia to the Trans...
BIO's comments to Health Resources and Services Administration (HRSA) on dispute resolution authorized in Section 7102 of the Patient Protection and Affordable Care Act
November 19, 2010
Re: Comments on Dispute Resolution Dear Ms. Taylor: The Biotechnology Industry Organization (“BIO”) appreciates this opportunity to respond to HRSA’s September 20, 2010 advance notice of proposed rulemaking and request for...
BIO's comments to Health Resources and Services Administration (HRSA) on the Civil Monetary Penalties authority provided by Section 7102(a) of the Patient Protection and Affordable Care Act
November 19, 2010
Re: Comments on the Civil Monetary Penalties Dear Mr. Lang: The Biotechnology Industry Organization (BIO) appreciates this opportunity to respond to HRSA’s September 20, 2010 advance notice of proposed rulemaking and request for comments...
BIO Comments to USPTO on Incentivizing Humanitarian Technologies and Licensing Through the Intellectual Property System
November 19, 2010
Re: Request for Comments on Incentivizing Humanitarian Technologies and Licensing Through the Intellectual Property System, 75 Fed. Reg. 181, 57261 Washington, D.C., November 19, 2010 Dear Under Secretary Kappos: The Biotechnology Industry...
Food Labeling; Labeling of Food Made From AquAdvantage Salmon
November 19, 2010
Re: (Docket No. FDA-2010-N-0385) Food Labeling; Labeling of Food Made From AquAdvantage Salmon Dear Sir/Madam: The Biotechnology Industry Organization (BIO) appreciates the opportunity to provide input on the application of the food labeling...
Draft Guidance for Industry on Suicidality: Prospective Assessment of Occurrence in Clinical Trials
November 8, 2010
Re: Docket No. FDA-2010-D-0451: Draft Guidance for Industry on Suicidality: ProspectiveAssessment of Occurrence in Clinical Trials Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for...
FDA: Strategic Priorities for Fiscal Year 2011-2015
November 1, 2010
Re: Docket No. Docket No. FDA-2010-N-0506, Request for Comments on the Food and Drug Administration Fiscal Year 2011-2015 Strategic Priorities Document Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug...
FDA Guidance Document: Transdermal Drug Delivery Systems
November 1, 2010
Re: Docket No. FDA-2010-D-0246: Draft Guidance for Industry on Residual Drug in Transdermal and Related Drug Delivery Systems Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the...
BIO and AUTM File Joint Brief Defending Patentability of DNA-Based Inventions
October 29, 2010
No. 2010-1406 UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT ——————————— THE ASSOCIATION FOR MOLECULAR PATHOLOGY, THE AMERICAN COLLEGE OF MEDICAL GENETICS, THE AMERICAN...
Plant Biotechnology: Proposed Labeling of Foods and Food Ingredients obtained through Certain Techniques of Genetic Modification/Genetic Engineering
October 29, 2010
RE: Request for comments and information at Step 3 on the proposed draft Recommendations for the Labeling of Foods and Food Ingredients obtained through Certain Techniques of Genetic Modification/Genetic Engineering (ALINORM 10/33/22 paras.159 to...
BIO's comments to the FDA supporting the goals of the Draft Guidance to reduce the potential for suicidal behavior, ideation and attempts during drug treatment.
October 29, 2010
Re: Docket No. FDA–2010–N–0437, Development and Distribution of Patient Medication Information for Prescription Drugs Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA...
Patient Therapy: Patient Medication Information
October 29, 2010
BIO submitted comments on FDA’s "Development and Distribution of Patient Medication Information for Prescription Drugs." The comments elaborate on previous comments and further address the questions raised at the September 27-28...