BIO appreciates this opportunity to provide comments to the Food and Drug Administration (FDA) on its request for comments on the draft guidance for industry (GFI) #187, entitled Regulation of Intentionally Altered Genomic DNA in Animals2. This draft guidance would revise GFI #187…
May 19, 2017Docket No. APHIS-2014-0056Regulatory Analysis and DevelopmentPlant Protection Division - APHISStation 3A–03.84700 River Road Unit 118Riverdale, MD 20737–1238.http://www.regulations.gov/#!docketDetail;D=APHIS-2014-0056Re: Animal and Plant Health Inspection Service Docket No. APHIS–2014…
BIO submitted comments in response to the Centers for Medicare and Medicaid Services' (CMS's) Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System Proposed Policy Changes and Fiscal Year 2018 Rates Proposed Rule on…
BIO submitted comments in response to the Centers for Medicare and Medicaid Services' (CMS's) CY 2018 Updates to the Quality Payment Program Proposed Rule. BIO supports the development and implementation of the Quality Payment Program (QPP) tracks: Advanced Alternative Payment Models (APMs) and the…
August 25, 2017Mr. Bruce SummersActing AdministratorAgricultural Marketing ServiceUnited States Department of Agriculture1400 Independence Avenue, SWRoom 3069 South BuildingWashington, DC 20250Submitted via GMOlabeling@ams.usda.govRE: Proposed Rule Questions Under Consideration (Posted June 26,…
Dear Sir/Madam:The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments to FDA’s Draft Guidance entitled Product Identifier Requirements Under the Drug Supply Chain Security Act-Compliance Policy (Draft Guidance).BIO is the…
BIO submitted comments to the U.S. Pharmacopeial Convention (USP) Healthcare Quality and Safety Expert Committee (Expert Committee) in response to the second round of public comment on the USP Drug Classification System (USP DC), released September 25, 2017.In response to the USP DC, BIO offers…
BIO submitted comments in response to the Health and Human Services (HHS/the Agency) Draft Strategic Plan for Fiscal Years 2018-2022. BIO strongly supports HHS’ mission to enhance the health and well-being of Americans, by providing for effective health and human services and by fostering sound,…