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Questions for the District of Columbia Board of Pharmacy for the drafting of SafeRx

Mar 10 2016
Frequently Asked Questions Document

Clinical Trials: ICTRP guidelines

Mar 10 2016
BIO urges the ICTRP to focus on developing a procedure that would address the need to balance the incentive to innovate with the need to provide patients and health care providers with the information they need in order to assess the availability and suitability of a clinical trial.

Clinical Trials: Review of the Declaration of Helsinki

Mar 10 2016
BIO’s comments on the World Medical Association’s (WMA’s) Declaration of Helsinki.

Request for Comment Extension RE: Docket No. APHIS-2014-0054 – Environmental Impact Statement; Introduction of the Products of Biotechnology

Feb 18 2016
We, the undersigned organizations, appreciate the opportunity to provide comment on APHIS’ Notice of Intent (NOI) to prepare an environmental impact statement in connection with potential changes to APHIS biotechnology regulations (7 CFR 340). Our member organizations represent a broad cross-section of stakeholders having a significant interest in the future of U.S. agriculture, including farmers, grower groups, handlers, marketers, processors, manufacturers, distributors and exporters of agricultural products, as well as seed companies and technology providers.

BIO 2016 Special 301 Submission

Feb 8 2016
The Biotechnology Innovation Organization (BIO) appreciates the opportunity to comment on the 2016 Special 301 Submission. 

BIO Comments on FDA voluntary labeling of GE salmon

Jan 26 2016
Food and Drug Administration Docket No. FDA-2015-D-4272; Food Labeling; Voluntary Labeling Indicating Whether Food Has or Has Not Been Derived From Genetically Engineered Atlantic Salmon; Draft Guidance for Industry.

BIO Submits Comments Re: MIPS, Promotion of Alternative Payment Models, and Incentive Payments for Participation in Eligible Alternative Payment Models RFI

Dec 22 2015
RE: CMS Regarding Implementation of the Merit-Based Incentive Payment System, Promotion of Alternative Payment Models, and Incentive Payments for Participation in Eligible Alternative Payment Models

BIO Submits Comments Re: HRSA's PPA Information Collection Request

Dec 22 2015
Captain Krista M. Pedley, PharmD, M.S., USPHS, Director Office of Pharmacy Affairs Health Resources and Services Administration Department of Health and Human Services 5600 Fishers Lane, Parklawn Building, Mail Stop 10C-03 Rockville, Maryland 20857   BY ELECTRONIC SUBMISSION   Re: Proposed Information Collection: Enrollment and Re-Certification of Entities in the 340B Drug Pricing Program and Collection of Manufacturer Data to Verify 340B Drug Pricing Program Ceiling Price Calculations [OMB No. 0915-0327- Revision]   Dear Captain Pedley:   The Biotechnology Industry Organization (“BIO”) appreciates the opportunity to submit the following comments in response to the proposed Information Collection Request (“ICR”), issued by the Health Resources and Services Administration (“HRSA”) and published in the Federal Register on October 20, 2015, entitled Enrollment and Re- Certification of Entities in the 340B Drug Pricing Program and Collection of Manufacturer Data to Verify 340B Drug Pricing Program Ceiling Price Calculations [OMB No. 0915-0327- Revision] (the “Proposed ICR”).

BIO Submits Comments Re: HCP LAN APM Draft Framework

Dec 22 2015
Alternative Payment Model Framework and Progress Tracking Work Group Health Care Payment Learning & Action Network U.S. Department of Health and Human Services 200 Independence Avenue, S.W. Washington, D.C. 20201   BY ELECTRONIC DELIVERY   RE: Alternative Payment Models Framework Draft White Paper   Dear Alternative Payment Model Framework and Progress Tracking Work Group:   The Biotechnology Industry Organization (BIO) is pleased to submit feedback in response to the U.S. Department of Health and Human Services’ (HHS’s) Health Care Payment and Learning Action Network’s (HCP LAN) “Alternative Payment Models Framework Draft White Paper” (the “Draft White Paper”), released on October 22, 2015.1 BIO represents biotechnology companies, academic institutions, state biotechnology centers, and related organizations across the United States and in more than 30 other nations. BIO’s members develop medical products and technologies to treat patients afflicted with serious diseases, to delay the onset of these diseases, or to prevent them in the first place. In that way, our members’ novel therapeutics, vaccines, and diagnostics not only have improved health outcomes, but also have reduced healthcare expenditures due to fewer physician office visits, hospitalizations, and surgical interventions.

BIO Submits Comments Re: HHS Notice of Benefit and Payment Parameters for 2017

Dec 22 2015
Sylvia Mathews Burwell Secretary U.S. Department of Health and Human Services 200 Independence Avenue, S.W. Washington, D.C. 20201   Andrew M. Slavitt Acting Administrator Centers for Medicare and Medicaid Services 7500 Security Boulevard Baltimore, M.D. 21244   BY ELECTRONIC DELIVERY   Re: Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2017 [CMS-9937-P]