BIO Food and Agriculture Section Comments to FDA on Review of Existing General Regulatory and Information Collection Requirements

February 5, 2017
Dockets Management Staff (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

Re: Docket No. FDA-2017-N-5093. Review of Existing General Regulatory and Information Collection Requirements of the Food and Drug Administration.

Dear Sir/Madam:

The Food and Agriculture Section of the Biotechnology Innovation Organization (BIO) is pleased to submit these comments in response to the U.S. Food and Drug Administration’s (FDA) request for public input on a notice published in the Federal Register entitled “Review of Existing General Regulatory and Information Collection Requirements of the Food and Drug Administration,” as well as several related Center-specific notices. Because the issues raised in our comments often relate to more than one FDA Center, we provide here one consolidated set of comments, indicating to which Center or Centers the comments refer, and submit a copy of these comments to the respective dockets for the the individual centers referenced herein. In particular, our comments relate to the Center for Biologics Evaluation and Research CBER), Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH), the Center for Food Safety and Applied Nutrition (CFSAN), and the Center for Veterinary Medicine (CVM). 

BIO is the world's largest trade association representing roughly 1,000 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO represents many of the agricultural biotechnology product developers in North America, including companies developing products affected by actions of one or more FDA Center.