Tom Harkin: “I ask unanimous consent that, pursuant to Public Law 112-144, the Food and Drug Administration Safety and Innovation…”

“I ask unanimous consent that, pursuant to Public Law 112-144, the Food and Drug Administration Safety and Innovation Act, the following letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives be printed into the Record. There being no objection, the material was ordered to be printed in the Record, as follows: MDUFA Performance Goals and Procedures The performance goals and procedures agreed to by the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) of the United States Food and Drug Administration (``FDA'' or ``the Agency'') for the medical device user fee program in the Medical Device User Fee Amendments of 2012, are summarized below. FDA and the industry are committed to protecting and promoting public health by providing timely access to safe and effective medical devices. Nothing in this letter precludes the Agency from protecting the public health by exercising its authority to provide a reasonable assurance of the safety and effectiveness of medical devices. Both FDA and the industry are committed to the spirit and intent of the goals described in this letter. I. Process Improvements A. Pre-Submissions FDA will institute a structured process for managing Pre- Submissions.…”