Department of Health and Human Services November 29, 2016 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

As required by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that a meeting of the Chronic Fatigue Syndrome Advisory Committee (CFSAC) will take place. This meeting will be open to the public.

The Food and Drug Administration (FDA or we) is extending the comment period for a notice that appeared in the Federal Register of September 14, 2016. In that notice, FDA requested comments regarding the establishment of appropriately targeted durations of use of antimicrobial drugs of importance to human medicine (i.e., medically important antimicrobial drugs) when they are administered in the feed or water of food-producing animals for therapeutic purposes. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Abbreviated New Drug Applications and 505(b)(2) Applications'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) has determined the regulatory review period for IXINITY and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Providing Postmarketing Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report).'' This guidance is intended to inform applicants of the conditions under which FDA will exercise its waiver authority to permit applicants to submit an International Council for Harmonisation (ICH) (formerly International Conference on Harmonisation) E2C(R2) Periodic Benefit-Risk Evaluation Report (PBRER) in place of the ICH E2C(R1) Periodic Safety Update Report (PSUR), U.S. Periodic adverse drug experience report (PADER), or U.S. Periodic adverse experience report (PAER), to satisfy the periodic safety reporting requirements in FDA regulations. The guidance describes the steps applicants can take to submit the PBRER, and discusses the format, content, submission deadline, and frequency of reporting for the PBRER.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Mitigating the Risk of Cross-Contamination From Valves and Accessories Used for Irrigation Through Flexible Gastrointestinal Endoscopes.'' Flexible gastrointestinal endoscopes and accessories are class II devices and identified with product codes such as FDF, FDS, and OCX. When using these devices during an entire day of procedures (e.g., colonoscopies), clinicians typically use one irrigation system (i.e., one water bottle, one set of tubing and valves, etc.) without cleaning and sterilizing all the system components between patients. This guidance highlights the cross-contamination risk associated with day-use of irrigation systems used with flexible gastrointestinal endoscopes; clarifies terminology used to describe these devices; and outlines strategies to mitigate the risk of cross-contamination between patients during these procedures.

The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule/regulation to establish requirements for the electronic filing of entries of FDA-regulated products in the Automated Commercial Environment (ACE) or any other electronic data interchange (EDI) system authorized by the U.S. Customs and Border Protection Agency (CBP), in order for the filing to be processed by CBP and to help FDA in determining admissibility of that product. ACE is a commercial trade processing system operated by CBP that is designed to implement the International Trade Data System (ITDS), automate import and export processing, enhance border security, and foster U.S. economic security through lawful international trade and policy. FDA is a Partner Government Agency (PGA) for purposes of submission of import data in ACE. As of July 23, 2016, ACE became the sole EDI system authorized by CBP for entry of FDA-regulated articles into the United States. We also updated certain sections of FDA regulations related to imports. This rule will facilitate effective and efficient admissibility review by the Agency and protect public health by allowing FDA to focus its limited resources on those FDA-regulated products being imported or offered for import that may be associated with a greater public health risk.