Department of Health and Human Services January 22, 2018 – Federal Register Recent Federal Regulation Documents

In a final rule published on January 19, 2017, federal departments and agencies listed in this document made revisions to the Federal Policy for the Protection of Human Subjects. The Consumer Product Safety Commission (CPSC) adopted the same regulatory changes in a separate final rule published on September 18, 2017. The revised policy, reflected in both final rules, is described here as the ``2018 Requirements.'' The 2018 Requirements are scheduled to become effective on January 19, 2018, with a general compliance date of January 19, 2018 (with the exception of the revisions to the cooperative research provision). This interim final rule delays the effective date and general compliance date of the 2018 Requirements to July 19, 2018. The federal departments and agencies listed in this document are in the process of developing a proposed rule to further delay implementation of the 2018 Requirements. The limited implementation delay accomplished by this interim final rule both provides additional time to regulated entities for the preparations necessary to implement the 2018 Requirements, and additional time for the departments and agencies listed in this document to seek input from interested stakeholders through a notice and comment rulemaking process that allows for public engagement on the proposal for a further implementation delay.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for NINLARO 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 drug product.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ZURAMPIC 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 drug product.

In accordance with the Federal Advisory Committee Act, the CDC National Institute for Occupational Safety and Health (NIOSH), announces the following meeting for the World Trade Center Health Program Scientific/Technical Advisory Committee (WTCHP STAC). This meeting is open to the public, limited only by the number of telephone lines. The room will accommodate approximately 100 persons. The public is also welcome to listen to the meeting by dial-in number 1 (888) 982- 4611, the passcode 3778171, and will accommodate up to 50 callers. To view the web conference, enter the following web address in your web browser: https://odniosh.adobeconnect.com/wtchpstac18-1/.