The Food and Drug Administration makes available additional draft and revised draft product-specific bioequivalence (BE) recommendations on the design of BE studies to support abbreviated new drug applications. Comments are requested by November 13, 2012.

The National Institutes of Health (NIH) publishes final changes to the NIH Guidelines addressing “biosafety considerations for research with synthetic nucleic acids” and modifying “the criteria for determining whether an experiment to introduce drug resistance into a microorganism must be reviewed by the Recombinant DNA Advisory Committee and approved by the NIH Director” as a major action. Proposed in March 2009, the changes will take effect March 5, 2013.

The U.S. Patent and Trademark Office issues a final rule “adjusting certain patent fee amounts for fiscal year 2013 to reflect fluctuations in the Consumer Price Index.” The rule takes effect October 5, 2012.

The U.S. Patent and Trademark Office issues a notice of proposed rulemaking that would “set or adjust patent fees as authorized by the Leahy-Smith America Invents Act.” Among other matters, the proposed fees are intended to “provide the Office with a sufficient amount of aggregate revenue to recover its aggregate cost of patent operations, while helping the Office implement a sustainable funding model, reduce the current patent application backlog, decrease patent pendency, improve patent quality, and upgrade the Office’s patent business information technology capability and infrastructure.” The proposal would also reduce fees for micro entities. Comments are requested by November 5, 2012.

The U.S. Patent and Trademark Office (USPTO) issues a final rule revising the rules of practice under the Leahy-Smith America Invents Act. Effective March 16, 2013, the rule creates “a new derivation proceeding to be conducted before the Patent Trial and Appeal Board.” According to USPTO, the new proceeding aims “to ensure the first person to file a patent application is actually the true inventor.”