The U.S. Food and Drug Administration requests comments on the estimated time burdens of a proposed study that “will investigate the impact of limiting the risks presented in DTC [direct-to-consumer] prescription drug television ads to those that are serious and actionable, and including a disclosure to alert consumers that there are other product risks not disclosed in the ads.” According to the agency, concerns have arisen over whether the “major statement” included in current TV ads is “too long, which may result in reduced consumer comprehension, minimization of important risk information and, potentially, therapeutic noncompliance due to fear of side effects.” Comments are requested by April 21, 2014. The U.S. Food and Drug Administration reports on “the status of post- marketing requirements and commitments required of, or agreed upon by, holders of approved drug and biological products. This notice is the Agency’s report on the status of the studies and clinical trials that applicants have agreed to, or are required to, conduct.”
The U.S. International Trade Administration issues a request for nominations to 16 Industry Trade Advisory Committees (ITACs) for which it has renewed the charters until February 2018. Among those committees with vacancies are ITAC 3, Chemicals, Pharmaceuticals, Health/science Products and services; ITAC 15, Intellectual Property Rights and ITAC 16 standards and Technical Trade Barriers. Applicants must be U.S. citizens and must not be federally registered lobbyists. Meetings occur in Washington, D.C., some six times each year. Nominations will be accepted through February 14, 2018.
The U.S. Patent and Trademark Office extends the comment deadline and schedules two public hearings—March 13 and 26, 2014, in Alexandria, Virginia, and San Francisco, California, respectively—on a notice of proposed rulemaking (NPR) that would change the rules of practice to “require that the attributable owner, including the ultimate parent entity, be identified during the pendency of a patent application and at specified times during the life of a patent. The Office is specifically proposing that the attributable owner be identified on filing of an application (or shortly thereafter), when there is a change in the attributable owner during the pendency of an application, at the time of issue fee and maintenance fee payments, and when a patent is involved in supplemental examination, ex parte reexamination, or a trial proceeding before the Patent Trial and Appeal Board.” Comments are now requested by April 24, 2014.