The U.S. Patent and Trademark Office (USPTO) requests nominations for open three-year positions on the Patent Public Advisory Committee and Trademark Public Advisory Committee. These committees review USPTO’s policies, goals, performance, budget, and user fees; members must represent small and large entity applicants in the United States. Nominations are requested by July 25, 2014.
The U.S. Food and Drug Administration issues a draft document titled “Guidance for Industry: Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products.” Intended for investigational new drug application sponsors and applicants for a biologics license application or its supplementation, the document sets forth “recommendations on considerations when assessing whether to submit an Environmental Assessment (EA) for gene therapies, vectored vaccines, and related recombinant viral or microbial products.” It also indicates what information should be included in an EA and what to expect once an EA is filed. Comments are requested by September 18, 2014.
The National Institutes of Health seeks “available data and information on devices and/or technologies currently used for identifying potential inhalation hazards. Submitted information will be used to assess the state of the science and determine the technical needs for a dynamic nonanimal system to assess the potential toxicity of inhaled chemicals and nanomaterials.” The deadline for submissions is July 18, 2014.
The U.S. Food and Drug Administration issues the first part of its finalized industry guidance on the global unique device identification database, a critical component of the unique device identification system mandated under the Food and Drug Administration Safety and Innovation Act of 2012. The remaining sections of the draft guidance, issued in September 2013 for public comment, will be finalized in one or more additional parts and published at a later date. The first part includes those sections that generated the most comments or questions. Labelers are responsible for submitting information to the database, and the guidance provides them with general information on obtaining a database account and beginning their initial submissions.
The U.S. Food and Drug Administration (FDA) seeks comments on draft guidance titled “Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products—Recommended Practices.” It “describes FDA’s current thinking on recommended practices for drug manufacturers and their representatives to follow when distributing to health care professionals or health care entities scientific or medical journal articles that discuss new risk information for approved prescription drugs for human use, including drugs licensed as biological products, and approved animal drugs.” Comments are requested by August 11, 2014.
The U.S. Food and Drug Administration requests comments on draft industry guidance titled “Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification.” The guidance is intended to assist “certain trading partners (manufacturers, repackagers, wholesale distributors, and dispensers),” in identifying a product that is illegitimate or at high risk of illegitimacy and notifying the agency and all immediate trading partners within 24 hours of making this determination. Comments on the draft guidance should be submitted by August 11, 2014, to be considered in its finalization.