Department of Health and Human Services March 14, 2014 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products.'' This guidance clarifies the FDA requirements and regulations pertaining to allowable excess volume in injectable vials and reinforces the importance of appropriate packaging sizes for injectable drug \1\ and biological products.

This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive license to practice the inventions embodied in U.S. Patent Application 61/ 172,099 entitled ``Anti-human ROR1 Antibodies'' [HHS Ref. E-097-2009/0- US-01], PCT Application No. PCT/US2010/032208 entitled ``Anti-human ROR1 Antibodies'' [HHS Ref. E-097-2009/0-PCT-02], U.S. Patent Application 61/418,550 entitled, ``Chimeric Rabbit/Human ROR1 Antibodies'' [HHS Ref. No. E-039-2011/0-US-01], and PCT Application No. PCT/US2011/062670 entitled, ``Chimeric Rabbit/Human ROR1 Antibodies'', and all related continuing and foreign patents/patent applications for the technology family, to Ardeagen Corporation. The patent rights in these inventions have been assigned to the Government of the United States of America. The prospective start-up exclusive evaluation option license territory may be worldwide and the field of use may be limited to pre- clinical evaluation and commercial development of an antibody-drug conjugate comprising an anti-tyrosine protein kinase transmembrane receptor (ROR1) antibody for the treatment of human ROR1 expressing cancers, wherein the antibody moiety comprises the anti-ROR1 antibodies designated as 2A2, 2D11, R11, R12, or R31. For avoidance of doubt, this Agreement explicitly excludes the development of an immunotoxin comprising 2A2 and Pseudomonas exotoxin A targeted immunotoxins for the treatment of human ROR1 expressing cancers. Upon expiration or termination of the start-up exclusive evaluation option license, Ardeagen Corporation will have the right to execute a start-up exclusive patent commercialization license which will supersede and replace the start-up exclusive evaluation option license with no broader territory than granted in the start-up exclusive evaluation option license and the field of use will be commensurate with the commercial development plan at the time of conversion.

Respiratory protective devices (RPDs) that are approved by the National Institute for Occupational Safety and Health (NIOSH) and also cleared by the Food and Drug Administration (FDA) \a\ as medical devices are widely used in surgical and non-surgical healthcare environments. There are reports \b\ that other NIOSH-approved RPDs that are not FDA-cleared medical devices are also being used to protect healthcare workers from inhalation hazards. The desirability of NIOSH incorporating additional requirements and tests in its 42 CFR Part 84 respirator approval process to parallel the protections in the FDA clearance process for Surgical N95 Respirators in surgical and non- surgical healthcare environments has been mentioned during broad-based and cross-agency discussions for future pandemic events as well as day- to-day use in healthcare settings.