Department of Health and Human Services September 30, 2015 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is issuing this notice to request that industry trade associations, whose members include drug companies currently engaged in development or manufacture of biosimilar biological products in the U.S., or drug companies intending to engage in these activities during the period of FY 2018-2022, notify FDA of their intent to participate in industry stakeholder meetings in support of timely reauthorization of the Biosimilar User Fee Act of 2012 (BsUFA). The statutory authority for BsUFA expires at the end of September 2017. At that time, new legislation will be required for FDA to continue collecting user fees to fund the biosimilar biological product review process. The Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires that FDA engage in negotiations with regulated industry to develop recommendations to present to Congress with respect to the reauthorization of BsUFA. The purpose of this request for notification is to ensure that qualifying industry organizations notify FDA of their intention to participate in the planned negotiation process.

The Agency for Toxic Substances and Disease Registry (ATSDR), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995 (PRA). This notice invites comment on the three- year extension of information collection clearance for the ``Prospective Birth Cohort Study Involving Environmental Uranium Exposure in the Navajo Nation'' project (OMB Control No. 0923-0046; expiration date 05/31/2016). The purpose of the study is to examine the potential association between environmental contaminants (i.e., uranium and other heavy metal exposures) and reproductive birth outcomes by recruiting Navajo mothers to assess and follow theirs and their children's uranium exposures at birth and at key developmental milestones.

The Food and Drug Administration (FDA) is announcing the availability of a small entity compliance guide and guidance for industry #120 entitled ``Veterinary Feed Directive Regulation Questions and Answers.'' This guidance aids industry in complying with the requirements of the Veterinary Feed Directive (VFD) final rule that published in the Federal Register on June 3, 2015. The purpose of this document is to describe the Veterinary Feed Directive requirements for veterinarians, feed manufacturers and other distributors, animal producers, and other parties involved in the distribution or use of medicated feed containing a Veterinary Feed Directive drug (VFD feed).