Department of Health and Human Services March 8, 2019 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled ``Nonproprietary Naming of Biological Products: Update.'' This draft guidance describes FDA's current thinking on nonproprietary names of biological products licensed under the Public Health Service Act (PHS Act) that do not include an FDA-designated suffix. Specifically, the nonproprietary names of these products need not be revised to accomplish the objectives of the naming convention described in the final guidance for industry, ``Nonproprietary Naming of Biological Products,'' dated January 2017. Similarly, FDA does not intend to apply the naming convention described in the final guidance for industry, ``Nonproprietary Naming of Biological Products,'' to biological products that are the subject of an approved application under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as of March 23, 2020, when such an application is deemed to be a biologics license application (BLA) under the PHS Act (transition biological products). FDA is also reconsidering whether vaccines should be within the scope of the naming convention. In addition, the draft guidance describes FDA's current thinking on the appropriate suffix format for the nonproprietary name of an interchangeable biological product licensed under the PHS Act. Based on the comments received in the docket, we intend to revise the final guidance, ``Nonproprietary Naming of Biological Products,'' dated January 2017 and to amend sections in that document regarding the subjects addressed in this draft guidance.

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with the processes available to outside stakeholders to request additional review of decisions or actions by Center for Devices and Radiological Health (CDRH) employees.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Pediatric Advisory Committee (PAC). The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.