Department of Health and Human Services December 9, 2020 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA, Agency, or we) 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 the information collection pertaining to Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products.'' FDA is issuing this draft guidance to help sponsors develop human nonprescription drug product proprietary names. This draft guidance describes best practices to help minimize medication errors and otherwise avoid adoption of proprietary names that contribute to violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its implementing regulations. The draft guidance also describes the framework FDA uses in evaluating proposed proprietary names for nonprescription drug products, which is available to sponsors to use before marketing a nonprescription drug product bearing a particular proprietary name. This draft guidance is issued in response to industry stakeholders' requests to specifically address the approaches for naming of human nonprescription drug products.

The Administration for Children and Families (ACF) is requesting a revision to the Social Services Block Grant (SSBG) Post- Expenditure Report, Pre-Expenditure Report, and Intended Use Plan (OMB #0970-0234), previously titled, ``Social Services Block Grant (SSBG) Post-Expenditure Report''). ACF is proposing to expand the information collection to include the collection of states' Intended Use Plans and retitle the information collection to clarify the role of the Pre- Expenditure Report.

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces a webinar entitled, ``CDC STI Treatment Guidelines Update''. The purpose of the webinar is for CDC to receive comments from potential users on the proposed updated guidelines. This webinar is an opportunity for all interested parties to ask questions and provide feedback, but is specifically directed toward clinicians, such as medical doctors, nurse practitioners, and physician's assistants. CDC will consider comments made during the webinar prior to finalizing the updated STI Treatment Guidelines for publication.