Department of Health and Human Services July 18, 2018 – 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 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 for drug establishment registration and product listing.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Innovative Approaches for Nonprescription Drug Products.'' This draft guidance describes two innovative approaches that may be useful to consider for demonstrating safety and effectiveness for a nonprescription drug product in cases where the drug facts labeling (DFL) alone is not sufficient to ensure that the drug product can be used safely and effectively in a nonprescription setting: The development of labeling in addition to the DFL and the implementation of additional conditions so that consumers appropriately self-select and use the product.