Department of Health and Human Services July 2, 2019 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is issuing a final rule to amend its regulations regarding internal agency supervisory review of certain decisions related to devices regulated by the Center for Devices and Radiological Health (CDRH or the Center) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to conform to the applicable provisions in the FD&C Act, as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA) and the 21st Century Cures Act (Cures Act). This final rule codifies the procedures and timeframes for supervisory review of significant decisions pertaining to devices within CDRH. FDA is also finalizing regulations to provide new procedural requirements for requesting internal agency supervisory review within CDRH of other types of decisions made by CDRH not addressed in FDASIA and the Cures Act. This action is also part of FDA's implementation of Executive Orders (EOs) 13771 and 13777. Under these EOs, FDA is comprehensively reviewing existing regulations to identify opportunities for repeal, replacement, or modification that will result in meaningful burden reduction, while allowing the Agency to achieve its public health mission and fulfill statutory obligations.

In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.

The Food and Drug Administration (FDA or Agency) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Instructions for UsePatient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination ProductsContent and Format.'' This draft guidance provides recommendations for developing the content and format of an Instructions for Use (IFU) document for human prescription drugs and biological products and drug-device or biologic-device combination products submitted under a new drug application (NDA) or a biologics license application (BLA). The IFU is developed by applicants for patients who use drug products that have complicated or detailed patient-use instructions. The recommendations in this draft guidance are intended to help develop consistent content and format across IFUs and to help ensure that patients receive clear, concise information that is easily understood for the safe and effective use of prescription drug products.