Department of Health and Human Services February 2019 – Federal Register Recent Federal Regulation Documents

The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this notice to Morphiex Biotherapeutics (``Morphiex'') located in Boston, MA.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway.'' This guidance discusses FDA's recommendations for developing the indication and usage statements in the prescribing information for drugs approved under the accelerated approval regulatory pathway (hereafter accelerated approval). The guidance also discusses labeling considerations for indications approved under accelerated approval when clinical benefit has been verified and FDA terminates the conditions of accelerated approval, or when FDA withdraws accelerated approval of an indication while other indications for the drug remain approved. This guidance finalizes the draft guidance of the same name issued March 25, 2014.

The Food and Drug Administration (FDA or Agency) has determined that ESBRIET (pirfenidone), film coated tablets, 534 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for pirfenidone, film coated tablets, 534 mg, if all other legal and regulatory requirements are met.

This proposed rule would update proficiency testing (PT) regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to address current analytes (that is, substances or constituents for which the laboratory conducts testing) and newer technologies. This proposed rule would also make additional technical changes to PT referral regulations to more closely align them with the CLIA statute.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Survey Methodologies to Assess REMS Goals That Relate to Knowledge; Draft Guidance For Industry.'' This draft guidance provides recommendations to industry on conducting risk evaluation and mitigation strategies (REMS) assessment surveys used to evaluate respondent knowledge of REMS-related information. Most applicants use surveys to evaluate patients' and healthcare providers' understanding of the serious risks associated with, and safe use of, their drugs to assess REMS knowledge goals. The draft guidance discusses general principles and recommendations related to conducting REMS assessment knowledge surveys, including study design, survey instrument development, survey data collection and processing, and data analysis.