Department of Health and Human Services February 19, 2019 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Evaluation of Devices Used with Regenerative Medicine Advanced Therapies; Guidance for Industry.'' The guidance document provides manufacturers, applicants, and sponsors engaged in the development of regenerative medicine therapies, with our current thinking regarding evaluation of devices used in the recovery, isolation or delivery of regenerative advanced therapies, which FDA generally refers to as ``regenerative medicine advanced therapies'' or ``RMATs.'' Specifically, the guidance addresses how FDA intends to simplify and streamline its application of regulatory requirements for combination device and cell or tissue products; what, if any, intended uses or specific attributes would result in a device used with a regenerative therapy product to be classified as a class III device; the factors to consider in determining whether a device may be labeled for use with a specific RMAT or class of RMATs; when a device may be limited to a specific intended use with only one particular type of cell; and application of the least burdensome approach to demonstrate how a device may be used with more than one cell type. The issuance of this guidance fulfills the statutory requirement set forth in a certain section of the 21st Century Cures Act (Cures Act). The guidance announced in this notice finalizes the draft guidance of the same title dated November 2017.

The National Toxicology Program (NTP) at the National Institute of Environmental Health Sciences is seeking input on assays and approaches for evaluating chemical effects on cancer pathways, specifically, pathways that map to the hallmarks of cancer and key characteristics of carcinogens.

This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from October through December 2018, relating to the Medicare and Medicaid programs and other programs administered by CMS.

The Agency for Healthcare Research and Quality (AHRQ) invites nominations of individuals qualified to serve as members of the U.S. Preventive Services Task Force (USPSTF).

The Administration for Children and Families (ACF), Office of Planning, Research, and Evaluation (OPRE) is proposing an extension of a currently approved generic clearance (OMB no. 0970-0477) for Grant Reviewer Recruitment (GRR) forms. The GRR forms will be used to select reviewers who will participate in the grant review process for the purpose of selecting successful applications.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Nonbinding Feedback After Certain FDA Inspections of Device Establishments.'' The FDA Reauthorization Act of 2017 (FDARA) mandated that FDA issue draft guidance specifying how FDA provides nonbinding feedback to the owner, operator, or agent in charge of a device establishment after an inspection of such establishment within 45 days of FDA's receipt of a request for such feedback if the request meets certain statutory criteria. This draft guidance describes FDA's proposed approach for providing nonbinding feedback, including the procedures for requesting nonbinding feedback and FDA's review of requests for nonbinding feedback. This draft guidance is not final nor is it in effect at this time.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Competitive Generic Therapies.'' On August 18, 2017, the FDA Reauthorization Act of 2017 (FDARA), which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act), was signed into law. Under FDARA, a section was added to the FD&C Act that established a new process to designate, and expedite the development and review of, certain drugs intended for submission or submitted in an abbreviated new drug application (ANDA) and for which there is ``inadequate generic competition.'' This draft guidance provides a description of the process that applicants should follow to request designation of a drug as a competitive generic therapy (CGT) and the criteria for designating a drug as a CGT. This draft guidance also includes information on the actions FDA may take to expedite the development and review of an ANDA for a drug designated as a CGT. This draft guidance also provides information on how FDA implements the statutory provisions providing for a 180-day exclusivity period for certain first approved applicants that submit ANDAs for drugs designated as CGTs.

The Food and Drug Administration (FDA or the Agency) is issuing a final rule to establish criteria for and identify an initial list of bulk drug substances that can be used to compound drug products in accordance with certain compounding provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act), although they are neither the subject of an applicable United States Pharmacopeia (USP) or National Formulary (NF) monograph nor components of FDA-approved drugs. Specifically, the Agency is placing six bulk drug substances on the list. This final rule also identifies four bulk drug substances that FDA has considered and is not including on the list. Additional bulk drug substances nominated by the public for inclusion on this list are currently under consideration and will be the subject of a future rulemaking.