Department of Health and Human Services October 2017 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is denying Matthew Schroeder's (Schroeder's) request for a hearing and is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) permanently debarring Schroeder from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Schroeder was convicted of a felony under Federal law for conduct relating to the regulation of a drug product under the FD&C Act. Schroeder failed to file with the Agency information and analyses sufficient to create a basis for a hearing concerning this action.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Pharmacy Compounding Advisory Committee (PCAC). The general function of the committee is to provide advice on scientific, technical, and medical issues concerning drug compounding under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), and, as required, any other product for which FDA has regulatory responsibility, and to make appropriate recommendations to the Agency. The meeting will be open to the public.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Deciding When to Submit a 510(k) for a Change to an Existing Device.'' FDA is issuing this final guidance document to clarify when a change in a legally marketed medical device would require that a manufacturer submit a premarket notification (510(k)) to FDA. This guidance document supersedes ``Deciding When to Submit a 510(k) for a Change to an Existing Device,'' issued January 10, 1997. FDA is correcting an error in the docket number assigned to the ``Deciding When to Submit a 510(k) for a Change to an Existing Device'' notice of availability when it published in the Federal Register (81 FR 52443, August 8, 2016). The docket number currently is FDA-2016-D-2021. FDA is changing the docket number to FDA-2011-D-0453. This action is administrative in nature and is being taken to avoid any potential confusion in the docket.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Breakthrough Devices Program; Draft Guidance for Industry and Food and Drug Administration Staff.'' This guidance document describes policies that FDA intends to use to implement the new Breakthrough Devices Program, established by the 21st Century Cures Act (Cures Act). The Breakthrough Devices Program supersedes and combines elements from FDA's Expedited Access Pathway (EAP), which was intended to facilitate the development and expedite review of breakthrough technologies, as well as the Priority Review Program, which implemented statutory criteria for granting priority review to premarket approval applications (PMAs) and applied those criteria to other types of premarket submissions for medical devices. This draft guidance clarifies certain principles and features of the new program, the designation criteria for Breakthrough Devices, the designation request review process, the process for withdrawing from the program, as well as the recommended information device manufacturers should provide in their designation request for entrance into the program. This draft guidance is not final nor is it in effect at this time.

The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

The National Cancer Institute and Clinical Center, institutes of the National Institutes of Health, Department of Health and Human Services, are contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the U.S. Patents and Patent Applications listed in the SUPPLEMENTARY INFORMATION section of this notice to ScanMed, LLC located in Omaha, NE.

The Food and Drug Administration (FDA or the Agency) is announcing the availability of the Animal Drug User Fee Act (ADUFA) reauthorization draft recommendations and extending the comment period to allow interested persons 30 days to submit comments on these draft recommendations.

The Food and Drug Administration (FDA or Agency) is announcing the availability of two draft guidances for industry entitled ``In Vitro Metabolism- and Transporter-Mediated Drug-Drug Interaction Studies'' (in vitro DDI guidance) and ``Clinical Drug Interaction StudiesStudy Design, Data Analysis, and Clinical Implications'' (clinical DDI guidance). These two draft guidances will update and replace the revised draft guidance for industry entitled ``Drug Interaction StudiesStudy Design, Data Analysis, Implications for Dosing, and Labeling Recommendations'' issued February 21, 2012 (2012 draft guidance). These draft guidances are intended to assist drug developers in the planning and evaluation of drug-drug interaction (DDI) potential during drug development. In particular, the in vitro DDI guidance focuses on in vitro experimental approaches for evaluating metabolizing enzyme- and transporter-based drug interaction potential and how to extrapolate in vitro data to decide on the need for clinical DDI studies. The clinical DDI guidance focuses on clinical studies that evaluate the potential for DDIs, which alter a drug's pharmacokinetics by modulating the effects of drug metabolizing enzymes and transporters, and advises sponsors on the timing and design of the clinical studies, interpretation of the results, and options for managing DDIs in patients. Together, these two draft guidances describe a systematic, risk-based approach to the assessment of DDIs.

The Food and Drug Administration (FDA or Agency) is announcing support for the most current B3-format annual version of the World Health Organization (WHO) Drug Global (WHODG) (formerly named WHO Drug Dictionary) (available at https://www.who-umc.org), end of support for earlier versions of WHODG, and an update to the FDA Data Standards Catalog (Catalog) for study data provided in new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), and certain investigational new drug applications (INDs) to the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER).

The Food and Drug Administration (FDA) is denying Trang Doan Nguyen's (Nguyen's) request for a hearing and is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Nguyen for 5 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Nguyen was convicted of a misdemeanor under Federal law for conduct relating to the development or approval of a drug product or otherwise relating the regulation of a drug product under the FD&C Act and that the type of conduct underlying the conviction undermines the process for the regulation of drugs. In determining the appropriateness and period of Nguyen's debarment, FDA has considered the relevant factors listed in the FD&C Act. Nguyen has failed to file with the Agency information and analyses sufficient to create a basis for a hearing concerning this action.

The Food and Drug Administration (FDA or we) is classifying the device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the device to detect and measure non- microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for OBIZUR and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for MITRACLIP CDS and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.

The Food and Drug Administration (FDA or Agency) has determined that ELAVIL (amitriptyline hydrochloride) oral tablets, 10 milligrams (mg), 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for amitriptyline hydrochloride oral tablets, 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg, if all other legal and regulatory requirements are met.

The Indian Health Service published a notice in the Federal Register (FR) on October 11, 2017, for the Fiscal Year 2018 Youth Regional Treatment Center Aftercare Pilot Project, Funding Announcement Number: HHS-2018-IHS-YRTC-0001. Several Key Dates have been modified. The Application Due Date is November 12, 2017 and the Earliest Anticipated Start Date is December 1, 2017.

This final rule amends the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations to clarify that the waived test categorization applies only to non-automated fecal occult blood tests.

This notice supports expansion of research on the impact of CMS programs on the Indian health care system through a single source award. The Indian Health Service (IHS), Tribes and Tribal Organizations and Urban programs, deliver health care services to American Indian/ Alaska Native (AI/AN) people through a network of hospitals, clinics and other providers. This award expands research on the impact of CMS programs and the delivery of health care to AI/AN beneficiaries.