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

The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that KYMRIAH (tisagenlecleucel), manufactured by Novartis Pharmaceuticals Corporation, meets the criteria for a priority review voucher.

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.

As part of the implementation of Executive Order 13771 entitled, ``Reducing Regulation and Controlling Regulatory Costs,'' and Executive Order 13777 entitled, ``Enforcing the Regulatory Reform Agenda,'' the Food and Drug Administration (FDA, Agency, or we) is seeking comments and information from interested parties to help FDA identify existing regulations and related paperwork requirements that could be modified, repealed, or replaced, consistent with the law, to achieve meaningful burden reduction while allowing us to achieve our public health mission and fulfill statutory obligations. This document relates to general regulatory and information collection requirements that affect multiple FDA Centers and/or Offices.

As part of the implementation of Executive Order 13771 entitled, ``Reducing Regulation and Controlling Regulatory Costs,'' and Executive Order 13777 entitled, ``Enforcing the Regulatory Reform Agenda,'' the Food and Drug Administration (FDA, Agency, or we) is seeking comments and information from interested parties to help FDA identify existing regulations and related paperwork requirements that could be modified, repealed, or replaced, consistent with the law, to achieve meaningful burden reduction while allowing us to achieve our public health mission and fulfill statutory obligations. This document relates to the products regulated by the Center for Devices and Radiological Health (CDRH).

As part of the implementation of Executive Order 13771 entitled, ``Reducing Regulation and Controlling Regulatory Costs,'' and Executive Order 13777 entitled, ``Enforcing the Regulatory Reform Agenda,'' the Food and Drug Administration (FDA, Agency, or we) is seeking comments and information from interested parties to help FDA identify existing regulations and related paperwork requirements that could be modified, repealed, or replaced, consistent with the law, to achieve meaningful burden reduction while allowing us to achieve our public health mission and fulfill statutory obligations. This document relates to the products regulated by the Center for Biologics Evaluation and Research (CBER).

As part of the implementation of Executive Order 13771 entitled, ``Reducing Regulation and Controlling Regulatory Costs,'' and Executive Order 13777 entitled, ``Enforcing the Regulatory Reform Agenda,'' the Food and Drug Administration (FDA, Agency, or we) is seeking comments and information from interested parties to help FDA identify existing regulations and related paperwork requirements that could be modified, repealed, or replaced, consistent with the law, to achieve meaningful burden reduction while allowing us to achieve our public health mission and fulfill statutory obligations. This document relates to the products regulated by the Center for Food Safety and Applied Nutrition (CFSAN).

The National Institutes of Health (NIH) announces the persons who will serve on the National Institutes of Health's Senior Executive Service 2017 Performance Review Board.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled ``Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products Regulated Solely Under Section 361 of the Public Health Service Act and 21 CFR part 1271; Guidance for Industry.'' The guidance document provides establishments that manufacture non-reproductive human cells, tissues, and cellular and tissue-based products (HCT/Ps), regulated solely under the Public Health Service Act (PHS Act) and under FDA regulations, with recommendations and relevant examples for complying with the requirements to investigate and report HCT/P deviations. The guidance announced in this notice finalizes the draft guidance of the same title dated December 2015.

The Food and Drug Administration (FDA or Agency) has determined that GYNOREST (dydrogesterone) oral tablets, 5 milligrams (mg) and 10 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 GYNOREST (dydrogesterone) oral tablets, 5 mg and 10 mg, if all other legal and regulatory requirements are met.

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on Mobile Proximity Initial User Feedback information collection project.

The Food and Drug Administration (FDA or we) is announcing the following public meeting entitled ``Development of a List of Pre-DSHEA Dietary Ingredients.'' The purpose of the meeting is to give interested stakeholders an opportunity to discuss issues related to FDA's future development of such a list.

The Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), is sponsoring a public workshop entitled ``CDER Rare Diseases Public Workshop: Strategies, Tools, and Best Practices for Effective Advocacy in Rare Diseases Drug Development.'' This public workshop builds upon previous CDER patient advocacy public workshops and is primarily for the rare disease community to help them effectively understand what FDA needs to enhance drug development. This effort is consistent with FDA's efforts to support the integration of patient experience in drug development programs, including through implementation of the ``Patient-Focused Drug Development'' provisions of the 21st Century Cures Act (Cures Act). This public workshop will include case studies demonstrating the beneficial overlap of effective advocacy techniques and FDA regulations in rare disease drug development.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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 proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected; and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

The Patient Safety Rule authorizes AHRQ, on behalf of the Secretary of HHS, to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found to no longer meet the requirements of the Patient Safety Act and Patient Safety Rule, when a PSO chooses to voluntarily relinquish its status as a PSO for any reason, or when a PSO's listing expires. AHRQ has accepted a notification of voluntary relinquishment from the Quantros Patient Safety Center of its status as a PSO, and has delisted the PSO accordingly.

The Food and Drug Administration (FDA or Agency) has determined that ENJUVIA (estrogens, conjugated synthetic B) tablets, 0.625 milligrams (mg) and 1.25 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 ENJUVIA (estrogens, conjugated synthetic B) tablets, 0.625 mg and 1.25 mg, if all other legal and regulatory requirements are met.

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 Commercialization Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this notice to Nanobernetics, LLC (``Nanobernetics'') located in Maryland.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Providing Regulatory Submissions in Electronic FormatContent of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling.'' This draft guidance is being issued in accordance with the Food and Drug Administration Safety and Innovation Act (FDASIA), which amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to require that certain submissions under the FD&C Act and the Public Health Service Act (PHS Act) be submitted in electronic format, beginning no earlier than 24 months after issuance of final guidance on electronic format for submissions. The draft guidance describes how FDA plans to implement the requirements for the electronic submission of Risk Evaluation and Mitigation Strategies (REMS) documents in certain submissions under new drug applications, abbreviated new drug applications, and biologics license applications, beginning no earlier than 24 months after issuance of the final guidance.