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

The statute requires aggregate reductions to state Medicaid Disproportionate Share Hospital (DSH) allotments annually beginning with fiscal year (FY) 2020. This final rule delineates the methodology to implement the annual allotment reductions.

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Public Health Accreditation Board (PHAB): Assessment of Processes and Outcomes. This proposed collection aims to learn about program processes and the accreditation/ reaccreditation standards to improve the program's quality, and to document program outcomes to demonstrate impact and inform decision making about future program direction.

The Food and Drug Administration (FDA) is issuing a proposed rule that would set forth requirements for premarket tobacco product applications (PMTAs) and would require manufacturers to maintain records establishing that their tobacco products are legally marketed. The proposed rule would help to ensure that PMTAs contain sufficient information for FDA to determine whether a marketing order should be issued for a new tobacco product, including detailed information regarding the physical aspects of a tobacco product, as well as full reports of information to demonstrate the scope of, and details regarding, investigations that may show the potential health risks of the product. The proposed rule would codify the general procedures FDA would follow when evaluating PMTAs, including application acceptance, application filing, and inspections, and would also create postmarket reporting requirements for applicants that receive marketing orders. The proposed rule would allow for the submission of PMTAs in alternative formats in certain instances to reduce the burden of submitting a PMTA for modifications to a product that previously received a PMTA marketing order or resubmitting a PMTA to address deficiencies specified in a no marketing order. The proposed rule would also require tobacco product manufacturers to keep records regarding the legal marketing of certain tobacco products without a PMTA, such as documents showing that a tobacco product is not required to undergo premarket review or has received premarket authorization.

The Food and Drug Administration (FDA, Agency, or we) has determined that ATROPINE SULFATE ANSYR PLASTIC SYRINGE (atropine sulfate solution) intravenous, intramuscular, subcutaneous, and endotracheal, 0.5 milligram (mg)/5 milliliters (mL) (0.1 mg/mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for atropine sulfate solution intravenous, intramuscular, subcutaneous, and endotracheal, 0.5 mg/5 mL (0.1 mg/mL), if all other legal and regulatory requirements are met.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for MED-EL Electric and Acoustic Stimulation Hybrid Hearing Prosthesis System (MED-EL EAS) and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application 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) is announcing the availability of a final guidance for industry entitled ``Wholesale Distributor Verification Requirement for Saleable Returned Drug ProductCompliance Policy.'' This guidance describes FDA's intention regarding enforcement of the Drug Supply Chain Security Act (DSCSA) provision requiring wholesale distributors to verify a product identifier prior to further distributing returned product beginning on November 27, 2019. Given concerns expressed by stakeholders and to minimize possible disruptions in the pharmaceutical distribution supply chain, FDA does not intend to take action against wholesale distributors who do not, prior to November 27, 2020, verify a product identifier prior to further distributing returned product as required under the DSCSA. This represents a 1-year delay in enforcement of this DSCSA requirement.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Patient Engagement in the Design and Conduct of Medical Device Clinical Investigations.'' The Patient Engagement Advisory Committee (PEAC) recommended that FDA and industry develop some type of framework to clarify how patient advisors can engage in the clinical investigation process. This draft guidance focuses on the applications, perceived barriers, and common challenges of patient engagement in the design and conduct of medical device clinical investigations. This draft guidance is not final nor is it in effect at this time.

The development of a National Vaccine Plan (NVP) was mandated by Congress as a mechanism for the Director of the National Vaccine Program (as delegated by the Assistant Secretary for Health) to communicate priorities for achieving the Program's responsibilities of ensuring adequate supply of and access to vaccines and ensuring the effective and optimal use of vaccines. The most recent NVP, released in 2010, provided a comprehensive 10-year national strategy for enhancing all aspects of the plan, including vaccine research and development, supply, financing, distribution, and safety; informed decision-making by consumers and health care providers; vaccine-preventable disease surveillance; vaccine effectiveness and use monitoring; and global cooperation (https://www.hhs.gov/nvpo/vacc_plan/). To help inform the development of the National Vaccine Plan 2020, HHS is issuing a Request for Information (RFI). The RFI will solicit specific information regarding the priorities, goals, and objectives in the next iteration of the NVP, remaining gaps, and stakeholder perspectives for the 2020-2025 timeframe.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program.'' The Pilot Accreditation Scheme for Conformity Assessment Program (hereafter referred to as the ASCA Pilot) is authorized under the Federal Food, Drug, and Cosmetic Act (FD&C Act). In accordance with amendments made to the FD&C Act by the FDA Reauthorization Act of 2017 (FDARA) and as part of the enactment of the Medical Device User Fee Amendments of 2017 (MDUFA IV), FDA was directed to issue a draft guidance regarding the goals and implementation of the ASCA Pilot. The establishment of the goals, scope, procedures, and a suitable framework for the voluntary ASCA Pilot supports the Agency's continued efforts to use its scientific resources effectively to protect and promote public health by simplifying certain aspects of premarket review, thereby reducing burdens on the Agency for individual submissions. FDA believes the voluntary ASCA Pilot may further encourage international harmonization of medical device regulation because it incorporates elements, where appropriate, from a well-established set of international conformity assessment practices and standards (e.g., ISO/IEC 17000 series). The voluntary ASCA Pilot does not supplant or alter any other existing statutory or regulatory requirements governing the decision-making process for premarket submissions. This draft guidance is not final nor is it in effect at this time.

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 (the 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 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates 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.

This proposed notice acknowledges the receipt of an application from The Compliance Team for initial recognition as a national accrediting organization for suppliers of home infusion therapy services that wish to participate in the Medicare program. Within 60 days of receipt of an organization's complete application, the statute requires that CMS publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.

In accordance with the requirements of the Privacy Act of 1974, as amended, the Department of Health and Human Services is modifying a system of records maintained by the National Institutes of Health (NIH), 09-25-0225 ``NIH Electronic Research Administration (eRA) Records, HHS/NIH/OD/OER,'' to include a new routine use allowing NIH to disclose information to applicant organizations for the purpose of communicating with the applicants about matters related to agency award programs.

The Administration for Children and Families (ACF), Office of Planning, Research, and Evaluation (OPRE) proposes to collect information as part of the Coparenting and Healthy Relationship and Marriage Education for Dads (CHaRMED) study. The purpose of the CHaRMED study is to better understand the services that fatherhood programs provide in the areas of Healthy Marriage and Relationship Education (HMRE) and coparenting to learn what strategies hold promise for promoting active engagement in these services.

The Food and Drug Administration (FDA or Agency) is announcing the availability of several device-specific draft guidance documents for the Safety and Performance Based Pathwayspecifically, ``Spinal Plating SystemsPerformance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff''; ``Cutaneous Electrode for Recording PurposesPerformance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff''; ``Conventional Foley CathetersPerformance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff''; and ``Orthopedic Non-Spinal Metallic Bone Screws and Washers Performance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff.'' The device-specific draft guidances identified in this notice were developed in accordance with the finalized guidance entitled ``Safety and Performance Based Pathway.'' These draft guidances are not final nor are they in effect at this time.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on FDA's Animal Feed Regulatory Program Standards (AFRPS).

The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorization (EUA) (the Authorization) issued to Luminex Corp., for the xMAP MultiFLEX Zika RNA Assay. FDA revoked this Authorization on July 3, 2019, under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as requested by Luminex Corp. by a letter dated June 18, 2019. The revocation, which includes an explanation of the reasons for revocation, is reprinted in this document.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act.'' Among other things, this guidance provides FDA's current thinking on what constitutes a 505(q) petition and describes some of the considerations that FDA will take into account in determining whether a petition is submitted with the primary purpose of delaying the approval of an application. This guidance finalizes the draft guidance for industry entitled ``Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act'' issued in October 2018.

The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on Therapies for Clinically Localized Prostate Cancer, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.