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

This document extends the comment period for the Risk Adjustment Data Validation (RADV) provisions of the proposed rule titled ``Medicare and Medicaid Programs; Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit, Program of All-inclusive Care for the Elderly (PACE), Medicaid Fee-For-Service, and Medicaid Managed Care Programs for Years 2020 and 2021'' that was published in the November 1, 2018 Federal Register. The comment period for the RADV provision of this proposed rule, which would end on April 30, 2019, is extended by 120 days until August 28, 2019. This document also announces that CMS will be releasing additional data underlying the FFS Adjuster Study released October 26, 2018.

In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.

The Administration for Community Living (ACL) is announcing the award of single-source supplement for the National Paralysis Resource Center (PRC) that was included in the 2019 Congressional budget appropriations. The National Paralysis Resource Center is operated by the Christopher and Dana Reeve Foundation, which offers important programmatic opportunities for persons with disabilities and older adults. The PRC provides comprehensive information for people living with spinal cord injury, paralysis, and mobility-related disabilities and their families. Resources include information and referral by phone and email in multiple languages; a peer and family support mentoring program; a military and veterans program; multicultural outreach services; multiple quality of life grants; and a national website. The administrative supplement for FY2019 will be in the amount of $1,000,000, bring the total award for FY 19 to $7,761,661. Program Name: National Paralysis Resource Center. Recipient: Christopher and Dana Reeve Foundation. Period of Performance: The supplement award will be issued for the second year of a three year project a project period, July 1, 2019 through June 30, 2020. Award Amount: $1,000,000. Award Type: Cooperative Agreement. Statutory Authority: This program is authorized under Section 317 of the Public Health Service Act (42 U.S.C. 247(b-4)); Consolidated and Further Continuing Appropriations Act, 2016, Public Law 114-113 (Dec. 18, 2015). CFDA Number: 93.325 Discretionary Projects.

This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from January through March 2019, relating to the Medicare and Medicaid programs and other programs administered by CMS.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee. The general function of the committees is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). A notice listing all currently HHS-certified laboratories and IITFs is published in the Federal Register during the first week of each month. If any laboratory or IITF certification is suspended or revoked, the laboratory or IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory or IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter. This notice is also available on the internet at https:// www.samhsa.gov/workplace.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Unique Device Identification: Convenience Kits; Guidance for Industry and Food and Drug Administration Staff.'' The unique device identification system regulations require that the label and device package of a device must bear a unique device identifier (UDI), unless an exception or alternative applies. An exception is provided for devices packaged within the immediate container of a convenience kit, if the label of the convenience kit bears a UDI. This guidance document describes FDA's interpretation of the definition of ``convenience kit.'' This guidance does not apply to in vitro diagnostic (IVD) devices that are subject to IVD labeling requirements nor does it apply to combination products.

The Food and Drug Administration (FDA or Agency) 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 information collection requirements relating to shipment of nonsterile devices that are to be sterilized elsewhere or are shipped to other establishments for further processing, labeling, or repacking.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices.'' The guidance identifies the types of UHMWPE commonly in use in orthopedic implants, as well as the recommended information and testing that should be included in premarket submissions for such devices.

In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting of the Advisory Board on Radiation and Worker Health (ABRWH). This meeting is open to the public, but without a public comment period. The public is welcome to submit written comments in advance of the meeting, to the contact person below. Written comments received in advance of the meeting will be included in the official record of the meeting. The public is also welcome to listen to the meeting by joining the audio conference (information below). The audio conference line has 150 ports for callers.

In compliance with of the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.

This document corrects the regulatory identification number (RIN) that appeared in the heading of a notice of proposed rulemaking published in the Federal Register of December 18, 2018. Through that document, OCSE proposed to eliminate regulations rendered outdated or unnecessary and make technical amendments to the Flexibility, Efficiency, and Modernization in Child Support Enforcement final rule, published on December 20, 2016, including proposing to amend the compliance date for review and adjustment of child support orders.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for government public health and emergency response stakeholders entitled ``Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles.'' This document provides guidance to government stakeholders on testing to extend the expiration dateunder the Federal Food, Drug, and Cosmetic Act (FD&C Act)of stockpiled doxycycline tablets and capsules for public health emergency preparedness and response purposes for an anthrax emergency. This guidance has been prepared in response to requests from States asking FDA what would be necessary to provide confidence that stockpiled doxycycline tablets and capsules have retained their original quality beyond the manufacturer's labeled expiration date so the replacement of stockpiled product could be deferred. This guidance and any resulting expiration date extensions authorized by FDA do not apply to doxycycline available commercially or otherwise held for any other nonemergency purpose. This guidance finalizes the draft guidance issued in April 2017.

This proposed rule would update the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs) for fiscal year (FY) 2020. We also propose minor revisions to the regulation text to reflect the revised assessment schedule under Patient Driven Payment Model (PDPM). Additionally, we propose to revise the definition of group therapy under the SNF PPS, and to implement a subregulatory process for updating the code lists (International Classification of Diseases, Tenth Version (ICD-10) codes) used under PDPM. We are also soliciting comments on stakeholder concerns regarding the appropriateness of the wage index used to adjust SNF payments. In addition, the proposed rule includes proposals for the SNF Quality Reporting Program (QRP) and the SNF Value-Based Purchasing (VBP) Program that will affect Medicare payment to SNFs.

The Food and Drug Administration (FDA or we) is announcing the availability of an update to the immediately in effect guidance for industry entitled ``Compliance Policy for Combination Product Postmarketing Safety Reporting.'' This guidance describes FDA's compliance policy for combination product applicants and constituent part applicants and activities under FDA regulations that addresses combination product postmarketing safety reporting. FDA is updating this guidance by extending the period of time during which FDA does not intend to enforce certain combination product postmarketing safety reporting requirements.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Surgical Staplers and Staples for Internal UseLabeling Recommendations.'' FDA is issuing this draft guidance to provide labeling recommendations for surgical staplers and staples for internal use. These labeling recommendations are being issued because malfunctions and misuse associated with these devices have resulted in serious adverse events, including deaths. This draft guidance is not final nor is it currently in effect.