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

In compliance with 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.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings- Labeling Considerations.'' This guidance addresses labeling considerations for devices containing lubricious coatings used in the vasculature. The purpose of this guidance is to provide recommendations for information to be included in the device labeling, as submitted in premarket applications (PMAs) or premarket notification submissions (510(k)s) for Class III and Class II devices, to enhance the consistency of information across these product areas as well as to promote the safe use of these devices in the clinical setting.

The Office of Pediatric Therapeutics, Food and Drug Administration (FDA), is announcing a public workshop entitled ``Advancing the Development of Pediatric Therapeutics (ADEPT 6): Pediatric Clinical Trial Endpoints for Rare Diseases with a Focus on Pediatric Patient Perspectives.'' The purpose of this workshop is to discuss pediatric patient-specific engagement in the development of clinical trial endpoints for rare diseases.

In compliance with the Paperwork Reduction Act of 1995, HRSA 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.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination.'' This guidance, developed by the Oncology Center of Excellence at FDA, describes an optional streamlined submission process to determine whether use of an investigational in vitro diagnostic in an oncology clinical trial is considered significant risk, nonsignificant risk, or exempt from investigational device exemption requirements. In the streamlined process, the sponsor submits all information about the oncology trial (including information about the investigational in vitro diagnostic) to the investigational new drug application (IND). As part of IND review, the Center for Biologics Evaluation and Research (CBER) works with the Center for Drug Evaluation and Research (CDER), or CDER or CBER works with the Center for Devices and Radiological Health (CDRH), as appropriate, to determine if the investigational in vitro diagnostic is significant risk, nonsignificant risk, or exempt.

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 a proposed information collection titled The National Intimate Partner and Sexual Violence Survey (NISVS). CDC will collect information about individual's experiences of sexual violence, stalking and intimate partner violence and information about the health consequences of these forms of violence. CDC produces national and state level prevalence estimates of these types of violence.

Public Law 115-123 added two new programs to title IV-E of the Social Security Act: The Prevention Services Program and the Kinship Navigator Program. Title IV-E agencies will be required to report information regarding these programs in title IV-E plans. Therefore, the Administration for Children and Families (ACF) is requesting to revise the existing information collection Plan for Foster Care and Adoption Assistance (OMB #0970-0433) to include two new information collections specific to these two new programs.

The Food and Drug Administration (FDA) is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may be self-nominated or may be nominated by a consumer organization. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.

The Administration for Community Living (ACL) is announcing an opportunity for the public to review substantive changes to the proposed collection of information listed above. Under the Paperwork Reduction Act of 1995 (PRA), Federal agencies are required to publish a notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information.

On May 22, 2019, HRSA published a 30-day notice in the Federal Register soliciting feedback on a range of issues pertaining to the Scholarships for Disadvantaged Students (SDS) Program to assist the agency in updating certain SDS policies. HRSA requested feedback on adjusting funding allocations to respond to projected workforce shortages, transitioning data collection from 1 year of data to a 3- year average to demonstrate eligibility, and increasing the maximum scholarship award from $30,000 to $40,000. As a result of HRSA's comprehensive review of existing policies, and taking into consideration the comments received, HRSA is issuing this final notice.

This document corrects technical and typographical errors in the final rule that appeared in the August 16, 2019 issue of the Federal Register titled ``Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2020 Rates; Quality Reporting Requirements for Specific Providers; Medicare and Medicaid Promoting Interoperability Programs Requirements for Eligible Hospitals and Critical Access Hospitals.''

In accordance with requirements of the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS) is updating an existing system of records maintained by the Centers for Medicare & Medicaid Services (CMS), system No. 09-70-0550, titled ``Medicare Retiree Drug Subsidy Program'' (RDSP), and renaming it ``Retiree Drug Subsidy (RDS), HHS/CMS/CM.'' This system collects and maintains information about individuals who are qualifying covered retirees so that accurate and timely subsidy payments may be made to plan sponsors who continue to offer actuarially equivalent prescription drug coverage to the qualifying covered retirees.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Endocrinologic and Metabolic Drugs Advisory Committee. The general function of the committee 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.