Department of Health and Human Services August 2020 – Federal Register Recent Federal Regulation Documents

The Office of Combination Products (OCP) in the Food and Drug Administration (FDA) is soliciting applications from members of the public interested in participating in a voluntary pilot program to help OCP evaluate a potential new electronic submissions process for Requests for Designation (RFD) and Pre-RFD. This RFD and Pre-RFD electronic submission process is intended to improve efficiency and completeness of RFD and Pre-RFD submissions. OCP plans to accept up to nine participants for the pilot program. The pilot program is intended to provide OCP input to inform this evaluation.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project ``Programmatic Information Collection for the AHRQ Initiative to Support Primary Care to Advance Cardiovascular Health in States with High Prevalence of Preventable CVD Events.''

The Administration for Children and Families (ACF), within the U.S. Department of Health and Human Services (HHS), oversees the Home Visiting Evidence of Effectiveness (HomVEE) review, which is proposing to revise the procedures and standards that guide its work. The revised procedures and standards will be presented in two separate Federal Register notices. The current Federal Register notice seeks comments on proposed updated definitions, rules, and procedures related to handling home visiting model versions (commonly referred to in the home visiting research literature as adaptations) in the HomVEE review. Another Federal Register notice summarizes proposed changes and clarifications to HomVEE's procedures and standards for rating the quality of impact studies and determining which home visiting models meet HHS criteria for evidence of effectiveness. Readers are referred to the full text of the HomVEE Draft Version 2 Handbook on the HomVEE website (https:// homvee.acf.hhs.gov/) for more details on all proposed changes.

This final rule updates the prospective payment rates, the outlier threshold, and the wage index for Medicare inpatient hospital services provided by Inpatient Psychiatric Facilities (IPF), which include psychiatric hospitals and excluded psychiatric units of an Inpatient Prospective Payment System hospital or critical access hospital. In addition, we are adopting more recent Office of Management and Budget statistical area delineations, and applying a 2-year transition for all providers negatively impacted by wage index changes. We are also removing the term licensed independent practitioner(s) from the regulations for psychiatric hospitals. On April 6, 2020, we published an interim final rule with comment period to implement this statutorily mandated change. This final rule responds to comments on the interim final rule regarding changes to the term licensed independent practitioner, finalizes the implementing regulation, and explains how the new procedure will be put into practice. These changes will be effective for IPF discharges beginning with the 2021 Fiscal Year (FY), which runs from October 1, 2020 through September 30, 2021 (FY 2021).

The Food and Drug Administration (FDA or the Agency) is requesting interested persons to submit comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use of 11 drug substances. These comments will be considered in preparing a response from the United States to the World Health Organization (WHO) regarding the abuse liability and diversion of these drugs. WHO will use this information to consider whether to recommend that certain international restrictions be placed on these drug substances. This notice requesting comments is required by the Controlled Substances Act (CSA).

The Office of Child Support Enforcement (OCSE), Administration for Children and Families (ACF), U.S. Department of Health and Human Services, is requesting a 3-year extension of the Voluntary Acknowledgment of Paternity and Required Data Elements for Paternity Establishment Affidavits (OMB #0970-0171). There are no changes requested to the form.

The Food and Drug Administration (FDA) is announcing the rates for biosimilar user fees for fiscal year (FY) 2021. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Biosimilar User Fee Amendments of 2017 (BsUFA II), authorizes FDA to assess and collect user fees for certain activities in connection with biosimilar biological product development; review of certain applications for approval of biosimilar biological products; and each biosimilar biological product approved in a biosimilar biological product application. BsUFA II directs FDA to establish, before the beginning of each fiscal year, the amount of initial and annual biosimilar biological product development (BPD) fees, the reactivation fee, and the biosimilar biological product application and program fees for such year. These fees apply to the period from October 1, 2020, through September 30, 2021.

The Food and Drug Administration (FDA or Agency) is announcing the availability of FDA guidance documents related to the Coronavirus Disease 2019 (COVID-19) public health emergency (PHE). This notice of availability (NOA) is pursuant to the process that FDA announced, in the Federal Register of March 25, 2020, for making available to the public COVID-19-related guidances. The guidances identified in this notice address issues related to the COVID-19 PHE and have been issued in accordance with the process announced in the March 25, 2020, notice. The guidance documents have been implemented without prior comment, but they remain subject to comment in accordance with the Agency's good guidance practices.

The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for fiscal year (FY) 2021 animal drug user fees. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Animal Drug User Fee Amendments of 2018 (ADUFA IV), authorizes FDA to collect user fees for certain animal drug applications and supplements, for certain animal drug products, for certain establishments where such products are made, and for certain sponsors of such animal drug applications and/or investigational animal drug submissions. This notice establishes the fee rates for FY 2021.

The Food and Drug Administration (FDA) is announcing the rates for prescription drug user fees for fiscal year (FY) 2021. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Prescription Drug User Fee Amendments of 2017 (PDUFA VI), authorizes FDA to collect application fees for certain applications for the review of human drug and biological products, and prescription drug program fees for certain approved products. This notice establishes the fee rates for FY 2021.

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 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 Multi-site Clinical Assessment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (MCAM). This collection is designed to assess and characterize illness heterogeneity of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), and uses a standardized approach including standardized protocols with standardized tests and instruments to collect data on patients from multiple clinical practices.

The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2021. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Medical Device User Fee Amendments of 2017 (MDUFA IV), authorizes FDA to collect user fees for certain medical device submissions and annual fees both for certain periodic reports and for establishments subject to registration. This notice establishes the fee rates for FY 2021, which apply from October 1, 2020, through September 30, 2021. To avoid delay in the review of your application, you should pay the application fee before or at the time you submit your application to FDA. The fee you must pay is the fee that is in effect on the later of the date that your application is received by FDA or the date your fee payment is recognized by the U.S. Treasury. If you want to pay a reduced small business fee, you must qualify as a small business before making your submission to FDA; if you do not qualify as a small business before making your submission to FDA, you will have to pay the higher standard fee. Please note that the establishment registration fee is not eligible for a reduced small business fee. As a result, if the establishment registration fee is the only medical device user fee that you will pay in FY 2021, you should not submit a Small Business Certification Request. This document provides information on how the fees for FY 2021 were determined, the payment procedures you should follow, and how you may qualify for reduced small business fees.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Initial Pediatric Study Plans.'' The purpose of this guidance is to provide information to sponsors regarding the submission of an initial pediatric study plan (iPSP) and any amendments to the iPSP. Specifically, this guidance addresses the FDA's current thinking regarding implementation of the requirement for sponsors to submit an iPSP as described in the Federal Food, Drug, and Cosmetic Act (FD&C Act). This guidance finalizes the draft guidance of the same name issued on March 9, 2016.