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

The Food and Drug Administration (FDA or Agency) has determined that PREXXARTAN (valsartan) oral solution, 20 milligrams (mg)/5 milliliters (mL) and 80 mg/20 mL, was not withdrawn from sale for reasons of safety or effectiveness.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 valsartan oral solution, 20 mg/5 mL and 80 mg/20 mL, if all other legal and regulatory requirements are met.

The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend its medical product ``intended use'' regulations. This action, if finalized, will amend FDA's regulations describing the types of evidence relevant to determining whether a product is intended for use as a drug or device under the Federal Food, Drug, and Cosmetic Act (FD&C Act), the Public Health Service Act (PHS Act), and FDA's implementing regulations, including whether an approved or cleared medical product is intended for a new use. This action will also repeal and replace the portions of a final rule issued on January 9, 2017, that never became effective. This action is intended to provide direction and clarity to regulated industry and other stakeholders.

The Administration for Children and Families (ACF) is requesting a 3-year extension of the Temporary Assistance for Needy Families (TANF) Expenditure Report, Form ACF-196R (OMB #0970-0446, expiration 2/28/2021). ACF is reporting a change to remove certain guidance that was associated with an earlier ACF-196 report in order to devote the instructions to the singular ACF-196R report. In addition, ACF has clarified instructions where states have previously expressed confusion and has reorganized the format and chronology of section headers to better reflect the flow of the TANF reporting process.

HRSA announces the award of a supplement of approximately $3,000,000 to the Immune Deficiency Foundation (IDF) for the Severe Combined Immunodeficiency (SCID) Screening and Education program for fiscal year (FY) 2020. The supplement will add another year of funding to the current recipient, during the period of 08/01/2020-07/31/2021, to allow the recipient to provide increased implementation, education, and awareness of newborn screening for SCID.

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.

This final rule amends the regulations implementing the National Organ Transplant Act of 1984, as amended (NOTA), to remove financial barriers to organ donation by expanding the scope of reimbursable expenses incurred by living organ donors to include lost wages, and child-care and elder-care expenses incurred by a caregiver. HHS is committed to reducing the number of individuals on the organ transplant waiting list by increasing the number of organs available for transplant. This final rule is associated with Section 8 of the Executive Order (E.O.) 13879 titled ``Advancing American Kidney Health,'' issued on July 10, 2019, which directed HHS to propose a regulation allowing living organ donors to be reimbursed for related lost wages, child-care expenses, and elder-care expenses through the Reimbursement of Travel and Subsistence Expenses Incurred toward Living Organ Donation program authorized under section 377 of the Public Health Service (PHS) Act, as amended.

The Food and Drug Administration (FDA or Agency) is announcing the withdrawal of a final guidance for industry entitled ``Investigational COVID-19 Convalescent Plasma,'' which was issued in April 2020 and updated in May 2020. FDA is withdrawing the guidance because the Agency is issuing a new guidance for industry of the same title.

The Administration for Children and Families (ACF) Office of Planning, Research, and Evaluation is requesting public comment on new data collection activities to gather information about how Maternal, Infant, and Early Childhood Home Visiting (MIECHV) state and territory local implementing agencies (LIAs) and tribal grantees recruit families for program participation and work with their community referral partners to recruit families. The project is designed to examine challenges programs experience reaching caseload capacity and promising strategies to address how challenges might be overcome.

In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Subcommittee for Dose Reconstruction Reviews Subcommittee (SDRR) of the Advisory Board on Radiation and Worker Health (ABRWH or the Advisory Board). 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 welcomed to listen to the meeting by joining the audio conference (information below). The audio conference line has 150 ports for callers.

The Department of Health and Human Services (HHS) Office of Infectious Disease and HIV/AIDS Policy (OIDP) in the Office of the Assistant Secretary for Health (OASH) announces the draft Sexually Transmitted Infections National Strategic Plan 2021-2025 (STI Plan) available for public comment. The draft STI Plan may be reviewed at www.hhs.gov/STI.

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: ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery.'' This proposed information collection was previously published in the Federal Register on June 11th, 2020 and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.

In accordance with the Privacy Act of 1974, as amended, the Department of Health and Human Services, Centers for Medicare & Medicaid Services (CMS) is providing notice of a new agreement re- establishing the ``Do Not Pay Initiative'' matching program between CMS and the Department of Treasury, Bureau of Fiscal Service (Fiscal Service).

The Administration for Children and Families (ACF) is requesting a 3-year extension of the Social Services Block Grant (SSBG) Post-Expenditure Report (OMB #0970-0234, expiration 1/31/2021). ACF is proposing to reduce the burden estimates in the previously approved request by removing use of the form for the Pre-Expenditure Report.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Eosinophilic Esophagitis: Developing Drugs for Treatment.'' This guidance is intended to describe the Agency's current thinking and recommended approach for the development of drugs and therapeutic biologics for the treatment of patients with eosinophilic esophagitis. This guidance finalizes the draft guidance of the same name issued February 6, 2019.