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

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 proposed updates to the approved information collection project ``Safety Program in Perinatal Care (SPPC)-II Demonstration Project.''

The National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) announces availability of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) Biennial Progress Report: 2018-2019. This report, prepared in accordance with requirements of the ICCVAM Authorization Act of 2000, describes activities and accomplishments from January 2018 through December 2019.

HHS is publishing this Request for Information (RFI) to seek public input on the development of a federal interagency Council on Economic Mobility (Council). HHS and the Council will analyze information collected in this RFI to gather feedback from our stakeholders to better inform the Council's priorities and how the Council can promote economic mobility, recovery, and resilience.

The Food and Drug Administration (FDA or the Agency) is announcing that the Initial Decision of the Administrative Law Judge (ALJ), to withdraw approval of the new drug application (NDA) for Vioform-Hydrocortisone Cream, Ointment, and Lotion containing Iodochlorhydroxyquin and Hydrocortisone (Vioform), is the final decision of the Commissioner by operation of law. Several parties to the hearing, including the NDA holder and identical, related, or similar (IRS) product manufacturers, and a non-party participant timely filed exceptions to the ALJ's Initial Decision. FDA recently requested that the current owner of the NDA application, the IRS product manufacturers, and the non-party participant that had timely filed exceptions, or their successors-in-interest, affirm within a specific timeframe their interest in pursuing their appeals of the ALJ's Initial Decision. The NDA holder responded within the timeframe and withdrew its appeal. No other appellants that received actual notice of the Agency's request responded within the timeframe. Accordingly, FDA now deems any exceptions filed by appellants that received notice of the Agency's request to be withdrawn. FDA is, however, offering an opportunity to other IRS product manufacturers, or successors-in- interest, that submitted exceptions to the ALJ's Initial Decision and did not receive notice of FDA's request, to affirm their desire to pursue the appeal. The ALJ's Initial Decision is the final decision of the Commissioner by operation of law; however, if FDA receives a valid request to affirm the appeal, as described in this notice, we will withdraw this notice.

The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on 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, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the Proposed Revised Collection and solicits comments on the information collection requirements related to the extension of the Title VI Program Performance Report.

The Food and Drug Administration (FDA or Agency), in response to suggestions submitted to the public docket number FDA-2008-N-0567 between October 1, 2018, and June 30, 2019, has analyzed whether coccidioidomycosis meets the statutory criteria for designation as a tropical disease for the purposes of obtaining a priority review voucher (PRV) under the Federal Food, Drug, and Cosmetic Act (FD&C Act), namely whether it primarily affects poor and marginalized populations, and whether there is ``no significant market'' for drugs that prevent or treat coccidioidomycosis infections in developed countries. The Agency has determined that coccidioidomycosis does not meet the statutory criteria for designation as a tropical disease eligible for PRV consideration because of the potential market for preventive products (such as vaccines), and therefore declines to designate it as an addition to the list of tropical disease PRV- eligible diseases at this time.

The Food and Drug Administration (FDA or Agency), in response to suggestions submitted to the public docket FDA-2008-N-0567, between June 20, 2018, and November 21, 2018, has analyzed whether the foodborne trematode infection clonorchiasis meets the statutory criteria for designation as a ``tropical disease'' for the purposes of obtaining a priority review voucher (PRV) under the Federal Food, Drug, and Cosmetic Act (FD&C Act), namely whether it primarily affects poor and marginalized populations and whether there is ``no significant market'' for drugs that prevent or treat clonorchiasis in developed countries. The Agency has determined at this time that clonorchiasis does not meet the statutory criteria for addition to the tropical diseases list under the FD&C Act. Although clonorchiasis disproportionately affects poor and marginalized populations, it is an infectious disease for which there is a significant market in developed nations; therefore, FDA declines to add it to the list of tropical diseases.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Providing Regulatory Submissions for Medical Devices in Electronic FormatSubmissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act.'' Amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act) by the FDA Reauthorization Act of 2017 (FDARA) require that certain pre- submissions and submissions for devices be submitted in electronic format specified by FDA beginning on such date as specified in final guidance. It also mandates that FDA issue draft guidance not later than October 1, 2019, and a final guidance not later than 1 year after the close of the public comment period, providing for further standards for the submission by electronic format, a timetable for establishment of these further standards, and criteria for waivers of and exemptions from the requirements. In addition, in the Medical Device User Fee Amendments of 2017 (MDUFA IV) Commitment Letter from the Secretary of Health and Human Services to Congress, FDA committed to developing electronic submission templates, and issuing a draft guidance on the topic. No later than 12 months after the close of the public comment period, the Agency will issue a final guidance. This guidance is intended to satisfy the final guidance documents referenced in the FDA&C Act and the MDUFA IV Commitment Letter.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #266 entitled ``Use of Real-World Data and Real-World Evidence to Support Effectiveness of New Animal Drugs.'' The draft guidance, if finalized, will describe FDA's current thinking with respect to assisting sponsors in incorporating real-world data and real-world evidence (including ongoing surveillance activities, observational studies, and registry data) into proposed clinical investigation protocols and applications for new animal drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #268 entitled ``Adaptive and Other Innovative Designs for Effectiveness Studies of New Animal Drugs.'' The draft guidance, if finalized, will describe FDA's current thinking with respect to assisting sponsors in incorporating complex adaptive and other novel investigation designs into proposed clinical investigation protocols and applications for new animal drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

This notice announces the public meeting of the Advisory Council on Alzheimer's Research, Care, and Services (Advisory Council). The Advisory Council provides advice on how to prevent or reduce the burden of Alzheimer's disease and related dementias on people with the disease and their caregivers. During the July 20, 2020 meeting, an invited panel will present on emergency preparedness for people with dementia with a special focus on the COVID-19 pandemic. The chairs of the subcommittees (Research, Clinical Care, and Long-Term Services and Supports) will present recommendations for adoption by the full Advisory Council.

This document is a notice of proposed rulemaking regarding grandfathered group health plans and grandfathered group health insurance coverage that would, if finalized, amend current rules to provide greater flexibility for certain grandfathered health plans to make changes to certain types of cost-sharing requirements without causing a loss of grandfather status.

The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), is issuing this Final Rule (FR) to amend two provisions within its Foreign Quarantine regulations to best protect the public health of the United States. The provisions in this Final Rule clarify various safeguards to prevent the importation and spread of communicable diseases affecting human health into the United States from threats posed by human remains.

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 ``Clinical Decision Support (CDS) for Chronic Pain Management.''

The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorization (EUA) (the Authorization) issued to Chembio Diagnostic Systems, Inc. (``Chembio'') for the DPP COVID-19 IgM/IgG System. FDA revoked this Authorization on June 16, 2020, under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), in consideration of new information from three evaluations performed since the Authorization of the device that demonstrate its performance may be both inconsistent and lower than that described in the request for Authorization. The revocation, which includes an explanation of the reasons for revocation, is reprinted in this document.

The Food and Drug Administration (FDA or Agency) Center for Biologics Evaluation and Research (CBER) is announcing support for the current version of Clinical Data Interchange Standards Consortium (CDISC) Standard for the Exchange of Nonclinical Data (SEND) and an update to the FDA Data Standards Catalog for the submission of nonclinical data in new drug applications (NDAs), abbreviated new drug applications (ANDAs), certain biologics license applications (BLAs), and certain investigational new drug applications (INDs). This update does not apply to noncommercial INDs for a product that is not intended for commercial distribution (research and investigator-sponsored INDs); INDs and BLAs for devices that are regulated by CBER as biological products under the Public Health Services (PHS) Act; and submissions for blood and blood components, including Source Plasma.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Select Updates for Peripheral Vascular Atherectomy DevicesPremarket Notification (510(k)) Submissions.'' FDA has developed this draft guidance to propose select updates to certain sections of the existing FDA guidance document ``Peripheral Vascular Atherectomy DevicesPremarket Notification (510(k)) Submissions.'' This draft guidance is not final nor is it in effect at this time.

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, limited only by the space available. The audio conference line has 150 ports for callers. 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 teleconference (information below).

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for CARTIVA 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) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.