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

The Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is inviting public comments on several proposed instruments. The instruments will be added to the following existing information collections: Services Provided to Unaccompanied Alien Children (OMB #0970-0553), Placement and Transfer of Unaccompanied Alien Children into ORR Care Provider Facilities (OMB #0970-0554), and Administration and Oversight of the Unaccompanied Alien Children Program (OMB #0970-0547).

In accordance with the Public Health Service Act and the Federal Advisory Committee Act, this notice announces that the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC or Committee) has scheduled a public meeting to be held on Tuesday, December 1, 2020. Information about the ACHDNC and the agenda for this meeting can be found on the ACHDNC website at https://www.hrsa.gov/ advisory-committees/heritable-disorders/.

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on January 8, 2020. The document announced the withdrawal of approval of 19 new drug applications (NDAs) from multiple applicants, withdrawn as of February 7, 2020. The document indicated that FDA was withdrawing approval of NDA 202342, Esomeprazole Strontium Delayed-Release Capsules, Equivalent to (EQ) 20 milligrams (mg) base and EQ 40 mg base, after receiving a withdrawal request from R2 Pharma, LLC, 11550 North Meridian St., Suite 290, Carmel, IN 46032-5505 (R2 Pharma). Because of clerical errors in the Agency's processing of communications regarding this application, FDA has determined that NDA 202342 remains approved. Accordingly, FDA's approval of NDA 202342 remains in effect. There are no changes with respect to the other 18 NDA withdrawals announced in the January 8, 2020 Federal Register notice.

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.

NIOSH announces the availability of Skin Notation Profiles for Chlorodiphenyl (42% chlorine) (CAS: 53469-21-9), Cyclohexanol (CAS: 108-93-0), Cyclohexanone (CAS: 108-94-1), Cyclonite (CAS: 121-82-4), and Diethylenetriamine (CAS: 111-40-0).

The Office of the Assistant Secretary for Health (OASH) in the Department of Health and Human Services, in partnership with other federal agencies, seeks to gain a more comprehensive understanding from health systems, community based organizations, academic institutions, non-federal government agencies, innovators, entrepreneurs, non-profit organizations, and other relevant stakeholders regarding innovative solutions to chronic disease management leveraging novel technologies (e.g., artificial intelligence (AI), biosensors, apps, remote monitoring, 5G) to optimize compliance with evidence-based standards of care in disease states that cause significant morbidity and mortality in aging populations in underserved areas (e.g., low income, Medicaid- eligible, rural). OASH will review information collected in this request for information (RFI) to better inform federal government priorities and programs. We also seek to identify opportunities to strengthen the U.S. healthcare system, as a whole, through public- private partnerships in data sharing, comprehensive analytics including AI, and other potential mechanisms. OASH welcomes public feedback related to how these questions should be addressed and/or potential solutions. The set of questions is available in the SUPPLEMENTARY INFORMATION section below.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Electromagnetic Compatibility (EMC) of Medical Devices.'' FDA has developed this guidance document to describe relevant information that should be provided in a premarket submission (i.e., premarket approval application (PMA), humanitarian device exemption (HDE), premarket notification (510(k)) submission, investigational device exemption (IDE), and De Novo request) to support a claim of electromagnetic compatibility for electrically powered medical devices and medical devices with electrical or electronic functions. This draft guidance is not intended to change current policy, but to provide specific technical information to address the recommendations originally described in the guidance entitled ``Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices'' published July 11, 2016 (2016 EMC guidance). This draft guidance is not final nor is it in effect at this time.

The Administration for Community Living is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under section 506(c)(2)(A) of the Paperwork Reduction Act of 1995. This 30-Day notice collects comments on the information collection requirements related to the proposed extension for the information collection requirements related to the NIDILRR Grantee Annual Performance Reporting (APR) and Final Report Forms.

The Health Information Technology Advisory Committee (HITAC) was established in accordance with the 21st Century Cures Act and the Federal Advisory Committee Act. The HITAC, among other things, identifies priorities for standards adoption and makes recommendations to the National Coordinator for Health Information Technology (National Coordinator). The HITAC will hold public meetings throughout 2021. See list of public meetings below.

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) will hold a virtual meeting. The meeting will be open to the public and public comment will be heard during the meeting.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Certificates of Confidentiality; Guidance for Sponsors, Sponsor-Investigators, Researchers, Industry, and Food and Drug Administration Staff.'' This guidance is intended to explain FDA implementation of the revised statutory provisions applicable to the request for, and issuance of, a Certificate of Confidentiality (CoC). The 21st Century Cures Act (Cures Act) amended the statutory provisions relating to the issuance of CoCs. A CoC is intended to help protect the privacy of human subject research participants from whom sensitive and identifiable information is being collected or used in furtherance of the research. Historically, a CoC generally protected a researcher from being compelled in a legal proceeding to disclose identifiable sensitive information about the research participant, created or compiled for the research. As amended, a CoC prohibits a researcher from disclosing such information unless a specified exception applies. This guidance finalizes the draft guidance of the same title issued on November 25, 2019.

On July 28, 2018 the Center for State, Tribal, Local, and Territorial Support (CSTLTS), Centers for Disease Control and Prevention (CDC), published a notice in the Federal Register announcing the Public Health Associate Program (PHAP) Alumni and Host Site Assessment. Written comments were to be received by September 28, 2020. The Docket Number that was included in the initial publication of this 60 Day Federal Register Notice was incorrect. CDC is announcing the reopening of the comment period.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #197 entitled ``Documenting Electronic Data Files and Statistical Analysis Programs.'' This guidance is intended to inform sponsors of recommendations for documenting electronic data files and statistical analyses submitted to the Center for Veterinary Medicine (CVM) to support new animal drug applications.

The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

In compliance with the requirement of the Paperwork Reduction Act of 1995, to provide opportunity for public comment on proposed data collection projects, the Office of Intramural Research (OIR), Office of the Director (OD), National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.