Department of Health and Human Services September 4, 2020 – Federal Register Recent Federal Regulation Documents
Results 1 - 26 of 26
Notice of Meeting for the Interdepartmental Serious Mental Illness Coordinating Committee (ISMICC)
The Secretary of Health and Human Services announces a meeting of the Interdepartmental Serious Mental Illness Coordinating Committee (ISMICC). The ISMICC is open to the public and members of the public can attend the meeting via telephone or webcast only, and not in person. Agenda with call-in information will be posted on SAMHSA's website prior to the meeting at: https://www.samhsa.gov/about-us/ advisory-councils/meetings. The meeting will include information on federal efforts related to serious mental illness (SMI) and serious emotional disturbance (SED).
Performance Review Board Members
The Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) is publishing the names of the Performance Review Board Members who are reviewing performance of Senior Executive Service (SES) members, Title 42 (T42) executives, and Senior Level (SL) employees for Fiscal Year 2020.
Proposed Information Collection Activity; Advance Planning Document (APD) Process (OMB #0970-0417)
The Administration for Children and Families' (ACF) Office of Child Support Enforcement (OCSE) is requesting an update to the existing data collection for the Advance Planning Document (APD) process (OMB #0970-0417). OCSE proposes revisions to the annual burden estimates to reflect an increase in the number of states seeking approval to implement modernization solutions in efforts to replace antiquated legacy child support enforcement systems and to address an excess demand for emergency funding requests due to the impacts of the COVID-19 pandemic.
Temporary Halt in Residential Evictions To Prevent the Further Spread of COVID-19
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) announces the issuance of an Order under Section 361 of the Public Health Service Act to temporarily halt residential evictions to prevent the further spread of COVID-19.
Charter Renewal for the Advisory Committee on Organ Transplantation
In accordance with the Federal Advisory Committee Act (FACA), HHS is hereby giving notice that the Advisory Committee on Organ Transplantation (ACOT) has been renewed. The effective date of the renewed charter is August 31, 2020.
Interagency Committee on Smoking and Health (ICSH)
In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC) announces the following meeting of the Interagency Committee on Smoking and Health (ICSH). This is a virtual meeting and is open to the public. The public is welcome to view the meeting via Zoom, limited only by the number of seats available, which is 500. This meeting will include time for members of the public to make an oral comment. Priority will be given to individuals who submit a request to make an oral public comment before the meeting according to the procedures below.
Solicitation of Nominations for Membership To Serve on the Advisory Committee on Heritable Disorders in Newborns and Children
HRSA is seeking nominations of qualified candidates to be considered for appointment as members of the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC or Committee). The Committee provides advice, recommendations, and technical information about aspects of heritable disorders and newborn and childhood screening to the Secretary of HHS (Secretary). HRSA is seeking nominations of qualified candidates for appointment to five positions on the Committee for terms of up to 4 years.
Issuance of Priority Review Voucher; Rare Pediatric Disease Product
The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that VILTEPSO (viltolarsen) manufactured by Nippon Shinyaku Co., Ltd. (NS Pharma Inc., U.S. Agent), meets the criteria for a priority review voucher.
Pharmacokinetics in Patients With Impaired Renal Function-Study Design, Data Analysis, and Impact on Dosing; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Pharmacokinetics in Patients with Impaired Renal FunctionStudy Design, Data Analysis, and Impact on Dosing.'' In general, drug development programs should be conducted so that when products are approved, the labeling provides appropriate dosing recommendations for patients with renal impairment. This draft guidance revises and replaces the draft guidance entitled ``Pharmacokinetics in Patients with Impaired Renal FunctionStudy Design, Data Analysis, and Impact on Dosing and Labeling'' (March 2010) and is meant to assist sponsors in the design and analysis of studies that assess the influence of impaired renal function on the pharmacokinetics (PK) and/or pharmacodynamics of an investigational drug and how such information can impact dosing.
Reallotment of Fiscal Year 2019 Funds for the Low Income Home Energy Assistance Program (LIHEAP)
Notice is hereby given of a preliminary determination that funds from the fiscal year (FY) 2019 Low Income Home Energy Assistance Program (LIHEAP) are available for reallotment to states, territories, tribes, and tribal organizations that received FY 2020 direct LIHEAP grants. No subgrantees or other entities may apply for these funds.
Promoting the Rule of Law Through Improved Agency Guidance Documents
On October 9, 2019, the President issued Executive Order (E.O.) 13891: Promoting the Rule of Law Through Improved Agency Guidance Document. This E.O. requires all Federal Agencies to establish an on-line guidance portal and to rescind any guidance documents that are no longer active or valid.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic Submission Process for Voluntary Allegations to the Center for Devices and Radiological Health
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.
Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The general function of the committees 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.
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