Department of Health and Human Services April 14, 2020 – Federal Register Recent Federal Regulation Documents

The Administration for Children and Families (ACF) is requesting a 3-year extension of form ACF-123: Guidance for Tribal Temporary Assistance for Needy Families (TANF) (OMB #0970-0157, expiration date: 6/30/2020). There are minor clarifying changes requested to the guidance.

The Department of Health and Human Service (HHS) is publishing this interim final rule to update the regulatory requirements used by the Centers for Disease Control and Prevention's (CDC) National Institute for Occupational Safety and Health (NIOSH) to test and approve air-purifying particulate respirators for use in the ongoing public health emergency. With this rulemaking, parallel performance standards are added to existing regulatory requirements for PAPRs to allow for the approval of respirators in a new class, PAPR100, that may be better suited to the needs of workers in the healthcare and public safety sectors currently experiencing a shortage of air-purifying particulate respirators due to Coronavirus Disease 2019 (COVID-19), the disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This rulemaking also consolidates the technical standards for all types of air-purifying particulate respirators into one subpart, and standards pertaining to obsolete respirators designed for dust, fume, and mist; pesticide; and paint spray are removed from the regulation entirely. This rulemaking will have no substantive impact on the continued certification testing and approval by the NIOSH National Personal Protective Technology Laboratory of existing PAPR class HE (high-efficiency series) respirators or non-powered air-purifying particulate respirators, including N95 filtering facepiece respirators, currently in demand by healthcare workers and emergency responders. NIOSH expects that the addition of PAPR100 devices to the marketplace will help to relieve the current high demand for possibly hundreds of thousands of additional particulate filtering facepiece respirators needed specifically for healthcare and emergency medical response settings.

The Food and Drug Administration (FDA or Agency) is announcing the availability of final guidances for industry entitled ``Guidance on Chloroquine Phosphate'' and ``Guidance on Hydroxychloroquine Sulfate.'' These guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products'' that explained the process that would be used to make product-specific guidances available to the public on FDA's website. The guidance entitled ``Guidance on Hydroxychloroquine Sulfate'' was developed using the process described in that guidance and finalizes the draft guidance of the same title issued in April 2011. The guidance entitled ``Guidance on Chloroquine Phosphate'' is being implemented without prior public comment because FDA has determined that prior participation for this guidance is not feasible or appropriate in light of the Coronavirus Disease 2019 (COVID-19) public health emergency but remains subject to comment in accordance with the Agency's good guidance practices.

In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.