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

The Secretary is issuing this amendment pursuant to section 319F-3 of the Public Health Service Act to extend liability immunity for activities related to medical countermeasures against COVID-19 authorized under the Coronavirus Aid, Relief, and Economic Security Act.

The Intergovernmental Reference Guide (IRG) is a centralized and automated repository of state and tribal profiles that contains high-level descriptions of each state and tribal child support enforcement (CSE) program. These profiles provide state, tribal, and foreign country CSE agencies with an effective and efficient method for updating and accessing information needed to process intergovernmental child support cases.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

The Food and Drug Administration (FDA or we) is reopening the comment period for the proposed rule, published in the Federal Register of October 19, 2005, entitled ``Cheeses and Related Cheese Products; Proposal to Permit the Use of Ultrafiltered Milk.'' The proposed rule would amend our regulations to provide for the use of fluid ultrafiltered (UF) milk in the manufacture of standardized cheeses and related cheese products. FDA is reopening the comment period to update comments and to receive any new information.

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.

The National Institute of Diabetes and Digestive and Kidney Disease and National Institute of Dental and Craniofacial Research, institutes of the National Institutes of Health, Department of Health and Human Services, are contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the United States, European and Canadian Applications listed in the Supplementary Information section of this notice to Kriya Therapeutics, Inc., located in Palo Alto, California, USA.

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 (the 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 new information collection requirements related to an outcome evaluation for ACL's Long-term Ombudsman Program (LTCOP).

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 ``Evaluating the Implementation of Products by AHRQ's Learning Health Systems to Inform and Encourage Use of AHRQ Evidence Reports.'' This proposed information collection was previously published in the Federal Register on February 4, 2020 and allowed 60 days for public comment. AHRQ did not receive comments from members of the public. The purpose of this notice is to allow an additional 30 days for public comment.

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: ``Evaluating the Dissemination and Implementation of PCOR to Increase Referral, Enrollment, and Retention through Automatic Referral to Cardiac Rehabilitation (CR) with Care Coordination.'' This proposed information collection was previously published in the Federal Register on February 4th, 2020 and allowed 60 days for public comment. AHRQ did not receive comments from members of the public. The purpose of this notice is to allow an additional 30 days for public comment.

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.

The subcommittees listed below are part of AHRQ's Health Services Research Initial Review Group Committee. Grant applications are to be reviewed and discussed at these meetings. Each subcommittee meeting will be closed to the public.