Department of Health and Human Services September 2020 – 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 requesting to continue the data collection approved by the Office of Management and Budget (OMB) under expedited review.

This proposed notice acknowledges the receipt of an application from the Accreditation Commission for Healthcare (ACHC) for continued recognition as a national accrediting organization for home health agencies (HHAs) that wish to participate in the Medicare or Medicaid programs. The statute requires that within 60 days of receipt of an organization's complete application, the Centers for Medicare & Medicaid Services (CMS) publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.

This final notice announces our decision to approve The Compliance Team for initial recognition as a national accrediting organization for home infusion therapy suppliers that wish to participate in the Medicare program. A home infusion therapy supplier that participates must meet the Medicare conditions for coverage.

This notice announces the annual adjustment in the amount in controversy (AIC) threshold amounts for Administrative Law Judge (ALJ) hearings and judicial review under the Medicare appeals process. The adjustment to the AIC threshold amounts will be effective for requests for ALJ hearings and judicial review filed on or after January 1, 2021. The calendar year 2021 AIC threshold amounts are $180 for ALJ hearings and $1,760 for judicial review.

The Food and Drug Administration (FDA or Agency) is announcing the availability of three final guidance documents for the Accreditation Scheme for Conformity Assessment Pilot Program specifically, ``The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program; Guidance for Industry, Accreditation Bodies, Testing Laboratories, and FDA Staff''; ``Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical EquipmentStandards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program: Guidance for Industry, Accreditation Bodies, Testing Laboratories, and FDA Staff''; and ``Biocompatibility Testing of Medical DevicesStandards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program: Guidance for Industry, Accreditation Bodies, Testing Laboratories, and FDA Staff.'' These guidances describe the goals, scope, procedures, and framework for the voluntary ASCA Pilot program, and provide information about two groups of consensus standards within the scope of the pilot program.

The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research (CDER) is proposing to withdraw approval of five abbreviated new drug applications (ANDAs) and is announcing an opportunity for the ANDA holders to request a hearing on this proposal. The basis for the proposal is that the ANDA holders have repeatedly failed to file required annual reports for those ANDAs and have failed to satisfy the requirement to have an approved risk evaluation and mitigation strategy (REMS).

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.

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.''

This gives notice under the Federal Advisory Committee Act of October 6, 1972, that the Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP), Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2-year period through September 18, 2022.

The Food and Drug Administration (FDA or we) is announcing a final determination that the adoption and implementation by Spain and the Netherlands of the European Union's (EU's) system of food safety control measures for raw bivalve molluscan shellfish (``shellfish''), along with their application of additional measures specifically adopted for this purpose, i.e., for export to the United States, provides at least the same level of sanitary protection as comparable food safety measures in the United States and is therefore equivalent. This final equivalence determination will permit the importation of raw shellfish harvested from certain production areas in Spain and the Netherlands from establishments that have been listed by FDA on the Interstate Certified Shellfish Shippers List (ICSSL).

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public meeting entitled ``CBD and Other Cannabinoids: Sex and Gender Differences in Use and Responses.'' The purpose of the public meeting is to discuss potential sex (biological) and gender (psychosocial) differences in use and responses to cannabidiol (CBD) and other cannabinoids. Researchers, educators, clinicians, and patients may benefit from attending this multidisciplinary scientific conference on CBD and other cannabinoids. Presentations will address patient and healthcare provider perspectives on CBD and other cannabinoid use, sex differences in the effects of CBD and other cannabinoids, use of CBD and other cannabinoids in pregnancy, and government agency perspectives on CBD research and evaluation.

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.