Department of Health and Human Services December 1, 2020 – Federal Register Recent Federal Regulation Documents

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 survey previously ran a 60-day FRN in 83 FR 66276 on 12/ 26/2018. As required under the PRA we are providing the public an opportunity to comment on any changes or updates applied to this IC since the 2018 publication. We are requesting an abbreviated public comment period for additional 30-days prior to publication of a 30-day FRN and submittal to OMB. Any changes to the survey from the initial 60-day FRN publication are incorporated into the revised version of the survey. This notice solicits comments on any revisions since the initial publication in 2018. This is a new information collection 0985-New Inventory of Adult Protective Services Practices and Service Innovations.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications.'' This draft guidance focuses on specific recommendations pertinent to gastric pH- dependent drug-drug interaction (DDI) assessment and describes the FDA's recommendations regarding when clinical DDI studies with acid- reducing agents (ARAs) are needed; design of the clinical studies; interpretation of study results; and communicating findings and options for managing pH-dependent DDIs in product labeling.

The Food and Drug Administration (FDA or Agency) 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.

The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITFs) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine or Oral Fluid (Mandatory Guidelines).

This final rule adopts certain changes to the risk adjustment data validation error estimation methodology beginning with the 2019 benefit year for states where the Department of Health and Human Services (HHS) operates the risk adjustment program. This rule is finalizing changes to the HHS-RADV error estimation methodology, which is used to calculate adjusted risk scores and risk adjustment transfers, beginning with the 2019 benefit year of HHS-RADV. This rule also finalizes a change to the benefit year to which HHS-RADV adjustments to risk scores and risk adjustment transfers would be applied beginning with the 2020 benefit year of HHS-RADV. These policies seek to further the integrity of HHS-RADV, address stakeholder feedback, promote fairness, and improve the predictability of HHS-RADV adjustments.