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

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on CDC Diabetes Prevention Recognition Program (DPRP). This collection allows CDC to administer the Diabetes Prevention Recognition Program (DPRP) and collects information needed by the Centers for Medicare & Medicaid Services (CMS) to support the Medicare Expanded Model (Medicare Diabetes Prevention Program [MDPP]).

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled ``DOP Cross-Site Evaluation of Overdose Data to Action Program.'' This collection is designed to assess the implementation and the effectiveness of the Overdose Data to Action (OD2A) program (CDC-RFA-CE19-1904) activities and identify the conditions under which these activities are effective and for whom.

The Administration for Children and Families (ACF) is requesting a three-year extension of the form Income Withholding Order/ Notice for Support (IWO) (OMB #0970-0154, expiration 8/31/2020). This request includes minor revisions to the approved forms.

The Indian Health Service (IHS) of the Department of Health and Human Services (HHS or ``the Department'') is issuing this Notice of Proposed Rulemaking (NPRM) to remove obsolete language appearing in the Code of Federal Regulations, regarding the rates charged for the provision of IHS services to ineligible individuals.

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed revision of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments revising the information collection by adding Form FDA 3601a, entitled ``Device Facility User Fee Cover Sheet,'' which is submitted along with registration and listing fee payments.

The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice of availability that published in the Federal Register on November 20, 2019. In that notice, FDA requested comments on the draft guidance for industry (GFI) #256 entitled ``Compounding Animal Drugs from Bulk Drug Substances.'' FDA is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

In compliance with of the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30 day comment period for this Notice has closed.

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: ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery.''

ACF, ORR, Division of Refugee Health announces the intent to award 35 OPDIV-Initiated Supplements in amounts ranging from $23,500 to $95,569 to grantees providing direct services funded through the Services for Survivors of Torture Program. See Table 1 below for more details on the supplement awards.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Institutional Review Board (IRB) Review of Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products During the COVID-19 Public Health Emergency.'' To facilitate patient access to investigational drugs for treating COVID-19, FDA is issuing this guidance to provide recommendations regarding the key factors and procedures IRBs should consider when reviewing requests including when such reviews are conducted by a single-member of an IRBfor individual patient expanded access. Given the public health emergency presented by COVID-19, this guidance is being implemented without prior public comment because FDA has determined that prior public participation is not feasible or appropriate, but it remains subject to comment in accordance with the Agency's good guidance practices.

This rule is intended to eliminate regulations that are outdated or unnecessary and to make technical amendments to the Flexibility, Efficiency, and Modernization in Child Support Enforcement (FEM) final rule, published on December 20, 2016, including to amend the compliance date for review and adjustment of child support orders. The Office of Child Support Enforcement is also making conforming amendments to the regulations as a result of the Bipartisan Budget Act of 2018.