Department of Health and Human Services December 2022 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled ``ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions.'' For purposes of implementing the Generic Drug User Fee Amendments of 2022 (GDUFA III), the Pre-Submission Facility Correspondence (PFC) process was revised as part of the performance goals and program enhancements agreed to by FDA and industry, as described in the GDUFA Reauthorization Performance Goals and Program Enhancements, Fiscal Years 2023 through 2027 (GDUFA III commitment letter). FDA assesses facility information submitted in a PFC to inform the Agency's decision regarding the need for facility inspections that support assessment of the abbreviated new drug application (ANDA). A complete and accurate PFC allows the Agency to begin the facility assessment process in advance of the planned ANDA submission for priority ANDAs, allowing the Agency more time to make preapproval inspection decisions. A PFC meeting the conditions outlined in the revised draft guidance will qualify the ANDA for a shorter, 8- month priority review goal. This revised draft guidance describes the content, timing, and assessment of a complete and accurate PFC for purposes of GDUFA III. Additionally, this revised draft guidance provides information on the Agency's rationale for and current approach to assessing a PFC and replaces the previous draft guidance for industry, ``ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications (Pre-Submission Facility Correspondence),'' issued in November 2017.

The Office of Child Support Enforcement (OCSE), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing to add additional data collection activities as part of the rigorous evaluation of the Procedural Justice-Informed Alternatives to Contempt (PJAC) Demonstration. The proposed revision to conduct additional data collection is part of a research supplement that builds on the PJAC study to understand the role of bias in child support program enforcement actions.

This notice announces a $688.00 calendar year (CY) 2023 application fee for institutional providers that are initially enrolling in the Medicare or Medicaid program or the Children's Health Insurance Program (CHIP); revalidating their Medicare, Medicaid, or CHIP enrollment; or adding a new Medicare practice location. This fee is required with any enrollment application submitted on or after January 1, 2023 and on or before December 31, 2023.

The Department of Health and Human Services (HHS or ``the Department'') is issuing this notice of proposed rulemaking (NPRM) to solicit public comment on its proposal to modify its regulations to implement section 3221 of the Coronavirus Aid, Relief, and Economic Security (CARES) Act.

The Secretary of Health and Human Services delegates to the National Institutes of Health (NIH) Director and the Food and Drug Administration (FDA) Commissioner the authorities vested in the Secretary of Health and Human Services under Section 3 of the Accelerating Access to Critical Therapies for ALS Act, as amended, to establish and implement a Public-Private Partnership for rare neurodegenerative diseases. These authorities may be redelegated. Exercise of this authority shall be in accordance with established policies, procedures, guidelines, and regulations as prescribed by the Secretary. The Secretary retains the authority to submit reports to Congress and promulgate regulations.

The Administration for Children and Families (ACF) is requesting approval of the ACF Congressionally Directed Community ProjectsUniversal Project Description (CDCP-UPD). This new information collection is proposed to collect information from recipients of ACF Congressionally Directed funds. A Congressional Directive is an authorization act or appropriations act that requires ACF to make an award(s) to a named recipient(s) for a particular program, project, activity, or geographic area(s).

In accordance with the Federal Advisory Committee Act, HHS is hereby giving notice that the National Advisory Council on Nurse Education and Practice (NACNEP) has been rechartered. The effective date of the recharter is November 30, 2022.

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces fees for vessel sanitation inspections for Fiscal Year (FY) 2023. These inspections are conducted by HHS/CDC's Vessel Sanitation Program (VSP). VSP helps the cruise ship industry fulfill its responsibility for developing and implementing comprehensive sanitation programs to minimize the risk for acute gastroenteritis. Every vessel that has a foreign itinerary and carries 13 or more passengers is subject to twice-yearly unannounced operations inspections and, when necessary, reinspection.