Department of Health and Human Services May 2023 – 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 a proposed information collection project titled National Electronic Health Records Survey (NEHRS). NEHRS will collect information about the use of electronic health records (EHRs) systems, documentation of social determinants of health or social needs, interoperability, exchange of patient health information with public health agencies, and use of telemedicine technology among office-based and outpatient physicians in the United States.

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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Pediatric Drug Development: Regulatory ConsiderationsComplying With the Pediatric Research Equity Act and Qualifying for Pediatric Exclusivity Under the Best Pharmaceuticals for Children Act.'' This draft guidance, when finalized, is intended to provide recommendations to industry on complying with the pediatric study requirements under the Pediatric Research Equity Act (PREA), and to describe the process for qualifying for pediatric exclusivity and the protections that pediatric exclusivity offers under the Best Pharmaceuticals for Children Act (BPCA). Combining discussion of PREA and the BPCA together in regulatory guidance emphasizes the sponsor's need to consider both laws when developing pediatric drugs and biological products.

The Food and Drug Administration (FDA or we) is correcting a final order that appeared in the Federal Register on April 14, 2023. The document responded to objections and requests for a public hearing on the final rule to revoke the standards for lowfat yogurt and nonfat yogurt and amend the standard for yogurt. The final order published with an inadvertent error. This document corrects that error.

The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of the Agency's annual compilation of notices of updates to the Agency's Susceptibility Test Interpretive Criteria web page with updates made in 2021 and 2022. The Agency established the Susceptibility Test Interpretive Criteria web page on December 13, 2017, and since establishment has provided updates to both the format of the web pages and to the susceptibility test interpretive criteria identified and recognized by FDA on the web pages. FDA is publishing this notice in accordance with procedures established by the 21st Century Cures Act (Cures Act).

This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) is supporting a supplement in scope of the original award for the one grant recipient, the Community Anti-Drug Coalitions of America (CADCA), funded in FY 2019 under the National Anti-Drug Coalitions Training and Workforce Development award, Notice of Funding Opportunity (NOFO) SP-19-002. The recipient may receive up to $175,000 and the project period will be extended by 12 months until November 30, 2024. The supplemental funding to CADCA will be used to continue the Voices of Youth Training Initiative. The Voices of Youth Training Initiative has shown positive results, and the continuation of the program will support finalizing the sustainability and scalability beyond the supplements. The supplement will continue to connect the Future Health Professionals (HOSA) national student organization with CADCA to support youth-led strategic planning for the prevention field and develop leadership skills for the future workforce. This supplement will also allow CADCA to provide HOSA students an opportunity to both learn about and provide valuable input into strategic initiatives for prevention.

The Food and Drug Administration (FDA or we) is announcing the extension of a temporary permit issued to Bongards Creameries (the applicant) to market test several pasteurized standardized cheeses that deviate from the U.S. standards of identity for cheese products. The extension allows the applicant to continue to evaluate commercial viability of the products and to collect data on consumer acceptance of the products, in support of a petition to amend the standard of identity for cheese products. We also invite other interested parties to participate in the market test.

The Office of Refugee Resettlement (ORR) is requesting a 3- year extension with revisions of the Unaccompanied Refugee Minors (URM) Program Application and Withdrawal of Application or Declination of Placement Form (OMB #0970-0550, expiration 08/31/2023). Proposed revisions include additional instructions, a small number of new questions, dropping a few questions, and rephrasing existing questions.

The U.S. Department of Health and Human Services is hereby giving notice that the Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA) will hold a meeting. The meeting will be open to the public via webcast. The committee will discuss and vote on a recommendation related to surge capacity for blood and blood products.

In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

The Office of Planning, Research, and Evaluation (OPRE) within the Administration for Children and Families (ACF) is proposing an extension with revisions to the data collection activities conducted as part of the National Survey of Child and Adolescent Well-Being (NSCAW III) (Office of Management and Budget #0970-0202). NSCAW is the only source of nationally representative, longitudinal, firsthand information about the functioning and well-being, service needs, and service utilization of children and families who come to the attention of the child welfare system. This request will allow additional time to conduct participant data collections. Minor changes to the instruments are requested to restore an in-person data collection option.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for Zemdri and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

The Administration for Children and Families (ACF) Office of Planning, Research, and Evaluation (OPRE) at the U.S. Department of Health and Human Services is proposing to collect information to examine a promising strategy to support the child care and early education (CCEE) workforce in Colorado as part of the Building and Sustaining the Child Care and Early Education Workforce (BASE) project. This project aims to build evidence about workforce development strategies designed to promote, retain, and advance the CCEE workforce by improving the economic well-being of CCEE workers.

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 (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 a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate 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 Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.

Delegation of authorities are being redelegated from the Deputy Assistant Secretary, Office of Planning, Research and Evaluation (OPRE), Administration for Children and Families (ACF), to the Chief Technology Officer, Office of the Chief Technology Officer (CTO/ACF Tech), ACF. This action is necessary to complete the transition of the function of multi-program advance planning documents to the CTO/ACF Tech.