Department of Health and Human Services May 15, 2023 – Federal Register Recent Federal Regulation Documents

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.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the final decision withdrawing approval of MAKENA (hydroxyprogesterone caproate injection, 250 milligrams (mg) per milliliter (mL), once weekly), under the new drug application (NDA) 021945, held by Covis Pharma Group/Covis Pharma GmbH (Covis), and the eight abbreviated new drug applications (ANDAs) from multiple ANDA holders that reference NDA 021945. The Commissioner of Food and Drugs (the Commissioner) and the Chief Scientist jointly issued the decision following an October 2022 public hearing.

HRSA will provide supplemental funding to UMass, a current Regional AETC Program award recipient, for a 1-year period of performance and 1-year budget period to support a program designed to train internal and family medicine residents to specialize in HIV treatment and care management. This training program is critically needed, as it will help increase the number of primary HIV care providers available to diagnose, treat, and medically manage people with HIV and address urgent needs stemming from the HIV care workforce shortage.

This notice announces continuation of the May 4, 2023, meeting of the National Toxicology Program (NTP) Board of Scientific Counselors (BSC) on May 16, 2023. The BSC is a federally chartered, external advisory group composed of scientists from the public and private sectors. During a public meeting on May 4, the BSC considered a report from its Working Group containing proposed recommendations on whether NTP authors sufficiently addressed internal and external scientific comments on NTP's systematic review to evaluate the neurobehavioral health effects from exposure to fluoride during development, as set forth in NTP's Draft State of the Science Monograph and Draft Meta- Analysis Manuscript. After deliberation and discussion, the BSC voted to accept the Working Group's report in full, with the exception of one paragraph on page 323 related to an IQ statistic that the BSC asked the Working Group to verify or correct. The Working Group has reexamined the text, and the BSC will discuss and deliberate the Working Group's updated input at the meeting on May 16. This is a virtual meeting and open to the public. This notice is being published less than 15 days prior to the meeting due to scheduling difficulties.

The Administration for Children and Families' (ACF) Office of Planning, Research, and Evaluation (OPRE) requests Office of Management and Budget (OMB) approval for an overarching generic clearance to collect data on programs serving youth transitioning out of foster care as part of the Chafee Strengthening Outcomes for Transition to Adulthood (Chafee SOTA) Project. The generic mechanism will allow ACF to conduct rapid-cycle evaluations that would not otherwise be feasible under the timelines associated with the Paperwork Reduction Act of 1995. The purpose of the data collections submitted under the generic will be to inform ACF programming by building the evidence about what works to improve outcomes for the target population and to identify innovative learning methods that address common evaluation challenges.