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

The Administration for Children and Families at HHS is requesting an extension to continue data collection for an evaluation of the initiative, Community Collaborations to Strengthen and Preserve Families (also referred to as Child Welfare Community Collaborations [CWCC]). The cross-site process evaluation will provide insight to ACF about the various factors that promote or impede the implementation of child welfare community collaborations.

The Office on Trafficking in Persons (OTIP), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing to collect data for a new grant program: SOAR (Stop, Observe, Ask, Respond) to Health and Wellness Training (SOAR) Demonstration Grant Program Data.

The Food and Drug Administration (FDA) 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.

In accordance with the Federal Advisory Committee Act, this notice announces that the Secretary's National Advisory Committee on Rural Health and Human Services (NACRHHS) has scheduled a public meeting. Information about NACRHHS and the agenda for this meeting is available on the NACRHHS website at: https://www.hrsa.gov/advisory- committees/rural-health/.

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 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 Administration for Community Living (ACL) is announcing the award of a sole-source supplement for the National Paralysis Resource Center (PRC) as a result of the 2022 Congressional budget appropriations. The National Paralysis Resource Center is operated by the Christopher and Dana Reeve Foundation and offers important programmatic opportunities for persons with disabilities and older adults. The NPRC provides comprehensive information for people living with spinal cord injury, paralysis, and mobility-related disabilities and their families. Resources include information and referral by phone and email in multiple languages; a peer and family support mentoring program; a military and veterans' program; multicultural outreach services; multiple quality of life grants; and a national website. The administrative supplement for FY 2022 will be in the amount of $747,037, bringing the total award for FY 2022 to $9,447,037.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled ``Charging for Investigational Drugs Under an IND: Questions and Answers.'' Since issuance of the final guidance in 2016, FDA has received questions from stakeholders through the docket and in the form of communications with review divisions. These questions relate to the implementation of FDA's regulation on charging for investigational drugs under an investigational new drug application (IND) for the purpose of either clinical trials or expanded access for treatment use. FDA is providing this revised draft guidance in a question-and-answer format, addressing the most recently asked questions. When finalized, this revised draft guidance will replace the final guidance of the same title issued in June 2016.

This Federal Register notice sets forth two Special Fraud Alerts previously published by OIG on its website. We are publishing these Special Fraud Alerts in the Federal Register to ensure widespread dissemination of the Special Fraud Alerts to the general public and to satisfy the Federal Register publication requirement.

The Office of Planning, Research, and Evaluation (OPRE), Administration for Children and Families (ACF), is proposing to collect information for The Role of Licensing in Early Care and Education (TRLECE) project. This data collection aims to examine the child care and early education (CCEE) licensing system through surveys of child care licensing administrators, front-line child care licensing staff, and child care providers.

The Administration for Children and Families (ACF) is requesting revisions to the approved ACF Uniform Project Description (UPD) (Office of Management and Budget (OMB) #0970-0139, expiration March 31, 2025).

The Centers for Disease Control and Prevention (CDC) is seeking nominations for membership on the Board of Scientific Counselors, National Center for Health Statistics (BSC, NCHS). The BSC, NCHS consists of up to 15 experts including the Chair in fields associated with statistical, demographic, and epidemiological research, such as biostatistics/biometry, survey methodology and polling, sociology, reproductive health, minority health, nutrition, social and behavioral health sciences, and population-based public and environmental health; public health practice, e.g., state and local health data systems; operations research, health policy, and health services research, including health economics and econometrics; provision of health services, e.g., medicine, nursing, rehabilitation, other allied health care, and preventive medicine; health quality measurement and health indicators; health promotion; medical informatics; and data and health information security, storage, confidentiality, and dissemination.