Department of Health and Human Services February 2023 – Federal Register Recent Federal Regulation Documents

The Administration for Community Living is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under the Paperwork Reduction Act of 1995. This 30-Day notice collects comments on the information collection requirements related to an extension without change and solicits comments on the information collection requirements related to the on the information collection requirements relating to the National Adult Maltreatment Reporting System (NAMRS).

The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on the proposed collection of information listed above. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish a notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the Proposed Revision and solicits comments on the information collection requirements related to the ``National SHIP-SMP Beneficiary Survey of Group Outreach and Education Events.''

The Administration for Children and Families (ACF) is requesting a 3-year extension of the ACF Program Instruction Children's Justice Act (Office of Management and Budget (OMB) #0970- 0425, expiration 6/30/2023). There are no changes to the Program Instruction.

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.

HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.

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

ACF is proposing to revise the definition of ``foster family home'' to allow each title IV-E agency to adopt foster family home licensing or approval standards for foster family homes of individuals related to a child by blood, marriage, or adoption and other individuals who have an emotionally significant relationship with the child, including fictive kin, (referred herein as ``relative(s) and kin(ship)'') that differ from non-relative foster family homes agency standards. In this context, a ``non-relative'' foster family home means a home of an unrelated individual who is not kin or fictive kin. This notice of proposed rulemaking (NPRM) would allow a title IV-E agency to claim title IV-E federal financial participation (FFP) for the cost of foster care maintenance payments (FCMP) on behalf of an otherwise eligible child who is placed in a relative or kinship licensed or approved foster family home when the agency uses different licensing or approval standards for relative or kinship foster family homes and non- relative foster family homes. In addition, the NPRM would amend the requirement that title IV-E agencies review the amount of FCMPs to also assure that the agency provides a licensed or approved relative and kinship foster family home the same amount of FCMP that would have been made if the child was placed in a non-related foster family home.

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 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.

CDC has modified its structure. This notice announces the establishment of the Coronavirus and other Respiratory Viruses Division and other organizational components within the National Center for Immunization and Respiratory Diseases (NCIRD), Deputy Director for Infectious Diseases (DDID), CDC.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development.'' This guidance is intended to provide a framework for considering whether and what type of long-term neurologic, sensory, and/or developmental evaluations could be useful in supporting a determination of safety of a regulated product for use in neonates, and which domains of assessment may be most pertinent. Although short-term safety evaluations may be acceptable for adults or other populations, such short-term evaluations may not identify important adverse events in the neonatal population, as latent effects may follow early-life exposures and drug treatment during the neonatal period coincides with a time of critical growth and physiologic development. Consideration of these potential long-term neurologic, sensory, and development effects in the neonatal population early in a drug development program will help ensure a safer product.