Department of Health and Human Services October 2019 – Federal Register Recent Federal Regulation Documents

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.

The Office on Trafficking in Persons (OTIP), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is requesting to reinstate a previously approved information collection with revisions to information collected on clients enrolled in the Trafficking Victim Assistance Grant Program.

This notice announces the annual adjustment in the amount in controversy (AIC) threshold amounts for Administrative Law Judge (ALJ) hearings and judicial review under the Medicare appeals process. The adjustment to the AIC threshold amounts will be effective for requests for ALJ hearings and judicial review filed on or after January 1, 2020. The calendar year 2020 AIC threshold amounts are $170 for ALJ hearings and $1,670 for judicial review.

The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during April, May, and June 2019. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to make technical amendments to improve the accuracy of the regulations.

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.

In compliance with of the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.

In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Mine Safety and Health Research Advisory Committee (MSHRAC). This meeting is open to the public, limited only by the space available. The meeting room accommodates approximately 75 people. If you wish to attend in person or by phone, please contact Marie Chovanec by email at MChovanec@cdc.gov or by phone at 412-386-5302 at least 5 business days in advance of the meeting.

The Administration for Children and Families (ACF) at the U.S. Department of Health and Human Services (HHS) intends to collect data 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.

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 Institute of Mental Health (NIMH), National Institutes of Health (NIH), will publish periodic summaries of propose projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this Notice to Ziopharm Oncology, Inc. (``Ziopharm''), headquartered in Boston, MA.

The Food and Drug Administration (FDA) is announcing the availability of a final guidance for industry entitled ``Investigational Enzyme Replacement Therapy Products: Nonclinical Assessment.'' The purpose of this guidance is to help sponsors design and conduct nonclinical studies needed to support initiation of clinical trials, ongoing clinical development, and marketing approval of enzyme replacement therapy (ERT) products. This guidance incorporates the comments received for and finalizes the draft guidance of the same title issued May 13, 2015.

As part of the Administration for Children and Families (ACF) commitment to supporting working families and promoting the healthy development and well-being of children, ACF is seeking input from the public and interested stakeholders on strategies to improve access to high quality, affordable child care in the U.S. Child care is one of the biggest expenses a family faces and can be a barrier to work. The average cost of center-based infant child care in 28 states is more than college tuition. At the same time, child care settings are a place of learning and education for children from the time they are infants and toddlers through their school-age years. Access to high quality learning opportunities lays the foundation for children's development and, ultimately, their success in school and in life. Unfortunately, many families do not have access to the affordable, high quality child care their children need. This Request for Information seeks public comment on: Identifying emerging and innovative practices to improve access to high quality child care, as well as identifying regulatory and other policies that unnecessarily drive up the cost of care or limit parents' choice of different child care options; and identifying ways to improve funding of child care and other related early education programs to support quality and create a more streamlined, equitable, and sustainable financing framework for future generations. Information collected through this request may be used by ACF in the development of future rulemaking and technical assistance, formation of legislative proposals and research agendas, and/or strategic planning.

The Administration of Children and Families (ACF), Office of Community Services (OCS) is requesting a three-year extension with minor changes of the Community Services Block Grant (CSBG) Annual Report (OMB No.: 0970-0492, expiration 1/31/2020). This request will support the currently utilized CSBG Annual Report, comprised of Modules 1-4, and incorporates performance management.