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

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 This guidance incorporates the comments received for and finalizes the draft guidance of the same title issued May 13, 2015.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.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Guidance for Industry.'' The guidance document provides blood collection establishments and transfusion services with recommendations to control the risk of bacterial contamination of room temperature stored platelets intended for transfusion. The recommendations in the guidance apply to all platelet products stored at room temperature in plasma or additive solutions, including platelets manufactured by automated methods (apheresis platelets), and Whole Blood derived (WBD) single and pooled (pre-storage and post-storage) platelets. Additionally, the guidance provides licensed blood establishments with recommendations on how to report implementation of manufacturing and labeling changes. The guidance announced in this notice finalizes the draft guidance of the same title dated December 2018.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Immunology Devices Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on scientific issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry, FDA staff, and other stakeholders entitled ``Patient-Focused Drug Development: Methods To Identify What Is Important to Patients.'' This guidance (Guidance 2) is the second in a series of four methodological guidance documents that FDA committed to develop to describe how to collect and submit information from patients and caregivers to be used for medical product development and regulatory decision-making.

The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). A notice listing all currently HHS-certified laboratories and IITFs is published in the Federal Register during the first week of each month. If any laboratory or IITF certification is suspended or revoked, the laboratory or IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory or IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter. This notice is also available on the internet at https://www.samhsa.gov/workplace.

The Food and Drug Administration (FDA or we) is announcing that Evonik Corp. has filed a petition proposing that the food additive regulations be amended to provide for the safe use of silicon dioxide as an anticaking agent, grinding aid, antifoaming agent, or carrier in animal feed components (ingredients, intermediate premixes, premixes, supplements, or concentrates).

The Food and Drug Administration (FDA or the Agency) is announcing the fee rate for using a material threat medical countermeasure (MCM) priority review voucher for fiscal year (FY) 2020. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the 21st Century Cures Act (Cures Act), authorizes FDA to determine and collect material threat MCM priority review user fees for certain applications for review of human drug products when those applications use a material threat MCM priority review voucher. These vouchers are awarded to the sponsors of material threat MCM applications that meet all the requirements of this program and upon FDA approval of such applications. The amount of the fee for using a material threat MCM priority review voucher is determined each FY based on the difference between the average cost incurred by FDA to review a human drug application designated as priority review in the previous FY, and the average cost incurred in the review of an application that is not subject to priority review in the previous FY. This notice establishes the material threat MCM priority review fee rate for FY 2020 and outlines the payment procedures for such fees.

The Food and Drug Administration (FDA or the Agency) is announcing the fee rates for using a tropical disease priority review voucher for fiscal year (FY) 2020. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration Amendments Act of 2007 (FDAAA), authorizes FDA to determine and collect priority review user fees for certain applications for review of drug and biological products when those applications use a tropical disease priority review voucher. These vouchers are awarded to the sponsors of certain tropical disease product applications, submitted after September 27, 2007, upon FDA approval of such applications. The amount of the fee submitted to FDA with applications using a tropical disease priority review voucher is determined each fiscal year based on the difference between the average cost incurred by FDA to review a human drug application designated as priority review in the previous fiscal year and the average cost incurred in the review of an application that is not subject to priority review in the previous fiscal year. This notice establishes the tropical disease priority review fee rate for FY 2020.

In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Healthcare Infection Control Practices Advisory Committee (HICPAC). This meeting is open to the public, is limited only by room seating available (120). The public is also welcome to listen to the meeting via teleconference at 888-769- 9417, passcode: 4538315; 100 teleconference lines are available. Time will be available for public comment. The public is welcome to submit written comments in advance of the meeting.