Department of Health and Human Services June 27, 2019 – Federal Register Recent Federal Regulation Documents

HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by Section 2112(b)(2) of 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 (the Court) is charged by statute with responsibility for considering and acting upon the petitions.

In FY 2019, HRSA received funding from the Minority HIV/AIDS Fund from the Office of Secretary. The purpose of Minority HIV/AIDS Fund is to reduce new HIV infections, improve HIV-related health outcomes, and to reduce HIV-related health disparities for racial and ethnic minority communities by supporting innovation, collaboration, and the integration of best practices, effective strategies, and promising emerging models in the response to HIV among minority communities. HRSA will be providing supplemental funds to support activities for the Association of State and Territorial Health Officials (ASTHO), to support the Ending the HIV Epidemic: A Plan for America (EtHE) initiative to eliminate new HIV infections by providing communities most severely affected by HIV with critical resources to address the HIV epidemic. The supplemental funds will be used to augment the awardee's current activities to improve access to quality services, support a skilled health workforce, develop innovative programs, and prevent and suppress communicable diseases to preserve and improve public health through the National Organizations for State and Local Officials program. The purpose of this supplement is to identify key stakeholders in the seven southern states that have a substantial rural HIV burden and establish collaborative partnerships in each state by convening leadership meetings with State Health Officials, Ryan White HIV/AIDS Program Part B Directors, HIV Surveillance Coordinators, HIV Prevention Directors, and other partners engaged in EtHE efforts.

In accordance with the Federal Advisory Committee Act, this notice announces that the Council on Graduate Medical Education (COGME) has scheduled a public meeting. Information about COGME and the agenda for this meeting can be found on the COGME website at: https:// www.hrsa.gov/advisory-committees/graduate-medical-edu/index.h tml.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``E19 Optimisation of Safety Data Collection.'' The draft guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The draft guidance provides recommendations regarding appropriate use of a selective approach to safety data collection in some late-stage pre- or postmarketing studies of drugs where the safety profile, with respect to commonly occurring adverse events, is well understood and documented. The draft guidance is intended to advance important clinical research questions through the conduct of clinical investigations that collect relevant patient data, which will enable an adequate benefit-risk assessment of the drug for its intended use, while reducing the burden to patients from unnecessary tests that may yield limited additional information.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``M10 Bioanalytical Method Validation.'' The draft guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The draft guidance describes the method validation expectations for bioanalytical assays for nonclinical and clinical studies that generate data to support regulatory submissions. The draft guidance also describes the procedures and processes that should be characterized for chromatographic and ligand-binding assays that are used to measure the parent and active metabolites of drugs administered in nonclinical and clinical subjects. The draft guidance is intended to provide industry with the regulatory expectations for bioanalytical method validation of assays used to support regulatory submissions.

This notice announces the next meeting of the APOE (the Panel) in accordance with the Federal Advisory Committee Act. The Panel advises and makes recommendations to the Secretary of the U.S. Department of Health and Human Services (HHS) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) on opportunities to enhance the effectiveness of consumer education strategies concerning the Health Insurance Marketplace, Medicare, Medicaid, and the Children's Health Insurance Program (CHIP). This meeting is open to the public.