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

This notice announces the rechartering and appointment of seven new members to the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests (the CDLT Panel). The purpose of the CDLT Panel is to advise the Secretary of the Department of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services on issues related to clinical diagnostic laboratory tests.

This notice announces the public meeting of the Advisory Council on Alzheimer's Research, Care, and Services (Advisory Council). The Advisory Council on Alzheimer's Research, Care, and Services provides advice on how to prevent or reduce the burden of Alzheimer's disease and related dementias on people with the disease and their caregivers. The Advisory Council will spend the majority of time during the July 29, 2019 meeting considering recommendations made by each of the three subcommittees to present to the Secretary of HHS and Congress. Additional presentations will include updates on the latest biomedical research findings, an overview of the Healthy Brain Initiative: The Road Map for Indian Country, and a discussion of the progress made since 2011 through the National Plan to Address Alzheimer's Disease. Federal workgroups will also provide updates.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Treatment for Heart Failure: Endpoints for Drug Development.'' This draft guidance clarifies that an effect on symptoms or physical function, without a favorable effect on survival or hospitalization, can be a basis for approving drugs to treat heart failure. It also provides recommendations to sponsors on the need to assess mortality effects of drugs under development to treat heart failure.

The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend its regulations concerning the use of master files for biological products. This action, if finalized, will allow certain biological products approved under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to continue to incorporate by reference information about drug substances, drug substance intermediates, or drug products contained in master files after those products are deemed to be licensed under the Public Health Service Act (PHS Act) on March 23, 2020. The proposed rule also codifies FDA's practice of permitting applications for biological products submitted under the PHS Act to incorporate by reference information other than drug substance, drug substance intermediate, or drug product information contained in a master file. In addition, the proposed rule codifies FDA's practice of permitting investigational new drug applications to incorporate by reference any information contained in a master file for products subject to licensure under the PHS Act.

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.

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 Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on administrative procedures for Clinical Laboratory Improvement Amendments of 1988 (CLIA) categorization of certain in vitro diagnostic tests.

The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled ``Reducing Microbial Food Safety Hazards in the Production of Seed for Sprouting.'' The draft guidance document, when finalized, will make the sprout seed industry (seed growers, conditioners, packers, holders, suppliers, and distributors) aware of FDA's serious concern with the continuing outbreaks of foodborne illness associated with the consumption of raw and lightly-cooked sprouts and provide FDA's recommendations to firms throughout the production chain of seed for sprouting.

This notice informs the public of the availability of the complete lists of all geographic areas, population groups, and facilities designated as primary medical care, mental health, and dental health professional shortage areas (HPSAs) as of May 1, 2019. The lists are available on HRSA's HPSAFind website.