Department of Health and Human Services July 2, 2021 – Federal Register Recent Federal Regulation Documents

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.

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposal to allow CDC's National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Division of Adolescent and School Health (DASH) to conduct a research information collection project titled ``Teen and Parents Surveys of Health (TAPS)''. This project serves to inform the CDC's Division of Adolescent and School Health's (DASH) key school- based programmatic strategies of improving family- and school-level protective factors, bolstering health education, and increasing adolescent access to quality health services.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.

The Centers for Disease Control and Prevention (CDC) is seeking nominations for membership on the Advisory Board on Radiation and Worker Health (ABRWH) for the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA). The ABRWH consists of not more than 20 members appointed by the President of the United States, and shall reflect a balance of scientific, medical, and worker perspectives. Nominations are being sought for individuals who have expertise and qualifications necessary to contribute to the accomplishments of the ABRWH's objectives. Nominees will be appointed based on their demonstrated qualifications, professional experience, and knowledge of issues the ABRWH may be asked to consider. Federal employees will not be considered for membership.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Assessment of Adhesion for Topical and Transdermal Systems Submitted in New Drug Applications.'' Transdermal delivery systems are designed to deliver a drug across the skin and into systemic circulation, whereas topical delivery systems are designed to deliver the drug to local tissue. There is pharmaceutical and other stakeholder interest in the development of new transdermal and topical products, and this guidance provides recommendations on the clinical assessment of adhesion for such products that will be submitted as new drug applications (NDAs) or supplemental new drug applications. This guidance provides additional study design and methodology recommendations on conducting in vivo adhesion studies. This guidance takes these developments into consideration. When final, this draft guidance will expand upon the recommendation for in vivo adhesion studies in section V., Special Topics, subsection A., Product Adhesion Considerations, in the draft guidance for industry Transdermal and Topical Delivery SystemsProduct Development and Quality Considerations issued on November 21, 2019.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Evaluating Cancer Drugs in Patients with Central Nervous System Metastases; Guidance for Industry.'' The guidance document provides recommendations regarding the design of clinical trials of drugs and biological products regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) that are intended to support product labeling describing the antitumor activity in patients with central nervous system (CNS) metastases from solid tumors originating outside the CNS. The guidance includes study design recommendations regarding the patient population, available therapy, prior therapies, assessment of CNS disease, study endpoints, and leptomeningeal disease. The guidance announced in this notice finalizes the draft guidance of the same title dated August 2020.

The Administration for Children and Families (ACF) at the U.S. Department of Health and Human Services (HHS) seeks approval to collect new information to use in testing measures of the implementation and costs of high-quality early care and education as part of the project, Assessing the Implementation and Cost of High-Quality Early Care and Education (ECE-ICHQ). The study received approval for a field test to validate and improve the psychometric properties of these measures in November 2019. This request is to add a measure to the approved field test to help further assess the associations between measures of implementation, cost, and quality.