Department of Health and Human Services January 2021 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or we) 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 Food and Drug Administration (FDA or the Agency) 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.

In accordance with the requirements of the Privacy Act of 1974, as amended, the Department of Health and Human Services is updating and renaming an existing system of records maintained by the National Institutes of Health (NIH), 09-25-0165, ``National Institutes of Health (NIH) Office of Loan Repayment and Scholarship (OLRS) Record System, HHS/NIH/OD'' (to be renamed ``NIH Loan Repayment Records''). In a separate Notice of Proposed Rulemaking (NPRM) published elsewhere in today's Federal Register, HHS/NIH is proposing to exempt a subset of records in the system of records from certain requirements of the Privacy Act, based on subsection (k)(5) of the Privacy Act.

HRSA's Federal Office of Rural Health Policy (FORHP) is modifying the definition it uses of rural for the determination of geographic areas eligible to apply for or receive services funded by FORHP's rural health grants. This notice revises the definition of rural and responds to comments received on proposed modifications to how FORHP designates areas to be eligible for rural health grant programs published in the Federal Register on September 23, 2020. After consideration of the public comments received, FORHP is adding Metropolitan Statistical Area (MSA) counties that contain no Urbanized Area (UA) population to the areas eligible for rural health grant programs.

The Department of Health and Human Services is issuing this Notice to clarify that persons that entered into the over-the-counter drug industry for the first time in order to supply hand sanitizers during the COVID-19 Public Health Emergency are not persons subject to the facility fee the Secretary is authorized to collect under section 744M of the Food, Drug, and Cosmetic Act.

Under the National Childhood Vaccine Injury Act (NCVIA), the Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) develops vaccine information materials that all health care providers are required to give to patients/parents prior to administration of specific vaccines. HHS/CDC seeks written comment on proposed updated vaccine information statements for vaccines covered by the National Vaccine Injury Compensation Program (VICP).

The Food and Drug Administration (FDA, we, or Agency) is requesting comments on a document entitled ``Potential Approach for Defining Durations of Use for Medically Important Antimicrobial Drugs Intended for Use In or On Feed: A Concept Paper.'' The concept paper outlines a potential framework for how sponsors of new animal drug products containing medically important antimicrobial drugs approved for use in or on animal feed might voluntarily establish appropriately defined durations of therapeutic administration to food-producing animals where none currently exist. Establishing appropriately defined durations of use to mitigate development of antimicrobial resistance would be consistent with previous efforts by FDA to protect public health by promoting the judicious use of these drugs in food-producing animals.