Department of Health and Human Services December 9, 2022 – Federal Register Recent Federal Regulation Documents

In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

The Food and Drug Administration (FDA, the Agency, or we) is proposing to replace its current annual reporting requirement for investigational new drug applications (INDs) with a new requirement: the annual FDA development safety update report (FDA DSUR). The proposed annual FDA DSUR is intended to be consistent with the format and content of the DSUR that is supported by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), which is described in FDA's ICH guidance for industry entitled ``E2F Development Safety Update Report'' (E2F DSUR) (August 2011). The proposed annual FDA DSUR regulation, if finalized, would require an annual report that is more comprehensive and informative than the IND annual report currently required under FDA regulations.

The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend its regulations on investigational new drug applications (INDs) to exempt from the IND requirements certain clinical investigations of lawfully marketed foods for human consumption (including both conventional foods and dietary supplements) and cosmetics when the product is to be studied to evaluate its use as a drug. Under the proposal, clinical studies to evaluate a drug use of such products would not have to be conducted under an IND when, among other things, the study is not intended to support a drug development plan or a labeling change that would cause the lawfully marketed product to become an unlawfully marketed drug, and the study does not present a potential for significant risk to the health, safety, or welfare of subjects. Though exempt from the IND requirements, such investigations would still be subject to other regulations designed to protect the rights and safety of subjects, including requirements for informed consent and review by institutional review boards (IRBs). By exempting from the IND requirements certain clinical investigations of products lawfully marketed as a food or cosmetic, the proposed provisions are intended to reduce the regulatory burden of conducting such studies while retaining protections for human subjects.

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.