Department of Health and Human Services January 26, 2022 – Federal Register Recent Federal Regulation Documents
Results 1 - 6 of 6
Food Additives: Food Contact Substance Notification That Is No Longer Effective
The Food and Drug Administration (FDA or we) is proposing to amend its regulations relating to the procedures by which we determine that a premarket notification for a food contact substance (FCN) is no longer effective. The proposed rule, if finalized, would, among other things, ensure that manufacturers or suppliers have the opportunity to provide input before we could determine that an FCN is no longer effective. The proposed rule also would provide additional reasons that could be the basis for FDA to determine that an FCN is no longer effective. We are proposing these changes to better enable FDA to respond to new information on the safety and use of food contact substances, as well as manufacturers' business decisions, which would also improve our FCN program's efficiency.
Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation; Guidance for Industry and Food and Drug Administration Staff, and Other Stakeholders; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation.'' FDA encourages the collection, analysis, and integration of patient perspectives in the development, evaluation, and surveillance of medical devices, including digital health technologies. Patient-reported outcome (PRO) instruments facilitate the systematic collection of patient perspectives as valid scientific evidence to support the regulatory and healthcare decision-making process. This guidance describes principles that should be considered when using PRO instruments in the evaluation of medical devices and provides recommendations about the importance of ensuring the measures are fit- for-purpose. This guidance is not meant to replace the Patient-Focused Drug Development (PFDD) guidance series. Some of the comments received in the docket may be addressed in PFDD Guidance #3, which is currently in development.
Patient Engagement in the Design and Conduct of Medical Device Clinical Studies; Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Patient Engagement in the Design and Conduct of Medical Device Clinical Studies.'' The Patient Engagement Advisory Committee (PEAC) recommended that FDA and industry develop a framework to clarify how patient advisors can engage in the clinical investigation process. This guidance focuses on the applications, perceived barriers, and common challenges of patient engagement in the design and conduct of medical device clinical studies.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
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.
Submission for OMB Review; Request for Certification of Adult Victims of Human Trafficking
The Administration for Children and Families (ACF), Office on Trafficking in Persons (OTIP), is requesting a 3-year extension of the Request for Certification of Adult Victims of Human Trafficking (RFC) form (Office of Management and Budget (OMB) #: 0970-0454, expiration 2/ 28/22). Minor revisions have been made to the form, including the addition of a few fields that will enable OTIP to be more responsive to congressional inquiries, federal reporting requirements, and the needs of victims.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. to achieve expeditious commercialization of results of federally-funded research and development.
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