Department of Health and Human Services June 12, 2023 – Federal Register Recent Federal Regulation Documents
Results 1 - 25 of 25
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Administrative Practices and Procedures
The Food and Drug Administration (FDA, Agency, 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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Regulations for Type A Medicated Articles
The Food and Drug Administration (FDA) 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.
Opportunity To Collaborate in the Evaluation of Serologic and Nucleic Acid Tests for Detecting HIV and Nucleic Acid Tests for Quantifying HIV
The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), announces an opportunity for industry and the public to collaborate on a project to evaluate nucleic acid and serologic tests. CDC is interested in evaluating serologic and nucleic acid tests that can be used to aid in the diagnosis of HIV-1 infection, including serologic tests that can secondarily differentiate recent infection, and nucleic acid tests for the quantitation or semi-quantitation of HIV RNA. Tests of interest include those that use whole blood, serum, plasma, or dried blood spots. Performance will be evaluated relative to Food and Drug Administration (FDA)-approved qualitative and quantitative nucleic acid tests as well as serologic immunoassays. More than one collaborator may be selected.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Notification of Devices
The Food and Drug Administration (FDA, Agency, 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 (PRA).
Agency Information Collection Activities; Proposed Collection; Comment Request; Allegations of Regulatory Misconduct Voluntarily Submitted to the Center for Devices and Radiological Health
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 information collection associated with allegations of regulatory misconduct voluntarily submitted to FDA's Center for Devices and Radiological Health (CDRH).
Luis Anarbol Moran: Final Debarment Order
The Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Luis Anarbol Moran for a period of 5 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. Moran was convicted of one felony count under Federal law for smuggling goods into the United States. The factual basis supporting Mr. Moran's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Moran was given notice of the proposed debarment and was given an opportunity to request a hearing to show why he should not be debarred. As of March 30, 2023 (30 days after receipt of the notice), Mr. Moran had not responded. Mr. Moran's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adverse Event Program for Medical Devices (Medical Product Safety Network)
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.
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.
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