Department of Health and Human Services September 3, 2019 – Federal Register Recent Federal Regulation Documents
Results 1 - 14 of 14
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Evaluation of the Food and Drug Administration's General Market Youth Tobacco Prevention Campaigns
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.
List of Bulk Drug Substances for Which There is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act
The Food and Drug Administration (FDA or Agency) is developing a list of bulk drug substances (active pharmaceutical ingredients) for which there is a clinical need (the 503B Bulks List). Drug products that outsourcing facilities compound using bulk drug substances on the 503B Bulks List can qualify for certain exemptions from the Federal Food, Drug, and Cosmetic Act (FD&C Act) provided certain conditions are met. This notice identifies nine bulk drug substances that FDA has considered and is proposing not to include on the list: Dipyridamole, ephedrine sulfate, famotidine, hydralazine hydrochloride, methacholine chloride, sodium bicarbonate, sodium tetradecyl sulfate, trypan blue, and vecuronium bromide. Additional bulk drug substances nominated by the public for inclusion on this list are currently under consideration and will be the subject of future notices.
Testing and Labeling Medical Devices for Safety in the Magnetic Resonance Environment; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Extension of Comment Period
The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice of availability that appeared in the Federal Register of August 2, 2019. In the notice of availability, FDA requested comments on draft guidance for industry and FDA staff entitled ``Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment.'' The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.
Notice of Meetings
The subcommittees listed below are part of AHRQ's Health Services Research Initial Review Group Committee. Grant applications are to be reviewed and discussed at these meetings. Each subcommittee meeting will commence in open session before closing to the public for the duration of the meeting.
Draft Guideline for Prevention and Control of Infections in Neonatal Intensive Care Unit Patients: Draft Recommendations for the Prevention and Control of Staphylococcus aureus in Neonatal Intensive Care Unit Patients
The Centers for Disease Control and Prevention (CDC), in the Department of Health and Human Services (HHS), announces the opening of a docket to obtain comment on the Draft Guideline for Prevention and Control of Infections in Neonatal Intensive Care Unit Patients: Draft Recommendations for the Prevention and Control of Staphylococcus aureus in Neonatal Intensive Care Unit Patients (``Draft Guideline''). The Draft Guideline provides new, evidence-based recommendations specific to the prevention and control of Staphylococcus aureus (S. aureus), including methicillin-resistant S. aureus (MRSA) and methicillin- sensitive S. aureus (MSSA), in neonatal intensive care unit (NICU) patients.
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