Department of Health and Human Services February 8, 2023 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or the Agency) is denying Hassan Tahsildar's (Dr. Tahsildar's) request for a hearing and issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Dr. Tahsildar for 2 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Dr. Tahsildar was convicted of a misdemeanor under Federal law for causing the introduction or delivery for introduction of misbranded drugs into interstate commerce. Additionally, FDA finds that the conduct underlying Dr. Tahsildar's conviction related to the regulation of drugs under the FD&C Act and that the type of conduct underlying his conviction undermines the process for the regulation of drugs. In determining the appropriateness and period of Dr. Tahsildar's debarment, FDA considered the relevant factors listed in the FD&C Act and concluded that a hearing is unnecessary.

The Administration for Community Living is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under section 506(c)(2)(A) of the Paperwork Reduction Act of 1995. This 30-day notice collects comments on the information collection requirements related to the Office of Healthcare Information and Counseling (OHIC) Profiles project at ACL.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for REMEDE SYSTEM and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.

In compliance with of the Paperwork Reduction Act of 1995, HRSA submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30-day comment period for this notice has closed.