Health and Human Services Department, Food and Drug Administration
The Food and Drug Administration (FDA or Agency) is denying a request for a hearing submitted by Rahim Shafa (Dr. Shafa) and is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Dr. Shafa from providing services in any capacity to a person that has an approved or pending drug product application and debarring Dr. Shafa for 20 years from importing or offering for import any drug into the United States. FDA bases this order on the findings that Dr. Shafa was convicted of multiple felonies under Federal law that relate to the regulation of any drug product under the FD&C Act and the importation into the United States of any drug or controlled substance under the FD&C Act. FDA provided notice to Dr. Shafa of the proposed debarment and an opportunity to request a hearing. Dr. Shafa submitted a request for a hearing but failed to file with the Agency information and analyses sufficient to create a basis for a hearing.
Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2025-N-1599] AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA or Agency) is denying a request for a hearing submitted by Rahim Shafa (Dr. Shafa) and is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Dr. Shafa from providing services in any capacity to a person that has an approved or pending drug product application and debarring Dr. Shafa for 20 years from importing or offering for import any drug into the United States. ( printed page 55887) FDA bases this order on the findings that Dr. Shafa was convicted of multiple felonies under Federal law that relate to the regulation of any drug product under the FD&C Act and the importation into the United States of any drug or controlled substance under the FD&C Act. FDA provided notice to Dr. Shafa of the proposed debarment and an opportunity to request a hearing. Dr. Shafa submitted a request for a hearing but failed to file with the Agency information and analyses sufficient to create a basis for a hearing. DATES: This order is applicable August 31, 2026. ADDRESSES: Any application for termination of debarment by Dr. Shafa under section 306(d) of the FD&C Act ( 21 U.S.C. 335a(d) ) (application) may be submitted as follows: Electronic Submissions Federal eRulemaking Portal: https://www.regulations.gov . Follow the instruction…
Citation: 91 FR 55886
