United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2022_register executive 2022-07-07 article Notices D09002ee1c7a3b9a1 D09002ee1c7a3ba32 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Jhanna Novikov 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 Ms. Novikov was convicted of one felony count under Federal law for smuggling goods into the United States. The factual basis supporting Ms. Novikov's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Ms. Novikov was given notice of the proposed debarment and was given an opportunity to request a hearing to show why she should not be debarred. As of April 8, 2022 (30 days after receipt of the notice), Ms. Novikov had not responded. Ms. Novikov's failure to respond and request a hearing within the prescribed timeframe constitutes a waiver of her right to a hearing concerning this matter. 87 FR 40539 https://www.govinfo.gov/app/details/FR-2022-07-07/2022-14433 2022-14433 fr07jy22-67 4164-01-P Docket No. FDA-2021-N-1358 https://www.govinfo.gov/app/details/FR-2022-07-07/2022-14433 https://www.govinfo.gov/content/pkg/FR-2022-07-07/html/2022-14433.htm https://www.govinfo.gov/content/pkg/FR-2022-07-07/pdf/2022-14433.pdf 2 p. 40539 40540 87 FR 40539 Jhanna Novikov: Final Debarment Order; Federal Register Vol. 87, Issue NOTICE 2022-14433 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2021-N-1358 4164-01-P 2022-14433 Notice.

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Jhanna Novikov 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 Ms. Novikov was convicted of one felony count under Federal law for smuggling goods into the United States. The factual basis supporting Ms. Novikov's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Ms. Novikov was given notice of the proposed debarment and was given an opportunity to request a hearing to show why she should not be debarred. As of April 8, 2022 (30 days after receipt of the notice), Ms. Novikov had not responded. Ms. Novikov's failure to respond and request a hearing within the prescribed timeframe constitutes a waiver of her right to a hearing concerning this matter.

This order is applicable July 7, 2022. Jaime Espinosa, Division of Enforcement (ELEM-4029), Office of Strategic Planning and Operational Policy, Office of Regulatory Affairs, Food and Drug Administration, 12420 Parklawn Dr., Rockville, MD 20857, 240-402-8743, or at debarments@fda.hhs.gov. Final Debarment Order: Jhanna Novikov, debarments@fda.hhs.gov https://www.regulations.gov Vol. 87, no. 129 Office of the Federal Register, National Archives and Records Administration 2022-07-07 continuing daily deposited born digital 288 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2022-07-07 P0b002ee1b664c4af 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr07jy22 https://www.govinfo.gov/app/details/FR-2022-07-07 https://www.govinfo.gov/content/pkg/FR-2022-07-07/pdf/FR-2022-07-07.pdf https://www.govinfo.gov/content/pkg/FR-2022-07-07/xml/FR-2022-07-07.xml fdlp 40429 40706 DGPO 2022-07-07 2024-05-29 FR-2022-07-07 machine generated eng FR FR-2022-07-07 87 129