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 2020_register executive 2020-07-08 article Notices D09002ee1c7b782bb D09002ee1c7b7833d 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 or Agency) is announcing the establishment of a docket to solicit comments on the listing of patent information in the FDA publication, "Approved Drug Products With Therapeutic Equivalence Evaluations" (commonly known as the "Orange Book"). We are soliciting comments on the types of patents currently listed in the Orange Book and the impact that any change to current patent listing practices may have on drug product development. This notice is not intended to communicate our regulatory expectations on these issues but is instead intended to seek early input from the public to inform further regulatory action if determined to be appropriate. 85 FR 33169 https://www.govinfo.gov/app/details/FR-2020-06-01/2020-11684 2020-11684 fr01jn20-74 4164-01-P Docket No. FDA-2020-N-1127 https://www.govinfo.gov/app/details/FR-2020-06-01/2020-11684 https://www.govinfo.gov/content/pkg/FR-2020-06-01/html/2020-11684.htm https://www.govinfo.gov/content/pkg/FR-2020-06-01/pdf/2020-11684.pdf 5 p. 33169 33173 85 FR 33169 Listing of Patent Information in the Orange Book; Establishment of a Public Docket; Request for Comments; Federal Register Vol. 85, Issue NOTICE 2020-11684 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2020-08-31 Docket No. FDA-2020-N-1127 4164-01-P 2020-11684 Notice; establishment of a public docket; request for comments.

The Food and Drug Administration (FDA or Agency) is announcing the establishment of a docket to solicit comments on the listing of patent information in the FDA publication, "Approved Drug Products With Therapeutic Equivalence Evaluations" (commonly known as the "Orange Book"). We are soliciting comments on the types of patents currently listed in the Orange Book and the impact that any change to current patent listing practices may have on drug product development. This notice is not intended to communicate our regulatory expectations on these issues but is instead intended to seek early input from the public to inform further regulatory action if determined to be appropriate.

Submit either electronic or written comments by August 31, 2020. Elizabeth Giaquinto Friedman, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1670, Silver Spring, MD 20993, 240- 402-7930, Elizabeth.Giaquinto@fda.hhs.gov. Elizabeth.Giaquinto@fda.hhs.gov https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072884.pdf https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf https://www.regulations.gov Vol. 85, no. 105 Office of the Federal Register, National Archives and Records Administration 2020-06-01 continuing daily deposited born digital 559 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2020-06-01 P0b002ee1a7580315 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr01jn20 https://www.govinfo.gov/app/details/FR-2020-06-01 https://www.govinfo.gov/content/pkg/FR-2020-06-01/pdf/FR-2020-06-01.pdf https://www.govinfo.gov/content/pkg/FR-2020-06-01/xml/FR-2020-06-01.xml fdlp 32977 33525 DGPO 2020-07-08 2024-05-30 FR-2020-06-01 machine generated eng FR FR-2020-06-01 85 105