A List of Biomarkers Used as Outcomes in Development of FDA-Approved New Molecular Entities and New Biological Therapeutics (October 2007 to December 2015); Establishment of a Public Docket; Correction

---
identifier: "/us/fr/2016-23106"
source: "fr"
legal_status: "authoritative_unofficial"
title: "A List of Biomarkers Used as Outcomes in Development of FDA-Approved New Molecular Entities and New Biological Therapeutics (October 2007 to December 2015); Establishment of a Public Docket; Correction"
title_number: 0
title_name: "Federal Register"
section_number: "2016-23106"
section_name: "A List of Biomarkers Used as Outcomes in Development of FDA-Approved New Molecular Entities and New Biological Therapeutics (October 2007 to December 2015); Establishment of a Public Docket; Correction"
positive_law: false
currency: "2016-09-26"
last_updated: "2016-09-26"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "2016-23106"
document_type: "notice"
publication_date: "2016-09-26"
agencies:
  - "Health and Human Services Department"
  - "Food and Drug Administration"
fr_citation: "81 FR 66039"
fr_volume: 81
docket_ids:
  - "Docket No. FDA-2016-N-2610"
fr_action: "Notice; correction."
---


#  A List of Biomarkers Used as Outcomes in Development of FDA-Approved New Molecular Entities and New Biological Therapeutics (October 2007 to December 2015); Establishment of a Public Docket; Correction

**AGENCY:**

Food and Drug Administration, HHS.

**ACTION:**

Notice; correction.

**SUMMARY:**

The Food and Drug Administration is correcting a notice entitled “A List of Biomarkers Used as Outcomes in Development of FDA-Approved New Molecular Entities and New Biological Therapeutics (October 2007 to December 2015); Establishment of a Public Docket” that appeared in the *Federal Register* of September 19, 2016 (81 FR 64177). The document announced the establishment of a docket to receive suggestions, recommendations, and comments from interested parties (such as academic researchers, regulated industries, consortia, and patient groups) on a list of biomarkers that were used as outcomes to develop FDA-approved new molecular entities (NMEs) and New Biological Therapeutics from October 2007 to December 2015. The document was published without an active Web link. This document corrects that error.

**FOR FURTHER INFORMATION CONTACT:**

Lisa Granger, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3330, Silver Spring MD 20993-0002, 301-796-9115, *[email protected]* .

**SUPPLEMENTARY INFORMATION:**

In the *Federal Register* of Monday, September 19, 2016, in FR Doc. 2016-22470, on page 64178 the following correction is made:

On page 64178, in the second column, in the last sentence of the first paragraph under Section I, Background, “Biomarkers Used as Outcomes in Development of FDA-Approved Therapeutics (October 2007 to December 2015)” is corrected to read “ *http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugDevelopmentToolsQualificationProgram/ucm483052.htm* ”.

Dated: September 21, 2016.

Leslie Kux,

Associate Commissioner for Policy.