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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

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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.

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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, lisa.granger@fda.hhs.gov.

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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”.

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Dated: September 21, 2016.

Leslie Kux,

Associate Commissioner for Policy.

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[FR Doc. 2016-23106 Filed 9-23-16; 8:45 am]

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