Document ID: FDA-2016-N-2610-0002
Agency: fda
Document Type: Notice
Title: A List of Biomarkers Used as Outcomes in Development of FDAApproved
New Molecular Entities and New Biological Therapeutics (October 2007 to December 2015); Establishment of a Public Docket; Correction
Posted Date: 2016-09-26T04:00Z

[Federal Register Volume 81, Number 186 (Monday, September 26, 2016)]
[Notices]
[Pages 66039-66040]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-23106]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-2610]

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.

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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, lisa.granger@fda.hhs.gov.

[[Page 66040]]

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.
[FR Doc. 2016-23106 Filed 9-23-16; 8:45 am]
 BILLING CODE 4164-01-P