Document ID: FDA-2014-N-2187-0002
Agency: fda
Document Type: Notice
Title: Identifying Potential Biomarkers for Qualification and Describing Contexts of Use To Address Areas Important to Drug Development; Extension of Comment Period
Posted Date: 2015-04-03T04:00Z

[Federal Register Volume 80, Number 64 (Friday, April 3, 2015)]
[Notices]
[Page 18244]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-07631]

[[Page 18244]]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-2187]

Identifying Potential Biomarkers for Qualification and Describing 
Contexts of Use To Address Areas Important to Drug Development; 
Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; extension of comment period.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is extending the 
comment period for the notice entitled ``Identifying Potential 
Biomarkers for Qualification and Describing Contexts of Use to Address 
Areas Important to Drug Development; Request for Comments'' that 
appeared in the Federal Register of February 13, 2015 (80 FR 8089). In 
the notice, FDA requested comments on identifying potential biomarkers 
for qualification and describing contexts of use to address areas 
important to drug development. The Agency is taking this action for an 
extension to allow interested persons additional time to submit 
comments.

DATES: Submit either electronic or written comments by May 15, 2015

ADDRESSES: Submit electronic comments to http://www.regulations.gov. 
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Marianne Noone, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 21, Rm. 4528, Silver Spring, MD 20993-0002, 301-
796-7495.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of February 13, 2015 (80 FR 8089), FDA 
published a notice with a 60-day comment period to request comments on 
identifying potential biomarkers for qualification and describing 
contexts of use to address areas important to drug development. FDA is 
encouraging interested groups and individuals to submit information on 
specific medical and biological areas where novel biomarkers can be 
identified that would meaningfully advance drug development.
    The current 60-day comment period does not allow sufficient time to 
obtain the broad public response that will inform FDA's Biomarker 
Qualification Program going forward. FDA is extending the comment 
period for an additional 30 days, thus extending the comment period to 
May 15, 2015. The Agency believes that a 30-day extension allows 
adequate time for interested persons to submit comments without 
significantly delaying progress on these important issues.

II. Request for Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: March 30, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-07631 Filed 4-2-15; 8:45 am]
 BILLING CODE 4164-01-P