Document ID: FDA-2015-N-2881-0002
Agency: fda
Document Type: Notice
Title: Standards-Based Approach to Analytical Performance Evaluation of
Next Generation Sequencing in Vitro Diagnostic Tests; Public Workshop;
Reopening of Comment Period
Posted Date: 2015-12-09T05:00Z

[Federal Register Volume 80, Number 236 (Wednesday, December 9, 2015)]
[Notices]
[Pages 76500-76501]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-30937]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-2881]

Standards-Based Approach to Analytical Performance Evaluation of 
Next Generation Sequencing in Vitro Diagnostic Tests; Public Workshop; 
Reopening of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; reopening of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is reopening the 
comment period for the notice of a public workshop that appeared in the 
Federal Register of September 9, 2015. In the notice of the public 
workshop, FDA requested comments on the workshop topics about the 
proposed standards-based regulatory strategy for next-generation 
sequencing (NGS) tests that produce results on variation in the human 
genome. The Agency is taking this action in response to requests to 
allow interested persons additional time to submit comments.

DATES: FDA is reopening the comment period for the notice of the public 
workshop published September 9, 2015. Submit either electronic or 
written comments by December 24, 2015.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2015-N-2881 for ``Standards-Based Approach to Analytical 
Performance Evaluation of Next-Generation Sequencing In Vitro 
Diagnostic Tests.'' Received comments will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at http://www.regulations.gov or at the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information

[[Page 76501]]

redacted/blacked out, will be available for public viewing and posted 
on http://www.regulations.gov. Submit both copies to the Division of 
Dockets Management. If you do not wish your name and contact 
information to be made publicly available, you can provide this 
information on the cover sheet and not in the body of your comments and 
you must identify this information as ``confidential.'' Any information 
marked as ``confidential'' will not be disclosed except in accordance 
with 21 CFR 10.20 and other applicable disclosure law. For more 
information about FDA's posting of comments to public dockets, see 80 
FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Zivana Tezak, Center for Devices and 
Radiological Health, Food and Drug Administration, Bldg. 66, Rm. 4544, 
Silver Spring, MD 20993, 301-796-6206, zivana.tezak@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In the Federal Register of September 9, 2015 
(80 FR 54292), FDA published a notice of a public workshop with a 
deadline of November 25, 2015, to request comments on the workshop 
topics about the proposed standards-based regulatory strategy for NGS 
tests that produce results on variation in the human genome. Comments 
on the public meeting topics will inform FDA's development of such 
strategies.
    FDA is reopening the comment period for the notice of the public 
workshop until December 24, 2015. The Agency believes that the 
extension allows adequate time for interested persons to submit 
comments without significantly delaying decisionmaking on these 
important issues.

    Dated: December 3, 2015.
Peter Lurie,
Associate Commissioner for Public Health Strategy and Analysis.
[FR Doc. 2015-30937 Filed 12-8-15; 8:45 am]
BILLING CODE 4164-01-P