AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop; request for comments.
SUMMARY: The Food and Drug Administration (FDA) is announcing a public
workshop entitled "Next Generation Sequencing-Based Oncology Panels."
The purpose of this workshop is to obtain feedback on analytical and
clinical validation approaches for next generation sequencing (NGS)-
based oncology panels. Comments and suggestions generated through this
workshop will help guide the development of appropriate regulatory
standards for evaluation of NGS-based oncology panels in cancer patient
DATES: The public workshop will be held on February 25, 2016, from 8:30
a.m. to 5 p.m. Submit either electronic or written comments on the
public workshop by March 28, 2016.
ADDRESSES: The public workshop will be held at FDA's White Oak Campus,
10903 New Hampshire Ave., Bldg. 31, Rm. 1503 B and C (the Great Room),
Silver Spring, MD 20993. Entrance for the public workshop participants
(non-FDA employees) is through Building 1 where routine security check
procedures will be performed. For parking and security information,
please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
You may submit comments as follows:
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").
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-4990 for "Next Generation Sequencing-Based Oncology
Panels." 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 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: Jennifer Dickey, Center for Devices
and Radiological Health, Food and Drug Administration, Bldg. 66, Rm.
5648, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-5028,