[Federal Register Volume 81, Number 83 (Friday, April 29, 2016)]
[Notices]
[Pages 25678-25679]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-10106]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0610]
Mass Spectrometry in the Clinic: Regulatory Considerations
Surrounding Validation of Liquid Chromatography-Mass Spectrometry Based
Devices; 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 March 9, 2016. In the notice of the public
workshop, FDA requested comments on the workshop topics concerning the
use of liquid chromatography/mass-spectrometry (LC/MS)-based in vitro
diagnostic devices (IVDs) in the clinical laboratory. 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 public
workshop published March 9, 2016. Submit either electronic or written
comments by June 2, 2016.
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-2016-N-0610 for ``Mass Spectrometry in the Clinic: Regulatory
Considerations Surrounding Validation of Liquid Chromatography-Mass
Spectrometry Based Devices.'' 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
[[Page 25679]]
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: Julia Tait Lathrop, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5614, Silver Spring, MD 20993, 240-402-
5034, [email protected].
SUPPLEMENTARY INFORMATION: In the Federal Register of March 9, 2016,
(81 FR 12511), FDA published a notice of a public workshop with a
deadline of April 20, 2016, to request comments on the workshop topics
concerning the use of LC/MS-based IVDs in the clinical laboratory.
Comments on the public workshop topics will inform FDA's development
and validation of LC/MS-based devices, especially validation
considerations for protein- and peptide-based LC/MS devices.
FDA is reopening the comment period for the notice of the public
workshop until June 2, 2016. The Agency believes that the extension
allows adequate time for interested persons to submit comments without
significantly delaying decision making on these important issues.
Dated: April 26, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-10106 Filed 4-28-16; 8:45 am]
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