Document ID: FDA-2017-N-4180-0003
Agency: fda
Document Type: Notice
Title: Voluntary Medical Device Manufacturing and Product Quality Program; Public Workshop; Request for Comments; Reopening of Comment Period
Posted Date: 2017-10-30T04:00Z

[Federal Register Volume 82, Number 208 (Monday, October 30, 2017)]
[Notices]
[Pages 50147-50148]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-23498]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-4180]

Voluntary Medical Device Manufacturing and Product Quality 
Program; Public Workshop; Request for Comments; Reopening of Comment 
Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reopening of the comment period.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
reopening the comment period provided in the notice entitled 
``Voluntary Medical Device Manufacturing and Product Quality Program; 
Public Workshop; Request for Comments,'' published in the Federal 
Register of July 25, 2017 (82 FR 34531). That notice announced the 
public workshop to be held on October 10, 2017, and requested comments 
by October 18, 2017. The Agency is taking this action to allow 
interested parties additional time to submit comments.

DATES: FDA is reopening the comment period for the public workshop 
``Voluntary Medical Device Manufacturing and Product Quality Program; 
Public Workshop; Request for Comments'' published on July 25, 2017 (82 
FR 34531). Submit either electronic or written comments on this public 
workshop by December 14, 2017.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before December 14, 2017. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of December 14, 2017. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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-2017-N-4180 for ``Voluntary Medical Device Manufacturing and 
Product Quality Program; Public Workshop; Request for Comments; 
Reopening of Comment Period.'' Received comments, those filed in a 
timely manner (see ADDRESSES), will be placed in the docket and, except 
for those submitted as ``Confidential Submissions,'' publicly viewable 
at https://www.regulations.gov or at the Dockets Management Staff 
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

[[Page 50148]]

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 https://www.regulations.gov. Submit both copies to the Dockets 
Management Staff. 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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Francisco Vicenty, Food and Drug 
Administration, Center for Devices and Radiological Health, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 3426, Silver Spring, MD 20993, 301-796-
5577, email: [email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of July 25, 2017 (82 
FR 34531), FDA published a notice announcing the public workshop 
entitled ``Voluntary Medical Device Manufacturing and Product Quality 
Program; Public Workshop; Request for Comments'' with an 85-day comment 
period to request comments. The public workshop was held on October 10, 
2017. FDA is reopening the comment period for the public workshop until 
December 14, 2017. The Agency believes that this will allow adequate 
time for interested persons to submit comments without significantly 
delaying the action by the Agency.

    Dated: October 24, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-23498 Filed 10-27-17; 8:45 am]
 BILLING CODE 4164-01-P