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###### Department of Health and Human Services

###### Food and Drug Administration

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

# 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                            ( print 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:                         *Francisco.Vicenty@fda.hhs.gov.*

# 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