2018-20795. Pediatric Medical Device Development; Public Meeting; Request for Comments; Reopening of Comment Period

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice; reopening of comment period.

SUMMARY:

The Food and Drug Administration (FDA or Agency) is reopening the comment period provided in the notice entitled “Pediatric Medical Device Development; Public Meeting; Request for Comments” that appeared in the Federal Register on February 16, 2018. That notice announced the public meeting to be held on August 13 and 14, 2018, and requested comments by September 14, 2018. FDA is reopening the public meeting's comment period until November 26, 2018. 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 meeting “Pediatric Medical Device Development; Public Meeting; Request for Comments” published on February 16, 2018 (83 FR 7052). Submit either electronic or written comments on this meeting by November 26, 2018.

ADDRESSES:

You may submit comments as follows:

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-2018-N-0404 for “Pediatric Medical Device Development; Public Meeting; Request for Comments; Reopening of Comment Period.” Received comments 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 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:

Victoria Wagman, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5562, Silver Spring, MD 20993, 301-796-6581, [e-mail].

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of February 16, 2018 (83 FR 7052), FDA published a notice announcing the public meeting entitled “Pediatric Medical Device Development” with a 30-day comment period post the meeting to request comments. The public meeting was held on August 13 and 14, 2018. FDA is reopening the comment period for the public meeting until November 26, 2018. The Agency believes that this will allow adequate time for interested persons to submit comments without significantly delaying action by the Agency.

Dated: September 19, 2018.

Leslie Kux,

Associate Commissioner for Policy.