[Federal Register Volume 81, Number 153 (Tuesday, August 9, 2016)]
[Notices]
[Pages 52695-52696]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-18814]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-2147]


General and Plastic Surgery Devices Panel of the Medical Devices 
Advisory Committee; Notice of Meeting, Establishment of a Public 
Docket, Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice, establishment of a public docket, request for comments.

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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming 
public advisory committee meeting of the General and Plastic Surgery 
Devices Panel of the Medical Devices Advisory Committee. The general 
function of the committee is to provide advice and recommendations to 
the Agency on FDA's regulatory issues. The meeting will be open to the 
public. FDA is establishing a docket for public comment on this 
document.

DATES: The meeting will be held on September 20 and 21, 2016, from 8 
a.m. to 6 p.m.

ADDRESSES: Hilton Washington, DC North/Gaithersburg, Grand Ballroom, 
620 Perry Pkwy., Gaithersburg, MD 20877. The hotel's telephone number 
is 301-977-8900. Answers to commonly asked questions including 
information regarding special accommodations due to a disability, 
visitor parking, and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    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-2147 for ``General and Plastic Surgery Devices Panel of the 
Medical Devices Advisory Committee; Notice of Meeting; Establishment of 
a Public Docket; Request for Comments.'' 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

[[Page 52696]]

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: Evella Washington, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 1535, Silver Spring, MD 20993-0002, 301-
796-6683, [email protected], or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area).
    A notice in the Federal Register about last minute modifications 
that impact a previously announced advisory committee meeting cannot 
always be published quickly enough to provide timely notice. Therefore, 
you should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate 
advisory committee meeting link, or call the advisory committee 
information line to learn about possible modifications before coming to 
the meeting.

SUPPLEMENTARY INFORMATION:
    Agenda: On September 20 and 21, 2016, the Committee will discuss 
and make recommendations regarding the classification of certain wound 
care products containing antimicrobials and other drugs as part of the 
routine process for device classification. These products are regulated 
under product code FRO, ``Dressing, Wound, Drug,'' and are considered 
``pre-amendments'' because they were in commercial distribution prior 
to May 28, 1976, when the Medical Devices Amendments were enacted, and 
have not yet been classified under section 513 of the Federal Food, 
Drug, and Cosmetic Act.
    As a part of the classification process, FDA is seeking committee 
input on the indications for use, risks to health, and safety and 
effectiveness of these wound care products, and how they should be 
classified. They may be classified in class I (general controls), class 
II (special and general controls), or class III (premarket approval 
(PMA), requiring demonstration of safety and effectiveness for each 
product).
    FDA believes some of these products may meet the definition of 
class II whereas others may meet the definition of class III in light 
of their intended use, composition, the extent of evidence of clinical 
benefit, and the risks they pose. For the subset of the these products 
that contain antibiotics, FDA appreciates the importance of 
appropriately addressing the risk of antimicrobial resistance (AMR) in 
light of the increasingly significant national public health concern 
posed by AMR. FDA is also aware of differences in the claims made for 
some products even though they may be regulated in the same manner.
    FDA intends to make background material available to the public on 
its Web site at least 2 business days before the meeting. If FDA is 
unable to post the background material on its Web site prior to the 
meeting, the background material will be made publicly available at the 
location of the meeting, and the background material will be posted on 
FDA's Web site after the meeting. Background material will be available 
at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll 
down to the appropriate advisory committee meeting link.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 
Written submissions may be made to the contact person on or before 
September 6, 2016. Oral presentations from the public will be scheduled 
between approximately 1 p.m. and 2 p.m. on September 20 and between 
approximately 9 a.m. and 10:30 a.m. on September 21, 2016. Those 
individuals interested in making formal oral presentations should 
notify the contact person and submit a brief statement of the general 
nature of the evidence or arguments they wish to present, the names and 
addresses of proposed participants, and an indication of the 
approximate time requested to make their presentation on or before 
August 26, 2016. Time allotted for each presentation may be limited. If 
the number of registrants requesting to speak is greater than can be 
reasonably accommodated during the scheduled open public hearing 
session, FDA may conduct a lottery to determine the speakers for the 
scheduled open public hearing session. The contact person will notify 
interested persons regarding their request to speak by August 29, 2016.
    Persons attending FDA's advisory committee meetings are advised 
that the Agency is not responsible for providing access to electrical 
outlets.
    FDA is establishing a docket for public comment on this document. 
The docket number is FDA-2016-N-2147. The docket will close on October 
20, 2016. Comments received on or before September 1, 2016, will be 
provided to the committee. Comments received after that date will be 
taken into consideration by the Agency.
    For press inquiries, please contact the Office of Media Affairs at 
[email protected] or 301-796-4540.
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
disabilities. If you require accommodations due to a disability, please 
contact AnnMarie Williams at [email protected], or 301-796-
5966 at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures 
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: August 3, 2016.
Janice M. Soreth,
Acting Associate Commissioner, Special Medical Programs.
[FR Doc. 2016-18814 Filed 8-8-16; 8:45 am]
 BILLING CODE 4164-01-P