[Federal Register Volume 81, Number 4 (Thursday, January 7, 2016)]
[Notices]
[Pages 784-786]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-00065]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-4602]


Streamlining Regulations for Good Manufacturing Practices for 
Hearing Aids; Public Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
following public workshop entitled ``Streamlining Regulations for Good 
Manufacturing Practices (GMPs) for Hearing Aids.'' The topic to be 
discussed is the appropriate level of good manufacturing practices 
(GMPs) regulation to ensure the safety and effectiveness of air-
conduction hearing aid devices.

DATES: The public workshop will be held on April 21, 2016, from 8:30 
a.m. to 5 p.m. Submit either electronic or written comments on the 
public workshop by May 19, 2016.

ADDRESSES: The public workshop will be held at FDA's White Oak Campus, 
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room 
(Rm. 1503), Silver Spring, MD 20993-0002. Entrance for the public 
meeting participants (non-FDA employees) is through Building 1 where 
routine security check procedures will be performed. For parking and 
security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.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-2015-N-4602 for ``Streamlining Regulations for Good Manufacturing 
Practices (GMPs) for Hearing Aids.'' 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 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.

[[Page 785]]


FOR FURTHER INFORMATION CONTACT: Srinivas Nandkumar, Food and Drug 
Administration, Center for Devices and Radiological Health, Bldg. 66, 
Rm. 2436, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-
6480, FAX: 301-847-8126, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Over 35 million people in the United States have some degree of 
hearing loss. However, it is estimated that only 20 percent of 
individuals who could benefit from hearing aids are using them. There 
are several well-recognized reasons or ``barriers'' causing underuse of 
hearing aids, including the high cost of these devices, the stigma 
associated with hearing aid use, and the fact that hearing aids do not 
restore hearing to normal the way that eyeglasses can correct visual 
problems. On October 26, 2015, the President's Council on Science and 
Technology (PCAST) issued a report in recognition of the substantial 
national public health problem of barriers to accessibility and 
affordability of hearing aids for Americans with ``normal, age-related, 
progressive, mild-to-moderate hearing loss'' and the underuse of these 
devices in the older American population. The report includes a number 
of recommendations regarding possible modifications to Federal 
Regulation of hearing aids by FDA and the Federal Trade Commission, 
which PCAST believes could ``enhance the pace of innovation and level 
of competition, leading to rapid decrease in cost and improvement in 
capability, convenience, and use of assistive hearing devices'' 
(https://www.whitehouse.gov/sites/default/files/microsites/ostp/PCAST/pcast_hearing_tech_letterreport_final2.pdf). Among these 
recommendations, PCAST recommended FDA exempt hearing aids indicated 
for bilateral, gradual onset, mild-to-moderate age-related hearing loss 
from the Quality System Regulation (QSReg) in its present form and 
``substitute compliance with standards for product quality and 
recordkeeping appropriate for the consumer electronics industry, 
developed by an appropriate third-party organization and approved by 
FDA.''

II. Topics for Discussion at the Public Workshop

    In response to PCAST's recommendations outlined in this document, 
the workshop will discuss the current GMPs that are required under the 
QSReg and gather suggestions for an alternative model for quality 
verification. Invited speakers will discuss how the current regulations 
may be unsuitable for air-conduction hearing aids and may hinder 
innovation, reduce competition, and lead to increased cost and reduced 
use of these devices by Americans with age-related hearing loss. 
Additionally, the potential exemption of hearing aids from the QSReg, 
through use of alternative standards developed in collaboration with 
key stakeholders and standards development organizations, and 
recognized by FDA and recordkeeping to ensure product quality, will be 
discussed.
    Registration: Registration is free and available on a first-come, 
first-served basis. Persons interested in attending this public 
workshop must register online by 4 p.m. on April 13, 2016. Early 
registration is recommended because facilities are limited and, 
therefore, FDA may limit the number of participants from each 
organization. If time and space permits, onsite registration on the day 
of the public workshop will be provided beginning at 7:30 a.m.
    If you need special accommodations due to a disability, please 
contact Susan Monahan, Center for Devices and Radiological Health, 
Office of Communication and Education, 301-796-5661, 
[email protected] no later than April 7, 2016.
    To register for the public workshop, please visit FDA's Medical 
Devices News & Events--Workshops & Conferences calendar at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. 
(Select this meeting/public workshop from the posted events list.) 
Please provide complete contact information for each attendee, 
including name, title, affiliation, email, and telephone number. Those 
without Internet access should contact Susan Monahan (contact for 
special accommodations) to register. Registrants will receive 
confirmation after they have been accepted. You will be notified if you 
are on a waiting list.
    Streaming Webcast of the Public Workshop: This public workshop will 
also be Webcast. The Webcast link will be available on the workshop Web 
page after April 14, 2016. Please visit FDA's Medical Devices News & 
Events--Workshops & Conferences calendar at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select 
this public workshop from the posted events list.) If you have never 
attended a Connect Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a 
quick overview of the Connect Pro program, visit http://www.adobe.com/go/connectpro_overview. FDA has verified the Web site addresses in this 
document, as of the date this document publishes in the Federal 
Register, but Web sites are subject to change over time.
    Requests for Oral Presentations: This public workshop includes a 
public comment session and topic-focused sessions. During online 
registration, you may indicate if you wish to present during a public 
comment session or participate in a specific session, and which topics 
you wish to address. FDA has included general topics in this document. 
FDA will do its best to accommodate requests to make public comments. 
Individuals and organizations with common interests are urged to 
consolidate or coordinate their presentations, and request time for a 
joint presentation, or submit requests for designated representatives 
to participate in the focused sessions. Following the close of 
registration, FDA will determine the amount of time allotted to each 
presenter and the approximate time each oral presentation is to begin, 
and will select and notify participants by April 15, 2016. All requests 
to make oral presentations must be received by the close of 
registration on April 13, 2016, 4 p.m. If selected for presentation, 
any presentation materials must be emailed to Srinivas Nandkumar (see 
FOR FURTHER INFORMATION CONTACT) no later than April 19, 2016. No 
commercial or promotional material will be permitted to be presented or 
distributed at the public workshop.
    FDA is holding this public workshop to obtain information on the 
appropriate level of good manufacturing practices for hearing aids. In 
order to permit the widest possible opportunity to obtain public 
comment, FDA is soliciting either electronic or written comments on all 
aspects of the public workshop topics. The deadline for submitting 
comments related to this public workshop is May 19, 2016.
    Transcripts: Please be advised that as soon as a transcript is 
available, it will be accessible at http://www.regulations.gov. It may 
be viewed at the Division of Dockets Management (see ADDRESSES). A 
transcript will also be available in either hardcopy or on CD-ROM, 
after submission of a Freedom of Information request. The Freedom of 
Information office address is available on the Agency's Web site at 
http://www.fda.gov. A link to the transcripts will also be available 
approximately 45 days after the public workshop on the Internet at 
http://www.fda.gov/MedicalDevices/

[[Page 786]]

NewsEvents/WorkshopsConferences/default.htm. (Select this meeting/
public workshop from the posted events list.)

    Dated: December 31, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-00065 Filed 1-6-16; 8:45 am]
BILLING CODE 4164-01-P