[Federal Register Volume 81, Number 89 (Monday, May 9, 2016)]
[Notices]
[Pages 28083-28084]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-10798]


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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; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA or we) is extending the 
comment period for the document entitled ``Streamlining Regulations for 
Good Manufacturing Practices for Hearing Aids; Public Workshop'' that 
appeared in the Federal Register of January 7, 2016. In the document, 
FDA requested comments on the appropriate level of good manufacturing 
practices (GMPs) regulation to ensure the safety and effectiveness of 
air-conduction hearing aid devices. The Agency is taking this action in 
response to requests for an extension to allow interested persons 
additional time to submit comments.

DATES: FDA is extending the comment period on the document published 
January 7, 2016 (81 FR 784). Submit either electronic or written 
comments by June 30, 2016.

ADDRESSES: 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

[[Page 28084]]

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 for Hearing Aids; Public Workshop; 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 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: 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: In the Federal Register of January 7, 2016 
(81 FR 784), FDA published a document with a 30-day comment period to 
request comments on the appropriate level of GMPs regulation to ensure 
the safety and effectiveness of air-conduction hearing aid devices; the 
current regulations for air-conduction hearing aids that may hinder 
innovation, reduce competition, and lead to increased cost and reduced 
use of these devices by Americans with age-related hearing loss; and 
the potential exemption of hearing aids from the Quality System 
Regulation (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. Comments on the ``Streamlining Regulations for Good 
Manufacturing Practices for Hearing Aids'' will inform the Agency on an 
alternative model for quality verification.
    The Agency has received requests for a 30-day extension of the 
comment period for the document. Each request conveyed concern that the 
current 30-day comment period does not allow sufficient time to develop 
a meaningful or thoughtful response to the document on ``Streamlining 
Regulations for Good Manufacturing Practices for Hearing Aids.''
    FDA has considered the requests and is extending the comment period 
for the document on ``Streamlining Regulations for Good Manufacturing 
Practices for Hearing Aids'' for 30 days, until June 30, 2016. The 
Agency believes that a 30-day extension allows adequate time for 
interested persons to submit comments without significantly delaying 
regulation on these important issues.

    Dated: May 3, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-10798 Filed 5-6-16; 8:45 am]
 BILLING CODE 4164-01-P