[Federal Register Volume 81, Number 4 (Thursday, January 7, 2016)]
[Notices]
[Pages 786-787]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-00066]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1295]


Regulatory Requirements for Hearing Aid Devices and Personal 
Sound Amplification Products; Draft Guidance for Industry and Food and 
Drug Administration Staff; Reopening of the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reopening of the comment period.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is reopening 
the comment period for the draft guidance entitled ``Regulatory 
Requirements for Hearing Aid Devices and Personal Sound Amplification 
Products.'' A notice of availability requesting comments on the draft 
guidance document appeared in the Federal Register of November 7, 2013. 
The Agency is reopening the comment period to receive updated comments 
and any new information.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment of this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by May 6, 2016.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 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-2013-D-1295 for ``Regulatory Requirements for Hearing Aid Devices 
and Personal Sound Amplification Products'' draft guidance. 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.
    An electronic copy of the draft guidance document is available for 
download from the Internet. See the SUPPLEMENTARY INFORMATION section 
for information on electronic access to the draft guidance. Submit 
written requests for a single hard copy of the draft guidance document 
entitled ``Regulatory Requirements for Hearing Aid Devices and Personal 
Sound Amplification Products'' to the Office of the Center Director, 
Guidance and Policy Development, Center for Devices and Radiological 
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-addressed 
adhesive label to assist that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Eric Mann, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 2438, Silver Spring, MD 20993-0002, 301-796-6460.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of November 7, 2013 (78 FR 66940), FDA 
published a notice of availability with a 90-day comment period to 
request comments on the draft guidance entitled ``Regulatory 
Requirements for Hearing Aid Devices and Personal Sound Amplification 
Products.''
    Since issuance of the November 7, 2013, draft guidance entitled 
``Regulatory Requirements for Hearing Aid Devices and Personal Sound 
Amplification Products,'' FDA has become aware of other efforts by the 
President's Council of Advisors on Science and Technology (PCAST) and

[[Page 787]]

Institute of Medicine (IOM) regarding hearing aids and personal sound 
amplification products (PSAP). In order to allow FDA and other 
interested parties to consider the PCAST recommendations and 
information presented and discussed during the recent public IOM 
meetings on this issue, FDA is reopening the comment period. This will 
further allow FDA to ensure consistent interpretation, consistent 
application of relevant regulatory requirements, and adequate 
protection of the public health.
    FDA is reopening the comment period for 120 days. The Agency 
believes that a 120-day extension allows adequate time for interested 
parties to submit comments without significantly delaying finalizing 
the draft guidance on these important issues.

II. Other Issues for Consideration

    FDA is soliciting comments on the availability, accessibility, and 
use of hearing aids and PSAPs for consumers with hearing impairment. 
Further, FDA requests interested parties to comment on the key issues 
and recommendations identified in the PCAST reporting, including: (1) 
The degree to which current FDA regulatory requirements may be acting 
as a barrier to hearing aid accessibility, affordability, and use of 
hearing aids; (2) the appropriateness of creating a ``basic'' category 
of hearing aids for consumers with ``bilateral, gradual onset, mild-to-
moderate age-related hearing loss'' with appropriate labeling for over-
the-counter sale; and (3) whether the benefits of expanded, over-the-
counter access to hearing aids in this age-related hearing loss 
population outweigh the risks of forgoing the condition for sale (that 
the consumer may waive) that requires a medical evaluation to rule out 
treatable, potentially progressive causes of hearing loss.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do 
so by downloading an electronic copy from the Internet. A search 
capability for all Center for Devices and Radiological Health guidance 
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at http://www.regulations.gov. Persons 
unable to download an electronic copy of ``Regulatory Requirements for 
Hearing Aid Devices and Personal Sound Amplification Products'' may 
send an email request to CDRH-Guidance@fda.hhs.gov to receive an 
electronic copy of the document. Please use the document number1832 to 
identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR part 801 have been approved under 
OMB control number 0910-0485, and the collections of information in 21 
CFR part 807 subpart E have been approved under OMB control number 
0910-0120.

    Dated: December 31, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-00066 Filed 1-6-16; 8:45 am]
BILLING CODE 4164-01-P