81_FR_790 81 FR 786 - Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products; Draft Guidance for Industry and Food and Drug Administration Staff; Reopening of the Comment Period

81 FR 786 - Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products; Draft Guidance for Industry and Food and Drug Administration Staff; Reopening of the Comment Period

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 4 (January 7, 2016)

Page Range786-787
FR Document2016-00066

The Food and Drug Administration (FDA or Agency) is reopening the comment period for the draft guidance entitled ``Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products.'' A notice of availability requesting comments on the draft guidance document appeared in the Federal Register of November 7, 2013.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

Federal Register, Volume 81 Issue 4 (Thursday, January 7, 2016) 
[Federal Register Volume 81, Number 4 (Thursday, January 7, 2016)]
[Notices]
[Pages 786-787]
From the Federal Register Online  [www.thefederalregister.org]
[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Sound Amplification Products; Draft Guidance for Industry and Food and 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the comment period for the draft guidance entitled ``Regulatory 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 A notice of availability requesting comments on the draft 
guidance document appeared in the Federal Register of November 7, 2013.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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by May 6, 2016.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 [email protected] 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

786 Federal Register / Vol. 81, No. 4 / Thursday, January 7, 2016 / Notices NewsEvents/WorkshopsConferences/ anyone else’s Social Security number, or sheet and not in the body of your default.htm. (Select this meeting/public confidential business information, such comments and you must identify this workshop from the posted events list.) as a manufacturing process. Please note information as ‘‘confidential.’’ Any Dated: December 31, 2015. that if you include your name, contact information marked as ‘‘confidential’’ Leslie Kux, information, or other information that will not be disclosed except in identifies you in the body of your accordance with 21 CFR 10.20 and other Associate Commissioner for Policy. comments, that information will be applicable disclosure law. For more [FR Doc. 2016–00065 Filed 1–6–16; 8:45 am] posted on http://www.regulations.gov. information about FDA’s posting of BILLING CODE 4164–01–P • If you want to submit a comment comments to public dockets, see 80 FR with confidential information that you 56469, September 18, 2015, or access do not wish to be made available to the the information at: http://www.fda.gov/ DEPARTMENT OF HEALTH AND public, submit the comment as a regulatoryinformation/dockets/ HUMAN SERVICES written/paper submission and in the default.htm. manner detailed (see ‘‘Written/Paper Docket: For access to the docket to Food and Drug Administration Submissions’’ and ‘‘Instructions’’). read background documents or the [Docket No. FDA–2013–D–1295] electronic and written/paper comments Written/Paper Submissions received, go to http:// Regulatory Requirements for Hearing Submit written/paper submissions as www.regulations.gov and insert the Aid Devices and Personal Sound follows: docket number, found in brackets in the Amplification Products; Draft • Mail/Hand delivery/Courier (for heading of this document, into the Guidance for Industry and Food and written/paper submissions): Division of ‘‘Search’’ box and follow the prompts Drug Administration Staff; Reopening Dockets Management (HFA–305), Food and/or go to the Division of Dockets of the Comment Period and Drug Administration, 5630 Fishers Management, 5630 Fishers Lane, Rm. Lane, Rm. 1061, Rockville, MD 20852. AGENCY: Food and Drug Administration, • For written/paper comments 1061, Rockville, MD 20852. HHS. submitted to the Division of Dockets An electronic copy of the draft Notice; reopening of the ACTION: Management, FDA will post your guidance document is available for comment period. comment, as well as any attachments, download from the Internet. See the SUPPLEMENTARY INFORMATION section for except for information submitted, SUMMARY: The Food and Drug marked and identified, as confidential, information on electronic access to the Administration (FDA or Agency) is if submitted as detailed in draft guidance. Submit written requests reopening the comment period for the ‘‘Instructions.’’ for a single hard copy of the draft draft guidance entitled ‘‘Regulatory Instructions: All submissions received guidance document entitled ‘‘Regulatory Requirements for Hearing Aid Devices must include the Docket No. FDA– Requirements for Hearing Aid Devices and Personal Sound Amplification 2013–D–1295 for ‘‘Regulatory and Personal Sound Amplification Products.’’ A notice of availability Requirements for Hearing Aid Devices Products’’ to the Office of the Center requesting comments on the draft and Personal Sound Amplification Director, Guidance and Policy guidance document appeared in the Products’’ draft guidance. Received Development, Center for Devices and Federal Register of November 7, 2013. comments will be placed in the docket Radiological Health, Food and Drug The Agency is reopening the comment and, except for those submitted as Administration, 10903 New Hampshire period to receive updated comments ‘‘Confidential Submissions,’’ publicly Ave., Bldg. 66, Rm. 5431, Silver Spring, and any new information. viewable at http://www.regulations.gov MD 20993–0002. Send one self- DATES: Although you can comment on or at the Division of Dockets addressed adhesive label to assist that any guidance at any time (see 21 CFR Management between 9 a.m. and 4 p.m., office in processing your request. 10.115(g)(5)), to ensure that the Agency Monday through Friday. FOR FURTHER INFORMATION CONTACT: Eric considers your comment of this draft • Confidential Submissions—To Mann, Center for Devices and guidance before it begins work on the submit a comment with confidential Radiological Health, Food and Drug final version of the guidance, submit information that you do not wish to be Administration, 10903 New Hampshire either electronic or written comments made publicly available, submit your Ave., Bldg. 66, Rm. 2438, Silver Spring, on the draft guidance by May 6, 2016. comments only as a written/paper MD 20993–0002, 301–796–6460. ADDRESSES: You may submit comments submission. You should submit two SUPPLEMENTARY INFORMATION: as follows: copies total. One copy will include the information you claim to be confidential I. Background Electronic Submissions with a heading or cover note that states In the Federal Register of November 7, Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS 2013 (78 FR 66940), FDA published a following way: CONFIDENTIAL INFORMATION.’’ The notice of availability with a 90-day • Federal eRulemaking Portal: http:// Agency will review this copy, including comment period to request comments www.regulations.gov. Follow the the claimed confidential information, in on the draft guidance entitled instructions for submitting comments. its consideration of comments. The ‘‘Regulatory Requirements for Hearing Comments submitted electronically, second copy, which will have the Aid Devices and Personal Sound including attachments, to http:// claimed confidential information Amplification Products.’’ www.regulations.gov will be posted to redacted/blacked out, will be available Since issuance of the November 7, rmajette on DSK2TPTVN1PROD with NOTICES the docket unchanged. Because your for public viewing and posted on 2013, draft guidance entitled comment will be made public, you are http://www.regulations.gov. Submit ‘‘Regulatory Requirements for Hearing solely responsible for ensuring that your both copies to the Division of Dockets Aid Devices and Personal Sound comment does not include any Management. If you do not wish your Amplification Products,’’ FDA has confidential information that you or a name and contact information to be become aware of other efforts by the third party may not wish to be posted, made publicly available, you can President’s Council of Advisors on such as medical information, your or provide this information on the cover Science and Technology (PCAST) and VerDate Sep<11>2014 18:29 Jan 06, 2016 Jkt 238001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 E:\FR\FM\07JAN1.SGM 07JAN1

Federal Register / Vol. 81, No. 4 / Thursday, January 7, 2016 / Notices 787 Institute of Medicine (IOM) regarding use the document number1832 to B), CBP issued a final determination hearing aids and personal sound identify the guidance you are concerning the country of origin of amplification products (PSAP). In order requesting. certain intermodal containers, which to allow FDA and other interested may be offered to the U.S. Government IV. Paperwork Reduction Act of 1995 parties to consider the PCAST under an undesignated government recommendations and information This draft guidance refers to procurement contract. This final presented and discussed during the previously approved collections of determination, HQ H267876, was issued recent public IOM meetings on this information found in FDA regulations. under procedures set forth at 19 CFR issue, FDA is reopening the comment These collections of information are part 177, subpart B, which implements period. This will further allow FDA to subject to review by the Office of Title III of the Trade Agreements Act of ensure consistent interpretation, Management and Budget (OMB) under 1979, as amended (19 U.S.C. 2511–18). consistent application of relevant the Paperwork Reduction Act of 1995 In the final determination, CBP regulatory requirements, and adequate (44 U.S.C. 3501–3520). The collections concluded that the processing in the protection of the public health. of information in 21 CFR part 801 have United States does not result in a FDA is reopening the comment period been approved under OMB control substantial transformation. Therefore, for 120 days. The Agency believes that number 0910–0485, and the collections the country of origin of the intermodal a 120-day extension allows adequate of information in 21 CFR part 807 containers is the country of origin of the time for interested parties to submit subpart E have been approved under imported panels for purposes of U.S. comments without significantly OMB control number 0910–0120. Government procurement for purposes delaying finalizing the draft guidance on Dated: December 31, 2015. of U.S. Government procurement. these important issues. Section 177.29, CBP Regulations (19 Leslie Kux, II. Other Issues for Consideration Associate Commissioner for Policy. CFR 177.29), provides that a notice of final determination shall be published FDA is soliciting comments on the [FR Doc. 2016–00066 Filed 1–6–16; 8:45 am] in the Federal Register within 60 days availability, accessibility, and use of BILLING CODE 4164–01–P of the date the final determination is hearing aids and PSAPs for consumers issued. Section 177.30, CBP Regulations with hearing impairment. Further, FDA (19 CFR 177.30), provides that any requests interested parties to comment DEPARTMENT OF HOMELAND party-at-interest, as defined in 19 CFR on the key issues and recommendations SECURITY 177.22(d), may seek judicial review of a identified in the PCAST reporting, final determination within 30 days of including: (1) The degree to which U.S. Customs and Border Protection publication of such determination in the current FDA regulatory requirements Notice of Issuance of Final Federal Register. may be acting as a barrier to hearing aid accessibility, affordability, and use of Determination Concerning Certain Dated: December 23, 2015. hearing aids; (2) the appropriateness of Intermodal Containers Myles B. Harmon, creating a ‘‘basic’’ category of hearing AGENCY: U.S. Customs and Border Acting Executive Director, Regulations and aids for consumers with ‘‘bilateral, Rulings, Office of International Trade. Protection, Department of Homeland gradual onset, mild-to-moderate age- Security. H267876 related hearing loss’’ with appropriate ACTION: Notice of final determination. OT:RR:CTF:VS H267876 TMF labeling for over-the-counter sale; and (3) whether the benefits of expanded, SUMMARY: This document provides CATEGORY: Country of Origin over-the-counter access to hearing aids notice that U.S. Customs and Border Michael G. McManus in this age-related hearing loss Protection (‘‘CBP’’) has issued a final Duane Morris LLP population outweigh the risks of determination concerning the country of 505 9th Street, N. W., Suite 1000 forgoing the condition for sale (that the origin of certain intermodal containers. Washington, DC 20004–2166 consumer may waive) that requires a Based upon the facts presented, CBP has Re: U.S. Government Procurement; Title III, medical evaluation to rule out treatable, concluded that the country of origin of Trade Agreements Act of 1979 (19 U.S.C. potentially progressive causes of hearing 2511); Substantial Transformation; the intermodal containers is the country Intermodal Shipping Containers loss. of origin of the imported panels for Dear Mr. McManus: III. Electronic Access purposes of U.S. Government procurement. This is in response to your correspondence Persons interested in obtaining a copy of July 29, 2015, supplemented by your letter of the draft guidance may do so by DATES: The final determination was of September 30, 2015, requesting a final downloading an electronic copy from issued on December 23, 2015. A copy of determination on behalf of Sea Box, Inc. the Internet. A search capability for all the final determination is attached. Any (‘‘Sea Box’’), pursuant to subpart B of part party-at-interest, as defined in 19 CFR 177, U.S. Customs and Border Protection Center for Devices and Radiological (‘‘CBP’’ Regulations (19 CFR 177.21 et seq.). Health guidance documents is available 177.22(d), may seek judicial review of Under pertinent regulations, which at http://www.fda.gov/MedicalDevices/ this final determination within February implement Title II of the Trade Agreements DeviceRegulationandGuidance/ 8, 2016. Act of 1979, as amended (19 U.S.C. 2511 et GuidanceDocuments/default.htm. FOR FURTHER INFORMATION CONTACT: seq.), CBP issues country of origin advisory Guidance documents are also available Teresa M. Frazier, Valuation and rulings and final determinations as to at http://www.regulations.gov. Persons Special Programs Branch, Regulations whether an article is, or would be a product rmajette on DSK2TPTVN1PROD with NOTICES unable to download an electronic copy and Rulings, Office of International of a designated country or instrumentality for of ‘‘Regulatory Requirements for Trade (202) 325–0139. the purpose of granting waivers of certain ‘‘Buy American’’ restrictions in U.S. law or Hearing Aid Devices and Personal SUPPLEMENTARY INFORMATION: Notice is practice for products offered for sale to the Sound Amplification Products’’ may hereby given that on December 23, 2015, U.S. Government. send an email request to CDRH- pursuant to subpart B of Part 177, U.S. This final determination concerns the Guidance@fda.hhs.gov to receive an Customs and Border Protection country of origin of Sea Box shipping electronic copy of the document. Please Regulations (19 CFR part 177, subpart containers. We note that Sea Box, Inc. is a VerDate Sep<11>2014 18:29 Jan 06, 2016 Jkt 238001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 E:\FR\FM\07JAN1.SGM 07JAN1


Document Created: 2016-01-07 00:13:09
Document Modified: 2016-01-07 00:13:09
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice; reopening of the comment period.
DatesAlthough 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.
ContactEric 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.
FR Citation81 FR 786 
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