81 FR 784 - Streamlining Regulations for Good Manufacturing Practices for Hearing Aids; Public Workshop; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 4 (January 7, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 4 (January 7, 2016)
| Page Range | 784-786 | |
| FR Document | 2016-00065 |
[Federal Register Volume 81, Number 4 (Thursday, January 7, 2016)] [Notices] [Pages 784-786] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-00065] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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
![784 Federal Register / Vol. 81, No. 4 / Thursday, January 7, 2016 / Notices
Estimated Total Annual Burden discussed is the appropriate level of • For written/paper comments
Hours: 540. good manufacturing practices (GMPs) submitted to the Division of Dockets
In compliance with the requirements regulation to ensure the safety and Management, FDA will post your
of Section 506(c)(2)(A) of the Paperwork effectiveness of air-conduction hearing comment, as well as any attachments,
Reduction Act of 1995, the aid devices. except for information submitted,
Administration for Children and DATES: The public workshop will be marked and identified, as confidential,
Families is soliciting public comment held on April 21, 2016, from 8:30 a.m. if submitted as detailed in
on the specific aspects of the to 5 p.m. Submit either electronic or ‘‘Instructions.’’
information collection described above. written comments on the public Instructions: All submissions received
Copies of the proposed collection of workshop by May 19, 2016. must include the Docket No. FDA–
information can be obtained and 2015–N–4602 for ‘‘Streamlining
ADDRESSES: The public workshop will
comments may be forwarded by writing Regulations for Good Manufacturing
be held at FDA’s White Oak Campus, Practices (GMPs) for Hearing Aids.’’
to the Administration for Children and 10903 New Hampshire Ave., Bldg. 31
Families, Office of Planning, Research Received comments will be placed in
Conference Center, the Great Room (Rm. the docket and, except for those
and Evaluation, 370 L’Enfant 1503), Silver Spring, MD 20993–0002.
Promenade SW., Washington, DC 20447, submitted as ‘‘Confidential
Entrance for the public meeting Submissions,’’ publicly viewable at
Attn: ACF Reports Clearance Officer. participants (non-FDA employees) is
Email address: infocollection@ http://www.regulations.gov or at the
through Building 1 where routine Division of Dockets Management
acf.hhs.gov. All requests should be security check procedures will be
identified by the title of the information between 9 a.m. and 4 p.m., Monday
performed. For parking and security through Friday.
collection. information, please refer to http://
The Department specifically requests • Confidential Submissions—To
www.fda.gov/AboutFDA/ submit a comment with confidential
comments on: (a) Whether the proposed WorkingatFDA/BuildingsandFacilities/
collection of information is necessary information that you do not wish to be
WhiteOakCampusInformation/ made publicly available, submit your
for the proper performance of the ucm241740.htm.
functions of the agency, including comments only as a written/paper
You may submit comments as submission. You should submit two
whether the information shall have follows:
practical utility; (b) the accuracy of the copies total. One copy will include the
agency’s estimate of the burden of the Electronic Submissions information you claim to be confidential
proposed collection of information; (c) with a heading or cover note that states
Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
the quality, utility, and clarity of the following way: CONFIDENTIAL INFORMATION.’’ The
information to be collected; and (d) • Federal eRulemaking Portal: http:// Agency will review this copy, including
ways to minimize the burden of the www.regulations.gov. Follow the the claimed confidential information, in
collection of information on instructions for submitting comments. its consideration of comments. The
respondents, including through the use Comments submitted electronically, second copy, which will have the
of automated collection techniques or including attachments, to http:// claimed confidential information
other forms of information technology. www.regulations.gov will be posted to redacted/blacked out, will be available
Consideration will be given to the docket unchanged. Because your for public viewing and posted on
comments and suggestions submitted comment will be made public, you are http://www.regulations.gov. Submit
within 60 days of this publication. solely responsible for ensuring that your both copies to the Division of Dockets
Robert Sargis, comment does not include any Management. If you do not wish your
Reports Clearance Officer. confidential information that you or a name and contact information to be
[FR Doc. 2016–00054 Filed 1–6–16; 8:45 am]
third party may not wish to be posted, made publicly available, you can
such as medical information, your or provide this information on the cover
BILLING CODE 4184–01–P
anyone else’s Social Security number, or sheet and not in the body of your
confidential business information, such comments and you must identify this
DEPARTMENT OF HEALTH AND as a manufacturing process. Please note information as ‘‘confidential.’’ Any
HUMAN SERVICES that if you include your name, contact information marked as ‘‘confidential’’
information, or other information that will not be disclosed except in
Food and Drug Administration identifies you in the body of your accordance with 21 CFR 10.20 and other
comments, that information will be applicable disclosure law. For more
[Docket No. FDA–2015–N–4602]
posted on http://www.regulations.gov. information about FDA’s posting of
Streamlining Regulations for Good • If you want to submit a comment comments to public dockets, see 80 FR
Manufacturing Practices for Hearing with confidential information that you 56469, September 18, 2015, or access
Aids; Public Workshop; Request for do not wish to be made available to the the information at: http://www.fda.gov/
Comments public, submit the comment as a regulatoryinformation/dockets/
written/paper submission and in the default.htm.
AGENCY: Food and Drug Administration, manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
HHS. Submissions’’ and ‘‘Instructions’’). read background documents or the
ACTION: Notice of public workshop; electronic and written/paper comments
Written/Paper Submissions received, go to http://
request for comments.
rmajette on DSK2TPTVN1PROD with NOTICES
Submit written/paper submissions as www.regulations.gov and insert the
SUMMARY: The Food and Drug follows: docket number, found in brackets in the
Administration (FDA) is announcing the • Mail/Hand delivery/Courier (for heading of this document, into the
following public workshop entitled written/paper submissions): Division of ‘‘Search’’ box and follow the prompts
‘‘Streamlining Regulations for Good Dockets Management (HFA–305), Food and/or go to the Division of Dockets
Manufacturing Practices (GMPs) for and Drug Administration, 5630 Fishers Management, 5630 Fishers Lane, Rm.
Hearing Aids.’’ The topic to be Lane, Rm. 1061, Rockville, MD 20852. 1061, Rockville, MD 20852.
VerDate Sep<11>2014 18:26 Jan 06, 2016 Jkt 238001 PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 E:\FR\FM\07JAN1.SGM 07JAN1](https://thefederalregister.org/doc/81_FR_788/page/1.svg)
![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](https://thefederalregister.org/doc/81_FR_788/page/3.svg)
Document Created: 2016-01-07 00:13:17
Document Modified: 2016-01-07 00:13:17
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of public workshop; request for comments. | |
| 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. | |
| 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] | |
| FR Citation | 81 FR 784 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR