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Federal Register / Vol. 86, No. 200 / Wednesday, October 20, 2021 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration Docket No. FDA2020D1380

Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products; Draft Guidance for Industry and Food and Drug Administration Staff; Availability Food and Drug Administration, Health and Human Services HHS.
ACTION: Notice of availability.
AGENCY:

The Food and Drug Administration FDA or Agency is announcing the availability of the draft guidance entitled Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products. The FDA Reauthorization Act of 2017 FDARA directed FDA to update and finalize the draft guidance entitled Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products, issued on November 7, 2013. Therefore, FDA is issuing this updated draft guidance, which supersedes the November 7, 2013, draft guidance. This updated draft guidance is intended to describe hearing aids, personal sound amplification products PSAPs, their respective intended uses, and the regulatory requirements that apply to these products. This draft guidance is not final nor is it in effect at this time.
DATES: Submit either electronic or written comments on the draft guidance by January 18, 2022 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
ADDRESSES: You may submit comments on any guidance at any time as follows:

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SUMMARY:

Electronic Submissions Submit electronic comments in the following way:
Federal eRulemaking Portal:
https www.regulations.gov. Follow the instructions for submitting comments.
Comments submitted electronically, including attachments, to https
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 elses 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
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identifies you in the body of your comments, that information will be posted on https 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: Dockets Management Staff HFA305, Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets Management Staff, 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
2020D1380 for Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products. Received comments will be placed in the docket and, except for those submitted as Confidential Submissions, publicly viewable at https www.regulations.gov or at the Dockets Management Staff between 9
a.m. and 4 p.m., Monday through Friday, 2404027500.
Confidential SubmissionsTo 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 https www.regulations.gov. Submit both copies to the Dockets Management Staff. 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
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more information about FDAs posting of comments to public dockets, see 80
FR 56469, September 18, 2015, or access the information at: https
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https
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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 2404027500.
You may submit comments on any guidance at any time see 21 CFR
10.115g5.
An electronic copy of the 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 Policy, 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: ShuChen Peng, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1224, Silver Spring, MD 209930002, 3017966481.
SUPPLEMENTARY INFORMATION:
I. Background The FDA Reauthorization Act of 2017
FDARA Pub. L. 11552 directs FDA
to establish a category of over-thecounter OTC hearing aids through rulemaking, and mandates that FDA
establish various requirements for this category of devices. FDA has issued a proposed rule to establish the OTC
category of hearing aids and to implement the requirements of FDARA
Proposed Rule as published elsewhere in this edition of the Federal Register. In the proposed rule, FDA has also proposed multiple related changes to the overall regulatory framework for hearing aids to harmonize existing regulations with the proposed OTC
category while continuing to provide a reasonable assurance of safety and effectiveness.

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