Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations-Premarket Notification (510(k)) Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability, 48472-48473 [2023-15879]

Download as PDF 48472 Federal Register / Vol. 88, No. 143 / Thursday, July 27, 2023 / Notices This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on ‘‘CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality.’’ It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501– 3521) is not required for this guidance. The previously approved collections of information are subject to review by OMB under the PRA. The collection of information in this guidance has been approved under OMB control number 0910–0139. III. Electronic Access Persons with access to the internet may obtain the guidance at https:// www.fda.gov/drugs/guidancecompliance-regulatory-information/ guidances-drugs, https://www.fda.gov/ regulatory-information/search-fdaguidance-documents, or https:// www.regulations.gov. Dated: July 24, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–15916 Filed 7–26–23; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2022–D–0986] ddrumheller on DSK120RN23PROD with NOTICES1 Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations— Premarket Notification (510(k)) Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ‘‘Hydrogen PeroxideBased Contact Lens Care Products: SUMMARY: VerDate Sep<11>2014 17:21 Jul 26, 2023 Jkt 259001 Consumer Labeling Recommendations— Premarket Notification (510(k)) Submissions.’’ FDA is issuing this guidance to provide labeling recommendations for Hydrogen Peroxide-Based Contact Lens Care Products (HPCPs) submitted in premarket notification (510(k)) submissions. The labeling recommendations in this guidance are intended to promote the safe and effective use of HPCPs and help consumers receive and understand information regarding the benefits and risks associated with the use of the device. The announcement of the guidance is published in the Federal Register on July 27, 2023. ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time as follows: DATES: 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 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 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 (HFA–305), 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 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2022–D–0986 for ‘‘Hydrogen PeroxideBased Contact Lens Care Products: Consumer Labeling Recommendations— Premarket Notification (510(k)) Submissions.’’ 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, 240–402–7500. • 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 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 more information about FDA’s 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, 240–402–7500. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). An electronic copy of the guidance document is available for download E:\FR\FM\27JYN1.SGM 27JYN1 Federal Register / Vol. 88, No. 143 / Thursday, July 27, 2023 / Notices from the internet. See the section for information on electronic access to the guidance. Submit written requests for a single hard copy of the guidance document entitled ‘‘Hydrogen PeroxideBased Contact Lens Care Products: Consumer Labeling Recommendations— Premarket Notification (510(k)) Submissions’’ to the Office of Policy, 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: Angelo Green, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1306, Silver Spring, MD 20993–0002, 301–796–6860. SUPPLEMENTARY INFORMATION: SUPPLEMENTARY INFORMATION I. Background The safety and effectiveness of HPCPs when used as directed has been well established in the last few decades; however, FDA had become aware of an increase in the number of adverse event reports related to the misuse of these products. These reports led FDA to convene a meeting of the Ophthalmic Devices Panel of the Medical Devices Advisory Committee and the Risk Communication Advisory Committee on March 17, 2017, to discuss additional measures to mitigate the potential risk for misuse of these devices. The meeting covered a range of important issues, including appropriate labeling and II. Electronic Access Persons interested in obtaining a copy of the 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 https://www.fda.gov/medical-devices/ device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This guidance document is also available at https://www.regulations.gov, https:// www.fda.gov/regulatory-information/ search-fda-guidance-documents. Persons unable to download an electronic copy of ‘‘Hydrogen PeroxideBased Contact Lens Care Products: Consumer Labeling Recommendations— Premarket Notification (510(k)) Submissions’’ may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number GUI00018041 and complete title to identify the guidance you are requesting. III. Paperwork Reduction Act of 1995 While this guidance contains no new collection of information, it does refer to previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501– 3521) is not required for this guidance. The previously approved collections of information are subject to review by OMB under the PRA. The collections of information in the following FDA regulations have been approved by OMB as listed in the following table: OMB control No. 21 CFR part Topic 807, subpart E ........................................................ 800, 801, 809, and 830 .......................................... Premarket notification ..................................................................................... Medical Device Labeling Regulations; Unique Device Identification ............. Dated: July 19, 2023. Lauren K. Roth, Associate Commissioner for Policy. BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2022–N–2857] Diana Daffin: Final Debarment Order AGENCY: Food and Drug Administration, HHS. ACTION: Notice. VerDate Sep<11>2014 17:21 Jul 26, 2023 Jkt 259001 The Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Diana Daffin from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Ms. Daffin was convicted of a felony under Federal law for conduct that relates to the regulation of any drug product under the FD&C Act. Ms. Daffin was given notice of the proposed permanent debarment and was given an opportunity to request a hearing to show why she should not be debarred. As of April 2, 2023 (30 days after receipt of the notice), Ms. Daffin has not SUMMARY: [FR Doc. 2023–15879 Filed 7–26–23; 8:45 am] ddrumheller on DSK120RN23PROD with NOTICES1 packaging of these products and the importance of clearly communicating these concerns to the consumer public, which were incorporated into this guidance. This guidance is intended to provide recommendations concerning the content and format of labeling for HPCPs. FDA believes that the labeling recommendations in this guidance may help manufacturers develop labeling with information about specific risks and directions for use of the HPCPs in conjunction with a user’s prescribed contact lenses. A notice of availability of the draft guidance appeared in the Federal Register of August 17, 2022 (87 FR 50629). FDA considered the comments received and revised the guidance as appropriate in response to the comments, including clarifying examples and language included in the guidance recommendations. This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on ‘‘Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations—Premarket Notification (510(k)) Submissions.’’ It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 48473 0910–0120 0910–0485 responded to the notice. Ms. Daffin’s failure to respond and request a hearing within the prescribed timeframe constitutes a waiver of her right to a hearing concerning this action. DATES: This order is applicable July 27, 2023. Any application by Ms. Daffin for special termination of debarment under section 306(d)(4) of the FD&C Act (21 U.S.C. 335a(d)(4)) may be submitted as follows: ADDRESSES: Electronic Submissions D Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. An application submitted electronically, E:\FR\FM\27JYN1.SGM 27JYN1

Agencies

[Federal Register Volume 88, Number 143 (Thursday, July 27, 2023)]
[Notices]
[Pages 48472-48473]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-15879]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-0986]


Hydrogen Peroxide-Based Contact Lens Care Products: Consumer 
Labeling Recommendations--Premarket Notification (510(k)) Submissions; 
Guidance for Industry and Food and Drug Administration Staff; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a final guidance entitled ``Hydrogen Peroxide-Based 
Contact Lens Care Products: Consumer Labeling Recommendations--
Premarket Notification (510(k)) Submissions.'' FDA is issuing this 
guidance to provide labeling recommendations for Hydrogen Peroxide-
Based Contact Lens Care Products (HPCPs) submitted in premarket 
notification (510(k)) submissions. The labeling recommendations in this 
guidance are intended to promote the safe and effective use of HPCPs 
and help consumers receive and understand information regarding the 
benefits and risks associated with the use of the device.

DATES: The announcement of the guidance is published in the Federal 
Register on July 27, 2023.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

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 
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 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 (HFA-305), 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-2022-D-0986 for ``Hydrogen Peroxide-Based Contact Lens Care 
Products: Consumer Labeling Recommendations--Premarket Notification 
(510(k)) Submissions.'' 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, 240-
402-7500.
     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 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 more information about FDA's 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-2015-09-18/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, 240-402-7500.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    An electronic copy of the guidance document is available for 
download

[[Page 48473]]

from the internet. See the SUPPLEMENTARY INFORMATION section for 
information on electronic access to the guidance. Submit written 
requests for a single hard copy of the guidance document entitled 
``Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling 
Recommendations--Premarket Notification (510(k)) Submissions'' to the 
Office of Policy, 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: Angelo Green, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1306, Silver Spring, MD 20993-0002, 301-796-6860.

SUPPLEMENTARY INFORMATION:

I. Background

    The safety and effectiveness of HPCPs when used as directed has 
been well established in the last few decades; however, FDA had become 
aware of an increase in the number of adverse event reports related to 
the misuse of these products. These reports led FDA to convene a 
meeting of the Ophthalmic Devices Panel of the Medical Devices Advisory 
Committee and the Risk Communication Advisory Committee on March 17, 
2017, to discuss additional measures to mitigate the potential risk for 
misuse of these devices. The meeting covered a range of important 
issues, including appropriate labeling and packaging of these products 
and the importance of clearly communicating these concerns to the 
consumer public, which were incorporated into this guidance. This 
guidance is intended to provide recommendations concerning the content 
and format of labeling for HPCPs. FDA believes that the labeling 
recommendations in this guidance may help manufacturers develop 
labeling with information about specific risks and directions for use 
of the HPCPs in conjunction with a user's prescribed contact lenses.
    A notice of availability of the draft guidance appeared in the 
Federal Register of August 17, 2022 (87 FR 50629). FDA considered the 
comments received and revised the guidance as appropriate in response 
to the comments, including clarifying examples and language included in 
the guidance recommendations.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on ``Hydrogen Peroxide-Based Contact Lens Care 
Products: Consumer Labeling Recommendations--Premarket Notification 
(510(k)) Submissions.'' It does not establish any rights for any person 
and is not binding on FDA or the public. You can use an alternative 
approach if it satisfies the requirements of the applicable statutes 
and regulations.

II. Electronic Access

    Persons interested in obtaining a copy of the 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 https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also 
available at https://www.regulations.gov, https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to 
download an electronic copy of ``Hydrogen Peroxide-Based Contact Lens 
Care Products: Consumer Labeling Recommendations--Premarket 
Notification (510(k)) Submissions'' may send an email request to [email protected] to receive an electronic copy of the document. 
Please use the document number GUI00018041 and complete title to 
identify the guidance you are requesting.

III. Paperwork Reduction Act of 1995

    While this guidance contains no new collection of information, it 
does refer to previously approved FDA collections of information. 
Therefore, clearance by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required for this guidance. The previously approved collections of 
information are subject to review by OMB under the PRA. The collections 
of information in the following FDA regulations have been approved by 
OMB as listed in the following table:

------------------------------------------------------------------------
                                                            OMB control
            21 CFR part                     Topic               No.
------------------------------------------------------------------------
807, subpart E....................  Premarket                  0910-0120
                                     notification.
800, 801, 809, and 830............  Medical Device             0910-0485
                                     Labeling
                                     Regulations; Unique
                                     Device
                                     Identification.
------------------------------------------------------------------------


    Dated: July 19, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-15879 Filed 7-26-23; 8:45 am]
BILLING CODE 4164-01-P

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