Soft (Hydrophilic) Daily Wear Contact Lenses-Performance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff; Availability, 12788-12789 [2020-04425]

Download as PDF 12788 Federal Register / Vol. 85, No. 43 / Wednesday, March 4, 2020 / Notices Currently, UCEDDs engage in four broad tasks: Conducting interdisciplinary training, promoting exemplary community service programs and providing technical assistance at all levels from local service delivery to community and state governments, conducting research, and disseminating information to the field. UCEDD accomplishments include: • Directing exemplary training programs. The provision of training is offered in an interdisciplinary format where faculty and trainees represent a variety of disciplines, such as pediatrics, education, psychology, and Respondent/data collection activity Number of respondents Responses per respondent Hours per response Annual burden hours Total ................................................................................................. 67 1 143 9,581 Dated: February 25, 2020. Lance Robertson, Administrator and Assistant Secretary for Aging. You may submit comments on any guidance at any time as follows: ADDRESSES: Electronic Submissions [FR Doc. 2020–04414 Filed 3–3–20; 8:45 am] BILLING CODE 4154–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–D–4843] Soft (Hydrophilic) Daily Wear Contact Lenses—Performance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS.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 The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ‘‘Soft (Hydrophilic) Daily Wear Contact Lenses— Performance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff.’’ The devicespecific guidance identified in this notice was developed in accordance with the final guidance entitled ‘‘Safety and Performance Based Pathway.’’ This draft guidance is not final nor is it in effect at this time. DATES: Submit either electronic or written comments on the draft guidance by May 4, 2020 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. SUMMARY: jbell on DSKJLSW7X2PROD with NOTICES • Contributing to the development of new knowledge through research and information dissemination. UCEDDs develop and field test models of service delivery and evaluate existing innovative practices, which are then disseminated to the field to translate research into practice. The proposed data collection tools may be found on the ACL website for review at https://www.acl.gov/aboutacl/public-input. Estimated Program Burden: ACL estimates the burden associated with this collection of information as follows: nursing thereby expanding opportunities for students to learn about the differing perspectives of various professionals providing services to individuals with developmental disabilities and their families. • Providing community services and technical assistance. Staff offer expertise through training and technical assistance activities to individuals with developmental disabilities, family members of these individuals, professionals, paraprofessionals, students, systems, support service organizations, volunteers, among others. VerDate Sep<11>2014 16:41 Mar 03, 2020 Jkt 250001 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 PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 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– 2019–D–4843 for ‘‘Soft (Hydrophilic) Daily Wear Contact Lenses— Performance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff.’’ 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. • 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 E:\FR\FM\04MRN1.SGM 04MRN1 Federal Register / Vol. 85, No. 43 / Wednesday, March 4, 2020 / Notices 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. 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 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 draft guidance document entitled ‘‘Soft (Hydrophilic) Daily Wear Contact Lenses— Performance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff’’ 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 selfaddressed adhesive label to assist that office in processing your request. FOR FURTHER INFORMATION CONTACT: Jason Ryans, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1613, Silver Spring, MD 20993–0002, 301–796–4908. SUPPLEMENTARY INFORMATION: I. Background This draft device-specific guidance document provides performance criteria for premarket notification (510k) submissions to support the optional Safety and Performance Based Pathway, as described in the final guidance entitled ‘‘Safety and Performance Based Pathway.’’ 1 As described in that guidance, substantial equivalence is rooted in comparisons between new devices and predicate devices. However, the Federal Food, Drug, and Cosmetic Act does not preclude FDA from using performance criteria to facilitate this comparison. If a legally marketed device performs at certain levels relevant to its safety and effectiveness, and a new device meets those levels of performance for the same characteristics, FDA could find the new device as safe and effective as the legally marketed device. Instead of reviewing data from direct comparison testing between the two devices, FDA could support a finding of substantial equivalence with data demonstrating the new device meets the level of performance of an appropriate predicate device(s). Under this optional Safety and Performance Based Pathway, a submitter could satisfy the requirement to compare its device with a legally marketed device by, among other things, independently demonstrating that the device’s performance meets performance criteria as established in the above-listed guidance, when finalized, rather than using direct predicate comparison testing for some of the performance characteristics. II. Significance of Guidance This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on performance criteria for the Safety and Performance Based Pathway for soft (hydrophilic) daily wear contact lenses. 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. 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 https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. This guidance document is also available at https://www.regulations.gov. Persons unable to download an electronic copy of ‘‘Soft (Hydrophilic) Daily Wear Contact Lenses—Performance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff’’ may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 19022 to identify the guidance you are requesting. IV. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information. 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. 3501–3521). The collections of information have been approved by OMB as listed in the following table: OMB control No. 21 CFR part or guidance Topic 807, subpart E ............................................................................................. ‘‘Requests for Feedback on Medical Device Submissions: The Q-Submission Program and Meetings with Food and Drug Administration Staff’’. Premarket Notification ................................................................................ Q-Submissions ........................................................................................... Dated: February 28, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. jbell on DSKJLSW7X2PROD with NOTICES [FR Doc. 2020–04425 Filed 3–3–20; 8:45 am] BILLING CODE 4164–01–P 1 Available at https://www.fda.gov/regulatoryinformation/search-fda-guidance-documents/ safety-and-performance-based-pathway. VerDate Sep<11>2014 16:41 Mar 03, 2020 Jkt 250001 PO 00000 Frm 00030 Fmt 4703 Sfmt 9990 12789 E:\FR\FM\04MRN1.SGM 04MRN1 0910–0120 0910–0756

Agencies

[Federal Register Volume 85, Number 43 (Wednesday, March 4, 2020)]
[Notices]
[Pages 12788-12789]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-04425]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-4843]


Soft (Hydrophilic) Daily Wear Contact Lenses--Performance 
Criteria for Safety and Performance Based Pathway; Draft 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 the draft guidance entitled ``Soft (Hydrophilic) 
Daily Wear Contact Lenses--Performance Criteria for Safety and 
Performance Based Pathway; Draft Guidance for Industry and Food and 
Drug Administration Staff.'' The device-specific guidance identified in 
this notice was developed in accordance with the final guidance 
entitled ``Safety and Performance Based Pathway.'' 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 May 4, 2020 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:

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-2019-D-4843 for ``Soft (Hydrophilic) Daily Wear Contact Lenses--
Performance Criteria for Safety and Performance Based Pathway; Draft 
Guidance for Industry and Food and Drug Administration Staff.'' 
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.
     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

[[Page 12789]]

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.
    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 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 draft guidance document entitled 
``Soft (Hydrophilic) Daily Wear Contact Lenses--Performance Criteria 
for Safety and Performance Based Pathway; Draft Guidance for Industry 
and Food and Drug Administration Staff'' 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: Jason Ryans, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1613, Silver Spring, MD 20993-0002, 301-796-4908.

SUPPLEMENTARY INFORMATION:

I. Background

    This draft device-specific guidance document provides performance 
criteria for premarket notification (510k) submissions to support the 
optional Safety and Performance Based Pathway, as described in the 
final guidance entitled ``Safety and Performance Based Pathway.'' \1\ 
As described in that guidance, substantial equivalence is rooted in 
comparisons between new devices and predicate devices. However, the 
Federal Food, Drug, and Cosmetic Act does not preclude FDA from using 
performance criteria to facilitate this comparison. If a legally 
marketed device performs at certain levels relevant to its safety and 
effectiveness, and a new device meets those levels of performance for 
the same characteristics, FDA could find the new device as safe and 
effective as the legally marketed device. Instead of reviewing data 
from direct comparison testing between the two devices, FDA could 
support a finding of substantial equivalence with data demonstrating 
the new device meets the level of performance of an appropriate 
predicate device(s). Under this optional Safety and Performance Based 
Pathway, a submitter could satisfy the requirement to compare its 
device with a legally marketed device by, among other things, 
independently demonstrating that the device's performance meets 
performance criteria as established in the above-listed guidance, when 
finalized, rather than using direct predicate comparison testing for 
some of the performance characteristics.
---------------------------------------------------------------------------

    \1\ Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-and-performance-based-pathway.
---------------------------------------------------------------------------

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on performance 
criteria for the Safety and Performance Based Pathway for soft 
(hydrophilic) daily wear contact lenses. 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.

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 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This 
guidance document is also available at https://www.regulations.gov. 
Persons unable to download an electronic copy of ``Soft (Hydrophilic) 
Daily Wear Contact Lenses--Performance Criteria for Safety and 
Performance Based Pathway; Draft Guidance for Industry and Food and 
Drug Administration Staff'' may send an email request to [email protected] to receive an electronic copy of the document. 
Please use the document number 19022 to identify the guidance you are 
requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information. 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. 3501-3521). The collections of information have 
been approved by OMB as listed in the following table:

------------------------------------------------------------------------
                                                            OMB control
    21 CFR part or guidance               Topic                 No.
------------------------------------------------------------------------
807, subpart E.................  Premarket Notification.       0910-0120
``Requests for Feedback on       Q-Submissions..........       0910-0756
 Medical Device Submissions:
 The Q-Submission Program and
 Meetings with Food and Drug
 Administration Staff''.
------------------------------------------------------------------------


    Dated: February 28, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-04425 Filed 3-3-20; 8:45 am]
BILLING CODE 4164-01-P
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