Federal Register / Vol. 87, No. 71 / Wednesday, April 13, 2022 / Notices 21889 

clinical trial to verify clinical benefit of 

duvelisib in follicular lymphoma. 

Because the confirmatory trial was not 

underway and would not be conducted, 

the Agency recommended withdrawal 

of approval of the follicular lymphoma 

indication pursuant to § 314.150(d) (21 

CFR 314.150(d)). On November 24, 

2021, Secura Bio, Inc. submitted a letter 

requesting withdrawal of approval of 

the follicular lymphoma indication for 

COPIKTRA (duvelisib) Capsules and 

waiving its opportunity for hearing. 

Therefore, under § 314.150(d), 

approval of the follicular lymphoma 

indication for COPIKTRA (duvelisib) 

Capsules is withdrawn effective April 

13, 2022. Withdrawal of approval of the 

follicular lymphoma indication does not 

affect any other approved indication for 

COPIKTRA. 

Dated: April 7, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–07931 Filed 4–12–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–D–0603 and FDA– 

2021–D–0604] 

Performance Criteria for Safety and 

Performance Based Pathway; 

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 two final 

device-specific guidance documents for 

the Safety and Performance Based 

Pathway—specifically, ‘‘Denture Base 

Resins—Performance Criteria for Safety 

and Performance Based Pathway; 

Guidance for Industry and Food and 

Drug Administration Staff’’ and ‘‘Facet 

Screw Systems—Performance Criteria 

for Safety and Performance Based 

Pathway; Guidance for Industry and 

Food and Drug Administration Staff.’’ 

The device-specific guidances identified 

in this notice were developed in 

accordance with the final guidance 

entitled ‘‘Safety and Performance Based 

Pathway.’’ 

DATES: The announcement of the 

guidance is published in the Federal 

Register on April 13, 2022. 

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– 

2021–D–0603 for ‘‘Denture Base 

Resins—Performance Criteria for Safety 

and Performance Based Pathway; 

Guidance for Industry and Food and 

Drug Administration Staff’’ or Docket 

No. FDA–2021–D–0604 for ‘‘Facet 

Screw Systems—Performance Criteria 

for Safety and Performance Based 

Pathway; 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, 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 

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 ‘‘Denture Base 

Resins—Performance Criteria for Safety 

and Performance Based Pathway; 

Guidance for Industry and Food and 

Drug Administration Staff’’ or ‘‘Facet 

Screw Systems—Performance Criteria 

for Safety and Performance Based 

Pathway; Guidance for Industry and 

Food and Drug Administration Staff’’ to 

the Office of Policy, Center for Devices 


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21890 Federal Register / Vol. 87, No. 71 / Wednesday, April 13, 2022 / Notices 

1Available at https://www.fda.gov/regulatoryinformation/search-fda-guidance-documents/ 

safety-and-performance-based-pathway. 

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 

These device-specific guidance 

documents provide performance criteria 

for premarket notification (510(k)) 

submissions to support the optional 

Safety and Performance Based Pathway, 

as described in the 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 guidances, rather than 

using direct predicate comparison 

testing for some of the performance 

characteristics. 

A notice of availability of the draft 

guidances ‘‘Denture Base Resins’’ and 

‘‘Facet Screw Systems’’ appeared in the 

Federal Register of August 30, 2021 (86 

FR 48430). FDA considered comments 

received on the ‘‘Denture Base Resins’’ 

and revised the guidance as appropriate 

by clarifying what information should 

be included in premarket submissions 

for denture resins that are additively 

manufactured. There were no comments 

received for the ‘‘Facet Screw Systems’’ 

guidance. 

These guidance documents are being 

issued consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). The guidance documents 

represent the current thinking of FDA 

on performance criteria for ‘‘Denture 

Base Resins’’ and ‘‘Facet Screw 

Systems.’’ They do not establish any 

rights for any person and are 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-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This 

guidance document is also available at 

https://www.regulations.gov or https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents. 

Persons unable to download an 

electronic copy of either ‘‘Denture Base 

Resins—Performance Criteria for Safety 

and Performance Based Pathway; 

Guidance for Industry and Food and 

Drug Administration Staff (document 

number 20001)’’ or ‘‘Facet Screw 

Systems—Performance Criteria for 

Safety and Performance Based Pathway; 

Guidance for Industry and Food and 

Drug Administration Staff (document 

number 21001)’’ may send an email 

request to CDRH-Guidance@fda.hhs.gov 

to receive an electronic copy of the 

document. Please use the document 

number and complete title to identify 

the guidance you are requesting. 

III. Paperwork Reduction Act of 1995 

While these guidance documents 

contain no new collection of 

information, they do 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 these guidance 

documents. The previously approved 

collections of information are subject to 

review by OMB under the PRA. The 

collections of information in the 

following FDA regulations and guidance 

have been approved by OMB as listed in 

the following table: 

21 CFR part or guidance Topic OMB control No. 

807, subpart E ................................................................................ Premarket notification ............... 0910–0120 

‘‘Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program’’.Q-submissions; Pre-submissions.0910–0756 

Dated: April 8, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–07934 Filed 4–12–22; 8:45 am] 

BILLING CODE 4164–01–P 


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