83020 Federal Register / Vol. 89, No. 199 / Tuesday, October 15, 2024 / Notices 

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 of an endosseous implant and 

endosseous implant abutment device 

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 relevant above-listed guidance 

rather than using direct predicate 

comparison testing for some of the 

performance characteristics. 

This guidance is being implemented 

without prior public comment because 

FDA has determined that prior public 

participation for this guidance is not 

feasible or appropriate (see section 

701(h)(1)(C) of the FD&C Act (21 U.S.C. 

371(h)(1)(C)) and 21 CFR 10.115(g)(2)). 

FDA has determined that this guidance 

document presents a less burdensome 

policy that is consistent with public 

health. Although this policy is being 

implemented immediately without prior 

comment, it remains subject to comment 

in accordance with FDA’s good 

guidance practices regulation (21 

CFR 10.115(g)(3)(D)). FDA will consider 

all comments received and revise the 

guidance document as appropriate. 

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 Endosseous Dental 

Implants and Endosseous Dental 

Implant Abutments—Performance 

Criteria for Safety and Performance 

Based Pathway. 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-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 ‘‘Endosseous Dental 

Implants and Endosseous Dental 

Implant Abutments—Performance 

Criteria for Safety and Performance 

Based Pathway’’ may send an email 

request to CDRH-Guidance@fda.hhs.gov 

to receive an electronic copy of the 

document. Please use the document 

number GUI00021017 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. The previously approved 

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 in 

the following table have been approved 

by OMB: 

21 CFR part; guidance; or FDA form 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 and Early Payor Feedback Request Programs 

for Medical Devices.

0910–0756 

Dated: October 4, 2024. 

Kimberlee Trzeciak, 

Deputy Commissioner for Policy, Legislation, 

and International Affairs. 

[FR Doc. 2024–23716 Filed 10–11–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–0026] 

Issuance of Priority Review Voucher; 

Rare Pediatric Disease Product; 

MIPLYFFA (Arimoclomol) 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

issuance of a priority review voucher to 

the sponsor of a rare pediatric disease 

product application. The Federal Food, 

Drug, and Cosmetic Act (FD&C Act) 

authorizes FDA to award priority review 

vouchers to sponsors of approved rare 

pediatric disease product applications 

that meet certain criteria. FDA is 

required to publish notice of the award 

of the priority review voucher. FDA has 

determined that MIPLYFFA 

(arimoclomol), approved on September 

20, 2024, manufactured by Zevra 

Denmark AS, meets the criteria for a 

priority review voucher. 

FOR FURTHER INFORMATION CONTACT: 

Cathryn Lee, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993–0002, 

301–796–1394. 

SUPPLEMENTARY INFORMATION: FDA is 

announcing the issuance of a priority 

review voucher to the sponsor of an 

approved rare pediatric disease product 

application. Under section 529 of the 

FD&C Act (21 U.S.C. 360ff), FDA will 

award priority review vouchers to 

sponsors of approved rare pediatric 

disease product applications that meet 

certain criteria. FDA has determined 

that MIPLYFFA (arimoclomol), 

manufactured by Zevra Denmark AS, 

meets the criteria for a priority review 

voucher. MIPLYFFA (arimoclomol) is 

indicated for the treatment of adults and 

pediatric patients 2 years of age and 

older with Niemann-Pick disease type 

C. 

For further information about the Rare 

Pediatric Disease Priority Review 

Voucher Program and for a link to the 

full text of section 529 of the FD&C Act, 

go to https://www.fda.gov/ForIndustry/ 

DevelopingProductsforRareDiseases

Conditions/RarePediatricDiseasePriority

VoucherProgram/default.htm. For 

further information about MIPLYFFA 

(arimoclomol), go to the ‘‘Drugs@FDA’’ 

website at https://

www.accessdata.fda.gov/scripts/cder/ 

daf/. 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 89, No. 199 / Tuesday, October 15, 2024 / Notices 83021 

Dated: October 8, 2024. 

Eric Flamm, 

Acting Associate Commissioner for Policy. 

[FR Doc. 2024–23646 Filed 10–11–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0335] 

Revocation of Emergency Use of a 

Biological Product During the COVID– 

19 Pandemic; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the revocation of the 

Emergency Use Authorization (EUA) 

(the Authorization) issued to Janssen 

Biotech, Inc. (Janssen), for the Janssen 

COVID–19 Vaccine. FDA revoked the 

Authorization on June 1, 2023, under 

the Federal Food, Drug, and Cosmetic 

Act (FD&C Act). The revocation, which 

includes an explanation of the reasons 

for the revocation, is reprinted in this 

document. 

DATES: The Authorization is revoked as 

of June 1, 2023. 

ADDRESSES: Submit written requests for 

a single copy of the revocation to the 

Office of Communication, Outreach and 

Development, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 3128, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

request or include a Fax number to 

which the revocation may be sent. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the 

Authorization. 

FOR FURTHER INFORMATION CONTACT: 

Tami Belouin, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002, 240– 

402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 564 of the FD&C Act (21 

U.S.C. 360bbb–3) allows FDA to 

strengthen the public health protections 

against biological, chemical, nuclear, 

and radiological agents. Among other 

things, section 564 of the FD&C Act 

allows FDA to authorize the use of an 

unapproved medical product or an 

unapproved use of an approved medical 

product in certain situations. On 

February 27, 2021, FDA issued an 

Authorization (EUA 27205) to Janssen 

for the Janssen COVID–19 Vaccine, 

subject to the terms of the 

Authorization. Notice of the issuance of 

the Authorization was published in the 

Federal Register on May 27, 2021 (86 

FR 28608), as required by section 

564(h)(1) of the FD&C Act. Subsequent 

updates to the Authorization were made 

available on FDA’s website. The 

authorization of a biological product for 

emergency use under section 564 of the 

FD&C Act may, pursuant to section 

564(g)(2) of the FD&C Act, be revoked 

when the criteria under section 564(c) of 

the FD&C Act for issuance of such 

authorization are no longer met (section 

564(g)(2)(B) of the FD&C Act), or other 

circumstances make such revocation 

appropriate to protect the public health 

or safety (section 564(g)(2)(C) of the 

FD&C Act). 

II. EUA Revocation Request 

In a request received by FDA on May 

22, 2023, Janssen requested withdrawal 

of, and on June 1, 2023, FDA revoked, 

the Authorization for the Janssen 

COVID–19 Vaccine. Janssen notified 

FDA that the last lots of the Janssen 

COVID–19 Vaccine purchased by the 

U.S. Government have expired, that 

there is no demand for new lots of the 

Janssen COVID–19 Vaccine in the 

United States, and that it does not 

intend to update the strain composition 

of this vaccine to address emerging 

variants. Based on FDA’s understanding 

that Janssen does not intend to offer the 

Janssen COVID–19 Vaccine in the 

United States under the EUA anymore 

and Janssen’s request that FDA revoke 

the EUA for the Janssen COVID–19 

Vaccine, FDA has determined that it is 

appropriate to revoke this Authorization 

to protect the public health or safety. 

III. The Revocation 

Having concluded that the criteria for 

revocation of the Authorization under 

section 564(g)(2)(C) of the FD&C Act are 

met, FDA has revoked the EUA for the 

Janssen COVID–19 Vaccine. Although 

FDA revoked the Authorization for the 

Janssen COVID–19 Vaccine on June 1, 

2023, as was publicly announced on the 

Agency’s website, publication of notice 

of this revocation in the Federal 

Register was inadvertently delayed. The 

revocation in its entirety follows and 

provides an explanation of the reasons 

for revocation, as required by section 

564(h)(1) of the FD&C Act. 

IV. Electronic Access 

An electronic version of this 

document and the full text of the 

Authorizations and revocation are 

available on the internet at https://

www.fda.gov/emergency-preparednessand-response/mcm-legal-regulatoryand-policy-framework/emergency-useauthorization. 

BILLING CODE 4164–01–P 


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