Federal Register / Vol. 89, No. 189 / Monday, September 30, 2024 / Notices 79615 

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)). 

Submit written requests for single 

copies of the guidance to the Policy and 

Regulations Staff, Center for Veterinary 

Medicine, Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855. Send one selfaddressed adhesive label to assist that 

office in processing your requests. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance document. 

FOR FURTHER INFORMATION CONTACT: Li 

You, Center for Veterinary Medicine, 

Food and Drug Administration, 7500 

Standish Pl., Rockville, MD 20855, 240– 

402–0828, Li.You@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft GFI #116 (VICH GL23) entitled 

‘‘Studies to Evaluate the Safety of 

Residues of Veterinary Drugs in Human 

Food: Genotoxicity Testing (Revision 

2).’’ This draft revised guidance 

recommends a Standard Battery of Tests 

that can be used for the evaluation of 

the genotoxicity of veterinary drug 

residues. The Standard Battery of Tests 

intends to achieve reasonable 

confidence in the assessment of the 

genotoxicity potential of veterinary drug 

residues and to be in harmony with the 

requirements of International Council 

for Harmonisation of Technical 

Requirements for Pharmaceuticals for 

Human Use for testing human drugs for 

genotoxicity. This draft guidance also 

advises on modifications to the 

Standard Battery of Tests and on 

interpretation of test results. The 

objective of this guidance is to ensure 

international harmonization of 

genotoxicity testing of veterinary drug 

residues. 

FDA has participated in efforts to 

enhance harmonization and is 

committed to seeking scientifically 

based harmonized technical procedures 

for pharmaceutical development. One of 

the goals of harmonization is to identify, 

and then reduce, differences in 

technical requirements for drug 

development among regulatory agencies 

in different countries. FDA has actively 

participated in the International 

Conference on Harmonization of 

Technical Requirements for Approval of 

Pharmaceuticals for Human Use to 

develop harmonized technical 

requirements for the approval of human 

pharmaceutical and biological products 

among the European Union, Japan, and 

the United States. The VICH is a parallel 

initiative for veterinary medicinal 

products. The goal of the VICH is to 

develop harmonized technical 

requirements for the approval of 

veterinary medicinal products in the 

European Union, Japan, and the United 

States, and receives input from both 

regulatory and industry representatives. 

The VICH Steering Committee is 

composed of member representatives 

from the European Commission and 

European Medicines Agency; 

AnimalhealthEurope; FDA—Center for 

Veterinary Medicine and U.S. 

Department of Agriculture—Center for 

Veterinary Biologics; the U.S. Animal 

Health Institute; the Japanese Ministry 

of Agriculture, Forestry and Fisheries; 

and the Japanese Veterinary Products 

Association. There are 10 observers to 

the VICH Steering Committee: 1 

representative from government and 1 

representative from industry of 

Australia, New Zealand, Canada, South 

Africa, and the United Kingdom. The 

World Organisation for Animal Health 

is an associate member of the VICH. The 

VICH Secretariat, which coordinates the 

preparation of documentation, is 

provided by HealthforAnimals. 

This level 1 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 ‘‘Studies to Evaluate 

the Safety of Residues of Veterinary 

Drugs in Human Food: Genotoxicity 

Testing (Revision 2).’’ 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. 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 (PRA) (44 U.S.C. 

3501–3521). The collections of 

information in 21 CFR part 514 have 

been approved under OMB control 

number 0910–0032. The collections of 

information in 21 CFR part 511 have 

been approved under OMB control 

number 0910–0117. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

www.fda.gov/AnimalVeterinary/ 

GuidanceComplianceEnforcement/ 

GuidanceforIndustry/default.htm, 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments, or https://

www.regulations.gov. 

Dated: September 24, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–22301 Filed 9–27–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–D–4168; FDA–2024– 

D–4169; FDA–2024–D–4170; and FDA– 

2024–D–4171] 

Safety and Performance Based 

Pathway Device-Specific Guidances; 

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 four final 

device-specific guidance documents for 

the Safety and Performance Based 

Pathway—specifically, ‘‘Air Powered 

Dental Handpieces and Air Motors— 

Performance Criteria for Safety and 


ddrumheller on DSK120RN23PROD with NOTICES1
79616 Federal Register / Vol. 89, No. 189 / Monday, September 30, 2024 / Notices 

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

safety-and-performance-based-pathway. 

Performance Based Pathway,’’ ‘‘Dental 

Ceramics—Performance Criteria for 

Safety and Performance Based 

Pathway,’’ ‘‘Dental Impression 

Materials—Performance Criteria for 

Safety and Performance Based 

Pathway,’’ and ‘‘Dental Cements— 

Performance Criteria for Safety and 

Performance Based Pathway.’’ The 

device-specific guidances identified in 

this notice were developed in 

accordance with the finalized guidance 

entitled ‘‘Safety and Performance Based 

Pathway.’’ 

DATES: The announcement of the 

guidances is published in the Federal 

Register on September 30, 2024. 

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– 

2024–D–4168 for ‘‘Air Powered Dental 

Handpieces and Air Motors— 

Performance Criteria for Safety and 

Performance Based Pathway,’’ Docket 

No. FDA–2024–D–4169 for ‘‘Dental 

Ceramics—Performance Criteria for 

Safety and Performance Based 

Pathway,’’ Docket No. FDA–2024–D– 

4170 for ‘‘Dental Impression Materials— 

Performance Criteria for Safety and 

Performance Based Pathway,’’ or Docket 

No. FDA–2024–D–4171 for ‘‘Dental 

Cements—Performance Criteria for 

Safety and Performance Based 

Pathway.’’ 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 

documents are available for download 

from the internet. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidances. Submit written requests for a 

single hard copy of the guidance 

document entitled ‘‘Air Powered Dental 

Handpieces and Air Motors— 

Performance Criteria for Safety and 

Performance Based Pathway,’’ ‘‘Dental 

Ceramics—Performance Criteria for 

Safety and Performance Based 

Pathway,’’ ‘‘Dental Impression 

Materials—Performance Criteria for 

Safety and Performance Based 

Pathway,’’ or ‘‘Dental Cements— 

Performance Criteria for Safety and 

Performance Based Pathway’’ 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 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 

FDA is announcing the availability of 

four final device-specific guidance 

documents for the Safety and 

Performance Based Pathway— 

specifically, ‘‘Air Powered Dental 

Handpieces and Air Motors— 

Performance Criteria for Safety and 

Performance Based Pathway,’’ ‘‘Dental 

Ceramics—Performance Criteria for 

Safety and Performance Based 

Pathway,’’ ‘‘Dental Impression 

Materials—Performance Criteria for 

Safety and Performance Based 

Pathway,’’ and ‘‘Dental Cements— 

Performance Criteria for Safety and 

Performance Based Pathway.’’ 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 


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Federal Register / Vol. 89, No. 189 / Monday, September 30, 2024 / Notices 79617 

rooted in comparisons between new 

devices and predicate devices. However, 

the Federal Food, Drug, and Cosmetic 

Act (FD&C 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 of air powered dental 

handpieces and air motors, or dental 

cement devices 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 abovelisted guidance rather than using direct 

predicate comparison testing for some of 

the performance characteristics. 

These guidances are being 

implemented without prior public 

comment because the Agency has 

determined that prior public 

participation 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 these guidance 

documents present less burdensome 

policies that are consistent with public 

health. Although these guidances are 

being implemented immediately, FDA 

will consider all comments received and 

revise the guidance documents as 

appropriate. 

These guidances are being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

These guidances represent the current 

thinking of FDA on ‘‘Air Powered 

Dental Handpieces and Air Motors— 

Performance Criteria for Safety and 

Performance Based Pathway,’’ ‘‘Dental 

Ceramics—Performance Criteria for 

Safety and Performance Based 

Pathway,’’ ‘‘Dental Impression 

Materials—Performance Criteria for 

Safety and Performance Based 

Pathway,’’ and ‘‘Dental Cements— 

Performance Criteria for Safety and 

Performance Based Pathway.’’ 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 guidances 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. These 

guidance documents are also available 

at https://www.regulations.gov or 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments. Persons unable to download 

an electronic copy of ‘‘Air Powered 

Dental Handpieces and Air Motors— 

Performance Criteria for Safety and 

Performance Based Pathway,’’ ‘‘Dental 

Ceramics—Performance Criteria for 

Safety and Performance Based 

Pathway,’’ ‘‘Dental Impression 

Materials—Performance Criteria for 

Safety and Performance Based 

Pathway,’’ or ‘‘Dental Cements— 

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 GUI00021014 for 

‘‘Air Powered Dental Handpieces and 

Air Motors—Performance Criteria for 

Safety and Performance Based 

Pathway,’’ document number 

GUI00007014 for ‘‘Dental Ceramics— 

Performance Criteria for Safety and 

Performance Based Pathway,’’ 

document number GUI00007013 for 

‘‘Dental Impression Materials— 

Performance Criteria for Safety and 

Performance Based Pathway,’’ or 

document number GUI00021005 for 

‘‘Dental Cements—Performance Criteria 

for Safety and Performance Based 

Pathway’’ to identify the guidance you 

are requesting. 

III. Paperwork Reduction Act of 1995 

While these guidances contain no 

new collection of information, they do 

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 (PRA) (44 U.S.C. 3501– 

3521). The collections of information in 

the following table have been approved 

by OMB: 

21 CFR part; 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: September 24, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–22309 Filed 9–27–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–N–0008] 

Request for Nominations for 

Individuals and Consumer 

Organizations for Advisory 

Committees 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

requesting that any consumer 

organizations interested in participating 

in the selection of voting and/or 

nonvoting consumer representatives to 

serve on its advisory committees or 

panels notify FDA in writing. FDA is 

also requesting nominations for voting 

and/or nonvoting consumer 

representatives to serve on advisory 

committees and/or panels for which 

vacancies currently exist or are expected 

to occur in the near future. Nominees 


ddrumheller on DSK120RN23PROD with NOTICES1