21124 Federal Register / Vol. 87, No. 69 / Monday, April 11, 2022 / Notices 

requires that each institution also 

provide a copy of the notice to the 

servicer of the loan (if different from the 

originating lender). Section 100239 of 

the Biggert-Waters Flood Insurance 

Reform Act of 2012 requires each 

federal banking agency (including the 

FDIC), and the Farm Credit 

Administration, to adopt implementing 

regulations to direct regulated lending 

institutions to accept ‘‘private flood 

insurance,’’ as defined by the BiggertWaters Act. A lending institution would 

be required to implement policies and 

procedures to comply with the BiggertWaters Act provision and verify in 

writing that a private insurance policy 

satisfies the criteria included in the 

definition or document findings that 

separate required criteria have been met 

when accepting a private flood 

insurance policy in satisfaction of the 

mandatory flood insurance purchase 

requirement of the Flood Disaster 

Protection Act. The institution must 

also maintain records to permit 

examination staff to ascertain how the 

institution has met the requirements of 

the regulation. 

The FDIC has reviewed its previous 

submission related to the PRA and has 

updated its methodology to align with 

the Office of the Comptroller of the 

Currency’s corresponding information 

collection (1557–0326). The decrease in 

the estimated annual burden of 409,935 

hours is the result of this change in 

methodology. 

Request for Comment 

Comments are invited on: (a) Whether 

the collection of information is 

necessary for the proper performance of 

the FDIC’s functions, including whether 

the information has practical utility; (b) 

the accuracy of the estimates of the 

burden of the information collection, 

including the validity of the 

methodology and assumptions used; (c) 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. All comments will become 

a matter of public record. 

Federal Deposit Insurance Corporation. 

Dated at Washington, DC, on April 5, 2022. 

James P. Sheesley, 

Assistant Executive Secretary. 

[FR Doc. 2022–07639 Filed 4–8–22; 8:45 am] 

BILLING CODE 6714–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–D–0552] 

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 two final 

device-specific guidance documents for 

the Safety and Performance Based 

Pathway—specifically, ‘‘Surgical 

Sutures—Performance Criteria for Safety 

and Performance Based Pathway’’ and 

‘‘Orthopedic Fracture Fixation Plates— 

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 April 11, 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– 

2022–D–0552 for ‘‘Surgical Sutures— 

Performance Criteria for Safety and 

Performance Based Pathway’’ or 

‘‘Orthopedic Fracture Fixation Plates— 

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. 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 87, No. 69 / Monday, April 11, 2022 / Notices 21125 

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

safety-and-performance-based-pathway. 

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 ‘‘Surgical Sutures— 

Performance Criteria for Safety and 

Performance Based Pathway; Guidance 

for Industry and Food and Drug 

Administration Staff’’ or the guidance 

document entitled ‘‘Orthopedic Fracture 

Fixation Plates—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 

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 

The FDA is announcing the 

availability of two final device-specific 

guidance documents for the Safety and 

Performance Based Pathway— 

specifically, ‘‘Surgical Sutures— 

Performance Criteria for Safety and 

Performance Based Pathway’’ and 

‘‘Orthopedic Fracture Fixation Plates— 

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 

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 a surgical suture or 

orthopedic fracture fixation plate 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. 

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 ‘‘Surgical Sutures— 

Performance Criteria for Safety and 

Performance Based Pathway’’ and 

‘‘Orthopedic Fracture Fixation Plates— 

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 ‘‘Surgical 

Sutures—Performance Criteria for Safety 

and Performance Based Pathway’’ or 

‘‘Orthopedic Fracture Fixation Plates— 

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 20002 for ‘‘Surgical 

Sutures—Performance Criteria for Safety 

and Performance Based Pathway’’ or 

document number 19044 for 

‘‘Orthopedic Fracture Fixation Plates— 

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. Therefore, 

clearance by the Office of Management 

and Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3521) is not required for these 

guidances. The previously approved 

collections of information are subject to 

review by OMB under the PRA. The 

collections of information in the 

following FDA regulation and guidance 

have been approved by OMB as listed in 

the following table: 

21 CFR part; guidance Topic OMB control No. 

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


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21126 Federal Register / Vol. 87, No. 69 / Monday, April 11, 2022 / Notices 

21 CFR part; guidance Topic OMB control No. 

‘‘Requests for Feedback and Meetings for Medical Device 

Submissions: The Q-Submission Program’’.

Q-submissions; pre-submissions ............................................. 0910–0756 

Dated: April 5, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–07684 Filed 4–8–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–D–5225] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Foreign Supplier 

Verification Programs for Food 

Importers 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by May 11, 

2022. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, Fax: 202– 

395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0752. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–45, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Foreign Supplier Verification Programs 

(FSVP) for Food Importers—21 CFR 

Part 1, Subpart L 

OMB Control Number 0910–0752— 

Extension 

This information collection supports 

FDA regulations in 21 CFR part 1, 

subpart L (21 CFR 1.500 through 1.514 

(§§ 1.500 through (§§ 1.514)), which 

help to implement section 805 of the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) (21 U.S.C. 384a). Section 

805 authorizes the Agency’s FSVP and 

establishes requirements applicable to 

imported food. Respondents to the 

information collection are importers, as 

defined in section 805(a)(1) of the FD&C 

Act. The regulations are intended to 

provide verification that imported food 

is produced in compliance with 

statutory requirements that include the 

implementation of appropriate riskbased preventive controls. The 

regulations also establish that importers 

of foods must develop, maintain, and 

follow an FSVP that provides adequate 

assurances a foreign supplier is 

producing the food in compliance with 

processes and procedures that provide 

at least the same level of public health 

protection as those required under 

section 418 of the FD&C Act (21 U.S.C. 

350g) (regarding hazard analysis and 

risk-based preventive controls for 

certain foods) or 419 (21 U.S.C. 350h) 

(regarding standards for produce safety), 

if either is applicable, and the 

implementing regulations, and is 

producing the food in compliance with 

sections 402 (21 U.S.C. 342) (regarding 

adulteration) and 403(w) (21 U.S.C. 

343(w)) (if applicable) (regarding 

misbranding with respect to labeling for 

the presence of major food allergens) of 

the FD&C Act. The regulations also 

provide for certain exemptions. To 

assist respondents with understanding 

the requirements we have developed 

Agency guidance, available at: https://

www.fda.gov/food/food-safetymodernization-act-fsma/fsma-final-ruleforeign-supplier-verification-programsfsvp-importers-food-humans-andanimals. 

Specifically, regulations in § 1.501 set 

forth the applicability of requirements 

for FSVP, while regulations in §§ 1.502 

through 1.508, prescribe specific 

activities for developing, maintaining, 

and following an FSVP; as well as for 

evaluating compliance and for 

identifying and correcting hazards. 

Finally, regulations in § 1.509 identify 

required data elements applicable to 

food products offered for importation 

into the United States, while regulations 

in § 1.510 govern required records, 

providing that records be made 

available to FDA upon request and that 

records be maintained electronically. 

On May 10, 2021, FDA launched the 

FSVP Importer Portal for FSVP Records 

Submission as a means for importers to 

upload FSVP records electronically and 

submit them to the Agency, after 

receiving a request for records from 

FDA. The portal may be found at 

https://www.access.fda.gov/, and a user 

guide is available at https://

www.fda.gov/media/148312/download. 

In the Federal Register of January 28, 

2022 (87 FR 4607), we published a 60- 

day notice requesting public comment 

on the proposed collection of 

information. No comments were 

received. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity; 21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden per 

response Total hours 

Exemption for food for research; 1.501(c) ............... 36,360 40 1,454,400 0.083 (5 minutes) ..... 120,715 

Identifier for filing with U.S. Customs and Border 

Protection; 1.509.

56,800 157 8,917,600 0.02 (1.2 minutes) .... 178,352 

Total ................................................................... ........................ ........................ 10,372,000 ................................... 299,067 

1There are no capital costs or operating and maintenance costs associated with the information collection. 


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