4612 Federal Register / Vol. 87, No. 19 / Friday, January 28, 2022 / Notices 

delaying guidance on these important 

issues. 

This draft guidance is being issued 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The draft guidance, when finalized, will 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 ‘‘Assessing the Credibility of 

Computational Modeling and 

Simulation in Medical Device 

Submissions.’’ 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of the draft guidance may do so by 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/medical-devices/ 

device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This draft 

guidance document is also available at 

https://www.regulations.gov and at 

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

an electronic copy of ‘‘Assessing the 

Credibility of Computational Modeling 

and Simulation in Medical Device 

Submissions’’ may send an email 

request to CDRH-Guidance@fda.hhs.gov 

to receive an electronic copy of the 

document. Please use the document 

number 1500056 and complete title to 

identify the guidance you are 

requesting. 

Dated: January 25, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–01788 Filed 1–27–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–5925] 

21st Century Cures Act: Annual 

Compilation of Notices of Updates 

From the Susceptibility Test 

Interpretive Criteria Web Page; 

Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is announcing the availability of the 

Agency’s annual compilation of notices 

of updates to the Agency’s 

Susceptibility Test Interpretive Criteria 

Web Page. The Agency established the 

Susceptibility Test Interpretive Criteria 

Web Page on December 13, 2017, and 

since establishment has provided 

updates to both the format of the web 

pages and to the susceptibility test 

interpretive criteria identified and 

recognized by FDA on the web pages. 

FDA is publishing this notice in 

accordance with procedures established 

by the 21st Century Cures Act (Cures 

Act). 

DATES: This notice is published in the 

Federal Register on January 28, 2022. 

ADDRESSES: You may submit either 

electronic or written comments and 

information 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– 

2017–N–5925 for ‘‘Susceptibility Test 

Interpretive Criteria Recognized and 

Listed on the Susceptibility Test 

Interpretive Web Page; Request for 

Comments.’’ 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. 

FOR FURTHER INFORMATION CONTACT: 

Jacquelyn Rosenberger, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Rm. 6242, 

Silver Spring, MD 20993–0002, 301– 


jspears on DSK121TN23PROD with NOTICES1
Federal Register / Vol. 87, No. 19 / Friday, January 28, 2022 / Notices 4613 

796–9179, Jacquelyn.Rosenberger@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background

Section 511A of the Federal Food,

Drug, and Cosmetic Act (FD&C Act) (21 

U.S.C. 360a–2), as added by section 

3044 of the Cures Act (Pub. L. 114–255), 

was signed into law on December 13, 

2016. This provision clarified FDA’s 

authority to identify and efficiently 

update susceptibility test interpretive 

criteria, including through the 

recognition by FDA of standards 

established by standards development 

organizations (SDOs). It also clarified 

that sponsors of antimicrobial 

susceptibility testing devices may rely 

upon listed susceptibility test 

interpretive criteria to support 

premarket authorization of their 

devices, provided they meet certain 

conditions, which allows for a more 

streamlined process for incorporating 

up-to-date information into such 

devices. 

In the Federal Register notice of 

December 13, 2017 (82 FR 58617), FDA 

announced the establishment of the 

Susceptibility Test Interpretive Criteria 

Web Page. This web page recognizes 

susceptibility test interpretive criteria 

established by an SDO that fulfills the 

requirements under section 

511A(b)(2)(A) of the FD&C Act; 

identifies when FDA does not recognize, 

in whole or in part, susceptibility test 

interpretive criteria established by an 

SDO; and lists susceptibility test 

interpretive criteria identified by FDA 

outside the SDO process. The 

susceptibility test interpretive criteria 

listed by FDA on the Susceptibility Test 

Interpretive Criteria Web Page is 

deemed to be recognized as a standard 

under section 514(c)(1) of the FD&C Act 

(21 U.S.C. 360d(c)(1)). The 

Susceptibility Test Interpretive Criteria 

Web Page can be found at https://

www.fda.gov/STIC. 

On March 1, 2018, FDA published a 

notice in the Federal Register (83 FR 

8883) requesting comments on FDA’s 

initial susceptibility test interpretive 

criteria recognition and listing 

determinations on the Susceptibility 

Test Interpretive Criteria Web Page 

(https://www.federalregister.gov/ 

documents/2018/03/01/2018-04175/ 

susceptibility-test-interpretive-criteriarecognized-and-listed-on-thesusceptibility-test). FDA may consider 

information provided by interested third 

parties as a basis for evaluating new or 

updated interpretive criteria standards 

(section 511A(c)(2)(B) of the FD&C Act); 

third parties should submit any 

information they wish to convey to the 

Agency to Docket No. FDA–2017–N– 

5925. If comments are received, FDA 

will review those comments and will 

make, as appropriate, updates to the 

recognized standards or susceptibility 

test interpretive criteria. 

At least every 6 months after the 

establishment of the Susceptibility Test 

Interpretive Criteria web page, FDA is 

required, as appropriate to: (1) Publish 

on that web page a notice recognizing 

new or updated susceptibility test 

interpretive criteria standards, or 

recognizing or declining to recognize 

parts of standards; (2) withdraw 

recognition of susceptibility test 

interpretive criteria standards, or parts 

of standards; and (3) make any other 

necessary updates to the lists published 

on the Susceptibility Test Interpretive 

Criteria web page (section 511A(c)(1)(A) 

of the FD&C Act). FDA has provided 

notices of updates on the Susceptibility 

Test Interpretive Criteria web page, 

which can be found here: https://

www.fda.gov/Drugs/Development

ApprovalProcess/ 

DevelopmentResources/ 

ucm593952.htm. Interested parties may 

also sign up to receive emails informing 

them of these updates as they occur by 

using the link provided either on the 

main Susceptibility Test Interpretive 

Criteria web page (https://www.fda.gov/ 

STIC) or on the updates page. 

Once a year, FDA is required to 

compile the new notices published on 

the Susceptibility Test Interpretive 

Criteria web page, publish them in the 

Federal Register, and provide for public 

comment (see section 511A(c)(3) of the 

FD&C Act). This Federal Register notice 

satisfies that requirement. If comments 

are received, FDA will review them and 

make updates to the recognized 

standards or susceptibility test 

interpretive criteria as needed. 

II. Annual Compilation of Notices:

Susceptibility Test Interpretive Criteria

Web Page

TABLE 1—NOTICES OF UPDATES TO RECOGNIZED OR UPDATED SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA (STIC) BY

DRUG

Drug Route of 

administration Action taken Therapeutic category Date 

Cefiderocol ..................... Injection ......................... FDA has updated STIC and added STIC for 

Acinetobacter baumannii complex.

Antibacterial .................. 9/25/20 

Ceftaroline fosamil ......... Injection ......................... For Staphylococcus aureus, FDA has reviewed 

STIC and concludes no changes are needed 

at this time. Rationale available at https://

www.fda.gov/drugs/development-resources/ 

fda-rationale-recognition-decision-ceftarolinefosamil.

Antibacterial .................. 4/16/20 

Ciprofloxacin .................. Oral, Injection ................ For Salmonella spp., the updated standard is 

recognized.

Antibacterial .................. 2/28/20 

Daptomycin .................... Injection ......................... FDA updated STIC (Rationale available at 

https://www.fda.gov/drugs/development-resources/fda-rationale-recognition-decisiondaptomycin).

Antibacterial .................. 8/25/20 

Delafloxacin ................... Injection, Oral ................ FDA identified STIC for Staphylococcus 

lugdunensis for Acute Bacterial Skin and Skin 

Structure Infections.

Antibacterial .................. 10/06/20 

Imipenem-CilastatinRelebactam.Injection ......................... FDA identified STIC for Acinetobacter 

calcoaceticus-baumannii complex and 

Haemophilus influenzae.

Antibacterial .................. 6/4/20 

Levofloxacin ................... Oral, Injection ................ For Salmonella spp., the updated standard is 

recognized.

Antibacterial .................. 2/28/20 

Ofloxacin ........................ Oral ............................... For Salmonella spp., the updated standard is 

recognized.

Antibacterial .................. 2/28/20 


jspears on DSK121TN23PROD with NOTICES1
4614 Federal Register / Vol. 87, No. 19 / Friday, January 28, 2022 / Notices 

TABLE 1—NOTICES OF UPDATES TO RECOGNIZED OR UPDATED SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA (STIC) BY

DRUG—Continued 

Drug Route of 

administration Action taken Therapeutic category Date 

Omadacycline ................ Injection, Oral ................ FDA updated disk breakpoints for Streptococcus 

pneumoniae for community acquired bacterial 

pneumonia.

Antibacterial .................. 8/25/20 

Dated: January 21, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–01693 Filed 1–27–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–1022] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Reporting 

Associated With Food Additive 

Petitions, Investigational Food 

Additive Files Exemptions, and 

Declaration of Color Additives on 

Animal Food Labels 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) 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: Submit written comments 

(including recommendations) on the 

collection of information by February 

28, 2022. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. The OMB 

control number for this information 

collection is 0910–0546. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: Ila 

S. Mizrachi, Office of Operations, Food 

and Drug Administration, Three White 

Flint North, 10 a.m.–12 p.m., 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–7726, 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. 

Reporting Associated With Food 

Additive Petitions, Investigational Food 

Additive Files Exemptions, and 

Declaration of Color Additives on 

Animal Food Labels—21 CFR 501.22(k), 

570.17, 571.1, and 571.6 

OMB Control Number 0910–0546— 

Extension 

This information collection supports 

FDA regulations as discussed below. In 

this notice, we are combining all 

reporting burden associated with FDA’s 

regulations at §§ 501.22(k), 570.17, 

571.1, and 571.6 (21 CFR 501.22(k), 

570.17, 571.1, and 571.6) into one 

collection and are consolidating the 

burden for OMB control numbers 0910– 

0546 and 0910–0721. Upon approval of 

the consolidated collection OMB control 

number 0910–0546, we will ask OMB to 

discontinue OMB control number 0910– 

0721. The information collection 

provisions approved under OMB control 

numbers 0910–0546 and 0910–0721 are 

similar in that they support FDA’s 

regulations at §§ 501.22(k), 570.17, 

571.1, and 571.6. Thus, with this notice, 

FDA proposes to consolidate these 

collections of information into one OMB 

control number for government 

efficiency and to allow the public to 

look to one OMB control number for all 

reporting associated with FDA’s 

regulations at §§ 501.22(k), 570.17, 

571.1, and 571.6. 

Food Additive Petitions and 

Investigational Food Additive Files 

Exemptions 

Section 409(a) of the Federal Food, 

Drug and Cosmetic Act (FD&C Act) (21 

U.S.C. 348(a)) provides that a food 

additive shall be deemed to be unsafe 

unless its use is permitted by a 

regulation which prescribes the 

condition(s) under which it may safely 

be used, or unless it is exempted by 

regulation for investigational use. 

Section 409(b) of FD&C Act specifies the 

information that must be submitted by 

a petitioner in order to establish the 

safety of a food additive and to secure 

the issuance of a regulation permitting 

its use. 

To implement the provisions of 

section 409 of the FD&C Act, we issued 

procedural regulations under 21 CFR 

part 571. These procedural regulations 

are designed to specify more thoroughly 

the information that must be submitted 

to meet the requirement set down in 

broader terms by the FD&C Act. The 

regulations add no substantive 

requirements to those indicated in the 

FD&C Act but attempt to explain these 

requirements and provide a standard 

format for submission to speed 

processing of the food additive petition. 

Labeling requirements for food additives 

intended for animal consumption are 

also set forth in various regulations 

contained in parts 501, 573, and 579 (21 

CFR parts 501, 573, and 579). The 

labeling regulations are considered by 

FDA to be cross-referenced to § 571.1, 

which is the subject of this same OMB 

clearance for food additive petitions. 

Regarding the investigational use of 

food additives, section 409(j) of the 

FD&C Act provides that any food 

additive or any food bearing or 

containing such an additive may be 

exempted from the requirements of this 

section if intended solely for 

investigational use by qualified experts. 

Investigational use of a food additive is 

typically to address the safety and/or 

intended physical or technical effect of 

the additive. To implement the 

provisions of section 409(j) of the FD&C 

Act, we issued regulations under 

§ 570.17. These regulations are designed 

to specify more thoroughly the 

information that must be submitted to 

meet the requirement set down in broad 

terms by the FD&C Act. Labeling 

requirements for investigational food 

additive files are also set forth in 

various regulations contained in part 

501. The labeling regulations are 

considered by FDA to be crossreferenced to § 570.17, which is the 

subject of this same OMB clearance for 

investigational food additive files. 

The information collected is 

necessary to protect the public health. 

We use the information submitted by 


jspears on DSK121TN23PROD with NOTICES1