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 


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Federal Register / Vol. 87, No. 19 / Friday, January 28, 2022 / Notices 4615 

food manufacturers or food additive 

manufacturers to ascertain whether the 

data establish the identity of the 

substance, justify its intended effect in/ 

on the food, and establish that its 

intended use in/on food is safe. 

Animal Food Labeling; Declaration of 

Certified and Non-Certified Color 

Additives 

FDA has the authority under the 

FD&C Act to issue regulations 

concerning animal food. Specifically, 

section 403(i) of the FD&C Act (21 

U.S.C. 343(i)) requires that certified 

color additives used in or on a food 

must be declared by their common or 

usual names and not be designated by 

the collective term ‘‘colorings.’’ Our 

regulations in part 501 set forth the 

requirements for animal food labeling. 

Under § 501.22(k), animal food 

manufacturers must declare on the 

animal food label the presence of 

certified and noncertified color 

additives in their animal food products. 

Our animal food labeling regulation at 

§ 501.22(k) is consistent with the 

regulations requiring the declaration of 

color additives on human food labels. 

The purpose of the labeling is to provide 

animal owners with information on the 

color additives used in animal food. 

Animal owners use the information to 

become knowledgeable about the foods 

they purchase for their animals. 

Description of Respondents: 

Respondents to this collection of 

information are manufacturers of animal 

food products that contain color 

additives or are manufacturers of food 

additives. 

In the Federal Register of October 8, 

2021 (86 FR 56277), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. Although three comments 

were received, they were not responsive 

to the four collection of information 

topics solicited and therefore will not be 

discussed in this document. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden 

per response Total hours 

Food Additive Petitions: 

571.1(c); Moderate Category ............................ 6 1 6 3,000 ......................... 18,000 

571.1(c); Complex Category ............................. 5 1 5 10,000 ....................... 50,000 

571.6; Amendment of Petition .......................... 5 1 5 1,300 ......................... 6,500 

Investigational Food Additive Files: 

570.17; Moderate Category .............................. 6 1 6 1,500 ......................... 9,000 

570.17; Complex Category ............................... 7 1 7 5,000 ......................... 35,000 

Color Additives: 

501.22(k); labeling of color additive or lake of 

color additive; labeling of color additives not 

subject to certification.

3,120 0.8292 2,587 0.25 (15 minutes) ...... 647 

Total ........................................................... ........................ ........................ ........................ .................................... 119,147 

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

For the purpose of this consolidation, 

we base our estimate of the total annual 

responses on submissions received 

during fiscal years 2019 and 2020. We 

base our estimate of the hours per 

response on our experience with the 

labeling, food additive petition, and 

filing processes. 

The information collection reflects a 

net decrease of 70,453 hours (189,600 

OMB approved hours—119,147 

estimated hours). We also experienced a 

net increase of 2,587 responses from 35 

OMB approved annual responses to 

2,616 estimated annual responses. 

These changes were due to the 

consolidating of the information 

collection covered by OMB control 

number 0910–0721 and due to 

estimated changes of the number of 

respondents for food additive petitions 

and investigational food additive files. 

Section 571.1(c) Moderate Category: 

The estimated time requirement per 

food additive petition remains at 

approximately 3,000 hours; however, 

we now estimate that the number of 

annual respondents has decreased from 

12 to 6 respondents for a total of 18,000 

hours. 

Section 571.1(c) Complex Category: 

The estimated time requirement per 

food additive petition remains at 

approximately 10,000 hours; however, 

we now estimate that the number of 

annual respondents has decreased from 

12 to 5 respondents for a total of 50,000 

hours. 

Section 571.6 Amendment of 

Petition: We estimated that the number 

of annual respondents that will submit 

an amendment has increased from two 

to five respondents who will each 

submit one amendment for a total of 

6,500 hours. This is an increase of three 

respondents and 3,900 hours from the 

burden approved by OMB. 

Section 570.17 Moderate Category: 

We estimated that the number of annual 

respondents for investigational food 

additive files has increased from four to 

six respondents who will each submit 

one file for a total of 9,000 hours. This 

is an increase of two respondents and 

3,000 hours from the burden approved 

by OMB. 

Section 570.17 Complex Category: We 

estimated that the number of annual 

respondents for investigational food 

additive files has increased from five to 

seven respondents who will each 

submit one such file, for a total of 

35,000 hours. This is an increase of 

10,000 hours from the burden approved 

by OMB. 

Section 501.22(k) Labeling of Color 

Additive or Lake of Color Additive; 

Labeling of Color Additives Not Subject 

to Certification: The information 

collection reflects an adjustment in 

burden by 647 hours and 2,587 

responses. We attribute this adjustment 

due to the consolidation of OMB control 

numbers 0910–0546 and 0910–0721. 

Dated: January 25, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–01792 Filed 1–27–22; 8:45 am] 

BILLING CODE 4164–01–P 


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