34882 Federal Register / Vol. 87, No. 110 / Wednesday, June 8, 2022 / Notices 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section; activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden per 

response Total hours 

§§ 514.1 and 514.6; applications and amended applications.187 0.07 13 212 ......................... 2,756 

§§ 514.1(b)(8) and 514.8(c)(1); 2 evidence to establish safety and effectiveness.187 0.44 82 90 ........................... 7,380 

§ 514.5(b), (d), and (f); requesting presubmission 

conferences.

187 0.67 125 50 ........................... 6,250 

§ 514.8(b); manufacturing changes to an approved 

application.

187 2 374 35 ........................... 13,090 

§ 514.8(c)(1); labeling and other changes to an approved application.187 0.06 11 71 ........................... 781 

§ 514.8(c)(2) and (3); labeling and other changes to 

an approved application.

187 0.84 157 20 ........................... 3,140 

§ 514.11; submission of data studies and other information.187 0.13 24 1 ............................. 24 

§ 558.5(i); requirements for liquid medicated feed ...... 187 0.01 2 5 ............................. 10 

Applications for conditional approval submitted under 

section 571 of the FD&C Act.

1 1 1 1 ............................. 1 

Form FDA 356V .......................................................... 187 36.5 6,825 0.75 (45 minutes) ... 5,118 

VMF submissions ........................................................ 15 1 15 20 ........................... 300 

Total ...................................................................... ........................ ........................ 7,628 ................................ 38,849 

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

2 NADAs and supplements regarding antimicrobial animal drugs that use a recommended approach to assessing antimicrobial concerns as 

part of the overall preapproval safety evaluation. 

Although we have characterized the 

information collection activity as a 

reporting burden, we include in our 

estimate time required for searching 

data sources, and preparing and 

maintaining necessary and applicable 

records. As stated above, although we 

receive fewer than one submission 

annually when averaged over a 3-year 

period, we attribute one response and 1 

hour annually to account for CNADA 

submissions. 

We have adjusted our estimate of the 

information collection to reflect a 

decrease in burden associated with 

application submissions in 

acknowledgement of respondents’ 

preference in using FDA’s ‘‘eSubmitter’’ 

system, which automatically generates 

Form FDA 356v and allows respondents 

to complete the form and submit 

applications and associated information 

electronically. 

Dated: June 3, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–12355 Filed 6–7–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–1192] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Substances 

Generally Recognized as Safe: 

Notification Procedure 

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: Submit written comments 

(including recommendations) on the 

collection of information by July 8, 

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 0910–0342. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Rachel Showalter, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 240–994–7399, 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. 

Substances Generally Recognized as 

Safe: Notification Procedure—21 CFR 

Part 170, Subpart E and 21 CFR Part 

570, Subpart E 

OMB Control Number 0910–0342— 

Extension 

The Federal Food, Drug, and Cosmetic 

Act (FD&C Act) requires that all food 

additives (as defined by section 201(s) 

(21 U.S.C. 321(s)) be approved by FDA 

before they are marketed. Section 409 of 

the FD&C Act (21 U.S.C. 348) 

establishes a premarket approval 

requirement for ‘‘food additives.’’ 

Section 201(s) of the FD&C Act provides 

an exclusion to the definition of food 

additive and, thus, from the premarket 

approval requirement for uses of 

substances that are generally recognized 

as safe (GRAS) by qualified experts. The 

GRAS provision of section 201(s) of the 

FD&C Act is implemented in parts 170 


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Federal Register / Vol. 87, No. 110 / Wednesday, June 8, 2022 / Notices 34883 

and 570 (21 CFR parts 170 and 570) for 

human food and animal food, 

respectively. Part 170, subpart E and 

part 570, subpart E provide a standard 

format for the submission of a notice. 

This collection utilizes a voluntary 

administrative procedure for notifying 

FDA about a conclusion that a substance 

is GRAS under the conditions of its 

intended use in human food or animal 

food. The information submitted to us 

in a GRAS notice is necessary to allow 

us to administer efficiently the FD&C 

Act’s various provisions that apply to 

the use of substances added to food, 

specifically with regard to whether a 

substance is GRAS under the conditions 

of its intended use or is a food additive 

subject to premarket review. We use the 

information collected through the GRAS 

notification procedures to complete our 

evaluation within specific timelines. 

To assist respondents with 

submissions to the Center for Food 

Safety and Applied Nutrition, we offer 

Form FDA 3667 entitled ‘‘Generally 

Recognized as Safe Notice’’ (http://

www.fda.gov/downloads/AboutFDA/ 

ReportsManualsForms/Forms/ 

UCM350015.pdf). The form, and 

elements prepared as attachments to the 

form, may be submitted in electronic 

format via the Electronic Submission 

Gateway (https://www.fda.gov/industry/ 

electronic-submissions-gateway), or may 

be submitted in paper format, or as 

electronic files on physical media with 

paper signature page. While we do not 

expect Form FDA 3667 to reduce 

reporting time for respondents, use of 

the form helps to expedite our review of 

the information being submitted. 

Description of Respondents: The 

respondents to this collection of 

information are manufacturers of 

substances used in human food and 

animal food and feed. 

In the Federal Register of November 

19, 2021 (86 FR 64945), FDA published 

a 60-day notice requesting public 

comment on the proposed collection of 

information. We received one comment 

responsive to the four information 

collection topics solicited in the 60-day 

notice. 

The comment offers that FDA 

underestimated the average burden per 

response for information collection 

activities related to animal food GRAS 

notices. It asserts that GRAS notices for 

animal food and feed require peer 

reviewed journal publications to 

support the safety of ingredients, rather 

than accepting additional ways to 

demonstrate general recognition of 

safety of an ingredient for an intended 

use. 

For any substance used in animal 

food to be GRAS under the conditions 

of its intended use, the data and 

information relied on to establish the 

safety of the use of the substance must 

be generally available, and that 

information can be in published 

scientific literature or other publicly 

available sources (e.g., textbooks, 

journal articles). While the notifier may 

conduct their own study and publish it 

in a peer reviewed journal, the 

information provided in a GRAS notice 

can include other generally available 

information (i.e., in the public domain). 

The notifier is not required to conduct 

de novo studies (and get that 

information published) in order to 

submit a GRAS notice. The regulations 

for human food GRAS notifications and 

animal food GRAS notifications are 

similar, thus the average burden 

provided for animal food GRAS 

notifications is therefore consistent with 

the estimates for GRAS notifications for 

human food. Therefore, the average 

burden hours for this collection remain 

unchanged. 

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 

GRAS notification procedure for human food; 170.210– 

170.280 (part 170, subpart E) .......................................... 100 1 100 170 17,000 

GRAS notification procedure for animal food and animal 

feed; 570.210–570.280 (part 570, subpart E) .................. 25 1 25 170 4,250 

Total .............................................................................. ........................ ........................ 125 ........................ 21,250 

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

Based on a review of the information 

collection since our last request for 

OMB approval, we have made no 

adjustments to our burden estimate. 

This estimate is based on our experience 

with this information collection and the 

number of notifications received in the 

past 3 years, which has remained 

constant. 

Dated: June 3, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–12367 Filed 6–7–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–N–0691] 

Advisory Committee; Peripheral and 

Central Nervous System Drugs 

Advisory Committee; Renewal 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; renewal of Federal 

advisory committee. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

renewal of the Peripheral and Central 

Nervous System Drugs Advisory 

Committee by the Commissioner of 

Food and Drugs (the Commissioner). 

The Commissioner has determined that 

it is in the public interest to renew the 

Peripheral and Central Nervous System 

Drugs Advisory Committee for an 

additional 2 years beyond the charter 

expiration date. The new charter will be 

in effect until the June 4, 2024, 

expiration date. 

DATES: Authority for the Peripheral and 

Central Nervous System Drugs Advisory 

Committee will expire on June 4, 2024, 

unless the Commissioner formally 

determines that renewal is in the public 

interest. 

FOR FURTHER INFORMATION CONTACT: 

Jessica Seo, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 31, Rm. 2417, Silver Spring, 


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