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, 


khammond on DSKJM1Z7X2PROD with NOTICES
34884 Federal Register / Vol. 87, No. 110 / Wednesday, June 8, 2022 / Notices 

MD 20993–0002, 301–796–7699, email: 

PCNS@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Pursuant 

to 41 CFR 102–3.65 and approval by the 

Department of Health and Human 

Services and by the General Services 

Administration, FDA is announcing the 

renewal of the Peripheral and Central 

Nervous System Drugs Advisory 

Committee (the Committee). The 

Committee is a discretionary Federal 

advisory committee established to 

provide advice to the Commissioner. 

The Committee advises the 

Commissioner or designee in 

discharging responsibilities as they 

relate to helping to ensure safe and 

effective drugs for human use and, as 

required, any other product for which 

FDA has regulatory responsibility. 

The Committee reviews and evaluates 

data concerning the safety and 

effectiveness of marketed and 

investigational human drug products for 

use in the treatment of neurologic 

diseases. 

The Committee shall consist of a core 

of nine voting members, including the 

Chair. Members and the Chair are 

selected by the Commissioner or 

designee from among authorities 

knowledgeable in the fields of 

neurology, neuropharmacology, 

neuropathology, otolaryngology, 

epidemiology or statistics, and related 

specialties. Members will be invited to 

serve for overlapping terms of up to 4 

years. Non-Federal members of this 

committee will serve as Special 

Government Employees, representatives 

or ex-officio members. Federal members 

will serve as Regular Government 

Employees or ex-officio members. The 

core of voting members may include one 

technically qualified member, selected 

by the Commissioner or designee, who 

is identified with consumer interests 

and is recommended by either a 

consortium of consumer-oriented 

organizations or other interested 

persons. In addition to the voting 

members, the Committee may include 

one non-voting representative member 

who is identified with industry 

interests. There may also be an alternate 

industry representative. 

Further information regarding the 

most recent charter and other 

information can be found at https://

www.fda.gov/advisory-committees/ 

peripheral-and-central-nervous-systemdrugs-advisory-committee/peripheraland-central-nervous-system-drugsadvisory-committee-charter or by 

contacting the Designated Federal 

Officer (see FOR FURTHER INFORMATION

CONTACT). In light of the fact that no 

change has been made to the committee 

name or description of duties, no 

amendment will be made to 21 CFR 

14.100. 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app.). For general information 

related to FDA advisory committees, 

please visit us at https://www.fda.gov/ 

AdvisoryCommittees/default.htm. 

Dated: June 3, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–12368 Filed 6–7–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2021–M–0228, FDA– 

2021–M–0202, FDA–2021–M–0203, FDA– 

2021–M–0178, FDA–2021–M–0153, FDA– 

2021–M–0135, FDA–2021–M–0325, FDA– 

2021–M–0303, FDA–2021–M–0288, FDA– 

2021–M–0421, FDA–2021–M–0416, FDA– 

2021–M–0355, FDA–2021–M–0354, FDA– 

2021–M–0520, FDA–2021–M–0615, FDA– 

2021–M–0531, FDA–2021–M–0527, FDA– 

2021–M–0820, FDA–2021–M–0769, FDA– 

2021–M–0766, FDA–2021–M–0676, FDA– 

2021–M–0690, FDA–2021–M–0656, FDA– 

2021–M–0494, FDA–2021–M–0915, FDA– 

2021–M–0911, FDA–2021–M–0853, FDA– 

2021–M–0805, FDA–2021–M–1046, FDA– 

2021–M–1010, FDA–2021–M–0991, FDA– 

2021–M–0989, FDA–2021–M–0975, FDA– 

2021–M–0962, FDA–2021–M–1176, FDA– 

2021–M–1119, FDA–2021–M–1116, FDA– 

2021–M–0532, FDA–2021–M–1058, FDA– 

2021–M–1182, FDA–2021–M–1023, FDA– 

2021–M–1207, FDA–2021–M–1284, FDA– 

2021–M–1271, FDA–2021–M–1317, FDA– 

2021–M–1321, FDA–2021–M–1316, FDA– 

2021–M–1325, FDA–2021–M–1352, FDA– 

2022–M–0029, FDA–2022–M–0071, FDA– 

2022–M–0087, FDA–2022–M–0089, FDA– 

2022–M–0090, and FDA–2022–M–0171]. 

Medical Devices; Availability of Safety 

and Effectiveness Summaries for 

Premarket Approval Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

publishing a list of premarket approval 

applications (PMAs) that have been 

approved from January 1, 2021, through 

February 14, 2022. This list is intended 

to inform the public of the availability 

of safety and effectiveness summaries of 

approved PMAs through the internet 

and the Agency’s Dockets Management 

Staff. This is the last notice of this kind 

considering FDA’s rule discontinuing 

the practice of publishing such 

summaries in the Federal Register. As 

indicated in that rule, FDA will 

continue to publish to make available 

on the internet and place on public 

display summaries of safety and 

effectiveness for approved PMAs. 

ADDRESSES: You may submit comments 

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 Nos. FDA– 

2021–M–0228, FDA–2021–M–0202, 

FDA–2021–M–0203, FDA–2021–M– 

0178, FDA–2021–M–0153, FDA–2021– 

M–0135, FDA–2021–M–0325, FDA– 

2021–M–0303, FDA–2021–M–0288, 

FDA–2021–M–0421, FDA–2021–M– 

0416, FDA–2021–M–0355, FDA–2021– 

M–0354, FDA–2021–M–0520, FDA– 

2021–M–0615, FDA–2021–M–0531, 

FDA–2021–M–0527, FDA–2021–M– 

0820, FDA–2021–M–0769, FDA–2021– 

M–0766, FDA–2021–M–0676, FDA– 


khammond on DSKJM1Z7X2PROD with NOTICES