[Federal Register Volume 87, Number 110 (Wednesday, June 8, 2022)]
[Notices]
[Pages 34882-34883]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-12367]


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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.

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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, 
[email protected].

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

[[Page 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\
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                                                     Number of
    Activity; 21 CFR section         Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
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GRAS notification procedure for              100               1             100             170          17,000
 human food; 170.210-170.280
 (part 170, subpart E)..........
GRAS notification procedure for               25               1              25             170           4,250
 animal food and animal feed;
 570.210-570.280 (part 570,
 subpart E).....................
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    Total.......................  ..............  ..............             125  ..............          21,250
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\1\ There 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