Notice2022-12367
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Substances Generally Recognized as Safe: Notification Procedure
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 8, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 110 (Wednesday, June 8, 2022)</title>
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[Federal Register Volume 87, Number 110 (Wednesday, June 8, 2022)]
[Notices]
[Pages 34882-34883]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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,
<a href="/cdn-cgi/l/email-protection#8ededccfddfaefe8e8cee8eaefa0e6e6fda0e9e1f8"><span class="__cf_email__" data-cfemail="eabab8abb99e8b8c8caa8c8e8bc4828299c48d859c">[email protected]</span></a>.
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'' (<a href="http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM350015.pdf">http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM350015.pdf</a>). The form, and
elements prepared as attachments to the form, may be submitted in
electronic format via the Electronic Submission Gateway (<a href="https://www.fda.gov/industry/electronic-submissions-gateway">https://www.fda.gov/industry/electronic-submissions-gateway</a>), 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
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