Notice2025-16268
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Substances Generally Recognized as Safe (GRAS): Notifications and Convening Panels
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
August 26, 2025
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 90 Issue 163 (Tuesday, August 26, 2025)</title>
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[Federal Register Volume 90, Number 163 (Tuesday, August 26, 2025)]
[Notices]
[Pages 41579-41581]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-16268]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-0123]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Substances Generally
Recognized as Safe (GRAS): Notifications and Convening Panels
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 September 25, 2025.
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
[[Page 41580]]
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: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
<a href="/cdn-cgi/l/email-protection#540406150720353232143230357a3c3c277a333b22"><span class="__cf_email__" data-cfemail="346466756740555252745250551a5c5c471a535b42">[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 (GRAS): Notifications and
Convening Panels--21 CFR 170, Subpart E and 21 CFR 570, Subpart E
OMB Control Number 0910-0342--Revision
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 GRAS by qualified experts.
The GRAS provision of section 201(s) of the FD&C Act is implemented in
21 CFR part 170 (part 170) and 21 CFR part 570 (part 570) for human
food and animal food, respectively. Part 170, subpart E, and part 570,
subpart E, establish a standard format for the submission of a notice.
Information submitted to FDA in a GRAS notice by respondents is
necessary to allow us to administer efficiently the various FD&C Act
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.
Form FDA 3667, entitled ``Generally Recognized as Safe Notice''
(<a href="https://www.fda.gov/media/85886/download">https://www.fda.gov/media/85886/download</a>), provides a standardized
format for the submission of information and is intended to assist
respondents with the submission of GRAS notices. Form FDA 3667 and any
attachments may be submitted in electronic format via the Centralized
Online Submission Module (<a href="https://www.fda.gov/food/registration-food-facilities-and-other-submissions/centralized-online-submission-module-cosm">https://www.fda.gov/food/registration-food-facilities-and-other-submissions/centralized-online-submission-module-cosm</a>), or may be submitted in paper format, or as electronic files on
physical media with paper signature page. For submissions to the Center
for Veterinary Medicine, respondents may continue to send GRAS notices
in paper format, or as electronic files on physical media with paper
signature page to the Agency.
For efficiency of Agency operations, we are revising the
information collection to account for burden that may be attributable
to the guidance document entitled ``Best Practices for Convening a
Generally Recognized as Safe Panel'' (December 2022) (<a href="https://www.fda.gov/media/109006/download">https://www.fda.gov/media/109006/download</a>), currently approved in OMB control
number 0910-0911. The guidance document was developed to assist persons
who choose to convene a panel of experts in support of a conclusion
that the use of a substance in food is GRAS. Specifically, the guidance
document includes recordkeeping recommendations and disclosure
recommendations pertaining to the administration of GRAS panel and GRAS
panel membership.
Description of Respondents: The respondents to this collection of
information are manufacturers of substances used in human food and
animal food and feed. Respondents also include persons (``proponents'')
who are responsible for a conclusion that a substance may be used in
food on the basis of the GRAS provision of the FD&C Act when such
persons convene a GRAS panel to evaluate whether the available
scientific data, information, and methods establish that the substance
is safe under the conditions of its intended use in human food or
animal food. Respondents also include members and prospective members
of GRAS panels. The term ``GRAS panel'' is defined as a panel of
individuals convened for the purpose of evaluating whether the
available scientific data, information, and methods establish that a
substance is safe under the conditions of its intended use in food.
In the Federal Register of June 27, 2025 (90 FR 27642), we
published a 60-day notice soliciting comment on the proposed collection
of information. No comments were received.
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 12 1 12 170 2,040
animal food and animal feed;
570.210-570.280 (part 570,
subpart E).....................
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Total....................... .............. .............. 125 .............. 19,040
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
In row 2 of table 1, we are decreasing our estimate for the number
of respondents submitting GRAS notices for animal food and animal feed
from 25 to 12, which results in a decrease of 2,210 burden hours (4,250
hours minus 2,040 hours). This estimate is based on the number of
submissions we received over the last 3 years.
[[Page 41581]]
Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of Average
Activity; guidance document Number of records per Total annual burden per Total hours
section recordkeepers recordkeeper records recordkeeping
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Maintaining written GRAS panel 696 1 696 2 1,392
policy; V. Recommendations.....
Application of written GRAS 94 6 564 16 9,024
panel policy to GRAS panel
members; V. Recommendations....
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Total....................... .............. .............. 1,260 .............. 10,416
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
Row 1 of table 2 reflects a decrease in our estimate of the average
burden per recordkeeping from 40 hours to 2 hours annually. We believe
that respondents will have realized burden associated with the initial
documentation of written GRAS panel policies and have modified our
estimate to reflect burden associated with maintaining the applicable
records.
Table 3--Estimated Annual Third-Party Disclosure Burden \1\
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Number of
Activity; guidance document Number of disclosures Total annual Average burden
section respondents per disclosures per disclosure Total hours
respondent
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Potential GRAS panel members 564 1 564 4 2,256
provide information to the
proponents of GRAS conclusions;
V. Recommendations.............
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
We have made no change in our estimate associated with the
disclosure recommendations discussed in the guidance document.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-16268 Filed 8-25-25; 8:45 am]
BILLING CODE 4164-01-P
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