[Federal Register Volume 90, Number 122 (Friday, June 27, 2025)]
[Notices]
[Pages 27642-27644]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-11960]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-0123]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Substances Generally Recognized as Safe: Notifications
and Convening Panels
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the collections of information associated
with provisions of the notification procedure for substances generally
recognized as safe (GRAS) and with recommended activities found in the
guidance for convening a GRAS panel.
DATES: Either electronic or written comments on the collection of
information must be submitted by August 26, 2025.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of August 26, 2025. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.
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 No.
FDA-2025-N-0123 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Substances Generally Recognized
as Safe: Notifications and Convening Panels.'' Received comments, those
filed in a timely manner (see ADDRESSES), will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the
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electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Substances Generally Recognized as Safe: 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 provide a standard format for the submission of a notice.
This collection utilizes an administrative procedure for a proponent to
notify 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 by a proponent 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.
To support a GRAS conclusion, a proponent may convene a panel of
qualified experts to provide evidence that generally available safety
data and information about the intended use of the substance in food
are generally accepted among experts, which is one of the criteria for
eligibility for GRAS status (81 FR 54960 at 54975; August 17, 2016).
FDA issued a guidance entitled ``Best Practices for Convening a
Generally Recognized as Safe Panel'' (December, 2022) (https://www.fda.gov/media/109006/download) 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. The guidance recommends specific content
elements pertaining to recordkeeping and third-party disclosure. The
guidance explains a recordkeeping recommendation for proponents to
develop a written GRAS panel policy record describing how it will
convene a panel. The proponent creates the written policy to fit its
needs. The guidance discusses a third-party disclosure recommendation
for prospective panel members to provide vetting information to
proponents, to ascertain expertise, and reduce risk of bias. The
guidance also explains a recordkeeping recommendation for proponents to
document the application of the GRAS panel policy to each GRAS panel
member as part of the vetting process. Respondents do not submit to FDA
the recordkeeping or third-party disclosure information. The
collections of information in the guidance are currently approved under
OMB control number 0910-0911. Upon approval of the requested revision,
we plan to discontinue OMB control number 0910-0911.
To assist respondents with submissions to the Human Foods Program,
we offer Form FDA 3667 entitled ``Generally Recognized as Safe Notice''
(https://www.fda.gov/media/85886/download). The form, and elements
prepared as attachments to the form, may be submitted in electronic
format via the Centralized Online Submission Module (https://www.fda.gov/food/registration-food-facilities-and-other-submissions/centralized-online-submission-module-cosm), 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. 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, as instructed in the Federal
Register of June 4, 2010 (75 FR 31800).
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 would 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
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evaluating whether the available scientific data, information, and
methods establish that a substance is safe under the conditions of its
intended use in food.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of Total Average
Activity; 21 CFR section Number of responses per annual burden per Total
respondents respondent responses response hours
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GRAS notification procedure for human food; 100 1 100 170 17,000
170.210-170.280 (part 170, subpart E).........
GRAS notification procedure for animal food and 12 1 12 170 2,040
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.
Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of Total Average burden
Activity; guidance document section Number of records per annual per Total
recordkeepers recordkeeper records recordkeeping hours
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Maintaining written GRAS panel policy; V. 696 1 696 2 1,392
Recommendations...........................
Application of written GRAS panel policy to 94 6 564 16 9,024
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 of the average burden per
recordkeeping as compared to the corresponding estimate under OMB
control number 0910-0911, which decreased from 40 hours to 2 hours per
recordkeeping. When we issued the guidance for convening a GRAS panel,
we estimated that a proponent would take 40 hours to create and
establish a written GRAS panel policy. We presume that proponents will
have now established their written GRAS panel policy and only needs to
maintain it, which we estimate will take 2 hours for each proponent.
Table 3--Estimated Annual Third-Party Disclosure Burden \1\
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Number of Average
Activity; guidance document section Number of disclosures per Total annual burden per Total
respondents respondent disclosures disclosure hours
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Potential GRAS panel members provide 564 1 564 4 2,256
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 are revising the information collection to include related
activities associated with the guidance for convening a GRAS panel,
currently approved under OMB control number 0910-0911, ``Substances
Generally Recognized as Safe: Best Practices for Convening a GRAS
Panel.'' The revision will add 10,462 hours and 1,824 responses. This
estimate is based on our experience with this information collection
and the number of notifications received in the past 3 years.
Dated: June 24, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-11960 Filed 6-26-25; 8:45 am]
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