[Federal Register Volume 87, Number 207 (Thursday, October 27, 2022)]
[Notices]
[Pages 65081-65085]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-23378]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-0085]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Substances Generally 
Recognized as Safe: Best Practices for Convening a Generally Recognized 
as Safe Panel

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 November 28, 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 title of this 
information collection is ``Substances Generally Recognized as Safe: 
Best Practices for Convening a GRAS Panel.'' 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.

I. Background

Best Practices for Convening a Generally Recognized as Safe Panel

OMB Control Number 0910-NEW
    This information collection supports FDA's implementation of Agency 
guidance. In 2017, FDA developed and published for comment a draft 
guidance entitled ``Best Practices for Convening a Generally Recognized 
as Safe Panel,'' (https://www.fda.gov/media/109006/download) which, 
once finalized, would assist persons who choose to convene a panel of 
experts in support of a conclusion that the use of a substance in food 
is generally recognized as safe (GRAS).
    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 for their intended use in food 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

[[Page 65082]]

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 GRAS by qualified experts.
    The GRAS provision of section 201(s) of the FD&C Act is implemented 
in 21 CFR part 170 for human food and 21 CFR part 570 for animal food. 
The regulations provide the criteria for when the use of a substance in 
food for humans or animals is GRAS. Part 170, subpart E and part 570, 
subpart E provide the procedure under which a person (also referred to 
as the ``proponent'' of a GRAS conclusion) may notify FDA about a 
conclusion that a substance is GRAS under the conditions of its 
intended use in human and/or animal food. This includes a standard 
format for the submission of a GRAS notice. 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, whether a substance is GRAS 
under the conditions of its intended use or whether it is a food 
additive subject to premarket review and approval by FDA. 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 54959 at 54975; August 17, 2016).
    From 2008 to 2010, the Government Accountability Office (GAO) 
conducted a study related to ingredients used in human food on the 
basis of the GRAS provision in section 201(s) of the FD&C Act. In 2010, 
GAO issued a report (the GAO report \1\) that included recommendations 
for FDA. Of relevance here, the GAO report recommended that FDA develop 
a strategy to minimize the potential for conflicts of interest among 
GRAS panel members, including issuing guidance for companies on 
conflict of interest, and we requested comment on issuing such a 
guidance in our reopening notice (75 FR 81536 at 81542; December 28, 
2010). In the GRAS final rule, we stated our intent to issue such 
guidance (see Response 125, 81 FR 54959 at 55026). This guidance 
recommends an assessment for conflict of interest and the appearance of 
conflict of interest as part of the best practices for convening a GRAS 
panel and would address the final outstanding GAO recommendation for 
FDA from the 2010 report.
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    \1\ United States Government Accountability Office (2010). 
``Report to Congressional Requestors on Food Safety: FDA Should 
Strengthen Its Oversight of Food Ingredients Determined to Be 
Generally Recognized as Safe (GRAS),'' Report No. GAO-10-246. 
Available at https://www.gao.gov/assets/gao-10-246.pdf.
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    The guidance document recommends specific content elements 
pertaining to recordkeeping and third-party disclosure. The guidance 
explains a recordkeeping recommendation for proponents to develop a 
one-time, written GRAS panel policy record describing how it will 
convene a panel. The proponent creates the written policy to fit its 
needs. The guidance document 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 document 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 guidance will assist respondents convening a GRAS panel. The 
information collection recommendations (establishment of a written GRAS 
panel policy, solicitation of information from prospective GRAS panel 
members about potential conflicts of interest and other sources of 
bias, and documentation of the application of the GRAS panel policy to 
each GRAS panel member) would help the respondent to identify GRAS 
panel members who have appropriate and balanced expertise and reduce 
the risk that bias (or the appearance of bias) will affect the 
credibility of the GRAS panel's output.
    Description of Respondents: Respondents to this collection of 
information are 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 independently 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. We estimate that there are 1,260 such respondents as discussed 
more fully below. 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 November 16, 2017 (82 FR 53433), we 
published a draft guidance requesting public comment on the proposed 
collection of information. We received 13 comments with almost half 
being responsive to PRA topics. All comments were considered even if 
they were not fully captured by our paraphrasing in this document. Most 
comments communicated general support for the information collection. 
Comments articulated that the guidance would promote uniformity of 
practices for industry and mitigate potential conflicts and biases. One 
comment expressed that the recommendations for preparing a GRAS panel 
policy are not unusual or burdensome to proponents, although another 
comment believed that establishment and implementation of a written 
GRAS panel policy would be burdensome. However, the comment recognized 
that the proponent drafts the written policy, which allows the 
proponent to tailor the policy to itself and make the policy broad 
enough to cover the wide range of issues it may encounter. The comment 
further stated that many in industry already employ policies and 
procedures recommended in the guidance. Another comment believed that 
the time estimates to perform the information collections are 
reasonable. No other comments were received disputing the need for the 
information, the accuracy of our burden estimate, or ways to minimize 
burden. Although we are preparing to finalize the guidance document to 
clarify discussions around evaluating and managing conflicts of 
interest and appearance issues, to emphasize that a GRAS panel is not 
necessary, and providing additional background information regarding 
the value of a GRAS panel in providing evidence to support the 
``general acceptance'' aspect of the criteria for eligibility for GRAS 
status through scientific procedures, none of the revisions pertain to 
the information collection recommendations discussed in our 60-day 
notice.
    Since the publication of the 60-day notice, we have further 
considered the burden estimate and adjusted it based on updated 
information available to us from FDA's GRAS Notices Inventory and the 
Independent GRAS Conclusion Inventory Database (Refs. 1, 2, and 3).
    The records recommended in the guidance to be maintained by a 
proponent include a one-time information collection burden pertaining 
to a written GRAS panel policy to govern the assembly and

[[Page 65083]]

conduct of a GRAS panel. The records recommended in the guidance also 
include annual information collection burdens pertaining to documenting 
the application of the written GRAS panel policy to each member of a 
GRAS panel convened in a given year and collecting information from 
prospective members of the GRAS panel to conduct the vetting process as 
detailed in the written GRAS panel policy. Finally, the guidance 
recommends that a GRAS panel provides a written report of its findings; 
however, we consider a written GRAS panel report as customary business 
practice that is already being created by GRAS panels and, thus, we do 
not estimate an annual information collection burden for the creation 
of a GRAS panel report.
    We estimate the burden of this collection of information as 
follows:

Burden Estimate for Written GRAS Panel Policy Recommendation

                                                  Table 1--Estimated One-Time Recordkeeping Burden \1\
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                                                                                    Number of                       Average burden per
                           Activity                                Number of       records per      Total annual     recordkeeping (in     Total hours
                                                                 recordkeepers     recordkeeper       records             hours)
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Establishing written GRAS panel policy.......................              696                1              696                    40           27,840
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    For the purpose of this analysis, we make the conservative 
assumption that all proponents who document a GRAS conclusion will 
create a written GRAS panel policy that would apply to GRAS panels 
convened in the first year that the final guidance would be in effect, 
as well as to GRAS panels convened in subsequent years. We also assume 
that these proponents will create a written GRAS panel policy 
regardless of whether they report the panel's documented GRAS 
conclusion to FDA in the form of a GRAS notice. Therefore, for the 
purpose of this analysis we: (1) calculated the number of proponents 
who have submitted at least one GRAS notice to FDA and (2) estimated 
the number of proponents who have documented at least one GRAS 
conclusion without reporting that documented GRAS conclusion to FDA in 
the form of a GRAS notice.
    Using the data in our inventories of GRAS notices submitted for 
substances intended for use in human food (Ref. 1) and animal food 
(Ref. 2) during the time period of April 17, 1997, through October 2, 
2020, we calculate that 466 proponents submitted at least one GRAS 
notice for a substance intended for use in human food, and 20 
proponents submitted at least one GRAS notice for a substance intended 
for use in animal food. For the purpose of this analysis, we make the 
conservative assumption that there will be no overlap between 
proponents who submit GRAS notices for substances intended for use in 
human food and proponents who submit GRAS notices for substances 
intended for use in animal food. Therefore, the total number of 
proponents who have submitted at least one GRAS notice to FDA is 486 
(466 human food proponents + 20 animal food proponents).
    We have very little information about the number of proponents who 
have documented a GRAS conclusion without reporting that GRAS 
conclusion to FDA in the form of a GRAS notice. To estimate the number 
of such proponents, we used a publicly available database entitled 
``Independent GRAS (Generally Recognized As Safe) Conclusion Inventory 
Database'' (Ref. 3), which is a compilation of the results of a 
consulting company's search of publicly available information in 
industry trade journals about documented GRAS conclusions for 
substances intended for use in human food. The oldest entry is for the 
year 1995. We received the first GRAS notice for substances intended 
for use in human food in 1998 and, thus, the database covers the entire 
timeframe during which FDA has been receiving GRAS notices for 
substances intended for use in human food. As of October 2, 2020, that 
database recorded that there had been a total of 213 documented GRAS 
conclusions, with 41 of those documented GRAS conclusions reported to 
FDA as a GRAS notice and 172 of those documented GRAS conclusions not 
reported to FDA as a GRAS notice. In contrast, as of October 2, 2020, 
FDA's inventory of GRAS notices shows that the number of GRAS 
conclusions reported to FDA during this timeframe was 937, not 41 (Ref. 
1). We assume that the reduced number of documented GRAS conclusions 
that the database recorded as being reported to FDA is due to the 
mechanism by which the database searches for documented GRAS 
conclusions (i.e., publications in industry trade journals). For 
example, there could be less incentive for a business that reports its 
documented GRAS conclusion to FDA to publicize that GRAS conclusion 
through industry trade journals, because the business can publicize 
FDA's response to the GRAS notice in other ways.
    The database attributes the 172 documented GRAS conclusions not 
reported to FDA to 146 different proponents. However, 62 of these 
proponents have also submitted a GRAS notice to FDA and, thus, we 
calculate that the database attributes documented GRAS conclusions to 
84 proponents who have not submitted a GRAS notice to FDA (146 
proponents listed in the database--62 proponents whom we already 
counted because they submitted a GRAS notice to FDA). We also make the 
conservative assumption that the number of proponents who have 
documented GRAS conclusions without reporting them to FDA since FDA 
began receiving GRAS notices is twice as high as recorded in the 
database--i.e., 168 proponents (84 proponents listed in the database x 
2).
    The publicly available database does not record documented GRAS 
conclusions for substances intended for use in animal food. In the 
burden estimate for the approved information collection ``Substances 
Generally Recognized as Safe: Notification Procedure'' (OMB control 
number 0910-0342), we estimated that 100 GRAS notices would be 
submitted to FDA for substances intended for use in human food and that 
25 GRAS notices will be submitted to FDA for substances intended for 
use in animal food (86 FR 64943; November 19, 2021). For the purpose of 
our current analysis, we use that 25 percent ratio to estimate that the 
number of proponents who have documented GRAS conclusions for 
substances intended for use in animal food without reporting those GRAS 
conclusions to FDA is 25 percent of the number of proponents who 
documented GRAS conclusions for substances intended for use in human 
food without reporting those GRAS conclusions to FDA--i.e., 42 
proponents (168 estimated proponents who have documented GRAS 
conclusions without reporting those GRAS conclusions to FDA x 0.25). We 
estimate that the total number of proponents who documented GRAS 
conclusions without reporting those

[[Page 65084]]

GRAS conclusions to FDA is 210 proponents (168 estimated proponents who 
have documented GRAS conclusions for substances intended for use in 
human food + 42 estimated proponents who have documented GRAS 
conclusions for substances intended for use in animal food).
    To estimate the total number of proponents, we are adding 210 
estimated proponents who have not reported their documented GRAS 
conclusions to FDA to the 486 proponents who have already submitted at 
least one GRAS notice to FDA for a total of 696 proponents who will 
document a GRAS conclusion (210 non-reporting proponents + 486 
reporting proponents). As already stated, for the purpose of this 
analysis we make the conservative assumption that all of these 
proponents who document GRAS conclusions (i.e., 696 proponents) will 
create a written GRAS panel policy. We estimate that it will take 40 
hours to create a written GRAS panel policy, including 8 hours to 
review relevant, publicly available policies that address conflict of 
interest and 32 hours to tailor a GRAS panel policy specific to the 
proponent, using relevant information from such existing policies as 
appropriate to the needs of the proponent. As shown in table 1, the 
total one-time burden to create a written GRAS panel policy is 40 hours 
per proponent x 696 proponents = 27,840 hours.

Burden Estimate for Records Documenting the Application of the GRAS 
Panel Policy to GRAS Panel Members

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                                                    Number of                       Average burden per
                           Activity                                Number of       records per      Total annual     recordkeeping (in     Total hours
                                                                 recordkeepers     recordkeeper       records             hours)
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Application of written GRAS panel policy to GRAS panel                      94                6              564                    16            9,024
 members.....................................................
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 \1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Based on the number of annual GRAS notices submitted to FDA in 
recent years, we previously estimated that 100 GRAS notices will be 
submitted to FDA for substances intended for use in human food and that 
25 GRAS notices will be submitted to FDA for substances intended for 
use in animal food (OMB control number 0910-0342; 86 FR 64943), for a 
total number of 125 GRAS notices submitted to FDA each year. We count 
each GRAS notice as a single GRAS conclusion, and, for the purpose of 
our analysis, we assume that a different proponent submits each of 
these GRAS notices. Therefore, we estimate that the total number of 
documented GRAS conclusions submitted to FDA on an annual basis is 125 
GRAS conclusions and that these GRAS conclusions are submitted by 125 
proponents.
    We have not previously estimated the annual number of documented 
GRAS conclusions that are not reported to FDA as a GRAS notice. To 
estimate such GRAS conclusions, we used the same database (Ref. 3) that 
we used to estimate the total number of proponents who document GRAS 
conclusions without reporting the GRAS conclusions to FDA in the form 
of a GRAS notice. As already stated, the oldest recorded entry in the 
database is for the year 1995. However, with the exception of that 
single entry for 1995, the remaining entries are for the years 2001 and 
beyond. Therefore, we use 20 years (i.e., from 2001 through 2020) as 
the number of years covering those documented GRAS conclusions that are 
not reported to FDA. For the purpose of calculating the annual number 
of documented GRAS conclusions that are for substances intended for use 
in human food and are not reported to FDA, we estimate that there are 
171 such GRAS conclusions (172 documented, unreported GRAS conclusions 
for substances intended for use in human food minus 1 GRAS conclusion 
reported before 2001). We calculate that, on average, the annual number 
of documented, unreported GRAS conclusions for substances intended for 
use in human food and recorded in the database is 9 (171 documented, 
unreported GRAS conclusions/20 years = 8.55 documented, unreported GRAS 
conclusions per year recorded in the database, rounded up to 9). As 
with our analysis of the total number of proponents, we conservatively 
assume that the annual number of documented, unreported GRAS 
conclusions for substances intended for use in human food could be 
twice as high as the annual number of documented, unreported GRAS 
conclusions recorded in the database--i.e., 18 documented, unreported 
GRAS conclusions for substances intended for use in human food each 
year (9 documented, unreported GRAS conclusions recorded in the 
database on an annual basis x 2). As with documented GRAS conclusions 
that are reported to FDA, we assume that a different proponent is 
responsible for each documented GRAS conclusion not reported to FDA 
and, thus, on an annual basis there are 18 proponents who do not report 
their documented GRAS conclusions for substances intended for use in 
human food to FDA. We previously estimated that 100 GRAS notices will 
be submitted to FDA for substances intended for use in human food and 
that 25 GRAS notices will be submitted to FDA for substances intended 
for use in animal food (OMB control number 0910-0342; 84 FR 29216). 
Using that ratio, we conservatively assume that the annual number of 
documented, unreported GRAS conclusions for substances intended for use 
in animal food is 25 percent of the annual number of documented, 
unreported GRAS conclusions for substances intended for use in human 
food--i.e., 5 documented, unreported GRAS conclusions for substances 
intended for use in animal food on an annual basis (18 documented, 
unreported GRAS conclusions for substances intended for use in human 
food x 0.25 = 4.5, rounded up to 5). We also calculate that there are a 
total of 23 documented, unreported GRAS conclusions each year (18 
documented, unreported GRAS conclusions for substances intended for use 
in human food + 5 documented, unreported GRAS conclusions for 
substances intended for use in animal food). We therefore calculate 
that there are 148 proponents who document a GRAS conclusion on an 
annual basis (125 proponents who submit their documented GRAS 
conclusions to FDA in a GRAS notice + 23 proponents who do not submit 
their documented GRAS conclusions to FDA in a GRAS notice).
    We have information about the percentage of proponents who convene 
a GRAS panel for a documented GRAS conclusion and also submit a GRAS 
notice to FDA. During the time period April 17, 1997, through October 
2, 2020, on average, 57 percent of proponents who submitted a GRAS 
notice for a substance intended for use in human food, and 55 percent 
of proponents who

[[Page 65085]]

submitted a GRAS notice for a substance intended for use in animal 
food, convened a GRAS panel. We therefore estimate that, on an annual 
basis, 57 proponents will convene a GRAS panel and submit a GRAS notice 
to FDA for substances intended for use in human food (57 percent x 100 
proponents), and 14 proponents will convene a GRAS panel and submit a 
GRAS notice to FDA for substances intended for use in animal food (55 
percent x 25 proponents). We calculate that the total number of 
proponents who will convene a GRAS panel and submit a GRAS notice to 
FDA is 71 proponents (57 human food proponents + 14 animal food 
proponents). We also assume that all proponents will document the 
application of a written GRAS panel policy to each member of the GRAS 
panel.
    We have very little information about the percentage of proponents 
who convene a GRAS panel for a documented GRAS conclusion but do not 
report their documented GRAS conclusions to FDA in a GRAS notice. For 
the purpose of this analysis, we make the conservative assumption that 
all 23 proponents who annually document GRAS conclusions without 
reporting them to FDA will convene a GRAS panel. Taking into account 
the estimated number of proponents who convene a GRAS panel and submit 
a GRAS notice to FDA, and the estimated number of proponents who 
convene a GRAS panel but do not submit a GRAS notice to FDA, we 
calculate that the total number of proponents who will convene a GRAS 
panel and document the application of the written GRAS panel policy to 
each member of a GRAS panel on an annual basis is 94 proponents (71 
proponents who submit GRAS notices to FDA + 23 proponents who do not 
submit GRAS notices).
    Based on the recommendations in the guidance, we assume that all 
GRAS panels will include at least 3 panel members and that some GRAS 
panels will include as many as 6 panel members. We assume that a GRAS 
panel will include 5 panel members on average. We also assume that the 
proponent will reject at least one individual with applicable expertise 
due to a conflict of interest and, thus, that 94 proponents will 
document the application of the written GRAS panel policy to 6 
individual GRAS panel members, for a total of 564 documentations of the 
application of the written GRAS panel policy (94 proponents x 6 panel 
members). As shown in table 2, we estimate that it will take the 
proponent 16 hours to document the application of the written GRAS 
policy to each panel member, for a total of 9,024 hours (564 
documentations x 16 hours).

Burden Estimate for Disclosures by GRAS Panel Members to Proponents of 
GRAS Conclusions

                                               Table 3--Estimated Annual Third-Party Disclosure Burden \1\
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                                                                                      Number of                         Average burden
                            Activity                                Number of      disclosures per     Total annual     per disclosure     Total hours
                                                                   respondents        respondent       disclosures        (in hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
GRAS panel members provide information to the proponents of                 564                  1              564                  4            2,256
 GRAS conclusions..............................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    As shown in table 3, we assume that all 564 individuals who are 
being considered as members of a GRAS panel will each need 4 hours to 
provide information related to the panel selection and vetting process 
to the proponent, as detailed in the written GRAS panel policy, for a 
total of 2,256 hours (564 individuals x 4 hours).
    FDA plans to consolidate this collection with OMB control number 
0910-0342, ``Substances Generally Recognized as Safe: Notification 
Procedure'' which contains the regulatory procedures under which a 
person may notify FDA about a conclusion that a substance is GRAS under 
the conditions of its intended use in human and/or animal food and 
includes a standard format for the submission of a GRAS notice. The 
revision will add 39,120 burden hours and 1,260 respondents.
    This guidance also refers to previously approved FDA collections of 
information. The collections of information in 21 CFR parts 170 and 570 
have been approved under OMB control number 0910-0342.

II. References

    The following references are on display with the Dockets Management 
Staff (see ADDRESSES) and are available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also 
available electronically at https://www.regulations.gov. FDA has 
verified the website addresses, as of the date this document publishes 
in the Federal Register, but websites are subject to change over time.

1. FDA (2020). GRAS Notices. Available at https://www.accessdata.fda.gov/scripts/fdcc/?set=GRASNotices.
2. FDA (2020). Current Animal Food GRAS Notices Inventory. Available 
at https://www.fda.gov/animal-veterinary/generally-recognized-safe-gras-notification-program/current-animal-food-gras-notices-inventory.
3. AIBMR Life Sciences, Inc. (2020). Independent GRAS (Generally 
Recognized As Safe) Conclusion Inventory Database. Available at 
http://aibmr.com/natural-products-industry-compliance-consultation/gras-generally-recognized-as-safe-safety-studies/.

    Dated: October 20, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-23378 Filed 10-26-22; 8:45 am]
BILLING CODE 4164-01-P