[Federal Register Volume 90, Number 184 (Thursday, September 25, 2025)]
[Notices]
[Pages 46213-46215]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-18617]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-0195]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Production, Storage,
and Transportation of Shell Eggs (Preventing Salmonella Enteritidis)
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 October 27, 2025.
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
[[Page 46214]]
by using the search function. The OMB control number for this
information collection is 0910-0660. Also include the FDA docket number
found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
[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.
Production, Storage, and Transportation of Shell Eggs (Preventing
Salmonella Enteritidis (SE))--21 CFR 118.10 and 118.11
OMB Control Number 0910-0660--Extension
This information collection supports Agency regulations in part 118
(21 CFR part 118), Production, Storage, and Transportation of Shell
Eggs, and Form FDA 3733, Shell Egg Producer Registration Form. The
Public Health Service Act (PHS Act) (42 U.S.C. 264) authorizes the
Secretary of Health and Human Services to make and enforce such
regulations as ``are necessary to prevent the introduction,
transmission, or spread of communicable diseases from foreign countries
into the States . . . or from one State . . . into any other State''
(section 361(a) of the PHS Act (42 U.S.C. 264(a))). This authority has
been delegated to the Commissioner of Food and Drugs. Under section
402(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 342(a)(4)), a food is adulterated if it is prepared, packed, or
held under insanitary conditions whereby it may have been contaminated
with filth or rendered injurious to health. Under section 701(a) of the
FD&C Act (21 U.S.C. 371(a)), FDA is authorized to issue regulations for
the efficient enforcement of the FD&C Act.
Under part 118, shell egg producers are required to implement
measures to prevent SE from contaminating eggs on the farm and from
further growth during storage and transportation. Shell egg producers
also are required to maintain records concerning their compliance with
part 118 and to register with FDA. As described in more detail about
each information collection provision of part 118, each farm site with
3,000 or more egg-laying hens that sells raw shell eggs, other than
directly to the consumer, must refrigerate, register, and keep certain
records. Farms that do not send all of their eggs to treatment are also
required to have an SE prevention plan and to test for SE.
Section 118.10 of FDA's regulations requires recordkeeping for all
measures a farm takes to prevent SE in its flocks. Since many existing
farms participate in voluntary egg quality assurance programs, those
respondents may not have to collect any additional information. Records
are compiled and retained at each farm site and examined there
periodically by FDA inspectors. Section 118.10 also requires each farm
site with 3,000 or more egg-laying hens that sells raw shell eggs to
the table egg market, other than directly to the consumer, and does not
have all of the shell eggs treated, to design and implement an SE
prevention plan. Section 118.10 requires recordkeeping for each of the
provisions included in the plan and for plan review and modifications
if corrective actions are taken.
Finally, Sec. 118.11 (21 CFR 118.11) of FDA's regulations requires
that each farm covered by Sec. 118.1(a) register with FDA using Form
FDA 3733. The term ``Form FDA 3733'' refers to both the paper version
of the form and the electronic system known as the Shell Egg Producer
Registration Module, which is available at https://www.access.fda.gov.
We strongly encourage electronic registration because it is faster and
more convenient. The system accepts electronic registrations 24 hours a
day, 7 days a week. A registering shell egg producer receives
confirmation of electronic registration instantaneously once all the
required fields on the registration screen are completed. However,
paper registrations also are accepted. Form FDA 3733 is available for
download for registration by mail, Fax or CD-ROM. More information is
available at our website at https://www.fda.gov/food/registration-food-facilities-and-other-submissions/shell-egg-producer-registration and
https://www.fda.gov/food/shell-egg-producer-registration/shell-egg-producer-registration-registrationcancellation-paper-mail-or-fax-or-cd-rom.
Recordkeeping and registration are necessary for the success of the
SE prevention measures. Written SE prevention plans and records of
actions taken due to each provision are essential for farms to
implement SE prevention plans effectively. Further, they are essential
for us to be able to determine compliance. Information provided under
these regulations helps us to quickly notify the facilities that might
be affected by a deliberate or accidental contamination of the food
supply. In addition, data collected through registration is used to
support our enforcement activities.
Description of Respondents: Respondents to this information
collection include farm sites with 3,000 or more egg-laying hens that
sell raw eggs, other than directly to the consumer.
In the Federal Register of June 27, 2025 (90 FR 27614), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Recordkeeping Burden \1\
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Number of Number of Average burden
Activity; 21 CFR section recordkeepers records per Total annual per Total hours
\2\ recordkeeper records recordkeeping
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Refrigeration Records; Sec. 2,600 52 135,200 0.5 (30 minutes) 67,600
118.10(a)(3)(iv).
Testing, Diversion, and 343 52 17,836 0.5 (30 minutes) 8,918
Treatment Records; Sec.
118.10(a)(3)(v) through
(viii) (positive) \3\.
Egg Testing; Sec. 331 7 2,317 8.3............. 19,231
118.10(a)(3)(vii).
Environmental Testing; Sec. 6,308 23 145,084 0.25 (15 36,271
118.10(a)(3)(v) \3\. minutes).
Testing, Diversion, and 5,965 1 5,965 0.5 (30 minutes) 2,983
Treatment Records; Sec.
118.10(a)(3)(v) through
(viii) (negative) \3\.
Prevention Plan Review and 331 1 331 10.............. 3,310
Modifications; Sec.
118.10(a)(4).
Chick and Pullet Procurement 4,731 1 4,731 0.5 (30 minutes) 2,366
Records; Sec. 118.10(a)(2).
[[Page 46215]]
Rodent and Other Pest Control; 9,462 52 492,024 0.5 (30 minutes) 246,012
Sec. 118.10(a)(3)(ii), and
Biosecurity Records; Sec.
118.10(a)(3)(i).
Prevention Plan Design; Sec. 350 1 350 20.............. 7,000
118.10(a)(1).
Cleaning and Disinfection 331 1 331 0.5 (30 minutes) 166
Records; Sec.
118.10(a)(3)(iii).
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Total..................... .............. .............. .............. ................ 393,857
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Some records are kept on a by-farm basis and others are kept on a by-house basis.
\3\ Calculations include requirements for pullet and layer houses.
Table 2--Estimated Annual Reporting Burden \1\
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Number of
Activity; 21 CFR section Form Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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Registrations or Updates; Sec. 118.11... FDA 3733 \2\................ 350 1 350 2.3 805
Cancellations; Sec. 118.11.............. FDA 3733.................... 30 1 30 1 30
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Total................................. ............................ .............. .............. .............. .............. 835
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ The term ``Form FDA 3733'' refers to both the paper version of the form and the electronic system known as the Shell Egg Producer Registration
Module, which is available at http://www.access.fda.gov per Sec. 118.11(b)(1).
Our estimates for the recordkeeping burden and the reporting burden
are based on our experience with similar recordkeeping activities and
the number of registrations and cancellations received in the past 3
years. Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-18617 Filed 9-24-25; 8:45 am]
BILLING CODE 4164-01-P