Notice2022-00863
Agency Information Collection Activities; Proposed Collection; Comment Request; Prevention of Salmonella Enteritidis in Shell Eggs During Production; Recordkeeping and Registration Provisions
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Published
January 19, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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 information collection provisions of FDA's recordkeeping and registration requirements for shell egg producers.
Full Text
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<title>Federal Register, Volume 87 Issue 12 (Wednesday, January 19, 2022)</title>
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[Federal Register Volume 87, Number 12 (Wednesday, January 19, 2022)]
[Notices]
[Pages 2797-2800]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-00863]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0297]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Prevention of Salmonella Enteritidis in Shell Eggs
During Production; Recordkeeping and Registration Provisions
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 information collection provisions of
FDA's recordkeeping and registration requirements for shell egg
producers.
[[Page 2798]]
DATES: Submit either electronic or written comments on the collection
of information by March 21, 2022.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before March 21, 2022. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of March 21, 2022. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-2013-N-0297 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Prevention of Salmonella
Enteritidis in Shell Eggs During Production; Recordkeeping and
Registration Provisions.'' 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
<a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between
9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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: 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#1e4e4c5f4d6a7f78785e787a7f3076766d30797168"><span class="__cf_email__" data-cfemail="a5f5f7e4f6d1c4c3c3e5c3c1c48bcdcdd68bc2cad3">[email protected]</span></a>.
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.
Prevention of Salmonella Enteritidis in Shell Eggs During Production--
Recordkeeping and Registration Provisions--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
[[Page 2799]]
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 Salmonella Enteritidis (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 to the table egg market, 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 the 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 maintained on file 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 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 <a href="https://www.access.fda.gov">https://www.access.fda.gov</a>. We strongly
encourage electronic registration because it is faster and more
convenient. The system can accept 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 will also be accepted. Form FDA 3733 is available
for download for registration by mail, fax or CD-ROM. For more
information, we invite you to visit our website at <a href="https://www.fda.gov/food/registration-food-facilities-and-other-submissions/shell-egg-producer-registration">https://www.fda.gov/food/registration-food-facilities-and-other-submissions/shell-egg-producer-registration</a>.
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 to the table egg market, other than directly to the
consumer.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Recordkeeping Burden \1\
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Number of
Activity; 21 CFR section Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers \2\ recordkeeper records
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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 Treatment Records; 343 52 17,836 0.5 (30 minutes)....................... 8,918
Sec. 118.10(a)(3)(v) through (viii)
(positive) \3\.
Egg Testing; Sec. 118.10(a)(3)(vii)....... 331 7 2,317 8.3.................................... 19,231
Environmental Testing; Sec. 6,308 23 145,084 0.25 (15 minutes)...................... 36,271
118.10(a)(3)(v) \3\.
Testing, Diversion, and Treatment Records; 5,965 1 5,965 0.5 (30 minutes)....................... 2,983
Sec. 118.10(a)(3)(v) through (viii)
(negative) \3\.
Prevention Plan Review and Modifications; 331 1 331 10..................................... 3,310
Sec. 118.10(a)(4).
Chick and Pullet Procurement Records; Sec. 4,731 1 4,731 0.5 (30 minutes)....................... 2,366
118.10(a)(2).
Rodent and Other Pest Control; Sec. 9,462 52 492,024 0.5 (30 minutes)....................... 246,012
118.10(a)(3)(ii), and Biosecurity Records,
Sec. 118.10(a)(3)(i).
Prevention Plan Design; Sec. 118.10(a)(1). 350 1 350 20..................................... 7,000
Cleaning and Disinfection Records; Sec. 331 1 331 0.5 (30 minutes)....................... 166
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 <a href="http://www.access.fda.gov">http://www.access.fda.gov</a> per Sec. 118.11(b)(1).
[[Page 2800]]
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate. 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.
Dated: January 11, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-00863 Filed 1-18-22; 8:45 am]
BILLING CODE 4164-01-P
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