Document ID: FDA-2013-N-0297-0015
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection; Comment Request; Prevention of Salmonella Enteritidis in Shell Eggs During Production; Recordkeeping and Registration Provisions
Posted Date: 2022-01-19T05:00Z

[Federal Register Volume 87, Number 12 (Wednesday, January 19, 2022)]
[Notices]
[Pages 2797-2800]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-00863]

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 https://www.regulations.gov 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:
     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-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 
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 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: 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: 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 https://www.access.fda.gov. 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 https://www.fda.gov/food/registration-food-facilities-and-other-submissions/shell-egg-producer-registration.
    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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                    Number of
          Activity; 21 CFR section                Number of        records per    Total annual       Average burden per recordkeeping       Total hours
                                              recordkeepers \2\   recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
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).
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  .................  ..............  ..............  .......................................         393,857
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                             Number of
        Activity; 21 CFR section                       Form                  Number of     responses per   Total annual   Average burden    Total hours
                                                                            respondents     respondent       responses     per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
                                                                         -------------------------------------------------------------------------------
    Total...............................  ..............................  ..............  ..............  ..............  ..............             835
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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).

[[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