Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Production, Storage, and Transportation of Shell Eggs (Preventing Salmonella Enteritidis)

<NOTICE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Food and Drug Administration</SUBAGY> <DEPDOC>[Docket No. FDA-2025-N-0195]</DEPDOC> <SUBJECT>Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Production, Storage, and Transportation of Shell Eggs (Preventing Salmonella Enteritidis)</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Food and Drug Administration, HHS. <HD SOURCE="HED">ACTION:</HD> Notice. <SUM> <HD SOURCE="HED">SUMMARY:</HD> 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. </SUM> <DATES> <HD SOURCE="HED">DATES:</HD> Submit written comments (including recommendations) on the collection of information by October 27, 2025. </DATES> <HD SOURCE="HED">ADDRESSES:</HD> To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to <E T="03">https://www.reginfo.gov/public/do/PRAMain.</E> Find this particular information collection by selecting “Currently under Review—Open for Public Comments” or 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. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> 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, <E T="03">PRAStaff@fda.hhs.gov.</E> </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. <HD SOURCE="HD1">Production, Storage, and Transportation of Shell Eggs (Preventing Salmonella Enteritidis (SE))—21 CFR 118.10 and 118.11</HD> <HD SOURCE="HD2">OMB Control Number 0910-0660—Extension</HD> 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, § 118.11 (21 CFR 118.11) of FDA's regulations requires that each farm covered by § 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 <E T="03">https://www.access.fda.gov.</E> 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 <E T="03">https://www.fda.gov/food/registration-food-facilities-and-other-submissions/shell-egg-producer-registration</E> and <E T="03">https://www.fda.gov/food/shell-egg-producer-registration/shell-egg-producer-registration-registrationcancellation-paper-mail-or-fax-or-cd-rom.</E> 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. <E T="03">Description of Respondents:</E> 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 <E T="04">Federal Register</E> 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: <GPOTABLE COLS="6" OPTS="L2,nj,i1" CDEF="s50,12,12,12,r25,12"> <TTITLE> Table 1—Estimated Annual Recordkeeping Burden  <SU>1</SU> </TTITLE> <CHED H="1">Activity; 21 CFR section</CHED> <CHED H="1"> Number of recordkeepers  <SU>2</SU> </CHED> <CHED H="1">Number of records per recordkeeper</CHED> <CHED H="1">Total annual records</CHED> <CHED H="1"> Average burden per recordkeeping </CHED> <CHED H="1">Total hours</CHED> <ROW> <ENT I="01">Refrigeration Records; § 118.10(a)(3)(iv)</ENT> <ENT>2,600</ENT> <ENT>52</ENT> <ENT>135,200</ENT> <ENT>0.5 (30 minutes)</ENT> <ENT>67,600</ENT> </ROW> <ROW> <ENT I="01"> Testing, Diversion, and Treatment Records; § 118.10(a)(3)(v) through (viii) (positive)  <SU>3</SU> </ENT> <ENT>343</ENT> <ENT>52</ENT> <ENT>17,836</ENT> <ENT>0.5 (30 minutes)</ENT> <ENT>8,918</ENT> </ROW> <ROW> <ENT I="01">Egg Testing; § 118.10(a)(3)(vii)</ENT> <ENT>331</ENT> <ENT>7</ENT> <ENT>2,317</ENT> <ENT>8.3</ENT> <ENT>19,231</ENT> </ROW> <ROW> <ENT I="01"> Environmental Testing; § 118.10(a)(3)(v)  <SU>3</SU> </ENT> <ENT>6,308</ENT> <ENT>23</ENT> <ENT>145,084</ENT> <ENT>0.25 (15 minutes)</ENT> <ENT>36,271</ENT> </ROW> <ROW> <ENT I="01"> Testing, Diversion, and Treatment Records; § 118.10(a)(3)(v) through (viii) (negative)  <SU>3</SU> </ENT> <ENT>5,965</ENT> <ENT>1</ENT> <ENT>5,965</ENT> <ENT>0.5 (30 minutes)</ENT> <ENT>2,983</ENT> </ROW> <ROW> <ENT I="01">Prevention Plan Review and Modifications; § 118.10(a)(4)</ENT> <ENT>331</ENT> <ENT>1</ENT> <ENT>331</ENT> <ENT>10</ENT> <ENT>3,310</ENT> <ENT I="01">Chick and Pullet Procurement Records; § 118.10(a)(2)</ENT> <ENT>4,731</ENT> <ENT>1</ENT> <ENT>4,731</ENT> <ENT>0.5 (30 minutes)</ENT> <ENT>2,366</ENT> </ROW> <ROW> <ENT I="01">Rodent and Other Pest Control; § 118.10(a)(3)(ii), and Biosecurity Records; § 118.10(a)(3)(i)</ENT> <ENT>9,462</ENT> <ENT>52</ENT> <ENT>492,024</ENT> <ENT>0.5 (30 minutes)</ENT> <ENT>246,012</ENT> </ROW> <ROW> <ENT I="01">Prevention Plan Design; § 118.10(a)(1)</ENT> <ENT>350</ENT> <ENT>1</ENT> <ENT>350</ENT> <ENT>20</ENT> <ENT>7,000</ENT> <ENT I="01">Cleaning and Disinfection Records; § 118.10(a)(3)(iii)</ENT> <ENT>331</ENT> <ENT>1</ENT> <ENT>331</ENT> <ENT>0.5 (30 minutes)</ENT> <ENT>166</ENT> </ROW> <ROW> <ENT I="03">Total</ENT>  There are no capital costs or operating and maintenance costs associated with this collection of information. </TNOTE> <TNOTE> <SU>2</SU>  Some records are kept on a by-farm basis and others are kept on a by-house basis. </TNOTE> <TNOTE> <SU>3</SU>  Calculations include requirements for pullet and layer houses. </TNOTE> </GPOTABLE> <GPOTABLE COLS="7" OPTS="L2,nj,i1" CDEF="s50,r25,12,12,12,12,12"> <TTITLE> Table 2—Estimated Annual Reporting Burden  <SU>1</SU> </TTITLE> <CHED H="1">Activity; 21 CFR section</CHED> <CHED H="1">Form</CHED> <CHED H="1">Total annual responses</CHED> <ENT I="01">Registrations or Updates; § 118.11</ENT> <ENT>2.3</ENT> <ENT>805</ENT> </ROW> <ROW RUL="n,n,s"> <ENT I="01">Cancellation ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 11k characters. 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