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 Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2013-N-0297]
 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.
 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, 
                        *PRAStaff@fda.hhs.gov.*


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 
                    ( print 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, § 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 
                    *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
Activity; 21 CFR section
Number of
                             
                                recordkeepers 2
Number of
                             records per 
                             recordkeeper
Total annual
                             records
Average
                             burden per 
                             recordkeeping
Total hoursRefrigeration Records; § 118.10(a)(3)(iv)
2,600
52
135,200
0.5  (30 minutes)
67,600Testing, Diversion, and Treatment Records; § 118.10(a)(3)(v) through (viii) (positive) 3
343
52
17,836
0.5 (30 minutes)
8,918Egg Testing; § 118.10(a)(3)(vii)
331
7
2,317
8.3
19,231Environmental Testing; § 118.10(a)(3)(v) 3
6,308
23
145,084
0.25 (15 minutes)
36,271Testing, Diversion, and Treatment Records; § 118.10(a)(3)(v) through (viii) (negative) 3
5,965
1
5,965
0.5 (30 minutes)
2,983Prevention Plan Review and Modifications; § 118.10(a)(4)
331
1
331
10
3,310Chick and Pullet Procurement Records; § 118.10(a)(2)
4,731
1
4,731
0.5 (30 minutes)
2,366Rodent and Other Pest Control; § 118.10(a)(3)(ii), and Biosecurity Records, § 118.10(a)(3)(i)
9,462
52
492,024
0.5 (30 minutes)
246,012Prevention Plan Design; § 118.10(a)(1)
350
1
350
20
7,000Cleaning and Disinfection Records; § 118.10(a)(3)(iii)
331
1
331
0.5 (30 minutes)
166Total




393,8571
                         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 Burden1
Activity; 21 CFR section
Form
Number of
                             respondents
Number of
                             responses per 
                             respondent
Total annual
                             responses
Average
                             burden per 
                             response
Total hoursRegistrations or Updates; § 118.11
FDA 3733 2
350
1
350
2.3
805Cancellations; § 118.11
FDA 3733
30
1
30
1
30Total





8351
                         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 § 118.11(b)(1).
 
 
 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