Prevention of Salmonella Enteritidis in Shell Eggs During Production---Recordkeeping and Registration Provisions

Forms and Documents

Document Name	Status
Form FDA 3733 Registration Cancellation Form and Instruction	Removed
Form FDA 3733 Reporting Producer Registrations Form and Instruction	Removed
Form 3733 Registrations or Update and Cancellations Form and Instruction	Modified
Form 3733 Prevention of Salmonella Enteritidis in Shell Eggs During Production - Recordkeeping Form and Instruction	Modified
0660 SUPPORTING STATEMENT FINAL 6-28-2016.doc Supporting Statement A	2016-06-28

IC Document Collections

IC ID	Document Title	Status
207117	Registration Cancellation Form and Instruction	Removed
192701	Egg Testing	Removed
192698	Environmental Testing	Removed
190258	Reporting Producer Registrations Form and Instruction	Removed
190257	Prevention Plan Review and Modification	Removed
190255	Testing, Diversion, and Treatment (Negative)	Removed
190254	Testing, Diversion or Treatment (Positive)	Removed
190251	Refrigeration Records	Removed
190250	Cleaning and Disinfection Records	Removed
190248	Rodent and Other Pest Control and Biosecurity Records	Removed
190247	Registrations or Update and Cancellations Form and Instruction	Modified
190246	Prevention of Salmonella Enteritidis in Shell Eggs During Production - Recordkeeping Form and Instruction	Modified

ICR Details

OMB Control No: 0910-0660	ICR Reference No: 201606-0910-010
Status: Historical Active	Previous ICR Reference No: 201305-0910-007
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Prevention of Salmonella Enteritidis in Shell Eggs During Production---Recordkeeping and Registration Provisions
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 08/10/2016
	Date Received in OIRA: 07/05/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2019	36 Months From Approved	08/31/2016
Responses	804,449	0	804,134
Time Burden (Hours)	393,577	0	390,217
Cost Burden (Dollars)	0	0	0

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Abstract: This collection requires producers of shell eggs to maintain records and provide reports regarding the implementation of preventative measures to ensure that eggs contaminated with salmonella enteritidis do not reach the public marketplace.

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Authorizing Statute(s): US Code: 21 USC 342 Name of Law: Federal Food, Drug, and Cosmetic Act
   US Code: 21 USC 371 Name of Law: Federal Food, Drug, and Cosmetic Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 4923	01/28/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 40312	06/21/2016
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Prevention of Salmonella Enteritidis in Shell Eggs During Production - Recordkeeping	3733	DHHS/FDA Shell Egg Producer Registration
Registrations or Update and Cancellations	3733	DHHS/FDA Shell Egg Producer Registration
Rodent and Other Pest Control and Biosecurity Records
Cleaning and Disinfection Records
Egg Testing
Registration Cancellation	FDA 3733	DHHS/FDA Shell Egg Producer Registration
Refrigeration Records
Testing, Diversion or Treatment (Positive)
Testing, Diversion, and Treatment (Negative)
Prevention Plan Review and Modification
Reporting Producer Registrations	FDA 3733	SHELL EGG PRODUCER REGISTRATION FORM
Environmental Testing

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ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	804,449	804,134	0	0	315	0
Annual Time Burden (Hours)	393,577	390,217	0	0	3,360	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: The hourly burden request for the renewal of this collection of information is higher than that requested in the currently approved collection (393,577 versus 390,217), and the number of responses is higher than the currently approved collection (804,449 versus 804,134.) This adjustment reflects an increase of 3,360 hours and 315 more responses that is primarily the result of new farm registrations expected to be received (i.e., an increase in the estimated number of farm registrations from 150 to 300, an increase in the estimated number of cancellations received from 15 to 30, and an increase in the number of recordkeepers and their responses from 150 to 300 for Prevention Plan Design under section 118.10(a)(1)). This expected annual increase in burden hours and responses is based on information received over the past three years. This increase in the number of farm registrations and cancellations is expected to result in an increase in recordkeeping burden hours for prevention plan designs under section 118.10(a)(1) (from 3,000 to 6,000 hours). The increase is also expected to increase the number of reporting burden hours for registrations under section 118.11 (from 345 to 690 hours) and the number of expected cancellations under section 118.11 (from 15 to 30 hours.) The total number of burden hour increase, therefore, is expected to be 3,360 hours (3,000 recordkeeping hours plus 345 reporting hours plus 15 reporting hours.)The total number of burden response increase is expected to be 315 responses (150 recordkeeping plus 150 reporting plus 15 reporting responses.) The previously approved ICR submitted to OMB in 2013 included twelve ICs entered in ROCIS. Upon this submission we are consolidating the ICs, thereby reducing the number of ICs in ROCIS to two. The information collection activities, however, remain broken down in this supporting statement document.

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Annual Cost to Federal Government: $33,417

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 07/05/2016

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