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	New
Form FDA 3733 Reporting Producer Registrations Form and Instruction	Modified
0660 Supporting Statement 2013.doc Supporting Statement A	2013-05-30

IC Document Collections

IC ID	Document Title	Status
207117	Registration Cancellation Form and Instruction	New
192701	Egg Testing	Modified
192698	Environmental Testing	Modified
190258	Reporting Producer Registrations Form and Instruction	Modified
190257	Prevention Plan Review and Modification	Modified
190255	Testing, Diversion, and Treatment (Negative)	Modified
190254	Testing, Diversion or Treatment (Positive)	Modified
190251	Refrigeration Records	Modified
190250	Cleaning and Disinfection Records	Modified
190248	Rodent and Other Pest Control and Biosecurity Records	Modified
190247	Chick and Pullet Procurement Records	Modified
190246	Prevention Plan Design	Modified

ICR Details

OMB Control No: 0910-0660	ICR Reference No: 201305-0910-007
Status: Historical Active	Previous ICR Reference No: 200908-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No: 19695
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: 08/12/2013
	Date Received in OIRA: 05/30/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2016	36 Months From Approved	08/31/2013
Responses	804,134	0	805,796
Time Burden (Hours)	390,217	0	406,750
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: FFDCA
   US Code: 21 USC 371 Name of Law: FFDCA
  

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:
	78 FR 18605	03/27/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 32400	05/30/2013
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 12

IC Title	Form No.	Form Name
Egg Testing
Environmental Testing
Registration Cancellation	FDA 3733	DHHS/FDA Shell Egg Producer Registration
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
Chick and Pullet Procurement Records
Rodent and Other Pest Control and Biosecurity Records
Cleaning and Disinfection Records
Prevention Plan Design
Refrigeration Records

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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	804,134	805,796	0	0	-1,662	0
Annual Time Burden (Hours)	390,217	406,750	0	0	-16,533	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 shown in the current inventory (406,750 hours) is higher than the requested burden of 390,217 hours. This adjustment reflects a reduction of 16,533 hours and 1,662 fewer responses that is primarily the result of respondents achieving compliance with the final rule (small farms were given up to three years to comply with the recordkeeping and registration provisions of the rule). Additionally, we estimate a reduction in the number of new registrations required by ? 118.11. Assuming that existing farms are in compliance with the rule and that new registrations will only be submitted by an estimated 150 new farms annually in the next three year, this results in a reduction of 2,193 hours, notwithstanding that cancellation of registrations have been itemized as a new reporting IC. We also estimate a reduction in the number of new prevention plan designs required by ? 118.10(a)(1). We assume that existing farms are in compliance with the rule and that new plan design will only be undertaken by an estimated 150 new farms annually in the next three years, resulting in a reduction of 14,340 hours. Thus, the total reduction is 16,533 hours and 1,662 responses.

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Annual Cost to Federal Government: $16,146

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: 05/30/2013

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