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

ICR 201606-0910-010

OMB: 0910-0660

Federal Form Document

ICR Details
0910-0660 201606-0910-010
Historical Active 201305-0910-007
HHS/FDA CFSAN
Prevention of Salmonella Enteritidis in Shell Eggs During Production---Recordkeeping and Registration Provisions
Extension without change of a currently approved collection   No
Regular
Approved without change 08/10/2016
Retrieve Notice of Action (NOA) 07/05/2016
  Inventory as of this Action Requested Previously Approved
08/31/2019 36 Months From Approved 08/31/2016
804,449 0 804,134
393,577 0 390,217
0 0 0

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.

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
  
None

Not associated with rulemaking

  81 FR 4923 01/28/2016
81 FR 40312 06/21/2016
Yes

  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
No
No
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.

$33,417
No
No
No
No
No
Uncollected
Ila Mizrachi 301 796-7726 ila.mizrachi@fda.hhs.gov

  No

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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
07/05/2016


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