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

ICR 201305-0910-007

OMB: 0910-0660

Federal Form Document

Forms and Documents
Document
Name
Status
Form and Instruction
New
Form and Instruction
Modified
Supporting Statement A
2013-05-30
ICR Details
0910-0660 201305-0910-007
Historical Active 200908-0910-004
HHS/FDA 19695
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 08/12/2013
Retrieve Notice of Action (NOA) 05/30/2013
  Inventory as of this Action Requested Previously Approved
08/31/2016 36 Months From Approved 08/31/2013
804,134 0 805,796
390,217 0 406,750
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: FFDCA
   US Code: 21 USC 371 Name of Law: FFDCA
  
None

Not associated with rulemaking

  78 FR 18605 03/27/2013
78 FR 32400 05/30/2013
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 804,134 805,796 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
No
No
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.

$16,146
No
No
No
No
No
Uncollected
Domini Bean 301 796-5733 domini.bean@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.
05/30/2013


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