OMB.report

Federal forms, ICRs, and supporting documents

Information Collection Request

Food Canning Establishment Registration, Process Filing and Recordkeeping for Acidified and Thermally Processed Low-Acid Foods

ICR 200806-0910-001 · OMB 0910-0037 · Historical Active

Forms and Documents
Document
Name
Status
Supporting Statement A
2008-06-03
IC Document Collections
IC ID
Document
Title
Status
5692
Modified
185242
New
185241
New
185240
New
ICR Details
0910-0037 200806-0910-001
Historical Active 200504-0910-006
HHS/FDA
Food Canning Establishment Registration, Process Filing and Recordkeeping for Acidified and Thermally Processed Low-Acid Foods
Extension without change of a currently approved collection   No
Regular
Approved without change 08/15/2008
Retrieve Notice of Action (NOA) 06/05/2008
  Inventory as of this Action Requested Previously Approved
08/31/2011 36 Months From Approved 08/31/2008
21,457 0 17,586
1,868,352 0 1,985,108
0 0 0
Under the Federal Food, Drug, and Cosmetic Act (the act), FDA is authorized to prevent the interstate distribution of food products that may be injurious to health or that are otherwise adulterated, as defined in section 402 of the act (21 U.S.C. 342). Under the authority granted to FDA by section 404 of the act (21 U.S.C. 344), FDA regulations require registration of food processing establishments, filing of process or other data, and maintenance of processing and production records for acidified foods and thermally processed low-acid foods in hermetically sealed containers. These requirements are intended to ensure safe manufacturing, processing, and packing procedures and to permit FDA to verify that these procedures are being followed. Improperly processed low-acid foods present life-threatening hazards if contaminated with foodborne microorganisms, especially Clostridium botulinum. The spores of C. botulinum must be destroyed or inhibited to avoid production of the deadly toxin that causes botulism. This is accomplished with good manufacturing procedures, which must include the use of adequate heat processes or other means of preservation.
US Code: 21 USC 342 Name of Law: FFDCA
  
None
Not associated with rulemaking
  73 FR 11649 03/04/2008
73 FR 31694 06/03/2008
No
  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 21,457 17,586 0 0 3,871 0
Annual Time Burden (Hours) 1,868,352 1,985,108 0 0 -116,756 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
$895,820
No
No
Uncollected
Uncollected
Uncollected
Uncollected
Jonnalynn Capezzuto 3018274659
  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.
06/05/2008