AUTOMATIC DETENTION AND PRIVATE LABORATORY TESTING OF FDA-REGULATED PRODUCTS FOR IMPORT ENTRY

ICR 198903-0910-008

OMB: 0910-0261

Federal Form Document

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ICR Details
0910-0261 198903-0910-008
Historical Active
HHS/FDA
AUTOMATIC DETENTION AND PRIVATE LABORATORY TESTING OF FDA-REGULATED PRODUCTS FOR IMPORT ENTRY
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 06/22/1989
Retrieve Notice of Action (NOA) 03/24/1989
This information collection is approved with the understanding that FDA will ensure that the Customs' paperless project efforts adequately account for this automatic detention process in the agreed upon data elements, i.e., the paperless system has to have a mechanism to track the status of products that have been detained. FDA will also submit a revised response to question #13 describing the revised burden estimate.
  Inventory as of this Action Requested Previously Approved
06/30/1991 06/30/1991
4,000 0 0
36,500 0 0
0 0 0

FDA HAS THE RESPONSIBILITY FOR ASSURING THE ADMISSIBILITY OF FOODS, DRUGS, MEDICAL DEVICES AND COSMETICS OFFERED FOR IMPORT INTO THE UNITE STATES. THE AUTOMATIC DETENTION PROGRAM EXISTS TO ASSURE THE QUALITY OF INCOMING PRODUCTS WHERE A HISTORY OF VIOLATIONS EXISTS. THIS HAS RESULTED IN INCREASED USED OF PRIVATE LABORATORIES FOR TESTING PURPOSES BECAUSE LABORATORY RESULTS FOR EACH SHIPMENT OF A PRODUCT IN

None
None


No

1
IC Title Form No. Form Name
AUTOMATIC DETENTION AND PRIVATE LABORATORY TESTING OF FDA-REGULATED PRODUCTS FOR IMPORT ENTRY

  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 4,000 0 0 4,000 0 0
Annual Time Burden (Hours) 36,500 0 0 36,500 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
No

$0
No
No
Uncollected
Uncollected
Uncollected
Uncollected

  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.
03/24/1989


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