OTC Test Sample Collection Systems for Drugs of Abuse Testing - 21 CFR Part 809

ICR 200305-0910-007

OMB: 0910-0368

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0910-0368 200305-0910-007
Historical Active 200102-0910-002
OTC Test Sample Collection Systems for Drugs of Abuse Testing - 21 CFR Part 809
No material or nonsubstantive change to a currently approved collection   No
Approved without change 05/07/2003
Retrieve Notice of Action (NOA) 05/07/2003
  Inventory as of this Action Requested Previously Approved
05/31/2003 05/31/2003 03/31/2004
20 0 20
2,000 0 2,000
0 0 0

Because of increasing interest in extending testing for drugs of abuse to the home setting level, FDA reclassified OTC test sample collections for drugs of abuse from class III (premarket approval) to clas I (General Controls). Under this regulation three restrictions were established. First, the laboratory tests incorporated in these systems are required to be cleared, approved, or recognized by fDA as accurate and reliable for laboratory use. The laboratory performing the underlying tests is requied to reliably perform the necessary screening and conformity tests, and samples must be adequately identified......



IC Title Form No. Form Name
OTC Test Sample Collection Systems for Drugs of Abuse Testing - 21 CFR Part 809

  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 20 20 0 0 0 0
Annual Time Burden (Hours) 2,000 2,000 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0



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.

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