Classification/reclassification; Restricted Devices; Analyte Specific Reagents

ICR 200101-0910-002

OMB: 0910-0361

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
ICR Details
0910-0361 200101-0910-002
Historical Active 199711-0910-006
HHS/FDA
Classification/reclassification; Restricted Devices; Analyte Specific Reagents
Extension without change of a currently approved collection   No
Regular
Approved without change 03/12/2001
Retrieve Notice of Action (NOA) 01/02/2001
  Inventory as of this Action Requested Previously Approved
03/31/2004 03/31/2004 03/31/2001
300 0 300
15,000 0 15,000
0 0 0

FDA restricts distribution of ASR's to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as qualified to perform high complexity testing to manufacturers of in vitro diagnostic products and to organizations that use the tests for reasons other than providing diagnostic information to physicians and patients. FDA has established certain labeling requirements for suppliers of ASR's and some requirements regarding advertising and promotional materials for ASR's. FDA believes that labeling requirements and restrictions on advertising and promotion are necessary to...

None
None


No

1
IC Title Form No. Form Name
Classification/reclassification; Restricted Devices; Analyte Specific Reagents N/A

  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 300 300 0 0 0 0
Annual Time Burden (Hours) 15,000 15,000 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
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.
01/02/2001


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