Blood Bank Inspection Checklist and Report and Supporting Regulations in 42 CFR 493.1269-493-1285

ICR 200208-0938-001

OMB: 0938-0170

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
ICR Details
0938-0170 200208-0938-001
Historical Active 199908-0938-002
HHS/CMS
Blood Bank Inspection Checklist and Report and Supporting Regulations in 42 CFR 493.1269-493-1285
Extension without change of a currently approved collection   No
Regular
Approved without change 09/23/2002
Retrieve Notice of Action (NOA) 08/05/2002
Agency is granted permission to not display OMB expiration date.
  Inventory as of this Action Requested Previously Approved
09/30/2005 09/30/2005 09/30/2002
1,363 0 1,250
682 0 625
0 0 0

The Clinical Laboratory Improvement Amendment (CLIA) of 1988 requires the Department of Health and Human Services (HHS) to establish certification requirements for any laboratory that performs tests on human specimens, and to certify through the issuance of a certificate that those laboratories meet the requirements established by HHS. The law provides for inspections on an announced or unannounced basis during regular hours of operation. All records and information having a bearing on whether the laboratory is being operated in accordance with the law can be requested by the surveyor.......

None
None


No

1
IC Title Form No. Form Name
Blood Bank Inspection Checklist and Report and Supporting Regulations in 42 CFR 493.1269-493-1285 CMS-282

  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 1,363 1,250 0 0 113 0
Annual Time Burden (Hours) 682 625 0 0 57 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.
08/05/2002


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