Human Tissue Intended for Transplantation

ICR 200704-0910-003

OMB: 0910-0302

Federal Form Document

Forms and Documents
Document
Name
Status
Supplementary Document
0000-00-00
Supplementary Document
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Supplementary Document
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Supplementary Document
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Supporting Statement A
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ICR Details
0910-0302 200704-0910-003
Historical Active 200401-0910-011
HHS/FDA
Human Tissue Intended for Transplantation
Extension without change of a currently approved collection   No
Regular
Approved with change 08/20/2007
Retrieve Notice of Action (NOA) 04/27/2007
This information collection request is approved as revised. Note that the burden tables were changed to reflect that the burden changes were due to adjustment rather than agency action, consistent with submission as "extension without change."
  Inventory as of this Action Requested Previously Approved
08/31/2010 36 Months From Approved 08/31/2007
782,562 0 62
783,332 0 592,166
0 0 0

This collection of information requirements helps prevent the transmission of communicable diseases through transplantation by allowing FDA inspections of persons and tissue establishments engaged in the recovery, screening, testing, processing, storage, or distribution of human tissue. These facilities are required to meet standards intended to ensure appropriate screening and testing of human tissue donors and insure that records are kept documenting that the appropriate screening and testing have been completed. If regulations are violated, then retention, recall and destruction orders may be issued to these facilities. Respondents to this collection of information are manufacturers of human tissue intended for transplantation.

US Code: 42 USC 264 Name of Law: Public Health Service Act
  
None

Not associated with rulemaking

  71 FR 70410 12/04/2006
72 FR 20555 04/25/2007
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 782,562 62 0 0 782,500 0
Annual Time Burden (Hours) 783,332 592,166 0 0 191,166 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
Yes
Miscellaneous Actions
The increase in burden is due to the increase in the number of conventional tissue products. The number doubled since our last request for approval.

$190,000
No
No
Uncollected
Uncollected
Uncollected
Uncollected
Saleda Perryman

  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.
04/27/2007


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