PHS (Public Health Service) Guideline on Infectious Disease Issues in Xenotransplantation

ICR 200010-0910-003

OMB: 0910-0456

Federal Form Document

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Document
Name
Status
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ICR Details
0910-0456 200010-0910-003
Historical Active
HHS/FDA
PHS (Public Health Service) Guideline on Infectious Disease Issues in Xenotransplantation
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 01/19/2001
Retrieve Notice of Action (NOA) 10/19/2000
This collection is approved. FDA should provide OMB and update of its efforts to develop a national xenotransplantation database within 6 months.
  Inventory as of this Action Requested Previously Approved
01/31/2004 01/31/2004
53 0 0
343 0 0
0 0 0

The PHS guideline recommends procedures to diminish the risk of transmission of infectious agents to the xenotransplantation product recipient and the general public. The collection of information described in this guideline will provide general guidance to sponsors in the development of xenotransplantation clinical protocols, in preparing submissions to FDA, and in the conduct of xenotransplantation clinical trials. Also, the collection of information will help ensure that the sponsor maintains important information in a cross-referenced system that links the relevant records of the xenotransplantation product....

None
None


No

1
IC Title Form No. Form Name
PHS (Public Health Service) Guideline on Infectious Disease Issues in Xenotransplantation

  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 53 0 0 53 0 0
Annual Time Burden (Hours) 343 0 0 343 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.
10/19/2000


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