Infectious Disease Issues in Xenotransplantation

ICR 200310-0910-011

OMB: 0910-0456

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
IC ID
Document
Title
Status
6147
Migrated
ICR Details
0910-0456 200310-0910-011
Historical Active 200010-0910-003
HHS/FDA
Infectious Disease Issues in Xenotransplantation
Extension without change of a currently approved collection   No
Regular
Approved without change 12/17/2003
Retrieve Notice of Action (NOA) 10/27/2003
  Inventory as of this Action Requested Previously Approved
12/31/2006 12/31/2006 01/31/2004
50 0 53
156 0 343
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 sponor maintains important information in a cross-referenced system that links the relevant records of the xenotransplantation....

None
None


No

1
IC Title Form No. Form Name
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 50 53 0 0 -3 0
Annual Time Burden (Hours) 156 343 0 0 -187 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.
10/27/2003


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