PHS Guideline on Infectious Disease Issues in Xenotransplantation

ICR 201211-0910-003

OMB: 0910-0456

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2013-02-27
IC Document Collections
IC ID
Document
Title
Status
6147 Modified
204798 New
204797 New
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ICR Details
0910-0456 201211-0910-003
Historical Active 200912-0910-001
HHS/FDA
PHS Guideline on Infectious Disease Issues in Xenotransplantation
Extension without change of a currently approved collection   No
Regular
Approved with change 03/20/2013
Retrieve Notice of Action (NOA) 11/09/2012
  Inventory as of this Action Requested Previously Approved
03/31/2016 36 Months From Approved 03/31/2013
139 0 50
47 0 156
0 0 0
The Public Health Service (PHS) Guideline addresses the public health issues related to xenotransplantation and recommends procedures for diminishing the risk of transmission of infectious agents to the xenotransplantation product recipient, to health care workers, and to the general public. The collection of information described in the PHS Guideline include the notification of certain information to FDA or to the sponsor, and documentation of certain information associated with xenotransplantation. The collection of information is intended to provide general guidance on the following topics: (1) the development of xenotransplantation clinical protocols; (2) the preparation of submissions to FDA; and (3) the conduct of xenotransplantation clinical trials. Also, the collection of information is intended to help ensure that the sponsor maintains important information in a cross-referenced system that links the relevant records of the xenotransplantation product recipient, xenotransplantation product, source animal(s), animal procurement center, and significant nosocomial exposures.
US Code: 42 USC 262 Name of Law: Public Health Service Act
   US Code: 42 USC 264 Name of Law: Public Health Service Act
   US Code: 21 USC 301 Name of Law: Federal Food Drug and Cosmetic Act
  
None
Not associated with rulemaking
  77 FR 35683 06/14/2012
77 FR 65560 10/29/2012
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 139 50 0 0 89 0
Annual Time Burden (Hours) 47 156 0 0 -109 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
The number of responses is up because the information collections are counted separately in this submission. While the information collections have not changed; parsing them out separately gives the appearance of increases responses. The average time burden is down because there are fewer respondents.
$4,160
No
No
No
No
No
Uncollected
ILa Mizrachi 301 796-7726 ila.mizrachi@fda.hhs.gov
  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.
11/09/2012
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