PHS Guideline on Infectious Disease Issues in Xenotransplantation

ICR 202507-0910-010

OMB: 0910-0456

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2025-07-30
ICR Details
0910-0456 202507-0910-010
Received in OIRA 202109-0910-004
HHS/FDA CBER
PHS Guideline on Infectious Disease Issues in Xenotransplantation
Extension without change of a currently approved collection   No
Regular 07/30/2025
  Requested Previously Approved
36 Months From Approved 07/31/2025
209 216
62 59
3,798 3,922

This information collection supports implementation of sections 351 and 361 of the Public Health Service Act (PHS Act) (42 U.S.C. 262 and 264) and certain drug provisions of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), regarding xenotransplantation. As set forth in the “PHS Guideline on Infectious Disease Issues in Xenotransplantation,” guidelines were developed by the Public Health Service (PHS) to identify general principles for the prevention and control of infectious diseases associated with xenotransplantation that may pose a risk to public health. The PHS guideline recommends procedures to diminish the risk of transmission of infectious agents to the xenotransplantation product recipient and to the general public.

US Code: 21 USC 301 Name of Law: Federal Food Drug and Cosmetic Act
   US Code: 42 USC 264 Name of Law: Public Health Service Act
   US Code: 42 USC 262 Name of Law: Public Health Service Act
  
None

Not associated with rulemaking

  90 FR 18669 05/01/2025
90 FR 35689 07/29/2025
Yes

3
IC Title Form No. Form Name
Disclosures to sponsors
PHS Xenotransplantation Guidelines REPORTING
Xenotransplantation Recordkeeping

  Total Request 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 209 216 0 0 -7 0
Annual Time Burden (Hours) 62 59 0 0 3 0
Annual Cost Burden (Dollars) 3,798 3,922 0 0 -124 0
No
No
The total estimated annual burden is 62.12 hours. Based on a review of the information collection since our last request for OMB approval, we have adjusted our burden estimate to 62.12 hours (an increase of 3.09 hours) and 7 fewer responses annually.

$5,360
No
    Yes
    No
No
No
No
No
Domini Bean 301 796-5733 [email protected]

  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.
07/30/2025


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