PHS Guideline on Infectious Disease Issues in Xenotransplantation

ICR 201906-0910-001

OMB: 0910-0456

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2019-06-01
IC Document Collections
IC ID
Document
Title
Status
6147 Modified
204798 Removed
204797 Removed
204796 Removed
204795 Removed
204794 Modified
204793 Removed
204792 Removed
204791 Removed
204790 Removed
204789 Removed
204788 Removed
204787 Removed
204786 Removed
204785 Removed
204784 Removed
204783 Removed
204782 Removed
204781 Removed
204780 Modified
ICR Details
0910-0456 201906-0910-001
Active 201601-0910-012
HHS/FDA CBER
PHS Guideline on Infectious Disease Issues in Xenotransplantation
Extension without change of a currently approved collection   No
Regular
Approved without change 06/07/2019
Retrieve Notice of Action (NOA) 06/04/2019
  Inventory as of this Action Requested Previously Approved
06/30/2022 36 Months From Approved 06/30/2019
216 0 216
60 0 60
3,922 0 0

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 have been 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

  83 FR 48441 09/25/2018
84 FR 18551 05/01/2019
No

3
IC Title Form No. Form Name
Disclosures to sponsors
Maintain Summary of Individual Source Animal Record to Permanent Medical Record of the Xeno Product Recipient, 3.5.4
Link Xeno Product Recipients to Individual Source Animal Records and Archived Biologic Speciments, 3.7
Record Base line sera of Xeno HealthCare Workers and Speciifc Nosocomial Exposure, 4.2.3.2
Document Each Xenotransplant Procedures, 4.3.1
Standard Operating Procedures of Source Animal Facility Should be Available to Review Bodies, 3.4
Sponsor to make Linked Records Described in Section 3.2.7 Available for Review, 3.5.4
Document Results of Monitoring Program Used to Detect Introduction of Infectious Agents Which May not be Apparent Clinically, 3.4.2
Sponsor to Maintain Cross-Referenced System that Links all Relevant Records, 4.3
Document Full Necropsy Investigations Including Evaluation for Infectious Etiologies, 3.4.3.2
Document Absence of Infectious Agent in Xeno Product if its Presence Elsewhere in Source Animal Does not Preclude Using It, 3.5.2
Document Complete Necropsy Results on Source Animals (50 year record retention), 3.6.4
Record base-line sera of Xeno Health Care Workers and Specific Nonsocomial Exposure, 4.2.3.2
Keep a Log of Health Care Workers, 4.2.3 and 4.3.2
Document Location and Nature of Archived PHS Specimens in Health Care Records for Xeno Product Recipient and Source Animal, 5.2
Include Increased Infectious Risk in Inormed Consent if Source Animal Quarantine Period of 3 Weeks is Shortened, 3.5.1
Source Animal Facility to Notify Clinical Center when Infectious Agency is Identified in Source Animal or Herd After Xeno Product Procurement, 3.5.5
Justify Shortening a Source Animal's Quarantine Period of 3 Weeks Prior to Xenotransplantation Product Procurement, 3.5.1
Notification to FDA when source facility or sponsor ceases operations
Xenotransplantation Recordkeeping

  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 216 216 0 0 0 0
Annual Time Burden (Hours) 60 60 0 0 0 0
Annual Cost Burden (Dollars) 3,922 0 0 0 3,922 0
No
No
Individual ICs have been consolidated. Costs previously disclosed in 12b. of the supporting statement but not uploaded into ROCIS are now reflected in ICR.

$4,640
No
    Yes
    No
No
No
No
Uncollected
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.
06/04/2019


© 2024 OMB.report | Privacy Policy