PHS Guideline on Infectious Disease Issues in Xenotransplantation

ICR 201601-0910-012

OMB: 0910-0456

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2016-01-27
IC Document Collections
IC ID
Document
Title
Status
6147 Modified
204798 Modified
204797 Modified
204796 Modified
204795 Modified
204794 Modified
204793 Modified
204792 Modified
204791 Modified
204790 Modified
204789 Modified
204788 Modified
204787 Modified
204786 Modified
204785 Modified
204784 Modified
204783 Modified
204782 Modified
204781 Modified
204780 Modified
ICR Details
0910-0456 201601-0910-012
Historical Active 201211-0910-003
HHS/FDA CBER
PHS Guideline on Infectious Disease Issues in Xenotransplantation
Extension without change of a currently approved collection   No
Regular
Approved without change 06/20/2016
Retrieve Notice of Action (NOA) 01/27/2016
  Inventory as of this Action Requested Previously Approved
06/30/2019 36 Months From Approved 06/30/2016
216 0 139
60 0 47
0 0 0

The PHS Guideline recommends procedures to diminish the risk of transmission of infectious agents to the xenotransplantation product recipient and to the general public. The PHS Guideline is intended to address public health issues raised by xenotransplantation, through identification of general principles of prevention and control of infectious diseases associated with xenotransplantation that may pose a hazard to the public health. The collections of information described in this PHS Guideline include the notification of certain information to FDA or to the sponsor, and documentation of certain information associated with xenotransplantation. The collections of information are 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 collections of information are 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. The PHS Guideline describes an occupational health service program for the protection of health care workers involved in xenotransplantation procedures, caring for xenotransplantation product recipients, and performing associated laboratory testing.

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
   US Code: 42 USC 262 Name of Law: Public Health Service Act
  
None

Not associated with rulemaking

  80 FR 60153 10/05/2015
81 FR 4628 01/27/2016
Yes

20
IC Title Form No. Form Name
Sponsor to make Linked Records Described in Section 3.2.7 Available for Review, 3.5.4
Source Animal Facility to Notify Clinical Center when Infectious Agency is Identified in Source Animal or Herd After Xeno Product Procurement, 3.5.5
Notify Sponor or FDA of New Archive Site When the Source Animal Facility or Sponsor Ceases Operations, Section 3.2.7.2
Establish Records Linking each Xenotransplantation Product Recipient with Relevant Records, Section 3.2.7
Sponsor to Maintain Cross-Referenced System that Links all Relevant Records, 4.3
Document Results of Monitoring Program Used to Detect Introduction of Infectious Agents Which May not be Apparent Clinically, 3.4.2
Document Full Necropsy Investigations Including Evaluation for Infectious Etiologies, 3.4.3.2
Justify Shortening a Source Animal's Quarantine Period of 3 Weeks Prior to Xenotransplantation Product Procurement, 3.5.1
Document Absence of Infectious Agent in Xeno Product if its Presence Elsewhere in Source Animal Does not Preclude Using It, 3.5.2
Maintain Summary of Individual Source Animal Record to Permanent Medical Record of the Xeno Product Recipient, 3.5.4
Document Complete Necropsy Results on Source Animals (50 year record retention), 3.6.4
Link Xeno Product Recipients to Individual Source Animal Records and Archived Biologic Speciments, 3.7
Record base-line sera of Xeno Health Care Workers and Specific Nonsocomial Exposure, 4.2.3.2
Record Base line sera of Xeno HealthCare Workers and Speciifc Nosocomial Exposure, 4.2.3.2
Keep a Log of Health Care Workers, 4.2.3 and 4.3.2
Document Each Xenotransplant Procedures, 4.3.1
Document Location and Nature of Archived PHS Specimens in Health Care Records for Xeno Product Recipient and Source Animal, 5.2
Notify Sponsor or FDA of New Archive Site When the Source Animal Facility or Sponsor Ceases Operations, 3.2.7.2
Standard Operating Procedures of Source Animal Facility Should be Available to Review Bodies, 3.4
Include Increased Infectious Risk in Inormed Consent if Source Animal Quarantine Period of 3 Weeks is Shortened, 3.5.1

  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 216 139 0 0 77 0
Annual Time Burden (Hours) 60 47 0 0 13 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
The previous total estimated annual burden was 47 hours. The current total annual burden increase to 60 hours (+13 hours) is mainly attributed to a slight increase in the number of recordkeepers for both the estimated number of clinical centers doing xenotransplantation procedures and the number of sponsors of INDs that include protocols for xenotransplantation in humans.

$4,480
No
No
No
No
No
Uncollected
Ila Mizrachi 301 796-7726 [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.
01/27/2016


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