PHS Guideline on Infectious Disease Issues in Xenotransplantation

Forms and Documents

Document Name	Status
SUPPORTING STATEMENT FINAL 0456 1-27-2016.docx Supporting Statement A	2016-01-27

IC Document Collections

IC ID	Document Title	Status
6147	Notify Sponor or FDA of New Archive Site When the Source Animal Facility or Sponsor Ceases Operations, Section 3.2.7.2 Other-PHS Guideline	Modified
204798	Source Animal Facility to Notify Clinical Center when Infectious Agency is Identified in Source Animal or Herd After Xeno Product Procurement, 3.5.5 Other-PHS Guideline	Modified
204797	Sponsor to make Linked Records Described in Section 3.2.7 Available for Review, 3.5.4 Other-PHS Guideline	Modified
204796	Include Increased Infectious Risk in Inormed Consent if Source Animal Quarantine Period of 3 Weeks is Shortened, 3.5.1 Other-PHS Guideline	Modified
204795	Standard Operating Procedures of Source Animal Facility Should be Available to Review Bodies, 3.4 Other-PHS Guideline	Modified
204794	Notify Sponsor or FDA of New Archive Site When the Source Animal Facility or Sponsor Ceases Operations, 3.2.7.2 Other-PHS Guideline	Modified
204793	Document Location and Nature of Archived PHS Specimens in Health Care Records for Xeno Product Recipient and Source Animal, 5.2 Other-PHS Guideline	Modified
204792	Document Each Xenotransplant Procedures, 4.3.1 Other-PHS Guideline	Modified
204791	Keep a Log of Health Care Workers, 4.2.3 and 4.3.2 Other-PHS Guideline	Modified
204790	Record Base line sera of Xeno HealthCare Workers and Speciifc Nosocomial Exposure, 4.2.3.2 Other-PHS Guideline	Modified
204789	Record base-line sera of Xeno Health Care Workers and Specific Nonsocomial Exposure, 4.2.3.2 Other-PHS Guideline	Modified
204788	Link Xeno Product Recipients to Individual Source Animal Records and Archived Biologic Speciments, 3.7 Other-PHS Guideline	Modified
204787	Document Complete Necropsy Results on Source Animals (50 year record retention), 3.6.4 Other-PHS Guideline	Modified
204786	Maintain Summary of Individual Source Animal Record to Permanent Medical Record of the Xeno Product Recipient, 3.5.4 Other-PHS Guideline	Modified
204785	Document Absence of Infectious Agent in Xeno Product if its Presence Elsewhere in Source Animal Does not Preclude Using It, 3.5.2 Other-PHS Guideline	Modified
204784	Justify Shortening a Source Animal's Quarantine Period of 3 Weeks Prior to Xenotransplantation Product Procurement, 3.5.1 Other-PHS Guideline	Modified
204783	Document Full Necropsy Investigations Including Evaluation for Infectious Etiologies, 3.4.3.2 Other-PHS Guideline	Modified
204782	Document Results of Monitoring Program Used to Detect Introduction of Infectious Agents Which May not be Apparent Clinically, 3.4.2 Other-PHS Guideline	Modified
204781	Sponsor to Maintain Cross-Referenced System that Links all Relevant Records, 4.3 Other-PHS Guideline	Modified
204780	Establish Records Linking each Xenotransplantation Product Recipient with Relevant Records, Section 3.2.7 Other-PHS Guideline	Modified

ICR Details

OMB Control No: 0910-0456	ICR Reference No: 201601-0910-012
Status: Historical Active	Previous ICR Reference No: 201211-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No: CBER
Title: PHS Guideline on Infectious Disease Issues in Xenotransplantation
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 06/20/2016
	Date Received in OIRA: 01/27/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2019	36 Months From Approved	06/30/2016
Responses	216	0	139
Time Burden (Hours)	60	0	47
Cost Burden (Dollars)	0	0	0

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Abstract: 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.

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Authorizing Statute(s): 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
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 60153	10/05/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 4628	01/27/2016
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 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

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ICR Summary of Burden

	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

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: 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.

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Annual Cost to Federal Government: $4,480

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 01/27/2016

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