PHS Guideline on Infectious Disease Issues in Xenotransplantation

Forms and Documents

Document Name	Status
0456 Xenotransplantation SSA 2019 Ext.pdf Supporting Statement A	2019-06-01

IC Document Collections

IC ID	Document Title	Status
6147	Notification to FDA when source facility or sponsor ceases operations 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	Removed
204797	Sponsor to make Linked Records Described in Section 3.2.7 Available for Review, 3.5.4 Other-PHS Guideline	Removed
204796	Include Increased Infectious Risk in Inormed Consent if Source Animal Quarantine Period of 3 Weeks is Shortened, 3.5.1 Other-PHS Guideline	Removed
204795	Standard Operating Procedures of Source Animal Facility Should be Available to Review Bodies, 3.4 Other-PHS Guideline	Removed
204794	Disclosures to sponsors 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	Removed
204792	Document Each Xenotransplant Procedures, 4.3.1 Other-PHS Guideline	Removed
204791	Keep a Log of Health Care Workers, 4.2.3 and 4.3.2 Other-PHS Guideline	Removed
204790	Record Base line sera of Xeno HealthCare Workers and Speciifc Nosocomial Exposure, 4.2.3.2 Other-PHS Guideline	Removed
204789	Record base-line sera of Xeno Health Care Workers and Specific Nonsocomial Exposure, 4.2.3.2 Other-PHS Guideline	Removed
204788	Link Xeno Product Recipients to Individual Source Animal Records and Archived Biologic Speciments, 3.7 Other-PHS Guideline	Removed
204787	Document Complete Necropsy Results on Source Animals (50 year record retention), 3.6.4 Other-PHS Guideline	Removed
204786	Maintain Summary of Individual Source Animal Record to Permanent Medical Record of the Xeno Product Recipient, 3.5.4 Other-PHS Guideline	Removed
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	Removed
204784	Justify Shortening a Source Animal's Quarantine Period of 3 Weeks Prior to Xenotransplantation Product Procurement, 3.5.1 Other-PHS Guideline	Removed
204783	Document Full Necropsy Investigations Including Evaluation for Infectious Etiologies, 3.4.3.2 Other-PHS Guideline	Removed
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	Removed
204781	Sponsor to Maintain Cross-Referenced System that Links all Relevant Records, 4.3 Other-PHS Guideline	Removed
204780	Xenotransplantation Recordkeeping Other-PHS Guideline	Modified

ICR Details

OMB Control No: 0910-0456	ICR Reference No: 201906-0910-001
Status: Active	Previous ICR Reference No: 201601-0910-012
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: 06/07/2019
	Date Received in OIRA: 06/04/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2022	36 Months From Approved	06/30/2019
Responses	216	0	216
Time Burden (Hours)	60	0	60
Cost Burden (Dollars)	3,922	0	0

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Abstract: 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.

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Authorizing Statute(s): 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
  

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:
	83 FR 48441	09/25/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 18551	05/01/2019
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 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

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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	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

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: Individual ICs have been consolidated. Costs previously disclosed in 12b. of the supporting statement but not uploaded into ROCIS are now reflected in ICR.

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Annual Cost to Federal Government: $4,640

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

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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: 06/04/2019

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