PHS Guideline on Infectious Disease Issues in Xenotransplantation

Forms and Documents

Document	Type	Status	Availability
0456 SUPPORTING STATEMENT FINAL 2-27-13.doc	Supporting Statement A	Uploaded 2013-02-27	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
6147	Notify FDA regarding new archive site	Other-PHS Guideline	Modified
204798	Notify sponsor regarding infectious agent in source animal/herd	Other-PHS Guideline	New
204797	Provide xenotransplant product recipient records to appropriate review bodies	Other-PHS Guideline	New
204796	Provide informed consent document regarding potentially increased infectious risk	Other-PHS Guideline	New
204795	Provide SOPs of source animal facility to appropriate review bodies	Other-PHS Guideline	New
204794	Notify sponsor regarding new archive site	Other-PHS Guideline	New
204793	Document location and nature of archived specimens in health care records	Other-PHS Guideline	New
204792	Document xenotransplant procedures	Other-PHS Guideline	New
204791	Document and maintain health care worker exposure records	Other-PHS Guideline	New
204790	Maintain health care worker monitoring records	Other-Guidance	New
204789	Maintain health care worker monitoring records	Other-PHS Guideline	New
204788	Maintain archives of Source Animal Medical Records	Other-PHS Guideline	New
204787	Document complete necropsy results	Other-PHS Guideline	New
204786	Maintain summary of source animal records	Other-PHS Guideline	New
204785	Document presence/absence of infectious agent	Other-PHS Guideline	New
204784	Document justification of quarantine period	Other-PHS Guideline	New
204783	Document necropsy investigations	Other-PHS Guideline	New
204782	Document monitoring program results	Other-PHS Guideline	New
204781	Maintain medical and research records	Other-PHS Guideline	New
204780	Establish records regarding xenotransplantation product recipient	Other-PHS Guideline	New

ICR Details

OMB Control No: 0910-0456	ICR Reference No: 201211-0910-003
Status: Historical Active	Previous ICR Reference No: 200912-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No:
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 with change	Conclusion Date: 03/20/2013
	Date Received in OIRA: 11/09/2012
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2016	36 Months From Approved	03/31/2013
Responses	139	0	50
Time Burden (Hours)	47	0	156
Cost Burden (Dollars)	0	0	0

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Abstract: The Public Health Service (PHS) Guideline addresses the public health issues related to xenotransplantation and recommends procedures for diminishing the risk of transmission of infectious agents to the xenotransplantation product recipient, to health care workers, and to the general public. The collection of information described in the PHS Guideline include the notification of certain information to FDA or to the sponsor, and documentation of certain information associated with xenotransplantation. The collection of information is 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 collection of information is 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.

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Authorizing Statute(s): US Code: 42 USC 262 Name of Law: Public Health Service Act
   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
  

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:
	77 FR 35683	06/14/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 65560	10/29/2012
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 20

IC Title	Form No.	Form Name
Provide xenotransplant product recipient records to appropriate review bodies
Notify sponsor regarding infectious agent in source animal/herd
Maintain medical and research records
Document monitoring program results
Document necropsy investigations
Document justification of quarantine period
Document presence/absence of infectious agent
Maintain summary of source animal records
Document complete necropsy results
Document xenotransplant procedures
Document location and nature of archived specimens in health care records
Notify sponsor regarding new archive site
Provide SOPs of source animal facility to appropriate review bodies
Provide informed consent document regarding potentially increased infectious risk
Maintain archives of Source Animal Medical Records
Maintain health care worker monitoring records
Maintain health care worker monitoring records
Document and maintain health care worker exposure records
Notify FDA regarding new archive site
Establish records regarding xenotransplantation product recipient

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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	139	50	0	0	89	0
Annual Time Burden (Hours)	47	156	0	0	-109	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 number of responses is up because the information collections are counted separately in this submission. While the information collections have not changed; parsing them out separately gives the appearance of increases responses. The average time burden is down because there are fewer respondents.

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Annual Cost to Federal Government: $4,160

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: 11/09/2012

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