Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components Intended for Transfusion

Forms and Documents

Document Name	Status
SUPPORTING STATEMENT FINAL 3-19-14.doc Supporting Statement A	2014-03-19

IC Document Collections

IC ID	Document Title	Status
195896	Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components Intended for Transfusion Other-Guidance	Modified

ICR Details

OMB Control No: 0910-0681	ICR Reference No: 201403-0910-008
Status: Historical Active	Previous ICR Reference No: 201101-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No: 21601
Title: Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components Intended for Transfusion
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: 04/29/2014
	Date Received in OIRA: 03/21/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2017	36 Months From Approved	04/30/2014
Responses	1	0	1
Time Burden (Hours)	1	0	1
Cost Burden (Dollars)	0	0	0

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Abstract: The guidance recommends that establishments that manufacture Whole Blood and blood components intended for transfusion should notify consignees of all previously collected in-date blood and blood components to quarantine and return the blood and blood components to establishments or to destroy them within 3 calendar days after a donor tests repeatedly reactive by a licensed test for T. cruzi antibody. When establishments identify a donor who is repeatedly reactive by a licensed test for T. cruzi antibodies and for whom there is additional information indicating risk of T. cruzi infection, such as testing positive on a licensed supplemental test (when such test is available) or until such test is available, information that the donor or donor's mother resided in an area endemic for Chagas disease (Mexico, Central and South America) or as a result of other medical diagnostic testing of the donor indicating T. cruzi infection, FDA recommends that the establishment notify consignees of all previously distributed blood and blood components collected during the "lookback" period, and, if blood or blood components were transfused, to encourage consignees to notify the recipient's physician of record of a possible increased risk of T. cruzi infection. The notification of consignees and of the recipient's physician of record is intended to provide the necessary information regarding possible increased risk of T. cruzi infection. All donors who test repeatedly reactive should be counseled to seek a physician's advice. It also may be helpful to refer them to their state and local health departments or to other appropriate community resources.

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Authorizing Statute(s): US Code: 42 USC 262 Name of Law: PHS 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:
	78 FR 46954	08/02/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 12506	03/05/2014
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components Intended for Transfusion

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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	1	1	0	0	0	0
Annual Time Burden (Hours)	1	1	0	0	0	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:

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Annual Cost to Federal Government: $0

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: 03/21/2014

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