Use of Serological Tests to Reduce the Risk of Transfusion-Transmitted Infection in Whole Blood and Blood Components; Agency Guidance

Forms and Documents

Document Name	Status
0681 CBER Nonsub Change Dec 2018.pdf Justification for No Material/Nonsubstantive Change	2018-12-05
CBER GFI Immunodeficiency Virus Transmission by Blood.pdf Supplementary Document	2018-12-05
CBER GFI Donor Questioning.pdf Supplementary Document	2018-12-05
CBER GFI Creutzfeldt Jakob and Variant by Blood and Blood Products.pdf Supplementary Document	2018-12-05
CBER GFI Blood donor assessment Ebola.pdf Supplementary Document	2018-12-05
CBER GFI West Nile Virus Transmission Blood.pdf Supplementary Document	2018-12-05
CBER GFI Reducing Babesia Transmission Blood.pdf Supplementary Document	2018-12-05
0681 SS for 2017 Extension.pdf Supporting Statement A	2017-04-18

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	Unchanged

ICR Details

OMB Control No: 0910-0681	ICR Reference No: 201811-0910-003
Status: Historical Active	Previous ICR Reference No: 201704-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No: CBER
Title: Use of Serological Tests to Reduce the Risk of Transfusion-Transmitted Infection in Whole Blood and Blood Components; Agency Guidance
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 12/07/2018
	Date Received in OIRA: 12/06/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2020	06/30/2020	06/30/2020
Responses	1	0	1
Time Burden (Hours)	1	0	1
Cost Burden (Dollars)	0	0	0

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Abstract: The information collection supports agency guidance. The guidance document implements the donor screening recommendations for the FDA - approved serological test systems for the detection of antibodies to T. cruzi. The use of the donor screening tests are to reduce the risk of transmission of T. cruzi infection by detecting antibodies to T. cruzi in plasma and serum samples from individual human donors, including donors of Whole Blood and blood components intended for transfusion.

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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 262 Name of Law: PHS 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:
	81 FR 78170	11/07/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 19062	04/25/2017
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

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.     No

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: 12/06/2018

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