Investigating the Cause of Post Donation Information Errors in Donor Screening Process

Forms and Documents

Document Name	Status
Form 2 Initial Telephone Contact and PDI Discussion Guide Form	New
Supporting_Statement_B1.doc Supporting Statement B	2010-08-02
Attachment 7 Memo for Privacy Act.docx Supplementary Document	2010-05-07
Attachment 5.5.pdf Supplementary Document	2010-02-26
Attachment 5.3_2007 UDHQ 1-2.pdf Supplementary Document	2010-02-26
Attachment 5.4_2007 Donor Ed materials 1-2.pdf Supplementary Document	2010-02-26
Attachment 5.2_Justification for Sensitive Questions.docx Supplementary Document	2010-02-26
Attachment 5.1.docx Supplementary Document	2010-02-26
Attachment 4_Informed Consent Form.docx Supplementary Document	2010-02-26
Attachment 3_PDI Study Protocol.docx Supplementary Document	2010-02-26
Attachment 1.pdf Supplementary Document	2010-02-26
Supporting_Statement_A1.doc Supporting Statement A	2010-08-02

IC Document Collections

IC ID	Document Title	Status
192913	Initial Telephone Contact and PDI Discussion Guide Form	New

ICR Details

OMB Control No: 0925-0617	ICR Reference No: 201005-0925-008
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: Investigating the Cause of Post Donation Information Errors in Donor Screening Process
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 08/03/2010
	Date Received in OIRA: 05/17/2010
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2013	02/28/2011
Responses	408	0	0
Time Burden (Hours)	84	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: Blood centers are required to use a health history screening questionnaire to obtain eligibility information for the protection of the donor and recipient prior to blood donation. However, the health history process is known to be error-prone and the reasons for those errors are largely unknown and untested. Donors often fail to report a risk that would have resulted in deferral. This deferral risk may be disclosed at a subsequent donation and is classified as Post Donation Information (PDI). While this deferral risk may be at the next donation event, many examples of PDI are not disclosed nor discovered until several intervening donation events have occurred. The reasons why donors fail to disclose a deferrable history at the time of one donation but subsequently disclose this information at a later time are unidentified. This protocol is designed to ascertain why PDI error events occur. It will be the first study of any kind to address the issue of PDI errors in any systematic fashion. By conducting interviews with donors involved in PDI errors, we will gain important qualitative knowledge about this problem. Information gathered from these interviews will not only elucidate the issue of PDI but will provide insight into donor understanding of the screening process and their feelings about the process and blood donation in general.

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Authorizing Statute(s): US Code: 42 USC 285b-4 Name of Law: Public Health Service Act
   US Code: 42 USC 285b-3 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:
	75 FR 8080	02/23/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 2365	05/03/2010
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
Initial Telephone Contact and PDI Discussion Guide	1, 2	Survey ,   Initial telephone interview

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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	408	0	0	408	0	0
Annual Time Burden (Hours)	84	0	0	84	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

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

Burden Reduction Due to:

Short Statement: This is a new collection of information

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Annual Cost to Federal Government: $240,042

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

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]? Uncollected

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: 05/17/2010

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