Recipient Epidemiology and Donor Evaluation Study-III (REDS-III)

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
REDS_III_Generic_Clearance_SSB_9_2012_V_2.0.docx	Supporting Statement B	Uploaded 2013-01-14	Repair queued
Attachment_6_CoC_6_2012_V_1.0.docx	Supplementary Document	Uploaded 2013-01-14	Repair queued
Attachment_5_Oversight_Committee_6_2012_V_1.0.docx	Supplementary Document	Uploaded 2013-01-14	Repair queued
Attachment_4_OSMB_Members_6_V_2012_1.0.docx.docx	Supplementary Document	Uploaded 2013-01-14	Repair queued
Attachment_3_Informed_Consent_6_21012_V_1.0.docx	Supplementary Document	Uploaded 2013-01-14	Repair queued
Attachment_2_Respondent_Survey_1_21013_V_2.0.docx	Supplementary Document	Uploaded 2013-01-14	Repair queued
Attachment_1_Example_Focus_Goup_Survey_1_2013_V_2.0.docx	Supplementary Document	Uploaded 2013-01-14	Repair queued
RED-III_Generic_Clearance-SSA_1_2013_V_12.0.docx	Supporting Statement A	Uploaded 2013-01-14	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form

ICR Details

OMB Control No:	ICR Reference No: 201302-0925-001
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: HHS/NIH	Agency Tracking No: 18520
Title: Recipient Epidemiology and Donor Evaluation Study-III (REDS-III)
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OIRA Conclusion Action: Withdrawn	Conclusion Date: 03/27/2013
	Date Received in OIRA: 02/08/2013
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date		36 Months From Approved
Responses	0	0	0
Time Burden (Hours)	0	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: Research projects conducted under the Recipient Epidemiology and Donor Evaluation Study-III (REDS-III) program focus on improving transfusion benefits and reducing its risks. This research effort should benefit both blood donors and transfusion recipients. The U.S. and international research groups participating in the program are determining the specific epidemiologic, survey, and laboratory studies to be carried out in phase 2 and phase 3 of the program. REDS-III seeks to build upon and extend the findings of the original REDS and REDS-II programs, and cover several new research areas. These include finding new ways to enhance blood supply safety and helping reduce the transmission infectious agents in nations in which those agents continue to limit the safety of the blood supply.

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Authorizing Statute(s): None

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 62518	10/15/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 8153	02/05/2013
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 0

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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 ICR.

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Annual Cost to Federal Government: $1,030,000

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]? 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: 02/08/2013

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