REDS-II Donor Iron Study (NHLBI)

Forms and Documents

Document Name	Status
Form 1 RED- II Donor Iron Study-Final Visit Form	Modified
Form 1 REDS-II Donor Iron Study-Baseline Visit Form	Modified
RISE_RLS-PICA_SupportingStatementB.doc Supporting Statement B	2009-05-18
Attachment7 - Other Study Docs.doc Supplementary Document	2009-05-18
Attachment6 - Informed Consent.doc Supplementary Document	2009-05-18
Attachment5 - OSMB Comments.doc Supplementary Document	2009-05-18
Attachment4 - Comm Members.doc Supplementary Document	2009-05-18
Attachment3 -Qx Source Goals.doc Supplementary Document	2009-05-18
Invitation to participate brochure.pdf Supplementary Document	2007-01-25
Supporting material.pdf Supplementary Document	2007-01-25
RISE_RLS-PICA_SupportingStatementA (3).doc Supporting Statement A	2009-05-18

IC Document Collections

IC ID	Document Title	Status
178919	RED- II Donor Iron Study-Final Visit Form	Modified
178918	REDS-II Donor Iron Study-Baseline Visit Form	Modified

ICR Details

OMB Control No: 0925-0581	ICR Reference No: 200905-0925-003
Status: Historical Active	Previous ICR Reference No: 200703-0925-001
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: REDS-II Donor Iron Study (NHLBI)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 07/21/2009
	Date Received in OIRA: 05/28/2009
Terms of Clearance: Approved consistent with previous Terms of Clearance: NIH will use revised interim post cards and consent forms, and all instruments will include the standard PRA blurb, OMB control number, and expiration date. NIH also agrees that it will not store biological samples for future testing, due to privacy and ethics reasons.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2012	36 Months From Approved	07/31/2009
Responses	3,870	0	6,330
Time Burden (Hours)	1,249	0	1,934
Cost Burden (Dollars)	0	0	0

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Abstract: Iron loss is a known consequence of blood donation. Although the overall health significance of iron depletion in blood donors is uncertain, iron depletion leading to iron deficient erythropoiesis and lowered hemoglobin levels results in donor deferral and, occasionally, in mild iron deficiency anemia. Hemoglobin deferrals represent more than half of all donor deferral, deferring 16% of donation attempts by women. This Iron Cohort study has been developed under the National Heart, Lung, and Blood Institute?s (NHLBI) Retrovirus Epidemiology Donor Study-II (REDS-II) contract. Among the six REDS-II blood centers, a longitudinal study of iron status in two cohorts of blood donors will be conducted. The first cohort will be comprised of 1920 first time and returning (reactivated) donors for whom baseline iron and hemoglobin status can be assessed without the influence of previous donations, and a second cohort of 1440 frequent donor, where the cumulative effect of additional frequent blood donations can be assessed.

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Authorizing Statute(s): US Code: 42 USC 285b3 Name of Law: COngressional Mandate
  

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:
	74 FR 10057	03/09/2009
30-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 25244	05/27/2009
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
REDS-II Donor Iron Study-Baseline Visit	1	Questionaires
RED- II Donor Iron Study-Final Visit	1	Questionaires

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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	3,870	6,330	0	0	-2,460	0
Annual Time Burden (Hours)	1,249	1,934	0	0	-685	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: $1,600,000

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]? Uncollected

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: 05/28/2009

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