This ICR is approved consistent with NIH memo of August 13, 2007. As noted in that memo, 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.
table that charts list comparision
Inventory as of this Action
Requested
Previously Approved
05/31/2009
05/31/2009
6,330
0
0
1,934
0
0
0
0
0
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. For each cohort, donors will routinely donate blood during the study period. As part of the research study, a sample of their blood will be collected for laboratory testing and on specific visits, for repository storage. Additionally we will enroll a group of 500 first time and reactivated donors who are deferred by the blood center for low hemoglobin to assess these donors? baseline iron and hemoglobin status. The primary goal of the study is to evaluate the effects of blood donation intensity on iron and hemoglobin status and assess how these are modified by demographic, reproductive and behavioral factors. This study aims to identify laboratory measures for predicting the development of iron depletion, and hemoglobin deferral in whole blood and double red cell donors as that could be potentially useful for donor management. The data collected will help evaluate hemoglobin distributions in the blood donor population (eligible and deferred donors) and compare them with NHANES data. It will also help formulate a predictive model for the development of iron depletion, hemoglobin deferral and/or iron deficient hemoglobin deferral in whole blood donors, which could be beneficial to developing optimal whole blood donation frequency guidelines.
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:
(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;
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.
Form 1 RED- II Donor Iron Study
Responses to OMB comments_final.doc
RED- II Donor Iron Study