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.
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