[Federal Register Volume 73, Number 31 (Thursday, February 14, 2008)]
[Notices]
[Pages 8701-8702]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-2748]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; comment request; The REDS-II Donor Iron 
Status Evaluation (RISE) Study

SUMMARY: In compliance with the requirement of Section 3506(c) (2) (A) 
of the Paperwork Reduction Act of 1995, for opportunity for public 
comment on proposed data collection projects, the National Heart, Lung, 
and Blood Institute (NHLBI), the National Institutes of Health (NIH), 
will publish periodic summaries of proposed projects to the Office of 
Management and Budget (OMB) for review and approval.

PROPOSED COLLECTION: Title: The REDS-II Donor Iron Status Evaluation 
(RISE) Study. Type of Information Collection Request: Revisions due to 
program adjustments. Need and Use of Information Collection: 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 women.
    Several cross sectional studies of blood donors, using older 
measures of iron status in blood donors have indicated that female sex, 
frequent donation and not taking iron supplements are predictors of 
iron depletion. However, none of these studies have included racial/
ethnic, anthropomorphic, or behavioral factors and none have evaluated 
the impact of newly discovered iron protein polymorphisms. The RISE 
Study is a longitudinal study of iron status in two cohorts of blood 
donors: A first time/reactivated donor cohort in which baseline iron 
and hemoglobin status can be assessed without the influence of previous 
donations, and a frequent donor cohort, where the cumulative effect of 
additional frequent blood donations can be assessed. Each cohort's 
donors will donate blood and provide evaluation samples during the 
study period.
    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 as a function of baseline iron/hemoglobin measures, 
demographic factors, and reproductive and behavioral factors. 
Hemoglobin levels, a panel of iron protein, red cell and reticulocyte 
indices

[[Page 8702]]

will be measured at baseline and at a final follow-up visit 15-24 
months after the baseline visit. A DNA sample will be obtained once at 
the baseline visit to assess three key iron protein polymorphisms. 
Donors will also complete a self-administered survey assessing past 
blood donation, smoking history, use of vitamin/mineral supplements, 
iron supplements, aspirin, frequency of heme rich food intake, and, for 
females, menstrual status and pregnancy history at these two time 
points. This study aims to identify the optimal laboratory measures 
that would predict the development of iron depletion, hemoglobin 
deferral, and/or iron deficient hemoglobin deferral in active whole 
blood and double red cell donors at subsequent blood donations. The 
data collected will help evaluate hemoglobin distributions in the blood 
donor population (eligible and deferred donors) and compare them with 
NHANES data. Other secondary objectives include elucidating key genetic 
influences on hemoglobin levels and iron status in a donor population 
as a function of donation history; and establishing a serum and DNA 
archive to evaluate the potential utility of future iron studies and 
genetic polymorphisms.
    This study will develop better predictive models for iron depletion 
and hemoglobin deferral (with or without iron deficiency) in blood 
donors; allow for the development of improved donor screening 
strategies and open the possibility for customized donation frequency 
guidelines for individuals or classes of donors; provide important 
baseline information for the design of targeted iron supplementation 
strategies in blood donors, and improved counseling messages to blood 
donors regarding diet or supplements; and by elucidating the effect of 
genetic iron protein polymorphisms on the development of iron 
depletion, enhance the understanding of the role of these proteins in 
states of iron stress, using frequent blood donation as a model.
    Frequency of Response: Twice. Affected Public: Individuals. Type of 
Respondents: Adult Blood Donors. The annual reporting burden is a 
follows: Estimated Number of Respondents: Baseline visit: 2,340, Follow 
up Visit: 1,530; Estimated Number of Responses per Respondent: 1; 
Average Burden of Hours per Response: Baseline Visit: 0.37, Follow up 
Visit: 0.17; and Estimated Total Annual Burden Hours Requested: 
Baseline visit: 866, Follow up Visit: 260. The annualized cost to 
respondents is estimated at: Baseline Visit: $15,588, Follow up Visit: 
$4,680 (based on $18 per hour). There are no Capital Costs to report. 
There are no Operating or Maintenance Costs to report.

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                                                                     Estimated                       Estimated
                                                     Estimated       number of    Average burden   total annual
               Type of respondents                   number of     responses per     hours per     burden hours
                                                    respondents     respondent       response        requested
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Blood donors at Baseline Visit..................           2,340               1            0.37             866
Blood donors at Follow-up Visit.................           1,530               1            0.17             260
                                                 ---------------------------------------------------------------
    Total.......................................  ..............  ..............  ..............           1,126
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    Request for Comments: Written comments and/or suggestions from the 
public and affected agencies should address one or more of the 
following points: (1) Whether the proposed collection of information is 
necessary for the proper performance of the function of the agency, 
including whether the information will have practical utility; (2) The 
accuracy of the agency's estimate of the burden of the proposed 
collection of information, including the validity of the methodology 
and the assumptions used; (3) Ways to enhance the quality, utility, and 
clarity of the information collected; and (4) Ways to minimize the 
burden of the collection of information on those who are to respond, 
including the use of appropriate automated, electronic, mechanical, or 
other technological collection techniques or other forms of information 
technology.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the data collection plans and 
instruments, contact Dr. George Nemo, Project Officer, NHLBI, Two 
Rockledge Center, Suite 10042, 6701 Rockledge Drive, Bethesda, MD 
20892-7950, or call 301-435-0075, or E-mail your request to 
[email protected].
    Comments Due Date: Comments regarding this information collection 
are best assured of having their full effect if received within 60 days 
of the date of this publication.

    Dated: February 4, 2008.
George Nemo,
NHLBI Project Officer, NHLBI, National Institutes of Health.
 [FR Doc. E8-2748 Filed 2-13-08; 8:45 am]
BILLING CODE 4140-01-P