[Federal Register Volume 74, Number 44 (Monday, March 9, 2009)]
[Notices]
[Pages 10057-10058]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-4836]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; Comment Request; 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: REDS-II Donor Iron Status Evaluation (RISE) Study. Type of 
Information Collection Request: Revision of a currently approved 
collection. OMB control  0925-0581. Expiration Date: 05/31/
2009. 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. 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 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.
    This request for modification is to add eleven questions to the 
RISE study final visit questionnaire that will include questions about 
Restless Leg Syndrome (RLS) and pica, two disorders associated with 
iron deficiency. RLS is a neurologic movement disorder in which 
patients complain of crawling, aching or indescribable feelings in 
their legs or just have the need to move. Pica is an eating disorder 
defined as compulsive ingestion of non-food substances. Blood donation 
results in the removal of 200-250 mg of iron from the donor. It is well 
established that repeated blood donation can produce iron deficiency, 
yet the prevalence of RLS and pica among blood donors is unknown. The 
REDS-II RISE study subjects are an ideal study population for the 
investigation of RLS and pica in blood donors. About 2,400 subjects 
with variable donation intensity (e.g. frequency with which a person 
donates blood) are currently enrolled in the RISE

[[Page 10058]]

Study. The iron status of all of these subjects is well characterized, 
including measurement of plasma ferritin and soluble transferrin 
receptor along with hemoglobin/hematocrit. These laboratory values 
allow each subject to be defined as (1) iron replete, (2) iron 
deficient without anemia or (3) iron deficiency anemia. The responses 
to these questions will be correlated with the laboratory test values 
to determine the relationship between blood donation and the 
development of RLS and pica and will establish its prevalence in these 
populations.
    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: 0.25; and Estimated Total Annual Burden Hours Requested: 
Baseline visit: 866. Follow up Visit: 383. The annualized cost to 
respondents is estimated at: Baseline Visit: $15,588, Follow up Visit: 
$6,894 (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      total annual
               Type of respondents                   number of     responses per   burden hours    burden hours
                                                    respondents     respondent     per 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            0.25             383
                                                 ---------------------------------------------------------------
    Total.......................................  ..............  ..............  ..............           1,249
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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) Evaluate 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) Evaluate the accuracy of the agency's estimate of the 
burden of the proposed collection of information, including the 
validity of the methodology and assumptions used; (3) Enhance the 
quality, utility, and clarity of the information to be collected; and 
(4) 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 27, 2009.
George Nemo,
NHLBI Project Officer, NHLBI, National Institutes of Health.
 [FR Doc. E9-4836 Filed 3-6-09; 8:45 am]
BILLING CODE 4140-01-P