[Federal Register Volume 74, Number 100 (Wednesday, May 27, 2009)]
[Notices]
[Pages 25244-25245]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-12210]


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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: Under the provisions of Section 3507(a)(1)(D) of the 
Paperwork Reduction Act of 1995, the National Heart, Lung, and Blood 
Institute (NHLBI), the National Institutes of Health (NIH) has 
submitted to the Office of Management and Budget (OMB) a request to 
review and approve the information collection listed below. This 
proposed information collection was previously published in the Federal 
Register on March 9, 2009, pages 10057-10058 and allowed 60-days for 
public comment. No comments were received in response to this notice. 
The purpose of this notice is to allow an additional 30 days for public 
comment. The National Institutes of Health may not conduct or sponsor, 
and the respondent is not required to respond to, an information 
collection that has been extended, revised, or implemented on or after 
October 1, 1995, unless it displays a current valid OMB control number.

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 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 as 
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

[[Page 25245]]

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) 
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.

Direct Comments to OMB

    Written comments and/or suggestions regarding the item(s) contained 
in this notice, especially regarding the estimated public burden and 
associated response time, should be directed to the: Office of 
Management and Budget, Office of Regulatory Affairs, New Executive 
Office Building, Room 10235, Washington, DC 20503, Attention: Desk 
Officer for NIH. 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 
361, 6700 Rockledge Drive, Bethesda, MD 20892, or call non-toll free 
number 301-435-0075, or e-mail your request, including your address to 
[email protected].

Comments Due Date

    Comments regarding this information collection are best assured of 
having their full effect if received within 30 days of the date of this 
publication.

    Dated: May 15, 2009.
George Nemo,
Project Officer, NHLBI.
[FR Doc. E9-12210 Filed 5-26-09; 8:45 am]
BILLING CODE 4140-01-P