[Federal Register Volume 72, Number 21 (Thursday, February 1, 2007)]
[Notices]
[Pages 4716-4717]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-1587]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; Comment Request; The REDS-II Donor Iron 
Study: Predicting Hemoglobin Deferral and Development of Iron Depletion 
in Blood Donors

    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 August 28, 2006, pages 50925-50926 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: The REDS-II Donor Iron Study: 
Predicting Hemoglobin Deferral and Development of Iron Depletion in 
Blood Donors. Type of Information Collection Request: NEW. 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 REDS-II Donor Iron 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. We 
also propose to assess the baseline status of a group of first-time 
donors who are deferred for low hemoglobin on their first visit.
    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. 
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: 4,290, Follow 
up Visit: 2,040; Estimated Number of Responses per Respondent: 1; 
Average Burden of Hours per Response: Baseline Visit: 0.12, Follow up 
Visit: 0.1; and Estimated Total Annual Burden Hours Requested: Baseline 
visit: 515, Follow up Visit: 204. The annualized cost to respondents is 
estimated at: Baseline Visit: $9,270, Follow up Visit: $3,672 (based on 
$18 per hour). There are no Capital Costs to report. There are no 
Operating or Maintenance Costs to report.

                    Table A.12.--Estimates of Hour Burden and Annualized Cost to Respondents
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                                                     Estimated                                       Estimated
                                     Estimated       number of        Average       Hourly wage    total annual
       Type of respondents           number of     responses per   burden hours      rate ($)      burden hours
                                    respondents     respondent     per response                      requested
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Blood donors at Baseline Visit..           4,290               1            0.12              18             515
Blood donors at Follow-up Visit.           2,040               1             0.1              18             204
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    Total.......................  ..............  ..............  ..............  ..............             719
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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

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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: January 25, 2007.
George Nemo,
Project Officer, NHLBI National Institutes of Health.
[FR Doc. E7-1587 Filed 1-31-07; 8:45 am]
BILLING CODE 4140-01-P