[Federal Register Volume 75, Number 88 (Friday, May 7, 2010)]
[Notices]
[Pages 25268-25269]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-10899]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; Comment Request; REDS-II--Does Pre-
Donation Behavioral Deferral Increase the Safety of the Blood Supply?

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 has submitted to the Office 
of Management and Budget (OMB) a request for review and approval of the 
information collection listed below. This proposed information 
collection was previously published in the Federal Register on February 
24, 2010 in Volume 75, No. 36, pages 8367-8368 and allowed 60-days for 
public comment. (No public comments were received.) 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 currently valid OMB control number.
    Proposed Collection: Title: REDS-II Does Pre-Donation Behavioral 
Deferral Increase the Safety of the Blood Supply?
    Type of Information Collection Request: New. Need and Use of 
Information Collection: While it is well-accepted that deferrals, as 
part of the ``layers of safety'' concept, increase the safety of the 
blood supply, studies with sufficiently large sample size to quantify 
HIV infection and other infectious marker rates in deferred donors are 
lacking. Evidence in support of increased safety is frequently inferred 
from studies conducted in other health care settings. For example, a 
small hospital-based case control study conducted in Brazil examined 
the association between infectious markers and body tattoos. Even 
though tattoos are not used as a criteria to determine blood donor 
eligibility in Brazil, having a tattoo was associated with HCV and also 
with having at least one positive infectious marker.(1) Significant 
associations were not independently observed for HIV, HBV, syphilis or 
Chagas. The authors reported an overall sensitivity of 11% and 
specificity of

[[Page 25269]]

97% for the presence of a tattoo as indicator of having HIV, HCV, HBV, 
or syphilis infection. The researchers then estimated the impact on 
blood donor selection and disease marker testing using the results from 
their hospital-based case control study. However, the assumptions such 
as disease marker prevalence of as much as 15% in donors who are 
deferred for tattoos and a prevalence of 4% of the potential donor base 
having a tattoo (2) do not represent current temporary deferrals in 
Brazil and do not address the most common behavior-related deferrals. A 
more detailed and targeted assessment of the value of relevant 
deferrals could be used to help inform blood donation policies in 
Brazil.
    In Brazilian blood collection centers, donor deferral is initiated 
either by the blood center staff, based on information disclosed by 
prospective donors, or by the donor through self-deferral. Either type 
of deferral occurs because of the belief that a donor's behavior, 
exposures, or history represents an increased risk to the safety of the 
blood supply.
    Although the general eligibility criteria are mandated by the 
Brazilian Ministry of Health, the specific criteria for screening 
potential donors and the procedures for implementing them may vary 
across the regional blood collection centers. This study will focus on 
sexual behavior deferrals and their impact on blood safety. The two 
main study aims are: (1) To assess infectious disease marker prevalence 
in donors who are deferred for higher risk sexual and non-injection 
drug use behavior; and (2) To determine if the different deferral 
classification procedures used by different blood centers in Brazil 
lead to a measurable difference in disease marker prevalence in 
deferred donors. To do this, deferred donors who agree to participate 
in this study will be asked to complete an audio computer assisted self 
interview (ACASI) questionnaire that measures two content areas (1) 
motivations for attempting to donate, (2) additional information on the 
deferral and other potentially undisclosed deferrable behaviors. A 
blood sample will be collected from the deferred donors and tested for 
the panel of infections currently screened for in Brazil (HIV, 
Hepatitis C, Hepatitis B, Human T-lymphotropic virus, syphilis, and 
Trypanosoma cruzi) using the same high-throughput laboratory reagents 
and procedures that are used to screen donations. These deferred donor 
marker rates will be compared to the marker rates among accepted donors 
with the same demographic characteristics. Marker rates in deferred 
donors will also be compared between the blood centers.
    Frequency of Response: Once. Affected Public: Individuals. Type of 
Respondents: Adult Blood Donors. The annual reporting burden is as 
follows: Estimated Number of Respondents: 4,860; Estimated Number of 
Responses per Respondent: 1; Average Burden of Hours per Response: 0.33 
(including administration of the informed consent form and 
questionnaire completion instructions); and Estimated Total Annual 
Burden Hours Requested: 1,604. The annualized cost to respondents is 
estimated at: $10,426 (based on $6.50 per hour). There are no Capital 
Costs to report. There are no Operating or Maintenance Costs to report.

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                                                                     Estimated                       Estimated
                                                                     number of        Average      total annual
                 Estimated number of respondents                   responses per   burden hours    burden hours
                                                                    respondent     per response      requested
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4,860...........................................................               1            0.33           1,604
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    Request for Comments: Written comments and/or suggestions from the 
public and affected agencies are invited on 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 assumptions used; (3) Ways to enhance the quality, utility, and 
clarity of the information to be 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, [email protected] or by fax to 202-395-6974, 
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 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 30-days 
of the date of this publication.

    Dated: April 29, 2010.
George Nemo,
Project Officer, NHLBI, National Institutes of Health.
[FR Doc. 2010-10899 Filed 5-6-10; 8:45 am]
BILLING CODE 4140-01-P