[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