[Federal Register Volume 75, Number 84 (Monday, May 3, 2010)]
[Notices]
[Pages 23265-23266]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-10283]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; Comment Request; Investigating the
Causes of Post Donation Information (PDI): Errors in the Donor
Screening Process
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 February
23, 2010, Volume 75, No. 35, pages 8080-8081 and allowed 60 days for
public comment. 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: Investigating the causes of post
donation information (PDI): Errors in the donor screening process. Type
of Information Collection Request: NEW. Need and Use of Information
Collection: Blood centers are required to use a health history
screening questionnaire to obtain eligibility information for the
protection of the donor and recipient prior to blood donation. However,
the health history process is known to be error-prone and the reasons
for those errors are largely unknown and untested. Donors often fail to
report a risk that would have resulted in deferral. This deferral risk
may be disclosed at a subsequent donation and is classified as Post
Donation Information (PDI). While this deferral risk may be at the next
donation event, many examples of PDI are not disclosed nor discovered
until several intervening donation events have occurred. The reasons
why donors fail to disclose a deferrable history at the time of one
donation but subsequently disclose this information at a later time are
unidentified. This protocol is designed to ascertain why PDI error
events occur. It will be the first study of any kind to address the
issue of PDI errors in any systematic fashion. By conducting interviews
with donors involved in PDI errors, we will gain important qualitative
knowledge about this problem. Information gathered from these
interviews will not only elucidate the issue of PDI but will provide
insight into donor understanding of the screening process and their
feelings about the process and blood donation in general.
The main objectives of the study are:
1. To explore reasons behind errors in the donor screening process
when donors initially fail to disclose an accurate and complete health
history.
2. To explore PDI donors' knowledge, attitudes, behaviors and
beliefs (KABB) about the health history questionnaire and their
experience with the screening process and the center.
3. To compare KABB in PDI donors to deferred (but not PDI) donors
and accepted donors.
The study sample will consist of three groups:
1. Donors with a PDI: all identified donors of interest with an FDA
reportable donor suitability error classified as PDI at the REDS-II
centers.
2. Deferred donors: appropriately deferred (but not PDI deferred
donors) at the REDS-II centers.
3. Accepted Donors: appropriately accepted for donation at the
REDS-II centers.
Telephone interviews will be conducted with consented donors to
collect information regarding their knowledge, attitudes, behaviors and
beliefs about the donor health history process. Even though the
interviews with the donors will be individual, we would like to form
groups of similar PDI and deferred donors for analysis purposes.
The five groups of interest include PDI occurrences or deferrals
that are due to:
Travel (malaria, vCJD).
Medical (history of diseases including jaundice/hepatitis,
surgery and medications needed to treat disease including Tegison,
Proscar and Accutane).
Blood/Disease Exposure--(tattoo, piercings, accidental
needle stick).
High Risk Behavior--Sexual (MSM, sex with IV drug user or
test-positive individual).
High Risk Behavior--Non-Sexual (IV drug use, non-sexual
exposure to Hepatitis C or Hepatitis B).
All interviews will be digitally-recorded and the recordings
uploaded onto computers as dss files; these files will be transcribed
and then coupled to the interviewer notes to form an analytic package
for the data analysts. Once the interview is conducted successfully,
each study donor will be mailed a check of $25 as an incentive for
participating in the study.
The cognitive testing of the interview guide will be conducted at
the Hoxworth Blood Center. For this purpose, the blood center staff
will identify 2 PDI and 2 deferred donors from the five broad
categories of interest. They will also contact 2 accepted donors for
study consent and interview. These donors will be approached and
consented by following the same procedures that will be used for the
actual study.
The data from the semi-structured interviews will be analyzed in
two ways. The close-ended responses will be analyzed quantitatively.
This will likely take the form of 3-way cross-tabulations of frequency
distributions in responses to key questions. The open-ended responses
will be analyzed as qualitative data. All analytic steps and
assumptions that led up to the conclusions, including competing
interpretations of the data, will be fully discussed in the final
report.
Frequency of Response: Once. Affected Public: Individuals. Type of
Respondents: Adult blood donors. The annual reporting burden is a
follows: Estimated Number of Respondents: 408; Estimated Number of
Responses per Respondent: 1; Average Burden of Hours per Response: 0.08
for the initial phone call and 0.5 for responding to the
[[Page 23266]]
actual interview; and Estimated Total Annual Burden Hours Requested:
83.64.The annualized cost to respondents is estimated at: $1505.52
(based on $18 per hour). There are no Capital Costs to report. There
are no Operating or Maintenance Costs to report.
Table 1: Estimate of Requested Burden Hours and Dollar Value of Burden
Hours
Table A.12-1 Estimates of Hour Burden
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Estimated number Average burden Estimated total
Type of respondents No. of of responses per hours per annual burden
respondents respondent response hours requested
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Donors initially contacted............. 408 1 .08 32.6
PDI Donors............................. *60 1 0.5 30
Deferred Donors........................ *30 1 0.5 15
Accepted Donors........................ *12 1 0.5 6
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Total.............................. 408 ................ ................ 83.64
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*These respondents are a subgroup of total 408 donors who will be initially contacted to participate in the
study.
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 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: April 26, 2010.
George Nemo,
Project Officer, NHLBI, National Institutes of Health.
[FR Doc. 2010-10283 Filed 4-30-10; 8:45 am]
BILLING CODE 4140-01-P