[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
----------------------------------------------------------------------------------------------------------------
                                                           Estimated number   Average burden    Estimated total
          Type of respondents                 No. of       of responses per      hours per       annual burden
                                            respondents       respondent         response       hours requested
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
    Total..............................               408  ................  ................              83.64
----------------------------------------------------------------------------------------------------------------
*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