[Federal Register Volume 61, Number 207 (Thursday, October 24, 1996)]
[Notices]
[Pages 55158-55159]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-27327]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood Institute; Proposed Collection;
Comment Request--National Donor Research and Education Study-II
SUMMARY: In compliance with the requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995, for opportunity for public comment
on proposed data collection projects, the National Heart, Lung and
Blood Institute (NHLBI), the National Institutes of Health (NIH) will
publish periodic summaries of proposed projects to be submitted to the
Office of Management and Budget (OMB) for review and approval.
PROPOSED COLLECTION: Title: National Donor Research and Education
Study-II. Type of Information Collection Request: NEW. Need and Use of
Information Collection: This study is the second stage anonymous mail
survey to be sent to a random sample of blood donors at five blood
centers participating in the Retrovirus Epidemiology Donor Study
(REDS). In addition to monitoring the safety of the U.S. blood supply,
study results will facilitate the development, evaluation and
refinement of educational, recruitment and qualification strategies for
U.S. blood donors. The proposed new study will update and extend the
unique findings obtained in the first blood donor survey so as to
minimize the likelihood that donors with risk factors for transfusion-
transmitted diseases will participate in the blood donor pool. There is
a strong likelihood that, like the first survey effort, the resulting
findings will be directly applied to blood banking operational
practice. Specific objectives of this survey are to: (1) Evaluate donor
understanding and acceptance, and the safety impact of newly-changed
laboratory and donor screening procedures that have been implemented
since the previous donor survey study (e.g. removal of the confidential
unit exclusion ``CUE'' process at two REDS sites; additional questions
about Creutzfeldt-Jacob and parasitic diseases; addition of HIV p24
antigen testing; increased use of donation incentives); (2) Pilot test
new donor screening procedures that are anticipated to occur within the
next 12-24 months in order to estimate their efficacy, safety impact
and donor acceptance (e.g. improved CUE procedures, implementation of
computer-assisted donor screening); (3) Provide ``pre-'' (baseline) and
``post-'' (evaluation) measures for new donor qualification procedures
expected to occur operationally at blood centers within the time period
of study including: deferral for intransal cocaine use in the past
year; modification of the time period for sexual risk deferrals from
``since 1977'' to within the past 12 (or 24) months; clarification of
wording regarding sexual contact with ``at-risk'' individuals; and
addition of questions about donating primarily for the purpose of
receiving the tests results for the AIDS virus; (4) Assess changes in
the prevalence and characteristics of donors who report donating for
therapeutic reasons (e.g., those with iron storage disease), and donors
who report donating primarily to receive test results for the AIDS
virus as a result of the March 1996 implementation of HIV p24 antigen
testing; (5) Determine the extent to which active donors with reactive
tests for anti-HBc and syphilis have increased levels of behavioral
risks that should have resulted in deferral; (6) Measure the extent to
which seropositivity for current syphilis screening tests predicts a
recent history of diagnosed syphilis: (7) Measure blood donor knowledge
of infectious disease risks and the behavioral factors that should
defer them from donating, to identify weaknesses in the current donor
educational process; and (8) Assess the attitudes of donors regarding
establishment of stored frozen repositories from their donations, use
of these samples for future research testing designed to improve
transfusion safety, and the adequacy of different levels of informed
consent. Frequency of Response: One-time data collection. Affected
Public: Individuals.
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Estimated
Estimated number of Average burden Estimated total
Type of respondents number of responses per hours per annual burden
respondents respondent responses hours requested
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Blood donors................................ 38,500 1 .3333 12,832
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The annualized cost to respondents is estimated at: $128,320 (based
on $10 per hour). There are no Capital Costs to report. There are no
Operating or Maintenance Costs to report.
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 technical collection techniques or other forms of
information technology.
FOR FURTHER INFORMATION: To request more information on the proposed
project or to obtain a copy of the data collection plans and
instruments, contact Dr. George J. Nemo, Group Leader, Transfusion
Medicine, Scientific Research Group, Division of Blood Diseases and
Resources, NHLBI,
[[Page 55159]]
NIH, Two Rockledge Centre, Suite 10042, 6701 Rockledge Drive, MSC 7950,
Bethesda, MD 20892-7950, or call non-toll free number (301) 435-0075 or
E-mail your request, including your address to:
nemog@gwgate.nhlbi.nih.gov>.
COMMENTS DUE DATE: Comments regarding this information collection are
best assured of having their full effect if received on or before
December 23, 1996.
Dated: October 17, 1996.
Shelia E. Merritt,
Executive Officer, NHLBI.
[FR Doc. 96-27327 Filed 10-23-96; 8:45 am]
BILLING CODE 4140-01-M
