[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.

                                                                                                                
----------------------------------------------------------------------------------------------------------------
                                                                  Estimated                                     
                                                 Estimated        number of      Average burden  Estimated total
             Type of respondents                 number of      responses per      hours per      annual burden 
                                                respondents       respondent       responses     hours requested
----------------------------------------------------------------------------------------------------------------
Blood donors................................          38,500                1            .3333           12,832 
----------------------------------------------------------------------------------------------------------------

    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: 
<[email protected]>.

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