[Federal Register Volume 62, Number 248 (Monday, December 29, 1997)]
[Notices]
[Pages 67643-67644]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-33745]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Heart, Lung, and Blood Institute; Submission for OMB 
Review; 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. This 
proposed information collection was previously published in Volume 62, 
Number 86 of the Federal Register on May 5, 1997 (page 24,492) and 
allowed 60 days for public comment. One comment was received. An 
individual requested a summary of the study protocol, which was 
provided to them. 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: National Donor Research and Education Study-II. Type of 
Information Collection Request: Reinstatement with changes to OMB 
#0925-0383, Expiration date: 1/31/96. Need and Use of Information 
Collection: This study is the second large 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 the REDS blood centers, this survey will also be sent to a 
sample of donors in selected non-REDS regions that utilize a variety of 
donor incentives. Study results will provide data for monitoring the 
safety of the U.S. blood supply, and 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 enter 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. The new survey is specifically designed to obtain 
data on the prevalence and impact of donor incentives on donor 
retention and blood safety. The FDA has identified this as a priority 
area for investigation. Other 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-jakob and parasitic 
diseases; and addition of HIV p24 antigen testing); (2) Estimate the 
efficacy, safety impact and donor acceptance of new donor screening 
procedures that are anticipated to occur within the next 12-24 months 
(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 intranasal 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 
test 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

[[Page 67644]]

informed consent. Frequency of Response: One-time data collection. 
Affected Public: Individuals.

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                                                                                                      Estimated 
                                                                            Estimated     Average       total   
                                                               Estimated    number of      burden       annual  
                     Type of respondents                       number of    responses    hours per      burden  
                                                              respondents      per       responses      hours   
                                                                            respondent                requested 
----------------------------------------------------------------------------------------------------------------
Blood Donors................................................       78,000            1        .3333       25,997
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    The annualized cost to respondents is estimated at: $259,974 (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 
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, New Executive 
Office Building, Room 10235, Washington, DC 20503, Attention: Desk 
Officer for NIH. To request more information on the proposed project or 
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, 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 January 28, 1998.

    Dated: December 17, 1997.
Sheila E. Merritt,
Executive Officer, NHLBI.
[FR Doc. 97-33745 Filed 12-24-97; 8:45 am]
BILLING CODE 4140-01-M