[Federal Register Volume 62, Number 86 (Monday, May 5, 1997)]
[Notices]
[Page 24492]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-11649]



[[Page 24492]]

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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 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; and (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. Frequency of Response: One-time data collection. 
Affected Public: Individuals.


----------------------------------------------------------------------------------------------------------------
                                                                     Estimated                       Estimated  
                                                     Estimated       number of    Average burden   total annual 
               Type of respondents                   number of     responses per     hours per     burden hours 
                                                    respondents     respondent       responses       requested  
----------------------------------------------------------------------------------------------------------------
Blood Donors....................................         77,000               1           .3333          25,664 
----------------------------------------------------------------------------------------------------------------

    The annualized cost to respondents is estimated at: $256,641 (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.

FOR FURTHER INFORMATION CONTACT: 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, 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 July 
7, 1997.

    Dated: April 25, 1997.
Sheila E. Merritt,
Executive Officer, NHLBI.
[FR Doc. 97-11649 Filed 5-2-97; 8:45 am]
BILLING CODE 4140-01-M