National Heart, Lung, and Blood Institute; Proposed Collection; Comment RequestNational Donor Research and Education Study-II

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:

[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