National Heart, Lung, and Blood Institute; Proposed Collection; Comment Request; National 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 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