02-13195. Submission for OMB review; Comment Request; Retrovirus Epidemiology Donor Study (REDS): A Study of Motivations and Deterrents to Blood Donation in the United States

SUMMARY:

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on May 29, 2001, pages 29, 152-29, 153 and allowed 60-days for public comment. The Institute mailed a summary of the protocol and copies of the survey instrument in response to a request. Additionally, the Institute received two comments. A professional association applauded the agency's efforts and urged the Institute to consider future population based studies that would account for views of those who never donate blood. The second comment was from an individual representing biomedical services of a national blood banking institution. This individual stressed the need to build upon previous research conducted by this blood banking organization. The Institute responded to both comments via letter. To the first the Institute replied that they were discussing future studies to assess reasons that some people never donate blood. To the second they responded that while it would be beneficial to build upon this previous data, published literature on this blood collection organization's research was not available. No further responses to the Institute were received. The purpose of this notice is to allow an additional 30 days for public comment. 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: Retrovirus Epidemiology Donor Study (REDS): A Study of Motivations and Deterrents to Blood Donation in the United States. Type of Information Collection Request: NEW. Need and Use of Information Collection: There are serious blood shortages in the U.S. and the situation is predicted to worsen unless corrective measures are initiated. Through a randomized mail survey of individuals who have donated blood at one of the blood centers participating in the NHLBI Retrovirus Epidemiology Donor Study (REDS), this study will examine the personal, or intrinsic reasons for choosing to donate blood, as well as external influences for choosing to donate blood. Donors will be given the option to respond via a mailed survey or a secured website. Comparisons will be made between lapsed and repeat donors with the premise that repeat donors may have a stronger altruistic impetus for donating than donors who donate less frequently or discontinue donating. Donors will be asked about factors influencing them to donate, the donation experience, and questions addressing accessibility to donate. Additionally, the study will examine possible barriers to donation, such as inconvenience, discomfort, and confidentiality. With the majority of the blood supply coming from committed, repeat donors, information regarding why an individual decides to donate, and more importantly, what motivates them to come back, will provide valuable insight on possible strategies to encourage increased donation frequency among the current blood donor population. Assessment of possible barriers to donation will provide areas for focusing improvement in the blood donation process. Data from this survey will provide a valuable perspective for devising strategies to increase blood donation the U.S., thus helping insure that there is an adequate supply to meet the needs of the American public. Frequency of Response: Once. Affected Public: Individuals. Type of Respondents: Adult Blood Donors. The annual reporting burden is as follows: Estimated Number of Respondents: 40, 000; Estimated Number of Responses per Respondent: 1; Average Burden Hours Per Response: 0.25; and Estimated Total Annual Burden Hours Requested: 10,000. The annualized cost to respondents is estimated at: $157,000. There are no Capital Costs, Operating Cost, and/or Maintenance Costs to report.

Type of respondents	Estimated number of respondents	Estimated number of responses per respondent	Average burden hours per response	Estimated total annual burden hours requested
Adult Blood Donors	40,000	1	0.25	10,000

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 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 Center, 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: [e-mail].

Comments Due Date

Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication.

Dated: May 10, 2002.

Donald Christoferson,

Executive Officer, NHLBI.