02-10840. Agency Information Collection Activities: Proposed Collection; Comment Request

In compliance with the requirement for opportunity for public comment on proposed data collection projects (section 3506(c)(2)(A) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Pub. L. 104-13), the Health Resources and Services Administration (HRSA) publishes periodic summaries of proposed projects being developed for submission to OMB under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, call the HRSA Reports Clearance Officer at [phone].

Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.

Proposed Project: Private Health Insurance Coverage of Immunosuppressive Drugs Survey—New

Public Law 106-310, Section 2101(b) of Title XXI of the Children's Health Act of 2000, states that the Secretary of Health and Human Services shall provide for a study to determine the costs of immunosuppressive drugs provided to children pursuant to organ transplants and to determine the extent to which health plans and health insurance cover such costs.

The Health Resources and Services Administration (HRSA) has determined the extent of government insurance coverage for immunosuppressive drugs given to children pursuant to organ transplantation. However, HRSA still does not know the extent of private health insurance coverage for immunosuppressive drugs. Analysis of the Organ Procurement and Transplantation Network (OPTN) database revealed that approximately 45% of pediatric organ transplant recipients list their primary insurer as being private health insurance—this category being the largest insurer of pediatric organ transplant recipients. Little is known about co-payments, limitation on drug usage, etc., in this category of patients.

In order to fulfill the requirements of Section 2101(b), the Division of Transplantation in the Office of Special Programs, HRSA, contracted with the EMMES Corporation to study the costs of immunosuppressive drugs and to conduct a survey to send to approximately 600 families of post-transplant liver and kidney patients who list private health insurance as their primary provider at the time of transplantation. Data collected and analyzed will be reported to Congress. The report will contain information about the extent to which private health insurance covers the cost of immunosuppressive drugs given pursuant to organ transplants and provide recommendations from the Secretary of Health and Human Services about the findings. Once information has been collected and the report to Congress submitted, the information will be incorporated into private databases maintained by the EMMES Corporation which are closely protected and not available to the public. Analytical requests can be made on the data, but requests are subject to an advisory board and the release in any type of personally-identifiable data or standard analytical file will not be available to the public. The Federal Government will not have access to any of the personally-identifiable data. All these measures will assure patient privacy.

Estimates of Annualized Hour Burden

Respondents	Number of respondents	Responses per respondents	Hours per response	Total hour burden
Guardians patients	600	1	.75	450
Transplant Centers	143	1	2.5	357.50
Total	743			807.50

Send comments to Susan G. Queen, Ph.D., HRSA Reports Clearance Officer, Room 11-05, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857. Written comments should be received within 60 days of this notice.

Dated: April 25, 2002.

Stephen R. Smith,

Acting Associate Administrator for Management and Program Support.