02-14020. 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 on [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: Data System for Organ Procurement and Transplantation Network and Associated Forms (OMB No. 0915-0157): Revision

Section 372 of the Public Health Service (PHS) Act requires that the Secretary, by contract, provide for the establishment and operation of an Organ Procurement and Transplantation Network (OPTN). The OPTN, among other responsibilities, operates and maintains a national waiting list of individuals requiring organ transplants, maintains a computerized system for matching donor organs with transplant candidates on the waiting list, and operates a 24-hour telephone service to facilitate matching organs with individuals included in the list.

Data for the OPTN data system are collected from transplant hospitals, organ procurement organizations, and tissue-typing laboratories. The information is used to match donor organs with recipients, to monitor compliance of member organizations with OPTN rules and requirements, and to report periodically on the clinical and scientific status of organ donation and transplantation in this country. Data are used in the development and revision of OPTN rules and requirements, operating procedures, and standards of quality for organ acquisition and preservation, some of which have provided the foundation for development of Federal regulations. The practical utility of the data collection is further enhanced by requirements that the OPTN data must be made available without restriction for use by OPTN members, the Scientific Registry of Transplant Recipients, the Department of Health and Human Services, and others for evaluation, research, patient information, and other important purposes.

Revisions in the 28 data collection forms are intended to clarify existing questions, to provide additional detail and categories to avoid confusion and be more inclusive, to remove obsolete data, and to comply with requests for more complete and precise data.

Estimates of Annualized Hour Burden

Form	Number of respondents	Responses per respondents	Total responses	Hours per response	Total burden hours
Cadaver Donor Registration	59	170	10,030	0.3	3,009.00
Death referral data	59	12	708	10	7,080.00
Living Donor Registration	668	11	7,348	0.2	1,469.60
Living Donor Follow-up	668	16	10,688	0.1	1,068.80
Donor Histocompatibility	156	86	13,416	0.1	1,341.60
Recipient Histocompatibility	156	161	25,116	0.1	2,511.60
Heart Candidate Registration	140	26	3,640	0.3	1,092.00
Lung Candidate Registration	75	29	2,175	0.3	652.50
Heart/Lung Candidate Registration	81	2	162	0.3	48.60
Thoracic Registration	140	29	4,060	0.3	1,218.00
Thoracic Follow-up	140	168	23,520	0.2	4,704.00
Kidney Candidate Registration	242	108	26,136	0.2	5,227.20
Kidney Registration	242	62	15,004	0.3	4,501.20
Kidney Follow-up *	242	444	107,448	0.2	21,489.60
Liver Candidate Registration	120	97	11,640	0.2	2,328.00
Liver Registration	120	44	5,280	0.4	2,112.00
Liver Follow-up	120	276	33,120	0.3	9,936.00
Kidney/Pancreas Candidate Registration	138	14	1,932	0.2	386.40
Kidney/Pancreas Registration (new form)	138	7	966	0.4	386.40
Kidney/Pancreas Follow-up (new form)	138	51	7,038	0.3	2,111.40
Pancreas Candidate Registration	138	7	966	0.2	193.20
Pancreas Registration	138	4	552	0.3	165.60
Pancreas Follow-up	138	12	1,656	0.2	331.20
Intestine Candidate Registration	38	6	228	0.2	45.60
Intestine Registration	38	3	114	0.2	22.80
Intestine Follow-up	38	9	342	0.2	68.40
Immunosuppression Treatment	668	39	26,052	0.025	651.30
Immunosuppression Treatment Follow-up	668	259	173,012	0.025	4,325.30
Post Transplant Malignancy	668	8	5,344	0.05	267.20
Total	883		517,693		78,744.50
* Includes an estimated 10,000 kidney transplant patients transplanted prior to the initiation of the data system.

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: May 30, 2002.

Jane M. Harrison,

Director, Division of Policy Review and Coordination.