E7-3918. Agency Information Collection Activities: Proposed Collection: Comment Request

In compliance with the requirement for opportunity for public comment on proposed data collection projects (44 U.D.C. 3506(c)(2)(A)), 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 system 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 indicate the disease severity of transplant candidates, 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 to develop transplant, donation and allocation policies, to determine if institutional members are complying with policy, to determine member specific performance, to ensure patient safety when no alternative sources of data exist and to fulfill the requirements of the OPTN Final Rule. The practical utility of the data collection is further enhanced by requirements that the OPTN data must be made available, consistent with applicable laws, 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 26 data collection forms are intended to implement approved reduction in data collection for candidates and recipients, to provide additional information specific to pediatric patients, and to clarify existing questions.

Estimates of Annualized Hour Burden

Form	Number of respondents	Responses per respondents	Total responses	Hours per response	Total burden hours
Deceased Donor Registration	58	215	12,470	0.4200	5,237.4000
Death referral data	58	12	696	10.0000	6,960.0000
Living Donor Registration	711	10	7,110	0.4100	2,915.1000
Living Donor Follow-up	711	18	12,798	0.3300	4,223.3400
Donor Histocompatibility	154	95	14,630	0.0600	877.8000
Recipient Histocompatibility	154	172	26,488	0.1100	2,913.6800
Heart Candidate Registration	135	23	3,105	0.2800	869.4000
Lung Candidate Registration	67	27	1,809	0.2800	506.5200
Heart/Lung Candidate Registration	59	1	59	0.2800	16.5200
Thoracic Registration	135	27	3,645	0.4400	1,603.8000
Thoracic Follow-up	135	229	30,915	0.4130	12,767.8950
Kidney Candidate Registration	250	133	33,250	0.2800	9,310.0000
Kidney Registration	250	69	17,250	0.4400	7,590.0000
Kidney Follow-up	250	544	136,000	0.3332	45,315.2000
Liver Candidate Registration	125	89	11,125	0.2800	3,115.0000
Liver Registration	125	54	6,750	0.4000	2,700.0000
Liver Follow-up	125	383	47,875	0.3336	15,971.1000
Kidney/Pancreas Candidate Registration	146	12	1,752	0.2800	490.5600
Kidney/Pancreas Registration	146	7	1,022	0.5300	541.6600
Kidney/Pancreas Follow-up	146	65	9,490	0.5027	4,770.6230
Pancreas Candidate Registration	146	7	1,022	0.2800	286.1600
Pancreas Registration	146	3	438	0.4400	192.7200
Pancreas Follow-up	146	23	3,358	0.4133	1,387.8614
Intestine Candidate Registration	45	8	360	0.2400	86.4000
Intestine Registration	45	4	180	0.5300	95.4000
Intestine Follow-up	45	17	765	0.5059	387.0135
Post Transplant Malignancy	711	6	4,266	0.0800	341.2800
Total	923		388,628		131,472.4329

Send comments to Susan G. Queen, PhD, HRSA Reports Clearance Officer, Room 10-33, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857. Written comments should be received within 60 days of this notice.

Dated: February 27, 2007.

Alexandra Huttinger,

Acting Director, Division of Policy Review and Coordination.