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 Department of Health and Human Services Health Resources and Services Administration
 Periodically, the Health Resources and Services Administration (HRSA) publishes abstracts of information collection requests under review by the Office of Management and Budget (OMB), in compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35). To request a copy of the clearance requests submitted to OMB for review, email 
                    *paperwork@hrsa.gov*
                     or call the HRSA Reports Clearance Office on (301) 443-1129. The following request has been submitted to the Office of Management and Budget for review under the Paperwork Reduction Act of 1995: Proposed Project: Data System for Organ Procurement and Transplantation Network and Associated Forms (OMB No. 0915-0157)—Extension 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 
                    ( print page 2733)
                    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. The OPTN is recommending addition of a new Liver Explant Pathology form to the OPTN data system. This new form was developed by the OPTN Liver and Intestinal Organ Transplantation Committee and will be used to collect pathology data on liver transplant recipients who received waitlist exception points as a result of a diagnosis of hepatocellular carcinoma. Existing OPTN policy requires submission of post-transplant pathology reports by fax transmission, and the proposed form will provide standardized collection of this already-required information. There are also minor revisions to the existing data collection forms; the added fields were inadvertently left off of the forms at the time of the initial submission. Several of these fields are “read only” and are included on the forms for information purposes only. One field is proposed to be removed as it represented duplicative information. The annual estimate of burden is as follows: Form
Number of
                             respondents
Responses
                             per 
                             respondents
Total
                             responses
Hours per
                             response
Total burden
                             hoursDeceased Donor Registration
58
228
13,224
0.7500
9,918.00Death referral data
58
12
696
10.0000
6,960.00Death Notification Referral—Eligible
58
145
8410
0.5000
4,205.00Death Notification Referral—Imminent
58
124
7192
0.5000
3,596.00Living Donor Registration
311
23
7153
0.6500
4,649.45Living Donor Follow-up
311
78
24,258
0.5000
12,129.00Donor Histocompatibility
158
94
14,852
0.1000
1,485.20Recipient Histocompatibility
158
171
27,018
0.2000
5,403.60Heart Candidate Registration
131
27
3,537
0.5000
1,768.50Lung Candidate Registration
66
41
2706
0.5000
1,353.00Heart/Lung Candidate Registration
50
1
50
0.5000
25.00Thoracic Registration
131
34
4454
0.7500
3,340.50Thoracic Follow-up
131
277
36,287
0.6500
23,586.55Kidney Candidate Registration
239
154
36,806
0.5000
18,403.00Kidney Registration
239
72
17,208
0.7500
12,906.00Kidney Follow-up *
239
693
165,627
0.5500
91,094.85Liver Candidate Registration
132
98
12,936
0.5000
6,468.00Liver Registration
132
48
6,336
0.6500
4,118.40Liver Explant Pathology
132
11
1,452
0.3400
493.68Liver Follow-up
132
459
60,588
0.5000
30,294.00Kidney/Pancreas Candidate Registration
144
11
1,584
0.5000
792.00Kidney/Pancreas Registration
144
6
864
0.9000
777.60Kidney/Pancreas Follow-up
144
75
10,800
0.8500
9,180.00Pancreas Candidate Registration
144
4
576
0.5000
288.00Pancreas Islet Candidate Registration
23
5
115
0.5000
57.50Pancreas Registration
144
2
288
0.7500
216.00Pancreas Follow-up
144
23
3312
0.6500
2,152.80Intestine Candidate Registration
43
5
215
0.5000
107.50Intestine Registration
43
3
129
0.9000
116.10Intestine Follow-up
43
25
1075
0.8500
913.75Post Transplant Malignancy
689
11
7579
0.2000
1,515.80Total


478,270

258,314.78* Includes an estimated 2,430 kidney transplant patients transplanted prior to the initiation of the data system.
 
 
 Written comments and recommendations concerning the proposed information collection should be sent within 30 days of this notice to the desk officer for HRSA, either by email to 
                    *OIRA_submission@omb.eop.gov*
                     or by fax to (202) 395-6974. Please direct all correspondence to the “attention of the desk officer for HRSA.” Dated: January 12, 2012. Reva Harris, Acting Director, Division of Policy and Information Coordination.


[FR Doc. 2012-954 Filed 1-18-12; 8:45 am] BILLING CODE 4165-15-P