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 Department of Health and Human Services Health Resources and Services Administration
 AGENCY: Health Resources and Services Administration, HHS.
 ACTION: Notice.
 SUMMARY: In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.
 DATES: Comments on this ICR should be received no later than January 2, 2015.
 ADDRESSES: Submit your comments, including the Information Collection Request Title, to the desk officer for HRSA, either by email to 
                        *OIRA_submission@omb.eop.gov*
                         or by fax to 202-395-5806.
 FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance requests submitted to OMB for review, email the HRSA Information Collection Clearance Officer at 
                        *paperwork@hrsa.gov*
                         or call (301) 443-1984.


SUPPLEMENTARY INFORMATION: *Information Collection Request Title:*
                     Data System for Organ Procurement and Transplantation Network OMB No. 0915-0157—Revision. *Abstract:*
                     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). This is a request for revisions to current OPTN data collection forms associated with donor organ procurement and an individual's clinical characteristics at the time of registration, transplant, and follow-up after the transplant. *Need and Proposed Use of the Information:*
                     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 whether institutional members are complying with policy, to determine member-specific performance, to ensure patient safety, 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 members of the public for evaluation, research, patient information, and other important purposes. *Likely Respondents:*
                     Transplant programs, organ procurement organizations, histocompatibility laboratories, medical and scientific organizations, and public organizations. *Burden Statement:*
                     Burden in this context means the time expended by persons to generate, maintain, retain, disclose or provide the information requested. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information; to search data sources; to complete and review the collection of information; and to transmit or otherwise disclose the information. The total annual burden hours estimated for this ICR are summarized in the table below. Total Estimated Annualized Burden—Hours
Form name
Number of
                             respondents
Number of
                             responses per 
                             respondent
Total
                             responses
Average
                             burden per 
                             response  
                             (in hours)
Total burden
                             hoursDeceased Donor Registration
58
158.2
9174
1.1
10091.4Living Donor Registration
296
20.2
5984
1.8
10771.2Living Donor Follow-up
296
59.5
17610
1.3
22893.0Donor Histocompatibility
154
94.8
14598
0.2
2919.6Recipient Histocompatibility
154
170.1
26199
0.4
10479.6Heart Candidate Registration
131
30.5
3991
0.9
3591.9Heart Recipient Registration
131
19.3
2525
1.4
3535.0Heart Follow Up (6 Month)
131
17.0
2229
0.4
891.6Heart Follow Up (1-5 Year)
131
73.9
9683
0.9
8714.7Heart Follow Up (Post 5 Year)
131
115.2
15091
0.5
7545.5Heart Post-Transplant Malignancy Form
131
11.0
1447
0.9
1302.3Lung Candidate Registration
65
39.0
2534
0.9
2280.6Lung Recipient Registration
65
29.6
1923
1.4
2692.2Lung Follow Up (6 Month)
65
25.8
1677
0.5
838.5Lung Follow Up (1-5 Year)
65
97.9
6364
1.1
7000.4Lung Follow Up (Post 5 Year)
65
64.6
4201
0.6
2520.6Lung Post-Transplant Malignancy Form
65
1.5
99
0.4
39.6Heart/Lung Candidate Registration
63
0.7
46
1.1
50.6Heart/Lung Recipient Registration
63
0.3
21
1.4
29.4Heart/Lung Follow Up (6 Month)
63
0.3
20
0.8
16.0Heart/Lung Follow Up (1-5 Year)
63
1.5
97
1.1
106.7Heart/Lung Follow Up (Post 5 Year)
63
3.1
194
0.6
116.4Heart/Lung Post-Transplant Malignancy Form
63
0.2
12
0.4
4.8Liver Candidate Registration
136
88.6
12048
0.8
9638.4Liver Recipient Registration
136
47.5
6457
1.3
8394.1Liver Follow-up (6 Month-5 Year)
136
229.4
31194
1.0
31194.0Liver Follow-up (Post 5 Year)
136
254.6
34622
0.5
17311.0Liver Recipient Explant Pathology Form
136
12.2
1665
0.6
999.0Liver Post-Transplant Malignancy
136
13.1
1786
0.8
1428.8Intestine Candidate Registration
41
4.4
182
1.3
236.6Intestine Recipient Registration
41
2.7
109
1.8
196.2Intestine Follow Up (6 Month-5 Year)
41
13.3
547
1.5
820.5Intestine Follow Up (Post 5 Year)
41
13.5
553
0.4
221.2Intestine Post-Transplant Malignancy Form
41
0.6
25
1.0
25.0Kidney Candidate Registration
235
161.2
37880
0.8
30304.0Kidney Recipient Registration
235
71.9
16904
1.3
21975.2Kidney Follow-Up (6 Month-5 Year)
235
376.3
88422
0.9
79579.8Kidney Follow-up (Post 5 Year)
235
343.7
80770
0.5
40385.0Kidney Post-Transplant Malignancy Form
235
17.9
4213
0.8
3370.4Pancreas Candidate Registration
135
3.5
479
0.9
431.1Pancreas Recipient Registration
135
1.9
259
1.1
284.9( print page 71439)Pancreas Follow-up (6 Month-5 Year)
135
10.4
1398
1.0
1398.0Pancreas Follow-up (Post 5 Year)
135
13.4
1804
0.5
902.0Pancreas Post-Transplant Malignancy Form
135
0.8
108
0.6
64.8Kidney/Pancreas Candidate Registration
13
98.5
1280
0.9
1152Kidney/Pancreas Recipient Registration
135
5.6
760
1.1
836.0Kidney/Pancreas Follow-up (6 Month-5 Year)
135
33.4
4509
1.0
4509.0Kidney/Pancreas Follow-up (Post 5 Year)
135
47.9
6465
0.6
3879.0Kidney/Pancreas Post-Transplant Malignancy Form
135
1.6
211
0.4
84.4Vascular Composite Allograft Candidate Registration
16
0.9
15
0.4
6.0Vascular Composite Allograft Recipient Registration
16
0.9
15
1.3
19.5Vascular Composite Allograft Recipient Follow Up
16
0.9
15
1.0
15.0Total
* 456

460414

358092.5* Total number of OPTN member institutions as of 09/9/2014. Number of respondents for transplant candidate or recipient forms based on number of organ specific programs associated with each form.
 Jackie Painter, Acting Director, Division of Policy and Information Coordination.


[FR Doc. 2014-28343 Filed 12-1-14; 8:45 am] BILLING CODE 4165-15-P