Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Request Title: Data System for Organ Procurement and Transplantation Network, OMB No. 0915-0157, Revision
Federal RegisterApr 14, 2017
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Request Title: Data System for Organ Procurement and Transplantation Network, OMB No. 0915-0157, Revision
AGENCY:
Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS).
ACTION:
Notice
SUMMARY:
In compliance with the Paperwork Reduction Act of 1995, 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 May 15, 2017.
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:
When submitting comments or requesting information, please include the information request collection title for reference, in compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995.
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 a subset of the 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 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 facilitate organ placement and match donor organs with recipients, monitor compliance of member organizations with Federal laws and regulations and with OPTN requirements, review and report periodically to the public on the status of organ donation and transplantation in the United States, provide data to researchers and government agencies to study the scientific and clinical status of organ transplantation, and perform transplantation-related public health surveillance including possible transmission of donor disease. This request revises a subset of the current OPTN data forms associated with donor organ procurement and an individual's clinical characteristics at the time of registration, transplant, and follow up.
In 2015, the OPTN Board of Directors approved policies that necessitate the addition of new data elements to registration forms for heart, lung, heart/lung, liver, intestine, kidney, pancreas, and kidney/pancreas recipients. The OPTN also approved policies that impact the data collection for deceased donor registration, pancreas candidate registration, kidney/pancreas candidate registration, pancreas follow-up, and kidney/pancreas follow-up forms. The policy modifications necessitate changes to 17 of the 52 forms contained in this data collection. For example, the pancreas and kidney/pancreas transplant recipient registration and follow up forms were modified to be consistent with an OPTN policy change pertaining to data collected from pancreas programs for pancreas graft failure. Specifically, the “graft status” section of the pancreas forms was updated to be consistent with a new policy that helps transplant professionals identify when pancreas allograft failure has occurred and how to document the pancreas graft failure event. In addition, “drop down” menus were added to facilitate reporting of toxoplasma serology results and infectious diseases, consistent with revised scope of policy requirements for infectious disease testing and reporting. Finally, a policy modification to improve collection of information on lungs perfused prior to transplant resulted in the creation of easy-to-complete data fields on lung and heart/lung recipient registration forms. The modified forms allow transplant centers to easily provide information on lung perfusion, which contributes to improved accuracy in monitoring of lung allocation, recipient safety, and organ and patient outcomes.
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. The burden will decrease by approximately 3,500 hours.
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 hours
Deceased Donor Registration
58
176.9
10,262
1.1
11,288.2
Living Donor Registration
304
19.5
5,936
1.8
10,684.8
Living Donor Follow-Up
304
58.2
17,686
1.3
22,991.8
Donor Histocompatibility
152
102.7
15,611
0.2
3,122.2
Recipient Histocompatibility
152
183.0
27,810
0.4
11,124.0
Heart Candidate Registration
137
32.4
4,439
0.9
3,995.1
Heart Recipient Registration
137
20.5
2.805
1.2
3,366.0
Heart Follow-Up (6 Months)
137
16.5
2,261
0.4
904.4
Heart Follow-Up (1-5 Years)
137
77.3
10,595
0.9
9,535.5
Heart Follow-Up (Post 5 Years)
137
117.4
16,085
0.5
8,042.5
Heart Post-Transplant Malignancy
137
11.8
1,623
0.9
1,460.7
Lung Candidate Registration
70
37.0
2,592
0.9
2,332.8
Lung Recipient Registration
70
29.4
2,058
1.2
2,469.6
Lung Follow-Up (6 Months)
70
25.8
1,809
0.5
904.5
Lung Follow-Up (1-5 Years)
70
99.1
6,939
1.1
7,632.9
Lung Follow-Up (Post 5 Years)
70
70.0
4,898
0.6
2,938.8
Lung Post-Transplant Malignancy
70
15.8
1,106
0.4
442.4
Heart/Lung Candidate Registration
68
0.7
46
1.1
50.6
Heart/Lung Recipient Registration
68
0.2
14
1.3
18.2
Heart/Lung Follow-Up (6 Months)
68
0.2
13
0.8
10.4
Heart/Lung Follow-Up (1-5 Years)
68
1.4
94
1.1
103.4
Heart/Lung Follow-Up (Post 5 Years)
68
2.9
199
0.6
119.4
Heart/Lung Post-Transplant Malignancy
68
0.3
21
0.4
8.4
Liver Candidate Registration
140
85.9
12,026
0.8
9,620.8
Liver Recipient Registration
140
50.9
7,125
1.2
8,550.0
Liver Follow-Up (6 Months-5 Years)
140
235.6
32,985
1
32,985.0
Liver Follow-Up (Post 5 Years)
140
279.3
39,108
0.5
19,554.0
Liver Recipient Explant Pathology
140
12.9
1,812
0.6
1,087.2
Liver Post-Transplant Malignancy
140
14.2
1,985
0.8
1,588.0
Intestine Candidate Registration
40
5.0
200
1.3
260.0
Intestine Recipient Registration
40
3.5
141
1.8
253.8
Intestine Follow-Up (6 Months-5 Years)
40
13.3
530
1.5
795.0
Intestine Follow-Up (Post 5 Years)
40
16.4
655
0.4
262.0
Intestine Post-Transplant Malignancy
40
0.6
24
1
24.0
Kidney Candidate Registration
238
151.6
36,076
0.8
28,860.8
Kidney Recipient Registration
238
75.2
17,899
1.2
21,478.8
Kidney Follow-Up (6 Months-5 Years)
238
383.3
91,234
0.9
82,110.6
Kidney Follow-Up (Post 5 Years)
238
375.9
89,453
0.5
44,726.5
Kidney Post-Transplant Malignancy
238
22.4
5,327
0.8
4,261.6
Pancreas Candidate Registration
133
2.9
389
0.6
233.4
Pancreas Recipient Registration
133
1.8
233
1.2
279.6
Pancreas Follow-Up (6 Months-5 Years)
133
9.4
1,252
0.5
626.0
Pancreas Follow-Up (Post 5 Years)
133
14.7
1,953
0.5
976.5
Pancreas Post-Transplant Malignancy
133
0.9
120
0.6
72.0
Kidney/Pancreas Candidate Registration
133
9.5
1,265
0.6
759.0
Kidney/Pancreas Recipient Registration
133
5.4
718
1.2
861.6
Kidney/Pancreas Follow-Up (6 Months-5 Years)
133
32.0
4,262
0.5
2,131.0
Kidney/Pancreas Follow-Up (Post 5 Years)
133
51.7
6,876
0.6
4,125.6
Kidney/Pancreas Post-Transplant Malignancy Form
133
2.1
283
0.4
113.2
VCA Candidate Registration
28
1.8
49
0.4
19.6
VCA Recipient Registration
28
1.8
49
1.3
63.7
VCA Recipient Follow-Up
28
1.8
49
1
49.0
Total
** 463
488,980
370,274.9
* The Number of Responses per Respondent was calculated by dividing the Total Responses by the Number of Respondents and rounding to the nearest tenth.
** Total number of OPTN member institutions as of April 6, 2017. Number of respondents for transplant candidate or recipient forms based on the organ-specific programs associated with each form.
Amy McNulty,
Deputy Director, Division of the Executive Secretariat.
[FR Doc. 2017-07526 Filed 4-13-17; 8:45 am]
BILLING CODE 4165-15-P
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