2020-14046. 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-Extension

AGENCY:

Health Resources and Services Administration (HRSA), Department of Health and Human Services.

ACTION:

Notice.

SUMMARY:

In compliance with of 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. OMB may act on HRSA's ICR only after the 30 day comment period for this notice has closed.

DATES:

Comments on this ICR should be received no later than July 30, 2020.

ADDRESSES:

Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/​public/​do/​PRAMain. Find this particular information collection by selecting “Currently under Review—Open for Public Comments” or by using the search function.

FOR FURTHER INFORMATION CONTACT:

To request a copy of the clearance requests submitted to OMB for review, email Lisa Wright-Solomon, the HRSA Information Collection Clearance Officer at [e-mail] or call [phone].

SUPPLEMENTARY INFORMATION:

When submitting comments or requesting information, please include the information request collection title for reference.

Information Collection Request Title: Data System for Organ Procurement and Transplantation Network OMB No. 0915-0157—Extension.

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 an extension of the current OPTN data collection forms associated with an individual's clinical characteristics at the time of registration, transplant, and follow-up after the transplant. This extension will apply to all forms collecting donor (living and deceased) data at the time of transplant as well. These specific data elements of the OPTN data system are collected from transplant hospitals, organ procurement organizations, and histocompatibility 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.

A 60-day notice published in the Federal Register on January 3, 2020, vol. 85, No. 2; pp. 324-325. HRSA received one comment. The commenter encouraged HRSA to carefully weigh potential cost implications and work burden against added value when considering future additions or changes to data collection requirements. The commenter suggested that HRSA encourage the use of automated data collection techniques to minimize the information collection burden. The OPTN contract that went into effect in April 2019 includes new tasks to require the OPTN Contractor to: (1) Develop and implement a plan to collect official OPTN data through direct electronic data submission and (2) supplement official OPTN data collected by the Contractor with information from external data sources to reduce the burden on OPTN members. HRSA appreciates all feedback, and we will continue to review and evaluate all data collection efforts going forward in consultation with the OPTN.

Need and Proposed Use of the Information: 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.

On May 31, 2019, OMB approved changes to four forms via the change memo process. The first change added a field to the Deceased Donor Registration form to allow OPOs that perform donor serology testing for Strongyloides to report the results. The second change modified a section of three forms that collect data on the health of lung transplant recipients post-transplant. The change allows for data to be collected on Chronic Lung Allograft Dysfunction, which is a broader, more contemporary definition of post-transplant lung dysfunction. Other fields pertaining to outdated measures of graft function were removed. The modifications were made to these three forms: Heart/Lung Transplant Recipient Follow-up 6 month form; Heart/Lung Transplant Recipient Follow-up 1-5 year form; and Heart/Lung Transplant Recipient Follow-up Post 5 year form.

Likely Respondents: Transplant programs, Organ Procurement Organizations, and Histocompatibility Laboratories.

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 hours
Deceased Donor Registration	58	185.0	10,731	1.1	11,804.1
Living Donor Registration	300	22.9	6,855	1.8	12,339.0
Living Donor Follow-up	300	62.2	18,669	1.3	24,269.7
Donor Histocompatibility	147	124.0	18,226	0.2	3,645.2
Recipient Histocompatibility	147	225.1	33,090	0.4	13,236.0
Heart Candidate Registration	140	33.7	4,717	0.9	4,245.3
Heart Recipient Registration	140	24.3	3,406	1.2	4,087.2
Heart Follow Up (6 Month)	140	22.0	3,082	0.4	1,232.8
Heart Follow Up (1-5 Year)	140	90.6	12,686	0.9	11,417.4
Heart Follow Up (Post 5 Year)	140	154.0	21,556	0.5	10,778.0
Heart Post-Transplant Malignancy Form	140	12.8	1,788	0.9	1,609.2
Lung Candidate Registration	71	45.2	3,210	0.9	2,889.0
Lung Recipient Registration	71	35.7	2,532	1.2	3,038.4
Lung Follow Up (6 Month)	71	32.4	2,297	0.5	1,148.5
Lung Follow Up (1-5 Year)	71	118.8	8,438	1.1	9,281.8
Lung Follow Up (Post 5 Year)	71	116.5	8,271	0.6	4,962.6
Lung Post-Transplant Malignancy Form	71	19.7	1,400	0.4	560.0
Heart/Lung Candidate Registration	69	1.0	67	1.1	73.7
Heart/Lung Recipient Registration	69	0.5	32	1.3	41.6
Heart/Lung Follow Up (6 Month)	69	0.4	31	0.8	24.8
Heart/Lung Follow Up (1-5 Year)	69	1.1	79	1.1	86.9
Heart/Lung Follow Up (Post 5 Year)	69	3.3	228	0.6	136.8
Heart/Lung Post-Transplant Malignancy Form	69	0.3	21	0.4	8.4
Liver Candidate Registration	146	90.3	13,183	0.8	10,546.4
Liver Recipient Registration	146	56.5	8,256	1.2	9,907.2
Liver Follow-up (6 Month-5 Year)	146	266.6	38,919	1.0	38,919.0
Liver Follow-up (Post 5 Year)	146	316.6	46,225	0.5	23,112.5
Liver Recipient Explant Pathology Form	146	10.6	1,544	0.6	926.4
Liver Post-Transplant Malignancy	146	16.3	2,387	0.8	1,909.6
Intestine Candidate Registration	20	7.0	139	1.3	180.7
Intestine Recipient Registration	20	5.2	104	1.8	187.2
Intestine Follow Up (6 Month-5 Year)	20	26.2	524	1.5	786.0
Intestine Follow Up (Post 5 Year)	20	37.2	744	0.4	297.6
Intestine Post-Transplant Malignancy Form	20	2.1	42	1.0	42.0
Kidney Candidate Registration	237	168.8	39,998	0.8	31,998.4
Kidney Recipient Registration	237	89.4	21,195	1.2	25,434.0
Kidney Follow-Up (6 Month-5 Year)	237	431.9	102,350	0.9	92,115.0
Kidney Follow-up (Post 5 Year)	237	449.4	106,507	0.5	53,253.5
Kidney Post-Transplant Malignancy Form	237	22.6	5,365	0.8	4,292.0
Pancreas Candidate Registration	133	2.8	368	0.6	220.8
Pancreas Recipient Registration	133	1.5	194	1.2	232.8
Pancreas Follow-up (6 Month-5 Year)	133	7.9	1,047	0.5	523.5
Pancreas Follow-up (Post 5 Year)	133	15.9	2,119	0.5	1,059.5
Pancreas Post-Transplant Malignancy Form	133	0.7	97	0.6	58.2
Kidney/Pancreas Candidate Registration	133	9.8	1,297	0.6	778.2
Kidney/Pancreas Recipient Registration	133	7.7	1,028	1.2	1,233.6
Kidney/Pancreas Follow-up (6 Month-5 Year)	133	32.8	4,363	0.5	2,181.5
Kidney/Pancreas Follow-up (Post 5 Year)	133	57.8	7,688	0.6	4,612.8
Kidney/Pancreas Post-Transplant Malignancy Form	133	2.2	292	0.4	116.8
VCA Candidate Registration	27	0.9	24	0.4	9.6
VCA Recipient Registration	27	1.6	43	1.3	55.9
VCA Recipient Follow Up	27	0.7	18	1.0	18.0
Total	6,204		567,472		425,925.1
* The Number of Responses per Respondent was calculated by dividing the Total Responses by the Number of Respondents and rounding to the nearest tenth.
** Numbers based on 2018 forms.

Maria G. Button,

Director, Executive Secretariat.