[Federal Register Volume 85, Number 126 (Tuesday, June 30, 2020)]
[Notices]
[Pages 39194-39196]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-14046]
-----------------------------------------------------------------------
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--Extension
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
[[Page 39195]]
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 [email protected] or
call (301) 443-1984.
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
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total burden per Total burden
Form name respondents responses per responses ** response (in hours
respondent * 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
[[Page 39196]]
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 140 12.8 1,788 0.9 1,609.2
Form...........................
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 71 19.7 1,400 0.4 560.0
Form...........................
Heart/Lung Candidate 69 1.0 67 1.1 73.7
Registration...................
Heart/Lung Recipient 69 0.5 32 1.3 41.6
Registration...................
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 69 3.3 228 0.6 136.8
Year)..........................
Heart/Lung Post-Transplant 69 0.3 21 0.4 8.4
Malignancy Form................
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 146 10.6 1,544 0.6 926.4
Pathology Form.................
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 20 26.2 524 1.5 786.0
Year)..........................
Intestine Follow Up (Post 5 20 37.2 744 0.4 297.6
Year)..........................
Intestine Post-Transplant 20 2.1 42 1.0 42.0
Malignancy Form................
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-5 237 431.9 102,350 0.9 92,115.0
Year)..........................
Kidney Follow-up (Post 5 Year).. 237 449.4 106,507 0.5 53,253.5
Kidney Post-Transplant 237 22.6 5,365 0.8 4,292.0
Malignancy Form................
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-5 133 7.9 1,047 0.5 523.5
Year)..........................
Pancreas Follow-up (Post 5 Year) 133 15.9 2,119 0.5 1,059.5
Pancreas Post-Transplant 133 0.7 97 0.6 58.2
Malignancy Form................
Kidney/Pancreas Candidate 133 9.8 1,297 0.6 778.2
Registration...................
Kidney/Pancreas Recipient 133 7.7 1,028 1.2 1,233.6
Registration...................
Kidney/Pancreas Follow-up (6 133 32.8 4,363 0.5 2,181.5
Month-5 Year)..................
Kidney/Pancreas Follow-up (Post 133 57.8 7,688 0.6 4,612.8
5 Year)........................
Kidney/Pancreas Post-Transplant 133 2.2 292 0.4 116.8
Malignancy Form................
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.
[FR Doc. 2020-14046 Filed 6-29-20; 8:45 am]
BILLING CODE 4165-15-P