Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: Data System for Organ Procurement and Transplantation Network, OMB No. 0915-0157-Revision, 48743-48745 [2021-18688]

Download as PDF Federal Register / Vol. 86, No. 166 / Tuesday, August 31, 2021 / Notices khammond on DSKJM1Z7X2PROD with NOTICES oversight, coordination, and logistical support for the Medical Expert Panel, as well as Clinical Reviewer contracts; (10) developing, reviewing, and analyzing pending and new legislation relating to program changes, new initiatives, the ACCV, and changes to the Vaccine and Countermeasures Injury Tables; (11) providing programmatic outreach efforts to maximize public exposure to private and public constituencies; and (12) providing guidance in using the results and decisions of the Medical Claims Review Panel to HHS Operating Divisions to improve the quality of health care in its facilities and by its practitioners. Division of National Hansen’s Disease Program (RRH) The National Hansen’s Disease Program, in accordance with regulations and the Public Health Service (PHS) Act, Sec. 320 as amended by Public Law 105–78, Sec. 211, (1) provides care and treatment for persons with Hansen’s Disease (leprosy), including managing a national short-term and outpatient health care delivery program providing specialized services to persons with Hansen’s Disease; (2) conducts and promotes the coordination of research (including clinical research), investigations, demonstrations, and studies relating to the causes, diagnosis, treatment, control, and prevention of Hansen’s disease and other mycobacterial diseases and complications related to such diseases; (3) conducts training in the diagnosis and management of Hansen’s disease and related complications; (4) provides education and training to staff from the outpatient Hansen’s Disease Clinics and to private physicians; (5) operates and oversees the National Hansen’s Disease Museum and Cemetery; (6) consults on the coordination of activities within HRSA and HHS, and with other federal agencies, state and local governments, and other public and private organizations involved in Hansen’s Disease activities; and (7) manages a network of contracted outpatient clinics providing care to persons with Hansen’s Disease; and (8) manages and coordinates the National Hansen’s Disease Program’s administrative and operational activities with HRSA and HHS; other federal agencies, state and local governments; and other public and private organizations involved in Hansen’s Disease activities. Section R.30 Delegation of Authority All prior delegations of authority and re-delegations of authority consistent with this reorganization are in effect. I affirm and ratify any actions taken by VerDate Sep<11>2014 20:08 Aug 30, 2021 Jkt 253001 HHS officials that involved the exercise of those authorities prior to the effective date of this reorganization. (Authority: 44 U.S.C. 3101) Dated: August 6, 2021. Xavier Becerra, Secretary. [FR Doc. 2021–18075 Filed 8–27–21; 4:15 pm] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: Data System for Organ Procurement and Transplantation Network, OMB No. 0915–0157—Revision Health Resources and Services Administration (HRSA), Department of Health and Human Services. ACTION: Notice. AGENCY: In compliance with the requirement for the opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR. DATES: Comments on this ICR should be received no later than November 1, 2021. ADDRESSES: Submit your comments to paperwork@hrsa.gov or mail the HRSA Information Collection Clearance Officer, Room 14N136B, 5600 Fishers Lane, Rockville, MD 20857. FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email paperwork@hrsa.gov or call Lisa Wright-Solomon, the HRSA Information Collection Clearance Officer at (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—Revision. SUMMARY: PO 00000 Frm 00085 Fmt 4703 Sfmt 4703 48743 Abstract: Section 372 of the Public Health Service Act requires that the Secretary, by contract, provide for the establishment and operation of a private, non-profit entity: The Organ Procurement and Transplantation Network (OPTN). The data collected pursuant to the OPTN’s regulatory authority in 42 CFR 121.11 of the OPTN Final Rule is collected through OMB approved data collection forms. Therefore, data approved for collection by the OPTN Board of Directors are submitted by HRSA for OMB approval under the Paperwork Reduction Act of 1995. This is a request for revising the current OPTN data collection associated with an individual’s clinical characteristics at the time of registration, transplant, and follow-up after the transplant to include data collection forms in the OPTN Organ Labeling, Packaging, and Tracking System, the OPTN Kidney Paired Donation Pilot Program (KPDPP), and the OPTN Patient Safety Reporting Portal (PSRP). This revision also includes OPTN Board of Directors approved changes to the existing OMB data collection forms. 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 (1) facilitate organ placement and match donor organs with recipients; (2) monitor compliance of member organizations with Federal laws and regulations and with OPTN requirements; (3) review and report periodically to the public on the status of organ donation and transplantation in the United States; (4) provide data to researchers and government agencies to study the scientific and clinical status of organ transplantation; (5) perform transplantation-related public health surveillance including the possible transmission of donor disease. HRSA is submitting the following changes to improve the OPTN organ matching and allocation process and improve OPTN member compliance with OPTN requirements. All of these proposed changes have been approved by the OPTN Board of Directors. (1) Adding two data collection forms for the OPTN Organ Labeling, Packaging, and Tracking System to the existing OMB approved Data System for Organ Procurement and Transplantation Network. The system has two forms that are used through mobile and web-based applications to ensure the correct organ is transplanted into the correct patient, minimize labeling and transport errors, accelerate organ information transfer, E:\FR\FM\31AUN1.SGM 31AUN1 48744 Federal Register / Vol. 86, No. 166 / Tuesday, August 31, 2021 / Notices and capture data regarding organ procurement. OPTN Organ Labeling, Packaging, and Tracking System is comprised of two data collection forms: Organ labeling and packaging, and organ tracking and validating. (2) Adding data collection forms for the OPTN KPDPP to the existing OMB approved Data System for Organ Procurement and Transplantation Network. Kidney paired donation is a transplant option for those patients waiting for a kidney transplant who have a willing living donor who is medically able but cannot donate a kidney to their intended candidate because they are incompatible. OPTN KPDPP matches living donors, and their intended candidates with other living donors or intended candidate pairs when the living donors cannot donate to the person(s) they initially hoped would receive their kidney. OPTN KPDPP is comprised of three data collection forms: Candidate registration, donor registration, and match offer management. (3) Adding data collection forms in the OPTN PSRP to the existing OMB approved Data System for Organ Procurement and Transplantation Network. OPTN PSRP allows the OPTN to collect reports on any event or process variance that could cause concerns from transplantation, donation, safety, or quality perspective. OPTN PSRP is comprised of four data collection forms: Disease transmission event, living donor event, safety situation, and potential disease transmission. (4) Additional revisions to existing data collection forms were made based on the OPTN Board of Directorsapproved changes to improve organ matching, allocation, and OPTN policy compliance. 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 memberspecific 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, 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 to collect, validate, and verify information, process and maintain information, and disclose and provide information; to train personnel and 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 Number of respondents khammond on DSKJM1Z7X2PROD with NOTICES Form name Deceased Donor Registration .............................................. Living Donor Registration .................................................... Living Donor Follow-up ........................................................ Donor Histocompatibility ...................................................... Recipient Histocompatibility ................................................. Heart Transplant Candidate Registration ............................ Heart Recipient Registration ................................................ Heart Follow Up (6 Month) .................................................. Heart Transplant Recipient Follow Up 1–5 Year ................. Heart Transplant Recipient Follow Up Post 5 Year ............ Heart Post-Transplant Malignancy Form ............................. Lung Transplant Candidate Registration ............................. Lung Transplant Recipient Registration .............................. Lung Transplant Recipient Follow Up 6 Month ................... Lung Transplant Recipient Follow Up 1–5 Year ................. Lung Transplant Recipient Follow Up Post 5 Year ............. Lung- Post-Transplant Malignancy Form ............................ Heart/Lung Transplant Candidate Registration ................... Heart/Lung Recipient Registration ....................................... Heart/Lung Transplant Recipient Follow Up 6 Month ......... Heart/Lung Transplant Recipient Follow Up 1–5 Year ........ Heart/Lung Transplant Recipient Follow Up Post 5 Year ... Heart/Lung Post-Transplant Malignancy Form .................... Liver Transplant Candidate Registration ............................. Liver Transplant Recipient Registration ............................... Liver Transplant Recipient Follow-Up 6 Month—5 Year ..... Liver Transplant Recipient Follow-up Post 5 Year .............. Liver Recipient Explant Pathology Form ............................. Liver Post-Transplant Malignancy ....................................... Intestine Transplant Candidate Registration ....................... Intestine Transplant Recipient Registration ......................... Intestine Transplant Recipient Follow Up 6 Month—5 Year Intestine Transplant Recipient Follow Up Post 5 Year ....... Intestine Post-Transplant Malignancy Form ........................ Kidney Transplant Candidate Registration .......................... VerDate Sep<11>2014 20:08 Aug 30, 2021 Jkt 253001 PO 00000 Frm 00086 Number of responses per respondent * 57 300 300 147 147 140 140 140 140 140 140 71 71 71 71 71 71 69 69 69 69 69 69 146 146 146 146 146 146 20 20 20 20 20 237 Fmt 4703 Sfmt 4703 188.26 22.85 62.23 123.99 225.10 33.69 24.33 22.01 90.61 153.97 12.77 45.21 35.66 32.35 118.85 116.49 19.72 0.97 0.46 0.45 1.14 3.30 0.30 90.29 56.55 266.57 316.61 10.58 16.35 6.95 5.20 26.20 37.20 2.10 168.77 Total responses 10,731 6,855 18,669 18,227 33,090 4,717 3,406 3,081 12,685 21,556 1,788 3,210 2,532 2,297 8,438 8,271 1,400 67 32 31 79 228 21 13,182 8,256 38,919 46,225 1,545 2,387 139 104 524 744 42 39,998 E:\FR\FM\31AUN1.SGM 31AUN1 Average burden per response (in hours) 1.10 2.19 1.53 0.20 0.40 0.90 1.20 0.40 0.90 0.50 0.90 0.90 1.20 0.50 1.10 0.60 0.40 1.10 1.30 0.80 1.10 0.60 0.40 0.80 1.20 1.00 0.50 0.60 0.80 1.30 1.80 1.50 0.40 1.00 0.80 Total burden hours 11,804 a 15,012 b 28,564 3,645 13,236 4,245 4,087 1,233 11,417 10,778 1,609 2,889 3,038 1,148 9,282 4,962 560 74 41 25 87 137 8 10,546 9,908 38,919 23,113 927 1,910 181 187 786 298 42 31,999 48745 Federal Register / Vol. 86, No. 166 / Tuesday, August 31, 2021 / Notices TOTAL ESTIMATED ANNUALIZED BURDEN HOURS—Continued Number of respondents Form name Number of responses per respondent * Total responses Average burden per response (in hours) Total burden hours Kidney Transplant Recipient Registration ........................... Kidney Transplant Recipient Follow-Up 6 Month—5 Year .. Kidney Transplant Recipient Follow-Up Post 5 Year .......... Kidney Post-Transplant Malignancy Form ........................... Pancreas Transplant Candidate Registration ...................... Pancreas Transplant Recipient Registration ....................... Pancreas Transplant Recipient Follow-Up 6 Month—5 Year .................................................................................. Pancreas Transplant Recipient Follow-Up Post 5 Year ...... Pancreas Post-Transplant Malignancy Form ...................... Kidney/Pancreas Transplant Candidate Registration .......... Kidney/Pancreas Transplant Recipient Registration ........... Kidney/Pancreas Transplant Recipient Follow-Up 6 Month—5 Year ................................................................. Kidney/Pancreas Transplant Recipient Follow-Up Post 5 Year .................................................................................. Kidney/Pancreas Post-Transplant Malignancy Form .......... VCA Transplant Candidate Registration .............................. VCA Transplant Recipient Registration ............................... VCA Transplant Recipient Follow Up .................................. Organ Labeling and Packaging ........................................... Organ Tracking and Validating ............................................ Kidney Paired Donation Candidate Registration ................. Kidney Paired Donation Donor Registration ........................ Kidney Paired Donation Match Offer Management ............. Disease Transmission Event ............................................... Living Donor Event .............................................................. Safety Situation .................................................................... Potential Disease Transmission .......................................... Request to Unlock ............................................................... 237 237 237 237 133 133 89.43 431.86 449.40 22.64 2.77 1.46 21,195 102,351 106,508 5,366 368 194 1.20 0.90 0.50 0.80 0.60 1.20 25,434 92,116 53,254 4,293 221 233 133 133 133 133 133 7.87 15.93 0.73 9.75 7.73 1,047 2,119 97 1,297 1,028 0.50 0.50 0.60 0.60 1.20 523 1,059 58 778 1,234 133 32.80 4,362 0.50 2,181 133 133 27 27 27 57 34 160 160 160 308 251 450 57 450 57.80 2.20 0.89 1.59 0.67 208.25 169.06 1.38 1.46 1.51 1.44 0.12 0.48 6.88 39.22 7,687 293 24 43 18 11,870 5,748 221 234 242 444 30 216 392 17,649 0.60 0.40 0.40 1.36 1.31 0.18 0.08 0.29 1.07 0.67 0.62 0.56 0.56 1.27 0.02 4,612 117 11 c 58 d 24 2,137 460 64 250 162 275 17 121 498 353 Total .............................................................................. 8,290 ........................ 604,519 ........................ 437,240 * The Number of Responses per Respondent was calculated by dividing the Total Responses by the Number of Respondents and rounding to the nearest tenth. a Total burden increased due to the approval of the ‘‘Modify Data Collection on VCA Living Donors’’ proposal approved by the OPTN Board of Directors (BOD) in December of 2020. The proposal required adding 54 new data fields onto this form and removing 1 data field from this form. b Total burden increased due to the approval of the ‘‘Modify Data Collection on VCA Living Donors’’ proposal approved by the OPTN BOD in December of 2020. The proposal required adding 17 new data fields onto this form. c Total burden increased due to the approval of the ‘‘Programming VCA Allocation in UNet’’ proposal approved by the OPTN BOD in December of 2020. The proposal required adding 16 new data fields onto this form and removing 10 data fields from this form. d Total burden increased due to the approval of the ‘‘Programming VCA Allocation in UNet’’ proposal approved by the OPTN BOD in December of 2020. The proposal required adding 54 new data fields onto this form and removing 5 data fields from this form. khammond on DSKJM1Z7X2PROD with NOTICES HRSA specifically requests comments on (1) the necessity and utility of the proposed information collection for the proper performance of the agency’s functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. Maria G. Button, Director, Executive Secretariat. [FR Doc. 2021–18688 Filed 8–30–21; 8:45 am] BILLING CODE 4165–15–P VerDate Sep<11>2014 20:08 Aug 30, 2021 Jkt 253001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Establishment of the Office of Climate Change and Health Equity Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services. ACTION: Notice. AGENCY: Statement of Organization, Functions, and Delegations of Authority Part A, Office of the Secretary, Statement of Organization, Function, and Delegation of Authority for the U.S. Department of Health and Human Services (HHS) is being amended at Chapter AC, Office of the Assistant Secretary for Health (OASH), as last amended at 75 FR 53304, dated August 31, 2010, and 72 FR 58095–96, dated PO 00000 Frm 00087 Fmt 4703 Sfmt 4703 October 12, 2007. Executive Order 14008, Tackling the Climate Crisis at Home and Abroad, section 222(d), directs the Secretary of Health and Human Services to establish an Office of Climate Change and Health Equity to address the impact of climate change on the health of the American people. This amendment reflects the establishment of an office to address the impact of climate change on the health of the American people and to empower individuals through information, data, and scientific approaches to pursue environmental justice. Specifically, this notice establishes the Office of Climate Change and Health Equity in the OASH. The changes are as follows: A. Under Part A, Chapter AC, under the Office of the Assistant Secretary for Health, add the following: 1. The Office of Climate Change and Health Equity (OCCHE), is headed by a E:\FR\FM\31AUN1.SGM 31AUN1

Agencies

[Federal Register Volume 86, Number 166 (Tuesday, August 31, 2021)]
[Notices]
[Pages 48743-48745]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-18688]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Proposed Collection: 
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.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: In compliance with the requirement for the opportunity for 
public comment on proposed data collection projects of the Paperwork 
Reduction Act of 1995, HRSA announces plans to submit an Information 
Collection Request (ICR), described below, to the Office of Management 
and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks 
comments from the public regarding the burden estimate, below, or any 
other aspect of the ICR.

DATES: Comments on this ICR should be received no later than November 
1, 2021.

ADDRESSES: Submit your comments to [email protected] or mail the HRSA 
Information Collection Clearance Officer, Room 14N136B, 5600 Fishers 
Lane, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the data collection plans and 
draft instruments, email [email protected] or call Lisa Wright-
Solomon, the HRSA Information Collection Clearance Officer at (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--Revision.
    Abstract: Section 372 of the Public Health Service Act requires 
that the Secretary, by contract, provide for the establishment and 
operation of a private, non-profit entity: The Organ Procurement and 
Transplantation Network (OPTN). The data collected pursuant to the 
OPTN's regulatory authority in 42 CFR 121.11 of the OPTN Final Rule is 
collected through OMB approved data collection forms. Therefore, data 
approved for collection by the OPTN Board of Directors are submitted by 
HRSA for OMB approval under the Paperwork Reduction Act of 1995.
    This is a request for revising the current OPTN data collection 
associated with an individual's clinical characteristics at the time of 
registration, transplant, and follow-up after the transplant to include 
data collection forms in the OPTN Organ Labeling, Packaging, and 
Tracking System, the OPTN Kidney Paired Donation Pilot Program (KPDPP), 
and the OPTN Patient Safety Reporting Portal (PSRP). This revision also 
includes OPTN Board of Directors approved changes to the existing OMB 
data collection forms. 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 (1) facilitate organ placement and match donor organs with 
recipients; (2) monitor compliance of member organizations with Federal 
laws and regulations and with OPTN requirements; (3) review and report 
periodically to the public on the status of organ donation and 
transplantation in the United States; (4) provide data to researchers 
and government agencies to study the scientific and clinical status of 
organ transplantation; (5) perform transplantation-related public 
health surveillance including the possible transmission of donor 
disease.
    HRSA is submitting the following changes to improve the OPTN organ 
matching and allocation process and improve OPTN member compliance with 
OPTN requirements. All of these proposed changes have been approved by 
the OPTN Board of Directors.
    (1) Adding two data collection forms for the OPTN Organ Labeling, 
Packaging, and Tracking System to the existing OMB approved Data System 
for Organ Procurement and Transplantation Network. The system has two 
forms that are used through mobile and web-based applications to ensure 
the correct organ is transplanted into the correct patient, minimize 
labeling and transport errors, accelerate organ information transfer,

[[Page 48744]]

and capture data regarding organ procurement. OPTN Organ Labeling, 
Packaging, and Tracking System is comprised of two data collection 
forms: Organ labeling and packaging, and organ tracking and validating.
    (2) Adding data collection forms for the OPTN KPDPP to the existing 
OMB approved Data System for Organ Procurement and Transplantation 
Network. Kidney paired donation is a transplant option for those 
patients waiting for a kidney transplant who have a willing living 
donor who is medically able but cannot donate a kidney to their 
intended candidate because they are incompatible. OPTN KPDPP matches 
living donors, and their intended candidates with other living donors 
or intended candidate pairs when the living donors cannot donate to the 
person(s) they initially hoped would receive their kidney. OPTN KPDPP 
is comprised of three data collection forms: Candidate registration, 
donor registration, and match offer management.
    (3) Adding data collection forms in the OPTN PSRP to the existing 
OMB approved Data System for Organ Procurement and Transplantation 
Network. OPTN PSRP allows the OPTN to collect reports on any event or 
process variance that could cause concerns from transplantation, 
donation, safety, or quality perspective. OPTN PSRP is comprised of 
four data collection forms: Disease transmission event, living donor 
event, safety situation, and potential disease transmission.
    (4) Additional revisions to existing data collection forms were 
made based on the OPTN Board of Directors-approved changes to improve 
organ matching, allocation, and OPTN policy compliance.
    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.
    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 to collect, validate, and verify information, process and 
maintain information, and disclose and provide information; to train 
personnel and 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
----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
            Form name                Number of     responses per       Total       per response    Total burden
                                    respondents    respondent *      responses      (in hours)         hours
----------------------------------------------------------------------------------------------------------------
Deceased Donor Registration.....              57          188.26          10,731            1.10          11,804
Living Donor Registration.......             300           22.85           6,855            2.19      \a\ 15,012
Living Donor Follow-up..........             300           62.23          18,669            1.53      \b\ 28,564
Donor Histocompatibility........             147          123.99          18,227            0.20           3,645
Recipient Histocompatibility....             147          225.10          33,090            0.40          13,236
Heart Transplant Candidate                   140           33.69           4,717            0.90           4,245
 Registration...................
Heart Recipient Registration....             140           24.33           3,406            1.20           4,087
Heart Follow Up (6 Month).......             140           22.01           3,081            0.40           1,233
Heart Transplant Recipient                   140           90.61          12,685            0.90          11,417
 Follow Up 1-5 Year.............
Heart Transplant Recipient                   140          153.97          21,556            0.50          10,778
 Follow Up Post 5 Year..........
Heart Post-Transplant Malignancy             140           12.77           1,788            0.90           1,609
 Form...........................
Lung Transplant Candidate                     71           45.21           3,210            0.90           2,889
 Registration...................
Lung Transplant Recipient                     71           35.66           2,532            1.20           3,038
 Registration...................
Lung Transplant Recipient Follow              71           32.35           2,297            0.50           1,148
 Up 6 Month.....................
Lung Transplant Recipient Follow              71          118.85           8,438            1.10           9,282
 Up 1-5 Year....................
Lung Transplant Recipient Follow              71          116.49           8,271            0.60           4,962
 Up Post 5 Year.................
Lung- Post-Transplant Malignancy              71           19.72           1,400            0.40             560
 Form...........................
Heart/Lung Transplant Candidate               69            0.97              67            1.10              74
 Registration...................
Heart/Lung Recipient                          69            0.46              32            1.30              41
 Registration...................
Heart/Lung Transplant Recipient               69            0.45              31            0.80              25
 Follow Up 6 Month..............
Heart/Lung Transplant Recipient               69            1.14              79            1.10              87
 Follow Up 1-5 Year.............
Heart/Lung Transplant Recipient               69            3.30             228            0.60             137
 Follow Up Post 5 Year..........
Heart/Lung Post-Transplant                    69            0.30              21            0.40               8
 Malignancy Form................
Liver Transplant Candidate                   146           90.29          13,182            0.80          10,546
 Registration...................
Liver Transplant Recipient                   146           56.55           8,256            1.20           9,908
 Registration...................
Liver Transplant Recipient                   146          266.57          38,919            1.00          38,919
 Follow-Up 6 Month--5 Year......
Liver Transplant Recipient                   146          316.61          46,225            0.50          23,113
 Follow-up Post 5 Year..........
Liver Recipient Explant                      146           10.58           1,545            0.60             927
 Pathology Form.................
Liver Post-Transplant Malignancy             146           16.35           2,387            0.80           1,910
Intestine Transplant Candidate                20            6.95             139            1.30             181
 Registration...................
Intestine Transplant Recipient                20            5.20             104            1.80             187
 Registration...................
Intestine Transplant Recipient                20           26.20             524            1.50             786
 Follow Up 6 Month--5 Year......
Intestine Transplant Recipient                20           37.20             744            0.40             298
 Follow Up Post 5 Year..........
Intestine Post-Transplant                     20            2.10              42            1.00              42
 Malignancy Form................
Kidney Transplant Candidate                  237          168.77          39,998            0.80          31,999
 Registration...................

[[Page 48745]]

 
Kidney Transplant Recipient                  237           89.43          21,195            1.20          25,434
 Registration...................
Kidney Transplant Recipient                  237          431.86         102,351            0.90          92,116
 Follow-Up 6 Month--5 Year......
Kidney Transplant Recipient                  237          449.40         106,508            0.50          53,254
 Follow-Up Post 5 Year..........
Kidney Post-Transplant                       237           22.64           5,366            0.80           4,293
 Malignancy Form................
Pancreas Transplant Candidate                133            2.77             368            0.60             221
 Registration...................
Pancreas Transplant Recipient                133            1.46             194            1.20             233
 Registration...................
Pancreas Transplant Recipient                133            7.87           1,047            0.50             523
 Follow-Up 6 Month--5 Year......
Pancreas Transplant Recipient                133           15.93           2,119            0.50           1,059
 Follow-Up Post 5 Year..........
Pancreas Post-Transplant                     133            0.73              97            0.60              58
 Malignancy Form................
Kidney/Pancreas Transplant                   133            9.75           1,297            0.60             778
 Candidate Registration.........
Kidney/Pancreas Transplant                   133            7.73           1,028            1.20           1,234
 Recipient Registration.........
Kidney/Pancreas Transplant                   133           32.80           4,362            0.50           2,181
 Recipient Follow-Up 6 Month--5
 Year...........................
Kidney/Pancreas Transplant                   133           57.80           7,687            0.60           4,612
 Recipient Follow-Up Post 5 Year
Kidney/Pancreas Post-Transplant              133            2.20             293            0.40             117
 Malignancy Form................
VCA Transplant Candidate                      27            0.89              24            0.40              11
 Registration...................
VCA Transplant Recipient                      27            1.59              43            1.36          \c\ 58
 Registration...................
VCA Transplant Recipient Follow               27            0.67              18            1.31          \d\ 24
 Up.............................
Organ Labeling and Packaging....              57          208.25          11,870            0.18           2,137
Organ Tracking and Validating...              34          169.06           5,748            0.08             460
Kidney Paired Donation Candidate             160            1.38             221            0.29              64
 Registration...................
Kidney Paired Donation Donor                 160            1.46             234            1.07             250
 Registration...................
Kidney Paired Donation Match                 160            1.51             242            0.67             162
 Offer Management...............
Disease Transmission Event......             308            1.44             444            0.62             275
Living Donor Event..............             251            0.12              30            0.56              17
Safety Situation................             450            0.48             216            0.56             121
Potential Disease Transmission..              57            6.88             392            1.27             498
Request to Unlock...............             450           39.22          17,649            0.02             353
                                 -------------------------------------------------------------------------------
    Total.......................           8,290  ..............         604,519  ..............         437,240
----------------------------------------------------------------------------------------------------------------
* The Number of Responses per Respondent was calculated by dividing the Total Responses by the Number of
  Respondents and rounding to the nearest tenth.
\a\ Total burden increased due to the approval of the ``Modify Data Collection on VCA Living Donors'' proposal
  approved by the OPTN Board of Directors (BOD) in December of 2020. The proposal required adding 54 new data
  fields onto this form and removing 1 data field from this form.
\b\ Total burden increased due to the approval of the ``Modify Data Collection on VCA Living Donors'' proposal
  approved by the OPTN BOD in December of 2020. The proposal required adding 17 new data fields onto this form.
\c\ Total burden increased due to the approval of the ``Programming VCA Allocation in UNet'' proposal approved
  by the OPTN BOD in December of 2020. The proposal required adding 16 new data fields onto this form and
  removing 10 data fields from this form.
\d\ Total burden increased due to the approval of the ``Programming VCA Allocation in UNet'' proposal approved
  by the OPTN BOD in December of 2020. The proposal required adding 54 new data fields onto this form and
  removing 5 data fields from this form.

    HRSA specifically requests comments on (1) the necessity and 
utility of the proposed information collection for the proper 
performance of the agency's functions, (2) the accuracy of the 
estimated burden, (3) ways to enhance the quality, utility, and clarity 
of the information to be collected, and (4) the use of automated 
collection techniques or other forms of information technology to 
minimize the information collection burden.

Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2021-18688 Filed 8-30-21; 8:45 am]
BILLING CODE 4165-15-P