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, 39194-39196 [2020-14046]
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39194
Federal Register / Vol. 85, No. 126 / Tuesday, June 30, 2020 / Notices
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third party may not wish to be posted,
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confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
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• If you want to submit a comment
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Written/Paper Submissions
Submit written/paper submissions as
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• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
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• For written/paper comments
submitted to the Dockets Management
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well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2020–D–1518 for ‘‘Development of AntiInfective Drug Products for the Pediatric
Population.’’ Received comments will
be placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
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• Confidential Submissions—To
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Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
VerDate Sep<11>2014
18:18 Jun 29, 2020
Jkt 250001
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002; or the Office of Communication,
Outreach, and Development, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
3128, Silver Spring, MD 20993–0002.
Send one self-addressed adhesive label
to assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Hiwot Hiruy, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 6395, Silver Spring,
MD 20993–0002, 240–402–0872; or
Stephen Ripley, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Development of Anti-Infective Drug
Products for the Pediatric Population.’’
The purpose of this guidance is to
provide general recommendations on
the development of anti-infective drug
products for pediatric patients. The
guidance addresses initiation of
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
pediatric clinical trials, enrollment
strategies, extrapolation of efficacy, and
other considerations to help facilitate
pediatric anti-infective drug
development.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘Development of Anti-Infective Drug
Products for the Pediatric Population.’’
It does not establish any rights for any
person and is not binding on FDA or the
public. You can use an alternative
approach if it satisfies the requirements
of the applicable statutes and
regulations.
II. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved FDA collections of
information. These collections of
information are subject to review by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501–3521). The
collections of information in 21 CFR
parts 50, 312, and 314, and in 21 CFR
201.56 and 201.57 have been approved
under OMB control numbers 0910–
0755, 0910–0014, 0910–0001, and 0910–
0572, respectively.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, or https://
www.regulations.gov.
Dated: June 25, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–14085 Filed 6–29–20; 8:45 am]
BILLING CODE 4164–01–P
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
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
AGENCY:
E:\FR\FM\30JNN1.SGM
30JNN1
39195
Federal Register / Vol. 85, No. 126 / Tuesday, June 30, 2020 / Notices
ACTION:
Notice.
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
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.
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
SUMMARY:
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 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.
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
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 Candidate Registration ..............................................
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Frm 00036
Number of
responses per
respondent *
58
300
300
147
147
140
Fmt 4703
Sfmt 4703
Total
responses **
185.0
22.9
62.2
124.0
225.1
33.7
E:\FR\FM\30JNN1.SGM
10,731
6,855
18,669
18,226
33,090
4,717
30JNN1
Average
burden per
response
(in hours)
1.1
1.8
1.3
0.2
0.4
0.9
Total
burden
hours
11,804.1
12,339.0
24,269.7
3,645.2
13,236.0
4,245.3
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Federal Register / Vol. 85, No. 126 / Tuesday, June 30, 2020 / 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
Heart Recipient Registration ................................................
Heart Follow Up (6 Month) ..................................................
Heart Follow Up (1–5 Year) .................................................
Heart Follow Up (Post 5 Year) ............................................
Heart Post-Transplant Malignancy Form .............................
Lung Candidate Registration ...............................................
Lung Recipient Registration .................................................
Lung Follow Up (6 Month) ...................................................
Lung Follow Up (1–5 Year) .................................................
Lung Follow Up (Post 5 Year) .............................................
Lung Post-Transplant Malignancy Form ..............................
Heart/Lung Candidate Registration .....................................
Heart/Lung Recipient Registration .......................................
Heart/Lung Follow Up (6 Month) .........................................
Heart/Lung Follow Up (1–5 Year) ........................................
Heart/Lung Follow Up (Post 5 Year) ...................................
Heart/Lung Post-Transplant Malignancy Form ....................
Liver Candidate Registration ...............................................
Liver Recipient Registration .................................................
Liver Follow-up (6 Month–5 Year) .......................................
Liver Follow-up (Post 5 Year) ..............................................
Liver Recipient Explant Pathology Form .............................
Liver Post-Transplant Malignancy .......................................
Intestine Candidate Registration ..........................................
Intestine Recipient Registration ...........................................
Intestine Follow Up (6 Month–5 Year) .................................
Intestine Follow Up (Post 5 Year) .......................................
Intestine Post-Transplant Malignancy Form ........................
Kidney Candidate Registration ............................................
Kidney Recipient Registration ..............................................
Kidney Follow-Up (6 Month–5 Year) ...................................
Kidney Follow-up (Post 5 Year) ...........................................
Kidney Post-Transplant Malignancy Form ...........................
Pancreas Candidate Registration ........................................
Pancreas Recipient Registration .........................................
Pancreas Follow-up (6 Month–5 Year) ................................
Pancreas Follow-up (Post 5 Year) ......................................
Pancreas Post-Transplant Malignancy Form ......................
Kidney/Pancreas Candidate Registration ............................
Kidney/Pancreas Recipient Registration .............................
Kidney/Pancreas Follow-up (6 Month–5 Year) ....................
Kidney/Pancreas Follow-up (Post 5 Year) ..........................
Kidney/Pancreas Post-Transplant Malignancy Form ..........
VCA Candidate Registration ................................................
VCA Recipient Registration .................................................
VCA Recipient Follow Up ....................................................
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
237
237
237
237
133
133
133
133
133
133
133
133
133
133
27
27
27
24.3
22.0
90.6
154.0
12.8
45.2
35.7
32.4
118.8
116.5
19.7
1.0
0.5
0.4
1.1
3.3
0.3
90.3
56.5
266.6
316.6
10.6
16.3
7.0
5.2
26.2
37.2
2.1
168.8
89.4
431.9
449.4
22.6
2.8
1.5
7.9
15.9
0.7
9.8
7.7
32.8
57.8
2.2
0.9
1.6
0.7
3,406
3,082
12,686
21,556
1,788
3,210
2,532
2,297
8,438
8,271
1,400
67
32
31
79
228
21
13,183
8,256
38,919
46,225
1,544
2,387
139
104
524
744
42
39,998
21,195
102,350
106,507
5,365
368
194
1,047
2,119
97
1,297
1,028
4,363
7,688
292
24
43
18
1.2
0.4
0.9
0.5
0.9
0.9
1.2
0.5
1.1
0.6
0.4
1.1
1.3
0.8
1.1
0.6
0.4
0.8
1.2
1.0
0.5
0.6
0.8
1.3
1.8
1.5
0.4
1.0
0.8
1.2
0.9
0.5
0.8
0.6
1.2
0.5
0.5
0.6
0.6
1.2
0.5
0.6
0.4
0.4
1.3
1.0
4,087.2
1,232.8
11,417.4
10,778.0
1,609.2
2,889.0
3,038.4
1,148.5
9,281.8
4,962.6
560.0
73.7
41.6
24.8
86.9
136.8
8.4
10,546.4
9,907.2
38,919.0
23,112.5
926.4
1,909.6
180.7
187.2
786.0
297.6
42.0
31,998.4
25,434.0
92,115.0
53,253.5
4,292.0
220.8
232.8
523.5
1,059.5
58.2
778.2
1,233.6
2,181.5
4,612.8
116.8
9.6
55.9
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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2020–14046 Filed 6–29–20; 8:45 am]
National Institutes of Health
khammond on DSKJM1Z7X2PROD with NOTICES
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National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
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The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
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[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
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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