Agency Information Collection Activities: Proposed Collection: Public Comment Request

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Published

August 25, 2022

Issuing agencies

Health and Human Services DepartmentHealth Resources and Services Administration

Abstract

In compliance with the requirement for 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.

Full Text

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<title>Federal Register, Volume 87 Issue 164 (Thursday, August 25, 2022)</title>
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[Federal Register Volume 87, Number 164 (Thursday, August 25, 2022)]
[Notices]
[Pages 52389-52391]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-18356]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration

Agency Information Collection Activities: Proposed Collection:
Public Comment Request

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

ACTION: Notice.

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SUMMARY: In compliance with the requirement for 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 October
24, 2022.

ADDRESSES: Submit your comments to <a href="/cdn-cgi/l/email-protection#ccbcadbca9bebba3bea78ca4bebfade2aba3ba"><span class="__cf_email__" data-cfemail="750514051007021a071e351d0706145b121a03">[email&#160;protected]</span></a> or by mail to 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 <a href="/cdn-cgi/l/email-protection#ee9e8f9e8b9c99819c85ae869c9d8fc0898198"><span class="__cf_email__" data-cfemail="7707160712050018051c371f05041659101801">[email&#160;protected]</span></a> or call Samantha Miller,
the HRSA Information Collection Clearance Officer at (301) 443-9094.

SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the information collection request title
for reference.
Information Collection Request Title: Membership Forms for Organ
Procurement (OPTN) and Transplantation Network OMB No. 0915-0184-
Revision.
Abstract: Membership in the OPTN is determined by submission of
application materials to the OPTN (not to HRSA) demonstrating that the
applicant meets all required criteria for membership and will agree to
comply with all applicable provisions of the National Organ Transplant
Act, as amended, 42 U.S.C. 273, et seq., the OPTN final rule, OPTN
Policies, and OPTN Bylaws. Section 1138 of the Social Security Act, as
amended, 42 U.S.C. 1320b-8 (section 1138) requires that hospitals in
which transplants are performed by members of, and abide by, the rules
and requirements of the OPTN (that have been approved by the Secretary
of HHS) as a condition of participation in Medicare and Medicaid.
Need and Proposed Use of the Information: The application materials
are needed to ensure that all members and prospective members of the
OPTN submit evidence that they meet the required qualifications for
membership. These materials provide the OPTN with information to permit
the OPTN to confirm and demonstrate that applicants meet OPTN
membership application requirements and to create a record of the
application review process and resulting actions for consideration by
the Secretary of HHS if an applicant subsequently appeals a membership
rejection by the OPTN.
This is a request to revise the current OPTN data collection
associated with transplant hospitals, organ procurement organizations,
transplant histocompatibility laboratories, medical/scientific and
public organizations, business organizations, and individuals to meet
or sustain requirements for OPTN membership to include data collection
forms for OPTN member hospitals requesting HIV Organ Policy Equity
(HOPE) Act Variances and Kidney Paired Donation Pilot Program (KPDPP)
contact update form. This revision also includes changes to the
existing OMB data collection forms. HRSA is submitting the following
changes to the Membership forms to clarify requirements and eliminate
redundancy while adding more explanatory language and instruction to
the applications, which include:
(1) Adding two new data collection forms for HOPE Act Variance
Request and KPDPP contact update form. The HOPE Act Variance Request is
for any OPTN member transplant program that wishes to start a variance
to receive HIV-positive organs for their HIV-positive patients. The
KPDPP contact

[[Page 52390]]

update is a form that indicates contact information for programs
participating in the KPDPP.
(2) Adding three standalone forms for revised data collection:
Primary Program Administrator, Primary Data Coordinator, and Additional
Surgeon and Physician. All three of these forms include data previously
collected on other OMB- approved forms in this package but now will be
standalone forms for greater ease of use for the applicant.
<bullet> The Primary Program Administrator data collection form
includes data previously collected in each organ-specific application
form. Users will only have to complete one form of the proposed Primary
Program Administrator serves in that role for multiple programs.
<bullet> The Primary Data Coordinator collection form includes data
previously collected in each organ-specific application form. This form
will be used for organ procurement organizations, histocompatibility
lab members, and organ transplant programs so that one standalone form
will serve all three member types.
<bullet> The Additional Surgeon and Physician data collection form
includes data previously collected in the Certificate of Assessment and
Program Coverage Plan (COA/PCP) Membership Application form. Users will
only have to complete one form if the proposed Surgeon and Physician
serve in that role for multiple programs.
The organ-specific application forms have been revised to include
the information found in the Certificate of Assessment and Program
Coverage Plan Membership Application (COA/PCP). The information found
in the COA/PCP has been embedded into all of the organ-specific
application forms, negating the need for an independent data collection
form.
Likely Respondents: New and existing transplant hospitals, organ
procurement organizations, histocompatibility laboratories, medical/
scientific organizations, public organizations, businesses, and
individual members.
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 total burden hours in the OMB inventory increased by 898 hours
from the previously OMB-approved data collection package from August
20, 2020. This increase is due in part to including new membership
forms.

Total Estimated Annualized Burden Hours
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Average
Number of Number of Total burden per Total burden
Form name respondents responses per responses response (in hours
\1\ respondent hours)
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OPTN Membership Application for 251 0.28 70 4 280
Transplant Hospitals...........
OPTN Membership Application for 234 0.56 132 8 1,056
Kidney Transplant Programs.....
OPTN Membership Application for 143 0.59 85 13 1,105
Liver Transplant Programs......
OPTN Membership Application for 120 0.26 32 13 416
Pancreas Transplant Programs...
OPTN Membership Application for 145 0.34 50 20.5 1,025
Heart Transplant Programs......
OPTN Membership Application for 72 0.64 46 9 414
Lung Transplant Programs.......
OPTN Membership Application for 19 0 0 5 0
Islet Transplant Programs \2\..
OPTN Membership Application for 43 0.98 42 15.5 651
Vascularized Composite
Allograft (VCA) Transplant
Programs.......................
OPTN Membership Application for 21 0.19 4 11 44
Intestine Transplant Programs..
OPTN Membership Application for 57 0.14 8 40 320
Organ Procurement Organizations
(OPOs).........................
OPTN Membership Application for 141 0.21 30 2.5 75
Histocompatibility Laboratories
OPTN Representative Form........ 1,760 0.02 37 0.25 9
OPTN Medical/Scientific 10 0.3 3 0.75 2
Membership Application.........
OPTN Public Organization 7 0.57 4 0.5 2
Membership Application.........
OPTN Business Membership 11 0.55 6 0.88 5
Application....................
OPTN Individual Membership 8 0.88 7 0.25 2
Application....................
OPTN Membership Application 0 0 0 0 0
Surgeon or Physician Log \3\...
Primary Program Administrator 1,562 0.047 74 0.25 19
Form...........................
Primary Data Coordinator Form... 1,760 0.03 52 0.13 7
Additional Surgeon and Physician 1,562 0.0736 115 1.17 135
Request Form...................
HOPE Act Variance Request Form 68 0 0 1.33 0
\4\............................
Kidney Paired Donation Pilot 159 0.33 53 1.63 86
Program (KPDPP) contact update
form...........................
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Total = 22 forms............ 8,153 .............. 850 .............. 5,653
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\1.\ The numbers of respondents were updated with the data as of December 31, 2021, and reflect changes in
members' statuses.

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\2.\ There were no Islet applications processed in 2021, hence no responses.
\3. \ The OPTN Membership Application Surgeon or Physician Log is an optional form. The information can also be
submitted by the OPTN member using a different format. The burden to complete is built into the organ
application data.
\4.\ There were no HOPE Act Variance Request forms processed in 2021, hence no responses.

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. 2022-18356 Filed 8-24-22; 8:45 am]
BILLING CODE 4165-15-P

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