[Federal Register Volume 87, Number 220 (Wednesday, November 16, 2022)]
[Notices]
[Pages 68713-68715]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-24926]


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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; Membership Forms for Organ 
Procurement and Transplantation Network, OMB No. 0915-0184--Revision

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

ACTION: Notice.

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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 December 
16, 2022.

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 Samantha Miller, the HRSA 
Information Collection Clearance Officer, at

[[Page 68714]]

[email protected] or call (301) 443-9094.

SUPPLEMENTARY INFORMATION:
    Information Collection Request Title: Membership Forms for Organ 
Procurement and Transplantation Network, OMB No. 0915-0184--Revision.
    Abstract: Membership in the Organ Procurement and Transplantation 
Network (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, 42 CFR part 121; OPTN 
policies; and OPTN bylaws. Section 1138 of the Social Security Act, as 
amended, 42 U.S.C. 1320b-8, 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 
Health and Human Services) as a condition of participation in Medicare 
and Medicaid.
    A 60-day notice was published in the Federal Register, 87 FR 52389 
(Aug. 25, 2022). There were no public comments.
    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 Health and Human Services 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 as well as the Kidney Paired Donation Pilot 
Program (KPDPP) contact update form. 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 update is a form that indicates contact information for 
programs participating in the KPDPP.
    (2) Adding three standalone forms for 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.
     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 if the proposed Primary 
Program Administrator serves in that role for multiple programs.
     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.
     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 COA/PCP, which 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 944 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              71            4.00             284
 Transplant Hospitals and
 Programs.......................
OPTN Membership Application for              234            0.56             132            8.00           1,056
 Kidney Transplant Programs.....
OPTN Membership Application for              143            0.59              85           13.00           1,105
 Liver Transplant Programs......
OPTN Membership Application for              120            0.26              32           13.00             416
 Pancreas Transplant Programs...
OPTN Membership Application for              145            0.34              50           20.50           1,025
 Heart Transplant Programs......

[[Page 68715]]

 
OPTN Membership Application for               72            0.64              47            9.00             423
 Lung Transplant Programs.......
OPTN Membership Application for               19            0.00               0            5.00               0
 Islet Transplant Programs \2\..
OPTN Membership Application for               43            0.98              43           15.50             667
 Vascularized Composite
 Allograft (VCA) Transplant
 Programs.......................
OPTN Membership Application for               21            0.19               4           11.00              44
 Intestine Transplant Programs..
OPTN Membership Application for               57            0.14               8           40.00             320
 Organ Procurement Organizations
 (OPOs).........................
OPTN Membership Application for              141            0.21              30            2.50              75
 Histocompatibility Laboratories
OPTN Representative Form........           1,760            0.02              36            0.25               9
OPTN Medical/Scientific                       10            0.30               3            0.75               3
 Membership Application.........
OPTN Public Organization                       7            0.57               4            0.50               2
 Membership Application.........
OPTN Business Membership                      11            0.55               7            0.88               7
 Application....................
OPTN Individual Membership                     8            0.88               8            0.25               2
 Application....................
OPTN Membership Application                    0            0.00               0            0.00               0
 Surgeon or Physician Log \3\...
Primary Program Administrator              1,562            0.05              79            0.25              20
 Form...........................
Primary Data Coordinator Form...           1,760            0.03              53            0.13               7
Additional Surgeon and Physician           1,562            0.08             125            1.17             147
 Request Form...................
HOPE Act Variance Request Form                68            0.00               0            1.33               0
 \4\............................
Kidney Paired Donation Pilot                 159            0.33              53            1.63              87
 Program (KPDPP) contact update
 form...........................
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    Total = 22 forms............           8,153  ..............             870  ..............           5,699
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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.
\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. 2022-24926 Filed 11-15-22; 8:45 am]
BILLING CODE 4165-15-P