[Federal Register Volume 85, Number 124 (Friday, June 26, 2020)]
[Notices]
[Pages 38380-38382]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-13793]


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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; Information Collection 
Request Title: 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 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 27, 
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--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: 
    Information Collection Request Title: Membership Forms for Organ 
Procurement and Transplantation Network OMB No. 0915-0184-Revision.

[[Page 38381]]

    Abstract: This is a request for OMB approval for revisions of the 
application documents used to collect information for determining if 
the interested party is compliant with membership requirements 
contained in the final rule Governing the Operation of the Organ 
Procurement and Transplantation Network (OPTN), (42 CFR part 121) ``the 
OPTN final rule.''
    A 60-day notice published in the Federal Register on February 13, 
2020, vol. 85, No. 30; pp. 8300-02. There were no public comments.
    Need and Proposed Use of the Information: 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.
    Proposed Revisions to OPTN Membership Applications: Changes to the 
forms are proposed to make application requirements more clear and 
organized, and thus less cumbersome for applicants to complete. 
Proposed revisions include changes to wording to make questions more 
consistent with the language of the OPTN Bylaws (Bylaws). In addition, 
the applications have been revised so that the sequence of questions is 
parallel to that of the Bylaws. Using the Bylaws as a baseline, the 
revamped applications have been constructed in parallel order of the 
Bylaws so that an applicant can have the application and Bylaws side-
by-side for easy reference. Additional proposed changes to the 
application include:
     A few major changes were made to the application order of 
documentation and attachments. The embedded transplant logs were 
revised in the form of a `universal' surgeon and physician log that 
will be provided as a separate attachment to the application. This new 
log will provide applicants with all OPTN Bylaws requirements. We hope 
the added technology utilized in the log will help applicants complete 
the log with limited errors.
     Also within the applications, ``checkboxes''--fillable 
tables that were not checkboxes at all--were removed, and working 
checkboxes were inserted. The ``narrative'' section was replaced by 
checkbox attestations, which will serve the same purpose--understanding 
relevant and recent surgeon and physician applicant experience.
     The previous membership applications had several places 
for the applicants to sign. The new application requests only one 
signature from each member applicant involved.
     Additional changes to the application process include 
streamlining previous application attachments for key personnel and 
living donor components into one form for the respective organ 
application.
     Pediatric Bylaw Requirements, where applicable, were also 
given their sections within the organ applications. Conversely, the 
Certificate of Assessment (formerly known as Certificate of 
Investigation) and the Primary Coverage Plan Checklist was pulled out 
of the previous organ-specific applications and given their own, 
separate attachment. These changes will allow OPTN application 
reviewers to give these application components to applicants in as few 
attachments as possible. These changes will also allow the United 
Network for Organ Sharing Membership Team to give these important 
application components to applicants in as few attachments as possible, 
but are inclusive of all possible changes within a program.
     Further changes have been made to the Vascularized 
Composite Allograft (VCA) Transplant program applications, which were 
previously submitted as separate applications for OMB approval based on 
body part transplanted. These forms have been revised into one single 
application with sections for each VCA organ type.
     Personnel changes for Organ Procurement Organizations 
(OPOs) and Histocompatibility Laboratories have also been consolidated 
into organization applications. OPO and Lab applicants will be able to 
use one respective application for new and/or personnel changes.
    Given these changes, the overall burden has decreased significantly 
from an estimated 7,020 total burden hours to 4,755 hours in this 
current proposed revision package, although some forms have been 
combined into one more comprehensive form resulting in increased burden 
hours for a particular form.
    Likely Respondents: Parties seeking initial OPTN membership 
approval and then maintenance of existing OPTN approval. Applicants 
include the following: Hospitals seeking to perform organ transplants, 
non-profit organizations seeking to become an organ procurement 
organization, and medical laboratories seeking to become an OPTN-
approved histocompatibility laboratory. In addition, there are other 
OPTN membership categories for organizations and individuals who want 
to participate in the organ transplant system, and they are also 
required to fill out an appropriate application.
    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
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                                                                                      Average
                                     Number of       Number of         Total        burden per     Total burden
            Form name               respondents    responses per     responses     response  (in       hours
                                                    respondent                        hours)
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OPTN Membership Application for                2               1               2               3               6
 Transplant Hospitals...........
OPTN Certificate of Assessment                 2               1               2               3               6
 and Program Coverage Plan
 Membership Application.........
OPTN Membership Application for              189               2             378               3           1,134
 Kidney Transplant Programs.....

[[Page 38382]]

 
OPTN Membership Application for              110               2             220               3             660
 Liver Transplant Programs......
OPTN Membership Application for              120               2             240               3             720
 Pancreas Transplant Programs...
OPTN Membership Application for              142               2             284               3             852
 Heart Transplant Programs......
OPTN Membership Application for               60               2             120               3             360
 Lung Transplant Programs.......
OPTN Membership Application for                4               2               8               2              16
 Islet Transplant Programs......
OPTN Membership Application for               53               2             106               2             212
 Vascularized Composite
 Allograft (VCA) Transplant
 Programs.......................
OPTN Membership Application for               90               2             180               3             540
 Intestine Transplant Programs..
OPTN Membership Application for               10               1              10               3              30
 Organ Procurement Organizations
 (OPOs).........................
OPTN Membership Application for               27               2              54               3             162
 Histocompatibility Laboratories
OPTN Representative Form........              20               2              40               1              40
OPTN Medical/Scientific                        7               1               7               1               7
 Membership Application.........
OPTN Public Organization                       4               1               4               1               4
 Membership Application.........
OPTN Business Membership                       2               1               2               1               2
 Application....................
OPTN Individual Membership                     4               1               4               1               4
 Application....................
OPTN Membership Application       ..............  ..............  ..............  ..............  ..............
 Surgeon or Physician Log *.....
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    Total = 18 forms............             846  ..............           1,661  ..............           4,755
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* The OPTN Membership Application Surgeon or Physician Log accompanies every individual organ application. The
  burden to complete is built into the organ application data.


Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2020-13793 Filed 6-25-20; 8:45 am]
BILLING CODE 4165-15-P