[Federal Register Volume 85, Number 30 (Thursday, February 13, 2020)]
[Notices]
[Pages 8300-8302]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-02870]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Proposed Collection: 
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 (HHS).

ACTION: Notice.

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[[Page 8301]]

SUMMARY: In compliance with 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 or any other aspect of the ICR.

DATES: Comments on this ICR should be received no later than April 13, 
2020.

ADDRESSES: Submit your comments to [email protected] or mail the HRSA 
Information Collection Clearance Officer, Room 14N136B, 5600 Fishers 
Lane, Rockville, Maryland 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 ICR title for reference.
    Information Collection Request Title: Membership Forms for Organ 
Procurement and Transplantation Network OMB No. 0915-0184-Revision
    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.''
    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 be 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. Section 1138 contains a similar provision for 
the organ procurement organizations (OPOs) and makes membership in the 
OPTN and compliance with its rules and requirements (that have been 
approved by the HHS Secretary), including those relating to data 
collection, mandatory for all transplant programs and OPOs.
    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 individual 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 own sections within the organ applications. Conversely, the 
Certificate of Assessment (formerly known as Certificate of 
Investigation) and the Primary Coverage Plan Checklist were 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 7,016 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.

[[Page 8302]]



                                     Total Estimated Annualized Burden Hours
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                                                   Number of                      Average burden
          Form name               Number of      responses per   Total responses   per response    Total burden
                                 respondents       respondent                       (in hours)         hours
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  OPTN Membership Application                2                1                2               3               6
      for Transplant Hospitals
          OPTN Certificate of                2                1                2               3               6
        Assessment and Program
      Coverage Plan Membership
                   Application
  OPTN Membership Application              189                2              378               3           1,134
         for Kidney Transplant
                      Programs
  OPTN Membership Application              110                2              220               3             660
          for Liver Transplant
                      Programs
  OPTN Membership Application              120                2              240               3             720
       for Pancreas Transplant
                      Programs
  OPTN Membership Application              142                2              284               3             852
          for Heart Transplant
                      Programs
  OPTN Membership Application               60                2              120               3             360
  for Lung Transplant Programs
  OPTN Membership Application                4                2                8               2              16
          for Islet Transplant
                      Programs
  OPTN Membership Application               53                2              106               2             212
    for Vascularized Composite
    Allograft (VCA) Transplant
                      Programs
  OPTN Membership Application               90                2              180               3             540
      for Intestine Transplant
                      Programs
  OPTN Membership Application               10                1               10               3              30
         for Organ Procurement
          Organizations (OPOs)
  OPTN Membership Application               27                2               54               3             162
        for 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*
    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.

    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. 2020-02870 Filed 2-12-20; 8:45 am]
 BILLING CODE 4165-15-P