Notice2022-24926
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
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
November 16, 2022
Issuing agencies
Health and Human Services DepartmentHealth Resources and Services Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 220 (Wednesday, November 16, 2022)</title>
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[Federal Register Volume 87, Number 220 (Wednesday, November 16, 2022)]
[Notices]
[Pages 68713-68715]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. 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]]
<a href="/cdn-cgi/l/email-protection#334352435641445c4158735b4140521d545c45"><span class="__cf_email__" data-cfemail="304051405542475f425b70584243511e575f46">[email protected]</span></a> 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.
<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 if 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 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
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