[Federal Register Volume 81, Number 237 (Friday, December 9, 2016)]
[Notices]
[Pages 89115-89117]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-29504]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Proposed Collection: 
Public Comment Request; Organ Procurement and Transplantation Network

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 (Section 3506(c)(2)(A) 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 Information Collection Request must be received 
no later than February 7, 2017.

ADDRESSES: Submit your comments to [email protected] or by mail to the 
HRSA Information Collection Clearance Officer, at 5600 Fishers Lane, 
Room 14N39, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain copies of the data collection plans and 
draft instruments, email [email protected] or call the HRSA 
Information Collection Clearance Officer at (301) 443-1984.

[[Page 89116]]


SUPPLEMENTARY INFORMATION: When submitting comments or requesting 
information, please include the information request collection title 
for reference.
    Information Collection Request Title: Organ Procurement and 
Transplantation Network OMB No. 0915-0184--Revision.
    Abstract: HRSA is proposing additions and revisions to the 
following documents used to collect information from existing or 
potential members of the Organ Procurement and Transplantation Network 
(OPTN). The documents under revision include: (1) Application forms for 
individuals or organizations interested in membership in OPTN, (2) 
application forms for OPTN members applying to have organ-specific 
transplant programs designated within their institutions, and (3) forms 
submitted by OPTN members to report certain personnel changes.
    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. 
(NOTA), OPTN Final Rule, 42 CFR part 121, OPTN bylaws, and OPTN 
policies. 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 (as approved by the Secretary of HHS) of the OPTN, 
including those relating to data collection, as a condition of 
participation in Medicare and Medicaid for the hospital. Section 1138 
contains a similar provision for organ procurement organizations (OPOs) 
and makes membership in the OPTN and compliance with its operating 
rules and requirements, including those relating to data collection, 
mandatory for all OPOs. The membership application forms listed below 
enable prospective OPTN members to submit the information necessary for 
OPTN to make membership decisions. Likewise, the designated transplant 
program application forms listed below enable OPTN members to submit 
the information necessary for OPTN to make designation decisions.
    New membership forms have been created for transplant centers 
seeking to perform Vascularized Composite Allograft (VCA) transplants, 
a new and emerging field. VCAs were added to the set of organs covered 
by NOTA and the OPTN final rule via regulation, effective July 3, 2014. 
The OPTN Board approved OPTN membership requirements for VCA programs 
in late 2015. Because a transplant center applying to be an OPTN-
approved VCA transplant program must already have current OPTN approval 
as a designated transplant program for at least one other organ, the 
VCA membership forms were developed based on existing membership forms.
    To keep pace with scientific and clinical advances in the field of 
transplantation, HRSA plans to submit a clearance package to OMB after 
reviewing comments to this notice. New forms and revisions to the 
current OPTN forms include the following:
     Organ-specific program and histocompatibility laboratory 
applications reflecting key personnel requirement revisions made to the 
OPTN bylaws (the bylaws revisions will be implemented upon approval of 
these forms).
     Program applications based on existing organ-specific 
application forms, for programs seeking intestinal and VCA 
transplantation approval OPTN-defined VCAs: VCA head and neck, VCA 
upper limb, VCA abdominal wall kidney, VCA abdominal wall liver, VCA 
abdominal wall pancreas, VCA abdominal wall intestine, and VCA other.
     Intestine program applications, based on an existing 
organ-specific application form.
     Cover pages, based on existing cover pages for other organ 
types, have been created for VCA new transplant program, VCA key 
personnel change, VCA other new transplant program, and VCA other key 
personnel change.
     Questions and tables reflecting new ordering and numbering 
for improved flow on various forms.
    The burden of completing the new and revised forms is expected to 
be minimal, as these forms are based on OPTN membership applications 
that organizations have completed in the past.
    Likely Respondents: Likely respondents to this notice include the 
following: Hospitals performing or seeking to perform organ 
transplants, organ procurement organizations, and medical laboratories 
seeking to become OPTN-approved histocompatibility laboratories.
    Burden Statement: Burden in this context means the time expended by 
persons to generate, maintain, retain, disclose, or provide the 
information requested, including the time needed to (1) review 
instructions; (2) develop, acquire, install, and utilize technology and 
systems for the purpose of collecting, validating, and verifying 
information, processing and maintaining information, and transmitting, 
disclosing, or providing information; (3) train personnel to respond to 
a collection of information; (4) search data sources; (5) complete and 
review the information collected; (6) and transmit or otherwise 
disclose the information. The total annual burden hours estimated for 
this Information Collection Request 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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A. New Transplant Member                       2               1               2               8              16
 Application--General...........
B Kidney (KI) Designated Program             118               2             236               4             944
 Application....................
B Liver (LI) Designated Program               59               2             118               4             472
 Application....................
B Pancreas (PA) Designated                    60               2             120               4             480
 Program Application............
B Heart (HR) Designated Program               92               2             184               4             736
 Application....................
B Lung (LU) Designated Program                30               2              60               4             240
 Application....................
B Islet (PI) Designated Program                2               2               4               3              12
 Application....................
B Living Donor (LD) Recovery                  42               2              84               3             252
 Program Application............
B VCA Head and Neck Designated                14               2              28               3              84
 Program Application............
B VCA Upper Limb Designated                   17               2              34               3             102
 Program Application............
B VCA Abdominal Wall *                        13               2              26               3              78
 Designated Program Application.

[[Page 89117]]

 
    VCA Abdominal Wall--Kidney
    VCA Abdominal Wall--Liver
    VCA Abdominal Wall--Pancreas
    VCA Abdominal Wall--
     Intestine
B VCA Other ** Designated                      9               2              18               2              36
 Program Application............
B Intestine Designated Program                40               2              80               3             240
 Application....................
C OPO New Application...........               0               1               0               4               0
D Histocompatibility Lab                       3               2               6               4              24
 Application....................
E Change in Transplant Program               395               2             790               4           3,160
 Key Personnel..................
F Change in Histocompatibility                25               2              50               2             100
 Lab Director...................
G Change in OPO Key Personnel...              10               1              10               1              10
H Medical Scientific Org                       7               1               7               2              14
 Application....................
I Public Org Application........               4               1               4               2               8
J Business Member Application...               2               1               2               2               4
K Individual Member Application.               4               1               4               1               4
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    Total = 25 forms............             948  ..............           1,867  ..............           7,016
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* VCA Abdominal Wall Designated Program qualification requirements require documentation on VCA Head and Neck,
  VCA Upper Limb, Kidney, Liver, Intestine, or Pancreas program requirements.
** VCA Other Designated Program Application data based on four categories of ``others'' including genitourinary
  and lower limb as defined by the OPTN bylaws.

    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.

Jason E. Bennett,
Director, Division of the Executive Secretariat.
[FR Doc. 2016-29504 Filed 12-8-16; 8:45 am]
BILLING CODE 4165-15-P