[Federal Register Volume 82, Number 91 (Friday, May 12, 2017)]
[Notices]
[Pages 22145-22147]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-09621]


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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: 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.

DATES: Comments on this ICR should be received no later than June 12, 
2017.

ADDRESSES: Submit your comments, including the ICR Title, to the desk 
officer for HRSA, either by email to [email protected] or by 
fax to 202-395-5806.

FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance 
requests submitted to OMB for review, email the HRSA Information 
Collection Clearance Officer at [email protected] or call (301) 443-
1984.

SUPPLEMENTARY INFORMATION: When submitting comments or requesting 
information, please include the information request collection title 
for reference, in compliance with Section 3506(c)(2)(A) of the 
Paperwork Reduction Act of 1995.
    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 the 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 Health and Human 
Services) of the OPTN, including those related to data collection, as a 
condition of participation in Medicare and Medicaid for the hospital. 
Section 1138 contains a similar provision for the organ procurement 
organizations (OPOs) and makes membership in the OPTN and compliance 
with its operating rules and requirements (as approved by the Secretary 
of Health and Human Services), including those relating to data 
collection, mandatory

[[Page 22146]]

for all OPOs. The membership application forms listed below enable 
prospective OPTN members to submit the information necessary for the 
OPTN to make membership decisions. Likewise, the designated transplant 
program application forms listed below enable OPTN members to submit 
the information necessary for the 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 definition of organs 
covered by the rules governing the operation of the OPTN, effective 
July 3, 2014. The OPTN Board approved OPTN membership requirements for 
VCA programs during late 2015. Because a transplant hospital 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.
    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 
program application forms, for programs seeking VCA transplantation 
approval. The OPTN Board of Directors has approved language modifying 
OPTN Policy 1.2 (definitions) to provide that VCAs, defined generally 
in OPTN Policy 1.2 include the following:
     Upper limb (including, but not limited to, any group of 
body parts from the upper limb or radial forearm flap);
     Head and neck (including, but not limited to, face 
including underlying skeleton and muscle, larynx, parathyroid gland, 
scalp, trachea, or thyroid);
     Abdominal wall (including, but not limited to, symphysis 
pubis or other vascularized skeletal elements of the pelvis);
     Genitourinary organs (including, but not limited to, 
uterus, internal/external male and female genitalia, or urinary 
bladder);
     Glands (including, but not limited to adrenal or thymus);
     Lower limb (including, but not limited to, pelvic 
structures that are attached to the lower limb and transplanted intact, 
gluteal region, vascularized bone transfers from the lower extremity, 
anterior lateral thigh flaps, or toe transfers);
     Musculoskeletal composite graft segment (including, but 
not limited to, latissimus dorsi, spine axis, or any other vascularized 
muscle, bone, nerve, or skin flap); and
     Spleen.
    Some of the program application forms for programs seeking VCA 
transplantation approval are specific to these body parts (e.g., VCA 
Upper Limb Transplant Program Application), and others are classified 
as VCA Other Program Applications with a checklist to indicate which of 
the listed body parts the program seeks designation to transplant.
     Program applications based on an existing organ-specific 
application form for programs seeking designation as an intestine 
transplant program.
     Cover pages, based on existing cover pages for other organ 
types, for VCA new transplant program, VCA key personnel change, VCA 
other new transplant program, and VCA other key personnel change forms.
     Questions and tables reflecting new ordering and numbering 
for improved flow on various forms.
    These forms are based on OPTN membership applications that 
organizations have completed in the past; the burden of completing the 
new and revised forms is minimized.
    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 disclosing and 
providing information; (3) train personnel to respond to a collection 
of information; (4) search data sources; (5) complete and review the 
information collected; and (6) 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        hours
                                                          respondent                  (in hours)
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A New Transplant Member/Program                      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 Program                  60               2          120            4             480
 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 Program                42               2           84            3             252
 Application.............................
B VCA Head and Neck Designated Program              14               2           28            3              84
 Application.............................
B VCA Upper Limb Designated Program                 17               2           34            3             102
 Application.............................
B VCA Abdominal Wall * Designated Program           13               2           26            3              78
 Application.............................
    VCA Abdominal Wall--Kidney
    VCA Abdominal Wall--Liver
    VCA Abdominal Wall--Pancreas
    VCA Abdominal Wall--Intestine
B VCA Other ** Designated Program                    9               2           18            2              36
 Application.............................
B Intestine Designated Program                      40               2           80            3             240
 Application.............................
C OPO New Application....................            0               1            0            4               0

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D Histocompatibility Lab Application.....            3               2            6            4              24
E Change in Transplant Program Key                 395               2          790            4           3,160
 Personnel...............................
F Change in Histocompatibility Lab                  25               2           50            2             100
 Director................................
G Change in OPO Key Personnel............           10               1           10            1              10
H Medical Scientific Org Application.....            7               1            7            2              14
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
                                          ----------------------------------------------------------------------
    Total = 25 forms.....................          948  ..............        1,867  ...........           7,016
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* There are 4 types of forms that can be used to apply for designation as a VCA Abdominal Wall Program.
** VCA Other Designated Program Application data based on four categories of ``others'' including genitourinary
  and lower limb as defined by the OPTN bylaws.


Jason E. Bennett,
Director, Division of the Executive Secretariat.
[FR Doc. 2017-09621 Filed 5-11-17; 8:45 am]
 BILLING CODE 4165-15-P