[Federal Register Volume 79, Number 41 (Monday, March 3, 2014)]
[Notices]
[Pages 11798-11799]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-04576]


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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

AGENCY: Health Resources and Services Administration, HHS.

ACTION: Notice.

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SUMMARY: In compliance with Section 3507(a)(1)(D) of the Paperwork 
Reduction Act of 1995, the Health Resources and Services Administration 
(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 within 30 days of this 
notice.

ADDRESSES: Submit your comments, including the Information Collection 
Request 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: 
    Information Collection Request Title: Organ Procurement and 
Transplantation Network (OPTN) Application Form
    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 and transplant 
program requirements contained in the Final Rule Governing the 
Operation of the Organ Procurement and Transplantation Network (OPTN), 
``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 transplant program requirements and will agree to comply 
with all applicable provisions of the National Organ Transplant Act, as 
amended, 42 U.S.C. 273, et seq. 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 the 
HHS) of the OPTN 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 (that 
have been approved by the Secretary), including those relating to data 
collection, mandatory for all transplant hospitals and OPOs. These 
applications are developed to prompt submission of all the information 
required to make such membership approval decisions. In addition, 
hospitals wishing to obtain designation for particular (e.g., organ 
specific) transplant programs must submit applications to the OPTN.
    Likely Respondents: Parties seeking initial OPTN membership 
approval and then maintenance of the existing OPTN approval. Applicants 
will include: every hospital seeking to perform organ transplants; 
every non-profit organization seeking to become an organ procurement 
organization; and every medical laboratory seeking to become a 
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 too are 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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                                                            Number of                  Average
                                               Number of    responses      Total      burden per   Total burden
                  Form name                   respondents      per       responses     response        hours
                                                            respondent                (in hours)
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A New Transplant Member/Program Application--           8            1            8            8              64
 General....................................
B Kidney (KI) Designated Program Application           94            2          188            4             752
B Liver (LI) Designated Program Application.           73            2          146            4             584
B Pancreas (PA) Designated Program                     56            2          112            4             448
 Application................................
B Heart (HR) Designated Program Application.           43            2           86            4             344
B Lung (LU) Designated Program Application..           50            2          100            4             400

[[Page 11799]]

 
B Islet (PI) Designated Program Application.            4            2            8            3              24
B Living Donor (LD) Recovery Program                   46            2           92            3             276
 Application................................
C OPO New Program Application...............            0            1            0            4               0
D Histocompatibility Lab Application........            2            2            4            4              16
E Change in Transplant Program Key Personnel          377            2          754            4            3016
F Change in Histocompatibility Lab Director.            8            1            8            2              16
G Change in OPO Key Personnel...............           10            1           10            1              10
H Medical Scientific Org Application........           16            1           16            2              72
I Public Org Application....................            6            1            6            2              12
J Business Member Application...............            3            1            3            2               6
K Individual Member Application.............            6            1            6            1               6
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    Total =17 forms.........................          802           26         1547           56            6046
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    Dated: February 21, 2014.
Jackie Painter,
Deputy Director, Division of Policy and Information Coordination.
[FR Doc. 2014-04576 Filed 2-28-14; 8:45 am]
BILLING CODE 4165-15-P