[Federal Register Volume 79, Number 173 (Monday, September 8, 2014)]
[Notices]
[Pages 53203-53204]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-21283]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Proposed Collection: 
Public Comment Request

AGENCY: Health Resources and Services Administration, 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), the Health Resources and Services 
Administration (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 
within 60 days of this notice.

ADDRESSES: Submit your comments to [email protected] or mail the HRSA 
Information Collection Clearance Officer, Room 10-29, Parklawn 
Building, 5600 Fishers Lane, Rockville, MD 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 the HRSA 
Information Collection Clearance Officer at (301) 443-1984.

SUPPLEMENTARY INFORMATION: When submitting comments or requesting 
information, please include the information request collection title 
for reference.
    Information Collection Request Title: Data System for Organ 
Procurement and Transplantation Network
    OMB No.: 0915-0157--Revision
    Abstract: Section 372 of the Public Health Service (PHS) Act 
requires that the Secretary, by contract, provide for the establishment 
and operation of an Organ Procurement and Transplantation Network 
(OPTN). This is a request for revisions to current OPTN data collection 
forms associated with donor organ procurement and an individual's 
clinical characteristics at the time of registration, transplant, and 
follow-up after the transplant. Data for the OPTN data system are 
collected from transplant hospitals, organ procurement organizations, 
and tissue-typing laboratories. The information is used to indicate the 
disease severity of transplant candidates, to monitor compliance of 
member organizations with OPTN rules and requirements, and to report 
periodically on the clinical and scientific status of organ donation 
and transplantation in this country. Data are used to develop 
transplant, donation, and allocation policies, to determine whether 
institutional members are complying with policy, to determine member-
specific performance, to ensure patient safety and to fulfill the 
requirements of the OPTN Final Rule. The practical utility of the data 
collection is further enhanced by requirements that the OPTN data must 
be made available, consistent with applicable laws, for use by OPTN 
members, the Scientific Registry of Transplant Recipients, the 
Department of Health and Human Services, and members of the public for 
evaluation, research, patient information, and other important 
purposes.
    Likely Respondents: Transplant programs, organ procurement 
organizations, histocompatibility laboratories, medical and scientific 
organizations, and public organizations.
    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; 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; train personnel to respond to a request for 
collection of information; search data sources; complete and review the 
collection of information; and to transmit or otherwise disclose the 
information. The total annual burden hours estimated for this 
Information Collection Request are summarized in the table below.

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                                                      Average                         Average
                                     Number of       number of     Total  number    burden per     Total  burden
        Section/activity            respondents    responses per   of  responses   response  (in       hours
                                                    respondent                        hours)
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Deceased Donor Registration.....              58           158.2            9174             1.1         10091.4
Living Donor Registration.......             290            20.6            5984             1.8         10771.2
Living Donor Follow-up..........             290            60.7           17610             1.3         22893.0
Donor Histocompatibility........             151            96.7           14598             0.2          2919.6
Recipient Histocompatibility....             151           173.5           26199             0.4         10479.6
Heart Candidate Registration....             131            30.5            3991             0.9          3591.9
Heart Recipient Registration....             131            19.3            2525             1.4          3535.0
Heart Follow Up (6 Month).......             131            17.0            2229             0.4           891.6
Heart Follow Up (1-5 Year)......             131            73.9            9683             0.9          8714.7
Heart Follow Up (Post 5 Year)...             131           115.2           15091             0.5          7545.5
Heart Post-Transplant Malignancy             131            11.0            1447             0.9          1302.3
 Form...........................
Lung Candidate Registration.....              64            39.6            2534             0.9          2280.6
Lung Recipient Registration.....              64            30.0            1923             1.4          2692.2
Lung Follow Up (6 Month)........              64            26.2            1677             0.5           838.5
Lung Follow Up (1-5 Year).......              64            99.4            6364             1.1          7000.4
Lung Follow Up (Post 5 Year)....              64            65.6            4201             0.6          2520.6
Lung Post-Transplant Malignancy               64             1.5              99             0.4            39.6
 Form...........................
Heart/Lung Candidate                          63             0.7              46             1.1            50.6
 Registration...................
Heart/Lung Recipient                          63             0.3              21             1.4            29.4
 Registration...................
Heart/Lung Follow Up (6 Month)..              63             0.3              20             0.8              16
Heart/Lung Follow Up (1-5 Year).              63             1.5              97             1.1           106.7
Heart/Lung Follow Up (Post 5                  63             3.1             194             0.6           116.4
 Year)..........................

[[Page 53204]]

 
Heart/Lung Post-Transplant                    63             0.2              12             0.4             4.8
 Malignancy Form................
Liver Candidate Registration....             135            89.2           12048             0.8          9638.4
Liver Recipient Registration....             135            47.8            6457             1.3          8394.1
Liver Follow-up (6 Month-5 Year)             135           231.1           31194               1         31194.0
Liver Follow-up (Post 5 Year)...             135           256.5           34622             0.5         17311.0
Liver Recipient Explant                      135            12.3            1665             0.6           999.0
 Pathology Form.................
Liver Post-Transplant Malignancy             135            13.2            1786             0.8          1428.8
Intestine Candidate Registration              41             4.4             182             1.3           236.6
Intestine Recipient Registration              41             2.7             109             1.8           196.2
Intestine Follow Up (6 Month-5                41            13.3             547             1.5           820.5
 Year)..........................
Intestine Follow Up (Post 5                   41            13.5             553             0.4           221.2
 Year)..........................
Intestine Post-Transplant                     41             0.6              25             1.0            25.0
 Malignancy Form................
Kidney Candidate Registration...             233           162.6           37880             0.8         30304.0
Kidney Recipient Registration...             233            72.5           16904             1.3         21975.2
Kidney Follow-Up (6 Month-5                  233           379.5           88422             0.9         79579.8
 Year)..........................
Kidney Follow-up (Post 5 Year)..             233           346.7           80770             0.5         40385.0
Kidney Post-Transplant                       233            18.1            4213             0.8          3370.4
 Malignancy Form................
Pancreas Candidate Registration.             134             3.6             479             0.9           431.1
Pancreas Recipient Registration.             134             1.9             259             1.1           284.9
Pancreas Follow-up (6 Month-5                134            10.4            1398             1.0          1398.0
 Year)..........................
Pancreas Follow-up (Post 5 Year)             134            13.5            1804             0.5           902.0
Pancreas Post-Transplant                     134             0.8             108             0.6            64.8
 Malignancy Form................
Kidney/Pancreas Candidate                    134             9.6            1280             0.9          1152.0
 Registration...................
Kidney/Pancreas Recipient                    134             5.7             760             1.1           836.0
 Registration...................
Kidney/Pancreas Follow-up (6                 134            33.6            4509             1.0          4509.0
 Month-5 Year)..................
Kidney/Pancreas Follow-up (Post              134            48.2            6465             0.6          3879.0
 5 Year)........................
Kidney/Pancreas Post-Transplant              134             1.6             211             0.4            84.4
 Malignancy Form................
VCA Candidate Registration......               9             1.7              15             0.4             6.0
VCA Recipient Registration......               9             1.7              15             1.3            19.5
VCA Recipient Follow Up.........               9             1.7              15             1.0            15.0
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    Total.......................            *453  ..............          460414  ..............        358092.5
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* Total number of OPTN member institutions as of 6/6/2014. Number of respondents for transplant candidate or
  recipient forms based on number of organ specific programs associated with each form.

    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.

    Dated: August 29, 2014.
Jackie Painter,
Acting Director, Division of Policy and Information Coordination.
[FR Doc. 2014-21283 Filed 9-5-14; 8:45 am]
BILLING CODE 4165-15-P