[Federal Register Volume 79, Number 231 (Tuesday, December 2, 2014)]
[Notices]
[Pages 71437-71439]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-28343]


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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 no later than January 2, 
2015.

ADDRESSES: Submit your comments, including the Information Collection 
Request Title, to the desk officer for HRSA, either by email to 
<a href="/cdn-cgi/l/email-protection#5916100b18062a2c3b34302a2a3036371936343b773c3629773e362f"><span class="__cf_email__" data-cfemail="6d22243f2c321e180f00041e1e0402032d02000f4308021d430a021b">[email protected]</span></a> 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 <a href="/cdn-cgi/l/email-protection#493928392c3b3e263b2209213b3a28672e263f"><span class="__cf_email__" data-cfemail="0777667762757068756c476f75746629606871">[email protected]</span></a> or call (301) 443-
1984.

[[Page 71438]]


SUPPLEMENTARY INFORMATION:
    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.
    Need and Proposed Use of the Information: 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; 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
----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
            Form name                Number of     responses per       Total       per response    Total burden
                                    respondents     respondent       responses      (in hours)         hours
----------------------------------------------------------------------------------------------------------------
Deceased Donor Registration.....              58           158.2            9174             1.1         10091.4
Living Donor Registration.......             296            20.2            5984             1.8         10771.2
Living Donor Follow-up..........             296            59.5           17610             1.3         22893.0
Donor Histocompatibility........             154            94.8           14598             0.2          2919.6
Recipient Histocompatibility....             154           170.1           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.....              65            39.0            2534             0.9          2280.6
Lung Recipient Registration.....              65            29.6            1923             1.4          2692.2
Lung Follow Up (6 Month)........              65            25.8            1677             0.5           838.5
Lung Follow Up (1-5 Year).......              65            97.9            6364             1.1          7000.4
Lung Follow Up (Post 5 Year)....              65            64.6            4201             0.6          2520.6
Lung Post-Transplant Malignancy               65             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            16.0
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)..........................
Heart/Lung Post-Transplant                    63             0.2              12             0.4             4.8
 Malignancy Form................
Liver Candidate Registration....             136            88.6           12048             0.8          9638.4
Liver Recipient Registration....             136            47.5            6457             1.3          8394.1
Liver Follow-up (6 Month-5 Year)             136           229.4           31194             1.0         31194.0
Liver Follow-up (Post 5 Year)...             136           254.6           34622             0.5         17311.0
Liver Recipient Explant                      136            12.2            1665             0.6           999.0
 Pathology Form.................
Liver Post-Transplant Malignancy             136            13.1            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...             235           161.2           37880             0.8         30304.0
Kidney Recipient Registration...             235            71.9           16904             1.3         21975.2
Kidney Follow-Up (6 Month-5                  235           376.3           88422             0.9         79579.8
 Year)..........................
Kidney Follow-up (Post 5 Year)..             235           343.7           80770             0.5         40385.0
Kidney Post-Transplant                       235            17.9            4213             0.8          3370.4
 Malignancy Form................
Pancreas Candidate Registration.             135             3.5             479             0.9           431.1
Pancreas Recipient Registration.             135             1.9             259             1.1           284.9

[[Page 71439]]

 
Pancreas Follow-up (6 Month-5                135            10.4            1398             1.0          1398.0
 Year)..........................
Pancreas Follow-up (Post 5 Year)             135            13.4            1804             0.5           902.0
Pancreas Post-Transplant                     135             0.8             108             0.6            64.8
 Malignancy Form................
Kidney/Pancreas Candidate                     13            98.5            1280             0.9            1152
 Registration...................
Kidney/Pancreas Recipient                    135             5.6             760             1.1           836.0
 Registration...................
Kidney/Pancreas Follow-up (6                 135            33.4            4509             1.0          4509.0
 Month-5 Year)..................
Kidney/Pancreas Follow-up (Post              135            47.9            6465             0.6          3879.0
 5 Year)........................
Kidney/Pancreas Post-Transplant              135             1.6             211             0.4            84.4
 Malignancy Form................
Vascular Composite Allograft                  16             0.9              15             0.4             6.0
 Candidate Registration.........
Vascular Composite Allograft                  16             0.9              15             1.3            19.5
 Recipient Registration.........
Vascular Composite Allograft                  16             0.9              15             1.0            15.0
 Recipient Follow Up............
                                 -------------------------------------------------------------------------------
    Total.......................           * 456  ..............          460414  ..............        358092.5
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* Total number of OPTN member institutions as of 09/9/2014. Number of respondents for transplant candidate or
  recipient forms based on number of organ specific programs associated with each form.


Jackie Painter,
Acting Director, Division of Policy and Information Coordination.
[FR Doc. 2014-28343 Filed 12-1-14; 8:45 am]
BILLING CODE 4165-15-P


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