[Federal Register Volume 60, Number 203 (Friday, October 20, 1995)]
[Notices]
[Pages 54237-54238]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-25970]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Proposed Data Collections Available for Public Comment and 
Recommendations

    In compliance with the requirement of Section 3506(c)(2)(A) of the 
Paperwork Reduction Act of 1995 for opportunity for public comment on 
proposed data collection projects, the Health Resources and Services 
Administration (HRSA) will publish periodic summaries of proposed 
projects. To request more information on the proposed project or to 
obtain a copy of the data collection plans and instruments, call the 
HRSA Reports Clearance Officer on (301) 443-1129.
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of the functions of 
the agency, including whether the information shall have practical 
utility; (b) the accuracy of the agency's estimate of the burden of the 
proposed collection of information; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (d) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques or other 
forms of information technology.

Proposed Projects:

    1. Organ Procurement and Transplantation Network Regulations--42 
CFR Part 121 (Final Rule)
    (OMB No. 0915-0184)--Extension and Revision--This final rule 
establishes the policies governing the Organ Procurement and 
Transplantation Network (OPTN). These rules will regulate the operation 
of the OPTN in four major areas: membership requirements, patient 
listing, organ allocation, and record maintenance and recording. The 
final rule contains three requirements not currently approved under the 
Paperwork Reduction Act, as indicated in the table below (footnote 2). 
The burden estimates are as follows:

----------------------------------------------------------------------------------------------------------------
                                                                                                        Total   
                           Title                              Number of    Frequency     Hours per      burden  
                                                             respondents  of response    response       hours   
----------------------------------------------------------------------------------------------------------------
121.3(a)(6)(ii) (Reporting) Submission of Policies &                                                            
 Procedures................................................            1            4          0.5             2
121.3(a)(6)(ii) \2\ (Disclosure) Sending policies &                                                             
 procedures to OPOs........................................            1           16         75           1,200
121.3(d)(1) (Reporting) Application requirements for OPOs,                                                      
 hospitals, & others.......................................        2,774        \3\ 1          0.5         1,387
121.5(c) \2\ (Reporting) Submitting criteria for organ                                                          
 accept....................................................          115            1          0.1            12
121.5(c) \2\ (Disclosure) Sending criteria to OPOs.........          115            1          0.1            12
121.6(b)(4) (Reporting) Reasons for refusal................          828           14          0.1         1,200
121.7(e) (Reporting) Transplant to prevent organ wastage...          278            4          0.1           111
121.8(b) (Reporting) Application requirements for                                                               
 transplant centers:                                                                                            
    A. Medicare/Medicaid Approved programs & VA Hospitals..          308        \3\ 1          0.5           154
    B. Other programs......................................          350        \3\ 1          2.0           700

[[Page 54238]]
                                                                                                                
121.11(b)(2): \1\                                                                                               
Transplant Candidate Registration..........................           66          536          0.1         3,540
    Donor Registration.....................................           66          131          0.2         1,730
    Potential Recipient Registration.......................           66          469          0.1         3,096
    Donor Histocompatability...............................           51          206          0.1         1,051
    Transplant Recipient Histocompatability................           41          369          0.1         1,881
    Transplant Recipient Registration......................          828           25          0.25        5,191
    Transplant Recipient Follow-up.........................          828          138          0.14       16,003
----------------------------------------------------------------------------------------------------------------
Note: Estimated Total Annual Burden: 37,270 hours.                                                              
\1\ The data collection forms for these activities have been approved by the Office of Management and Budget    
  under the Paperwork Reduction Act (OMB No. 0915-0157).                                                        
\2\ These requirements will be submitted for OMB approval.                                                      
\3\ This application burden is expected to occur almost entirely in the first year; the application burden for  
  years 2 and 3 is expected to be about 0.1 of the first-year burden.                                           


    The proposed rules also require OPOs and transplant hospitals to 
maintain records, as follows:

------------------------------------------------------------------------
               Section                            Requirement           
------------------------------------------------------------------------
121.6(b)(4).........................  Documentation of reason for       
                                       refusal.                         
121.6(c)(2).........................  Documentation of suitability      
                                       tests.                           
121.11(a)(2)........................  Maintain records on organ donors  
                                       and recipients.                  
------------------------------------------------------------------------

    According to staff of OPOs and transplant hospitals, such 
recordkeeping is integral to the operation of these facilities. 
Therefore, these recordkeeping requirements impose no additional 
burden.
    Send comments to Patricia Royston, HRSA Reports Clearance Officer, 
Room 14-36, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857. 
Written comments should be received within 60 days of this notice.

    Dated: October 16, 1995.
J. Henry Montes,
Associate Administrator for Policy Coordination.
[FR Doc. 95-25970 Filed 10-19-95; 8:45 am]
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