[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:
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Total
Title Number of Frequency Hours per burden
respondents of response response hours
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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
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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:
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Section Requirement
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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.
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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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