[Federal Register Volume 68, Number 228 (Wednesday, November 26, 2003)]
[Notices]
[Pages 66464-66465]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-29465]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Proposed Collection: 
Comment Request

    In compliance with the requirement for opportunity for public 
comment on proposed data collection projects (section 3506(c)(2)(A) of 
Title 44, United States Code, as amended by the Paperwork Reduction Act 
of 1995, Pub. L. 104-13), the Health Resources and Services 
Administration (HRSA) publishes periodic summaries of proposed projects 
being developed for submission to OMB under the Paperwork Reduction Act 
of 1995. To request more information on the proposed project or to 
obtain a copy of the data collection plans and draft 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 Project: Data System for Organ Procurement and Transplantation 
Network and Associated Forms (OMB No. 0915-0157): Revision

    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). The OPTN, 
among other responsibilities, operates and maintains a national waiting 
list of individuals requiring organ transplants, maintains a 
computerized system for matching donor organs with transplant 
candidates on the waiting list, and operates a 24-hour telephone 
service to facilitate matching organs with individuals included in the 
list.
    Data for the OPTN data system are collected from transplant 
hospitals, organ procurement organizations, and tissue-typing 
laboratories. The information is used to match donor organs with 
recipients, 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 in the development and revision of OPTN rules 
and requirements, operating procedures, and standards of quality for 
organ acquisition and preservation, some of which have provided the 
foundation for development of Federal regulations. The practical 
utility of the data collection is further enhanced by requirements that 
the OPTN data must be made available without restriction for use by 
OPTN members, the Scientific Registry of Transplant Recipients, the 
Department of Health and Human Services, and others for evaluation, 
research, patient information, and other important purposes.
    Revisions in the 28 data collection forms and addition of 2 survey 
instruments are intended to clarify existing questions, to provide 
additional detail and categories to avoid confusion and be more 
inclusive, to remove obsolete data, and to comply with requests for 
more complete and precise data.

                                       Estimates of Annualized Hour Burden
----------------------------------------------------------------------------------------------------------------
                                     Number of     Responses per       Total         Hours per     Total burden
              Form                  respondents     respondents      responses       response          hours
----------------------------------------------------------------------------------------------------------------
Deceased Donor Registration.....              59             173          10,207           0.3          3,062.10
Death referral data.............              59              12             708          10            7,080.00
Living Donor Registration.......             692              10           6,920           0.2          1,384.00
Living Donor Followup...........             692              19          13,148           0.1          1,314.80
Donor Histocompatibility........             152              87          13,224           0.1          1,322.40
Recipient Histocompatibility....             152             163          24,776           0.1          2,477.60
Heart Candidate Registration....             139              23           3,197           0.3            959.10
Lung Candidate Registration.....              70              28           1,960           0.3            588.00
Heart/Lung Candidate                          72               1              72           0.3             21.60
 Registration...................
Thoracic Registration...........             139              24           3,336           0.3          1,000.80
Thoracic Followup...............             139             174          24,186           0.2          4,837.20
Kidney Candidate Registration...             247             109          26,923           0.2          5,384.60
Kidney Registration.............             247              65          16,055           0.3          4,816.50
Kidney Followup *...............             247             493         121,771           0.2         24,354.20

[[Page 66465]]

 
Liver Candidate Registration....             123              82          10,086           0.2          2,017.20
Liver Registration..............             123              46           5,658           0.4          2,263.20
Liver Follow-up.................             123             299          36,777           0.3         11,033.10
Kidney/Pancreas Candidate                    139              12           1,668           0.2            333.60
 Registration...................
Kidney/Pancreas Registration....             139               7             973           0.4            389.20
Kidney/Pancreas Follow-up.......             139              64           8,896           0.3          2,668.80
Pancreas Candidate Registration.             139               7             973           0.2            194.60
Pancreas Registration...........             139               4             0.3         166.80              556
Pancreas Follow-up..............             139              20           2,780           0.2            556.00
Intestine Candidate Registration              44               5             220           0.2             44.00
Intestine Registration..........              44               3             132           0.2             26.40
Intestine Follow-up.............              44               8             352           0.2             70.40
Immunosuppression Treatment.....             692              38          26,296           0.025          657.40
Immunosuppression Treatment                  692             281         194,452           0.025        4,861.30
 Follow-up......................
Post Transplant Malignancy......             692               5           3,460           0.05           173.00
Annual Unet Satisfaction Survey.             750               1             750           0.03            22.50
Annual Organ Center Satisfaction             750               1             750           0.03            22.50
 Survey.........................
                                 -----------------
    Total.......................             903  ..............         561,262  ..............      84,102.90
----------------------------------------------------------------------------------------------------------------
Includes an estimated 6,000 kidney transplant patients transplanted prior to the initiation of the data system

    Send comments to Susan G. Queen, Ph.D., HRSA Reports Clearance 
Officer, Room 1445, Parklawn Building, 5600 Fishers Lane, Rockville, MD 
20857. Written comments should be received within 60 days of this 
notice.

    Dated: November 19, 2003.
Tina M. Cheatham,
Acting Director, Division of Policy Review and Coordination.
[FR Doc. 03-29465 Filed 11-25-03; 8:45 am]
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