Agency Information Collection Activities: Submission for OMB Review; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration

Agency Information Collection Activities: Submission for OMB

Review; Comment Request

Periodically, the Health Resources and Services Administration

(HRSA) publishes abstracts of information collection requests under

review by the Office of Management and Budget, in compliance with the

Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request a

copy of the clearance requests submitted to OMB for review, call the

HRSA Reports Clearance Office on (301)-443-1129.

The following request has been submitted to the Office of

Management and Budget for review under the Paperwork Reduction Act of

1995:

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 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

----------------------------------------------------------------------------------------------------------------

Cadaver Donor Registration...... 59 170 10,030 0.3 3,009.00

Death referral data............. 59 12 708 10 7,080.00

Living Donor Registration....... 668 11 7,348 0.2 1,469.60

Living Donor Follow-up.......... 668 16 10,688 0.1 1,068.80

Donor Histocompatibility........ 156 86 13,416 0.1 1,341.60

Recipient Histocompatibility.... 156 161 25,116 0.1 2,511.60

Heart Candidate Registration.... 140 26 3,640 0.3 1,092.00

Lung Candidate Registration..... 75 29 2,175 0.3 652.50

Heart/Lung Candidate 81 2 162 0.3 48.60

Registration...................

Thoracic Registration........... 140 29 4,060 0.3 1,218.00

Thoracic Follow-up.............. 140 168 23,520 0.2 4,704.00

Kidney Candidate Registration... 242 108 26,136 0.2 5,227.20

Kidney Registration............. 242 62 15,004 0.3 4,501.20

Kidney Follow-up *.............. 242 444 107,448 0.2 21,489.60

Liver Candidate Registration.... 120 97 11,640 0.2 2,328.00

Liver Registration.............. 120 44 5,280 0.4 2,112.00

Liver Follow-up................. 120 276 33,120 0.3 9,936.00

Kidney/Pancreas Candidate 138 14 1,932 0.2 386.40

Registration...................

Kidney/Pancreas Registration 138 7 966 0.4 386.40

(new form).....................

Kidney/Pancreas Follow-up (new 138 51 7,038 0.3 2,111.40

form)..........................

Pancreas Candidate Registration. 138 7 966 0.2 193.20

Pancreas Registration........... 138 4 552 0.3 165.60

Pancreas Follow-up.............. 138 12 1,656 0.2 331.20

Intestine Candidate Registration 38 6 228 0.2 45.60

Intestine Registration.......... 38 3 114 0.2 22.80

Intestine Follow-up............. 38 9 342 0.2 68.40

Immunosuppression Treatment..... 668 39 26,052 0.025 651.30

Immunosuppression Treatment 668 259 173,012 0.025 4,325.30

Follow-up......................

Post Transplant Malignancy...... 668 8 5,344 0.05 267.20

-----------------

Total....................... 883 .............. 517,693 .............. 78,744.50

----------------------------------------------------------------------------------------------------------------

* Includes an estimated 10,000 kidney transplant patients transplanted prior to the initiation of the data

system.

[[Page 63110]]

Written comments and recommendations concerning the proposed

information collection should be sent within 30 days of this notice to:

John Morrill, Human Resources and Housing Branch, Office of Management

and Budget, New Executive Office Building, Room 10235, Washington, DC.

Dated: October 3, 2002.

Jane M. Harrison,

Director, Division of Policy Review and Coordination.

[FR Doc. 02-25725 Filed 10-9-02; 8:45 am]

BILLING CODE 4165-15-P