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Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.
Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0915-0157
ICR Reference No:
200210-0915-003
Status:
Historical Active
Previous ICR Reference No:
199909-0915-001
Agency/Subagency:
HHS/HSA
Agency Tracking No:
Title:
Organ Procurement and Transplantation Network and Scientific Registry of Transplan Recipients Data System
Type of Information Collection:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved with change
Conclusion Date:
12/03/2002
Retrieve Notice of Action (NOA)
Date Received in OIRA:
10/04/2002
Terms of Clearance:
Approved as amended through 06/2004 under the following condi- tions: 1) The electronic data forms that will be used must match the paper forms that were submitted to OMB. Copies of the elec- tronic forms must be submitted to OMB for the public record; 2) OMB notes that this docket does not contain all UNet infor- mation collection requirements articulated in hard copy forms and/or computer queries, particularly those requirements related to the rulemaking requirements covered under OMB # 0915- 0184.As soon as possible (but no later than 1/30/2004),HRSA must identify and submit these requirements for PRA review and public comment; 3) OMB is concerned that new response categories for Functional Status will impede longitudinal analyses of these data. In particular, HRSA has revised response categories of many forms to include "No activity limitation (NYHA Class I)" in a single category. NYHA Classes II and III have been combined to form a category of "Peforms activities of daily living and some assistance. Only NYHA Class IV remains the same. HRSA should include all four NYHA categories unless it can present compelling clinical or analytic arguments supporting the proposed revisions; 4) In light of the numerous form amendments, HRSA must review the corresponding instructions to ensure they accurately reflect the revised forms. HRSA must submit the revised Instruc- tions to OMB for the public record; and 5) HRSA must raise the list of attached issues to the appropriate organ specific committees and new data integration committee for consideration. No later than June 30, 2003, HRSA must brief OMB on the outcome of the committees' deliberations on these issues.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
08/31/2004
08/31/2004
12/31/2002
Responses
517,693
0
376,520
Time Burden (Hours)
80,362
0
80,362
Cost Burden (Dollars)
0
0
0
Abstract:
SRTR collects information on transplant recipients and transplant procedures for an ongoing evaluation of the scientific and clinical status of organ transplantation, OPTN must assist in the distribution of organs equitably among transplant patients nationwide and adopt and use standards of quality for the acquisition and transportation of donated organs. The OPTN must maintain a national waiting list of individuals requiring organ transplants, maintain a computerized system for matching donor organs with transplant candidates list, and operate a 24-hour telephone services to access the waiting list and computer....
Authorizing Statute(s):
None
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Federal Register Notices & Comments
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
1
IC Title
Form No.
Form Name
Organ Procurement and Transplantation Network and Scientific Registry of Transplan Recipients Data System
ICR Summary of Burden
Total Approved
Previously Approved
Change Due to New Statute
Change Due to Agency Discretion
Change Due to Adjustment in Estimate
Change Due to Potential Violation of the PRA
Annual Number of Responses
517,693
376,520
0
141,173
0
0
Annual Time Burden (Hours)
80,362
80,362
0
0
0
0
Annual Cost Burden (Dollars)
0
0
0
0
0
0
Burden increases because of Program Change due to Agency Discretion:
No
Burden Increase Due to:
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
Annual Cost to Federal Government:
$0
Does this IC contain surveys, censuses, or employ statistical methods?
No
Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002?
No
Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]?
Uncollected
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
Uncollected
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
Uncollected
Is this ICR related to the Pandemic Response?
Uncollected
Common Form ICR:
No
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(a) It is necessary for the proper performance of agency functions;
(b) It avoids unnecessary duplication;
(c) It reduces burden on small entities;
(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
(f) It indicates the retention periods for recordkeeping requirements;
(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
(i) It uses effective and efficient statistical survey methodology (if applicable); and
(j) It makes appropriate use of information technology.
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
Certification Date:
10/04/2002