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
08/31/2004
08/31/2004
12/31/2002
517,693
0
376,520
80,362
0
80,362
0
0
0
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....
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:
(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;
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.
Organ Procurement and Transplantation Network and Scientific Registry of Transplan Recipients Data System