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[Federal Register Volume 66, Number 113 (Tuesday, June 12, 2001)]
[Notices]
[Pages 31652-31654]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-14721]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 01114]

Use of Logical Observations, Identifiers, and Names (LOINC) to 
Standardize the Electronic Exchange of Public Health Data; Notice of 
Availability of Funds

A. Purpose

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 2001 funds for a grant program for 
``Use of Logical Observations, Identifiers, and Names (LOINC) to 
Standardize the Electronic Exchange of Public Health Data.'' This 
program addresses the ``Healthy People 2010'' focus areas of Cancer.
    The purpose of this program is to: (1) Promote analyzation and 
evaluation of the LOINC vocabulary, a set of formal names and codes for 
clinical variables and laboratory test names applied with other 
numeric, coded, or narrative text values; (2) promote assessment and 
implementation of additional enhancements for the current data mapping 
tool which is Regenstrief LOINC Mapping Assistant (RELMA) as needed; 
(3) assessment and promotion of educational material which can be 
presented in appropriate settings such as workshops and conferences to 
illustrate how the mapping tool and LOINC vocabulary can be used; (4) 
analysis and refinement of additional semantic enhancements to the code 
sets based on previous findings (i.e., brief descriptions or names 
provided for each LOINC code) and evaluate the need for relationships 
to other code sets such as the International Classification of Disease 
(ICD) series or vocabularies (i.e., Systematized Nomenclature of 
Medicine, (SNOMED)); and (5) assessment of the need for and growth of 
enhancements to code set management and code set assignment (i.e 
methods to group domain areas to identify specific needs).

B. Eligible Applicants

    Assistance will be provided only to the Regenstrief Institute for 
Health Care, a non-profit organization. No other applications are 
solicited.
    The LOINC vocabulary is developed and managed only by the 
Regenstrief Institute for Health Care. The Regenstrief Institute for 
Health Care's mission is to conduct research to improve health care by 
improving the capture, analysis, content and delivery of the 
information needed by patients, their health care providers and policy 
makers, and to conduct intervention studies designed to measure the 
effect of the application of this research on the efficiency and 
quality of health care. The vocabulary of codes is freely distributed 
over the Web at the Regenstrief Web site. The Regenstrief Institute 
grants permission, without written agreement and without license or 
royalty fees, to use, copy, or distribute the LOINC codes, LOINC User's 
Guide, and the contents of the LOINC database for any purpose, so long 
as a copyright notice appears on any copies of the LOINC database and 
User's Guide, and that certain criteria are met. The Regenstrief 
Institute is the only organization which maintains and develops these 
standard codes.

    Note: Title 2 of the United States Code, Chapter 26, Section 
1611 states that an organization described in section 501(c)(4) of 
the Internal Revenue Code of 1986 that engages in lobbying 
activities is not eligible to receive Federal funds constituting an 
award, grant, cooperative agreement, contract, loan, or any other 
form.

C. Availability of Funds

    Approximately $100,000 is available in FY 2001 to fund one award. 
It is expected that the award will begin on or about September 30, 
2001, and will be made for a 12-month budget period within a project 
period of up to five years. Funding estimates may change.
    Continuation award within an approved project period will be made 
on the basis of satisfactory progress as evidenced by required reports 
and the availability of funds.

D. Program Requirements

    In conducting activities to achieve the purpose of this program, 
the recipient will be responsible for the following activities:
    1. Assess the need for enhancement of the LOINC vocabulary. Based 
on the

[[Page 31653]]

findings, develop recommendations and implement the findings for 
enhancement of the LOINC vocabulary.
    2. Develop recommendations and implement the findings for 
additional enhancements for the current data mapping tool, RELMA.
    3. Assess the need for and develop educational materials that can 
be presented at workshops and conferences (e.g., APHA, NAACCR, and 
clinical laboratory meetings) to demonstrate how the mapping tool and 
codes are used.
    4. Develop recommendations and implement the recommendations for 
additional semantic enhancements to the code sets.
    5. Develop recommendations and implement the recommendations for 
enhancements for code set management and code set assignment.
    6. Disseminate the findings.

E. Application Content

    Use the information in the Program Requirements, Other 
Requirements, and Evaluation Criteria sections to develop the 
application content. Your application will be evaluated on the criteria 
listed, so it is important to follow them in laying out your program 
plan. The narrative, not including appendices, should be no more than 
20 double-spaced pages, printed on one-side, with one inch margins, and 
unreduced font. Pages should be clearly numbered and a complete index 
to the application and any appendixes included. The original and each 
copy of the application should be submitted unstapled and unbound.

1. Executive Summary

    Provide a clear, concise, and objectively written statement of the 
major objectives and components of the proposed activities.

2. Existing Resources and Needs Assessment

    Describe the current activities related to the development and 
enhancements of the LOINC vocabulary, the mapping tool, RELMA or other 
necessary enhancements for LOINC code management and the need for 
enhancement.

3. Collaborative Relationships

    Describe collaborative relationships with other agencies and 
organizations relevant to exchanging clinical and laboratory 
information electronically using a standard exchange format such as 
Health Level 7.

4. Operational Plan

    Describe the objectives for the proposed project. The applicant 
should describe the specific outcome and process objectives that will 
be measured, the major steps required and a projected timetable for 
completion that displays time-lines for the accomplishment of specific 
proposed activities.

5. Management and Staffing Plan

    Describe how the program will be effectively managed including:
    a. Management structure including the lines of authority and plans 
for fiscal control.
    b. Qualifications and experience of the designated staff.
    c. The staff positions responsible for implementation of the 
program.

6. Budget and Justification

    Provide a detailed budget request and line-item justification of 
all proposed operating expenses.

F. Submission and Deadline

Application

    Submit the original and two copies of PHS 5161-1 (OMB Number 0920-
0428). Forms are available in the application kit and at the following 
Internet address: http://forms.pcs.gov. On or before July 15, 2001, 
submit the application to the Grants Management Specialist identified 
in the ``Where to Obtain Additional Information'' section of this 
announcement.

G. Evaluation Criteria

Application

    The application will be evaluated individually against the 
following criteria by an independent review group appointed by CDC.
1. Resources and Needs Assessment: (25 points)
    The extent to which the applicant describes how the current 
activities relating to the development of the LOINC vocabulary and the 
mapping tool and the identification and need for other necessary 
enhancements for LOINC code management and the need for enhancement.
2. Collaboration: (20 points)
    The extent to which the applicant provides evidence of 
collaborative relationships with other agencies and organizations 
relevant to exchanging clinical and laboratory information 
electronically using a standard exchange format such as Health Level 7 
and other possible methods.
3. Proposed Objectives: (30 points)
    The extent to which the applicant describes the specific outcome 
and process objectives for the proposed project; how they will be 
measured, and the major steps required to meet the objectives.
4. Operational Plan: (10 points)
    The extent to which the projected timetable for completion of 
objectives and for meeting objectives is reasonable and realistic.
5. Project Management and Staffing Plan: (15 points)
    The extent to which the applicant describes the management 
structure and staff positions with clear lines of authority and plans 
for fiscal control for proposed project staff and qualifications and 
experience of the proposed staff.
6. Budget: (Not Scored)
    The extent to which the applicant provides a detailed budget and 
justification consistent with the proposed program objectives and 
activities.

H. Other Requirements

Technical Reporting Requirements

    Provide CDC with original plus two copies of
    1. Annual progress reports which includes:
    a. A brief program description;
    b. A comparison of the actual accomplishments to the goals and 
objectives established for the period; and
    c. If established goals and objectives were not accomplished or 
were delayed, describe both the reason for the deviation and 
anticipated corrective action or deletion of the activity from the 
project.
    2. Financial status report, no more than 90 days after the end of 
the budget period; and
    3. Final financial and performance reports, no more than 90 days 
after the end of the project period.
    Send all reports to the Grants Management Specialist identified in 
the ``Where to Obtain Additional Information'' section of this 
announcement.
    The following additional requirements are applicable to this 
program. For a complete description of each, see Attachment I of the 
announcement.
AR-10  Smoke-Free Workplace Requirements
AR-11  Healthy People 2010
AR-12  Lobbying Restrictions
AR-14  Accounting System Requirements
AR-15  Proof of Non-Profit Status

[[Page 31654]]

I. Authority and Catalog of Federal Domestic Assistance Number

    This program is authorized under section 317(k)(2) of the Public 
Health Service Act, (42 U.S.C. 247b (k)(2)), as amended. The Catalog of 
Federal Domestic Assistance number is 93.283.

J. Where to Obtain Additional Information

    This and other CDC announcements can be found on the CDC home page 
Internet address--http://www.cdc.gov Click on ``Funding'' then ``Grants 
and Cooperative Agreements.'' To obtain business management technical 
assistance, contact: Glynnis Taylor, Grants Management Specialist, 
Grants Management Branch, Procurement and Grants Office, Centers for 
Disease Control and Prevention, Announcement 01114, 2920 Brandywine 
Road, Room 3000, Atlanta, GA 30341-4146, Telephone number: (770) 488-
2752, Email address: [email protected].
    For program technical assistance, contact: Warren Williams, MPH, 
Health Scientist, Cancer Surveillance Branch, Division of Cancer 
Prevention and Control, National Center for Chronic Disease Prevention 
and Health Promotion, Centers for Disease Control and Prevention, 4770 
Buford Hwy., NE (MS--K53), Atlanta, GA 30341-3717, Telephone number: 
(770) 488-3095, Email address: [email protected].

    Dated: June 6, 2001.
John L. Williams
Director, Procurement and Grants Office, Centers for Disease Control 
and Prevention (CDC).
[FR Doc. 01-14721 Filed 6-11-01; 8:45 am]
BILLING CODE 4163-18-P
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