[Federal Register Volume 69, Number 119 (Tuesday, June 22, 2004)]
[Notices]
[Pages 34677-34680]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-14044]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Developing and Implementing the Institute for Quality in 
Laboratory Medicine

    Announcement Type: New.
    Funding Opportunity Number: 04151.
    Catalog of Federal Domestic Assistance Number: The Catalog of 
Federal Domestic Assistance number is 93.064.
    Key Dates:
    Letter of Intent Deadline: July 7, 2004.
    Application Deadline: July 22, 2004.

I. Funding Opportunity Description

    Authority: This program is authorized under section 317 (k)(2) 
of the Public Health Service Act, 42 U.S.C. section 247b (k)(2), as 
amended.

    Purpose: The purpose of the program is to develop and implement a 
series of activities associated with the development of an Institute of 
Quality in Laboratory Medicine. These activities aim to improve the 
effectiveness of laboratory testing services while, at the same time, 
enhancing the quality of laboratory testing services in the United 
States. These enhancements in testing practices and the quality of 
laboratory testing services will be related to areas of public health 
significance such as, for example, detection and prevention of cancer, 
more timely assessment of human health, testing for genetic conditions, 
and other diseases of importance to the public's health, and the 
regulations, i.e., Clinical Laboratory Improvement Amendments of 1988 
(CLIA-88) governing laboratory testing.
    Measurable outcomes of the program will be in alignment with the 
following performance goal for the Public Health Practice Program 
Office (PHPPO): ``Assure the public health infrastructure at the 
Federal, state, and local levels has the capacity to provide essential 
public health services to the citizens of the nation to respond to 
bioterrorism, other infectious disease outbreaks, other public health 
threats, emergencies and prepare frontline state and local health 
departments and laboratories to respond to current and emerging public 
health threats.''
    This program addresses the ``Healthy People 2010'' focus area(s): 
``Access to Quality Health Services'' and ``Public Health 
Infrastructure''.

Activities

    Awardee activities, in collaboration with the CDC and its partners 
in the Quality Institute Conference, are as follows:
    a. Develop plans to establish and evaluate a core set of measures 
for the quality of laboratory services and assess the feasibility of 
using this core set of indicators in a variety of laboratory settings.
    b. Develop plans for implementing sentinel networks to enhance the 
value of laboratory practices and evaluate changes in practice over 
time; including alternative approaches to identified barriers (eg: 
regulatory barriers)
    c. Provide a plan for creating a national report on the quality of 
laboratory services including strategies that can be used to improve 
quality assurance activities, recognition of where most testing errors 
may be occurring, and issues related to near patient testing. The 
report may include such items as information on the electronic health 
record, the expanded role of the electronic health record, database 
interoperability, evidenced based practice, the changing laboratory 
quality assurance paradigm (pre-analytic, analytic, and post-analytic), 
models to integrate evidence, optimizing time from research evaluation 
of a diagnostic test to its clinical utility, current challenges, and 
long-term challenges. The plan would include suggested partners to 
provide data for the report, mechanisms to maintain the report as a 
virtual document, and an outline of the proposed report's content.
    d. Manage a process to incorporate and implement an Institute for 
Quality in Laboratory Medicine, including the logistics of the 
formation, legal documents, and structure of institute.
    e. Lead efforts to improve laboratory quality systems in resource 
limited laboratories through:
    i. Developing, promoting, and distributing laboratory health 
systems consensus standards, guidelines, and reports that target the 
needs of resource limited laboratories.
    ii. Providing education, training, and mentoring opportunities in 
quality systems for leaders and quality

[[Page 34678]]

assurance managers from resource-limited countries that have 
responsibilities for laboratory quality systems activities.

Phase 2, Year 2

    f. Develop a plan to evaluate the cost effectiveness of 
interventions and practices to enhance the quality of laboratory 
services and health care.
    g. Assist with integration of information systems, including the 
implementation of new electronic systems to improve communication 
between laboratories and care providers, and others in the health care 
system.
    h. Develop a program to assist laboratories in developing, 
implementing, and evaluating best practices in provision of laboratory 
services.

Phase III, Year 3

    i. Provide leadership in assessing the impact of IQLM on laboratory 
services and patient safety.
    j. Assist with planning a program of health services research for 
laboratory medicine and workforce training in health services research 
methods.
    In a cooperative agreement, CDC staff is substantially involved in 
the program activities, above and beyond routine grant monitoring. CDC, 
in collaboration with its partners from the Quality Institute 
Conference, will provide for this program the following:
    a. Provide consultation and technical assistance in the planning, 
implementation, and evaluation of program activities including an 
outline of a proposed business plan for IQLM.
    b. Serve in an advisory capacity to the awardee in the development 
of data collection instruments and not otherwise be involved in the 
collection, use, or ownership of the data.
    c. Provide a written summary of up to date scientific information 
related to the nation's laboratory capacity at the request of the 
awardee.
    d. Provide consultation and technical assistance related to testing 
and any published reports or other scientific information that would 
assist recipient in understanding the possible impact of laboratory 
service quality and patient safety on testing in the US.
    e. Provide a written summary of up to date testing information on 
the use of quality assurance materials, or other information recipient 
would find useful in developing programs related to testing.
    f. Provide current CLIA information and access to experienced 
senior CLIA staff to assist recipient concerning CLIA regulations and 
their impact on laboratory testing.
    g. Provide information from the CDC sponsored Quality Institute 
Conference and assist recipient in working with Quality Institute 
partners and in establishing any expert focus groups from whom 
strategies and recommendations could be developed, e.g., assistance 
might be related to helping establish collaborations with world expert 
scientists who may participate on focus group panels.

II. Award Information

    Type of Award: Cooperative Agreement.
    CDC involvement in this program is listed in the Activities Section 
above.
    Fiscal Year Funds: 2004.
    Approximate Total Fundings: $200,000.
    Approximate Number of Awards: One.
    Approximate Average Award: $200,000 (This amount is for the first 
12 month budget period, and includes both direct and indirect costs).
    Floor of Award Range: None.
    Ceiling of Award Range: $200,000.
    Anticipated Award Date: September 1, 2004.
    Budget Period Length: 12 months.
    Project Period Length: Three years.
    Throughout the project period, CDC's commitment to continuation of 
awards will be conditioned on the availability of funds, evidence of 
satisfactory progress by the recipient (as documented in required 
reports), and the determination that continued funding is in the best 
interest of the Federal Government.

III. Eligibility Information

III.1. Eligible Applicants

    Applications may be submitted by public and private nonprofit 
organizations and by governments and their agencies, such as:
     Public nonprofit organizations.
     Private nonprofit organizations.
     State and local governments or their Bona Fide Agents 
(this includes the District of Columbia, the Commonwealth of Puerto 
Rico, the Virgin Islands, the Commonwealth of the Northern Marianna 
Islands, American Samoa, Guam, the Federated States of Micronesia, the 
Republic of the Marshall Islands, and the Republic of Palau).
    A Bona Fide Agent is an agency/organization identified by the state 
as eligible to submit an application under the state eligibility in 
lieu of a state application. If you are applying as a bona fide agent 
of a state or local government, you must provide a letter from the 
state or local government as documentation of your status. Place this 
documentation behind the first page of your application form.

III.2. Cost Sharing or Matching

    Matching funds are not required for this program.

III.3. Other

    CDC will accept and review applications with budgets greater than 
the ceiling of the award range.
    If your application is incomplete or non-responsive to the 
requirements listed in this section, it will not be entered into the 
review process. You will be notified that your application did not meet 
submission requirements.
    Applications from the above referenced entities are being solicited 
because they represent organizations that have sufficient background, 
experience, and current knowledge of testing in the nation's clinical 
laboratories. The organizations already have in place established 
assessment programs for evaluating laboratory services and practices 
that can reach laboratories globally; have experience working with one 
or more of the following groups: medical specialty organizations, 
laboratory accreditation and standard setting bodies, laboratory 
professional organizations, who aim to enhance the laboratory 
infrastructure with regard to testing, practices, guidelines and 
standards. These organizations are being solicited because they have a 
variety of established methods for evaluating laboratory practices and 
services.

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

IV. Application and Submission Information

IV.1. Address To Request Application Package

    To apply for this funding opportunity use application form PHS 
5161. Application forms and instructions are available on the CDC web 
site, at the following Internet address: http://www.cdc.gov/od/pgo/forminfo.htm.
    If you do not have access to the Internet, or if you have 
difficulty accessing the forms on-line, you may contact the CDC 
Procurement and Grants Office Technical Information Management Section 
(PGO-TIM) staff at: 770-488-2700. Application forms can be mailed to 
you.

[[Page 34679]]

IV.2. Content and Form of Submission

    Letter of Intent (LOI): Your LOI must be written in the following 
format:
     Maximum number of pages: Five;
     Font size: 12-point unreduced;
     Double spaced;
     Paper size: 8.5 by 11 inches;
     Page margin size: One inch;
     Printed only on one side of page;
     Written in plain language, avoid jargon;
    Your LOI must contain the following information:
     Purpose;
     Goals and Objectives;
     Methods and Technical Approach;
     Project Management and Staffing;
     Budget;
    Application: You must submit a project narrative with your 
application forms. The narrative must be submitted in the following 
format:
     Maximum number of pages: 25
     If your narrative exceeds the page limit, only the first 
pages, which are within the page limit, will be reviewed.
     Font size: 12 point unreduced
     Paper size: 8.5 by 11 inches
     Page margin size: One inch
     Printed only on one side of page
     Held together only by rubber bands or metal clips; not 
bound in any other way
     Double spaced
    Your narrative should address activities to be conducted over the 
entire project period, and must include the following items in the 
order listed:
     Purpose
     Table of Contents
     Goals and Objectives
     Measures of effectiveness to demonstrate accomplishment of 
program activities
     Methods and Technical Approach
     Project Management and Staffing
     Evaluation Plan
     Required Resources/ Budget/timeline
     Performance Measures
    The budget justification will not be considered to be part of the 
page limit. Additional information may be included in the application 
appendices. The appendices will not be counted toward the narrative 
page limit. This additional information includes:
     Curriculum Vitaes, Resumes, Organizational Charts, Letters 
of Support
    You are required to have a Dun and Bradstreet Data Universal 
Numbering System (DUNS) number to apply for a grant or cooperative 
agreement from the Federal government. The DUNS number is a nine-digit 
identification number, which uniquely identifies business entities. 
Obtaining a DUNS number is easy and there is no charge. To obtain a 
DUNS number, access www.dunandbradstreet.com or call 1-866-705-5711.
    For more information, see the CDC Web site at: http://www.cdc.gov/od/pgo/funding/pubcommt.htm.
    If your application form does not have a DUNS number field, please 
write your DUNS number at the top of the first page of your 
application, and/or include your DUNS number in your application cover 
letter.
    Additional requirements that may require you to submit additional 
documentation with your application are listed in section ``VI.2. 
Administrative and National Policy Requirements.''

IV.3. Submission Dates and Times

    LOI Deadline Date: July 7, 2004.
    CDC requests that you send a LOI if you intend to apply for this 
program. Although the LOI is not required, not binding, and does not 
enter into the review of your subsequent application, the LOI will be 
used to gauge the level of interest in this program, and to allow CDC 
to plan the application review.
    Application Deadline Date: July 22, 2004.
    Explanation of Deadlines: Applications must be received in the CDC 
Procurement and Grants Office by 4 p.m. Eastern Time on the deadline 
date. If you send your application by the United States Postal Service 
or commercial delivery service, you must ensure that the carrier will 
be able to guarantee delivery of the application by the closing date 
and time. If CDC receives your application after closing due to: (1) 
carrier error, when the carrier accepted the package with a guarantee 
for delivery by the closing date and time, or (2) significant weather 
delays or natural disasters, you will be given the opportunity to 
submit documentation of the carrier's guarantee. If the documentation 
verifies a carrier problem, CDC will consider the application as having 
been received by the deadline.
    This announcement is the definitive guide on application submission 
address and deadline. It supersedes information provided in the 
application instructions. If your application does not meet the 
deadline above, it will not be eligible for review, and will be 
discarded. You will be notified that your application did not meet the 
submission requirements.
    CDC will not notify you upon receipt of your application. If you 
have a question about the receipt of your application, first contact 
your courier. If you still have a question, contact the PGO-TIM staff 
at: 770-488-2700. Before calling, please wait two to three days after 
the application deadline. This will allow time for applications to be 
processed and logged.

IV.4. Intergovernmental Review of Applications

    Executive Order 12372 does apply to this program. http://12.46.245.173/pls/portal30/SYSTEM.EXE_12372_RPT.show.

IV.5. Funding Restrictions

    Restrictions, which must be taken into account while writing your 
budget, are as follows:
    None.
    If you are requesting indirect costs in your budget, you must 
include a copy of your indirect cost rate agreement. If your indirect 
cost rate is a provisional rate, the agreement should be less than 12 
months of age.
    Awards will not allow reimbursement of pre-award costs.
    Guidance for completing your budget can be found on the CDC Web 
site, at the following Internet address: http://www.cdc.gov/od/pgo/funding/budgetguide.htm.

IV.6. Other Submission Requirements

    LOI Submission Address: Submit your LOI by express mail, delivery 
service, fax, or E-mail to:
    Tracy L. Carter, M.P.H., Laboratory Program Specialist, Centers for 
Disease Control and Prevention, PHPPO/DLS, MS-G25, 4770 Buford Highway 
NE., Atlanta, Georgia 30341, Telephone Number: 770-488-2523, Fax: 770-
488-8282, E-mail address: [email protected].
    Application Submission Address: Submit the original and two hard 
copies of your application by mail or express delivery service to: 
Technical Information Management-PA 04151, CDC Procurement and 
Grants Office, 2920 Brandywine Road, Atlanta, GA 30341.
    Applications may not be submitted electronically at this time.

V. Application Review Information

V.1. Criteria

    You are required to provide measures of effectiveness that will 
demonstrate the accomplishment of the various identified objectives of 
the cooperative agreement.
    Measures of effectiveness must relate to the performance goals 
stated in the ``Purpose'' section of this announcement. Measures must 
be objective and quantitative, and must measure the intended outcome. 
These measures of effectiveness must be submitted with the application 
and will

[[Page 34680]]

be an element of evaluation. Your application will be evaluated against 
the following criteria:
    1. Methods and Technical Approach (30 points)
    a. Does the applicant clearly and succinctly describe the steps to 
be taken in the planning and implementation of the proposed cooperative 
agreement?
    b. Are the methods to be used to carry out the responsibilities of 
the proposed cooperative agreement feasible and explained in sufficient 
detail?
    2. Project Management and Staffing (30 points)
    a. Does the applicant describe a project management and staffing 
plan, and demonstrate sufficient knowledge, expertise, and other 
resources required to perform the responsibilities in this project?
    b. Does the applicant describe the staff qualifications and time 
allocations of key personnel to be assigned to this project, facilities 
and equipment, and other resources available for performance of this 
project?
    3. Goals and Objectives (20 points)
    a. Does the applicant clearly describe an understanding of the 
objectives of this project, the relevance of the proposal to the stated 
objectives, and any unique characteristics of the populations to be 
studied?
    b. Are the goals and objectives measurable, specific, and 
achievable?
    4. Evaluation Plan (20 points)
    Does the applicant describe the schedule for accomplishing the 
activities to be carried out in this project and methods for evaluating 
the accomplishments?
    5. Budget (reviewed, but not scored)
    Is the proposed budget reasonable, clearly justified, and 
consistent with the intended use of funds?
    6. Performance Measures (reviewed, but not scored)
    Is the application consistent with the Government Performance and 
Results Act of 1993 (http://www.whitehouse.gov/omb/mgmt-gpra/gplaw2m.html)?

V.2. Review and Selection Process

    Applications will be reviewed for completeness by the Procurement 
and Grants Office (PGO) staff, and for responsiveness by PHPPO. 
Incomplete applications and applications that are non-responsive to the 
eligibility criteria will not advance through the review process. 
Applicants will be notified that their application did not meet 
submission requirements.
    An objective review panel will evaluate complete and responsive 
applications according to the criteria listed in the ``V.1. Criteria'' 
section above.

VI. Award Administration Information

VI.1. Award Notices

    Successful applicants will receive a Notice of Grant Award (NGA) 
from the CDC Procurement and Grants Office. The NGA shall be the only 
binding, authorizing document between the recipient and CDC. The NGA 
will be signed by an authorized Grants Management Officer, and mailed 
to the recipient fiscal officer identified in the application.
    Unsuccessful applicants will receive notification of the results of 
the application review by mail.

VI.2. Administrative and National Policy Requirements,

    45 CFR Part 74 and Part 92
    For more information on the Code of Federal Regulations, see the 
National Archives and Records Administration at the following Internet 
address: http://www.access.gpo.gov/nara/cfr/cfr-table-search.html.
    The following additional requirements apply to this project:
     AR-10 Smoke Free Workplace Requirements;
     AR-11 Healthy People 2010;
     AR-12 Lobbying Restrictions,;
     AR-15 Proof of Non-Profit Status.
    Additional information on these requirements can be found on the 
CDC web site at the following Internet address: http://www.cdc.gov/od/pgo/funding/ARs.htm.

VI.3. Reporting Requirements

    You must provide CDC with an original, plus two hard copies of the 
following reports:
    1. Interim progress report, no less than 90 days before the end of 
the budget period. The progress report will serve as your non-competing 
continuation application, and must contain the following elements:
    a. Current Budget Period Activities Objectives.
    b. Current Budget Period Financial Progress.
    c. New Budget Period Program Proposed Activity Objectives.
    d. Budget.
    e. Additional Requested Information.
    f. Measures of Effectiveness.
    2. Financial status report and annual progress report, no more than 
90 days after the end of the budget period.
    3. Final financial and performance reports, no more than 90 days 
after the end of the project period.
    These reports must be mailed to the Grants Management or Contract 
Specialist listed in the ``Agency Contacts'' section of this 
announcement.

VII. Agency Contacts

    For general questions about this announcement, contact: Technical 
Information Management Section, CDC Procurement and Grants Office, 2920 
Brandywine Road, Atlanta, GA 30341, Telephone: 770-488-2700.
    For program technical assistance, contact: Joe Boone, Ph.D., 
Associate Director for Science, Division of Laboratory Systems, Public 
Health Practice Program Office, 4770 Buford Hwy., NE., Atlanta, GA 
30341-3717, Telephone: (770) 488-8080, fax: (770) 488-8282, e-mail: 
[email protected].
    For financial, grants management, or budget assistance, contact: 
Sharon Robertson, Grants Management Specialist, CDC Procurement and 
Grants Office, 2920 Brandywine Road, Atlanta, GA 30341, Telephone: 770-
488-2748, e-mail: [email protected].

VIII. Other Information

    Web site for information about 2003 Quality Institute and related 
activities: http://www.phppo.cdc.gov/mlp/qiconference/.

    Dated: June 16, 2004.
William P. Nichols,
Acting Director, Procurement and Grants Office, Centers for Disease 
Control and Prevention.
[FR Doc. 04-14044 Filed 6-21-04; 8:45 am]
BILLING CODE 4163-18-P