[Federal Register: June 22, 2004 (Volume 69, Number 119)]
[Notices]
[Page 34677-34680]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22jn04-93]
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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 http://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: tsc1@cdc.gov.
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:
dboone@cdc.gov.
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: sqr2@cdc.gov.
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