[Federal Register: April 30, 2004 (Volume 69, Number 84)]
[Notices]
[Page 23763-23768]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30ap04-67]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Prevention Epicenter Program
Announcement Type: Competitive Supplemental.
Funding Opportunity Number: 04100.
Catalog of Federal Domestic Assistance Number: 93.283.
Key Dates: Application Deadline: June 14, 2004.
Executive Summary: This announcement encompasses two distinct
projects.
(1) Microbiology laboratory errors. Errors in the laboratory can
occur during the pre-analytical, analytical, and post analytical phases
of specimen management. Most studies on laboratory errors focus on the
analytical (testing) phase; however, preliminary data from a pilot
study conducted by CDC suggests that there are a significant numbers of
errors that occur with antimicrobial susceptibility testing results in
the post analytical reporting phase. This program focuses on assessing
the impact of both testing and reporting errors on patient management
and outcomes.
(2) C. difficile associated disease. C. difficile associated
disease (CDAD) is an important, yet under recognized, public health
problem that results in significant patient morbidity and
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increased healthcare costs. Recent estimates of the scope and magnitude
of CDAD suggest its incidence among acute care hospital patients,
results in over 500 million dollars in excess healthcare costs
annually. Moreover, various data sources suggest its incidence is
increasing. It is hypothesized that changing antimicrobial use patterns
and resistance may be contributing to this increasing incidence. In
addition, programs that include new methods of infection control (such
as novel methods of environmental disinfection, novel strain typing
methods and hand washing using alcohol-base products) as well as
improved laboratory detection and reporting methods may be impacting
the incidence of CDAD.
I. Funding Opportunity Description
Authority: Section 317(k)(2) of the Public Health Service Act
[42 U.S.C. 247b(k)(2)], as amended.
Purpose: The purpose of these supplemental awards is twofold: (1)
To determine the number and types of laboratory errors associated with
identification and antimicrobial susceptibility testing of bacteria
isolated from cultures of blood and sterile body sites of hospitalized
patients; and (2) to determine if recently introduced antimicrobial
agents and infection control practices are impacting rates of C.
difficile-associated disease and whether antimicrobial resistance could
be emerging. This program addresses the ``Healthy People 2010'' focus
area of Immunization and Infectious Diseases.
Measurable outcomes of the program will be in alignment with one or
more of the following performance goal(s) for the National Center for
Infectious Diseases: Protect Americans from infectious diseases, Reduce
the spread of antimicrobial resistance, and Protect Americans from
death and serious harm caused by medical errors and preventable
complications of healthcare.
Research Objectives: (1) Microbiology laboratory errors. Errors in
the laboratory can occur during the pre-analytical, analytical, and
post analytical phases of specimen management. Most studies on
laboratory errors focus on the analytical (testing) phase; however,
preliminary data from a pilot study conducted by CDC on laboratory
reports concerning bacterial pathogens causing bloodstream infections
suggest that there are a significant numbers of errors that occur with
antimicrobial susceptibility testing results in the post analytical
reporting phase. This program focuses on assessing the impact of both
testing and reporting errors on patient management and outcomes.
The knowledge gained through this research will help define what
interventions need to be made in laboratories to improve the accuracy
and utility of antimicrobial susceptibility tests reports (such as
cascading of results) to reduce errors and improve patient outcomes.
The objectives of this program are to:
Determine the number and types of microbiology
laboratory errors associated with processing cultures from blood and
sterile body sites (such as cerebrospinal fluid (CSF)) of hospitalized
patients;
Determine the accuracy of bacterial
identifications by participating laboratories;
Determine the accuracy of the antimicrobial
susceptibility patterns of the bacteria recovered from the blood and
sterile body sites; and
Determine the accuracy and appropriateness of
the reports issued to the patients' charts, along with the outcomes of
the patients for which errors are noted.
One possible study design would be to identify a series of positive
blood and body fluid cultures, to include both Gram-positive and Gram-
negative pathogens, and to track the flow of information from the
laboratory to the patients' chart, while concomitantly sending the
isolates and a copy of the microbiology results to a reference
laboratory for confirmation. The appropriateness of the antimicrobial
agents tested and reported, given the identification of the organism to
genus and species level, is critical. Thus, attention should be paid to
reporting of results for inappropriate antimicrobial agents (e.g.,
nitrofurantoin for blood cultures), or reporting results for fourth
generation cephalosporins or carbapenems, for organism that are
susceptible to first generation cephalosporins.
(2) C. difficile associated disease. (CDAD) According to national
data from hospital discharges, CDAD rates are increasing and CDAD is
now responsible for substantial patient morbidity and excess healthcare
costs. Because antimicrobial agents are a major risk factor for CDAD,
it is unknown whether the introduction and widespread use of certain
newer antimicrobials, especially those with anti-anaerobic activity,
may lead to increased rates of CDAD. In addition, certain infection
control practices, such as the use of alcohol gels for hand hygiene,
also may contribute to increasing rates of CDAD, whereas hospitals that
use bleach as a disinfectant for environmental surfaces may have better
controlled rates of CDAD. A rationale for introducing new antimicrobial
use guidelines and/or infection control policies will require knowing
the excess costs associated with CDAD and cost effectiveness of
prevention strategies. Finally, it is unknown whether the pathogen C.
difficile itself may be developing resistance to the antimicrobial
agents commonly used to treat CDAD (i.e. metronidazole and vancomycin).
The scientific knowledge to be achieved through this project
includes addressing each of the above questions and information gaps
regarding the contemporary epidemiology of CDAD in U.S. hospitals. To
this end, objectives for this project include the following:
Identify current antimicrobial agents that may
be risk factors for CDAD in several U.S. healthcare facilities.
Determine the antimicrobial susceptibility of at
least 100 recent isolates of Clostridium difficile.
Determine whether infection control practices,
including hand hygiene with alcohol gel (vs. soap and water) and
environmental cleaning with bleach, are risk or protective factors for
CDAD.
Determine the excess healthcare costs of CDAD.
The types of research and experimental approaches to be considered
in answering these questions and achieving the objectives include:
Case-control and/or cohort studies to determine risk factors for CDAD
and the attributable costs of CDAD; isolation of C. difficile from the
stool of CDAD patients followed by identification and susceptibility
testing of isolates; and environmental and hand sampling for C.
difficile and/or intervention studies to determine the impact of
different infection control strategies on either surface contamination
or incidence of CDAD.
Depending on current capabilities and needs, recipients may request
support under this supplement for one or both of the following
projects:
Microbiology Errors Associated with Processing
Blood and Sterile Body Site Cultures.
The Impact of New Forms of Antimicrobial Use,
Resistance, Laboratory Methods, and Infection Control Practices on the
Incidence of Clostridium difficile and Associated Patient Morbidity and
Healthcare Costs.
Activities: Awardee activities for this program are as follows:
[[Page 23765]]
Microbiology Errors Associated With Processing Blood and Sterile Body
Site Cultures
Determine the number and types of microbiology
laboratory errors associated with processing cultures from the blood
and sterile body sites (such as CSF) of hospitalized patients.
Identify the bacteria isolated.
Identify the accuracy of the antimicrobial
susceptibility patterns of the bacteria.
Determine the accuracy of the reports issued to
the patients' charts. Patients' charts should be reviewed and assessed,
along with the outcomes of the patients for which errors are noted.
Identify at least 10 microbiology laboratories
in different healthcare institutions that can serve as study sites.
Identify a central reference laboratory for confirmation of the
identification and antimicrobial susceptibility pattern of the isolates
(this could include the Division of Healthcare Quality Promotion (DHQP)
reference laboratories at CDC).
Prospectively collect at least 10 bacterial
isolates from each study site (at least 5 gram-positive and 5 gram-
negative organisms) for which routine antimicrobial susceptibility
tests are typically performed (excludes organisms such as Neisseria
meningitidis, Group B streptococci, or Haemophilus influenzae). Send
organisms, along with a copy of the organism's identification and
antimicrobial susceptibility test report when completed by the study
site laboratory, to the central laboratory for testing.
Assess whether the appropriate cultures were
collected for the suspected infection (i.e., the appropriate number and
timing of blood cultures, appropriate CSF tubes delivered to
microbiology laboratory within the designated time period established
by the laboratory).
Assess whether the report of culture results and
antimicrobial susceptibility test results on the patients' charts were
accurate and appropriate (e.g., no reports of antimicrobial agents that
are used for urinary tract infections for bacteria from cerebrospinal
fluid).
Assess clinician's response to laboratory data
(i.e., changes in antimicrobial chemotherapy based on susceptibility
test results).
Assess adverse patient outcomes based on
inaccurate or inappropriate reporting of culture and susceptibility
results.
Develop an educational program for reducing the
laboratory errors associated with testing and reporting results for
bacteria isolates from blood and sterile body fluids.
The Impact of New Forms of Antimicrobial Use, Resistance, Laboratory
Methods, and Infection Control Practices on the Incidence of
Clostridium difficile and Associated Patient Morbidity and Healthcare
Costs
Determine if recently introduced antimicrobial
agents (such as fluoroquinolones) or new modes of antimicrobial use
(such as clindamycin for community-associated Staphylococcus aureus
infections) constitute risk factors for C. difficile associated disease
(CDAD).
Determine whether there is emerging resistance
to the drugs of choice (i.e., vancomycin and metronidazole) in C.
difficile that could impede effective treatment.
Determine if new infection control measures
(such as hand washing with alcohol-based products or new disinfectants)
may impact the incidence of CDAD (e.g., risk factors for infection).
Determine the impact of new laboratory methods
(such as the use of assays that detect both toxin A and toxin B),
efforts to reduce turnaround time of assay or culture results, or
improved reporting methods, impact the incidence of CDAD.
Determine the patient morbidity and healthcare
costs associated with the excess or reduced number of cases of CDAD
resulting from any or all of these factors.
In a cooperative agreement, CDC staff is substantially involved in
the program activities, above and beyond routine grant monitoring.
CDC Activities for the two projects are as follows:
Collaborate with the recipient in all stages of
the program, and provide programmatic and technical assistance.
Collaborate with the recipient in all aspects of
the science.
Participate in the dissemination of findings and
information stemming from the project.
Participate in improving program performance
through consultation with recipient.
Facilitate communication of data and results
among stakeholders.
Assist in the development of research protocols
for IRB review by all cooperating institutions participating in the
research project. The CDC IRB will review and approve the protocol
initially and on at least an annual basis until the research project is
completed.
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 Funding: $634,000.
Approximate Number of Awards: Four (two per project).
Approximate Average Award: $158,500 (This amount is for the first
12-month budget period, and includes both direct and indirect costs).
Floor of Award Range: $157,000.
Ceiling of Award Range: $160,000.
Anticipated Award Date: August 16, 2004.
Budget Period Length: 12 months.
Project Period Length: Two 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
Eligibility is limited to the seven current Prevention Epicenter
Program grantees. They are: Harvard Pilgrim Health Care, Washington
University, Northwestern University, University of Iowa, McGuire
Research Institute, Memorial Sloan-Kettering Institute for Cancer
Research, and Johns Hopkins University. No other applications are
solicited.
Eligibility is limited to the Prevention Epicenters in order to
maximize the use of available funds by building on existing
infrastructure for evaluating healthcare-associated infections and
adverse events and utilizing highly demonstrated expertise in infection
control procedures and practices. The proposed supplemental projects
will complement activities associated with the established Prevention
Epicenter Program, which includes projects designed to develop,
implement, and evaluate the effectiveness of epidemiologically-based
strategies to improve healthcare quality and assure patient safety.
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
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entered into the review process. You will be notified that your
application did not meet submission requirements.
This program is designed and intended to support research,
therefore only research will be supported under this cooperative
agreement. Any applications proposing anything other than research will
be considered non-responsive.
Individuals Eligible to Become Principal Investigators: Any
individual with the skills, knowledge, and resources necessary to carry
out the proposed research is invited to work with their institution to
develop an application for support. Individuals from underrepresented
racial and ethnic groups as well as individuals with disabilities are
always encouraged to apply for CDC programs.
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 398
(OMB number 0925-0001 rev. 5/2001). Forms and instructions are
available in an interactive format on the CDC web site, at the
following Internet address: http://www.cdc.gov/od/pgo/forminfo.htm.
Forms and instructions are also available in an interactive format
on the National Institutes of Health (NIH) web site at the following
Internet address: http://grants.nih.gov/grants/funding/phs398/phs398.html
.
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.
IV.2. Content and Form of Application Submission
Application: Follow the PHS 398 application instructions for
content and formatting of your application. For further assistance with
the PHS 398 application form, contact PGO-TIM staff at 770-488-2700, or
contact GrantsInfo, Telephone (301) 435-0714, E-mail:
GrantsInfo@nih.gov.
Your research plan should address activities to be conducted over
the entire project period (through 1/31/2006).
Submit one application that includes one or both of the proposed
projects. Each project should be clearly identified in the application.
Provide a line-item budget and narrative justification for all
requested costs, and separate line-item budgets for each proposal
submitted.
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. Your DUNS number must be entered
on line 11 of the face page of the PHS 398 application form. 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.
This PA uses just-in-time concepts. It also uses the modular
budgeting as well as non-modular budgeting formats. See: http://grants.nih.gov/grants/funding/modular/modular.htm
for additional
guidance on modular budgets. Specifically, if you are submitting an
application with direct costs in each year of $250,000 or less, use the
modular budget format. Otherwise, follow the instructions for non-
modular budget research grant applications.
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
Application Deadline Date: June 14, 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 carriers 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
Your application is subject to Intergovernmental Review of Federal
Programs, as governed by Executive Order (EO) 12372. This order sets up
a system for state and local governmental review of proposed federal
assistance applications. You should contact your state single point of
contact (SPOC) as early as possible to alert the SPOC to prospective
applications, and to receive instructions on your state's process.
Click on the following link to get the current SPOC list: http://www.whitehouse.gov/omb/grants/spoc.html
.
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.
IV.6. Other Submission Requirements
Application Submission Address: Submit the original and five hard
copies of your application by mail or express delivery service to:
Technical Information Management--PA4100, 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
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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 be an
element of evaluation.
The goals of CDC-supported research are to advance the
understanding of biological systems, improve the control and prevention
of disease and injury, and enhance health. In the written comments,
reviewers will be asked to evaluate the application in order to judge
the likelihood that the proposed research will have a substantial
impact on the pursuit of these goals.
The scientific review group will address and consider each of the
following criteria in assigning the application's overall score,
weighting them as appropriate for each application. The application
does not need to be strong in all categories to be judged likely to
have major scientific impact and thus deserve a high priority score.
For example, an investigator may propose to carry out important work
that by its nature is not innovative, but is essential to move a field
forward.
The criteria that will be used to evaluate each project are as
follows:
Significance: Does this study address an important problem? If the
aims of the application are achieved, how will scientific knowledge be
advanced? What will be the effect of these studies on the concepts or
methods that drive this field?
Approach: Are the conceptual framework, design, methods, and
analyses adequately developed, well-integrated, and appropriate to the
aims of the project? Does the applicant acknowledge potential problem
areas and consider alternative tactics?
Innovation: Does the project employ novel concepts, approaches or
methods? Are the aims original and innovative? Does the project
challenge existing paradigms or develop new methodologies or
technologies?
Investigator: Is the investigator appropriately trained and well
suited to carry out this work? Is the work proposed appropriate to the
experience level of the principal investigator and other researchers
(if any)?
Environment: Does the scientific environment in which the work will
be done contribute to the probability of success? Do the proposed
experiments take advantage of unique features of the scientific
environment or employ useful collaborative arrangements? Is there
evidence of institutional support?
Additional Review Criteria: In addition to the above criteria, the
following items will be considered in the determination of scientific
merit and priority score: None
Protection of Human Subjects from Research Risks: Does the
application adequately address the requirements of Title 45 CFR Part 46
for the protection of human subjects? This will not be scored; however,
an application can be disapproved if the research risks are
sufficiently serious and protection against risks is so inadequate as
to make the entire application unacceptable.
Inclusion of Women and Minorities in Research: Does the application
adequately address the CDC Policy requirements regarding the inclusion
of women, ethnic, and racial groups in the proposed research? This
includes: (1) The proposed plan for the inclusion of both sexes and
racial and ethnic minority populations for appropriate representation;
(2) The proposed justification when representation is limited or
absent; (3) A statement as to whether the design of the study is
adequate to measure differences when warranted; and (4) A statement as
to whether the plans for recruitment and outreach for study
participants include the process of establishing partnerships with
community(ies) and recognition of mutual benefits.
Budget: The reasonableness of the proposed budget and the requested
period of support in relation to the proposed research.
V.2. Review and Selection Process
Applications will be reviewed for completeness by the Procurement
and Grants Office (PGO), and for responsiveness by the National Center
for Infectious Diseases. 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.
Applications that are complete and responsive to the PA will be
evaluated for scientific and technical merit by an appropriate peer
review group or charter study section convened by National Center for
Infectious Diseases in accordance with the review criteria listed
above. As part of the initial merit review, all applications may:
Undergo a process in which only those
applications deemed to have the highest scientific merit, generally the
top half of the applications under review, will be discussed and
assigned a priority score.
Receive a written critique.
Receive a second level review by CDC senior
staff.
Award Criteria: Criteria that will be used to make award decisions
include:
Scientific merit (as determined by peer review)
Availability of funds
Programmatic priorities
V.3. Anticipated Award Date
Award Date: August 16, 2004.
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-1--Human Subjects Requirements
AR-2--Requirements for Inclusion of Women and Racial
and Ethnic Minorities in Research
AR-7--Executive Order 12372
AR-10--Smoke-Free Workplace Requirements
AR-11--Healthy People 2010
AR-12--Lobbying Restrictions
AR-22--Research Integrity
AR-25--Release and Sharing of Data
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
You must provide CDC with an original, plus two hard copies of the
following reports:
1. Interim progress report, (use form PHS 2590, OMB Number 0925-
0001, rev. 5/2001 as posted on the CDC website) 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:
[[Page 23768]]
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 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 scientific/research issues, contact: Dr. Mary Lerchen, Acting
Director, Office of Extramural Research, Centers for Disease Control
and Prevention, National Center for Infectious Diseases, 1600 Clifton
Road, NE., Mailstop C-19, Atlanta, GA 30333, Telephone: 404-639-0043,
E-mail: mll0@cdc.gov.
For questions about peer review, contact: Barbara Stewart, Centers
for Disease Control and Prevention, National Center for Infectious
Diseases, 1600 Clifton Road, NE., Mailstop C-19, Atlanta, GA 30333,
Telephone: 404-639-0044, E-mail: bsg2@cdc.gov.
For financial, grants management, or budget assistance, contact:
Yolanda Sledge, Grants Management Specialist, CDC Procurement and
Grants Office, 2920 Brandywine Road, Atlanta, GA 30341, Telephone:
(770) 488-2787, E-mail: YSledge@cdc.gov.
Dated: April 26, 2004.
William P. Nichols,
Acting Director, Procurement and Grants Office, Centers for Disease
Control and Prevention.
[FR Doc. 04-9809 Filed 4-29-04; 8:45 am]
BILLING CODE 4163-18-P