[Federal Register Volume 69, Number 94 (Friday, May 14, 2004)]
[Notices]
[Pages 26836-26841]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-10947]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Request for Applications to Determine the Pharmacokinetics of 
Clostridium Botulinum Neurotoxins A, B, C, E, and F

    Announcement Type: New.
    Funding Opportunity Number: 04099.
    Catalog of Federal Domestic Assistance Number: 93.283.
    Key Dates:
    Letter of Intent Deadline: June 1, 2004.
    Application Deadline: June 28, 2004.
    Executive Summary: The Centers for Disease Control and Prevention 
(CDC) invites investigator-directed research grant applications that 
will lead to an understanding of the relationship between oral exposure 
to Clostridium botulinum neurotoxin, morbidity, and lethality. Research 
should include, but is not limited to, the establishment and 
implementation of methods and procedures in non-human primates for 
determination of the pharmacokinetics of both the di-chain and 
progenitor forms of C. botulinum neurotoxins A, B, C, E, and F. The 
information gathered by this study will help guide policy development 
and most importantly

[[Page 26837]]

enable informed treatment recommendations. Applications should define 
the proposed project goal, interim objectives (development milestone), 
potential ultimate product, and provide a timeline for milestone and 
goal attainment. This grant seeks researchers that can collaborate with 
relevant ongoing small animal studies or that have established small 
animal models and the ability to transfer these studies to non-human 
primates. Preference will be given to otherwise equivalent proposals 
that take measures to minimize suffering and preserve the life of 
animals utilized in this study to the extent possible. All applicants 
must comply with CDC guidelines on the care and use of laboratory 
animals.

I. Funding Opportunity Description

    Authority: This program is authorized under the Public Health 
Service Act Sections 301(a) [42 U.S.C.241(a)], as amended.
    Purpose: The purpose of this research grant is to support the 
development and utilization of a non-human primate model system to 
gather data on the adsorption, distribution, localization, metabolism 
and clearance of botulinum neurotoxins. The data obtained from this 
study will aid the development of methods and procedures to rapidly 
identify and more effectively treat a human population exposed to 
botulinum neurotoxin via natural or intentional mechanisms.
    The botulinal neurotoxins pose a significant threat to the public 
as bioterrorist weapons because of their potency, ease of production 
and transport, and the potential burden that affected individuals would 
place on the public health care system. These neurotoxins, which are 
produced by the ubiquitous pathogen Clostridium botulinum and some 
strains of Clostridium baratii and Clostridium butyricum, are among the 
most toxic substances known to man. The botulinum neurotoxins (BoNTs) 
are produced in seven antigenically distinct forms that are identified 
as types A, B, C, D, E, F, and G. The toxins are naturally found 
complexed to neuroassociated proteins (progenitor toxin), but can be 
purified to a fully active di-chain neurotoxin molecule. The BoNTs 
block the release of the neurotransmitter, acetylcholine, which 
uncouples the neuromuscular junction and results in paralysis and death 
if left untreated. Estimates suggest that as little as 1 ng/kg and 3 
ng/kg of neurotoxin type A is enough to kill 50 percent of a human 
population exposed by oral and inhalation routes, respectively.
    In the United States, less than 150 cases of laboratory confirmed 
botulism are reported each year and there are no preventative therapies 
for the general public at this time as natural cases of botulism are 
relatively rare. Most cases of botulism traditionally result from 
exposure to the BoNTs through ingestion of preformed toxin in foods or 
through secondary means in which a toxin producing organism is 
introduced and becomes established in the body. Inhalational botulism 
is not a common form of exposure. Most of the information on botulinum 
intoxication and treatment in humans is derived from cases of naturally 
occurring foodborne botulism. Neurological signs of botulism in humans 
include: symmetric, descending flaccid paralysis with bulbar palsies, 
ptosis, diplopia, blurred vision, enlarged pupils, dysarthria, 
dysphonia, and dysphagia. The lag time between exposure and rapidity of 
symptom onset is difficult to establish in naturally occurring 
foodborne cases as it is dependent on the rate and amount of toxin 
ingested by each affected individual among other variables. At this 
time, clinical presentation consistent with botulism, which may occur 
12-72 hours after toxin ingestion, is the only basis for implementation 
of antitoxin therapy, which will stop the progression of neuronal 
damage but not reverse it. Although clinical specimens such as 
aspirates, serum and stool can be analyzed for the presence of BoNT, 
the absence of toxin in such specimens does not rule out intoxication. 
Thus, although it is crucial that BoNT exposed individuals are 
identified and appropriately treated in a timely manner, insufficient 
data are available to establish a defined time line between exposure to 
botulinum toxin, adsorption by mucosal tissues, toxin stability in 
vivo, toxin serum levels over time, and clearance.
    Currently, the treatment of botulism patients requires extensive 
supportive care and passive immunization with equine antitoxin. Data 
from outbreaks resulting from ingestion of naturally contaminated foods 
suggest that up to 95 percent of exposed individuals require 
hospitalization and up to 62 percent require long-term ventilation. 
This suggests that with our current capabilities, a large outbreak 
would place an enormous strain on the existing health care 
infrastructure, possibly limiting treatment capacity. Although modern 
antitoxin therapy treatments are highly effective in reducing mortality 
in humans, existing supplies need to be used in an effective and timely 
manner.
    The determination of the pharmacokinetics of the BoNTs resulting 
from oral exposure will provide critical information that will aid 
early identification of exposed individuals and enable the development 
of informed guidelines that will maximize effective delivery of 
therapeutic antitoxin in a large scale outbreak.
    This program addresses the ``Healthy People 2010'' focus area of 
Immunization and Infectious Disease.
    Measurable outcomes of the program will be in alignment with the 
following performance goal for the National Center for Infectious 
Diseases (NCID): Protect Americans from infectious diseases.
    Research Objectives: Develop and utilize a non-human primate model 
system to determine the pharmacokinetics of both di-chain and 
progenitor forms of C. botulinum neurotoxins A, B, C, E, and F 
resulting from low to high level toxin exposure. The product of this 
research should establish a timeline of events and a relationship among 
the following: C. botulinum toxin exposure level, neurotoxin type (A, 
B, C, E, and F), toxin form (di-chain and progenitor toxin), rate of 
toxin adsorption into serum, distribution and quantity of toxin in body 
fluids and products (serum, and stool), toxin stability/duration of 
action, time of botulism symptom onset (as related to time of exposure, 
and toxin serum levels), biotransformation of toxin in body fluids/
products (i.e. presence of progenitor, di-chain, or another form of the 
toxin), rate of toxin clearance, variability in exposed population, and 
recovery.
    Activities: Awardee activities for this program but are not limited 
to the following:
     Establish a relevant small animal model (examples include 
guinea pigs or mice) to conduct pharmacokinetic studies on botulinum 
toxins that can be transferred to non-human primate studies. 
Alternatively, it is acceptable to establish collaboration with 
researcher(s) conducting ongoing small animal studies and to propose 
how those studies would be transferred to non-human primates.
     Develop protocols and procedures for testing, maintenance, 
and recovery of non-human primates.
     Describe a timeframe for development of a proof-of-concept 
small animal model, establishment of a non-human primate model, 
attainment of necessary materials to perform the study, collection and 
analysis of clinical specimens, and completion of the study.

[[Page 26838]]

     Develop and implement protocols to address the research 
objectives in a non-human primate model system, including but not 
limited to methods for oral toxin exposure, collection and testing of 
appropriate tissues and or body fluids/products, evaluation of botulism 
symptom onset, and evaluation of intra-study variation among test 
subjects.

II. Award Information

    Type of Award: Grant.
    Award Mechanism: R01.
    Fiscal Year Funds: 2004.
    Approximate Total Funding: $2,000,000.00.
    Approximate Number of Awards: 1-2.
    Approximate Average Award: $900,000.00.
    Floor of Award Range: None.
    Ceiling of Award Range: None.
    Anticipated Award Date: September 1, 2004.
    Budget Period Length: 12 months.
    Project Period Length: 3 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 organizations 
and by governments and their agencies, such as:
     Public nonprofit organizations.
     Private organizations.
     Universities.
     Colleges.
     Research institutions.
     Hospitals.
     Community-based organizations.
     Faith-based organizations.
     Federally recognized Indian tribal governments.
     Indian tribal 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).
     Political subdivisions of States (in consultation with 
States).
    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

    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.
    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

    Letter of Intent (LOI): Your LOI must be written in the following 
format:
     Maximum number of pages: 3.
     Font size: 12-point unreduced.
     Single 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:
     Descriptive title of the proposed research.
     Name, address, E-mail address, and telephone number of the 
Principal Investigator.
     Names of other key personnel.
     Participating institutions.
     Number and title of this Program Announcement.
    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: 
[email protected].
    Your research plan should address activities to be conducted over 
the entire project period.
    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

    LOI Deadline Date: June 1, 2004. CDC requests that you send a LOI 
if you

[[Page 26839]]

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: June 28, 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

    LOI Submission Address: Submit your LOI by express mail, delivery 
service, fax, or E-mail to: Barbara Stewart, Centers for Disease 
Control and Prevention, National Center for Infectious Diseases, 1600 
Clifton Road, NE., Mail Stop C-19, Atlanta, GA 30333, Phone: 404-639-
0044, Fax: 404-639-2469, E-mail Address: [email protected].
    Application Submission Address: Submit the original and five hard 
copies of your application by mail or express delivery service to: 
Technical Information Management-PA 04099, 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 grant. 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 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? Will this study make significant 
contributions to the existing knowledge base regarding effective 
antitoxin treatment of botulinum toxin exposed individuals?
    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? Has the applicant outlined a 
reasonable plan for attaining the objectives of this project within the 
indicated time frame? Are standardized operating procedures and 
documentation practices described?
    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? Is the entity or facility conducting 
the experiments approved to work with botulinum toxin by the Select 
Agent Program?
    Additional Review Criteria: In addition to the above criteria, the 
following items will be considered in the determination of scientific 
merit and priority score:
    Study Animal Model(s): Are the animal models described appropriate 
for attainment of study objectives? Has the applicant described a 
reasonable timeline and approach for development and implementation of 
a non-human primate model system? Has the applicant described an 
approach that will enable satisfactory attainment of the study 
objectives? Are adequate treatment/therapy methods described

[[Page 26840]]

for non-human primates used in this study?
    Laboratory Analysis and Clinical Evaluation: Has the applicant 
described satisfactory methods for collection of clinical specimens? Is 
a method described for analysis of clinical specimens and is this 
method adequately sensitive to detect relevant levels of toxin? Does 
the applicant recognize potential problems regarding sensitive 
detection of toxin in clinical specimens and considered alternative 
strategies? Has the applicant provided background and experience for 
the entity conducting laboratory testing, if applicable? Has the 
applicant described a reasonable method for evaluation of botulism 
symptom presentation in small animals and non-human primates?
    Study Timeline and Protocol: Has the applicant described a 
reasonable timeframe for completion of the proof-of-concept small 
animal study, initiation and completion of the non-human primate study, 
collection and analysis of clinical specimens, reporting, and 
successful completion of the program?
    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.
    Care and Use of Vertebrate Animals in Research: If vertebrate 
animals are to be used in the project, the five items described under 
Section f of the PHS 398 research grant application instructions will 
be assessed.
    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 NCID. 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 NCID 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).
     Ability of proposal to attain research objectives.
     Availability of funds.
     Programmatic priorities.

V.3. Anticipated Announcement and Award Dates

    Anticipated Award Date: September 1, 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 Parts 74 and 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-3 Animal Subjects Requirements.
     AR-7 Executive Order 12372.
     AR-10 Smoke-Free Workplace Requirements.
     AR-11 Healthy People 2010.
     AR-12 Lobbying Restrictions.
     AR-15 Proof of Non-Profit Status.
     AR-22 Research Integrity.
     AR-23 States and Faith-Based Organizations.
     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 Web site) 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 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, CDC, National Center for 
Infectious Diseases,

[[Page 26841]]

 1600 Clifton Road, NE., Mailstop: C-19, Atlanta, GA 30333, Telephone: 
404-639-0043, E-mail: [email protected].
    For questions about peer review, contact: Barbara Stewart, Public 
Health Analyst, CDC, National Center for Infectious Diseases, 1600 
Clifton Road, NE., Mailstop: C-19, Atlanta, GA 30333, Telephone: 404-
639-0044, E-mail: [email protected].
    For financial, grants management, or budget assistance, contact: 
Jeff Napier, Contract Specialist, CDC Procurement and Grants Office, 
2920 Brandywine Road, Atlanta, GA 30341, Telephone: 770-488-2628, E-
mail: [email protected].

VIII. Other Information

    None.

    Dated: May 10, 2004.
Bill Nichols,
Acting Director, Procurement and Grants Office, Centers for Disease 
Control and Prevention.
[FR Doc. 04-10947 Filed 5-13-04; 8:45 am]
BILLING CODE 4163-18-P