[Federal Register Volume 69, Number 80 (Monday, April 26, 2004)]
[Notices]
[Pages 22527-22531]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-9374]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Food Safety: Discovering Novel Causes of Foodborne Illness

    Announcement Type: New.
    Funding Opportunity Number: 04103.

    Catalog of Federal Domestic Assistance Number: 93.283.

    Key Dates: Letter of Intent Deadline: May 26, 2004.
    Application Deadline: June 25, 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. 247(k)(2)), as amended.

    Purpose: The purpose of the program is to better define the burden 
of foodborne, infectious diarrheal diseases among a broad array of 
known and potential pathogens, to test for novel pathogens and evaluate 
new diagnostic tests where the results will advance our knowledge of 
relative frequency of foodborne pathogens and improve disease 
surveillance and prevention efforts. This program addresses the 
``Healthy People 2010'' focus area of Food Safety. See Attachment II of 
this announcement as posted on the CDC Web site for more background 
information.
    Measurable outcomes of the program will be in alignment with the 
following performance goals for the National Center for Infectious 
Diseases (NCID): Protect Americans from infectious diseases and reduce 
the spread of antimicrobial resistance.
    Research Objectives:
     Develop a collaborative multisite study within 
Foodborne Diseases Active Surveillance Network (FoodNet) (see 
attachment II for FoodNet description) to expand activities into 
microbiologic research of potentially important foodborne etiologies of 
infectious diarrhea.
     Enroll persons with and without diarrhea in a 
study to determine the potential infectious etiologies of diarrheal 
illness.
     Determine the demographic and clinical 
characteristics of infectious etiologies of diarrheal illness.
     Determine major risk factors for the acquisition 
of diarrheagenic pathogens or antibiotic resistance among enteric 
pathogens or normal enteric flora.
     Develop and assess culture and non-culture 
techniques to identify and characterize potential foodborne diarrheal 
pathogens.

[[Page 22528]]

     Serve to evaluate stool samples for infectious 
etiologies from foodborne outbreaks of unknown etiology among FoodNet 
sites.
     Characterize antibiotic resistance determinants 
among pathogens and normal human fecal flora.
     Transfer new diagnostic technology to public 
health and clinical laboratories.
    Activities: Awardee activities of this program are as follows:
     Conduct all activities and studies in a 
collaborative network of investigators from the study sites, 
collaborating FoodNet sites, and the Centers for Diseases Control and 
Prevention (CDC). Study results from individual study sites will be 
combined for analyses, presentation and manuscripts.
     Develop a study protocol, standard 
questionnaires, medical chart data abstraction forms and databases in 
collaboration with study investigators from other FoodNet study sites 
and CDC.
     Establish clinic-based pediatric and adult 
patient enrollment in emergency departments and clinics to enroll case-
patients presenting with diarrhea and persons without diarrhea 
(controls). Case-patient enrollment, with the collection of bulk stool 
specimens, should exceed a minimum of 250 per year. An approximately 
equal number of control-patients, with bulk stool specimens collected, 
should be enrolled annually.
     Collect bulk stool specimens from all case- and 
control-patients and appropriately transport and store them for 
testing.
     Conduct interviews with case- and control-
patients using standardized questionnaires.
     Conduct standardized medical chart abstractions.
     Determine a broad array of bacterial, parasitic, 
and viral etiologies for diarrhea in all collected stool specimens. An 
example of a possible testing scheme is demonstrated in Attachment III. 
Tests proposed by applicants may or may not include, and are not 
limited to those in the example testing scheme.
     Seek heretofore unknown pathogens in select 
populations and circumstances.
     Establish a bank of frozen whole stool 
specimens, isolated pathogens, and nucleic acid extracts from stool 
specimens collected as part of this study.
     Determine antimicrobial drug susceptibilities 
for bacterial pathogens and selected normal fecal flora.
     Develop and/or evaluate new diagnostic tests for 
infectious diarrhea.
     Maintain a database of results using software 
and database structure which will allow merging data with that from 
other sites for combined analyses.
     Obtain and maintain all local approvals for 
human subjects' protection.
    In a cooperative agreement, CDC staff is substantially involved in 
the program activities, above and beyond routine grant monitoring.
    CDC Activities for this program are as follows:
     Organize and host initial and yearly 
investigator's meeting.
     Collaborate with recipients in the consensus 
development of the study protocols, questionnaires, medical chart 
abstraction forms and study databases.
     Provide coordination and technical assistance in 
carrying out project activities, including data analyses, presentations 
and manuscripts.
     If a proposed project involves research with 
human subjects and CDC scientists will be co-investigators in that 
research, assist in the development of a research protocol for IRB 
review by all institutions participating in the research project. The 
CDC IRB will review and approve the project initially and on, at least, 
an annual basis until the research project is completed.
     Making site visits to review progress.

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: $700,000.
    Approximate Number of Awards: Two.
    Approximate Average Award: $350,000.
    Floor of Award Range: None.
    Ceiling of Award Range: $700,000.
    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.
     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 you request a funding amount greater than the ceiling of the 
award range, your application will be considered non-responsive, and 
will not be entered into the review process. You will be notified that 
your application did not meet the submission requirements.
    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:
    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.
    An LOI is required for this program. Any application received 
without the prior submission of an LOI will be considered non-
responsive.
    Applications from principal participants of the FoodNet must

[[Page 22529]]

include a letter of collaboration and support from the research 
institution responsible for conducting advanced microbiologic testing.
    Applications from research institutions conducting advanced 
microbiologic testing must include a letter of collaboration and 
support from principal participants of the collaborating FoodNet site.
    This research study is intended as an expansion of activities among 
FoodNet collaborative partners. Other proposed studies within FoodNet 
will interface with this project. For example, FoodNet investigations 
into the etiology of outbreaks of unknown etiology will use the 
laboratory capacity established under this cooperative agreement to 
conduct advanced microbiologic testing.
    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): A Letter of Intent is required for this 
Program Announcement and must be written in the following format:
     Maximum number of pages: Two.
     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 
(PA).
    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 be single spaced and 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.
    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: May 26, 2004.
    Submission of an LOI is required if you intend to apply for this 
program. The LOI will not be evaluated or scored. It will be used to 
gauge the level of interest in this program and to allow CDC to plan 
the application review. If you do not submit an LOI, you will not be 
allowed to submit an application.
    Application Deadline Date: June 25, 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.

[[Page 22530]]

IV.5. Funding Restrictions

    Restrictions, which must be taken into account while writing your 
budget, are as follows:
     Construction is not allowable.
    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.

IV.6. Other Submission Requirements

    LOI Submission Address: Submit your LOI by express mail, delivery 
service, fax, or e-mail to: Ken Fortune, Extramural Program 
Coordinator, Centers for Disease Control and Prevention, National 
Center for Infectious Diseases, 1600 Clifton Road, NE., Mailstop C-19, 
Atlanta, GA 30333, Telephone Number: (404) 639-0890, Fax: (404) 639-
4195, E-mail: [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-PA04103, 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 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.
    Your application will be evaluated against the following criteria:
Operational Plan (40 Points)
    Does the applicant propose clear operational plan(s) for the 
various study components addressed? Collectively, how well do the 
applicant's proposed activities address the stated objectives and 
suggested activities outlined in the Activities section? Does the 
applicant describe the essential collaboration between FoodNet site 
investigators and research site investigators? Does the plan for case-
patient and control-patient enrollment, with whole stool specimen 
collection, indicate probable success in achieving the stated 
enrollment goals? Does the plan include adequate personnel to carry out 
the proposed enrollment, consent, patient interviews, chart reviews, 
specimen collection and microbiologic testing? Are letters of 
collaboration and support from collaborating investigators or 
institutions included?
Experimental Plan (40 Points)
    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, specifically concerning case-patient and 
control-patient enrollment and specimen collection? Does the proposed 
testing include a broad array of bacterial, parasitic, and viral 
pathogens? Does the proposed testing include proposals to identify 
novel agents? Does the proposal include the identification and 
characterization of antibiotic resistance determinants in pathogens and 
select normal stool flora? Does the proposal include diagnostic test 
development and/or evaluation?
Facilities and Personnel (10 Points)
    Do the proposed investigators and personnel have the background and 
experience to carry out the proposed activities? Do they have 
experience in related research? Are the facilities described and are 
they appropriate?
Understanding the Problem (10 Points)
    Does the applicant demonstrate a clear understanding of the 
surveillance, epidemiologic and microbiologic issues in determining the 
burden of foodborne illness among enteric pathogens, particularly for 
pathogens for which routine surveillance does not exist and for 
pathogens yet to be discovered?
Protection of Human Subjects From Research Risks (No Score)
    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 (No Score)
    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 (No Score)
    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.
    An objective review panel will evaluate complete and responsive 
applications according to the criteria listed in the ``V.1. Criteria'' 
section above.
    In addition, the following factors may affect the funding decision:
     Although new programs are encouraged, a funding 
preference will be given to current FoodNet participants or current or 
newly established collaborative university medical center partners of 
FoodNet sites (located in the States of Maryland, Connecticut, New 
York, Minnesota, California, Colorado, New Mexico, Georgia, Tennessee, 
and Oregon) over applications not already receiving support under the 
program. Current FoodNet sites have implemented networks that require 
continued support to become fully developed and to realize the benefits 
of the network activities.

[[Page 22531]]

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 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-9 Paperwork Reduction Act Requirements.
     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: Chris Braden, Program 
Official, Centers for Disease Control and Prevention, National Center 
for Infectious Diseases, 1600 Clifton Road, NE., Atlanta, GA 30333, 
Telephone: (404) 639-2206, E-mail: [email protected].
    For financial, grants management, or budget assistance, contact: 
Theresa Routh-Murphy, Contract Specialist, CDC Procurement and Grants 
Office, 2920 Brandywine Road, Atlanta, GA 30341, Telephone: (770) 488-
2648, E-mail: [email protected].

    Dated: April 20, 2004.
William P. Nichols,
Acting Director, Procurement and Grants Office, Centers for Disease 
Control and Prevention.
[FR Doc. 04-9374 Filed 4-23-04; 8:45 am]
BILLING CODE 4163-18-P