[Federal Register: April 26, 2004 (Volume 69, Number 80)]
[Notices]
[Page 22527-22531]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26ap04-73]
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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:
GrantsInfo@nih.gov.
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: kef2@cdc.gov.
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: crb5@cdc.gov.
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: tnr3@cdc.gov.
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