[Federal Register Volume 69, Number 185 (Friday, September 24, 2004)]
[Notices]
[Pages 57298-57304]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-21474]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Emerging Infections Programs

    Announcement Type: Competing Continuation.
    Funding Opportunity Number: CI05-026.
    Catalog of Federal Domestic Assistance Number: 93.283.
    Key Dates:
    Letter of Intent Deadline: October 11, 2004.
    Application Deadline: November 1, 2004.
    Executive Summary: The purpose of this program announcement is to 
provide continued support to existing Emerging Infections Programs 
(EIPs), or to develop new EIPs, as part of the national network. EIPs 
are population-based centers which assess the public health impact of 
and respond to emerging infections. Activities of the EIPs fall into 
these general categories: (1) Active surveillance; (2) applied public 
health epidemiologic and laboratory activities; and (3) implementation 
and evaluation of pilot prevention/intervention projects. The EIPs 
function as a collaborative network of public and private organizations 
that have an interest in addressing infectious diseases health issues; 
EIPs maintain sufficient flexibility to address infectious disease 
health issues as they emerge. EIPs are strategically located to serve a 
variety of geographical areas and diverse groups of people.
    The following guiding principles motivate the work of the EIPs: (1) 
EIPs aim to be a national resource for surveillance, prevention, and 
control of emerging infectious diseases--EIP functions go beyond the 
routine functions of health departments in ways that allow important 
public health questions to be answered; (2) EIP activities address 
important issues in infectious diseases, selected with regard to what 
is appropriate for this population-based infrastructure; (3) EIPs 
maintain sufficient flexibility for emergency response and to address 
new problems as they arise; (4) training is a key function of the EIPs; 
(5) EIPs develop and evaluate public health practices and transfer what 
is learned to the public health community; and (6) EIPs give high 
priority to activities that lead directly to prevention of disease.

I. Funding Opportunity Description

    Authority: This program is authorized under the Public Health 
Service Act Sections 301(a)[42 U.S.C. 241(a)], 317(k)(1)[42 U.S.C. 
247b(k)(1)], and 317(k)(2)[42 U.S.C. 247b(k)(2)], as amended.

    Purpose: The purpose of the program is to assist in local, state, 
and national efforts to conduct surveillance and public health 
epidemiologic and laboratory activities in emerging infectious 
diseases, and to pilot and evaluate methods for the prevention and 
control of emerging infectious diseases. This program addresses the 
``Healthy People 2010'' focus area(s) of Immunization and Infectious 
Diseases.
    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: The overall objective of the EIP cooperative 
agreement is to assess the public health impact of and respond to 
emerging infections. Activities of the EIPs fall into these general 
categories: (1) Active surveillance; (2) applied public health 
epidemiologic and laboratory activities; and (3) implementation and 
evaluation of pilot prevention/intervention projects. Specific 
objectives for research and other activities supported by this 
cooperative agreement are outlined in the individual Activities, below.
    Activities: Awardee activities for this program are as follows:
    (a) Functions and structure for EIP--Establish and operate an EIP 
to further local, State, and national efforts to address emerging 
infectious diseases.
    (1) Establish each EIP activity in a defined population, which 
could include either an entire State or a geographically defined area 
(or areas) within a State. The population base may vary for various 
activities. For certain activities, the population base may be defined 
by a healthcare delivery system such as a health maintenance 
organization (HMO). To accomplish the objectives of certain EIP 
activities, a minimum population base of approximately 1,500,000 may be 
necessary.

[[Page 57299]]

    (2) Provide effective scientific leadership, coordination, and 
execution of EIP activities.
    (3) Provide effective management to support operation of the EIP.
    (4) Organize the EIP so that it maintains the flexibility to 
respond to new health problems as they emerge.
    (5) Operate the EIP so that it can function effectively as part of 
a national network of EIPs. Collaborate with CDC and other EIPs, 
through the EIP steering group and other EIP working groups, to 
establish priorities, to coordinate and monitor projects, and to assure 
that important emerging infections issues are appropriately addressed.
    (6) Ensure that site representatives attend and participate in EIP 
Steering Group Meetings and other required EIP meetings.
    (7) As a part of certain EIP projects, provide specimens such as 
disease-causing isolates or serum specimens to appropriate 
organizations (which may include, but is not limited to CDC) for 
laboratory evaluation (e.g., molecular epidemiologic studies, 
evaluation of diagnostic tools).
    (8) Manage, analyze, and interpret data from EIP projects; publish 
and disseminate important public health information stemming from EIP 
projects in collaboration with CDC and other EIP sites.
    (9) Monitor and evaluate scientific and operational accomplishments 
and progress in achieving the purpose of this program.
    (10) If a proposed project involves research on human participants, 
ensure appropriate IRB review.
    (11) Information systems used or developed through this cooperative 
agreement should conform to the Public Health Information Network 
(PHIN) standards, the goal of which is the creation of standards-based, 
interoperable public health information systems. For more information 
on PHIN, the PHIN architecture, PHIN messaging, and PHIN standards, 
functions, and specifications, see the CDC Web site: http://www.cdc.gov/phin. CDC will work with EIP sites to evolve EIP 
information systems to conform to PHIN standards.
    (b) Partnerships--Develop the EIP as a partnership between the 
health department and other public and private organizations that have 
an interest in addressing public health issues relating to emerging 
infectious diseases, e.g., local public health agencies, academic 
institutions, health care providers, infection control professionals, 
clinical laboratories, other Federal and state government agencies, and 
research organizations. Build and draw upon these relationships for the 
conduct of specific EIP activities.
    (c) Tools and Capacities--Develop and utilize a set of tools or 
capacities to conduct EIP activities, e.g., active laboratory-based 
surveillance; medical records review for surveillance or studies; case-
control studies; selected laboratory testing of isolates or specimens; 
surveys (e.g., of laboratories, providers, public); collection of 
isolates of disease-causing agents in the context of surveillance; 
network of infection control professionals; and analyses of hospital 
admission or discharge data.
    (d) General EIP Activities--Activities of the EIPs generally fall 
into three categories:
    (1) Active population-based surveillance projects. These may 
include collection and submission of disease-causing infectious agents 
to state, CDC, or other laboratories. For example, the surveillance 
case definition for the condition might involve detection of a positive 
culture or a drug resistant isolate in a microbiology laboratory, a 
serologic test result, a histopathologic finding, or a clinical 
syndrome, depending upon the disease or condition under surveillance. 
The specific approach to surveillance could also vary depending on the 
disease or condition under surveillance. Surveillance should be 
comprehensive (e.g., may include audits to assure complete reporting) 
with active case-finding.
    (2) Applied epidemiologic and applied laboratory projects. Examples 
of potential projects include: Evaluation of illnesses often not 
specifically diagnosed for which information about trends and etiology 
are important (e.g., pneumonia); evaluation of clinical outcomes or 
risk factors for drug resistant infections; evaluation of the role of 
human genomics in disease causation and individual susceptibility; and 
evaluation of the efficacy of pneumococcal and meningococcal conjugate 
vaccines.
    (3) Implementation and evaluation of pilot prevention/intervention 
projects for emerging infectious diseases. Examples might include, 
e.g., evaluation of the impact of Group B Streptococcus prevention 
guidelines, or evaluation of the role of human genomics in public 
health investigations.
    (e) Specific EIP activities--All applicants should propose 
activities <greek-i>1-5; additional activities may be proposed 
(<greek-i>6-12) at the discretion of the applicant. Each application 
will be evaluated as a whole (see Criteria for evaluation in Section 
V.1 below). Therefore, any additional activity proposals should be 
commensurate with the applicant's capacity and should be designed to 
enhance the applications as whole. Applicants are invited to consult 
with CDC programs in planning their proposed activities. [For details 
about these activities, see Appendices posted on the CDC Web site: 
http://www.cdc.gov/od/pgo/funding/grantmain.htm.]
    (1) Active Bacterial Core surveillance (ABCs) and related 
activities--ALL applicants should propose this activity. CDC expects to 
provide support for ABCs activities in all EIPs, although some ABCs 
activities are expected to be conducted only in certain sites. For more 
details, see Appendix 1 posted on the CDC Web site: http://www.cdc.gov/od/pgo/funding/grantmain.htm.
    (2) Active population-based laboratory surveillance for food-borne 
diseases (FoodNet) and related activities--ALL applicants should 
propose this activity. CDC expects to provide support for FoodNet 
activities in all EIPs, although some FoodNet activities are expected 
to be conducted only in certain sites. For more details, see Appendix 2 
posted on the CDC Web site: http://www.cdc.gov/od/pgo/funding/grantmain.htm.
    (3) Surveillance for respiratory diseases and syndromes--ALL 
applicants should propose this activity. CDC expects to provide support 
for five to nine EIPs for one or more aspects of this activity. For 
more detailed guidance, see Appendix 3 posted on the CDC Web site: 
http://www.cdc.gov/od/pgo/funding/grantmain.htm.
    (4) Flexible Response to Emerging Problems--ALL applicants should 
propose this activity. Each EIP will be expected to participate in a 
workgroup to review newly emerging infectious disease issues on short 
notice and contribute to rapid study design, initiation, and 
completion. For more details, see Appendix 4 posted on the CDC Web 
site: http://www.cdc.gov/od/pgo/funding/grantmain.htm.
    (5) EIP rapid population-based survey capacity--ALL applicants 
should propose this activity. CDC expects to provide support for 
population-based survey capacity in all EIP sites. For detailed 
guidance on applying for this activity, see Appendix 5 posted on the 
CDC Web site: http://www.cdc.gov/od/pgo/funding/grantmain.htm.
    (6) Integrated hepatitis surveillance--Applicants may choose to 
propose some or all components of this activity, and CDC may provide 
some support for each of the components. For detailed guidance and 
specific eligibility criteria for this activity, see Appendix 6 posted 
on the CDC Web site: http://

[[Page 57300]]

www.cdc.gov/od/pgo/funding/grantmain.htm.
    (7) Surveillance for encephalitis syndrome--Applicants may choose 
to propose this activity. CDC expects to provide support for up to 
three EIPs for this activity. For more details, see Appendix 7 posted 
on the CDC Web site: http://www.cdc.gov/od/pgo/funding/grantmain.htm.
    (8) Surveillance for Unexplained Deaths (UNEX)--EIPs that are 
currently conducting UNEX may choose to propose to continue this 
activity. Any proposal for syndrome surveillance, e.g., respiratory 
syndromes, should be proposed and managed as part of the corresponding 
EIP syndrome activity, not separately as part of this activity. For 
more details, see Appendix 7 posted on the CDC Web site: http://www.cdc.gov/od/pgo/funding/grantmain.htm.
    (9) Border Infectious Disease Surveillance (BIDS)--Applicants along 
the U.S./Mexico Border may propose this activity. For more details, see 
Appendix 7 posted on the CDC Web site: http://www.cdc.gov/od/pgo/funding/grantmain.htm.
    (10) Incorporate a training activity into the operation of the 
EIP--Any applicant may propose this activity. See Appendix 7 for 
details.
    (11) Prepare for and engage in activities to assess human genomics 
risk factors into acute public health investigations--Any applicant may 
propose this activity. CDC may provide support for one to three sites 
for this activity. For more details, see Appendix 7 posted on the CDC 
Web site: http://www.cdc.gov/od/pgo/funding/grantmain.htm.
    (12) Site-specific EIP activity--Applicants may propose other 
activities of local interest or concern that are consistent with EIP 
objectives and guiding principles.
    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:
    (a) Provide general coordination for the EIPs as a network.
    (b) Assist in developing collaborative relationships and facilitate 
multi-site collaboration as needed to support the successful completion 
of the project.
    (c) Provide consultation, scientific and technical assistance in 
the operation of the EIP and in designing and conducting individual EIP 
projects. (Examples include, participating in protocol development, 
helping with study design, assisting in the development of information 
systems, data analysis and dissemination of results, coordinating and 
facilitating communications among EIPs).
    (d) Participate in analysis and interpretation of data from EIP 
projects. Participate in the dissemination of findings and information 
stemming from EIP projects.
    (e) Assist in monitoring and evaluating scientific and operational 
accomplishments of the EIP and progress in achieving the purpose and 
overall goals of this program.
    (f) If needed, perform laboratory evaluation of specimens or 
isolates (e.g., molecular epidemiologic studies, evaluation of 
diagnostic tools) obtained in EIP projects and integrate results with 
other data from EIP projects.
    (g) 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.
    (h) Consult with sites to assist evolution of EIP-related 
information systems to conform to Public Health Information Network 
(PHIN) standards.

II. Award Information

    Type of Award: Cooperative Agreement. CDC involvement in this 
program is listed in the Activities Section above.
    Mechanism of Support: U01.
    Fiscal Year Funds: 2005.
    Approximate Total Funding: $19,600,000.
    Approximate Number of Awards: 9.
    Approximate Average Award: $2,400,000. (This amount is for the 
first 12-month budget period, and includes both direct and indirect 
costs.)
    Floor of Award Range: $1,400,000.
    Ceiling of Award Range: $3,500,000.
    Anticipated Award Date: December 29, 2004.
    Budget Period Length: 12 months.
    Project Period Length: 5 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 state 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 
Mariana Islands, American Samoa, Guam, the Federated States of 
Micronesia, the Republic of the Marshall Islands, and the Republic of 
Palau).
    A Bona Fide Agent is an agency/organization identified by the state 
as eligible to submit an application under the state eligibility in 
lieu of a state application. If you are applying as a bona fide agent 
of a state or local government, you must provide a letter from the 
state or local government as documentation of your status. Place this 
documentation behind the first page of your application form.

III.2. Cost Sharing or Matching

    Matching funds are not required for this program.

III.3. Other

    CDC will accept and review applications with budgets greater than 
the ceiling of the award range.
Special 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.
    <bullet> Late applications will be considered non-responsive. See 
``Section IV.3. Submission Dates and Times'' for more information on 
deadlines.
    <bullet> 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.
Individuals Eligible To Become Principal Investigators or Co-Principal 
Investigators
    Any individual with the skills, knowledge, and resources necessary 
to carry out the proposed EIP activities 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.

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

[[Page 57301]]

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 Submission

Letter of Intent (LOI)
    A letter of intent is requested to help plan the application 
review, but it is not mandatory. Your LOI must be written in the 
following format:
    <bullet> Maximum number of pages: 2.
    <bullet> Font size: 12-point unreduced.
    <bullet> Single spaced.
    <bullet> Paper size: 8.5 by 11 inches.
    <bullet> Page margin size: One inch.
    <bullet> Printed only on one side of page.
    <bullet> Written in plain language, avoid jargon.
    Your LOI must include the following information:
    <bullet> Number and title of this Program Announcement (PA).
    <bullet> Name of Applicant (i.e. State Health Department or bona 
fide agent).
    If you are applying as a bona fide agent of a state or local 
government, you must provide a letter from the state as documentation 
of your status at the time of application.
    <bullet> Name, address, e-mail address, and telephone number of the 
Principal Investigator and Co-Investigator.
    <bullet> Brief description of your eligibility and intent to apply.
Application
    Follow the PHS 398 application instructions for content and 
formatting of your application. If the instructions in this 
announcement differ in any way from the PHS 398 instructions, follow 
the instructions in this announcement. 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: 
<a href="/cdn-cgi/l/email-protection#a7e0d5c6c9d3d4eec9c1c8e7c9cecf89c0c8d1"><span class="__cf_email__" data-cfemail="7d3a0f1c13090e34131b123d131415531a120b">[email protected]</span></a>.
    Your research plan should address activities to be conducted over 
the entire project period, focusing in detail on the first year and 
summarizing plans for subsequent years.
    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 announcement uses just-in-time concepts.
    This announcement uses the non-modular budgeting format.
    In place of the format specified for the Research Plan in PHS Form 
398, use the following format:
    <bullet> Maximum number of pages: 35 single-spaced (excluding 
budget, budget narrative, appendices, and required forms).
    If your narrative exceeds the page limit, only the first pages 
which are within the page limit will be reviewed. Materials or 
information that should be included in the narrative will not be 
reviewed if placed in the appendices.
    <bullet> Font size: 12 point unreduced.
    <bullet> Paper size: 8.5 by 11 inches.
    <bullet> Page margin size: One inch.
    <bullet> Printed only on one side of page.
    <bullet> Held together only by rubber bands or metal clips; not 
bound in any other way.
    Your narrative should address activities to be conducted over the 
entire project period, and must include the following items in the 
order listed:
    (1) Capacity to carry out the functions and responsibilities of an 
EIP.
    (2) Operational plan for the EIP in general and for specific EIP 
activities. (Include descriptions of populations for each proposed 
activity.)
    (3) Measures of Effectiveness (Include Measures for each of the 
specific EIP activities proposed.)
    (4) Human Subjects.
    Additional information may be included in the application 
appendices. The appendices will not be counted toward the narrative 
page limit. This additional information includes:
    <bullet> Documentation of bona fide agent status.
    <bullet> Letters of support (Do not solicit or include letters of 
support from CDC personnel.)
    <bullet> Curricula vitas.
    <bullet> Detailed budget justification (i.e., supporting budget 
information outlined in ``Budget and Budget Narrative'' below.)
    <bullet> Documentation of relevant accomplishments, such as 
abstracts, manuscripts, or bibliographies, may be included in 
appendices.
Budget and Budget Narrative
    This part of the application does not count toward the narrative 
page limit. For each line-item (as identified on the PHS Form 398, Page 
4), show both Federal and non-Federal (e.g., State funding) shares of 
total cost for the EIP. For each staff member listed under the 
Personnel line item, indicate their specific responsibilities relative 
to each of the proposed projects. All other line-items should also be 
clearly justified. In addition to the budget justification, provide an 
estimate of the budget for each separate activity or project (e.g., 
FoodNet, ABCs, etc. as outlined above in Section I, Activities, section 
(e)). If requesting funds for any contracts, provide the following 
information for each proposed contract: (1) Name of proposed 
contractor; (2) breakdown and justification for estimated costs; (3) 
description and scope of activities to be performed by contractor; (4) 
period of performance; and (5) method of contractor selection (e.g. 
sole-source or competitive solicitation).
    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
    October 11, 2004.
    CDC requests that you send a LOI if you intend to apply for this 
program. Although the LOI is not required, not binding, and does not 
enter into the review of your subsequent application, the LOI will be 
used to gauge the level of interest in this program, and to allow CDC 
to plan the application review.
Application Deadline Date
    November 1, 2004.
Explanation of Deadlines
    Applications must be received in the CDC Procurement and Grants 
Office by 4 p.m. eastern standard 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

[[Page 57302]]

weather delays or natural disasters, you will be given the opportunity 
to submit documentation of the carrier's guarantee. If the 
documentation verifies a carrier problem, CDC will consider the 
application as having been received by the deadline.
    This announcement is the definitive guide on application submission 
address and deadline. It supersedes information provided in the 
application instructions. If your application does not meet the 
deadline above, it will not be eligible for review, and will be 
discarded. You will be notified that your application did not meet the 
submission requirements.
    CDC will not notify you upon receipt of your application. If you 
have a question about the receipt of your application, first contact 
your courier. If you still have a question, contact the PGO-TIM staff 
at: (770) 488-2700. Before calling, please wait two to three days after 
the application deadline. This will allow time for applications to be 
processed and logged.

IV.4. Intergovernmental Review of Applications

    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:
    <bullet> Funds relating to the conduct of research will not be 
released until the appropriate assurances and Institutional Review 
Board approvals are in place.
    <bullet> Continuation awards within an approved project period will 
be made on the basis of satisfactory progress as evidenced by required 
reports and the availability of funds.
    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: Angela Slaughter, National Center for Infectious Diseases (NCID), 
Centers for Disease Control and Prevention (CDC), 1600 Clifton Rd, NE., 
Mailstop D-59, Atlanta, GA 30333, Telephone: (404) 371-5357, e-mail 
address: <a href="/cdn-cgi/l/email-protection#69081a05081c0e011d0c1b290a0d0a470e061f"><span class="__cf_email__" data-cfemail="ceafbda2afbba9a6baabbc8eadaaade0a9a1b8">[email protected]</span></a>.
Application Submission Address
    Submit the original and four hard copies of your application by 
mail or express delivery service to: Technical Information Management--
CI05-026, 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

    Applicants 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:
    (1) Capacity to carry out the functions and responsibilities of an 
EIP. (50 points)
    (a) Does the applicant demonstrate a clear understanding of the 
objectives of the EIP in the following aspects?
    (i) Background and objectives of this cooperative agreement 
program.
    (ii) The roles and responsibilities of participation in the EIP 
network.
    (iii) The requirements, responsibilities, problems, constraints, 
and complexities that may be encountered in establishing and operating 
the EIP.
    (b) EIP functions and structure.
    (i) To what extent does the applicant's plan for establishing and 
operating the EIP clearly describe the proposed organizational and 
operating structure/procedures; and clearly identify the roles and 
responsibilities of all participating agencies, organizations, 
institutions, and individuals?
    (ii) To what extent does the applicant describe how the EIP as a 
whole will be established in a defined population with a minimum 
population base of approximately 1,500,000 persons?
    (iii) To what extent does the applicant clearly describe how the 
EIP, or its design for the EIP, is flexible and able to swiftly address 
new public health challenges in infectious diseases?
    (iv) Does the applicant plan to provide effective scientific 
leadership and coordination, and adequate administrative 
infrastructure, to manage an EIP?
    (v) Does the applicant demonstrate ability to operate the EIP so it 
can function effectively as part of a national network of EIPs?
    (vi) To what extent does the applicant describe plans for 
collaboration with CDC and other EIP sites in the establishment and 
operation of the EIP and individual EIP projects, including project 
design/development (e.g., protocols), management and analysis of data, 
and synthesis and dissemination of findings?
    (c) Partnerships.
    (i) To what extent does the applicant demonstrate ability to 
develop and maintain strong cooperative relationships with public and 
private, local and regional, medical, public health, laboratory, 
academic, and community organizations? Does the applicant provide 
sufficient evidence of its ability to solicit and secure programmatic 
collaboration and support from such organizations?
    (ii) Are the applicant's partnerships with necessary and 
appropriate organizations adequate for establishing and operating the 
proposed EIP and for conducting individual EIP projects?
    (d) EIP tools and capacities.
    To what extent does the applicant demonstrate past experience and 
documentation of accomplishments in conducting active surveillance, 
applied epidemiologic research, applied laboratory research, and 
prevention research, in general, and on emerging infectious diseases, 
including antimicrobial resistant, food-borne and waterborne, and 
currently or potentially vaccine preventable diseases? Is a list of 
relevant papers and abstracts included in an appendix?

[[Page 57303]]

    (2) Operational Plan for the EIP in general and for specific EIP 
activities. (40 points)
    (a) General EIP Activities:
    (i) To what extent is the quality of the proposed projects (as 
requested in the Application Content section above), taken as a whole, 
consistent with EIP guiding principles, public health needs, intent of 
this program, feasibility, methodology/approach, and collaboration/
participation of partner organizations? Does the proposal include clear 
descriptions of the population bases for each project, and include 
descriptions of race and ethnic distributions and descriptions of 
various special populations as they relate to the proposed activities, 
such as the rural or inner-city poor, under-served women and children, 
the homeless, immigrants and refugees, and persons infected with HIV?
    (ii) Does the applicant demonstrate support from non-applicant 
participating agencies, institutions, organizations, laboratories, 
individuals, and consultants included in the operational plan? Does the 
applicant provide (in an appendix) letters of support which clearly 
indicate collaborators' commitment to participate in the EIP and define 
their roles?
    (iii) Does the applicant clearly identify key professional 
personnel to be assigned to the EIP and EIP projects as well as key 
professional personnel from other participating or collaborating 
institutions, agencies, and organizations outside of the applicant's 
agency that will be assigned to EIP activities? (Is curriculum vitae 
for each person included in an appendix?) Is there a clear 
identification of participants' respective roles in the management and 
operation of the EIP? Do participants have adequate experience in 
conducting work comparable to that described in this announcement?
    (iv) For projects involving human subjects 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.
    (b) Specific EIP Activities:
    (i) What is the quality of each proposed project with respect to 
planned approach and methodology, as well as consistency with EIP 
guiding principles, public health needs, intent of this program, and 
collaborations?
    (ii) For each proposed activity, is there a clear definition of the 
geographic area and population base in which the activity will operate 
(different activities may use different populations)?
    (iii) For each proposed activity, is there evidence of support from 
non-applicant participating agencies, institutions, organizations, 
laboratories, individuals, consultants, etc., included in the 
operational plan? Does the applicant provide (in an appendix) letters 
of support which clearly indicate collaborators' commitment to 
participate in the EIP and define their roles?
    (iv) For each proposed activity, does the applicant clearly 
identify key professional personnel to be assigned to the EIP and EIP 
projects as well as key professional personnel from other participating 
or collaborating institutions, agencies, and organizations outside of 
the applicant's agency that will be assigned to EIP activities (provide 
a curriculum vitae for each in an appendix). Clear identification of 
participants' respective roles in the management and operation of the 
EIP? Do participants have adequate experience in conducting work 
comparable to that proposed in this announcement?
    (3) Measures of Effectiveness (10 points)
    (a) Does the applicant provide measures of effectiveness for each 
proposed activity that will demonstrate the accomplishment of the 
cooperative agreement objectives identified in Section B ``Purpose'' of 
this program announcement?
    (b) Are the measures objective and quantitative, and do they 
adequately measure the intended outcome of each activity?
    (4) Budget (not scored)
    Is the line-item budget detail broken out for each activity (or 
project) and contract, clearly justified, and consistent with the 
purpose and objectives of this program? Does the applicant show both 
Federal and non-Federal (e.g., State funding) shares of total cost for 
the EIP?
    (5) Human Subjects (not scored)
    Does the application adequately address the requirements of Title 
45 CFR Part 46 for the protection of human subjects? (Not 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.)

V.2. Review and Selection Process

    Applications will be reviewed for completeness by the Procurement 
and Grants Office (PGO) staff, and for responsiveness by National 
Centers for Infectious Diseases (NCID) Office of Surveillance. 
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 against the evaluation criteria. In addition, the 
following factors may affect the funding decision:
    <bullet> Funding preference may be given to approved applications 
that would enhance the geographic diversity of the network to achieve 
appropriate geographic representation in the EIPs.
    <bullet> Funding preference may also be given to competing 
continuation applications over applications for programs not already 
receiving support under this cooperative agreement.

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:

    <bullet> AR-1 Human Subjects Requirements
    <bullet> AR-2 Requirements for Inclusion of Women and Racial and 
Ethnic Minorities in Research
    <bullet> AR-7 Executive Order 12372

[[Page 57304]]

    <bullet> AR-9 Paperwork Reduction Act Requirements
    <bullet> AR-10 Smoke-Free Workplace Requirements
    <bullet> AR-11 Healthy People 2010
    <bullet> AR-12 Lobbying Restrictions
    <bullet> AR-22 Research Integrity

    Additional information on these requirements can be found on the 
CDC Web site at the following Internet address: http://www.cdc.gov/od/pgo/funding/ARs.htm.

VI.3. Reporting Requirements

    You must provide CDC with an original, plus two hard copies of the 
following reports:
    (1) Interim progress report, (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 including report 
specifically on progress towards stated Measures of Effectiveness from 
the current budget period (i.e., previous application).
    (b) Current Budget Period Financial Progress.
    (c) New Budget Period Program Proposed Activity and Objectives.
    (d) Budget.
    (e) Measures of Effectiveness.
    (f) Additional Requested Information
    (2) Financial status report and annual progress report, no more 
than 90 days after the end of the budget period.
    (3) Final financial and performance reports, no more than 90 days 
after the end of the project period.
    These reports must be mailed to the Grants Management or Contract 
Specialist listed in the ``Agency Contacts'' section of this 
announcement.

VII. Agency Contacts

    For general questions about this announcement, contact: Technical 
Information Management Section, CDC Procurement and Grants Office, 2920 
Brandywine Road, Atlanta, GA 30341, Telephone: (770) 488-2700.
    For program technical assistance, contact: Catherine Rebmann, 
National Center for Infectious Diseases (NCID), Centers for Disease 
Control and Prevention (CDC), 1600 Clifton Rd, NE., Mailstop D-59, 
Atlanta, GA 30333, Telephone (404) 371-5363, e-mail address: 
<a href="/cdn-cgi/l/email-protection#4f2c3c3d760f2c2b2c61282039"><span class="__cf_email__" data-cfemail="b7d4c4c58ef7d4d3d499d0d8c1">[email protected]</span></a>.
    For financial, grants management, or budget assistance, contact: 
Lynn Walling, Grants Management Specialist, CDC Procurement and Grants 
Office, 2920 Brandywine Road, Atlanta, GA 30341, Telephone: (770) 488-
2612, e-mail: <a href="/cdn-cgi/l/email-protection#c8a4b9bffd88abacabe6afa7be"><span class="__cf_email__" data-cfemail="b6dac7c183f6d5d2d598d1d9c0">[email protected]</span></a>.

VIII. Other Information

    This and other CDC funding opportunity announcement can be found on 
the CDC Web site, Internet address: http://www.cdc.gov. Click on 
``Funding'' then ``Grants and Cooperative Agreements.''
    Visit these websites for additional information about the EIPs:

    http://www.cdc.gov/ncidod/EID/vol9no7/03-0083.htm,
    http://www.cdc.gov/ncidod/osr/site/eip/index.htm,
    http://www.cdc.gov/ncidod/osr/site/eip/publications.htm.

    Dated: September 20, 2004.
William P. Nichols,
Acting Director, Procurement and Grants Office, Centers for Disease 
Control and Prevention.
[FR Doc. 04-21474 Filed 9-23-04; 8:45 am]
BILLING CODE 4163-18-P


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