[Federal Register Volume 66, Number 18 (Friday, January 26, 2001)]
[Notices]
[Pages 7916-7919]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-2365]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 01022]


Epidemiology and Laboratory Capacity for Infectious Diseases; 
Notice of Availability of Funds

A. Purpose

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 2001 funds for a cooperative agreement 
program to promote adequate capacity of local, State, and national 
efforts for epidemiologic and laboratory surveillance and response for 
infectious diseases. This program addresses the ``Healthy People 2010'' 
focus area of Immunization and Infectious Diseases. For the conference 
copy of ``Healthy People 2010'', visit the internet site: http://www.health.gov/healthypeople>
    The purpose of the Epidemiology and Laboratory Capacity in 
Infectious Diseases (ELC) program is to assist State and eligible local 
public health agencies in strengthening basic epidemiologic and 
laboratory capacity to address infectious disease threats with a focus 
on notifiable diseases, food-, water-, and vector-borne diseases, 
vaccine-preventable diseases, and drug-resistant infections. Awards are 
intended to support activities that enhance the ability of a program to 
identify and monitor the occurrence of infectious diseases of public 
health importance in a community, characterize disease determinants, 
identify and respond to disease outbreaks, use public health data for 
priority setting and policy development, and assess the effectiveness 
of activities. Strengthening collaboration between laboratory and 
epidemiology practice is seen as a crucial component of this program.
    This program is designed to support grantees in a variety of ways. 
For example, in health departments where gaps in personnel and 
equipment are identified as major barriers to effective surveillance 
and response, the ELC program can provide resources to hire staff or 
purchase necessary equipment. Funds can also be used to enhance ongoing 
activities.

B. Eligible Applicants

Limited Competition

    Assistance will be provided only to the health departments of 
States or their bona fide agents, including the District of Columbia, 
the Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth 
of the Northern Mariana Islands, American Samoa, Guam, federally 
recognized Indian tribal governments, the Federated States of 
Micronesia, the Republic of the Marshall Islands, and the Republic of 
Palau. In addition, official public health agencies of city governments 
with jurisdictional populations greater than 1,500,000 or county 
governments with jurisdictional populations greater than 8,000,000 
(based on 1990 census data) are eligible to apply.
    The ELC program was initiated in 1995 with Program Announcement 
95043 and expanded in 1997 and 1999 with Program Announcements 97020 
and 99032, respectively. A total of 39 state and 4 local health 
departments have been funded to date. This announcement is a further 
expansion of the ELC program and is intended to add new eligible 
applicants not already funded in the program. States, counties, and 
cities currently funded under the ELC program are not eligible to apply 
under this program announcement.

C. Availability of Funds

    Approximately $5,250,000 is available in FY 2001 to fund 
approximately 15 awards. It is expected that the average award (total 
direct and indirect costs) will be $350,000. Individual awards may 
range from $100,000 to $500,000. It is expected that the awards will 
begin on or about April 1, 2001, and will be made for a 12-month budget 
period within a project period of up to five years. Funding estimates 
may change.
    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.

Recipient Financial Participation

    Although a requirement for matching funds is not a condition for 
receiving an award under this cooperative agreement program, applicants 
must document the non-Federal human and fiscal resources that will be 
available to conduct activities outlined in the proposal. Federal funds 
cannot be used to replace or supplant existing State and local support. 
See Evaluation Criteria (paragraph 6: Budget) for additional 
information.

D. Program Requirements

    In conducting activities to achieve the purpose of this program, 
the recipient will be responsible for the activities listed under 1. 
(Recipient Activities) and CDC will be responsible for the activities 
listed under 2. (CDC Activities).
1. Recipient Activities
    a. Enhance local capacity for gathering and evaluating infectious 
disease surveillance data, detecting and investigating outbreaks, and 
using surveillance data for public health practice and clinical follow-
up. Applicants should analyze their current surveillance 
infrastructure, identify gaps in core epidemiologic and laboratory 
capacity, and develop applications to this program announcement that 
address the needs of their respective health jurisdictions. National 
priority program areas are briefly described below and are examples of 
activities that would be appropriate to propose under this program 
announcement. Applicants are encouraged to consider activities in these 
areas, yet there is no requirement to do so. Details and example 
activities for each are provided as Attachments in the Application Kit.

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(1) Antimicrobial Resistance (Attachment 2)
    Develop or improve health department capacity for surveillance, 
prevention, and control of antimicrobial resistant infections.
(2) Food-borne Disease (Attachment 3)
    Enhance capacity for investigation, control, and reporting of 
foodborne disease outbreaks and improve laboratory-based surveillance 
for emerging foodborne pathogens.
(3) Hepatitis (Attachment 4)
    (a) Develop capacity to prevent and control hepatitis C virus (HCV) 
infection through activities that are integrated into existing public 
health prevention services and programs.
    (b) Enhance capacity for surveillance of chronic hepatitis B virus 
(HBV) and hepatitis C virus (HCV) infection.
(4) Influenza (Attachment 5)
    Develop and enhance capacity for influenza surveillance and 
response.
(5) National Electronic Disease Surveillance System (NEDSS) Assessment 
and Planning (Attachment 6)
    Assess current information systems personnel and technical 
infrastructure and develop a plan for the implementation of the NEDSS 
systems architecture (intended for applicants that did not receive any 
NEDSS funding from CDC in FY 2000).
(6) West Nile Virus (Attachment 7)
    Develop and implement effective surveillance, prevention, and 
control of West Nile virus and other arboviruses that occur in the U.S.
    b. Ensure appropriate representation at planning and priority-
setting meetings organized for recipients of this cooperative agreement 
program, including sending two representatives to the International 
Conference on Emerging Infections scheduled for March 2002 in Atlanta.
    c. If a proposed project involves research on human participants, 
ensure appropriate Independent Review Board (IRB) review.
2. CDC Activities
    a. Provide consultation and assistance in enhancing local 
epidemiologic and laboratory capacity for surveillance and response for 
infectious diseases.
    b. Assist in monitoring and evaluating scientific and operational 
accomplishments and progress in achieving the purpose of this program.
    c. Provide national coordination of activities where appropriate.
    d. If during the project period research involving human subjects 
should be conducted and if 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 protocol initially and on at least 
an annual basis until the research project is completed.

E. Application Content

Letter of Intent (LOI)

    In order to assist CDC in planning and executing the evaluation of 
applications submitted under this announcement, all parties intending 
to submit an application are requested to inform CDC of their intention 
to do so not later than February 9, 2001. Notification should include: 
(1) name and address of the institution, (2) name, address and 
telephone number of the contact person, and (3) a list of the 
activities/areas that will be addressed in the application. This letter 
of intent will not be used in evaluation of the application. 
Notification should be provided by facsimile, postal mail, or E-mail, 
to the Grants Management Specialist identified in the ``Where to Obtain 
Additional Information'' section of this announcement''.

Application

    Use the information in this section and in the Program 
Requirements, Other Requirements, and Evaluation Criteria sections to 
develop the application content.
    Your application will be evaluated on the criteria listed in 
Section G., so it is important that your narrative follow the criteria 
in the order presented.
    The application narrative (excluding budget, budget narrative, 
appendices, and required forms) must not exceed 20 single-spaced pages, 
printed on one side, with one inch margins, a font size no smaller than 
10, and on white 8.5"  x  11" paper. All pages must be clearly 
numbered, a complete index to the application and its appendices must 
be included, and the required original and two copies must be submitted 
unstapled and unbound (i.e., so it can be easily fed through an 
automatic document feed copier).
    To the extent possible, application narratives and budgets should 
clearly delineate separate and distinct program areas or groups of 
activities.
    If any proposed activities involve human subjects research, include 
plans to assure that appropriate Institutional Review Board (IRB) 
approval is obtained. Include protocols and IRB review/approval status 
if available.
    If indirect costs are being charged, include a copy of your 
organization's most current indirect cost rate agreement or cost 
allocation plan.
    Letters of support can be included if applicants anticipate the 
participation of other organizations or political subdivisions in 
conducting proposed activities. Specific roles and responsibilities 
should be delineated. Do NOT include any letters of support from CDC. 
CDC assistance will be provided to all recipients as described in CDC 
Activities, above.

F. Submission and Deadline

Letter of Intent (LOI)

    The Letter of Intent (LOI) should be submitted on or before 
February 9, 2001 and can be provided by facsimile, postal mail, or E-
mail to the Grants Management Specialist identified in the ``Where to 
Obtain Additional Information'' section of this announcement. Your 
letter of intent should include: (1) Name and address of the 
institution, (2) name, address, and telephone number of the contact 
person, and (3) a list of the activities/areas that will be addressed 
in the application.

Application

    Submit the original and two copies of CDC 0.1246(E). Forms are in 
the application kit. Submit the application to the Grants Management 
Specialist identified in the ``Where to Obtain Additional Information'' 
section of this announcement, on or before February 23, 2001.
    Deadline: Applications shall be considered as meeting the deadline 
if they are either:
    (a) Received on or before the deadline date; or
    (b) Sent on or before the deadline date and received in time for 
submission to the independent review group. (Applicants must request a 
legibly dated U.S. Postal Service postmark or obtain a legibly dated 
receipt from a commercial carrier or U.S. Postal Service. Private 
metered postmarks shall not be acceptable as proof of timely mailing.)
    Late Applications: Applications which do not meet the criteria in 
(a) or (b) above are considered late applications, will not be 
considered, and will be returned to the applicant.

G. Evaluation Criteria

    Each application will be evaluated individually against the 
following criteria by an independent review group appointed by CDC.
    1. Description of the population under surveillance, either the 
State or other

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appropriate jurisdiction (if an applicant is a county, city, or other 
agency) (5 points). Extent to which the application provides 
information on the population size, demographic characteristics, 
geographic distribution, racial/ethnic makeup, and health care delivery 
systems.
    2. Description of existing public health infectious disease 
epidemiology, laboratory, and information systems capacity (15 points). 
Extent to which the applicant:
    a. Describes existing infectious disease surveillance and response 
activities, including reporting requirements, spectrum of laboratory 
specimen testing performed, degree of automation of laboratory and 
epidemiologic information management, and public health response 
capacity.
    b. Provides information on existing staffing, management, material 
and equipment investment, training, space, and financial support of 
laboratory and epidemiologic capacity for public health surveillance 
and response for infectious diseases.
    c. Describes current collaboration between its epidemiology and 
laboratory programs in surveillance and response including the 
existence of, or potential for, integrated uses of surveillance data;
    d. Describes current or previous collaborative relationships with 
clinical laboratories, local health agencies, academic medicine groups, 
and health care practitioners, including HMOs or managed care 
providers; and demonstrates the potential of these relationships for 
enhanced surveillance and public health response activities.
    3. Identification of areas of need (gaps) in surveillance and 
response for infectious diseases and understanding of the objectives of 
this cooperative agreement program (20 points).
    The extent to which the applicant outlines State and local needs in 
epidemiology, laboratory, and/or information systems capacity for 
public health surveillance and response for infectious diseases.
    4. Operational Plan (Note: Provide a detailed description of first 
year activities only and briefly describe future year activities) (45 
points). Extent to which the proposed plan:
    a. Outlines activities that clearly address the applicant's 
identified needs in capacity and that are appropriate for any specific 
diseases, conditions, and/or national priority program areas addressed 
by the applicant.
    b. Describes steps to be taken to facilitate and strengthen 
collaboration between epidemiology and laboratory practice.
    c. Includes current letters of support from participating agencies, 
institutions, and organizations indicating their willingness to 
participate in the activities as proposed in the operational plan.
    d. If any research involving human subjects is proposed, has met 
the CDC Policy requirements regarding the inclusion of women, ethnic, 
and racial groups in any 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.
    (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.
    5. Plan for monitoring and evaluation (15 points). The extent to 
which the applicant describes a detailed plan for monitoring the 
implementation of the activities and evaluating the extent to which the 
proposed activities strengthen local and national epidemiologic and 
laboratory capacity for infectious diseases.
    6. Budget (not scored)
    a. A detailed budget with a line-item justification and any other 
information to demonstrate that the request for assistance is 
consistent with the purpose and objectives of this cooperative 
agreement program.
    b. Although matching funds are not a condition for receiving an 
award under this program, include in the budget, a separate line-item 
accounting of non-Federal contributions (funding, personnel, and other 
resources) that will be directly allocated to the proposed activities. 
Identify any non-applicant sources of these contributions.
    c. If requesting funds for any contractual activities, provide the 
following information for each 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, (5) method of contractor selection (e.g., sole-
source or competitive solicitation), and (6) method of accountability.
    7. Human Subjects: (Not Scored)
    If any research involving human subjects is proposed, does the 
application adequately address the requirements of Title 45 CFR part 46 
for the protection of human subjects?

H. Other Requirements

Technical Reporting Requirements
    Provide CDC with original plus two copies of:
    1. progress reports (annual), no more than 90 days after the end of 
the budget period;
    2. financial status report, no more than 90 days after the end of 
the budget period; and
    3. Final Financial Status and Performance reports, no more than 90 
days after the end of the project period.
    Send all reports to the Grants Management Specialist identified in 
the ``Where to Obtain Additional Information'' section of this 
announcement.
Public Health Surveillance and Information Systems
    To modernize and enhance public health surveillance and information 
systems, CDC and its public health partners are implementing the NEDSS. 
CDC's NEDSS implementation strategies include ensuring that relevant 
activities funded through its various cooperative agreement programs 
will be consistent with the functional and technical specifications of 
the NEDSS information architecture (www.cdc.gov/od/hissb/docs.htm). As 
part of the terms of this program announcement, grantees agree to 
evaluate current activities with respect to the NEDSS information 
systems architecture; plan how to modify these activities, if 
necessary, so that they are consistent with NEDSS specifications; and, 
if possible, begin to implement NEDSS specifications in relevant 
activities.
    The following additional requirements are applicable to this 
program. For a complete description of each, see Attachment 1 in the 
application kit.

AR-1  Human Subjects Requirements
AR-2  Requirements for Inclusion of Women and Racial and Ethnic 
Minorities in Research
AR-7  Executive Order 12372 Review
AR-10  Smoke-Free Workplace Requirements
AR-11  Healthy People 2010
AR-12  Lobbying Restrictions

I. Authority and Catalog of Federal Domestic Assistance Number

    This program is authorized under the Public Health Service Act 
Sections 301(a)[42 U.S.C. 241(a)] and 317(k)(2)[42 U.S.C. 247b(k)(2)], 
as amended. The Catalog of Federal Domestic Assistance number is 
93.283.

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J. Where to Obtain Additional Information

    This and other CDC announcements can be found on the CDC home page 
Internet address--http://www.cdc.gov>. Click on ``Funding'' then 
``Grants and Cooperative Agreements.''
    If you have questions after reviewing the contents of all the 
documents, business management technical assistance may be obtained 
from:

    Gladys Gissentanna, Grants Management Specialist, Grants Management 
Branch, Procurement and Grants Office, Centers for Disease Control and 
Prevention (CDC), 2920 Brandywine Road, Room 3000, Atlanta, Georgia 
30341-5539, Telephone (770) 488-2753, Email address : [email protected]

    For program technical assistance, contact: Deborah A. Deppe, 
M.P.A., National Center for Infectious Diseases, Mailstop C12, Centers 
for Disease Control and Prevention, Atlanta, GA 30333, Telephone (404) 
639-4668, E-mail address: [email protected]

    Dated: January 22, 2001.
John L. Williams,
Director, Procurement and Grants Office, Centers for Disease Control 
and Prevention (CDC).
[FR Doc. 01-2365 Filed 1-25-01; 8:45 am]
BILLING CODE 4163-18-P