[Federal Register Volume 66, Number 75 (Wednesday, April 18, 2001)]
[Notices]
[Pages 19958-19960]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-9566]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 01062]


Programs to Prevent the Emergence and Spread of Antimicrobial 
Resistance in Swine As Food Animals; Notice of Availability of Funds

A. Purpose

    The Centers for Disease Control and Prevention (CDC) is 
implementing a multifaceted effort to address the problem of 
antimicrobial resistance. As part of this, CDC, in collaboration with 
the Food and Drug Administration Center for Veterinary Medicine, 
announces the availability of fiscal year (FY) 2001 funds for a 
cooperative agreement program to provide assistance for the development 
and evaluation of demonstration projects to prevent and control the 
emergence and spread of antimicrobial resistance in swine as food 
animals. This program addresses the ``Healthy People 2010'' focus area 
of Immunization and Infectious Diseases. For more information visit the 
internet site: http://www.health.gov/healthypeople.
    The purpose of this program is to develop, implement, and evaluate 
a prudent antimicrobial use project to reduce the emergence, 
prevalence, and spread of antimicrobial resistance among target 
pathogens in swine as food animals.
    The intention of this project is to develop and evaluate a 
``prudent use of antimicrobial agents'' program in swine as food 
animal. It is hoped that this project would serve as a model towards 
the long-term goal of development of a national campaign for prudent 
antimicrobial use in swine as a food animal, and that additional 
resources towards achieving this goal would be provided by veterinary 
and animal industry organizations.
    Programs should address the problem of antimicrobial resistance 
through interventions potentially including, but not limited to:
    1. Promoting more judicious antimicrobial use (e.g., using 
antimicrobial agents only when needed, using appropriate doses of 
antimicrobial agents),
    2. Reducing transmission of antimicrobial resistant microorganisms 
among food animals through good management practices,
    3. Preventing colonization and infection of animals by pathogens 
through the use of probiotics, and
    4. Improving the ability to provide effective narrow spectrum 
therapy by rapidly and accurately diagnosing resistant microorganisms 
through the use of improved laboratory testing procedures and improved 
quality and flow of laboratory data.
    It is envisioned that the funded project will use a combination of 
approaches to achieve judicious antimicrobial use and other changes 
that will result in decreased appearance and spread of resistance. The 
funded project will also be expected to conduct a multifaceted 
evaluation of many aspects of the program, including assessing the 
costs and any cost-savings associated with any proposed intervention.

B. Eligible Applicants

    Applications may be submitted by public and private nonprofit 
organizations and by governments and

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their agencies; that is, universities, colleges, research institutions, 
hospitals, other public and private nonprofit organizations, State and 
local governments or their bona fide agents, and federally recognized 
Indian tribal governments, Indian tribes or Indian tribal 
organizations.

    Note: Public Law 104-65 states that an organization described in 
section 501(c)(4) of the Internal Revenue Code of 1986 that engages 
in lobbying activities is not eligible to receive Federal funds 
constituting an award, grant, cooperative agreement contract, loan, 
or any other form.

C. Availability of Funds

    Approximately $75,000 is available in FY 2001 to fund one award. It 
is expected that the award will begin on or about September 30, 2001, 
and will be made for a 12-month budget period within a project period 
of up to 3 years. The funding estimate 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.

D. Program Requirements

    In conducting activities to achieve the purpose of this program, 
the recipient will be responsible for the activities under 1. 
(Recipient Activities) and CDC will be responsible for conducting 
activities under 2. (CDC Activities).

1. Recipient Activities

    a. Utilizing the selected food animal focus (swine) and the defined 
foodborne pathogens of interest (e.g., Salmonella, Campylobacter), 
develop a study protocol and describe the partnerships necessary to 
conduct the study, including a veterinary diagnostic laboratory, 
veterinary professional associations, and animal commodity groups.
    b. Selecting the study population and identifying a population of 
adequate size for the purpose of the study. The population will likely 
include several farms and producers.
    c. Defining, collecting, and analyzing baseline data, so that 
evaluation of the interventions can be done. This includes at a minimum 
collecting prevalence data on antimicrobial resistance among the target 
pathogens and measuring antimicrobial agent usage pattern before the 
intervention.
    d. Designing and implementing an intervention promoting judicious 
antimicrobial use and other approaches to reducing antimicrobial 
resistance: It is anticipated that this will involve developing 
coalitions among veterinary professional societies, producers, 
commodity groups, and others, as well as implementing specific 
strategies. These strategies may include peer-education of 
veterinarians, producers, formulary guidelines, prescribing 
restrictions, and strategies which are likely to reduce transmission of 
pathogens. The choice of strategies should be justified based on the 
nature of the study population, and the infrastructure in which the 
study population receives veterinary care.
    e. Measuring the effects of the intervention:
    (1) Measuring the change in rates of antimicrobial resistance of 
organisms over time. Organisms whose resistance can be measured could 
include: human foodborne pathogens, animal pathogens, organisms that 
are opportunistic human pathogens (e.g., Enterococcus), normal animal 
fecal flora.
    (2) Measurement of antimicrobial resistance should be accomplished 
by a laboratory with proven ability to perform measurements using a 
standard approved methodology, yielding a quantitative measure of 
resistance, such as mean inhibitory concentration or zone size.
    (3) As decreases in resistance, as a result of the program, may 
take several months to years to manifest themselves, the recipient is 
responsible for measuring outcomes related to how well the 
interventions have been implemented.
    (4) Measuring cost implications of the intervention. This should 
include impact of the intervention on direct costs (e.g., costs of 
antibiotics, veterinary care visits, duration of illness, etc.) and 
indirect costs (e.g., lost productivity, decreased feed efficiency, 
etc.). Costs of the intervention program must be differentiated from 
those of the evaluation.
    (5) Consideration should be given to parallel measurements in a 
non-intervention group of animals, to better define the impact of the 
intervention.
    f. Dissemination of research findings: Disseminating research 
results by appropriate methods such as publication in journals, 
presentation at meetings, conferences, etc.

2. CDC Activities

    CDC, in collaboration with Food and Drug Administration Center for 
Veterinary Medicine, will provide technical assistance in the design 
and conduct of the research as resources permit. This may include:
    a. Providing technical assistance in the design and conduct of the 
project, including intervention methods and analytic approach;
    b. Performing selected laboratory tests as appropriate;
    c. Assisting in data management, the analysis of research data, and 
the interpretation and dissemination of research findings, as 
appropriate; and
    d. Assisting in the design of the evaluation, in particular, in the 
identification of outcome measures that will allow for later analysis 
of economic benefits.

E. Application Content

    Use the information in the Program Requirements, Other 
Requirements, and Evaluation Criteria sections to develop the 
application content. Your application will be evaluated on the criteria 
listed, so it is important to follow them in laying out your program 
plan. The narrative should be no more than 20 double-spaced pages 
(excluding appendices), printed on one side, with one inch margins, and 
unreduced (12 point) font, unbounded and unstapled.

F. Submission and Deadlines

Letter of Intent

    In order to assist CDC in planning and executing the evaluation of 
applications submitted under this Program Announcement, all parties 
intending to submit an application are requested to inform CDC of their 
intention. Notification should include the following information: (1) 
Announcement number 01062; (2) name and address of institution; and (3) 
name, address, and phone number of contact person.
    On or before May 15, 2001, the Letter of Intent 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

    Submit the original and five copies of PHS 398 [(OMB Number 0925-
0001) (adhere to the instructions on the Errata Instruction Sheet for 
PHS 398)]. Forms are in the application kit.
    On or before June 15, 2001, submit the application to the Grants 
Management Specialist identified in the ``Where to Obtain Additional 
Information Section of this announcement.
    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

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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

    The application will be evaluated against the following criteria by 
an independent review group appointed by CDC.

1. Background and Need (10 Points)

    Extent to which applicant's discussion of the background for the 
proposed project demonstrates a clear understanding of the purpose and 
objectives of this cooperative agreement program. Extent to which 
applicant illustrates and justifies the need for the proposed project 
that is consistent with the purpose and objectives of this program.

2. Capacity and Personnel (30 Points Total)

    a. Extent to which applicant describes adequate resources and 
facilities (both technical and administrative) for conducting the 
project. This includes the capacity to conduct quality laboratory 
measurements. (10 points)
    b. Extent to which applicant documents that professional personnel 
involved in the project are qualified and have past experience and 
achievements in research and programs related to that proposed as 
evidenced by curriculum vitae, publications, etc. (15 points)
    c. Extent to which applicant includes letters of support from non-
applicant organizations, individuals, etc. Extent to which the letters 
clearly indicate the author's commitment to participate as described in 
the operational plan. (5 points)

3. Objectives and Technical Approach (60 Points Total)

    a. Extent to which applicant describes specific objectives of the 
proposed project which are consistent with the purpose and goals of 
this program and which are measurable and time-phased. (10 points)
    b. Extent to which the applicant describes swine as the population 
for study, including whether the results of a study in this population 
will be generalizable to other populations in the United States. Extent 
to which the applicant identifies microbes/resistance patterns for 
study that are of public health importance. (10 points) Extent to which 
applicant presents a detailed operational plan for initiating and 
conducting the project, which clearly and appropriately addresses all 
Recipient Activities. Extent to which applicant clearly identifies 
specific assigned responsibilities for all key professional personnel. 
Extent to which the plan clearly describes applicant's technical 
approach/methods for developing and conducting the proposed program and 
evaluation and extent to which the plan is adequate to accomplish the 
study objectives. The extent to which applicant describes the existence 
of or plans to establish partnerships. (20 points)
    c. Extent to which the applicant describes any adequate and 
appropriate collaboration during various phases of the project. (10 
points)
    d. Extent to which applicant provides a detailed and adequate plan 
for evaluating study results (including laboratory data, data on 
prescribing practices, and data on direct costs and charges and 
indirect costs), as well as plans for evaluating progress toward 
achieving project objectives. (10 points)

4. Budget (Not Scored)

    Extent to which the proposed budget is reasonable, clearly 
justifiable, and consistent with the intended use of cooperative 
agreement funds.

5. Animal Subjects (Not Scored)

    Does the application adequately address the requirements of PHS 
Policy on Humane Care and Use of Laboratory Animals by Awardee 
Institutions?

H. Other Requirements

Technical Reporting Requirements

    Provide CDC with the original plus two copies of:
    1. progress reports (semiannual);
    2. financial status report, no more than 90 days after the end of 
the budget period; and
    3. final financial 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.
    The following additional requirements are applicable to this 
program. For a complete description of each, see Attachment I.
AR-3  Animal Subjects Requirements
AR-10  Smoke-Free Workplace Requirements
AR-11  Healthy People 2010
AR-12  Lobbying Restrictions
AR-15  Proof of Non-Profit Status

I. Authority and Catalog of Federal Domestic Assistance Number

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

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''.
    To receive additional written information and to request an 
application kit, call 1-888-GRANTS4 (1-888-472-6874). You will be asked 
to leave your name and address and will be instructed to identify the 
announcement number of interest.
    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, 2920 Brandywine Road, Room 3000, Atlanta, GA 
30341-4146, Telephone: (770) 488-2753, Email address: [email protected].
    For program technical assistance, contact: Frederick Angulo, DVM, 
PhD, Medical Epidemiologist, National Center for Infectious Diseases, 
Centers for Disease Control and Prevention, 1600 Clifton Road, N.E., 
Atlanta, GA 30333, Telephone: (404) 639-3623, Email address: 
[email protected].

    Dated: April 11, 2001.
John L. Williams,
Director, Procurement and Grants Office, Centers for Disease Control 
and Prevention (CDC).
[FR Doc. 01-9566 Filed 4-17-01; 8:45 am]
BILLING CODE 4163-18-P