[Federal Register Volume 63, Number 127 (Thursday, July 2, 1998)]
[Notices]
[Pages 36236-36240]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-17592]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Notice of Availability of Funds Program Announcement 98077, 
Programs To Prevent the Emergence and Spread of Antimicrobial 
Resistance in Food Animals

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) 1998 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 food animals. CDC 
is committed to achieving the health promotion and disease prevention 
objectives of Healthy People 2000, a national activity to reduce 
morbidity and mortality and improve the quality of life. This 
announcement is related to the priority area of Immunization and 
Infectious Diseases (For ordering a copy of Healthy People 2000, see 
the section Where to Obtain Additional Information).
    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 food animals.
    The intention of this project is to develop and evaluate a 
``prudent use of antimicrobial agents'' program in certain food animal 
groups. 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 food animals, and that additional resources 
towards achieving this goal would be provided by veterinary and animal 
industry organizations.
    Applicants 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

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among food animals through good management practices,
    3. Preventing colonization and infection of animals by pathogens 
through the use of probiotics,
    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 funded projects will use a combination of 
approaches to achieve judicious antimicrobial use and other changes 
that will result in decreased appearance and spread of resistance. 
Funded projects 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 governments and their agencies in the United States. 
Thus, universities, colleges, research institutions, hospitals, other 
public and private non profit organizations, including State and local 
governments or their bona fide agents, federally recognized Indian 
tribal governments, Indian tribes or Indian tribal organizations, and 
small, minority- and/or women-owned businesses are eligible to apply. 
Only one eligible application from an organization/government/agency 
will be accepted. Applicants from each organization/government/agency 
are encouraged to coordinate and combine their efforts prior to 
submitting their application.

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

C. Availability of Funds

    Approximately $120,000 is available in FY 1998 to fund one or two 
awards. These resources will be provided to support demonstration 
projects in food animals (e.g. swine, poultry, beef cattle, dairy 
cattle). It is expected that the average annual award for projects will 
be range from $40,000 up to $70,000 and will be made for a 12-month 
budget period within a project period of up to 3 years. Funding 
estimates may change. It is expected that awards will begin on or about 
September 30, 1998. Continuation awards within an approved project 
period will be made on the basis of satisfactory progress and 
availability of funds.

Use of Funds

    Restrictions on Lobbying. Applicants should be aware of 
restrictions on the use of HHS funds for lobbying of Federal or State 
legislative bodies. Under the provisions of 31 U.S.C. Section 1352 
(which has been in effect since December 23, 1989), recipients (and 
their subtier contractors) are prohibited from using appropriated 
Federal funds (other than profits from a Federal contract) for lobbying 
Congress or any Federal agency in connection with the award of a 
particular contract, grant, cooperative agreement, or loan. This 
includes grants/cooperative agreements that, in whole or in part, 
involve conferences for which Federal funds cannot be used directly or 
indirectly to encourage participants to lobby or to instruct 
participants on how to lobby.
    In addition, the FY 1998 Department of Labor, Health and Human 
Services, and Education, and Related Agencies Appropriations Act 
(Public Law 105-78) states in Section 503 (a) and (b) that no part of 
any appropriation contained in this Act shall be used, other than for 
normal and recognized executive-legislative relationships, for 
publicity or propaganda purposes, for the preparation, distribution, or 
use of any kit, pamphlet, booklet, publication, radio, television, or 
video presentation designed to support or defeat legislation pending 
before the Congress or any State legislature, except in presentation to 
the Congress or any State legislature itself. No part of any 
appropriation contained in this Act shall be used to pay the salary or 
expenses of any grant or contract recipient, or agent acting for such 
recipient, related to any activity designed to influence legislation or 
appropriations pending before the Congress or any State legislature.

D. Program Requirements

    In conducting activities to achieve the purpose of this program, 
the recipient shall be responsible for the activities under A, below, 
and CDC shall be responsible for conducting activities under B, below.

A. Recipient Activities

    Recipients are responsible for the following:
    1. Develop study protocol to include utilizing the selected food 
animal (e.g., beef cattle, dairy cattle, swine, poultry); defining 
foodborne pathogens of interest (e.g., Salmonella, Campylobacter), and 
describing the partnerships (e.g., including a veterinary diagnostic 
laboratory, veterinary professional associations, and animal commodity 
groups).
    2. Providing a descriptive analysis of the selected study 
population.
    3. 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.
    4. 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.
    5. Measuring the effects of the intervention:
    a. 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.
    b. 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.
    c. As decreases in resistance as a result of the program may take 
several months to years to manifest themselves, recipients are 
responsible for measuring outcomes related to how well the 
interventions have been implemented.
    d. 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.
    e. Consideration should be given to parallel measurements in a non-

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intervention group of animals, to better define the impact of the 
intervention.
    6. Dissemination of research findings: Disseminating research 
results by appropriate methods such as publication in journals, 
presentation at meetings, conferences, etc.

B. 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. This includes: (1) providing technical 
assistance in the design and conduct of the project, including 
intervention methods and analytic approach; (2) performing selected 
laboratory tests as appropriate; (3) assisting in data management, the 
analysis of research data, and the interpretation and dissemination of 
research findings, as appropriate; (4) assisting in the design of the 
evaluation and in the identification of outcome measures that will 
allow for later analysis of economic benefits.

E. Application Content

    All applicants must develop their application in accordance with 
the Form PHS-398 (revised 5/95), information contained in this 
cooperative agreement announcement, and the instructions outlined 
below. In order to ensure an objective, impartial, and prompt review, 
applications which do not conform to these instructions may be 
disqualified.

General Instructions

    1. All pages must be clearly numbered.
    2. A complete index to the application and its appendixes must be 
included.
    3. The original and two copies of the application must be submitted 
unstapled and unbound. Bound materials (e.g., pamphlets, booklets, 
etc.) will not be accepted in the narrative or appendices. To submit 
such materials, copy them onto 8\1/2\''  x  11'' white paper, one-side 
only.
    4. All materials must be typewritten, single spaced, and in 
unreduced type (no smaller than font size 12) on 8\1/2\'' by 11'' white 
paper, with at least 1'' margins, headers, and footers.
    5. All pages must be printed on one side only.

Specific Instructions

    The application narrative must not exceed 15 pages (excluding 
budget and appendixes). Unless indicated otherwise, all information 
requested below must appear in the narrative. Materials or information 
that should be part of the narrative will not be accepted if placed in 
the appendices. The application narrative must contain the following 
sections in the order presented below.
    1. Abstract: Provide a brief (two pages maximum) abstract of the 
project.
    2. Background and Need: Discuss the background and need for the 
proposed project. Illustrate and justify the need for the proposed 
project that is consistent with the purpose and objectives of this 
cooperative agreement program.
    3. Capacity and Personnel: Describe applicant's past experience in 
conducting projects/studies similar to that being proposed. Describe 
applicant's resources, laboratory and other facilities, and 
professional personnel that will be involved in conducting the project. 
Include in an appendix curriculum vitae for all professional personnel 
involved with the project. Describe plans for administration of the 
project and identify administrative resources that will be assigned to 
the project. Provide in an appendix letters of support from all key 
participating non-applicant organizations, individuals, etc., which 
clearly indicate their commitment to participate as described in the 
operational plan. Do not include letters of support from CDC personnel. 
Letters of support from CDC will not be accepted in the application.
    4. Objectives and Technical Approach: Describe specific objectives 
for the proposed project which are measurable and time-phased and are 
consistent with the purpose and goals of this cooperative agreement 
program. Include a detailed timeline for completion of key activities. 
Provide a detailed operational plan for initiating and conducting the 
project which clearly and appropriately addresses all Recipient 
Activities. Include a clear description of applicant's technical 
approach/methods which are directly relevant to the study objectives. 
Clearly identify specific assigned responsibilities/tasks for all key 
professional personnel. Describe the nature and extent of collaboration 
with CDC and/or others during various phases of the project. Clearly 
describe the population to be studied (minimum adequate numbers of 
animals are as follows: dairy cows-100, turkeys or chickens-5000, beef 
cattle-500, and swine-250). Describe in detail a plan for evaluating 
study results (including how data on prescribing practices, costs, and 
charges will be obtained) and for evaluating progress toward achieving 
project objectives. Justify the choice of organisms and antimicrobial 
susceptibility that will be used for evaluation, and include a 
description about how quality of laboratory measurements will be 
assured.
    5. Budget: Provide in an appendix a budget and accompanying 
detailed justification for the first year of the project that is 
consistent with the purpose and objectives of this program. Provide 
estimated total budgets for subsequent years. The last year may involve 
only data collection and analysis for purposes of evaluating the 
program. 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). (See sample budget included 
in application package.)

    Note: If indirect costs are requested, a copy of the applicant 
organization's current negotiated Federal indirect cost rate 
agreement or cost allocation plan must be provided.

F. Application Submission and Deadline

    The original and five copies of the completed application PHS Form 
398 (revised 5/95, OMB Control Number 0925-0001) must be submitted to 
the address below on or before August 7, 1998:

Sharron P. Orum, Grants Management Officer, ATTN: Gladys T. 
Gissentanna, Grants Management Branch, Procurement and Grants Office, 
Centers for Disease Control and Prevention (CDC), 255 East Paces Ferry 
Road, NE., Room 314, Mailstop E-18, Atlanta, Georgia 30305-2209

    1. 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 objective 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.)
    2. Late Applications: Applications which do not meet the criteria 
in 1. a. or 1. b. above are considered late applications. Late 
applications will not be considered in the current competition and will 
be returned to the applicant.

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G. Evaluation Criteria

    The applications will be reviewed and evaluated according to 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 identifies an appropriate 
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 applicant describes adequate and appropriate 
collaboration with CDC and/or others 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.

H. Other Requirements

Technical Reporting Requirements

    Semiannual progress reports are required and must be submitted no 
later than 30 days after each semiannual reporting period. The 
semiannual progress reports must summarize the following: (1) major 
accomplishments including information on women screened; (2) problems 
encountered in program implementation; and (3) efforts or proposed 
strategies to resolve problems. The final progress report is required 
no later than 90 days after the end of the project period. All 
manuscripts published as a result of the work supported in part or 
whole by the cooperative agreement will be submitted with the progress 
reports.
    An annual Financial Status Report (FSR) must be submitted no later 
than 90 days after the end of each budget period. The final financial 
status report is due no later than 90 days after the end of the project 
period.
    An original and two copies of all reports should be submitted to 
the Grants Management Officer, Grants Management Branch, CDC.

Executive Order 12372 Review

    Applications are subject to Intergovernmental Review of Federal 
Programs as governed by Executive Order 12372 (E.O.). E.O. 12372 sets 
up a system for State and local government review of proposed Federal 
assistance applications. Applicants (other than federally recognized 
Indian tribal governments) should contact their State Single Point of 
Contact (SPOC) as early as possible to alert them to the prospective 
applications and receive any necessary instructions on the State 
process. For proposed projects serving more than one State, the 
applicant is advised to contact the SPOC for each affected State. A 
current list of SPOCs is included in the application kit. Indian tribes 
are strongly encouraged to request tribal government review of the 
proposed application. If SPOCs or tribal governments have any process 
recommendations on applications submitted to CDC, they should forward 
them to Sharron Orum, Grants Management Officer, Grants Management 
Branch, Procurement and Grants Office, Centers for Disease Control and 
Prevention (CDC), 255 East Paces Ferry Road, NE., Mailstop E-18, Room 
314, Atlanta, Georgia 30305. The due date for State process 
recommendations is 30 days after the application deadline date for new 
and competing continuation awards (the appropriation for this financial 
assistance program was received late in the fiscal year and would not 
allow for an application receipt date that would accommodate the 60-day 
State recommendation process period). The granting agency does not 
guarantee to ``accommodate or explain'' for State process 
recommendations it receives after that date.
    The following additional requirements, incorporated by reference, 
are applicable to this program. For a complete description of each, see 
Attachment 2 (included in the application kit).

AR98-2-Animal Subjects Requirements
AR98-9-Paperwork Reduction Act Requirements
AR98-10-Smoke-Free Workplace Requirements
AR98-15-Proof of Non-Profit Status (See Eligibility Section)

I. Authority and Catalog of Federal Domestic Assistance Number

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

J. Where To Obtain Additional Information

    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 any questions after 
reviewing the contents of all the documents, business management 
technical assistance may be obtained from Gladys T. Gissentanna, Grants 
Management Specialist, Grants Management Branch, Procurement and Grants 
Office, Centers

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for Disease Control and Prevention (CDC), 255 East Paces Ferry Road, 
NE., Room 314, Mailstop E-18, Atlanta, Georgia 30305, Telephone (404) 
842-6801, Email address: [email protected].
    Programmatic technical assistance may be obtained from Frederick 
Angulo, DVM, PhD, Medical Epidemiologist, National Centers for 
Infectious Diseases, Division of Bacterial and Mycotic Diseases, 
Foodborne and Diarrheal Diseases Branch, Centers for Disease Control 
and Prevention (CDC), 1600 Clifton Road, NE., Mailstop A-38, Atlanta, 
Georgia 30333, Telephone (404) 639-2840, Facsimile: (404) 639-2205, 
Email address: [email protected].
    You may also obtain this announcement from one of two Internet 
sites on the actual publication date: CDC's homepage at http://
www.cdc.gov or at the Government Printing Office homepage (including 
free on-line access to the Federal Register at http://
www.access.gpo.gov).
John L. Williams,
Director, Procurement and Grants Office, Centers for Disease Control 
and Prevention (CDC).
[FR Doc. 98-17592 Filed 7-1-98; 8:45 am]
BILLING CODE 4163-18-P