[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-
[[Page 36238]]
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.
[[Page 36239]]
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
[[Page 36240]]
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: gcg4@cdc.gov.
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: fja0@cdc.gov.
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
