Applied Research on Antimicrobial Resistance; Notice of
Availability of Funds
[Federal Register: May 24, 2001 (Volume 66, Number 101)]
[Notices]
[Page 28751-28753]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24my01-72]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Program Announcement 01066]
Applied Research on Antimicrobial Resistance; 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 grant program for
Applied Research on Antimicrobial Resistance (AR). This program
addresses the ``Healthy People 2010'' focus area Immunization and
Infectious Diseases.
The purpose of the program is to provide assistance for applied
research aimed at prevention and control of the emergence and spread of
antimicrobial resistance in the U.S. This AR research program will
focus on two areas: (1) AR in rural areas; and (2) Microbiologic
mechanisms of dissemination of AR genes and relationship to
antimicrobial drug use, including (a) in health care settings and (b)
from food animals to humans. This program's design will implement Part
1 of the Public Health Action Plan to Combat Antimicrobial Resistance,
Domestic Issues. For more information visit the internet site:
www.cdc.gov/drugresistance/actionplan/index.htm.
1. AR in Rural Areas (See Attachment II for additional information)
This research includes four components that will provide
information needed to prevent and control AR in rural areas in the
U.S.: Surveillance of antimicrobial infections, promoting appropriate
antimicrobial drug prescribing, preliminary assessment of environmental
impact of antimicrobials, and development of new antimicrobial
products.
2. Microbiologic Mechanisms of Dissemination of AR Genes and
Relationship to Antimicrobial Drug Use (See Attachment III for
additional information)
This research will develop information necessary to prevent and
control the emergence and spread of resistance in selected bacteria in
health care settings and from food animals to humans, including
mechanisms of resistance, dissemination of resistance, and the impact
of antimicrobial use on dissemination of resistance.
B. Eligible Applicants
Applications may be submitted by public and private nonprofit
organizations and by governments and their agencies; that is,
universities, colleges, research institutions, hospitals, other public
and private nonprofit organizations, State and local governments 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, the Federated
States of Micronesia, the Republic of the Marshall Islands, and the
Republic of Palau, federally recognized Indian tribal governments,
Indian tribes, or Indian tribal organizations.
Applicants may apply for either Antimicrobial Resistance in Rural
Areas or Microbiologic Mechanisms of Dissemination of AR Genes and
Relationship to Antimicrobial Drug Use or both. Proposals for
Antimicrobial Resistance in Rural Areas must address all four
components: Surveillance, Promoting Appropriate Antimicrobial Drug
Prescribing, Assessment of Environmental Impact of Antimicrobials
(environmental sampling or sentinel human populations), and New
Antimicrobial Products.A separate application is required for each
research area (rural health and microbiologic mechanisms).
Note: Title 2 of the United States Code, Chapter 26, Section
1611 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 $3,100,000 is available in FY 2001 as follows:
Approximately $2,200,000 will be available for one award in focus area
(1) and approximately $900,000 will be available for five awards in
focus area (2), for an average award of $100,000 to $500,000. It is
expected that the awards 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 three years. The funding estimates may change.
A continuation award within an approved project period will be made
on the basis of satisfactory progress as
[[Page 28752]]
evidenced by required reports and the availability of funds.
D. Program Requirements
Projects must meet the following requirements
1. AR in Rural Areas (See Attachment II for additional information)
Develop and implement comprehensive intervention projects to
prevent and control AR in rural areas in the U.S.
a. Surveillance
Implement a practical, cost-effective system for monitoring
antimicrobial drug resistance and use patterns that is operationally
useful for prevention and control efforts in rural areas.
Taking into account factors relevant in rural settings, implement
an epidemiologically representative, clinical laboratory based
surveillance network for acute bacterial infections of public health
importance that are commonly acquired in one or more of three settings:
The community, health-care system, and/or the food supply.
b. Promoting Appropriate Antimicrobial Drug Prescribing
Measure antimicrobial drug prescribing and assess factors that
influence such prescribing in rural areas. Use these data to conduct
and evaluate appropriate use programs. Promote appropriate
antimicrobial drug prescribing in human medicine and optionally in
veterinary medicine.
c. Preliminary Assessment of Environmental Impact of Antimicrobials
Through pilot studies, assess the likelihood of environmental
impact of antimicrobial drug use in modern agriculture and/or
aquaculture.
d. New Antimicrobial Products
Identify and Investigate compounds, particularly naturally
occurring substances, that may be useful in combating antimicrobial
resistance in rural settings.
2. Microbiologic Mechanisms of Dissemination of AR Genes and
Relationship to Antimicrobial Drug Use (See Attachment III for
additional information)
Develop information necessary to prevent and control the emergence
and spread of resistance in selected bacteria (see below) through
better understanding the mechanisms through which resistance develops
and spreads in field settings.
Projects should address one or more of the following: (1)
Vancomycin resistance in staphylococci; (2) Cephalosporin resistance in
Klebsiella pneumoniae, Salmonellae, or other Enterobacteriaceae through
extended-spectrum -lactamases, AmpC, or other -
lactamases; (3) Streptogramin (e.g., quinupristin/dalfopristin)
resistance in enterococci; or (4) Fluoroquinolone resistance in
Escherichia coli.
E. Application Content
Letter of Intent (LOI)
Although not a prerequisite of application, a non-binding letter of
intent-to-apply is requested from potential applicants. The letter of
intent shall be submitted on or before June 15, 2001 to the Grants
Management Specialist identified in the ``Where to Obtain Additional
Information'' section of this announcement. The letter should identify
the announcement number, name the principal investigator, and briefly
describe the scope and intent of the proposed research work. The letter
of intent does not influence review or funding decisions, but the
number of letters received will enable CDC to plan the review more
effectively and efficiently.
Application
Use the information in the Program Requirements, Other
Requirements, and Evaluation Criteria sections to develop the
application content. The application will be evaluated on the
evaluation criteria listed below. The Research Plan for each research
area should be no more than 25 pages, printed on one side, with one
inch margins, and letters must not be smaller than 10 point font.
F. Submission and Deadline
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).
On or before July 16, 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
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. 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 grant program. Extent to which applicant illustrates
and justifies the need for the proposed project that is consistent with
the purpose and objectives of this grant program.
2. Capacity (40 points total)
a. Extent to which applicant describes adequate resources and
facilities (both technical and administrative) for conducting the
project. (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 related to that proposed as evidenced by
curriculum vitae, publications, etc. (20 points)
c. Extent to which applicant includes letters of support
appropriate non-applicant organizations, individuals, etc. Extent to
which the letters clearly indicate the author's commitment to
participate and/or collaborate as described in the operational plan.
(10 points)
3. Objectives and Technical Approach (50 points total)
a. Extent to which applicant describes specific objectives of the
proposed project which are consistent with the purpose and goals of
this grant program and which are measurable and time-phased. (10
points)
b. Extent to which applicant presents a detailed operational plan
for initiating and conducting the project, which clearly and
appropriately addresses all Program Requirements. Extent to which
applicant clearly identifies and describes appropriate study sites (per
Program Requirements 1.a and 3.a). 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 conducting the
[[Page 28753]]
proposed studies and extent to which the plan is adequate to accomplish
the objectives. Extent to which applicant describes specific study
protocol(s), the roles of partners or collaborators or plans for the
development of study protocols that are appropriate for achieving
project objectives. (30 points)
c. If the proposed project involves human subjects, the degree to
which the applicant has met 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. (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 will be
documented. (see Other Requirements for additional information
regarding this requirement for research projects). (5 points)
d. Extent to which applicant provides a detailed and adequate plan
for evaluating study results and for evaluating progress toward
achieving project objectives. (5 points)
4. Budget (not scored)
Extent to which the proposed budget is reasonable, clearly
justifiable, and consistent with the intended use of grant funds.
5. Human Subjects (not scored)
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 an original plus two copies of the following:
1. Annual progress reports;
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 in the
application kit.
AR-1 Human Subjects Requirements
AR-2 Requirements for Inclusion of Women and Racial and Ethnic
Minorities in Research
AR-9 Paperwork Reduction Act Requirements
AR-10 Smoke-Free Workplace Requirements
AR-11 Healthy People 2010
AR-12 Lobbying Restrictions
AR-15 Proof of Non-Profit Status
AR-22 Research Integrity
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, Room 3000, 2920 Brandywine Road, Mailstop K75,
Atlanta, GA 30341-4146, Telephone number: 770-488-2753, Email address:
gcg4@cdc.gov.
For program technical assistance, contact: Marsha Jones, Health
Scientist, National Center for Infectious Diseases, Centers for Disease
Control and Prevention, 1600 Clifton Road, N.E., Mailstop C-12,
Atlanta, GA 30333, Telephone number: 404-639-2603. Email address:
maj4@cdc.gov.
Dated: May 17, 2001.
John L. Williams,
Director, Procurement and Grants Office, Centers for Disease Control
and Prevention (CDC).
[FR Doc. 01-13127 Filed 5-23-01; 8:45 am]
BILLING CODE 4163-18-P
![[logo] US EPA](http://www.epa.gov/epafiles/images/logo_epaseal.gif){kind=logo}