[Federal Register Volume 66, Number 101 (Thursday, May 24, 2001)]
[Notices]
[Pages 28751-28753]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-13127]


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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

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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

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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: 
[email protected].
    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: 
[email protected].

    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