[Federal Register Volume 67, Number 107 (Tuesday, June 4, 2002)]
[Notices]
[Pages 38501-38503]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-13883]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 02175]


Applied Research on Antimicrobial Resistance (AR): Validation of 
National Committee for Clinical Laboratory Standards (NCCLS) 
Breakpoints for Human Pathogens of Public Health Importance; Notice of 
Availability of Funds

A. Purpose

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of a fiscal year (FY) 2002 funds for a grant program for 
Applied Research on Antimicrobial Resistance (AR): Validation of 
National Committee for Clinical Laboratory Standards (NCCLS) 
Breakpoints for Human Pathogens of Public Health Importance. 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 United States. This program will focus 
on validation of NCCLS breakpoints for human pathogens of public health 
importance. This program's design will implement Part 1 of the Public 
Health Action Plan to Combat Antimicrobial Resistance, Domestic Issues. 
Visit the Internet site: www.cdc.gov/drugresistance/actionplan/index.htm for more information on the Action Plan.
    This research includes three components that will provide 
information needed to prevent and control AR: (1) Validating existing 
interpretive criteria for pathogens of public health importance; (2) 
developing new interpretive criteria for pathogens of public health 
importance using existing NCCLS methods and quality control; and (3) 
developing new interpretive criteria and new antimicrobial 
susceptibility testing methods for pathogens of public health 
importance using existing NCCLS methods and quality control as a 
starting point for novel test development.
    Measurable outcomes of the program will be in alignment with one or 
more of the following performance goals for the National Center for 
Infectious Diseases: (1) Reduce the spread of antimicrobial resistance; 
(2) protect Americans from priority infectious diseases; and (3) apply 
scientific findings to prevent and control infectious diseases.

B. 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. 241(a) and 247b(k)(2)), as 
amended. The Catalog of Federal Domestic Assistance number is 93.283.

C. Eligible Applicants

    Applications may be submitted by public and private nonprofit 
organizations and by governments and their agencies; that is, 
universities, colleges, technical schools, research institutions, 
hospitals, other public and private nonprofit organizations, community-
based organizations, faith-based 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.

    Note: Title two of the United States Code section 1611 states 
that an organization described in section 501(c)(4) of the Internal 
Revenue Code that engages in lobbying activities is not eligible to 
receive Federal funds constituting an award, grant or loan.


[[Page 38502]]



D. Availability of Funds

    Approximately $600,000 is available in FY 2002 to fund 
approximately three awards. It is expected that the average award will 
be $200,000, ranging from $150,000 to $250,000. It is expected that the 
awards will begin on or about August 30, 2002, and will be made for a 
12-month budget period within a project period of up to three years. 
Funding estimates 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.

E. Program Requirements

    In conducting activities to achieve the purpose of this program, 
the recipient will be responsible for the following activities:
    1. Assemble data from population distributions of susceptible and 
resistant organisms [based on minimum inhibitory concentration (MIC) 
data], pharmacokinetic (PK) and pharmacodynamic (PD) parameters, and 
clinical trials to validate or revise existing breakpoints for bacteria 
of particular public health importance. The interpretive criteria must 
be developed using the standard NCCLS susceptibility testing methods 
outlined in NCCLS documents M2-A7 (2000) and M7-A5 (2000). These 
documents can be found at: www.nccls.org.
    2. Provide a method that is in line with other NCCLS methods to be 
elucidated, including the appropriate quality control organisms, and 
the ranges of MICs or zone diameters that constituted a test that was 
in control for organisms which NCCLS has yet to establish and publish a 
standardized susceptibility testing method. Thus, potential projects 
include validating existing interpretive criteria for pathogens of 
public health importance, developing new interpretive criteria for 
pathogens of public health importance using existing NCCLS methods and 
quality control, or developing new interpretive criteria and new 
antimicrobial susceptibility testing methods for pathogens of public 
health importance using existing NCCLS methods and quality control as a 
starting point for novel test development.

F. Content

Letter of Intent (LOI)

    An LOI is optional for this program. The Program Announcement title 
and number must appear in the LOI. The narrative should be no more than 
five double-spaced pages, printed on one side, with one-inch margins, 
and unreduced font. Your letter of intent will be used to plan the 
review more effectively and efficiently and should include the 
following information: (1) the name of the organization's principal 
investigator, and (2) a brief description of the scope and intent of 
the proposed research work.

Applications

    The Program Announcement title and number must appear in the 
application. 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 25 double-spaced pages, 
printed on one side, with one inch margins, and unreduced font.
    The narrative should consist of, at a minimum, a detailed Research 
Plan, Objectives, Methods, an Evaluation Plan and Budget.

G. Submission and Deadline

Letter of Intent (LOI)

    On or before June 15, 2002, submit the LOI to the Grants Management 
Specialist identified in the ``Where to Obtain Additional Information'' 
section of this announcement.

Application

    Submit the original and two copies of PHS-398 (OMB Number 0925-
0001) (adhere to the instructions on the Errata Instruction Sheet for 
PHS 398). Forms are available in the application kit and at the 
following Internet address: www.cdc.gov/od/pgo/forminfo.htm. 
Application forms must be submitted in the following order:

Cover Letter
Table of Contents
Application
Budget Information Form
Budget Justification
Checklist
Assurances
Certifications
Disclosure Form
HIV Assurance Form (if applicable)
Human Subjects Certification (if applicable)
Indirect Cost Rate Agreement (if applicable)
Narrative

    On or before 5:00 p.m. Eastern Time July 16, 2002, submit the 
application to: Technical Information Management Section, PA 
02175, Procurement and Grants Office, Centers for Disease Control and 
Prevention (CDC), 2920 Brandywine Road, Room 3000, Atlanta, GA 30341-
4146.
    Deadline: Applications will be considered as meeting the deadline 
if they are received before 5:00 p.m. Eastern Time on the deadline 
date. Applicants sending applications by the United States Postal 
Service or commercial delivery services must ensure that the carrier 
will be able to guarantee delivery of the application by the closing 
date and time. If an application is received after closing due to (1) 
carrier error, when the carrier accepted the package with a guarantee 
for delivery by the closing date and time, or (2) significant weather 
delays or natural disasters, CDC will upon receipt of proper 
documentation, consider the application as having been received by the 
deadline.
    Applications which do not meet the above criteria will not be 
eligible for competition and will be discarded. Applicants will be 
notified of their failure to meet submission requirements.

H. Evaluation Criteria

    Applicants are required to provide Measures of Effectiveness that 
will demonstrate the accomplishment of the various identified 
objectives of the grant. Measures of Effectiveness must relate to the 
performance goals as stated in section ``A. Purpose'' of this 
announcement. Measures must be objective and quantitative and must 
measure the intended outcome. These Measures of Effectiveness will be 
submitted with the application and will be an element of evaluation.
    Each application will be evaluated individually against the 
following criteria by a Special Emphasis Panel appointed by CDC and 
will be rated in accordance with current CDC peer review procedures:

1. Background and Public Health Importance

    Extent to which the 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 the applicant 
illustrates and justifies the need for the proposed project that is 
consistent with the purpose and objectives of this grant program.

2. Capacity

    a. Extent to which the applicant describes adequate resources and 
facilities (both technical and administrative) for conducting the 
project.

[[Page 38503]]

    b. Extent to which the 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.
    c. Extent to which the applicant includes letters of support from 
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.

3. Objectives and Technical Approach

    a. Extent to which the 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.
    b. Extent to which the applicant presents a detailed operational 
plan for initiating and conducting the project, which clearly and 
appropriately addresses all Program Requirements. Extent to which the 
applicant clearly identifies and describes appropriate study sites. 
Extent to which the applicant clearly identifies specific assigned 
responsibilities for all key professional personnel. Extent to which 
the plan clearly describes the applicant's technical approach/methods 
for conducting the proposed studies and extent to which the plan is 
adequate to accomplish the objectives. Extent to which the 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.
    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.
    d. Extent to which the applicant provides a detailed and adequate 
plan for evaluating study results and for evaluating progress toward 
achieving project objectives.

4. Measures of Effectiveness

    The extent to which the applicant provides Measures of 
Effectiveness that will demonstrate the accomplishment of the purpose 
of the grant. Are the measures objective/quantitative and do they 
adequately measure the intended outcome?

5. Budget (Not scored)

    The extent to which the proposed budget is reasonable, clearly 
justifiable, and consistent with the intended use of grant funds.

6. Human Subjects (Not scored)

    The extent to which the applicant adequately addresses the 
requirements of Title 45 CFR Part 46 for the protection of human 
subjects.

I. Other Requirements

Technical Reporting Requirements

    Provide CDC with an original plus two copies of:
    1. Semiannual progress reports The progress report will include a 
data requirement that demonstrates measures of effectiveness.
    2. Financial status report, no more than 90 days after the end of 
the budget period
    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 of the 
announcement in the application kit.

AR-1  Human Subjects Requirements
AR-2  Requirements for Inclusion of Women and Racial and Ethnic 
Minorities in Research
AR-7  Executive Order 12372 Review
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

J. Where to Obtain Additional Information

    This and other CDC announcements, the necessary applications, and 
associated forms can be found on the CDC home page Internet address--
http://www.cdc.gov. Click on ``Funding'' then ``Grants and Cooperative 
Agreements.''
    For business management technical assistance, contact: Rene' 
Benyard, Grants Management Specialist, Procurement and Grants Office, 
Centers for Disease Control and Prevention, 2920 Brandywine Road, Room 
3000, Mailstop K-75, Atlanta, GA 30341-4146. Telephone number: 
(770)488-2722. E-mail 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, NE, Mailstop C-12, Atlanta, 
GA 30333. Telephone number: (404)639-2603. E-mail address: 
[email protected].

    Dated: May 29, 2002.
Sandra R. Manning,
CGFM Director, Procurement and Grants Office, Center for Disease 
Control and Prevention.
[FR Doc. 02-13883 Filed 6-3-02; 8:45 am]
BILLING CODE 4163-18-P