02-13883. 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.

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.

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: [phone]. E-mail address: [e-mail].

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: [phone]. E-mail address: [e-mail].

Dated: May 29, 2002.

Sandra R. Manning,

CGFM Director, Procurement and Grants Office, Center for Disease Control and Prevention.