[Federal Register Volume 68, Number 86 (Monday, May 5, 2003)]
[Notices]
[Pages 23720-23722]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-10979]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 03120]


Applied Research on Antimicrobial Resistance: Characterization of 
Strains of Community-Associated Methicillin-Resistant Staphylococcus 
Aureus; Notice of Availability of Funds

    Application Deadline: June 19, 2003.

A. 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.

B. Purpose

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 2003 funds for a grant program for 
Applied Research on Antimicrobial Resistance (AR): Characterization of 
Strains of Community-Associated Methicillin-Resistant Staphylococcus 
Aureus (MRSA). This program addresses the ``Healthy People 2010'' focus 
area of 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 
AR in the United States. This grant will focus on characterization of 
strains of community-associated MRSA.
    This program's design will implement Part 1 of ``A Public Health 
Action Plan to Combat Antimicrobial Resistance, Domestic Issues.'' 
Visit the internet site: http://www.cdc.gov/drugresistance/actionplan/index.htm for more information on the Action Plan. See Attachments II 
and III on the CDC Web site (http://www.cdc.gov) for information 
related to this grant.
    This research includes three components that will provide 
information needed to prevent and control AR: (1) Identification and 
access to a defined population of persons within which community-
associated MRSA disease and data appear to be sufficiently prevalent to 
allow appropriate analyses; (2) obtaining strains of Staphylococcus 
aureus (S. aureus) causing disease in this population with appropriate, 
linked epidemiologic and clinical data; and (3) characterizing MRSA 
strains using a variety of molecular and biochemical techniques.
    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 (NCID): Reduce the spread of AR, and protect 
Americans from infectious diseases.

C. Eligible Applicants

    Applications may be submitted by public and private nonprofit 
organizations and by governments and their agencies; that is:

[sbull] Universities
[sbull] Colleges
[sbull] Technical schools
[sbull] Research Institutions
[sbull] Hospitals
[sbull] Community-based organizations
[sbull] Faith-based organizations
[sbull] Federally recognized Indian tribal governments
[sbull] Indian Tribes
    [sbull] Indian tribal organizations
    [sbull] State and local governments or their bona fide agents (this 
includes the District of Columbia, the Commonwealth of Puerto Rico, the 
Virgin Islands, the Commonwealth of the Northern Marianna Islands, 
American Samoa, Guam, the Federated States of Micronesia, the Republic 
of the Marshall Islands, and the Republic of Palau)
    [sbull] Political subdivisions of States (in consultation with 
States)

    Note: Title 2 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. Funding

Availability of Funds

    Approximately $600,000 is available in FY 2003 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, 2003, 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.

Recipient Financial Participation

    Matching funds are not required for this program.

E. Program Requirements

    In conducting activities to achieve the purpose of this program, 
the recipient will be responsible for all of the following activities:
    1. Assemble a network of partners (a consortium) to accomplish the 
objectives of the program announcement, including identification and 
access to a defined population of persons within which there is 
community-associated MRSA disease and data sufficiently prevalent to 
allow appropriate analyses.
    2. Obtain strains of S. aureus causing disease in this population 
with appropriate epidemiologic and clinical data to make findings 
generalizable to similar populations from diverse geographic areas. 
Ensure that the variety and quantity of distinguishable strain types 
included allow for valid comparisons between strain types.

[[Page 23721]]

    3. Characterize strains and/or the relationship between these 
strains using a variety of molecular and biochemical techniques, 
including, Pulsed Field Gel Electropheresis (PFGE), Multi Locus Sub 
Typing (MLST), and Polymerase Chain Reaction (PCR) for virulence genes. 
Studies could include demonstrating the correlation of host response to 
disease and strain characteristics, or relative impact strain 
characteristics have on colonization or invasive disease.

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 pages, double-spaced, printed on one side, with one-inch margins, 
and unreduced 12-point font. Your letter of intent will be used to 
estimate the potential reviewer workload and to avoid conflicts of 
interest during the peer review. It should include the following 
information: name, address, telephone number, and e-mail address of the 
Principal Investigator, the identities of other key personnel and 
participating institutions, and a narrative description of the proposed 
research project.

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 12-point 
font.
    The narrative should consist of, at a minimum, a detailed Research 
Plan, Objectives, Methods, an Evaluation Plan and Budget. The Research 
Plan should include activities to be conducted over the entire three 
year project period.

G. Submission and Deadline

Letter of Intent (LOI) Submission

    On or before June 4, 2003, submit the LOI to the Grants Management 
Specialist identified in the ``Where to Obtain Additional Information'' 
section of this announcement.

Application Forms

    Submit the signed original and two copies of PHS-398 (OMB Number 
0925-0001) Adhere to the instructions on the Errata Instruction Sheet 
(posted on the CDC Web site) for PHS 398. Forms are available at the 
following Internet address: http://www.cdc.gov/od/pgo/forminfo.htm.
    If you do not have access to the Internet, or if you have 
difficulty accessing the forms on-line, you may contact the CDC 
Procurement and Grants Office Technical Information Management Section 
(PGO-TIM) at: 770-488-2700. Application forms can be mailed to you.

Submission Date, Time, and Address

    The application must be received on or before 4 p.m. Eastern Time, 
June 19, 2003. Submit the application to: Technical Information 
Management--PA03120, CDC Procurement and Grants Office, 2920 Brandywine 
Road, Atlanta, GA 30341-4146.
    Applications may not be submitted electronically.

CDC Acknowledgment of Application Receipt

    A postcard will be mailed by PGO-TIM, notifying you that CDC has 
received your application.

Deadline

    Letters of intent and applications shall be considered as meeting 
the deadline if they are received before 4 p.m. Eastern Time on the 
deadline date. Any applicant who sends their application 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.
    Any application that does not meet the above criteria will not be 
eligible for competition and will be discarded. The applicant 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 purpose section of this announcement. 
Measures must be objective and quantitative and must measure the 
intended outcome. These measures of effectiveness shall be submitted 
with the application and shall be an element of evaluation.
    Upon receipt, applications will be reviewed for completeness and 
responsiveness jointly by PGO-TIM and the NCID Office of Extramural 
Research. Incomplete and/or non-responsive applications will be 
returned to the applicant without further consideration.
    Dual-Level Peer Review: As part of the initial merit review, all 
applicants will receive a written critique based on the comments and 
recommendations of the scientific (peer) review group. The review of 
most research applications will also include a process in which only 
those applications deemed to have the highest scientific merit, 
generally the top half of the applications under review, will be 
discussed, assigned a priority score, and receive a second level 
review. The second level of review will be performed by either CDC 
senior staff or the NCID Board of Scientific Counselors. Senior staff 
or Board recommendations are based not only on considerations of 
scientific merit, as judged by the scientific (peer) review group, but 
also on the relevance of the proposed study to the Center's programs 
and priorities.

Review Criteria

    The goal of this research is to prevent and control the emergence 
and spread of AR in the United States. In the written comments, 
reviewers will be asked to discuss the following aspects of the 
application in order to judge the likelihood that the proposed research 
will have a substantial impact on the pursuit of these goals:

    [sbull] Significance
    [sbull] Approach
    [sbull] Innovation
    [sbull] Investigator
    [sbull] Environment

    The peer review group will address and consider each of these 
criteria in assigning the application's overall score, weighting them 
as appropriate for each application. The application does not need to 
be strong in all categories to be judged likely to have major 
scientific impact and thus deserve a high priority score. For example, 
an investigator may propose to carry out important work that by its 
nature is not innovative but is essential to move a field forward.
    Significance: Does this study address an important problem? If the 
aims of the application are achieved, how will scientific knowledge be 
advanced? What will be the effect of these studies on the concepts or 
methods that drive this field?
    Approach: Are the conceptual framework, design, methods, and

[[Page 23722]]

analyses adequately developed, well integrated, and appropriate to the 
aims of the project? Does the applicant acknowledge potential problem 
areas and consider alternative tactics?
    Innovation: Does the project employ novel concepts, approaches or 
methods? Are the aims original and innovative? Does the project 
challenge existing paradigms or develop new methodologies or 
technologies?
    Investigator: Is the investigator appropriately trained and well 
suited to carry out this work? Is the work proposed appropriate to the 
experience level of the principal investigator and other researchers 
(if any)? Are the investigators committed to collaborative and 
cooperative nature of this program?
    Environment: Does the scientific environment in which the work will 
be done contribute to the probability of success? Do the proposed 
experiments take advantage of unique features of the scientific 
environment or employ useful collaborative arrangements? Is there 
evidence of institutional support?
    Additional Review Criteria: In addition to the above criteria, the 
following items will be considered in the determination of scientific 
merit and the priority score:
    Protection of Human Subjects from Research Risk: The involvement of 
human subjects and protections from research risk relating to their 
participation in the proposed research will be assessed. (See criteria 
included in Attachment I).
    Inclusion of Women, Minorities and Children in Research: The 
adequacy of plans to include subjects from both genders, all racial and 
ethnic groups (and subgroups), and children as appropriate for the 
scientific goals of the research. Plans for the recruitment and 
retention of subjects will also be evaluated. (See criteria included in 
Attachment I).
    Public Health Importance: Does the applicant justify the proposed 
project as important to the prevention of community-associated MRSA?
    Measures of Effectiveness: Does the applicant provide 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.

Additional Considerations

    Budget: The reasonableness of the proposed budget and the requested 
period of support in relation to the proposed research. (not scored)

I. Other Requirements

Technical Reporting Requirements

    Provide CDC with original plus two copies of:
    1. Interim progress report, no less than 90 days before the end of 
the budget period. The progress report will serve as your non-competing 
continuation application, and must contain the following elements:
    a. Current Budget Period Activity Objectives.
    b. Current Budget Period Financial Progress.
    c. New Budget Period Program Proposed Activity Objectives.
    d. Detailed Line-Item Budget and Justification.
    e. Additional Requested Information.
    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.

Additional Requirements

    The following additional requirements are applicable to this 
program. For a complete description of each, see Attachment I of the 
program announcement, as posted on the CDC Web site.

AR-1--Human Subjects Requirements
AR-2--Requirements for Inclusion of Women and Racial and Ethnic 
Minorities in Research
AR-7--Executive Order 12372
AR-10--Smoke Free Work Place 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 Web site, Internet address: 
http://www.cdc.gov.
    Click on ``Funding'' then ``Grants and Cooperative Agreements.''
    For general questions about this announcement, contact: Technical 
Information Management, CDC Procurement and Grants Office, 2920 
Brandywine Road, Atlanta, GA 30341-4146, Telephone: 770-488-2700.
    For business management and budget assistance, contact: Merlin 
Williams, Grants Management Specialist, Procurement and Grants Office, 
Centers for Disease Control and Prevention, 2920 Brandywine Road, 
Atlanta, GA 30341-4146, Telephone: 770-488-2765, E-mail Address: 
[email protected].
    For business management and budget assistance in the Territories, 
contact: Steward Nichols, CDC Procurement and Grants Office, 2920 
Brandywine Road, Atlanta, GA 30341-4146, Telephone: 770-488-2788, E-
mail address: [email protected].
    For program technical assistance, contact: Barbara Stewart, Program 
Analyst, National Center for Infectious Diseases, Centers for Disease 
Control and Prevention, 1600 Clifton Road, NE., Atlanta, GA 30333, 
Telephone: 404-639-0045, E-mail address: [email protected].

    Dated: April 29, 2003.
Sandra R. Manning,
Director, Procurement and Grants Office, Centers for Disease Control 
and Prevention.
[FR Doc. 03-10979 Filed 5-2-03; 8:45 am]
BILLING CODE 4163-18-P