[Federal Register: May 5, 2003 (Volume 68, Number 86)]
[Notices]
[Page 23720-23722]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05my03-81]
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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
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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:
mqw6@cdc.gov. 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: shn8@cdc.gov. 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: bstewart@cdc.gov.
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