[Federal Register: April 30, 2004 (Volume 69, Number 84)]
[Notices]
[Page 23759-23763]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30ap04-66]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Applied Research on Antimicrobial Resistance (AR): Estimates of
Economic Cost for Antimicrobial Resistant Human Pathogens of Public
Health Importance
Announcement Type: New.
Funding Opportunity Number: 04094.
Catalog of Federal Domestic Assistance Number: 93.283.
Key Dates:
Letter of Intent Deadline: May 17, 2004.
Application Deadline: June 14, 2004.
I. Funding Opportunity Description
Authority: Sections 319E(d) of the Public Health Service Act,
[42 U.S.C. 247d-5(d)], as amended.
Purpose: 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
addresses the ``Healthy People 2010'' focus area of Immunization and
Infectious Diseases.
Measurable outcomes of the program will be in alignment with the
following performance goals for the National Center for Infectious
Diseases: Protect Americans from infectious diseases and reduce the
spread of antimicrobial resistance.
The program's design must implement A Public Health Action Plan to
Combat Antimicrobial Resistance (Part I: Domestic Issues) (Action
Plan). For Research Objective I, measurable outcomes need to be
consistent with item (16) in Focus Area I, Surveillance of the Action
Plan: to provide health care system administrators and other decision
makers with data on the impact of drug-resistant organisms (e.g.,
outcome, treatment costs) and on effective prevention and control
measures. For Research Objective II, measurable outcomes need to be
consistent with one or more of the following action items: Focus Area
II. Prevention and Control, Item 23, 30 or 50. The Action Plan is
available at Internet site: http://www.cdc.gov/drugresistance/actionplan/index.htm.
Applications should address Research Objective I or Research
Objective II.
Research Objectives I: The priority objective of this program is to
create estimates of the economic costs of antimicrobial resistance in
human pathogens of public health importance by providing information
needed to
[[Page 23760]]
prevent and control AR. This should include:
Analysis of data on incidence, prevalence, and
antimicrobial susceptibility of specific infectious diseases.
Development of methods to determine costs which
are simple and reproducible for different antimicrobial resistant
organisms.
Calculation of economic costs (direct and
indirect) of infections that are resistant to one or more antimicrobial
agents compared with infections that are susceptible to those agents.
Activities: Awardee activities for this program must include ALL of
the following:
Assemble retrospective clinical data from a
sample of people infected with a specific organism (e.g., Streptococcus
pneumoniae, Staphylococcus aureus, Neisseria gonorrhoeae), some
susceptible and others resistant (as defined and outlined in NCCLS
document M100-S13) to specific antimicrobial agents or classes of
antimicrobial agents (e.g., penicillin, semi-synthetic penicillins,
erthromycin, macrolides, ciprofloxacin, fluroquinolones). Clinical data
include, but are not limited to demographic information, morbidity,
mortality, treatment, hospitalization, laboratory testing results, and
infection control measures and must be linked to individual patients
(that is, for a single patient, treatment and laboratory data must be
available; summary data for treatments and antimicrobial susceptibility
are not acceptable). Provide estimate, original or from existing data
sources, for burden of disease(s).
Provide a method for defining and calculating
costs of treatment and hospitalization and other relevant aspects of
care regarding infections with chosen organisms and which can be
readily reproduced for organisms in other situations (e.g., in a
spreadsheet format). This could include, but is not limited to treating
given resistant infection(s) with a drug to which a pathogen is
susceptible, likelihood of culturing, hospitalization or other
treatment, and transmission within households or healthcare facilities
or among contacts, and indirect costs as applicable.
Analysis of data to answer the questions:
--What is the cost of antimicrobial resistance in the chosen situation?
--How accurate is this method of data collection and analysis?
--Under what circumstances is this method of data collection and
analysis reliably reproducible?
Partnerships among an economist, statistician,
clinician and epidemiologist or others may be necessary to ensure
appropriate information is included in dataset and appropriate analysis
are conducted.
Research Objective II: Awardee activities for this program must
include research that addresses at least one of the following Action
Items found in A Public Health Action Plan to Prevent Antimicrobial
Resistance: Focus Area II. Prevention and Control, items 23 (Evaluate
the relationship between prescribing behavior and specific
antimicrobial drug marketing and promotional practices. Assess the
public health effects of these practices in collaboration with
partners.), 33 (Evaluate the potential impact of improved diagnostic
tests, including rapid point-of-care tests on antimicrobial drug use
and patient care, and assess their financial implications. Take into
account tests that distinguish between bacterial and viral infections,
tests that identify resistant pathogens, and tests that distinguish
common clinical entities such as bacterial sinusitis and acute
bacterial otitis media from illnesses with similar manifestations for
which antimicrobials are not beneficial.), and 50 (Conduct additional
research to further define the effects of using various veterinary
drugs on the emergence of resistant bacteria that infect or colonize
food animals of different species, using various animal husbandry
practices. Identify risk factors and preventive measures. Assess the
associated risk of: Transmission of AR infections to humans; Clinical
disease in humans; and Transfer of resistance factors from animal flora
to human flora.) In proposals that concern action items 23, 30, or 50,
research proposals must address a current and compelling problem of
antimicrobial resistance that is of high public health importance and
for which research is needed. Such proposals must provide arguments why
results of the proposed research could provide substantial impact and
improvement to the current methods of prevention and control of the
stated antimicrobial resistance problem. (Examples include but are not
limited to problems in community-associated, healthcare-associated and
foodborne-associated resistant infections).
II. Award Information
Type of Award: Grant.
Fiscal Year Funds: 2004.
Approximate Total Funding: $1,000,000.
Approximate Number of Awards: Five.
Approximate Average Award: $200,000 (This amount is for the first
12-month budget period, and includes both direct and indirect costs).
Floor of Award Range: None.
Ceiling of Award Range: None.
Anticipated Award Date: August 30, 2004.
Budget Period Length: 12 Months.
Project Period Length: Two Years for the economic research
proposal, Research Objective I; two years for Research Objective II,
unless a compelling argument is presented that describes why research
cannot be completed in less than three years. Throughout the project
period, CDC's commitment to continuation of awards will be conditioned
on the availability of funds, evidence of satisfactory progress by the
recipient (as documented in required reports), and the determination
that continued funding is in the best interest of the Federal
Government.
III. Eligibility Information
III.1. Eligible Applicants
Applications may be submitted by public and private nonprofit
organizations and by governments and their agencies, such as:
Public nonprofit organizations
Private nonprofit organizations
Universities
Colleges
Research institutions
Hospitals
Community-based organizations
Faith-based organizations
Federally recognized Indian tribal governments
Indian tribes
Indian tribal organizations
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)
Political subdivisions of States (in consultation
with States)
A Bona Fide Agent is an agency/organization identified by the state
as eligible to submit an application under the state eligibility in
lieu of a state application. If you are applying as a bona fide agent
of a state or local government, you must provide a letter from the
state or local government as
[[Page 23761]]
documentation of your status. Place this documentation behind the first
page of your application form.
III.2. Cost Sharing or Matching
Matching funds are not required for this program.
III.3. Other
CDC will accept and review applications with budgets greater than
the ceiling of the award range. If your application is incomplete or
non-responsive to the requirements listed in this section, it will not
be entered into the review process. You will be notified that your
application did not meet submission requirements.
Individuals Eligible to Become Principal Investigators: Any
individual with the skills, knowledge, and resources necessary to carry
out the proposed research is invited to work with their institution to
develop an application for support. Individuals from underrepresented
racial and ethnic groups as well as individuals with disabilities are
always encouraged to apply for CDC programs.
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.
IV. Application and Submission Information
IV.1. Address to Request Application Package
To apply for this funding opportunity, use application form PHS 398
(OMB number 0925-0001 rev. 5/2001). Forms and instructions are
available in an interactive format on the CDC Web site, at the
following Internet address: http://www.cdc.gov/od/pgo/forminfo.htm.
Forms and instructions are also available in an interactive format
on the National Institutes of Health (NIH) Web site at the following
Internet address: http://grants.nih.gov/grants/funding/phs398/phs398.html
.
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) staff at: 770-488-2700. Application forms can be mailed to
you.
IV.2. Content and Form of Application Submission
Letter of Intent (LOI): Your LOI must be written in the following
format:
Maximum number of pages: five
Font size: 12-point unreduced
Double spaced
Paper size: 8.5 by 11 inches
Page margin size: One inch
Printed only on one side of page
Written in plain language, avoid jargon Your LOI
must contain the following information:
Descriptive title of the proposed research
Name, address, E-mail address, and telephone number
of the Principal Investigator
Names of other key personnel
Participating institutions
Number and title of this Program Announcement (PA)
Application: Follow the PHS 398 application instructions for
content and formatting of your application. For further assistance with
the PHS 398 application form, contact PGO-TIM staff at 770-488-2700, or
contact Grants Info, Telephone (301) 435-0714, E-mail:
GrantsInfo@nih.gov.
Your research plan should address activities to be conducted over
the entire project period.
You are required to have a Dun and Bradstreet Data Universal
Numbering System (DUNS) number to apply for a grant or cooperative
agreement from the Federal government. Your DUNS number must be entered
on line 11 of the face page of the PHS 398 application form. The DUNS
number is a nine-digit identification number, which uniquely identifies
business entities. Obtaining a DUNS number is easy and there is no
charge. To obtain a DUNS number, access http://www.dunandbradstreet.com or
call 1-866-705-5711. For more information, see the CDC Web site at:
http://www.cdc.gov/od/pgo/funding/pubcommt.htm.
This PA uses just-in-time concepts. It also uses the modular
budgeting as well as non-modular budgeting formats. See: http://grants.nih.gov/grants/funding/modular/modular.htm
for additional
guidance on modular budgets. Specifically, if you are submitting an
application with direct costs in each year of $250,000 or less, use the
modular budget format. Otherwise, follow the instructions for non-
modular budget research grant applications.
Additional requirements that may require you to submit additional
documentation with your application are listed in section ``VI.2.
Administrative and National Policy Requirements.''
IV.3. Submission Dates and Times
LOI Deadline Date: May 17, 2004.
CDC requests that you send a LOI if you intend to apply for this
program. Although the LOI is not required, not binding, and does not
enter into the review of your subsequent application, the LOI will be
used to gauge the level of interest in this program, and to allow CDC
to plan the application review.
Application Deadline Date: June 14, 2004.
Explanation of Deadlines: Applications must be received in the CDC
Procurement and Grants Office by 4 p.m. eastern time on the deadline
date. If you send your application by the United States Postal Service
or commercial delivery service, you must ensure that the carrier will
be able to guarantee delivery of the application by the closing date
and time. If CDC receives your application 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, you will be given the opportunity to
submit documentation of the carriers guarantee. If the documentation
verifies a carrier problem, CDC will consider the application as having
been received by the deadline.
This announcement is the definitive guide on application submission
address and deadline. It supersedes information provided in the
application instructions. If your application does not meet the
deadline above, it will not be eligible for review, and will be
discarded. You will be notified that your application did not meet the
submission requirements.
CDC will not notify you upon receipt of your application. If you
have a question about the receipt of your application, first contact
your courier. If you still have a question, contact the PGO-TIM staff
at: 770-488-2700. Before calling, please wait two to three days after
the application deadline. This will allow time for applications to be
processed and logged.
IV.4. Intergovernmental Review of Applications
Your application is subject to Intergovernmental Review of Federal
Programs, as governed by Executive Order (EO) 12372. This order sets up
a system for state and local governmental review of proposed federal
assistance applications. You should contact your state single point of
contact (SPOC) as early as possible to alert the SPOC to prospective
applications, and to receive instructions on your state's process.
Click on the following link to get the current SPOC list: http://www.whitehouse.gov/omb/grants/spoc.html
.
[[Page 23762]]
IV.5. Funding Restrictions
Restrictions, which must be taken into account while writing your
budget, are as follows: None.
If you are requesting indirect costs in your budget, you must
include a copy of your indirect cost rate agreement. If your indirect
cost rate is a provisional rate, the agreement should be less than 12
months of age. Awards will not allow reimbursement of pre-award costs.
IV.6. Other Submission Requirements
LOI Submission Address: Submit your LOI by express mail, delivery
service, fax, or e-mail to: Barbara Stewart, Public Health Analyst,
Centers for Disease Control and Prevention, National Center for
Infectious Diseases, 1600 Clifton Road, NE., Mailstop C-19, Atlanta, GA
30333, Telephone: 404-639-0044, Fax: 404-639-2469, e-mail:
bsg2@cdc.gov.
Application Submission Address: Submit the original and five hard
copies of your application by mail or express delivery service to:
Technical Information Management-PA 04094, CDC Procurement and
Grants Office, 2920 Brandywine Road, Atlanta, GA 30341.
Applications may not be submitted electronically at this time.
V. Application Review Information
V.1. Criteria
You 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 stated in the ``Purpose'' section of this announcement. Measures
must be objective and quantitative, and must measure the intended
outcome. These measures of effectiveness must be submitted with the
application and will be an element of evaluation.
The goals of CDC-supported research are to advance the
understanding of biological systems, improve the control and prevention
of disease and injury, and enhance health. In the written comments,
reviewers will be asked to evaluate the application in order to judge
the likelihood that the proposed research will have a substantial
impact on the pursuit of these goals.
The scientific review group will address and consider each of the
following 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.
The criteria for review are the same for applications for either
Research Objective except where noted and are as follows:
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
analyses adequately developed, well integrated, and appropriate to the
aims of the project? Does the applicant acknowledge potential problem
areas and consider alternative tactics? Does the proposed research
consider all the activities listed in either ``Research Objective I''
or ``Research Objective II''?
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)?
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 priority score:
Applications for Research Objective I: Are there plans for analysis
of relevant epidemiological data, for development of methods that can
be readily reproduced for organisms in other situations, and for
analysis of data to answer questions on cost, accuracy and
reproducibility?
Are the measurable outcomes of the program consistent with Action
Item 16 (Provide health care system administrators and other decision
makers with data on the impact of drug-resistant organisms (e.g.,
outcome, treatment costs) and on effective prevention and control
measures.) in Focus Area I, Surveillance of A Public Health Action Plan
to Combat Antimicrobial Resistance (Part I: Domestic Issues)?
Applications for Research Objective II: Does the proposed research
help implement at least one of the following Action Items found in A
Public Health Action Plan to Prevent Antimicrobial Resistance (Part I:
Domestic Issues): Focus Area II, Prevention and Control, Action Items
23 (Evaluate the relationship between prescribing behavior and specific
antimicrobial drug marketing and promotional practices. Assess the
public health effects of these practices in collaboration with
partners.), 33 (Evaluate the potential impact of improved diagnostic
tests, including rapid point-of-care tests on antimicrobial drug use
and patient care, and assess their financial implications. Take into
account tests that distinguish between bacterial and viral infections,
tests that identify resistant pathogens, and tests that distinguish
common clinical entities such as bacterial sinusitis and acute
bacterial otitis media from illnesses with similar manifestations for
which antimicrobials are not beneficial.), and 50 (Conduct additional
research to further define the effects of using various veterinary
drugs on the emergence of resistant bacteria that infect or colonize
food animals of different species, using various animal husbandry
practices. Identify risk factors and preventive measures. Assess the
associated risk of: Transmission of AR infections to humans; Clinical
disease in humans; and Transfer of resistance factors from animal flora
to human flora.) Does the research address a current and compelling
problem of antimicrobial resistance that is of high public health
importance and for which research is needed?
Protection of Human Subjects from Research Risks: Does the
application adequately address the requirements of title 45 CFR part 46
for the protection of human subjects? This will not be scored; however,
an application can be disapproved if the research risks are
sufficiently serious and protection against risks is so inadequate as
to make the entire application unacceptable.
Inclusion of Women and Minorities in Research: Does the application
adequately address 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; and (4) A statement as
to whether the plans for recruitment and
[[Page 23763]]
outreach for study participants include the process of establishing
partnerships with community(ies) and recognition of mutual benefits.
Budget: The reasonableness of the proposed budget and the requested
period of support in relation to the proposed research.
V.2. Review and Selection Process
Applications will be reviewed for completeness by the Procurement
and Grants Office (PGO) and for responsiveness by the National Center
for Infectious Diseases. Incomplete applications and applications that
are non-responsive to the eligibility criteria will not advance through
the review process. Applicants will be notified that their application
did not meet submission requirements.
Applications that are complete and responsive to the PA will be
evaluated for scientific and technical merit by an appropriate peer
review group or charter study section convened by the National Center
for Infectious Diseases in accordance with the review criteria listed
above. As part of the initial merit review, all applications may:
Undergo 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 and
assigned a priority score.
Receive a written critique.
Receive a second level review.
Award Criteria: Criteria that will be used to make award decisions
include:
Scientific merit (as determined by peer review)
Availability of funds
Programmatic Priorities
V.3. Anticipated Award Date
August 30, 2004.
VI. Award Administration Information
VI.1. Award Notices
Successful applicants will receive a Notice of Grant Award (NGA)
from the CDC Procurement and Grants Office. The NGA shall be the only
binding, authorizing document between the recipient and CDC. The NGA
will be signed by an authorized Grants Management Officer, and mailed
to the recipient fiscal officer identified in the application.
Unsuccessful applicants will receive notification of the results of
the application review by mail.
VI.2. Administrative and National Policy Requirements
45 CFR Part 74 and Part 92
For more information on the Code of Federal Regulations, see the
National Archives and Records Administration at the following Internet
address: http://www.access.gpo.gov/nara/cfr/cfr-table-search.html.
The following additional requirements apply to this project:
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 Workplace Requirements
AR-11--Healthy People 2010
AR-12--Lobbying Restrictions
AR-15--Proof of Non-Profit Status
AR-22--Research Integrity
AR-23--States and Faith-Based Organizations
AR-25--Release and Sharing of Data
Additional information on these requirements can be found on the
CDC Web site at the following Internet address: http://www.cdc.gov/od/pgo/funding/ARs.htm
.
VI.3. Reporting
You must provide CDC with an original, plus two hard copies of the
following reports:
1. Interim progress report, (use form PHS 2590, OMB Number 0925-
0001, rev. 5/2001 as posted on the CDC Web site) 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 Activities Objectives.
b. Current Budget Period Financial Progress.
c. New Budget Period Program Proposed Activity Objectives.
d. Budget.
e. Additional Requested Information.
f. 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.
These reports must be mailed to the Grants Management Specialist
listed in the ``Agency Contacts'' section of this announcement.
VII. Agency Contacts
For general questions about this announcement, contact: Technical
Information Management Section, CDC Procurement and Grants Office, 2920
Brandywine Road, Atlanta, GA 30341, Telephone: 770-488-2700.
For scientific/research issues, contact: Mary Lerchen, DrPH, MS,
Extramural Program Official, National Center for Infectious Diseases,
1600 Clifton Road, NE., Atlanta, GA 30333, Telephone: 404-639-0043, E-
mail: mll0@cdc.gov.
For questions about peer review, contact:
Barbara Stewart, Public Health Analyst, National Center for
Infectious Diseases, 1600 Clifton Road, NE., Atlanta, GA 30333,
Telephone: 404-639-0044, E-mail: bsg2@cdc.gov.
For financial, grants management, or budget assistance, contact:
Sharon Robertson, Grants Management Specialist, CDC Procurement and
Grants Office, 2920 Brandywine Road, Atlanta, GA 30341, Telephone: 770-
488-2748, E-mail:sqr2@cdc.gov.
VIII. Other Information
None.
Dated: April 26, 2004.
William P. Nichols,
Acting Director, Procurement and Grants Office, Centers for Disease
Control and Prevention.
[FR Doc. 04-9808 Filed 4-29-04; 8:45 am]
BILLING CODE 4163-18-P