[Federal Register Volume 69, Number 84 (Friday, April 30, 2004)]
[Notices]
[Pages 23759-23763]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-9808]


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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: 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: 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: 
[email protected].
    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 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: 
[email protected].
    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: [email protected].
    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: [email protected].
    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:[email protected].

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