[Federal Register: April 8, 2005 (Volume 70, Number 67)]
[Notices]
[Page 18022-18028]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08ap05-61]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Linkage of International Collaboration and Research Programs for
Prevention and Control of Malaria
Announcement Type: New.
Funding Opportunity Number: RFA CI05-062.
Catalog of Federal Domestic Assistance Number: 93.283.
Application Deadline: May 23, 2005.
I. Funding Opportunity Description
Authority: 42 U.S.C. 241(a); 42 U.S.C. 2421.
Background
Burden of malaria in Africa and Asia: Each year, malaria causes an
estimated 500 million infections and more than one million deaths. The
main risk groups in highly endemic areas, such as in most of sub-
Saharan Africa, are children less than five years of age and pregnant
women. Malaria drains economies in Africa, Asia, and the Americas--
causing a loss of up to six percent of Gross National Product (GNP)
from lost productivity and health service costs, with over 50 percent
of the world's population at risk for malaria. Thus, prevention of
malaria and, when it occurs, its effective treatment, are high public
health priorities in endemic countries. There is a paucity of data on
the burden of malaria from Asia.
Malaria control: Three major tools are currently used to control
malaria: preventing and treating disease with drugs, reducing human-
vector contact such as by insecticide treated mosquito nets (ITNs), and
controlling mosquitoes (e.g. spraying of insecticides).
The use of drugs for treatment and prevention remains one of the
main pillars for the Roll Back Malaria initiative (RBM), but the
rampant spread of drug resistance of the malaria parasite to the cheap
and most commonly available antimalarials is a major problem.
Nevertheless, drug development has improved considerably in the last
five years and the outlook for new antimalarials is now better than it
has been for decades. Much needs to be done to test their safety and
efficacy and further work is needed to ensure that they are optimally
used and made accessible to the target population.
Reduction of human-vector contact by use of ITNs has been shown to
reduce under-five mortality by 18 percent in Africa and ITNs are now
one of the main RBM strategies. Despite the clear evidence of their
efficacy in Africa, very little is known about their impact in Asia. In
some regions of Asia the vector bites early in the evening or morning
thus ITNs may not be the optimal prevention tool and other methods that
reduce human-vector contact should be explored, including DEET
retaining repellents.
Vector control has saved millions of lives worldwide and indoor
residual spraying with insecticides (IRS) continues to play a major
role in much of Latin America and Asia, but its cost, logistical
complexity and moderate efficacy made it poorly suited for rural areas
of sub-Saharan Africa.
Nevertheless advances in genomics (including the mapping of the
mosquito and parasite genome), biotechnology, and mapping using
geographical information systems, present exiting new opportunities for
the development and employment of more cost-effective tools that take
aim at the mosquito.
Global collaboration: Although important progress in malaria
control has been accomplished in recent years, much more could have
been done. This slow progress is partly due to the lack of funding. CDC
recognizes that this is also due to lack of coordination between
research groups, and between researchers and donors, policy makers, and
Government Ministries responsible for implementation. After decades of
neglect the international community is showing a renewed interest in
controlling malaria. This has resulted in new initiatives, including
the RBM initiative, Global Fund Initiative (GFATM) and Malaria Vaccine
Initiative as well as significant new funding for both research and
program development. Global collaboration is now more critical than
ever to ensure translation of this commitment into action and avoid
fragmentation of efforts. Many of these studies require well-
coordinated multi-center trials to allow rapid accumulation of data and
account for the geographical variations in drug sensitivity, frequency
of host-genetic polymorphism, cultural preferences and economics.
Purpose
The purpose of this program is to strengthen international
collaborative efforts with leading European Institutions to expedite
the identification, evaluation and implementation of malaria control
strategies in sub-Saharan Africa and Asia. The aim is to move forward
the RBM agenda of increasing access to case management and preventive
interventions against malaria by promoting work in a complementary way
on key issues relevant to the control of malaria.
CDC is committed to achieving the health promotion and disease
prevention objectives of ``Healthy People 2010'', a national activity
to reduce morbidity and mortality and improve the quality of life. This
announcement addresses the ``Healthy People 2010'' focus areas of HIV,
Immunization, Infectious Diseases and Public Health Infrastructure. For
the conference copy of ``Healthy People 2010'', visit the Internet site
http://www.health.gov/healthy-people.
Measurable outcomes of the program will be in alignment with one
(or more) of the National Center for Infectious Disease (NCID) priority
areas identified in ``Protecting the Nation's Health in an Era of
Globalization: CDC's Global Strategy for Addressing Infectious
Diseases''. Priority areas for this cooperative agreement include: (1)
Applied research on diseases of global importance, (2) application of
proven public health tools, (3) global initiatives for disease control
and, (4) public health training and capacity building.
Research Objectives
Nature of the research problem.
Burden and control of malaria in India: Conventional estimates of
the global burden of malaria suggest that over 90 percent of the burden
occurs in Africa. There is however a paucity of reliable data from
Asia, particularly India, which has a population of 1 billion, more
than the entire African continent. India's National Vector Borne
Disease Control Programme reports less than two million cases annually,
but recent estimates from the World Health Organization (WHO) suggest
this may be as high as 45-100 million. Although transmission is lower
than in Africa, less malarial immunity is acquired during a lifetime of
exposure so that even adults remain at risk of dying from severe
malaria. Establishment of more accurate estimates of the burden of
malaria, and appropriate evidenced-based treatment and prevention
policies are essential to minimizing this public health threat of
malaria in India.
ITNs and IRS alone can reduce malaria transmission by as much as 90
percent. Despite this, a significant
[[Page 18023]]
proportion of the population remains infected. Evidence from Thailand
and Vietnam suggests that sustained reductions in transmission may be
achieved by combining vector control with use of antimalarials that
contain Artemisinin derivatives. Artemisinin containing combination
therapy (ACT) offers great hope for the control of malaria. These drugs
not only provide fast and highly effective treatment, but also have the
potential to interrupt transmission by markedly reducing gametocyte
development of the parasite and enhance the effects of vector control.
It is likely that these promising results from South East Asia are
applicable to large regions in India with similar transmission patterns
and vector behavior, and this now needs to be evaluated.
Malaria control in pregnancy: Intermittent preventive therapy (IPT)
and ITNs are the two main strategies for malaria control in pregnancy
in areas with moderate to high malaria transmission. Nevertheless, the
scientific evidence on which these policy recommendations are based is
incomplete and many research questions remain. For example it is
unclear whether IPT or ITNs work in areas with low malaria
transmission. Furthermore, for IPT there is a heavy reliance on
sulfadoxine-pyrimethamine (SP) and chloroquine and there is an urgent
need to identify alternative drugs as both these drugs have increasing
drug resistance. Despite the recognition that malaria poses an
important problem in pregnancy, the arsenal of drugs for the prevention
and control of malaria in pregnancy (MIP) lags behind that for
children. This can be attributed to the systematic exclusion of
pregnant women from trials for fear of toxicity to the fetus, the
scarcity of resources specific for this high-risk group, and to some
extent to the lack of global coordination of research agendas.
Recently a new global malaria in pregnancy research consortium (MIP
Consortium) of over 40 research institutions, together with the World
Health Organization (WHO/RBM), identified the key priority areas of
research for malaria control in pregnancy. These include: (1) The
determination of the burden of malaria in pregnancy in areas of low
transmission, such as in Asia, to enhance the ability of public health
programs to develop and target appropriate intervention approaches in
these regions; (2) studies of the pharmacokinetics, safety and efficacy
of alternative drugs for treatment and prevention of malaria in
pregnancy, and; (3) studies that determine how best to use ITNs and
antimalarial drugs in combination to maximize the prevention benefit
and limit adverse exposures in pregnancy.
Malaria control in children:
Treatment: SP has been the mainstay of malaria treatment in many
countries in Africa over the last 10 years, yet resistance to SP is
emerging rapidly. Artemisinin derivatives combined with other
antimalarial (ACTs) have the potential to improve cure rates and reduce
the development of drug resistance. There are a number of artemisinin-
based combinations that have or will become available and require
evaluation to assist in policy formulation.
New drug approaches to malaria prevention in children: Daily or
weekly malaria prophylaxis is no longer recommended for malaria endemic
countries and new strategies for the prevention of malaria involving
drugs are required. One such strategy is IPT, and consists of
administration of full treatment doses given presumptively (regardless
of the presence of malaria) at predefined intervals to provide
prolonged periods of protection. This approach is now widely advocated
for pregnant women attending antenatal care (IPTp) and is being
evaluated (by CDC and others) for the prevention of severe malaria and
anemia in infants (IPTi). More research is required to further develop
the concept of IPT in other high-risk populations such as in young
children admitted with severe malarial anemia requiring a blood
transfusion. Previous studies have indicated that this group is at very
high risk of rebound severe anemia and death in the six-month period
post-discharge. Prolonged periods of protection from malaria from
intermittent antimalarial treatment post discharge (IPTpd) may prevent
re-infection and increase hematological recovery and possibly reduce
death due to rebound severe anemia.
HIV-infected individuals: The burden of malaria is exacerbated by
the advent of HIV, which increases susceptibility to malaria,
particularly in pregnancy. Conversely acute malaria is associated with
transient rises in HIV viral load. It is unclear whether repeated
frequent malaria infections in areas with intense malaria transmission
is associated with increased AIDS disease progression, and if so,
whether prevention of malaria can reduce AIDS disease progression.
Furthermore with the wide spread use of antimalarials and with the
introduction of anti-retroviral drugs in Africa there is an urgent need
to determine the safety and kinetics of these drugs when used at the
same time.
Scientific knowledge to be achieved through research
supported by this program.
India & Asia:
1. Identifying the burden of malaria in selected Asian countries,
including India.
2. Identifying potential interventions to reduce the burden of
malaria in pregnant women in India.
3. Evidence of the effectiveness of reducing malaria transmission
in a large region through multi-pronged approach that uses a
combination of vector control measures and appropriate treatment and
prevention of malaria with artemisinin containing combination
therapies.
Pregnant Women:
4. Evidence of the pharmacokinetics, safety and efficacy of new
antimalarials for treatment and prevention of MIP.
5. Knowledge of how best to combine ITNs with antimalarials in the
prevention of malaria in pregnancy.
Children:
6. Evidence of the safety and efficacy of new antimalarials for the
treatment of non-severe malaria in children.
7. The degree to which IPT is effective for the prevention of
severe malaria and anemia among children.
HIV infected patients:
8. Knowledge of the safety and kinetics of ARVs and antimalarials
in HIV infected persons when used at the same time.
9. Knowledge of the impact of malaria prevention on the rate of HIV
disease progression.
Objectives of this research program.
Strengthen international collaborative efforts to expedite the
identification, evaluation, and implementation of malaria control
strategies in sub-Saharan Africa and Asia.
Identify the types of research and experimental approaches
that are being sought to achieve the objectives.
The recipient institution will work with CDC on a package of
research and policy into practice activities, mainly in India and
Africa, which require a range of experimental approaches and
activities. These include the development and evaluation of
epidemiological survey tools for the rapid assessment of the burden of
malaria in regions with low transmission, such as India. CDC has
developed rapid assessment tools for Africa, providing the groundwork
for this activity, but these tools need to be field tested and adopted
to the Asian setting. Further experimental approaches include the
design and coordination of multi-center trials of the treatment and
prevention of malaria, and the application of specific statistical
[[Page 18024]]
methods that allow individual patient data meta-analysis of these
multi-centre trials. Lastly, the global malaria in pregnancy research
consortium requires a secretariat to coordinate the activities for the
consortium.
Activities
Recipient activities for this program are as follows:
India and Asia:
1. Provide technical support to the Malaria Research Council
(Jabalpur, Madhya Pradesh, India) for studies that assess the burden of
malaria in pregnancy in India and for community and clinical studies by
the Malaria Research Council related to MIP and malaria in children and
adults.
2. Provide technical assistance to the WHO Southeast Asia Regional
Office (SEARO) to assess the burden of malaria in pregnancy in select
Asian countries and to develop appropriate standardized rapid
assessment tools for this purpose.
Malaria in Pregnancy:
3. Serve as the global Secretariat for the MIP Consortium to:
Provide a platform that enhances collaboration between
research groups and international organizations working on malaria in
pregnancy.
Coordinate interventional research relevant to the control
of malaria in pregnancy and to promote the quality of such research by
encouraging use of standardized research methods among consortium
members.
Act as an advocate for malaria in pregnancy research and
mobilize funding.
Coordinate or participate in the development of research
grants, and of research protocol development and execution of multi-
centre trials.
Identify, evaluate and implement appropriate new
interventions for the treatment and prevention of malaria in pregnancy
in Africa and Asia.
4. Determine the pharmacokinetics of new antimalarials for use in
pregnancy.
Children:
5. Design and conduct studies of IPT in the post-discharge period
(IPTpd) in children with severe malaria to determine whether IPTpd is
effective in preventing rebound severe malaria and anemia.
HIV and Malaria:
6. Design and conduct studies to assess drug interaction between
ARVs and antimalarials.
7. Provide technical support for grant writing, design, and conduct
of studies that determine the role of malaria on HIV disease
progression.
Capacity building:
8. Strengthen research capacity for endemic countries by providing
diploma, Master's and PhD level training in tropical medicine to
professionals from malaria endemic countries involved with CDC malaria-
related activities in Africa and Asia.
9. Provide technical support to select malaria endemic sub-Saharan
African countries to achieve RBM targets related to MIP and children.
Research synthesis and dissemination of results:
10. Coordinate research synthesis and provide individual patient
data meta-analysis of the multi-centre trials in children and pregnant
women.
11. Participate in the dissemination of research results or other
activities through written publications, including peer-reviewed
journals, oral presentations, or other means.
In a cooperative agreement, CDC staff is substantially involved in
the program activities, above and beyond routine grant monitoring. CDC
Activities for this program are as follows:
Provide technical assistance in the design and conduct of
the activities, including evaluation methods and analytic approach.
Provide consultation and assistance on methods for
treatment of malaria, enhancing capacity at different levels (local,
national) to increase use of prevention measures including insecticide
treated bed nets, or prevention of malaria and its adverse consequences
during pregnancy.
Provide consultation and assistance on operations research
study designs that may be identified and carried out by recipient or
MIP Consortium partners.
Participate as needed in data collection, data management,
analysis of research data, interpretation, and dissemination of
research findings.
Provide assistance in design of the evaluations.
Provide assistance in the development of any research
protocols for Institutional Review Board (IRB) review by all
cooperating institutions participating in research projects. The CDC
IRB will review and approve the protocol initially and on at least an
annual basis until research projects are completed.
II. Award Information
Type of Award: Cooperative Agreement.
CDC involvement in this program is listed in the Activities Section
above.
Mechanism of Support: U01.
Fiscal Year Funds: FY05.
Approximate Total Funding: $400,000. (This amount is an estimate,
and is subject to availability of funds. This amount includes both
direct and indirect costs.)
Approximate Number of Awards: 1.
Approximate Average Award: $400,000. (This amount is for the first
12-month budget period.)
Floor of Award Range: None.
Ceiling of Award Range: $400,000. (This ceiling is for the first
12-month budget period and includes both direct and indirect costs.)
Anticipated Award Date: August 15, 2005.
Budget Period Length: 12 months.
Project Period Length: Five 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.
Small, minority, women-owned businesses.
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 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.
[[Page 18025]]
III.3. Other
If you request a funding amount greater than the ceiling of the
award range, your application will be considered non-responsive, and
will not be entered into the review process. You will be notified that
your application did not meet the submission requirements.
Special Requirements
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.
Applicant must have experience and current activities coordinating
international networks that are relevant to malaria in pregnancy
research such as designation as a coordinating center or Secretariat;
one or more of the networks must include European institutions.
Applicant must have the capacity to conduct meta-analysis, this may
be through an well-established relationship with a group recognized for
meta-analysis work.
Applicant must have experience and current capability to conduct
malaria vector control research in partnership with other institutions.
Applicant must have an institutional link and access to a Liquid
Chromatography/Mass Spectrometry bioanalytical facility. The facility
must be recognized as a regional analytical reference site, preferably
one that includes some malaria endemic countries in Africa and Asia.
Applicant must have experience in conducting studies of anti-
retroviral drug interaction including the potential interactions
between anti-retrovirals and anti-malarials.
Applicant must have long-term technical and research collaborative
malaria-related activities in Africa and Asia; in addition, the
applicant must have an established relationship with the Malaria
Research Council of India and with the Kenya Medical Research
Institute/Centers for Disease Control and Prevention program.
Applicant must have an established multi-level academic program
suitable for training persons from malaria endemic countries in fields
suitable for malaria research and which leads to a recognized diploma,
certificate, and/or degree.
Applicant must have experience providing technical support to WHO
or similar international organizations, endemic country research
institutes and/or Ministries of Health for malaria in pregnancy
development and program implementation.
Late applications will be considered non-responsive. See section
``IV.3. Submission Dates and Times'' for more information on deadlines.
The applicant must document eligibility by providing the following
documentation which should be attached in an appendix to the
application: (a) Evidence of role with malaria research related
consortium(s) including current activities and evidence of the
inclusion of European-based organizations; (b) evidence of
organizational capacity to conduct meta analysis; this may be a letter
from the unit within the organization that outlines their capability
and support for the defined work; (c) evidence of organization's past
and current work conducted in partnership with other institutions to
conduct malaria vector control research; (d) evidence of an
institutional link and access to a Liquid Chromatography/Mass
Spectrometry bioanalytical facility that is a recognized regional
analytical reference site. This may be a letter of support from the
facility; (e) evidence of experience in conducting studies of anti-
retroviral drug interaction including the potential interactions
between anti-retrovirals and anti-malarials; (f) evidence of current
malaria research collaborations in sub-Sahara Africa including letters
of support from the Malaria Research Centre (Jababur, Madhya Pradesh,
India) for this work and the Kenya Medical Research Institute/Centers
for Disease Control and Prevention program in Kisumu, Kenya; (g)
evidence of an active multi-level academic program for training persons
from malaria endemic countries, especially those in Africa; and (h)
evidence of experience providing technical support to WHO or a similar
international organization, endemic country research institutes and/or
Ministries of Health for malaria in pregnancy development and program
implementation.
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.
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.
Additional Principal Investigator qualifications are as follows:
(a) Experience conducting field epidemiologic research in malaria
in pregnancy in sub-Sahara Africa or Asia that resulted in one or more
published articles in a peer reviewed journal.
(b) Experience mentoring local staff involved in an academic
program from a developing country in Africa or Asia.
(c) Experience setting up and running a research consortium.
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
Application: Follow the PHS 398 application instructions for
content and formatting of your application. If the instructions in this
announcement differ in any way from the PHS 398 instructions, follow
the instructions in this announcement. For further assistance with the
PHS 398 application form, contact PGO-TIM staff at 770-488-2700, or
contact GrantsInfo, 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,
[[Page 18026]]
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 announcement uses the non-modular budgeting format.
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
Application Deadline Date: May 23, 2005.
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 submit your application by the United States Postal
Service or commercial delivery service, you must ensure that the
carrier will be able to guarantee delivery by the closing date and
time. If CDC receives your submission 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 submission as having
been received by the deadline.
This announcement is the definitive guide on application content,
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 you did not meet the submission
requirements.
CDC will not notify you upon receipt of your submission. 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 submission deadline. This will allow time for submissions 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
.
IV.5. Funding Restrictions
Restrictions, which must be taken into account while writing your
budget, are as follows:
Funds relating to the conduct of research will not be
released until the appropriate assurances and Institutional Review
Board approvals are in place.
Reimbursement of pre-award costs is not allowed.
Funds may be spent for reasonable program purposes,
including personnel, travel, supplies, and services.
Equipment may be purchased if deemed necessary to accomplish
program objectives, however, prior approval by CDC officials must be
requested in writing.
The costs that are generally allowable in grants to
domestic organizations are allowable to foreign institutions and
international organizations, with the following exception: With the
exception of the American University, Beirut and the World Health
Organization, Indirect Costs will not be paid (either directly or
through sub-award) to organizations located outside the territorial
limits of the United States or to international organizations
regardless of their location.
The applicant may contract with other organizations under
this program; however the applicant must perform a substantial portion
of the activities (including program management and operations, and
delivery of prevention services for which funds are required.)
All requests for funds contained in the budget, shall be
stated in U.S. dollars. Once an award is made, CDC will not compensate
foreign grantees for currency exchange fluctuations through the
issuance of supplemental awards.
You must obtain annual audit of these CDC funds (program-
specific audit) by a U.S.--based audit firm with international branches
and current licensure/authority in-country, and in accordance with
International Accounting Standards or equivalent standard(s) approved
in writing by CDC.
A fiscal Recipient Capability Assessment may be required,
prior to or post award, in order to review the applicant's business
management and fiscal capabilities regarding the handling of U.S.
Federal funds.
IV.6. Other Submission Requirements
Application Submission Address: Submit the original and two hard
copies of your application by mail or express delivery service to:
Technical Information Management-RFA CI05-062, CDC Procurement and
Grants Office, 2920 Brandywine Road, Atlanta, GA 30341.
At the time of submission, three additional copies of the
application, and all appendices must be sent to: Dr. Trudy Messmer, RFA
CI05-062, National Center for Infectious Diseases (NCID), CDC, 1600
Clifton Road, MS C-19, Atlanta, GA 30333. E-mail: TMessmer@cdc.gov.
Applications may not be submitted electronically at this time.
V. Application Review Information
V.1. Criteria
The applicant is required to provide measures of effectiveness that
will demonstrate the accomplishment of the various identified
objectives of the cooperative agreement. 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 equally in assigning the application's overall
score, weighting them as appropriate for the 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 review criteria 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?
[[Page 18027]]
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?
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:
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?
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 outreach for study
participants include the process of establishing partnerships with
community(ies) and recognition of mutual benefits.
Budget: (This will not be scored) The reasonableness of the
proposed budget and the requested period of support in relation to the
proposed research.
V.2. Review and Selection Process
The application will be reviewed for completeness by the
Procurement and Grants Office (PGO) and for responsiveness by NCID. An
incomplete application or application that is 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.
A complete and responsive application will be evaluated for
scientific and technical merit by a Special Emphasis Panel comprised of
external experts convened by the NCID Office of Extramural Research in
accordance with the review criteria listed above. As part of the
scientific merit review, the application will:
Undergo a selection process in which only those
applications deemed to have the highest scientific merit by the review
group, generally the top half of the applications under review, will be
discussed and assigned a priority score.
Receive a written critique.
Receive a second programmatic level review by CDC senior
staff.
Award Criteria: Criteria that will be used to make award decisions
during the programmatic review include:
Scientific merit (as determined by peer review).
Availability of funds.
Programmatic priorities.
V.3. Anticipated Award Date
August 15, 2005.
VI. Award Administration Information
VI.1. Award Notices
Successful applicants receive a Notice of Award (NoA) from the CDC
Procurement and Grants Office. The NoA shall be the only binding,
authorizing document between the recipient and CDC. The NoA 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 parts 74 and 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-10 Smoke-Free Workplace Requirements.
AR-11 Healthy People 2010.
AR-12 Lobbying Restrictions.
AR-22 Research Integrity.
AR-24 Health Insurance Portability and Accountability Act
Requirements.
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 website) no less than 90 days
before the end of the budget period. The progress report will serve as
your non-competing continuation application
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
We encourage inquiries concerning this announcement.
For general questions, 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: Dr. Trudy Messmer,
Scientific Review Administrator, 1600 Clifton Road, MS C-19, Atlanta,
GA 30333. Telephone: 404-639-3770. E-mail: TMessmer@cdc.gov.
For questions about peer review, contact: Ms. Barbara Stewart,
Public Health Analyst, 1600 Clifton Road, MS C-19, Atlanta, GA 30333.
Telephone: 404-639-3770. E-mail: BStewart@cdc.gov.
For financial, grants management, or budget assistance, contact:
Steward Nichols, Grants Management Specialist, CDC Procurement and
Grants Office, 2920 Brandywine Road, Atlanta, GA 30341. Telephone: 770-
488-2788. E-mail: SHN8@cdc.gov.
VIII. Other Information
This and other CDC funding opportunity announcements can be found
on the CDC Web site, Internet address: http://www.cdc.gov. Click on
``Funding'' then ``Grants and Cooperative Agreements.''
[[Page 18028]]
Additional background information can be found at: http://www.cdc.gov/malaria/
.
Dated: April 4, 2005.
William P. Nichols,
Director, Procurement and Grants Office, Centers for Disease Control
and Prevention.
[FR Doc. 05-7047 Filed 4-7-05; 8:45 am]
BILLING CODE 4163-18-P