[Federal Register Volume 70, Number 67 (Friday, April 8, 2005)]
[Notices]
[Pages 18022-18028]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-7047]


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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: 
[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,

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

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