[Federal Register Volume 69, Number 90 (Monday, May 10, 2004)]
[Notices]
[Pages 25904-25909]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-10535]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 04132]


Organ Transplant Infection Detection and Prevention Program

    Announcement Type: New.
    Funding Opportunity Number: 04132.
    Catalog of Federal Domestic Assistance Number: 93.283.
    Key Dates: Letter of Intent Deadline: May 25, 2004.
    Application Deadline: June 24, 2004.
    Executive Summary: The Organ Transplant Infection Detection and 
Prevention (OTIP) Program will rapidly assess the public health impact 
of new infection prevention programs in organ transplant recipients 
through a program of sentinel surveillance, applied research and 
collaborative prevention studies. Such assessments would be the basis 
for national prevention programs to eliminate or minimize invasive 
fungal disease and related mortality in this population. In addition, 
the program would create a repository of clinically relevant isolates 
and specimens with relevant patient information from which applied 
research can further scientific knowledge regarding novel diagnostics 
and emerging antimicrobial resistance.

I. Funding Opportunity Description

    Authority: This program is authorized under the Public Health 
Service Act, section 317(k)(2) [42 U.S.C. 247b(k)(2)].

Purpose

    The purpose of the OTIP Program is to support organ transplant 
centers participating in existing surveillance or research networks to 
develop a consortium of centers of excellence in surveillance, 
infection prevention, and applied public health research involving 
solid organ and stem-cell transplant recipients. The OTIP should be 
designed to develop, implement, and evaluate effectiveness of 
epidemiologic-based strategies to reduce infectious outcomes among 
organ-transplant recipients. Examples of existing networks include The 
Centers for Disease Control and Prevention (CDC) Program of 
Surveillance for Invasive Fungal Infections in Transplant Recipients 
(TransNet), CDC's Prevention Epicenter Program, and National Marrow 
Donor Program's Infection Pilot Project.
    The goals of the OTIP program are: (1) Support activities at 
participating transplant centers for enhanced surveillance for fungal 
infections during the post-transplant period, using similar methods and 
intensity of case-ascertainment, with development of valid, useful, 
simple surveillance methods for exportation to non-program transplant 
centers; (2) support activities at participating transplant centers 
related to epidemiologic assessments and improved descriptions of 
established infectious syndromes through a repository of clinical 
samples (e.g., serial serum, bronchial-alveolar lavage) and 
identification of novel risk factors for disease (e.g., role of home 
environment in late onset aspergillosis); and (3) be a national 
resource for assessing effectiveness of new infection prevention 
strategies in this population. As invasive fungal infections represent 
the highest infection-related mortality in this population, initial 
activities should focus exclusively on these pathogens; other pathogens 
may be incorporated into later years of the program.
    This program addresses the ``Healthy People 2010'' focus area(s) of 
Immunization and Infectious Diseases. For the conference copy of 
``Healthy People 2010'', visit the Internet site: http://www.health.gov/healthypeople.
    Measurable outcomes of the program will be in alignment with the 
performance goal for the National Center for Infectious Diseases 
(NCID): To protect Americans from infectious diseases by planning, 
directing, and coordinating a national program to improve the 
identification, investigation, diagnosis, prevention, and control of 
infectious diseases in the United States and throughout the world.

Research Objectives

    Roughly 18,000 bone marrow/stem cell transplants (SCCs) and over 
23,000 solid organ transplants (SOTs) are performed annually within the 
U.S. Approximately 10-15 percent of recipients will develop an invasive 
fungal infection post-transplant. In this population, the mortality of 
invasive aspergillosis can exceed 90 percent; the mortality of invasive 
candidiasis is approximately 40 percent. The OTIP Program will provide 
the foundation for applied research designed to fulfill current gaps in 
scientific knowledge regarding surveillance and prevention of invasive 
fungal infections in the post-transplant period. Such knowledge

[[Page 25905]]

includes identification of an efficient and valid surveillance 
methodology, understanding the utility of novel diagnostics used to 
detect fungal, bacterial, or viral pathogens, and identification of 
modifiable risk factors for disease and effective prevention tools. In 
order to gain this knowledge, the objectives of the OTIP Program 
should: (1) Identify and validate efficient surveillance methodology 
exportable to non-program centers; (2) identify modifiable 
environmental or other factors extrinsic to the transplant patient 
(e.g., device-specific factors, environmental exposures) which can be 
addressed to prevent infectious diseases in the post-transplant period; 
(3) describe the pathogen and infection characteristics of common 
infections among patients in the post-transplant period; and (4) 
through knowledge gained from (1)-(3), demonstrate the efficacy of 
novel prevention measures in reducing post-transplant infectious 
complications and associated mortality. The types of experimental 
approaches that may be used to achieve the goals of the program 
include: development of the ``gold standard'' approach to surveillance 
for invasive fungal infections in the post-transplant population and 
validate efficacy of an exportable surveillance methodology; 
prospective case-control studies for common invasive fungal infections, 
such as late-onset aspergillosis, including targeted environmental 
sampling; establishment of a serum, urine, and/or bronchial-alveolar 
lavage specimen repository for determining effectiveness of novel 
diagnostics for infections (e.g., fungal, viral); and using risk-
adjusted infection-related outcomes, ascertain the effectiveness of 
novel prevention program in reducing disease (prophylaxis strategies, 
educational interventions). Because organ-transplant patients are at 
risk for prolonged periods post-transplant (i.e., several years), these 
activities must be conducted within a specialized network of 
collaborating centers capable of long-term continuity of care of these 
patients (i.e., over one year). The operational organization of The 
OTIP Program must include two or more consortiums of two to four 
transplant centers with sufficient infrastructure (e.g., surveillance 
staff and laboratory support) supported by the consortium leaders to 
accomplish the objectives.

Activities

    Awardee activities for this program are as follows:
    1. Establish a consortium of at least two solid-organ and/or stem-
cell transplant centers consistent with the purpose of the OTIP 
Program.
    2. Collaborate with other OTIP Program sites and CDC to operate as 
the OTIP Program, and facilitate and oversee implementation of core 
activities (e.g., activities to be done at all centers participating in 
the OTIP Program). This includes providing resources to investigators 
at centers participating in the applicant's consortium to support OTIP 
Program activities. Activities may be prioritized and time-phased. Core 
activities include:
    a. Perform ``gold standard'' surveillance for invasive fungal 
infections incorporating the following elements:
    i. Active-surveillance using standardized diagnostic evaluations 
and follow-up of patients among participating sites (e.g., proper 
training of surveillance personnel, collection and evaluation of fungal 
isolates).
    ii. Design and maintain an aggregate database (e.g., standardized 
protocol) recording both events and relevant patient data from all 
organ-transplant recipients to maintain a valid risk-adjusted 
surveillance system among all transplant sites.
    iii. Optionally, include time-phased plans to incorporate other 
infectious outcomes.
    iv. Optionally, include time-phased plans to explore utility of 
electronic capture of data elements and/or utilization of other 
existing data systems related to transplant recipients.
    b. Epidemiologic assessments to identify modifiable risk factors, 
focusing on those extrinsic to the patient, for invasive fungal disease 
in the post-transplant period.
    c. Development of a repository of clinical samples and relevant 
clinical data for assessment of novel diagnostics or pathogen 
discovery, and outline plans to facilitate making isolates available to 
a wider public health research community.
    d. Develop plans and implement OTIP Network study to assess novel 
prevention strategies based on (a)-(c) above.
    3. Participate in management, analysis, and interpretation data, 
publish and disseminate important medical and public health information 
stemming from OTIP Program activities in collaboration with all OTIP 
Program sites.
    4. Monitor and evaluate scientific and operational accomplishments 
and progress in achieving the purpose of this program.
    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:
    1. The CDC Staff will have substantial scientific-programmatic 
involvement during the conduct of these activities, through technical 
assistance, advice and coordination above and beyond normal program 
stewardship for grants, including participation in data collection, 
analysis, interpretation of data, and presentation of research 
findings.
    2. The CDC Staff will facilitate operations of the program through 
maintenance of a Steering Committee, and coordinate the dissemination 
of information to Principal Investigators and others.
    3. As requested, will serve as a reference laboratory and receive, 
process, store, and perform evaluation of clinical (e.g., serum 
repository) or environmental specimens, perform molecular epidemiologic 
studies, evaluate novel diagnostics, perform confirmatory testing and/
or susceptibility testing on fungal isolates obtained in OTIP projects.
    4. As requested, serve as a resource for and support data 
management, bio-statistical and epidemiologic analysis.
    5. Assist in the development of surveillance and research protocols 
for IRB review by all cooperating institutions participating in the 
research project, as well as CDC approval.
    Collaborative Activities for the Program are as follows:
    1. Timing, protocol development, and implementation strategy of 
core activities of the OTIP Program will be decided by Steering 
Committee consisting of Principal Investigators of each OTIP Program 
cooperative agreement, CDC, and other select representatives (e.g., 
participating transplant centers, professional society). The purpose of 
the Steering Committee is to share scientific information, assess 
scientific progress, identify new research opportunities, and decide on 
major aspects of program operations. Decisions will be made by a 
majority vote of a quorum, with an attempt for consensus when possible. 
The Steering Committee will convene through both telephone conference 
and in person.

II. Award Information

    Type of Award: Cooperative Agreement.
    CDC involvement in this program is listed in the Activities Section 
above.
    Fiscal Year Funds: 2004.
    Approximate Total Funding: $350,000.

[[Page 25906]]

    Approximate Number of Awards: One to two.
    Approximate Average Award: $175,000 (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: $200,000.
    Anticipated Award Date: August 30, 2004.
    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, such as:

     Public nonprofit organizations
     Private nonprofit organizations
     Universities
     Research institutions
     Hospitals

III.2. Cost Sharing or Matching

    Matching funds are not required for this program.

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.
    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.
    Other eligibility requirements include: (1) Identification of 
consortium of transplant centers which in aggregate perform on average 
1000 transplants per year and may include a combination of solid-organ 
and stem-cell transplants; (2) appropriate diagnostic evaluations are 
performed on patients post-transplant to ascertain etiology of the 
illness post-transplantation; (3) participating centers have capacity 
to perform intensive surveillance, epidemiologic assessments, and 
facilities to ensure efficient processing of patient specimens. 
Documentation of eligibility can be accomplished by including the 
following: (1) Infection control or other surveillance data (e.g., from 
sites currently participating in surveillance networks) from applicants 
and proposed collaborating sites describing total number of 
transplants, type of transplants, and percent of transplant patients 
developing invasive fungal infections; (2) outline of current practice 
in documenting etiology of post-transplant illness in this population; 
and (3) a bulleted list of titles of at least one, but no more than 
five, current or recent epidemiologic and/or prevention research 
projects or studies undertaken from each proposed collaborating sites 
(e.g., part of quality improvement projects, infection control, multi-
site or single-site epidemiologic studies).
    The limitation on eligibility is justified by the essential need to 
have sufficient numbers of transplanted individuals and sufficient 
disease incidence to adequately perform studies to achieve objectives 
of the OTIP Program. In addition, centers must currently practice a 
standard of care that will maximize identification of infecting 
pathogens in this population. Finally, demonstration of past 
performance in conducting epidemiologic investigation and prevention 
research will ensure applicants ability to perform objectives.
    Individuals Eligible to Become Principal Investigators: Any 
individual with the skills, knowledge, and resources necessary to carry 
out the proposed research is invited to work with their institution to 
develop an application for support. Individuals from underrepresented 
racial and ethnic groups as well as individuals with disabilities are 
always encouraged to apply for CDC programs.


    Note: Title 2 of the United States Code section 1611 states that 
an organization described in section 501(c)(4) of the Internal 
Revenue Code that engages in lobbying activities is not eligible to 
receive Federal funds constituting an award, grant, or loan.

IV. Application and Submission Information

IV.1. Address To Request Application Package

    To apply for this funding opportunity, use application form PHS 398 
(OMB number 0925-0001 rev. 5/2001). Forms and instructions are 
available in an interactive format on the CDC Web site, at the 
following Internet address: http://www.cdc.gov/od/pgo/forminfo.htm.
    Forms and instructions are also available in an interactive format 
on the National Institutes of Health (NIH) Web site at the following 
Internet address: http://grants.nih.gov/grants/funding/phs398/phs398.html.
    If you do not have access to the Internet, or if you have 
difficulty accessing the forms on-line, you may contact the CDC 
Procurement and Grants Office Technical Information Management Section 
(PGO-TIM) staff at: 770-488-2700. Application forms can be mailed to 
you.

IV.2. Content and Form of Application Submission

    Letter of Intent (LOI): Your LOI must be written in the following 
format:

 Maximum number of pages: One
 Font size: 12-point unreduced
 Single 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
 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 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, access http://www.dunandbradstreet.com 
or call 1-866-705-5711. For more information, see the CDC Web site at: 
http://www.cdc.gov/od/pgo/funding/pubcommt.htm.
    This PA uses just-in-time concepts. It also uses the modular 
budgeting as well as non-modular budgeting formats. See: http://grants.nih.gov/grants/funding/modular/modular.htm for additional 
guidance on modular budgets.

[[Page 25907]]

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 25, 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 21, 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.

IV.5. Funding Restrictions

    Restrictions, which must be taken into account while writing your 
budget, are as follows: a separate budget should be included for each 
proposed collaborating center. Within each budget, include line items, 
if appropriate, for specific funds addressing each respective recipient 
activity. Funds requested related to activities that are time-specific 
(e.g., risk factor study in year 2-3, adding repository of clinical 
specimens in year 2, adding food borne pathogen surveillance in year 3) 
should appear as line items in the appropriate years only. Cost for 
semi-annual steering group meetings, training sessions, or related 
travel/meeting expenses should be separated from other travel.
    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 Rd., MS C19, Atlanta, GA 30333, (404) 
639-0044, (404) 639-2469, [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 04132, 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 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 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 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 selection of 
transplant centers participating in the consortium allow for sufficient 
diversity or number of transplants to ensure success of the program? 
Are any unique features of the consortium that ensure success with the 
multi-site nature of the activities? If transplants of only a limited 
type (e.g., stem-cell only) are represented by the applicant's 
consortium, will such a homogenous patient mix result in improved 
scientific productivity and ability to accomplish objectives of the 
OTIP Program to justify the approach?

[[Page 25908]]

    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? Does the proposed consortium of 
transplant centers build on any existing surveillance and public health 
research infrastructure to ensure success?
    Additional Review Criteria: In addition to the above criteria, the 
following items will be considered in the determination of scientific 
merit and priority score:
    1. Program priorities include activities focused on invasive fungal 
infections. Bacterial and Viral pathogens should be phased in over time 
if funding becomes available.
    2. Proposed transplant centers participating in consortium should 
maximize use of scarce resources (e.g., utilizing same surveillance 
personnel for both stem-cell and solid-organ transplant patients if 
both transplant populations are participating, incorporation of some 
activities into routine infection control activities).
    3. Degree of commitment expressed in letters of support from all 
essential personnel or departments from proposed transplant centers to 
be in consortium (e.g., infection control, clinical microbiology, 
transplantation division).
    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 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 NCID. 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 NCID 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 by the Mycotic Diseases 
Branch.
    Award Criteria: Criteria that will be used to make award decisions 
include:
     Scientific merit (as determined by peer review).
     Availability of funds.
     Programmatic priorities.

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-3 Animal Subjects Requirements
 AR-6 Patient Care
 AR-7 Executive Order 12372
 AR-9 Paperwork Reduction Act Requirements
 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-24 Health Insurance Portability and Accountability Act 
Requirements

    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 and annual progress 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.

[[Page 25909]]

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: Dr. Mary Lerchen, 
Extramural Program Official, CDC, National Center for Infectious 
Diseases, 1600 Clifton Road, NE., Mailstop: C-19, Atlanta, GA 30333, 
Telephone: 404-639-0043, E-mail: [email protected].
    For questions about peer review, contact: Barbara Stewart, CDC, 
National Center for Infectious Diseases, 1600 Clifton Road, NE., 
Mailstop: C-19, 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.

William P. Nichols,
Acting Director, Procurement and Grants Office, Centers for Disease 
Control and Prevention.
[FR Doc. 04-10535 Filed 5-7-04; 8:45 am]
BILLING CODE 4163-18-P