[Federal Register Volume 69, Number 102 (Wednesday, May 26, 2004)]
[Notices]
[Pages 29953-29957]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-11872]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Study Effect of West Nile Virus Infection on Outcomes of 
Pregnancy in Humans

    Announcement Type: New.
    Funding Opportunity Number: 04213.
    Catalog of Federal Domestic Assistance Number: 93.283.
    Key Dates:
    Letter of Intent Deadline: June 15, 2004.
    Application Deadline: July 6, 2004.

I. Funding Opportunity Description

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

    Purpose and Research Objectives: The purpose of the program is to 
determine whether West Nile Virus (WNV) infection of pregnant women has 
adverse effects on the outcomes of pregnancy and to measure and 
describe the effects, if any, on the health of children born to women 
who were infected with WNV during their pregnancy.
    This program addresses the ``Healthy People 2010'' focus area of 
Immunization and Infectious Diseases.
    Measurable outcomes of the program will be in alignment with the 
following performance goal for the National Center on Birth Defects and 
Developmental Disabilities: To improve the understanding and find the 
causes and risk factors for birth defects and developmental 
disabilities in order to develop prevention strategies.
    WNV, a single-stranded RNA flavivirus with antigenic similarities 
to Japanese encephalitis and St. Louis encephalitis viruses, is 
transmitted to humans primarily through the bite of infected 
mosquitoes. Flavivirus infection during pregnancy has been rarely 
associated with both spontaneous abortion and neonatal illness, and 
these viruses have not been known to cause birth defects in humans. In 
2002, a 20-year old woman developed WNV encephalitis during the 27th 
week of pregnancy. At 38 weeks of gestation she delivered a live infant 
who appeared normal but on further examination had chorioretinitis and 
cystic cerebral tissue destruction. Tests for cytomegalovirus, rubella 
virus, herpes simplex virus, lymphocytic choriomeningitis virus, 
enterovirus, and toxoplasma provided no evidence that any of these 
agents had infected the infant. IgM antibody to WNV was found in cord 
blood and in the infant's serum and cerebrospinal fluid, indicating 
that the infant had acquired WNV infection in utero. WNV nucleic acid 
was found in the placenta and umbilical cord tissue. Although it is not 
possible to establish a direct link between WNV and the abnormalities 
seen in this infant, the abnormalities observed are consistent with 
those observed in intrauterine infections with other agents, suggesting 
that they may be related to WNV intrauterine infection. Three other 
instances of maternal WNV infection were investigated in 2002; in all 
three instances the infants were born at full term with normal 
appearance and without laboratory evidence of WNV infection, but 
cranial imaging studies and ophthalmologic examinations were not 
performed.
    During 2002 a total of 4,156 cases of WNV illness in humans, 
including 2,942 cases of neuroinvasive disease, were reported to the 
Centers for Disease Control and Prevention (CDC) from state health 
departments. During 2003 over 9,100 cases of WN illness, including over 
2,600 cases of neuroinvasive disease were reported to CDC. CDC is 
currently following over 70 women who were reported to have had WNV 
disease during pregnancy in 2003.
    The proportion of WNV infections during pregnancy that result in 
congenital infection of the newborn is unknown. The spectrum of 
clinical abnormalities associated with intrauterine infections with 
other agents is wide and includes embryonic death and resorption, 
abortion and stillbirth, prematurity, intrauterine growth retardation 
and low birth weight, developmental anomalies and teratogenesis, 
congenital disease, and persistent postnatal infection. The case 
described above from 2002 suggests that intrauterine transmission of 
WNV in some instances may have deleterious consequences, but the 
spectrum of abnormalities and degree of risk of intrauterine 
transmission are currently unknown. Improved understanding of these 
issues is essential to allow appropriate counseling of women

[[Page 29954]]

exposed to WNV and to fully appreciate the impact of this emerging 
infection.
    In December of 2003, the Division of Vector-Borne Infectious 
Diseases (DVBID) of the National Center for Infectious Diseases (NCID), 
and the Division of Birth Defects and Developmental Disabilities 
(DBDDD) of the National Center on Birth Defects and Developmental 
Disabilities (NCBDDD) sought the opinion of experts on the evaluation 
of congenital infections to develop interim guidelines for the 
evaluation of infants born to mothers who were infected with WNV during 
their pregnancy. These guidelines included careful evaluation of 
physical characteristics, growth, development, and hearing for these 
infants and ophthalmologic and dysmorphologic evaluations and imaging 
of the brain for infants with evidence of congenitally acquired WNV 
infection. Data obtained from these evaluations will need to be 
collected and carefully reviewed in order to better understand the 
effects of WNV on pregnancy and infant outcomes.
    Activities: Recipient activities for this program are as follows:
    (1) Develop a procedure for study subject enrollment. Collaborate 
with staff at DVBID and DBDDD to enroll women who have been infected 
with WNV during pregnancy into the study using the WNV pregnancy 
registry maintained by DVBID as a primary source for enrollment. 
Additional sources of enrollment may be used upon mutual agreement 
between the recipient and CDC.
    (2) Develop a procedure for enrollment of pregnant women who have 
not been infected with WNV to serve as study controls.
    (3) Develop a study protocol detailing the study design, sample 
size calculations, study timeline, and provisions to maintain 
confidentiality of study subjects.
    (4) Ensure that all WNV-infected women enrolled in the study have 
been or are reported to the state health department for the state in 
which they reside.
    (5) Evaluate outcomes of all pregnant women in the study to include 
documentation of complications of pregnancy, miscarriage, premature 
delivery and health of live-born infants according to the interim 
guidelines published in the Morbidity and Mortality Weekly Report, 
Volume 53, February 27, 2004, pages 154-157. Because of uncertainty 
regarding diagnostic tests for congenital WNV infection; for purposes 
of this project, all infants born to women who were suspected to be 
infected with WNV during the first trimester of their pregnancy should 
receive the evaluation recommended for infants suspected to have 
congenital WNV infection, subject to consent of the parents. Infants 
born to women suspected to have been infected with WNV during the 
second or third trimester of pregnancy should be evaluated as indicated 
in the interim guidelines mentioned above. More detailed evaluation may 
be proposed by the recipient subject to ethical human research review 
and approval of project staff at DVBID and DBDDD.
    (6) Publish and disseminate program results.
    CDC Responsibilities: In this cooperative agreement, CDC Scientists 
(Scientific Liaisons) within the DBDDD/NCBDDD and the DVBID/NCID are an 
equal partner with scientific and programmatic involvement during the 
conduct of the project through technical assistance, advice, and 
coordination. These Scientific Liaisons will:
    (1) Participate in the development of the protocol.
    (2) Participate in the analysis, interpretation, and reporting of 
findings in the scientific literature and other media to the community 
at large and the public policy community within the Federal government.
    (3) Participate in data management, analysis of data, and 
interpretation and dissemination of findings.
    (4) Provide scientific consultation and technical assistance in the 
design and conduct of the project, including protocol adherence, 
outcome measures, and analytical approaches in participation with the 
recipient organization.

CDC Scientific Program Administrator (SPA)

    The CDC NCBDDD will appoint an SPA, apart from the NCBDDD and DVBID 
Scientific Liaisons who will:
    (1) Serve as the Program Official for the funded research 
institutions.
    (2) Carry out continuous review of all activities to ensure 
objectives are being met.
    (3) Attend Coordination Committee meetings for purposes of 
assessing overall progress and for program evaluation purposes.
    (4) Provide scientific consultation and technical assistance in the 
conduct of the project as requested.
    (5) Conduct site visits to recipient institutions to determine the 
adequacy of the research and to monitor performance against approved 
project objectives.

Collaborative Responsibilities

    The planning and implementation of the cooperative aspects of the 
study will be effected by a Coordination Committee consisting of the 
Principal Investigator from the participating institution and the CDC 
Scientific Liaisons. This Coordinating Committee will formulate a plan 
for cooperative research.
    At periodic coordination committee meetings, the group will: (1) 
Make recommendations on the study protocol and data collection 
approaches; (2) discuss the target populations that have been or will 
be recruited; (3) identify and recommend solutions to unexpected study 
problems; and (4) discuss ways to efficiently coordinate study 
activities and best practices.

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.
    Approximate Number of Awards: One.
    Approximate Average Award: $350,000. (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: $350,000 in initial budget period. 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. Based upon budget 
constraints, requests for financial assistance are subject to reduction 
in accordance with available resources.
    Anticipated Award Date: September 1, 2004.
    Budget Period Length: 12 months.
    Project Period Length: Four 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 non-profit 
organizations and by governments and their agencies, such as:
     Public non-profit organizations.
     Private non-profit organizations.
     Universities.

[[Page 29955]]

     Colleges.
     Research Institutions.
     Hospitals.
     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 as documentation of your status. Place this documentation behind 
the first page of the application form.

III.2. Cost Sharing or Matching

    Matching funds are not required for this program.

III.3. Other

    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 under-represented 
racial and ethnic groups as well as individuals with disabilities are 
always encouraged to apply for CDC programs.
    Other Eligibility Requirements: If your application is incomplete 
or non-responsive to the requirements listed below, it will not be 
entered into the review process. You will be notified that your 
application did not meet submission requirements.
    Applicants must: (1) Document their present infrastructure, 
capacity, expertise, and experience in conducting clinical and 
epidemiological evaluations of birth defects and/or infectious diseases 
with a national sample; and (2) have in the past shown their ability to 
identify and enroll women with West Nile Virus or related birth defects 
and/or infectious diseases in studies related to infections during 
pregnancy and with related case controls.
    Applicants must provide specific evidence to substantiate this 
capacity, experience, and expertise. Through documentation of two pages 
in length, applicants must provide specific evidence that they can 
fully meet these eligibility criteria in order to be considered for 
formal review. This information must be included as part of the 
application and inserted immediately after the Face Page of the 
application.

    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 Submission

Letter of Intent (LOI)
    The LOI must be written in the following format:
     Maximum number of pages: Two.
     Font size: 12-point unreduced.
     Paper size: 8.5 by 11 inches.
     Page margin size: One-inch margins.
     Printed only on one side of page.
     Single spaced.
     Written in plain language; avoid jargon.
    The LOI must contain the following information: name, address, and 
telephone number of the proposed Principal Investigator, number and 
title of this program announcement, names of other key personnel, 
designations of collaborating institutions and entities, and an outline 
of the proposed work, recruitment approach, and expected outcomes.
    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].
    You must submit a signed original and five copies of your 
application form. The PHS 398 grant application form requires the 
applicant to enter the project title on page 1 (Form AA, ``Face Page'') 
and the project description (abstract on page 2).
    The main body of the application narrative should not exceed 30 
single-spaced pages. This narrative research plan should address 
activities to be conducted over the entire project period. Please note 
that this maximum number of pages allowed exceeds the maximum number of 
pages (25 pages) indicated in the PHS 398 grant application form 
(``Research Grant Table of Contents'').
    Additional information may be included in the application 
appendices. The appendices will not be counted toward the narrative 
page limit. This additional information may include curriculum vitae 
and resumes for key project staff, organizational charts, letters of 
support, etc.; and should be limited to those items relevant to the 
requirements of this announcement.
    All material must be typewritten, with 10 characters per inch type 
(12 point) on 8\1/2\ by 11 inch white paper with one inch margins, no 
headers or footers (except for applicant-produced forms such as 
organizational charts, c. vitae, graphs and tables, etc). Applications 
must be held together only by rubber bands or metal clips, and not 
bound together in anyway (including attachments/appendices).
    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.
    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 Time

    Letter of Intent (LOI) Deadline Date: June 15, 2004.
    CDC requests that you send a LOI if you intend to apply for this 
program.

[[Page 29956]]

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 will allow CDC to plan 
the application review.
    Application Deadline Date: July 6, 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 carrier's 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 three days after the 
application deadline. This will allow time for applications to be 
processed and logged.

IV.4. Intergovernmental Review of Applications

    Executive Order 12372 does not apply to this program.

IV.5. Funding Restrictions

    Restrictions, which must be taken into account while writing your 
budget are that project funds cannot be used to supplant other 
available applicant or collaborating agency funds for construction or 
for lease or purchase of facilities or space.
    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 must be less than 12 
months from the application due date.

IV.6. Other Submission Requirements

LOI Submission Address
    Lisa T. Garbarino, Public Health Analyst, National Center on Birth 
Defects and Developmental Disabilities, CDC, 1600 Clifton Road, 
Mailstop E-87, Atlanta, Georgia 30333. E-mail address: [email protected].
    Application Submission Address: Submit the original and five copies 
of your application by mail or express delivery service to: Technical 
Information Management--PA, CDC Procurement and Grants Office, 2920 
Brandywine Road, Atlanta, Georgia 30341.
    Applications may not be submitted by fax or e-mail at this time.

V. Application Review Information

V.1. Review Criteria

    You are required to provide measures of outcome and 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 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.
    Under the evaluation criteria noted below, applicants must describe 
how they will address the program components as they relate to the 
Purpose and Research Objectives, and Recipient Activities as cited in 
this Announcement.
    Your application will be evaluated against the following criteria:
    1. Background/Understanding/Competency, including:
    a. Identification of the problem and justification for the study, 
including accounts of understanding of West Nile Virus and its 
association with human illness, morbidity, and mortality;
    b. Accounts as to the level of review of relevant literature 
undertaken and the discussion of the foundation in science being 
utilized in addressing the purpose of the research;
    c. Description of the understanding of the implications and 
interrelationships between the vector and human host responses;
    d. Accounts of the applicants understanding of the possible 
association between West Nile Virus infection and outcomes of pregnancy 
in humans;
    e. Discussion of the unique capabilities residing in the applicant 
organization in conducting clinical and epidemiological evaluations of 
birth defects and/or infectious diseases on a national basis;
    f. Description of the study goals, objectives and/or hypotheses, 
and
    g. Intended use and applicability of study findings.
    2. Research Approach and Organizational Capacity, including:
    a. The overall strength and feasibility of the research design with 
an emphasis on pregnant women and the health of children born to women 
who were infected with West Nile Virus during pregnancy;
    b. Presentation of how the applicant is fully able to identify and 
enroll women with West Nile Virus during pregnancy and related case 
controls;
    c. Description and justification of the study population, including 
case definitions, number of participants, selection criteria, and 
methods for recruiting, enrolling, and sustaining participation;
    d. Description of the consent process, including procedures for 
informing participants about the study and methods for obtaining 
consent;
    e. The detailed description of the research design and all follow-
up protocols, including access to a national sample;
    f. Description of all study instruments including survey 
questionnaires, and a discussion of their reliability and validity;
    g. Data handling and analysis plans, including statistical 
methodology, data entry, storage, and disposition; and
    h. Plans for disseminating and reporting results to multiple (and 
applicant-identified) target audiences.
    3. Investigators/Collaborators/and Management Plans, including:
    a. Description of the major collaborators and their explicit 
contributions to project objectives;

[[Page 29957]]

    b. Discussion of investigator(s) qualifications, roles, tasks, time 
commitments, and responsibilities; and
    c. Detailed work plan with specific time frames for implementation 
of the project. This includes the presentation of overarching goals for 
the full four-year project period with a detailed work plan outlining 
monthly or quarterly objectives covering the first two budget years.
    4. Evaluation Plan, including:
    a. Description of how progress will be monitored and evaluated over 
the entire course of the research;
    b. The extent to which project goals are to be attained and 
specific objectives accomplished; and
    c. Description of expected outcomes and how the overall 
effectiveness of the research will be determined.
    5. Budget Description and Justification: This includes the 
comprehensiveness and adequacy of the proposed budget in relation to 
program operations, collaborations, and services; and the extent to 
which the budget is reasonable, clearly justified, accurate, and 
consistent with the purposes of this research.
    6. Protections: Does the application adequately address the 
requirements of title 45 CFR part 46 for the protection of human 
subjects? This criteria 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.
    7. Inclusion: Does the application adequately address the CDC 
policy requirements regarding the inclusion of women, ethnic, and 
racial groups in the proposed research? This includes:
    a. The proposed plan for the inclusion of both sexes and racial and 
ethnic minority populations for appropriate representation.
    b.The proposed justification when representation is limited or 
absent.
    c. A statement as to whether the design of the study is adequate to 
measure differences when warranted.
    d. 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.

V.2. Application Review Process

    Applications will be reviewed by CDC staff for completeness by the 
Procurement and Grants Office (PGO) and for responsiveness by NCBDDD as 
outlined in the ``Other Eligibility Requirements''. Incomplete 
applications and applications that are non-responsive will not advance 
through the review process. Applicants will be notified that their 
application did not meet submission requirements and will not receive 
further consideration.
    Applications, which are complete and responsive, will be subject to 
a preliminary evaluation (triage) by the scientific review group 
(Special Emphasis Panel--SEP) to determine if the application is of 
sufficient technical and scientific merit to warrant further review by 
the SEP.
    Applications that are determined to be non-competitive will not be 
considered, and the SEP will notify the investigator/program director 
and the official signing for the applicant organization. A dual review 
process will then evaluate those applications determined to be 
competitive.

V.3. Anticipated Award Date

    September 1, 2004.

VI. Award Administration Information

VI.1. Award Notices

    If your application is to be funded, you 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 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 Requirement for Inclusion of Women and Racial and 
Ethnic Minorities in Research.
     AR-9 Paperwork Reduction Act Requirements.
     AR-10 Smoke-Free Workplace Requirements.
     AR-11 Healthy People 2010.
     AR-12 Lobbying Restrictions.
     AR-14 Accounting Systems Requirements.
     AR-15 Proof of Non-Profit Status.
     AR-22 Research Integrity.
     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 copies of the 
following reports:
    1. Interim progress report, (PHS 2590, OMB Number 0925-0001, rev. 
5/2001), on a date to be determined for your project for each 
subsequent budget year. The progress report will serve as your non-
competing continuation application, and must contain the following 
elements:
    a. Current Budget Period Activities and Objectives.
    b. Current Budget Period Financial Progress.
    c. New Budget Period Program Proposed Activities and Objectives.
    d. Budget.
    e. Additional Requested Information.
    f. Measures of Effectiveness.
    2. Financial status report and annual 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 sent to the Grants Management Specialist 
listed in the ``Agency Contacts'' section of this announcement.

VII. Agency Contacts

    For general questions about this announcement, contact: Technical 
Information Management Section (PGO-TIM), CDC Procurement and Grants 
Office, 2920 Brandywine Road, Atlanta, Georgia 30341. Telephone: 770-
488-2700.
    For program technical assistance, contact: Lisa T. Garbarino, 
Public Health Analyst, National Center on Birth Defects and 
Developmental Disabilities, CDC, 1600 Clifton Road, Mailstop E-87, 
Atlanta, Georgia 30333. E-mail address: [email protected]; telephone: 404-
498-3979.
    For financial, grant management, or budget assistance, contact: 
Sylvia Dawson, Grants Management Specialist, CDC Procurement and Grants 
Office, 2920 Brandywine Road, Atlanta, Georgia 30341. Telephone: 770-
488-2771; e-mail: [email protected].

    Dated: May 20, 2004.
William P. Nichols,
Acting Director, Procurement and Grants Office, Centers for Disease 
Control and Prevention.
[FR Doc. 04-11872 Filed 5-25-04; 8:45 am]
BILLING CODE 4163-18-P