Feasibility and Impact of Influenza Vaccination by Pediatricians of Household Contacts of Children Less Than Two Years, 25063-25067 [05-9453]

Agencies

• Centers for Disease Control and Prevention
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 70, Number 91 (Thursday, May 12, 2005)]
[Notices]
[Pages 25063-25067]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-9453]



[[Page 25063]]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Feasibility and Impact of Influenza Vaccination by Pediatricians 
of Household Contacts of Children Less Than Two Years

    Announcement Type: New.
    Funding Opportunity Number: RFA IP05-097.
    Catalog of Federal Domestic Assistance Number: 93.185.
    Key Dates:
    Letter of Intent Deadline: June 13, 2005.
    Application Deadline: June 27, 2005.

I. Funding Opportunity Description

    Authority: Section 317(k)(1) of the Public Health Service Act, 42 
U.S.C. 247b(k)(1), as amended.
    Background: Influenza is associated with the hospitalization of 
approximately two out of every 1,000 children aged less than two years 
old each year on average. Influenza hospitalization rates up to five 
times higher have been reported among children aged zero to five months 
as compared with those 6-23 months. Beginning with the 2004-2005 
influenza season, influenza vaccination was fully recommended for 
children aged 6-23 months and for household contacts and out-of-home 
caregivers of children aged less than two years. Since children aged 
less than six months cannot be vaccinated against influenza and because 
of incomplete protection from influenza among vaccinated children aged 
6-23 months, vaccination of contacts is an important means to protect 
children less than two years old from influenza. Currently, no systems 
have been developed to reach household contacts of these young 
children. Evaluation of mechanisms to vaccinate household contacts of 
children aged less than two years, and particularly contacts of 
children aged less than six months, and an assessment of the impact on 
influenza in children with household contact vaccination are needed. 
Information about the relative benefit of household contact vaccination 
of children less than two years is particularly important when facing 
influenza vaccine shortage as occurred in 2004-2005 and is expected to 
occur at least in the early stages of a pandemic.
    Although a multi-pronged approach will likely be necessary to 
maximize vaccination of household contacts and out-of-home caregivers 
of young children, one source for household contact vaccination may be 
pediatricians who see young children on a regular basis for newborn 
check-ups and routine immunizations. Pediatricians could offer 
influenza vaccine to household contacts as well, at the same or 
subsequent visits. Vaccination of adults and older children in the 
household at the same visit as the child aged less than two years would 
offer convenience and limit missed opportunities to vaccinate these 
contacts.
    We propose a study to assess the feasibility and impact of 
influenza vaccination for household contacts of children less than two 
years of age.
    Purpose: The purpose of the program is to:
    1. Evaluate the feasibility of offering influenza vaccination to 
household contacts of children less than two years of age by 
pediatricians.
    2. Evaluate the impact of influenza vaccine coverage among 
household contacts on influenza illness in children less than six 
months and 6-23 months of age.
    This program addresses the ``Healthy People 2010'' focus area(s) of 
Immunization and Infectious Diseases.
    Measurable outcomes of the program will be in alignment with one 
(or more) of the following performance goal(s) for the National 
Immunization Program (NIP): Reduce the number of indigenous cases of 
vaccine-preventable diseases (VPD).
    Research Objectives: 1. To evaluate the feasibility of offering 
influenza vaccination to adult and pediatric household contacts of 
children less than two years of age by pediatricians.
    2. To evaluate the impact of influenza vaccine coverage among 
household contacts on influenza illness in children less than six 
months and 6-23 months of age in comparison to vaccination of the child 
alone after controlling for important co-factors (e.g., day care 
attendance, maternal influenza vaccination, household smoke exposure).
    Activities: Awardee activities for this program are as follows:
    1. Conduct a prospective case-control study among children and 
families enrolled in a group of pediatric practices in one or more 
geographic locations. Practices would be randomized to offering 
influenza vaccination to adult and pediatric household contacts of 
children less than two years of age at the pediatrician's office during 
or after the child's medical visit and educating the child's parent 
about the recommendation for vaccination of all of the child's 
household contacts versus education alone. For the intervention 
practices, evening vaccination clinics and walk-in influenza 
vaccination-only services for household contacts would also be 
provided. Influenza vaccine would be offered initially beginning on 
September 1, or as soon as vaccine is available for those children who 
would need two doses the first year and would begin October 1 for 
children who need only one dose. Vaccination efforts would continue 
through December 31. Educational materials including the Vaccine 
Information Statement should be provided to pediatric offices and staff 
and parents/guardians regarding the new recommendation and the 
rationale for the study.
    2. During the time that influenza is circulating in the community 
(based on local virologic surveillance), a sample of children aged less 
than two years who come for medical care to intervention and non-
intervention pediatric offices with fever and one or more acute 
respiratory symptoms or febrile seizure (ARI) will have the influenza 
vaccination histories of the child, parents and other household members 
collected plus other demographic information, such as daycare 
attendance and household smoke exposure. In addition, a respiratory 
specimen will be collected for rapid influenza testing. Influenza 
testing is essential since children in this age group experience an 
average of six respiratory illnesses a year and even during peak 
influenza activity, only 20-35 percent of respiratory illnesses would 
be expected to be influenza related.
    3. During the same period, parents of children who come for medical 
care to the clinic without respiratory illness (controls) will be asked 
to complete a questionnaire on vaccination status of the child and 
household contacts and other demographic information. Controls should 
be recruited 2:1 with ill case children during the same week as ill 
children and matched by age within plus or minus one month of age for 
children less than six months, plus or minus two months for children 
aged 6-12 months, and plus or minus four months for children aged 13-23 
months.
    4. An audit of a sample of charts of children 6-23 months should be 
reviewed to assess the overall vaccination rate among children 6-23 
months in the practice and to validate vaccination for a sample of 
children enrolled in the study.
    5. A survey of a sample of families should be conducted at the end 
of the year to assess vaccination rates of household contacts of 
children less than six months and 6-23 months.

[[Page 25064]]

    6. Physicians and nursing and administrative staff in the 
participating practices should be interviewed using a standard data 
collection instrument to assess logistical issues and difficulties 
anticipated or encountered both before and during implementation of the 
protocol to vaccinate the household contacts.
    7. Because the severity and timing of influenza activity and the 
influenza vaccine antigenic match can vary substantially from year to 
year, the study should be conducted and data collected from two 
complete influenza seasons.
    8. Analysis should include assessment of:
    a. Vaccination rates of children and their household contacts 
compared between non-ARI controls, patients with ARI who test positive 
for influenza and patients with ARI who test negative for influenza.
    b. Rates of laboratory-confirmed, medically-attended influenza 
illness among patients aged less than two years should be calculated 
among the participating practices after weighting based on the number 
of days and percentage of patients with ARI that are sampled.
    c. The following influenza vaccine effectiveness estimates should 
be calculated: (1) Effectiveness in preventing influenza among children 
6 to 23 months through vaccination of children in this age group, and 
(2) effectiveness in preventing influenza among household contacts of 
children less then six months and 6 to 23 months through vaccination of 
children in these two age groups.
    d. Vaccination rates of ARI and non-ARI controls household contacts 
between those practices with and without adult vaccination services 
should be compared to assess the success of the contact vaccination 
program.
    e. Sample sizes needed for analysis must be included.
    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. Provide CDC investigators to monitor the cooperative agreement 
as protocol investigators and project officer(s).
    2. Provide consultation, scientific, and technical assistance in 
designing and conducting the project. Assist in the development of 
Institutional Review Boards (IRB) approval review by all cooperating 
institutions and CDC.
    3. Participate in data analysis and interpretation, and co-
authoring of manuscripts.
    4. Participate in publication and dissemination of findings.

II. Award Information

    Type of Award: Cooperative Agreement.
    CDC involvement in this program is listed in the Activities Section 
above.
    Mechanism of Support: R01.
    Fiscal Year Funds: 2005 for Year One.
    Approximate Total Funding: $302,250 for Year One (This amount is an 
estimate, includes direct and indirect costs, and is subject to 
availability of funds.)
    Approximate Number of Awards: One.
    Approximate Average Award: $302,250 Year One and $300,750 Year Two 
(These amounts include direct and indirect costs).
    Floor of Award Range: None.
    Ceiling of Award Range: $302,250 (This ceiling is for the first 12-
month budget period and include direct and indirect costs.)
    Anticipated Award Date: August 31, 2005.
    Budget Period Length: 12 Months.
    Project Period Length: 2 Years.
    Throughout the project period, CDC's commitment to continuation of 
awards will be conditioned on the availability of funds, evidence of 
satisfactory progress by the recipient (as documented in required 
reports), and the determination that continued funding is in the best 
interest of the Federal Government.

III. Eligibility Information

III.1. Eligible Applicants

    Applications may be submitted by public and private nonprofit 
organizations and by governments and their agencies, such as:
     Public nonprofit organizations
     Private nonprofit organizations
     Universities
     Colleges
     Research institutions
     Hospitals
     Community-based organizations
     Faith-based organizations
     Federally recognized Indian tribal governments
     Indian tribes
     Indian tribal organizations
     State and local governments or their Bona Fide Agents 
(this includes the District of Columbia, the Commonwealth of Puerto 
Rico, the Virgin Islands, the Commonwealth of the Northern Marianna 
Islands, American Samoa, Guam, the Federated States of Micronesia, the 
Republic of the Marshall Islands, and the Republic of Palau)
     Political subdivisions of States (in consultation with 
States)
    A Bona Fide Agent is an agency/organization identified by the state 
as eligible to submit an application under the state eligibility in 
lieu of a state application. If you are applying as a bona fide agent 
of a state or local government, you must provide a letter from the 
state or local government as documentation of your status. Place this 
documentation behind the first page of your application form.

III.2. Cost Sharing or Matching

    Matching funds are not required for this program.

III.3. Other

    CDC will accept and review applications with budgets greater than 
the ceiling of the award range.
    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.
     Late applications will be considered non-responsive. See 
section ``IV.3. Submission Dates and Times'' for more information on 
deadlines

    . 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 
encouraged to apply.
    Additional Principal Investigator qualifications are as follows:
     Previous demonstration of ability to conduct and publish 
peer-reviewed epidemiologic studies on vaccine preventable diseases.
     Submission of letters of support.
     Be able to initiate the study the first year of funding 
and have complete data for two influenza seasons.

[[Page 25065]]

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. 9/2004). Forms and instructions are 
available in an interactive format on the CDC Web site, at the 
following Internet address: https://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: https://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: 2
     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, telephone number, and FAX 
number of the Principal Investigator
     Names of other key personnel
     Participating institutions
     Number and title of this Announcement
    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: 
GrantsInfo@nih.gov.
    Your research plan should address activities to be conducted over 
the entire project period.
    You are required to have a Dun and Bradstreet Data Universal 
Numbering System (DUNS) number to apply for a grant or cooperative 
agreement from the Federal government. Your DUNS number must be entered 
on line 11 of the face page of the PHS 398 application form. The DUNS 
number is a nine-digit identification number, which uniquely identifies 
business entities. Obtaining a DUNS number is easy and there is no 
charge. To obtain a DUNS number, access https://www.dunandbradstreet.com 
or call 1-866-705-5711.
    For more information, see the CDC Web site at: https://www.cdc.gov/
od/pgo/funding/pubcommt.htm.
    This announcement uses the modular budgeting as well as non-modular 
budgeting formats. See: https://grants.nih.gov/grants/funding/modular/
modular.htm for additional guidance on modular budgets. Specifically, 
if you are submitting an application with direct costs in each year of 
$250,000 or less, use the modular budget format. Otherwise, follow the 
instructions for non-modular budget research grant applications.
    Additional requirements that may require you to submit additional 
documentation with your application are listed in section ``VI.2. 
Administrative and National Policy Requirements.''

IV.3. Submission Dates and Times

    LOI Deadline Date: June 13, 2005.
    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 27, 2005.
    Explanation of Deadlines: LOIs must be received in the CDC Office 
of Public Health Research (OPHR) and 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 LOI and 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 LOI or application, first 
contact your courier. If you still have a question concerning your LOI, 
contact the OPHR staff at 404-371-5277. If you still have a question 
concerning your application, 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: https://
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:
     Construction
     Real estate lease or purchase
     Vehicle purchase
     Vehicle lease or rental
     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. Awarded 
funds may not be used for any of the above restrictions with the 
exception of vehicle rental directly associated with travel necessary 
to accomplish the requirements of the project and for incidental 
expenses associated with travel to meetings directly relating to the 
project.
    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.

[[Page 25066]]

IV.6. Other Submission Requirements

    LOI Submission Address: Submit your LOI by express mail or delivery 
service to: Mary Lerchen, DrPH, Scientific Review Administrator, CDC/
Office of Public Health Research, One West Court Square, Suite 7000, MS 
D-72, Telephone: 404-371-5277, Fax: 404-371-5215, E-mail: 
MLerchen@cdc.gov.
    Application Submission Address: Submit the original and one hard 
copy of your application by mail or express delivery service to: 
Technical Information Management--RFA IP05-097, CDC Procurement and 
Grants Office, 2920 Brandywine Road, Atlanta, GA 30341.
    At the time of submission, four additional copies of the 
application, and all appendices must be sent to: Mary Lerchen, DrPH, 
Scientific Review Administrator, CDC/Office of Public Health Research, 
One West Court Square, Suite 7000, MS D-72, Telephone: 404-371-5277, 
Fax: 404-371-5215, E-mail: MLerchen@cdc.gov.
    Applications may not be submitted electronically at this time.

V. Application Review Information

V.1. Criteria

    Applicants 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 equally 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 review criteria are as follows:
    Capability Demonstration: The application will be evaluated based 
on response to all lettered and numbered items listed under Activities, 
and demonstration of capability of conducting these activities.
    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 methods to address these problems? The 
application will also be evaluated based on: Appropriateness of power 
and sample size estimates; methodology for assessing influenza vaccine 
effectiveness by vaccinating household contacts in preventing illness 
in children 0-5 months and 6-23 months.
    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)? The extent to which the applicant's plan describes the 
organizational structure and procedures and identifies all 
participating persons and groups including identifying key professional 
staff and their roles and responsibilities. Past experience of key 
professional staff in conducting clinical pediatric epidemiologic 
research in vaccine preventable diseases, including past experience in 
epidemiological assessment of vaccine effectiveness. Previous 
demonstration of ability to conduct and publish peer-reviewed 
epidemiologic studies on vaccine preventable diseases. Submission of 
letters of support.
    Environment: Does the scientific environment in which the work will 
be done contribute to the probability of success? Do the proposed 
activities take advantage of unique features of the scientific 
environment or employ useful collaborative arrangements? Is there 
evidence of institutional support? Are letters of support included, if 
appropriate?
    Past experience working in pediatric outpatient clinics and with 
pediatric providers in conducting clinical research on vaccines.
    Support from non-applicant supporting agencies, institutions, 
organizations, laboratories, consultants, etc., indicated in 
applications operational plan. Do not include letters of support from 
CDC personnel.
    Clear definition of the populations that would be studied, 
including geographic description and population sizes and socio-
economic and racial-ethnic makeup.
    Additional Review Criteria: In addition to the above criteria, the 
following items will be considered in the determination of scientific 
merit and priority score:
     A clear understanding of the background and objectives of 
this cooperative agreement program.
     A clear understanding of the requirements, 
responsibilities, constraints, and complexities that may be encountered 
in establishing and conducting the study.
    Protection of Human Subjects from Research Risks: Does the 
application adequately address the requirements of Title 45 Part 46 for 
the protection of human subjects? The involvement of human subjects and 
protections from research risk relating to their participation in the 
proposed research will be assessed.
    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. The priority 
score should not be affected by the evaluation of the budget.

V.2. Review and Selection Process

    Applications will be reviewed for completeness by the Center for 
Scientific Review (CSR), and for responsiveness by OPHR. 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 announcement 
will be evaluated for scientific and technical merit by an appropriate 
peer review group or charter study section, a Special Emphasis Panel 
(SEP), convened by the OPHR in accordance with the review criteria 
listed above. As part of the

[[Page 25067]]

initial merit review, all applications will:
     Undergo a peer review by a Special Emphasis Panel. The SEP 
will be selected from the NIH pool of scientists or recommendations 
from the National Immunization Program to serve as reviewers on SEPs. 
Applications will be ranked for the secondary review according to 
scores submitted by the SEP. 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 the Office 
of Science, National Immunization Program.
    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
     Proposed budget

V.3. Anticipated Announcement and Award Dates

    Anticipated Award Date: August 31, 2005.

VI. Award Administration Information

VI.1. Award Notices

    Successful applicants will 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 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: https://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-6 Patient Care
     AR-7 Executive Order 12372
     AR-8 Public Health System Reporting Requirements
     AR-10 Smoke-Free Workplace Requirements
     AR-11 Healthy People 2010
     AR-12 Lobbying Restrictions
     AR-14 Accounting System Requirements
     AR-15 Proof of Non-Profit Status
     AR-22 Research Integrity
     AR-23 States and Faith-Based Organizations
     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: https://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. 9/2004 as posted on the CDC Web site) quarterly during the 
project. The progress report sent no later than 90 days before the end 
of the first half of the budget period will serve as your non-competing 
continuation application, and must contain the following additional 
elements:
    a. Reports of participant enrollment.
    b. Progress in analysis.
    c. Progress Toward Measures of Effectiveness.
    d. Additional Information Requested by Program.
    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: Susan Chu, PhD, MSPH, 
Extramural Program Official, Centers for Disease Control and 
Prevention, MS E-05, 1600 Clifton Road, Atlanta, GA 30333, Telephone: 
404 639-8727, E-mail: SChu@cdc.gov.
    For questions about peer review, contact: Mary Lerchen, DrPH, 
Scientific Review Administrator, CDC/Office of Public Health Research, 
One West Court Square, Suite 7000, MS D-72, Telephone: 404-371-5277, 
Fax: 404-371-5215, E-mail: MLerchen@cdc.gov.
    For financial, grants management, or budget assistance, contact: 
Mattie Jackson, Grants Management Specialist, CDC Procurement and 
Grants Office, 2920 Brandywine Road, Atlanta, GA 30341, Telephone: 770-
488-2696, E-mail: mij3@cdc.gov.

VIII. Other Information

    This and other CDC funding opportunity announcements can be found 
on the CDC Web site, Internet address: https://www.cdc.gov. Click on 
``Funding'' then ``Grants and Cooperative Agreements.'' https://
www.cdc.gov/nip and https://www.cdc.gov/flu.

    Dated: May 6, 2005.
William P. Nichols,
Director, Procurement and Grants Office, Centers for Disease Control 
and Prevention.
[FR Doc. 05-9453 Filed 5-11-05; 8:45 am]
BILLING CODE 4163-18-P