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

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Start Preamble Start Printed Page 25063

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. Start Printed 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. Start Printed 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: 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: 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 http://www.dunandbradstreet.com or call 1-866-705-5711.

For more information, see the CDC Web site at: http://www.cdc.gov/​od/​pgo/​funding/​pubcommt.htm.

This announcement uses the 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. 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: 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:

  • 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. Start Printed 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 Start Printed Page 25067initial 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: 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-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: 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. 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: http://www.cdc.gov. Click on “Funding” then “Grants and Cooperative Agreements.” http://www.cdc.gov/​nip and http://www.cdc.gov/​flu.

Start Signature

Dated: May 6, 2005.

William P. Nichols,

Director, Procurement and Grants Office, Centers for Disease Control and Prevention.

End Signature End Preamble

[FR Doc. 05-9453 Filed 5-11-05; 8:45 am]

BILLING CODE 4163-18-P