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Translating Research Into Action for Diabetes; Notice of Availability of Funds

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Information about this document as published in the Federal Register.

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Start Preamble

Application Deadline: September 4, 2003.

A. Authority and Catalog of Federal Domestic Assistance Number

This program is authorized under sections 301(a) and 317(k)(2)of the Public Health Service Act, (42 U.S.C. section 241(a) and 247b(k)(2)), as amended. The Catalog of Federal Domestic Assistance number is 93.283.

B. Purpose

The Centers for Disease Control and Prevention (CDC) announces the availability of fiscal year (FY) 2004 funds for a cooperative agreement program for Translating Research Into Action For Diabetes (TRIAD). This program addresses the “Healthy People 2010” focus area of Diabetes.

The purposes of this research program are to:

1. Continue or develop a multi-center study of diabetes within managed care settings examining the effect of managed care structure and organization using a systematic and standardized approach on processes and outcomes of diabetes care using two overarching hypotheses. The hypotheses are (1) Managed care structural factors (i.e. the ability to track, risk stratify, and/or manage persons with diabetes; guideline selection and implementation, patient education, experience with managed care, management of referral care, clinician incentives, financial barriers to care, and non-financial barriers to care) influence process of care (clinical process variables and service use process variables, i.e. Glycosylated hemoglobin tested/frequency, blood pressure (BP) assessment, lipids tested/frequency, eye exam, foot exam done/foot care recommendations, aspirin prescription, nephropathy assessment, exercise recommendations, smoking cessation counseling); and (2) Managed care structural factors influence long-term outcomes of care (glycosylated hemoglobin levels, lipid levels, BP level, quality of life, satisfaction with care, medical costs, hospitalization, diabetes-related complications).

2. Conduct systematic research aimed at gaining knowledge to improve care for people with diabetes using a standardized protocol across research centers. This protocol shall be designed to assess a diverse community-dwelling (non-institutionalized) population in terms of age (aged 18 or older), gender, race/ethnicity (English and Spanish-speaking), disease severity, geography, and socioeconomic factors.

3. Explore applied research questions aimed at delivering and evaluating primary prevention strategies for diabetes among people at high risk.

Measurable outcomes of the program will be in alignment with the following performance goal for the National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP): Help improve the availability, process, effectiveness, cost-effectiveness, and health outcomes of diabetes-related services provided within managed-care settings.

C. Eligible Applicants

Competition is open to colleges, universities, private non-profit and public nonprofit domestic organizations, research institutions, faith-based organizations, and managed care organizations.

Applicants claiming nonprofit status must include evidence of nonprofit status with their 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.

D. Funding

Availability of Funds

Approximately $3.9 million dollars will be available in FY 2004 to fund approximately six awards. It is expected that the average award will be $550,000, ranging from $400,000 to $700,000. It is expected that the awards will begin on or about February 1, 2004, and will be made for a 12-month budget period within a project period of up to five years. The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) will collaborate with CDC in support of the enhancement of diabetes prevention and control research through a Memorandum of Understanding (MOU) and funding of approximately $500,000 per year during the five-year project period, and based on the availability of funds. These funds are included in the total availability of funds above.

Funding estimates may change.

Continuation awards within an approved project period will be made on the basis of satisfactory progress demonstrated by investigators in Start Printed Page 43109attainment of the goals, objectives, and corresponding performance measures as evidenced by required reports, and based on the availability of funds.

Funding Preferences

Preference may be given to applicants previously funded under Program Announcement #98086 (“Translational Research Centers for Diabetes Control Within Managed-Care Settings”) because these organizations:

1. Are geographically located across the nation with access to diverse diabetic populations in terms of ethnicity/minority, age, and socio-economic factors.

2. Have proven collaboration in conducting multi-center studies using a common protocol with other managed care organizations and academic institutions.

3. Have demonstrated strategies for reaching target diabetic population and attaining a very high response rate (70 to 80 percent).

4. Have established infrastructure, pool of expertise, experienced personnel, and capacity to track and maintain (with retention rates close to 80 percent) a large diabetic cohort within managed care settings.

E. Program Requirements

In conducting activities to achieve the purpose of this program, the recipient will be responsible for the activities under 1. Recipient Activities, and CDC will be responsible for the activities listed under 2. CDC Activities.

1. Recipient Activities

Recipients will be responsible for the following activities:

a. Collaborate with other successful recipients and partners. Participate in the implementation of a multi-center standardized protocol, and in its further development, to include the design of the study, design of instruments, development of methods and procedures for the study, collection of the data, quality control, analysis and interpretation of the data, and dissemination of results.

b. Assist in the development of a research protocol for Institutional Review Board (IRB) review by all cooperating institutions participating in the research project that will include longitudinal ascertainment of serious health conditions. The local IRB will review and approve the protocol on an annual basis.

c. Assure and maintain the confidentiality of all study data.

d. Develop standardized and aggregate analytical processes and technical reports or manuscripts for peer-reviewed publications as appropriate.

e. Because the previous program announcement #98086 was designed using a standardized protocol and standardized data collection systems, new applicants must have access to existing data (at baseline, and at least one follow-up data collection within 18 months) collected in a similar standardized and systematic manner on diabetes patients within managed care settings, collected during the previous five years that may be appropriate for inclusion with any of the previously funded centers so that a diabetic cohort may be followed in a uniform manner. Data should have been collected from health plans, provider groups, racial and ethnic minority groups with diabetes, and adults over the age of 18; and may have been assembled through interviews of health plan and provider group leaders, telephone surveys, medical record reviews, and administrative data, and other appropriate sources in order to further the knowledge already gained.

f. Work collaboratively with similar organizations and recipients in a multi-center study using a common protocol to answer the following questions: (1) What is the level of quality of diabetes care and is it changing over time? (2) what is the relationship between structural aspects of care, for example, use of disease management strategies, profit status, management of referral care, guideline implementation (at system, provider, and patient levels) and diabetes quality of care, intermediate outcomes, and long term health (morbidity, mortality, quality of life) and economic outcomes? and (3) what interventions and strategies can improve diabetes quality of care and outcomes?

g. Collaborate in an interactive and ongoing basis with other health organizations, provider groups, community groups, etc., as necessary, to participate in research assessing the existing and changing structures, processes, delivery, and outcomes of care for people with diabetes.

h. Examine the relationship between individual- and area/community-level socioeconomic characteristics of persons with diabetes and their health behaviors, and quality of care (processes and outcomes). These objectives will be accomplished through collaboration with other funded research centers.

i. Identify innovative ways of optimizing the delivery of care and health outcomes; and identify and test strategies to improve care for people with diabetes using rigorous scientific methods and based on knowledge gained from this systematic and collaborative research program.

j. Utilize an existing Steering Committee which will consist of the Principal Investigators of the research study, and who will serve as the governing body for the study.

k. Follow the standardized protocol and manual(s) of operation to be developed by the Steering Committee.

l. Maintain an effective and adequate management and staffing plan with appropriate competencies to gather, analyze, and publish data; and collaborate with other recipients and use standardized systems such as computer assisted telephone systems, hospital record systems, chart review, and administrative data management systems for collecting patient data.

m. Communicate scientifically via publications, abstracts, and presentations, the main and secondary findings pertaining to the goals of the study.

n. Perform joint analysis with aggregate data. Performance will be measured by evidence that the grantee has demonstrated accomplishment of the activities described above in items a through n.

2. CDC Activities

CDC will be responsible for the following activities:

a. Provide assistance on the design of the multi-center study, to include assisting with the development of sampling procedures, design of the instruments, development of methods and procedures for the study, collection of data, analysis and interpretation of data, resolution of data quality issues and dissemination of results.

b. Assist in the development of a standardized research protocol for IRB review by all cooperating institutions participating in the research project.

c. Obtain and maintain Certificates of Confidentiality in the form of 301(d) and assurance of confidentiality 308(d), as appropriate for the study.

d. Collaborate to produce technical reports or manuscripts for peer-reviewed publications as appropriate. Provide assistance for joint analysis with aggregate data.

e. Serve as consultants to the Steering Committee.

f. Participate in research assessing the existing and changing structures, processes, delivery, and outcomes of care for people with diabetes.

g. Provide consultation to examine the relationship between individual and community socioeconomic characteristics of persons with diabetes and diabetes processes and outcomes of care.

h. Collaborate with research centers to identify and test strategies to improve Start Printed Page 43110care for people with diabetes using rigorous scientific methods.

F. Content

Applications

The Program Announcement title and number must appear in the application. Use the information in the Program Requirements, Other Requirements, and Evaluation Criteria sections to develop the application content. Your application will be evaluated on the criteria listed, therefore, it is important to follow them in presenting your program plan. The narrative should be no more than 50 double-spaced pages, printed on one side, with one-inch margins, and unreduced 12-point font.

Beginning October 1, 2003, applicants will be required to have a Dun and Bradstreet (DUNS) number to apply for a grant or cooperative agreement from the Federal government. 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.

Although obtaining a DUNS number is not required for applications submitted in response to announcements with deadlines on or before September 30, 2003, regardless of when the award is made, you are encouraged to obtain a DUNS number now if you believe you will be submitting an application to any Federal agency on or after October 1, 2003. Proactively obtaining a DUNS number at the current time will facilitate the receipt and acceptance of applications after September 2003.

To obtain a DUNS number, access: http://www.dunandbradstreet.com or call 1-866-705-5711.

Focus the application content on the planned “Recipient Activities” and describe accomplishments in the Background and Need section of your narrative. Provide supporting documentation such as resumes, job descriptions, and descriptions of collaborators as appropriate. The original and each copy of the application must be submitted unstapled and unbound. Pages should be clearly numbered and a complete index to the application and any appendices should be included.

1. Program Narrative

Under a section entitled Background and Need, describe the extent to which the applicant demonstrates an effective understanding of the burden of diabetes, the problems (structure, process of care, quality of care, endpoints, and outcomes); specific accomplishments of your diabetes research program, unmet needs, a need for the project, and a commitment to its execution. Describe your capacity to conduct a multi-center research study in managed care settings. Provide a detailed plan of activities to be performed in the first year. Briefly address activities for years 2-5.

2. Provide specific references to the following program requirements as described in the Recipient Activities section.

a. Provide evidence of participation and collaboration with other partners in a multi-center study. Provide evidence that the principal investigator has published reports emanating from multi-center investigations using common protocols of the relationship between structural factors and outcomes of diabetes care. Provide evidence of experience with developing and working with a multi-center standardized protocol to include the design of the study, design of instruments, development of methods and procedures for the study, collection of the data, quality control, analysis and interpretation of the data, and dissemination of results. Applicant must provide a copy of an approved protocol (as an attachment to the application) that describes the criteria listed above.

b. Provide evidence that the applicant and principal investigator have experience in the development of a research protocol for IRB review that includes multiple cooperating institutions participating in the research project and that will include longitudinal ascertainment of serious health conditions. Provide evidence that the local IRB will review and approve the protocol on an annual basis. Provide evidence of experience dealing with the challenges and solutions related to collecting data in a standardized manner within a multi-center study. For example, provide a narrative describing methods used to evaluate recruitment, retention, and show data on response rates obtained.

c. Provide evidence that applicant will assure and maintain the confidentiality of all study data.

d. Provide evidence that applicant can develop standardized and aggregate analytical processes and technical reports or manuscripts, from multi-center studies using a common protocol, for peer-reviewed publications as appropriate.

e. Provide evidence that applicant has access to research infrastructure; and provide summaries of existing data collected during the previous five years, linking structural characteristics (for example, use of disease management strategies, profit status, management of referral care, and guideline implementation) with patient level data, including that obtained from surveys, medical record reviews, and administrative health care utilization data access to existing data on diabetes patients within managed care settings, from health plans, provider groups, racial and ethnic minority groups with diabetes, and adults over the age of 18; assembled at a minimum through telephone surveys, medical record reviews, and administrative data, in order to further the knowledge already gained.

f. Provide evidence that applicant can and is willing to work collaboratively with the other recipients to answer the following questions: (1) What is the level of quality of diabetes care and is it changing over time? (2) What is the relationship between structural aspects of care, for example, use of disease management strategies, profit status, management of referral care, guideline implementation (at system, provider, and patient levels) and diabetes quality of care, intermediate outcomes, and long term health (morbidity, mortality, quality of life) and economic outcomes? and, (3) what interventions and strategies can improve diabetes quality of care and outcomes?

g. Provide evidence of applicant's ability to collaborate in an interactive and ongoing basis with other health organizations, provider groups, community groups, etc., as necessary, to participate in research assessing the existing and changing structures, processes, delivery, and outcomes of care for people with diabetes. Provide evidence in the form of multi-center aggregate data wherein key structural factors, processes, and outcomes of care are collected uniformly across research centers.

h. Provide evidence that the applicant has experience in examining the relationship between individual- and area/community-level socioeconomic characteristics of persons with diabetes and their health behaviors, and quality of care (processes and outcomes). These objectives will be accomplished through collaboration with other funded research centers.

i. Provide evidence that the applicant will focus on finding innovative ways of optimizing the delivery of care and health outcomes and will identify and test strategies to improve care for people with diabetes using rigorous scientific methods and based on knowledge gained from this systematic and collaborative research program.

j. Provide evidence that the principal investigator will be willing to utilize an existing Steering Committee which will consist of the Principal Investigators of Start Printed Page 43111the research study and who will serve as the governing body for the study.

k. Provide evidence that recipient will follow the standardized protocol and manual(s) of operation to be developed by the Steering Committee.

l. Provide evidence that the applicant will maintain an effective and adequate management and staffing plan, including an experienced and published principal investigator for the project who has experience in the management and oversight of a multi-center study.

m. Provide evidence of collaboration with others, and experience with the use of standardized systems such as computer assisted telephone systems, hospital record systems, chart review, and administrative data management systems for collecting patient data.

n. Provide evidence of applicant's experience and willingness to perform joint analysis with aggregate data from the study.

o. Provide evidence of applicant's willingness to communicate scientifically via publications, abstracts, and presentations, the main and secondary findings pertaining to the goals of the study.

3. Provide a detailed budget and line-item justification for the first year that is consistent with the stated objectives. Applicants are asked to include travel for up to three project staff, including the principal investigator, to attend four Steering Committee Meetings. For panel review purposes, the Program Narrative must be separate from the budget justification and budget summaries.

G. Submission and Deadline

Application Forms

Submit the original and two copies of PHS-398 (OMB Number 0925-0001). Adhere to the instructions on the Errata sheet (posted on the CDC Web site) for specific CDC instructions for the PHS 398 form. Forms are available at the following Internet address: http://www.cdc.gov/​od/​pgo/​forminfo.htm.

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) at: 770-488-2700. Application forms can be mailed to you.

Submission Date, Time, and Address

The application must be received in the CDC Procurement and Grants Office by 4 p.m. Eastern Time. September 4, 2003. Submit the application to: Technical Information Management-PA #04005, Procurement and Grants Office, Centers for Disease Control and Prevention, 2920 Brandywine Rd., Atlanta, GA 30341-4146.

Applications may not be submitted electronically.

CDC Acknowledgement of Application Receipt

A postcard will be mailed by PGO-TIM, notifying you that CDC has received your application.

Deadline

Applications shall be considered as meeting the deadline if they are received in the CDC Procurement and Grants Office before 4 p.m. Eastern Time on the deadline date. Any applicant who sends their application by the United States Postal Service or commercial delivery services must ensure that the carrier will be able to guarantee delivery of the application by the closing date and time. If an application is received 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, CDC will upon receipt of proper documentation, consider the application as having been received by the deadline.

Any application that does not meet the above criteria will not be eligible for competition, and will be discarded. The applicant will be notified of their failure to meet the submission requirements.

A. Evaluation Criteria

Application

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 as 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.

An independent review group appointed by CDC will evaluate each application against the following criteria (100 points total):

1. The extent to which the applicant addresses the specific Content 1.(a) through 1.(o), below. Total Score 95 points:

(a) Provide evidence of participation and collaboration with other partners in a multi-center study using a common protocol. Provide evidence that the Principal Investigator has published reports emanating from multi-center investigations of the relationship between structural factors and outcomes of diabetes care. Provide evidence of experience in developing and working with multi-center standardized protocol to include the design of the study, design of instruments, development of methods and procedures for the study, collection of the data, quality control, analysis and interpretation of the data, and dissemination of results. Provide copy of an approved standardized, common protocol that includes the criteria listed above, and implemented by the applicant. (10 points)

(b) Provide evidence that applicant and principal investigator have experience in the development of a research protocol for IRB review that includes multiple cooperating institutions participating in the research project that will include longitudinal ascertainment of serious health conditions. Provide evidence that the local IRB will review and approve the protocol on an annual basis. Provide evidence of experience dealing with the challenges and solutions related to collecting data in a standardized manner within a multi-center study. For example, provide a narrative describing methods used to evaluate recruitment, retention, and show data on response rates obtained. (10 points)

(c) Provide evidence that applicant can and will develop standardized and aggregate analytical processes and technical reports or manuscripts, from multi-center studies using a common protocol, for peer-reviewed publications as appropriate. (10 points)

(d) Provide evidence that applicant has access to research infrastructure. Provide summaries of existing data collected during the previous five years, linking structural characteristics (for example, use of disease management strategies, profit status, management of referral care, and guideline implementation) with patient level data (for example, data obtained from surveys, medical record reviews, administrative health care utilization data, existing data on diabetes patients within managed care settings, from health plans, provider groups, racial and ethnic minority groups with diabetes, and adults over the age of 18) assembled at a minimum through telephone surveys, medical record reviews, and administrative data, in order to further the knowledge already gained. (10 points)

(e) Provide evidence that applicant can and is willing to work collaboratively with the other recipients to answer the following questions: (1) What is the level of quality of diabetes care and is it changing over time? (2) Start Printed Page 43112what is the relationship between structural aspects of care, for example, use of disease management strategies, profit status, management of referral care, guideline implementation (at system, provider, and patient levels) and diabetes quality of care, intermediate outcomes, and long term health (morbidity, mortality, quality of life) and economic outcomes? and, (3) what interventions and strategies can improve diabetes quality of care and outcomes? (10 points)

(f) Provide evidence of applicant's ability to collaborate in an interactive and ongoing basis with other health organizations, provider groups, community groups, etc., as necessary, to participate in research assessing the existing and changing structures, processes, delivery, and outcomes of care for people with diabetes. Provide evidence in the form of multi-center aggregate data wherein key structural factors, processes, and outcomes of care are collected uniformly across research centers. (6 points)

(g) Provide evidence that the applicant will maintain an effective and adequate management and staffing plan, including an experienced and published principal investigator for the project who has experience in the management and oversight of a multi-center research study. (5 points)

(h) Provide evidence of collaboration with other organizations and experience with the use of standardized systems such as computer assisted telephone systems, hospital record systems, chart review, and administrative data management systems for collecting patient data. (5 points)

(i) Provide evidence of applicant's experience and willingness to perform joint analysis with aggregate data, collected using a common protocol from the study. (5 points)

(j) Provide evidence of applicant's willingness to communicate scientifically via publications, abstracts, and presentations, the main and secondary findings pertaining to the goals of the study. (5 points)

(k) Provide evidence that applicant will assure and maintain the confidentiality of all study data. (5 points)

(l) Provide evidence that the applicant will follow the standardized protocol and manual(s) of operation to be developed by the Steering Committee. (5 points)

(m) Provide evidence of applicant's ability to examine the relationship between individual and area/community level socioeconomic characteristics of persons with diabetes and their health behaviors, and quality of care (processes and outcomes). These objectives will be accomplished through collaboration with other funded research centers. (3 points)

(n) Provide evidence that the applicant will focus on finding innovative ways of optimizing the delivery of care and health outcomes, and will identify and test strategies to improve care for people with diabetes using rigorous scientific methods based on knowledge gained from this systematic and collaborative research program. (3 points)

(o) Provide evidence that the principal investigator will be willing to utilize an existing Steering Committee which will consist of the Principal Investigators of the research study and who will serve as the governing body for the study. (3 points)

2. Background and Program Need (Total 5 points). The extent to which the applicant demonstrates an effective understanding of the background and burden of diabetes, the problems (structure, process of care, quality of care, endpoints, and outcomes), specific accomplishments of your diabetes research program, unmet needs, a need for the project, and a commitment to its execution.

3. Budget and justification (Reviewed, but not weighted or scored).

Provide a detailed budget and line-item justification for the first year that is consistent with the stated objectives and planned activities. Applicant is asked to include travel for up to three project staff, including the principal investigator, to attend four steering committee meetings. For panel review purposes, the program narrative must be separate from the budget justification and budget summaries.

4. Human Subjects (Reviewed, but not weighted or scored) Does the application adequately address the requirements of title 45 CFR part 46 for the protection of human subjects? The degree to which the applicant has met the CDC Policy requirements regarding the inclusion of women, ethnic, and racial groups in any 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.

I. Other Requirements

Technical Reporting Requirements

Provide CDC with an original plus two copies of:

1. Interim progress report, no less than 90 days before the end of the budget period. The progress report will serve as your non-competing application, and must contain the following:

a. Current Budget Period Activities/Objectives.

b. Current Budget Period Financial Progress.

c. New Budget Period Program Proposed Activities/Objectives

d. Detailed, Line-Item Budget Justification.

e. Additional Requested Information.

2. Financial status report, no more than 90 days after the end of the budget period.

3. Final financial status report, no more than 90 days after the end of the project period.

Send all reports to the Grants Management Specialist identified in the “Where to Obtain Additional Information” section of this announcement.

Additional Requirements

The following additional requirements are applicable to this program. For a complete description of each, see Attachment I of the program announcement as posted on the CDC web site.

AR-1 Human Subjects Requirements

AR-2 Requirements for Inclusion of Women and Racial and Ethnic Minorities in Research

AR-7 Executive Order 12372 Review

AR-8 Public Health System Reporting Requirements

AR-9 Paperwork Reduction Act Requirements

AR-10 Smoke-Free Workplace Requirements

AR-11 Healthy People 2010

AR-12 Lobbying Restrictions

AR-15 Proof of Non-Profit Status

AR-22 Research Integrity

J. Where To Obtain Additional Information

This and other CDC announcements, the necessary applications, and associated forms can be found on the CDC Web site, Internet address: http://www.cdc.gov.

Click on “Funding” then “Grants and Cooperative Agreements”.

For general questions about this announcement, contact: Technical Start Printed Page 43113Information Management, CDC Procurement and Grants Office, 2920 Brandywine Rd, Atlanta, GA 30341-4146, Telephone: 770-488-2700.

For business management and budget assistance, contact: Angela Webb, Grants Management Specialist, Procurement and Grants Office, Centers for Disease Control and Prevention, 2920 Brandywine Road, Atlanta, GA 30341-4146, Telephone: (770) 488-2784, E-mail address: Awebb@cdc.gov.

For program technical assistance, contact: Bernice A. Moore, MBA, Division of Diabetes Translation, Epidemiology and Statistics Branch, Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, 4770 Buford Hwy., NE., MS-K10, Atlanta, GA 30341-3717, Telephone number: (770) 488-1257, E-mail address: bam0@cdc.gov.

Start Signature

Dated: July 15, 2003.

Sandra R. Manning,

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

End Signature End Preamble

[FR Doc. 03-18422 Filed 7-18-03; 8:45 am]

BILLING CODE 4163-18-P