[Federal Register Volume 67, Number 90 (Thursday, May 9, 2002)]
[Notices]
[Pages 31327-31331]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-11555]



[[Page 31327]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 02151]


A Research Study to Assess Multifaceted Fall Prevention 
Intervention Strategies Among Community-Dwelling Older Adults; Notice 
of Availability of Funds

A. Purpose

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year FY 2002 funds for a cooperative agreement 
for a Research Study to Assess Multifaceted Fall Prevention 
Intervention Strategies Among Community-Dwelling Older Adults. This 
Program Announcement addresses the ``Healthy People 2010'' focus area, 
Injury and Violence Prevention. A copy of ``Healthy People 2010'' is 
available at the following Internet site: http://www.health.gov/healthypeople.
    The purpose of this funding is to develop and implement 
scientifically-based multifaceted fall prevention strategies and 
evaluate their effectiveness in community settings. This program is 
intended to stimulate collaborative research by creating a community 
planning infrastructure in which State Health Departments, aging 
services and researchers partner with, for example, community groups, 
aging centers, health care providers, clinicians, and social service 
agencies to develop, implement, and evaluate comprehensive community-
based fall prevention strategies. This announcement seeks to support 
cross-disciplinary, multi-level research that will enhance the capacity 
of communities to deliver comprehensive multifactorial interventions. 
To accomplish this, applicants will need to develop model service 
delivery infrastructures that include partnerships between public 
health agencies and networks that serve the aging community to 
implement the study.
    In addition to developing and evaluating scientifically-based 
comprehensive fall-prevention strategies, it would be useful to 
understand the barriers to conducting research that involves 
collaborative efforts across agencies and among multiple partners, as 
well as the barriers to implementing community-based fall prevention 
interventions.
    Measurable outcomes of this research study will be in alignment 
with the following performance goals for the National Center for Injury 
Prevention and Control (NCIPC), described as a priority area in the 
NCIPC Research Agenda: to develop, evaluate, and study the 
dissemination of community-based interventions to prevent falls among 
older community-dwelling adults.

B. Eligible Applicants

    Applications may be submitted by public and private nonprofit 
organizations and by governments and their agencies; that is, 
universities, colleges, technical schools, research institutions, 
hospitals, managed care organizations and other public and private 
nonprofit organizations, community-based organizations, faith-based 
organizations, State and local governments or their bona fide agents, 
including the District of Columbia, the Commonwealth of Puerto Rico, 
the Virgin Islands, the Commonwealth of Northern Mariana Islands, 
American Samoa, Guam, the Federated States of Micronesia, the Republic 
of the Marshall Islands, and the Republic of Palau, and federally 
recognized Indian tribal governments, Indian tribes, or Indian tribal 
organizations.
    Other required eligibility criteria include the following:
    1. The recipient must provide evidence of effective and well 
defined collaborative relationships within the performing organization 
and with community partners that will ensure implementation of the 
proposed activities. The collaboration must include at least a State 
Health Department, an academic institution and an aging services 
agency. The applicant must include documentation, such as letters of 
support, that describes the specific commitments and responsibilities 
that will be undertaken by the collaborating organizations.
    2. The recipient must provide evidence of prior experience in 
designing, conducting, and analyzing multifaceted fall prevention 
studies among older adults and evidence of prior experience with 
randomized controlled trials. In addition, the recipient must provide 
evidence of access to a population of non-institutionalized seniors and 
experience with accessing and linking appropriate community level data 
with clinical, medical, pharmacy and falls data. The applicant must 
include documentation such as publications from peer reviewed journals.

    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 of 1986 that engages in lobbying activities is not 
eligible to receive Federal funds constituting an award, grant, or 
loan.

C. Availability of Funds

    Approximately $750,000 will be available in FY 2002 to fund one 
award. It is expected that the award will begin on or about September 
30, 2002 and will be made for a 12 month budget period within a project 
period of up to three years, in two phases. Funding estimates may 
change.
    Phase I, conducted during the first year, will be dedicated to 
identifying and building community infrastructures, to assessing 
community readiness and developing partnerships, building capacity, 
identifying, accessing and linking data, and designing appropriate 
interventions to be implemented during Phase II. At the end of Phase I, 
noncompetitive continuation funding will be available for Phase II, 
contingent upon successful progress in Phase I, approval of an 
appropriate research design including acceptable fall prevention 
strategies, and detailed plans and budget for implementing and 
evaluating the community-wide fall prevention interventions. Phase II, 
conducted during years two to three, will be dedicated to implementing 
and evaluating the comprehensive community-based interventions.
    Continuation awards within an approved project period will be made 
on the basis of satisfactory progress as evidenced by required reports 
and the availability of funds.

D. Program Requirements

Overall Study Objectives

    1. Develop strategies and establish mutually beneficial 
collaborations among state health departments, academics, and the 
community using a systems approach. Identify agencies and organizations 
with the infrastructure to support research-based interventions, the 
capabilities to develop linked electronic data bases, and a willingness 
to work together to establish local priorities and plan strategies to 
reduce falls and fall-related injuries in the community.
    2. Design a randomized multifaceted fall prevention intervention 
study among functionally competent, community-dwelling adults aged 65 
years or older. The interventions must include at least two components 
that address modifiable risk factors that have been shown 
scientifically in community settings to reduce falls among older 
persons (e.g., gait and strength training; exercise programs with 
balance training as one component; review and

[[Page 31328]]

modification of medications, especially psychotropic medications). In 
addition, interventions should include one or more components that are 
strongly associated with increased fall risk but have not been well 
studied in the community setting (e.g., identification and treatment of 
postural hypotension; vision screening and correction; and improved 
home lighting.) Community partners must be involved in selecting, 
developing, and implementing the intervention components.
    3. The study would utilize a strong experimental or quasi-
experimental research design (e.g., randomization, stratification) to 
identify the optimal type, duration and intensity of exercise for fall 
prevention while controlling for potential confounding factors within 
the study population, such as co-morbidities and functional 
limitations.
    4. Outcome measures based on multi-year follow up should include 
frequency and severity of falls and fall-related injuries (collected 
monthly), adherence to and compliance with the various intervention 
components, medical care utilization, intervention effectiveness among 
both high and low risk populations, changes in fear of falling and 
self-efficacy, and the program's cost effectiveness.
    5. Activities should be specifically designed to stimulate 
community ownership and investment in sustaining the program, if 
effective, beyond the funding period.
    In conducting activities to achieve the purposes of this program, 
the recipient will be responsible for the activities under ``Recipient 
Activities,'' and CDC will be responsible for the activities listed 
under ``CDC Activities.''
    Recipient Activities: (Phase I)
    1. Develop a plan to determine community readiness and 
infrastructure to undertake fall prevention activities, how the 
community will be involved in decision making about the intervention 
design and components, and the approach that will be used to identify 
and assess the data and data linkage systems necessary to conduct and 
evaluate a falls prevention intervention.
    2. Implement a plan for obtaining community input and building 
partner cooperation, assess community readiness, and identify mutually 
beneficial activities and linkages to a broad range of collaborators in 
the community. Develop and utilize a community advisory group 
consisting of a broad range of professionals, clients, older adults, 
care-givers, and providers to give the project ongoing guidance and 
direction.
    3. Develop collaborative relationships with organizations, agencies 
and programs that serve older adults. Partnerships must include 
organizations that provide medical and/or health care services as well 
as maintain electronic data base records, and have access to community-
dwelling older adults, such as geriatricians, injury control 
researchers, managed care organizations, and hospitals.
    4. Identify the best formats and channels for delivering 
interventions to ensure acceptability and adoption by community-
dwelling seniors.
    5. Develop a research and evaluation plan for Phase II based on the 
results and activities from Phase I, including the rationale and 
specific components of the interventions, identification and 
recruitment of program and control groups including randomization 
procedures, intervention implementation methods, strategies for 
obtaining, managing, and analyzing data, and methods of controlling for 
co-morbidities and multiple risk factors. Develop tools to maximize 
recruitment and retention of older adults into the study.
    6. Travel to Atlanta annually to present a briefing to NCIPC staff 
describing progress to date.
    Recipient Activities: (Phase II)
    1. Conduct a research study to address the objectives in Section A 
under ``Purpose'' by implementing and evaluating a randomized 
controlled study of multifaceted fall prevention interventions among 
community-dwelling adults aged 65 or older. Research is sought on 
strategies that combine both previously tested and effective approaches 
as well as promising components into comprehensive programs designed to 
reduce falls and fall risks.
    2. Identify appropriate personnel for the project. Skills and 
experience of project personnel must include: (1) Experience 
implementing and managing theory-driven intervention studies; (2) 
experience working with older adults; (3) knowledge of falls, fall risk 
factors and prevention strategies; (4) knowledge of behavioral theory; 
(5) experience with medical data and data linkage; (6) expertise in 
analysis of complex data sets; (7) evaluation expertise; (8) experience 
in working with community-based organizations; and (9) experience in 
conducting participatory research.
    3. Utilize collaborative relationships established during Phase I 
to accomplish the project goals.
    4. Collaborate and obtain approval for the study design and methods 
from CDC Injury Center staff. Prepare and submit the approved study 
protocols to the CDC, institutional, and local IRB review board(s). 
Activities must be conducted in compliance with Protection of Human 
Subjects (45 CFR 46).
    5. Establish procedures to maintain the rights and confidentiality 
of all study participants, including securing any assurances necessary 
to conduct research involving human subjects.
    6. Conduct data management activities including data collection and 
data linkage. Data collection may include medical record reviews, 
telephone and in-person interviews, and process measures. Data 
management must include security of data, assurance of participant 
confidentially, data editing, quality control procedures, and data 
entry.
    7. Analyze and disseminate results through reports, presentations, 
and publications.
    8. If effective, broadly disseminate the program through 
established partnerships with community programs, health providers, and 
social services that serve older adults.
    9. Travel to Atlanta annually to provide briefings to NCIPC staff 
describing study status and progress to date.
    CDC Activities:
    A cooperative agreement reflects an assistance relationship between 
the Federal Government and the recipient in which substantial 
programmatic involvement is anticipated about the scientific and/or 
technical management of this research during its performance. With this 
in mind, CDC will perform the following during Phases I and II:
    1. Provide up-to-date scientific information, technical assistance, 
and guidance in the design and conduct of the research.
    2. Provide technical assistance to awardees in developing data 
collection instruments and a centralized system for data management.
    3. Review plans for intervention development and implementation.
    4. Assist in developing a research protocol for annual 
Institutional Review Board (IRB) review by all cooperating institutions 
participating in the research study. The CDC IRB will review and 
approve the protocol initially and on at least an annual basis until 
the research study, including analyses, is completed.
    5. Assist in ensuring human subjects assurances are in place as 
needed.
    6. Provide technical assistance on intervention design, development 
and delivery, data collection methods, and data quality assurance.
    7. Assist in analysis and dissemination of results including the 
preparation of manuscripts, as needed.
    8. Monitor and evaluate the scientific and operational 
accomplishments of the project. This will be accomplished

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through periodic site visits, telephone calls, electronic 
communication, technical reports and interim data analyses.
    9. Convene meetings of recipients for the exchange of information.

E. Content

Letter of Intent (LOI)

    A LOI is required for this program. The Program Announcement title 
and number must appear on the LOI. The narrative should be no more than 
three single-spaced pages, printed on one side, with one inch margins, 
and unreduced 12 point Times Roman (or equivalent size) font. Your LOI 
will be used to prepare for the special emphasis panel (SEP) that will 
review the scientific merit of the applications, and should include the 
following information: Program Announcement Number 02151; name and 
address of institution; name and telephone number of a contact person; 
specific objectives to be addressed by the proposed project; and a 
brief description of project plans.

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 so it is important to address each, preferably in 
order, with sufficient detail. Applicants may submit only one proposal.
    The narrative should be no more than 25 (8\1/2\" x 11") double-
spaced pages, printed on one side, with one inch margins on four sides, 
unreduced 12 point Times Roman (or equivalent size) font, and a page 
number at the bottom of each page. The narrative should consist of, at 
a minimum, Aims and Background, Goals and Objectives, Research Design 
and Methods, Collaborations, Community Capacity, and Budget.
    Applications with more than 25 pages will be returned and not 
reviewed. Please provide only attachments or appendices that are 
directly relevant to this request for funding. Include sample forms and 
data collection instruments. The budget and attachments/appendices, 
including letters of support, are not included in the count for the 25 
page limit. All pages, including appendices, should be numbered 
sequentially. To document eligibility, the narrative must contain the 
following sections in the order presented below:
    1. Abstract (1 page recommended):
    Provide a brief abstract of the project. The abstract must reflect 
the project's focus and the length of the project period (maximum of 
(3) years) for which assistance is being requested (see ``Availability 
of Funds'' for additional information).
    2. Specific Aims and Background (3-5 pages recommended):
    List the aims and the specific research questions this application 
is intended to address. Briefly sketch the background leading to the 
present study. Provide background information to document the capacity 
to accomplish this study as demonstrated by relevant past or current 
research studies in injury prevention.
    3. Goals and Objectives (3-5 pages recommended):
    Provide information to support the scientific basis for the present 
proposal, the theoretical or conceptual framework based on a critical 
evaluation of existing knowledge about fall risk factors and 
intervention strategies, the hypotheses to be tested, the specific 
goals of the research study (including measurable objectives for each 
of these goals), and the project time-line.
    4. Research Design and Methods (10-15 pages recommended):
    a. Describe the research design and the procedures to be used to 
accomplish the specific aims of the study.
    b. Describe the intervention development process, content and 
delivery, including specific intervention protocols or plans for the 
development of intervention protocols.
    c. Describe the identification, recruitment, and retention of 
community-dwelling older adults.
    d. Describe how data will be collected. Provide power calculations 
to justify the sample size(s) and anticipated effect size(s). Describe 
data quality assurance plans.
    e. Describe the measures that will be used to evaluate the impact 
of the various interventions including functional, behavioral, and 
biological measures. Outcomes should include the following: (1) 
Morbidity outcomes (e.g., fall and fall injury rates), (2) functional 
outcomes (e.g., changes in balance and strength, (3) behavioral changes 
(e.g., changes in numbers or types of medications, corrections in 
vision, changes in home lighting), (4) social cognitive outcomes (e.g., 
changes in fear of falling and self-efficacy), and (5) cost-benefits 
estimates.
    f. Describe the data analysis plan including a justification for 
the statistical techniques chosen to analyze these data.
    g. Provide a detailed time-line for the first year of the study as 
well as a projected time-line for the subsequent two years.
    h. Describe the nature and extent of collaboration with CDC and/or 
others during various phases of the project.
    5. Collaborations (3-5 pages):
    Describe the proposed personnel and collaborative activities needed 
to accomplish the proposed activities including existing community 
partnerships. Personnel should include a range of disciplines and may 
include (but are not limited to) university scientists, medical and/or 
health care providers, injury control researchers, professional 
organizations, and staff from participating community-based 
organizations. The combined members of the research team must provide 
evidence of expertise in analytic research and evaluation, and 
familiarity with and success in providing services to older adults.
    6. Community Capacity (6-8 pages):
    Provide evidence of effective and well defined working 
relationships within and between the performing organization and 
community partners. The applicant should describe their experience in 
developing community partnerships and the existing and proposed network 
collaborations as well as the community's current and anticipated 
capacity to disseminate multi-level intervention programs.
    Provide evidence of the availability of appropriate scientific 
oversight necessary to fulfill research study and intervention 
implementation objectives. These will include development, 
implementation, evaluation of the intervention, recruitment and 
retention of participants, and collection and management of project 
related data, and experience in delivering behavioral and/or community 
level interventions. Evidence of the experience and capacity of the 
project team should include an attachment with curriculum vitaes and 
position descriptions for all key staff.
    7. Human Subject Involvement:
    Describe procedures that will provide for the protection of human 
subjects. Address how these procedures adequately address the 
requirements of 45 CFR 46 for the protection of human subjects.
    8. Inclusion of Women and Racial and Ethnic Populations:
    Describe the proposed plan for the inclusion of both sexes and 
racial and ethnic minority populations. Describe the proposed 
justification when representation is limited or absent. Include a 
statement as to whether the design of the study is adequate to measure 
differences when warranted.

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F. Submission and Deadline

Letter of Intent (LOI)

    On or before June 1, 2002, submit the LOI, on the applicant's 
letterhead, to the Grants Management Specialist identified in the 
``Where to Obtain Additional Information'' section of this 
announcement.

Application

    Submit the original and two copies of PHS 5161-1 (OMB Number 0920-
0428). Forms are available in the application kit and at the following 
Internet address: www.cdc.gov/od/pgo/forminfo.htm.
    Application forms must be submitted in the following order:
    Cover Letter
    Table of Contents
    Application
    Budget Information Form
    Budget Justification
    Checklist
    Assurances
    Certifications
    Disclosure Form
    Human Subjects Certification
    Indirect Cost Rate Agreement
    Narrative
    On or before 5 p.m. Eastern Time June 24, 2002, submit the 
application to:
    Technical Information Management-PA02151, Procurement and Grants 
Office, Centers for Disease Control and Prevention, 2920 Brandywine Rd, 
Room 3000, Atlanta, GA 30341-4146.
    Deadline: Letters of Intent and applications will be considered as 
meeting the deadline if they are received before 5 p.m. Eastern Time on 
the deadline date. Applicants sending applications 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.
    Applications which do not meet the above criteria will not be 
eligible for competition and will be discarded. Applicants will be 
notified of their failure to meet the submission requirements.

G. Evaluation Criteria

Applications

    CDC staff will review the application first for eligibility, 
responsiveness to the purpose of this program announcement (as 
described in Section A) and completeness as outlined under ``Eligible 
Applicants'' and ``Program Requirements.'' Applications from ineligible 
entities as well as incomplete and nonresponsive applications will be 
returned to the applicant without further consideration. It is 
important that the applicant's abstract reflects the project's focus 
because the abstract will be used to help determine the responsiveness 
of the 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 Section A ``Purpose'' of 
this announcement. Measures must be objective and quantitative and must 
measure the intended outcome. These Measures of Effectiveness will be 
submitted with the application and will be an element of evaluation.
    Each application will be evaluated individually against the 
following criteria by an independent review group appointed by CDC:
    1. Aims and Background (10 percent)
    Aims of this study and the specific research questions this 
application is intended to address. Background information that 
demonstrates the applicant's knowledge of the field and capacity to 
carry out the study including relevant past or current injury 
prevention research activities.
    2. Goals and Objectives (20 percent):
    Information that forms the basis for the present proposal, the 
theoretical or conceptual framework based on a critical review of 
existing knowledge about fall risk factors and intervention strategies, 
the hypotheses to be tested, the specific goals of the research study 
(including measurable objectives for each of these goals), and the 
project time-line.
    3. Research Design and Methods (35 percent):
    a. The adequacy of the proposed research design and procedures to 
be used to accomplish the specific aims of the study including 
justifiable sample sizes.
    b. The plans for the development of the interventions, including 
methods for obtaining community input and assessing community 
readiness, and how these data will be used in the development, content 
and delivery of specific interventions.
    c. How target and control populations will be selected and how they 
will be accessed, recruited and retained.
    d. The plans for data collection and data management including 
security of data, assurance of participant confidentially, data entry, 
editing, and quality assurance procedures.
    e. Evaluation of the study and the measurable outcomes to be used 
to evaluate the impact of the proposed interventions.
    f. A statistical analysis plan appropriate for the study design and 
for evaluating the interventions.
    g. A strategy to adequately address the CDC Policy requirements 
regarding the inclusion of women, ethnic, and racial groups in the 
proposed research. This includes the: (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; and (3) a statement as to whether 
the design of the study is adequate to measure differences when 
warranted.
    4. Collaborations (15 percent):
    The qualifications and appropriateness of the proposed personnel. 
The experience and capacity of the project team to accomplish the 
proposed activities and to provide appropriate scientific oversight 
necessary to fulfill research study and intervention dissemination 
objectives. The inclusion of multidisciplinary teams including (but not 
limited to) State health departments or agencies, university 
scientists, aging services agencies, medical and/or health care 
providers, injury control research centers, professional organizations, 
and staff from community-based organizations.
    5. Community Capacity (20 percent):
    Experience in developing community partnerships, evidence of 
community expertise with strong existing and proposed network 
collaborations, effective and well defined working relationships within 
and between the performing organization and other partners, and 
evidence of community capacity to promote and disseminate multi-level 
intervention programs using a variety of approaches including education 
and media support.
    6. Human Subjects (Not scored):
    Restate the strategies for the recruitment and retention of human 
subjects and how the applicant will obtain appropriate consent when 
necessary. Are the procedures proposed adequate for the protection of 
human subjects and are they fully documented? Does the application 
adequately address the requirements of Title 45 CFR part 46 for the 
protection of human subjects? (Not scored: however, an application can 
be disapproved if the research risks are sufficiently serious and 
protection

[[Page 31331]]

against risks is so inadequate as to make the entire application 
unacceptable.)
    7. Budget (Not scored):
    The extent to which the budget is reasonable, clearly justified, 
and consistent with the intended use of funds. All budget categories 
should be itemized and appropriately justified.

H. Other Requirements

Technical Reporting Requirements

    Provide CDC with original plus two copies of:
    1. Semiannual progress reports (The progress report will include a 
data requirement that demonstrates measures of effectiveness.)
    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.
    Send all reports to the Grants Management Specialist identified in 
the ``Where to Obtain Additional Information'' section of this 
announcement.
    The following additional requirements are applicable to this 
program. For a complete description of each, see Attachment II of the 
announcement.

AR-1  Human Subjects Requirements
AR-2  Requirements for Inclusion of Women and Racial and Ethnic 
Minorities in Research
AR-9  Paperwork Reduction Act Requirements
AR-10  Smoke-Free Workplace Requirements
AR-11  Healthy People 2010
AR-12  Lobbying Restrictions
AR-13  Prohibition of Use Certain Gun Control Act.
AR-14  Accounting System Requirements
AR-15  Proof of Non-Profit Status
AR-21  Small, Minority, And Women-owned Business
AR-22  Research Integrity

I. Authority and Catalog of Federal Domestic Assistance Number

    This program is authorized under sections 317 and 301 of the Public 
Health Service Act, (42 U.S.C. 241 and 247b) and CFR part 51b. The 
Catalog of Federal Domestic Assistance number is 93.136.

J. Where To Obtain Additional Information

    This and other CDC announcements can be found on the CDC home page 
Internet address, http://www.cdc.gov. Click on ``Funding'' then 
``Grants and Cooperative Agreements.''
    For business management technical assistance, contact: Nancy 
Pillar, Grants Management Specialist, Grants Management Branch, 
Procurement and Grants Office, Centers for Disease Control and 
Prevention, 2920 Brandywine Road, Room 3000, Atlanta, GA 30341-4146. 
Telephone number: 770-488-2721 e-mail address: [email protected].
    For program technical assistance, contact: Judy Stevens, Ph.D., 
Technical Adviser, National Center for Injury Prevention and Control, 
Centers for Disease Control and Prevention, 4770 Buford Highway NE., MS 
K-63, Atlanta, GA 30341-3724, Telephone number: (770) 488-4649 e-mail 
address: [email protected].

    Dated: May 3, 2002.
Sandra R. Manning,
Director, Procurement and Grants Office, Centers for Disease Control 
and Prevention.
[FR Doc. 02-11555 Filed 5-8-02; 8:45 am]
BILLING CODE 4163-18-P