[Federal Register Volume 62, Number 93 (Wednesday, May 14, 1997)]
[Notices]
[Pages 26521-26524]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-12606]



[[Page 26521]]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention
[Announcement Number 800]


Cooperative Agreements To Conduct Research on the Diagnosis and 
Pathogenesis of Lyme Disease in the United States

Introduction

    The Centers for Disease Control and Prevention (CDC) announces the 
expected availability of Fiscal Year (FY) 1998 funds for a cooperative 
agreement program to conduct research on Lyme disease and illnesses 
caused by other related Borrelia species. This program's objective is 
to achieve improved and standardized tools to accurately identify and 
characterize B. burgdorferi infection in humans, including test of 
cure, and to better understand the natural history of infection and 
disease caused by B. burgdorferi and related Borrelia species. These 
achievements should assist in the development of more effective Lyme 
disease surveillance, prevention, and control. Topics include: 
development and evaluation of new and improved diagnostic tests; and 
studies on the pathogenesis of infection with Borrelia burgdorferi and 
other related Borrelia species, including the development of animal 
models of infection and disease.
    CDC is committed to achieving the health promotion and disease 
prevention objectives of ``Healthy People 2000,'' a national activity 
to reduce morbidity and mortality and improve the quality of life. This 
announcement is related to the priority area of Immunization and 
Infectious Diseases. (For ordering a copy of ``Healthy People 2000,'' 
see the Section ``Where to Obtain Additional Information.'')

Authority

    This program is authorized under Sections 301 and 317(k)(2) of the 
Public Health Service Act, as amended (42 U.S.C 241 and 247b(k)(2)).

Smoke-Free Workplace

    CDC encourages all grant recipients to provide a smoke-free 
workplace and to promote the non-use of all tobacco products. Public 
Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain 
facilities that receive Federal funds in which education, library, 
daycare, health care, and early childhood development services are 
provided to children.

Eligible Applicants

    Applications may be submitted by public and private, nonprofit 
organizations, and governments and their agencies within the United 
States. Thus, universities, colleges, research institutions, hospitals, 
other public and private organizations, State and local health 
departments, or their bona fide agents, federally recognized Indian 
tribal governments, Indian tribes or Indian tribal organizations, and 
small, minority and/or women-owned, nonprofit businesses are eligible 
to apply as the principal investigating entities. These United States 
entities may propose collaborative arrangements with investigators 
outside the United States, provided the proposal has a direct impact on 
United States public health.
    Participation in proposed activities by scientists and health 
professionals with expertise and experience in Lyme disease and its 
associated microbiologic, immunologic and pathologic aspects are 
desirable. In addition, combined program activities involving State and 
local health departments, universities, colleges, and private nonprofit 
organizations are encouraged.

    Note: Effective January 1, 1996, Public Law 104-65 states that 
an organization described in section 501(c)(4) of the Internal 
Revenue Code of 1986 which engages in lobbying activities will not 
be eligible for the receipt of Federal funds constituting an award, 
grant (cooperative agreement), contract, loan, or any other form.

Availability of Funds

    CDC anticipates that approximately $1 million of the President's 
budget will be available for FY 1998 cooperative agreements to conduct 
research on the diagnosis and pathogenesis of Lyme disease in the 
United States. However, this announcement is made prior to the 
appropriation of fiscal year 1998 funds to allow new and competing 
continuation applicants sufficient time to prepare applications, and to 
enable timely award of the cooperative agreements. On the basis of the 
President's budget, it is anticipated that approximately $1 million 
will be available in FY 1998 to fund approximately five new and 
competing continuation awards. It is expected that the median award 
will be $200,000, ranging from $50,000 to $300,000. It is expected that 
the awards will begin on or about February 15, 1998. Awards will be 
funded for a 12-month budget period within a project period of up to 
three years. Funding estimates may vary and are subject to change. 
Continuation awards within the project period are made on the basis of 
satisfactory progress and the availability of funds. Funds are 
allocated to develop and standardize more specific and sensitive 
diagnostic tests and to study the pathogenesis of infection, including 
aspects related to the natural history of disease and its 
immunoprotection.

Recipient Financial Participation

    There are no matching or cost participation requirements; however, 
the applicant's anticipated contribution to the overall program costs, 
if any, should be provided on the application. These funds should not 
supplant existing expenditures in this disease area.

Background

    Lyme disease is one of the most important emerging infectious 
diseases in the United States, accounting for more than 90% of all 
reported vector-borne illness. The numbers of reported cases have 
increased steadily, resulting in a thirty-fold rise between 1982 and 
1996. More than 16,000 cases were reported by 44 States to the CDC in 
1996.
    Lyme borreliosis is a potentially serious and debilitating 
infection that may lead to subacute and chronic disease of the joints, 
the peripheral and central nervous system, the heart, and the skin. 
Questions have been raised about microbial persistence and chronic Lyme 
disease. Although transplacental transmission has been reported, 
epidemiologic studies have not shown an association between Lyme 
disease and adverse outcomes of pregnancy.
    Lyme disease cases have been reported nationwide; however, the 
disease is concentrated in three regions: the northeast and mid-
Atlantic, the north central, and the Pacific coastal regions. 
Distribution of cases is principally related to the density of infected 
tick vectors. Ixodes scapularis is the principal vector throughout the 
northeastern, mid-Atlantic, and north central States, and is the cause 
of significant peridomestic transmission. Ixodes pacificus transmits 
the disease in Pacific coastal areas. Ixodes spinipalpis maintains an 
enzootic cycle in Colorado and California. The role of the putative 
vectors in southern regions of the United States, Ixodes scapularis and 
Amblyomma americanum, is not clear.
    Standardized, more specific and sensitive tests that are rapid and 
easy to perform are needed for the laboratory diagnosis of Lyme 
disease. The priority need is for improved test methods to detect 
antibodies to B. burgdorferi antigens in serum and cerebrospinal fluid. 
There is also a need to develop improved and standardized alternative

[[Page 26522]]

test methods, such as antigen capture and polymerase chain reaction.

Purpose

    The purposes of these cooperative agreements are to: (1) Develop, 
validate, and standardize diagnostic tests that are more sensitive and 
specific than those currently available, and (2) better characterize 
the etiologic agents, the host-parasite relationships, and the 
pathogenesis of infection, including the development of immunity to 
infection.

Program Requirements

    In conducting activities to achieve the purpose of this program, 
the recipient will be responsible for conducting selected activities 
under A., below, and CDC will be responsible for conducting activities 
under B., below:

A. Recipient Activities

Develop Improved and Standardized Diagnostic Tests, and/or Conduct 
Studies on the Pathogenesis of Lyme Disease. (Conduct One or More of 
the Following):
    1. Develop more specific and sensitive serologic tests for 
detection of exposure to B. burgdorferi and other closely related 
Borrelia species.
    2. Evaluate and standardize the performance of new testing methods, 
including serologic, polymerase chain reaction or antigen detection 
methods, which may include field testing.
    3. Collect serum and other fluids and tissues to be used in test 
development from clinically well-characterized patients with objective 
manifestations of early localized, early disseminated, and late stage 
Lyme disease (including chronic, refractory disease), and from persons 
with conditions within the differential diagnosis of Lyme disease. 
Specimens from patients with bacteriologically confirmed infection are 
preferred in cases of early Lyme disease.
    4. Develop and use animal models of infection and disease to 
demonstrate the pathogenesis of infection with B. burgdorferi and 
related Borrelia species and the natural history of the diseases caused 
by these agents, and to evaluate approaches to improved diagnosis, 
immunoprotection and/or treatment of Lyme disease.

B. CDC Activities

    1. Provide technical assistance in the design and conduct of 
research.
    2. Assist in performing selected laboratory tests, as appropriate, 
depending on the needs of the recipient.
    3. Assist in the coordination of research activities among 
different recipient sites.
    4. Assist in the analysis of research data.

Technical Reporting Requirements

    Semiannual progress reports are required and must be submitted no 
later than 30 days after each semiannual reporting period. The 
semiannual progress reports must include the following for each 
program, function, or activity involved: (1) A comparison of actual 
accomplishments to the goal established for the period; (2) the reasons 
for failure, if established goals were not met; and (3) other pertinent 
information including, when appropriate, analysis and explanation of 
performance costs significantly higher than expected. The final 
progress report is required no later than 90 days after the end of the 
project period. All manuscripts published as a result of the work 
supported in part or whole by the cooperative agreement will be 
submitted with the progress reports.
    An annual Financial Status Report (FSR) is required no later than 
90 days after the end of each budget period. An original and two copies 
of all reports should be submitted to the Grants Management Branch, 
CDC.

Application Content

    The application should consist of the following:
    1. The abstract should summarize the background, needs, goals, 
objectives and methods of the proposal on one page.
    2. The program narrative should include the following sections: 
background, objectives, methods, plan of operation, and plan of 
evaluation. List and briefly describe specific, measurable, realistic, 
and time-phased objectives.
    3. A budget justification is required for all budget items and must 
be submitted with Standard Form 424A, ``Budget Information,'' as part 
of PHS 5161-1 (Revised 7/92). The budget should include the total funds 
requested for the project. For applicants requesting funding for 
subcontracts, include the name of the person or organization to receive 
the subcontract, the method of selection, the period of performance, 
and a description of the subcontracted service requested.
    4. If the proposed project involves human subjects, whether or not 
exempt from Department of Health and Human Services (DHHS) regulations, 
describe in the narrative adequate procedures for the protection of 
human subjects.
    5. Also, ensure that women, racial and ethnic minority populations 
are appropriately represented in applications for research involving 
human subjects by including a description of the composition of the 
proposed study population (for example, addressing the inclusion of 
women and members of minority groups and their sub-populations in the 
section that will describe the research design). The applicant will 
provide an explanation when the investigator cannot control the race, 
ethnicity and/or sex of the subjects. See Other Requirements for 
additional information.
    When applicable, letters of support must be included in an appendix 
if applicants anticipate the participation of other organizations or 
political subdivisions in conducting proposed activities. Specific 
roles and responsibilities must be delineated.

Notice of Intent To Apply

    In order to assist CDC in planning for and executing the evaluation 
of applications submitted under this Program Announcement, all parties 
intending to submit an application are requested to inform CDC of their 
intention to do so no later than June 13, 1997. Notification should 
include: (1) Name and address of institution; (2) name, address and 
telephone number of contact person; and (3) which programmatic focus 
area application will be submitted under. Notification may be provided 
by facsimile or postal mail to Sharron P. Orum, Grants Management 
Officer, Grants Management Branch, Centers for Disease Control and 
Prevention (CDC), 255 East Paces Ferry Road, NE., Room 305, Mailstop E-
18, Atlanta, GA 30305, facsimile (404) 842-6513.

Required Format for Applications

    Due to the need to reproduce copies of the applications for the 
reviewers, ALL pages of the application MUST be in the following 
format.
    1. The original and two copies must be UNSTAPLED and UNBOUND.
    2. ALL pages must be clearly numbered, and a complete index to the 
application and its appendices must be included.
    3. Begin each separate section (background, objectives, methods, 
plan of operation, and plan of evaluation) on a new page.
    4. All materials must be typewritten, single-spaced, using a font 
no smaller than a size 10, and typed ONLY on 8\1/2\'' by 11'' paper.
    5. Any reprints, brochures, or other enclosures must be copied onto 
8\1/2\'' by 11'' paper by the applicant.
    6. All pages must be printed on ONE side only, with at least 1'' 
margins, headers, and footers.

[[Page 26523]]

    7. The application narrative must be limited to 10 pages, excluding 
abstract, budget, and appendices.
    8. Materials that are part of the basic plan must not be placed in 
the appendices.
    Applications which do not conform to these instructions will not be 
accepted.

Evaluation Criteria

    Applications will be reviewed and evaluated according to the 
following criteria (Total 100 points):
    1. The extent to which background information and other data 
demonstrate that the applicant has the appropriate organizational 
structure, administrative support, and technical expertise to conduct 
the work proposed and has access to stated target populations or other 
study objects. (10 points)
    2. The degree to which the proposed objectives are consistent with 
the purpose as defined in the ``Purpose'' section of this application 
and are specific, measurable, and time-phased. (20 points)
    3. The degree to which the research plans will enable the applicant 
to achieve the stated objectives. The plans should specify the who, 
what, where, how, and timing for the start and completion of each 
activity. (30 points)
    4. The quality of the research methods and instruments to be used. 
(If the proposal involves human subjects, the degree to which the 
applicant has met CDC Policy requirements regarding the inclusion of 
women, ethnic, and racial groups in the proposed research will be 
evaluated. 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.) (20 points)
    5. The quality of the proposed methods for evaluating the 
project.(10 points)
    6. The extent to which qualifications (including expertise and 
experience in relevant work) of project personnel, and the projected 
level of effort by each toward accomplishment of the proposed 
activities demonstrate the ability to successfully conduct the proposed 
work. (10 points)
    7. The extent to which the budget is reasonable, clearly justified, 
and consistent with the intended use of cooperative agreement funds. 
(not scored)

Funding Priorities

    Priority will be given to applications which focus on the 
development, validation, and standardization of new and improved 
diagnostic tests; and to conduct research on the pathogenesis of 
disease, especially as related to the use of animal models to better 
understand the natural history of infection and disease in humans.
    Interested persons are invited to comment on the proposed funding 
priorities. All comments received on or before June 12, 1997, will be 
considered before the final funding priorities are established. If any 
funding priority should change as a result of any comments received, a 
revised Announcement will be published in the Federal Register and 
revised applications will be accepted prior to the final receipt of 
applications.
    Written comments should be addressed to: Sharron Orum, Grants 
Management Officer, Grants Management Branch, Procurement and Grants 
Office, Centers for Disease Control and Prevention (CDC), 255 East 
Paces Ferry Road, NE., Room 305, Mailstop E-18, Atlanta, GA 30305.
    All comments should reference the Program Announcement Number 800.

Executive Order 12372 Review

    This program is not subject to the Executive Order 12372 review.

Public Health System Reporting Requirements

    This program is not subject to the Public Health System Reporting 
Requirements.

Catalog of Federal Domestic Assistance Number

    The Catalog of Federal Domestic Assistance Number is 93.942.

Other Requirements

Human Subjects

    If the proposed project involves research on human subjects, the 
applicant must comply with the Department of Health and Human Services 
Regulations (45 CFR part 46) regarding the protection of human 
subjects. Assurance must be provided which demonstrates that the 
project will be subject to initial and continuing review by an 
appropriate institutional review committee. In addition to other 
applicable committees, Indian Health Service (IHS) institutional review 
committees also must review the project if any component of IHS will be 
involved or will support the research. If any American Indian community 
is involved, its Tribal government must also approve that portion of 
the project applicable to it. The applicant will be responsible for 
providing evidence of this assurance in accordance with the appropriate 
guidelines and forms provided in the application kit.

Animal Subjects

    If the proposed project involves research on animal subjects, the 
applicant must comply with the ``PHS Policy on Humane Care and Use of 
Laboratory Animals to Awardee Institutions.'' An applicant organization 
proposing to use vertebrate animals in CDC-supported activities must 
file an Animal Welfare Assurance with the Office for the Protection 
from Research Risks at the National Institutes of Health.

Women, Racial and Ethnic Minorities

    It is the policy of the Centers for Disease Control and Prevention 
(CDC) and the Agency for Toxic Substances and Disease Registry (ATSDR) 
to ensure that individuals of both sexes and the various racial and 
ethnic groups will be included in CDC/ATSDR-supported research projects 
involving human subjects, whenever feasible and appropriate. Racial and 
ethnic groups are those defined in OMB Directive No. 15 and include 
American Indian, Alaskan Native, Asian, Pacific Islander, Black and 
Hispanic. Applicants will ensure that women, racial and ethnic minority 
populations are appropriately represented in applications for research 
involving human subjects. Where clear and compelling rationale exist 
that inclusion is inappropriate or not feasible, this situation must be 
explained as part of the application. This policy does not apply to 
research studies when the investigator cannot control the race, 
ethnicity and/or sex of subjects. Further guidance to this policy is 
contained in the Federal Register, Vol. 60, No. 179, pages 47947-47951, 
dated Friday, September 15, 1995.

Application Submission and Deadline

    The original and two copies of the application form PHS 5161-1 
(Revised 7-92, OMB number 0937-0189) must be submitted to Sharron Orum, 
Grants Management Officer, Grants Management Branch, Procurement and 
Grants Office, Centers for Disease Control and Prevention (CDC), 255 
East Paces Ferry Road, NE., Room 305, Mailstop E-18, Atlanta, GA 30305, 
on or before July 28, 1997.
    1. Deadline: Applications will be considered as meeting the 
deadline if they are either:

[[Page 26524]]

    a. Received on or before the deadline date; or
    b. Sent on or before the deadline date and received in time for 
submission to the objective review group. (Applicants must request a 
legibly dated U.S. Postal Service postmark or obtain a legibly dated 
receipt from a commercial carrier or the U.S. Postal Service. Private 
metered postmarks will not be acceptable as proof of timely mailing).
    2. Late Applications: Applications which do not meet the criteria 
in 1.a. or 1.b. above are considered late applications. Late 
applications will not be considered and will be returned to the 
applicant.

Where To Obtain Additional Information

    To receive additional written information, call (404) 332-4561. You 
will be asked to leave your name, address, and telephone number. Please 
refer to Announcement #800. You will receive a complete program 
description, information on application procedures and application 
forms. If you have questions after reviewing the contents of all the 
documents, business management technical assistance may be obtained 
from Gladys T. Gissentanna, Grants Management Specialist, Grants 
Management Branch, Procurement and Grants Office, Centers for Disease 
Control and Prevention (CDC), 255 East Paces Ferry Road, NE., Room 314, 
Mailstop E-18, Atlanta, GA 30305, telephone (404) 842-6801. 
Programmatic technical assistance may be obtained from David Dennis, 
M.D. or Duane Gubler, Sc.D., Division of Vector-Borne Infectious 
Diseases, National Center for Infectious Diseases, Centers for Disease 
Control and Prevention (CDC), Fort Collins, CO 80522, telephone (970) 
221-6400. You may also obtain this announcement from one of two 
Internet sites on the actual publication date: CDC's homepage at http:/
/www.cdc.gov or the Government Printing Office homepage (including free 
on-line access to the Federal Register at http://www.access.gpo.gov). 
Other CDC Announcements are also listed on the Internet on the CDC 
homepage.
    Please refer to Announcement Number 800 when requesting information 
and submitting an application.
    Potential applicants may obtain a copy of ``Healthy People 2000'' 
(Full Report, Stock No. 017-001-00474-0) or ``Healthy People 2000'' 
(Summary Report, Stock No. 017-001-00473-1) referenced in the 
``Introduction'' through the Superintendent of Documents, Government 
Printing Office, Washington, DC 20402-9325, telephone (202) 512-1800.

    Dated: May 8, 1997.
Joseph R. Carter,
Acting Associate Director for Management and Operations, Centers for 
Disease Control and Prevention (CDC).
[FR Doc. 97-12606 Filed 5-13-97; 8:45 am]
BILLING CODE 4163-18-P