[Federal Register Volume 63, Number 130 (Wednesday, July 8, 1998)]
[Notices]
[Pages 36911-36915]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-18018]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention
[Announcement Number 99003]


Applied Research Program in Emerging Infections Investigations of 
Infectious Causes of Chronic Diseases; Notice of Availability of Funds 
for Fiscal Year 1999

Introduction

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 1999 funds for competitive grants and/
or cooperative agreements to support applied research on emerging 
infections. This announcement specifically addresses infectious causes 
of chronic diseases.
    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(a) and 317(k)(2) of 
the Public Health Service Act, as amended [42 U.S.C. 241(a) and 
247b(k)(2)].

Smoke-Free Workplace

    CDC strongly encourages all grant recipients to provide a smoke-
free workplace and to promote the non-use of all tobacco products, and 
Public Law 103-227, the Pro-Children's Act of 1994, prohibits smoking 
in certain facilities that receive Federal funds in which education, 
library, day-care, 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. Thus, universities, 
colleges, research institutions, hospitals, other public and private 
nonprofit organizations, including State and local governments or their 
bona fide agents, federally recognized Indian tribal governments, 
Indian tribes or Indian tribal organizations are eligible to apply.

    Note: Only one application will be accepted from any single 
applicant, organization, government, or agency.

Availability of Funds

    Approximately $500,000 is available in FY 1999 to fund one to three 
awards. It is expected that the average award will be $500,000, ranging 
from $100,000 to $500,000. It is expected the award(s) will begin on or 
about March 1, 1999, and will be made for a 12-month budget period 
within a project period of up to three years. (These funding amounts 
are for the first 12-month budget period and include both direct and 
indirect costs.)
    Funding estimates may vary and are subject to change.
    Continuation awards within an approved project period will be made 
on the basis of satisfactory progress and availability of funds.

Determination of Which Instrument to Use

    Applicants must specify the type of award for which they are 
applying, either grant or cooperative agreement. CDC will review the 
applications in accordance with the evaluation criteria. Before issuing 
awards, CDC will determine whether a grant or cooperative agreement is 
the appropriate instrument based upon the need for substantial CDC 
involvement in the project.

[[Page 36912]]

    To assist applicants in making a determination as to which type of 
award to apply for, the following information is provided:
1. Grants
    A research project grant is one in which substantial programmatic 
involvement by CDC is not anticipated by the recipient during the 
project period. Applicants for grants must demonstrate an ability to 
conduct the proposed research with minimal assistance, other than 
financial support, from CDC. This would include possessing sufficient 
resources for clinical, laboratory, and data management services and a 
level of scientific expertise to achieve the objectives described in 
their research proposal without substantial technical assistance from 
CDC.
2. Cooperative Agreements
    A research project cooperative agreement is one in which CDC will 
assist recipients in conducting the proposed research. The application 
should be presented in a manner that demonstrates the applicant's 
ability to address the research problem in a collaborative manner with 
CDC.

Use of Funds

Restrictions on Lobbying

    Applicants should be aware of restrictions on the use of HHS funds 
for lobbying of Federal or State legislative bodies. Under the 
provisions of 31 U.S.C. section 1352 (which has been in effect since 
December 23, 1989), recipients (and their subtier contractors) are 
prohibited from using appropriated Federal funds (other than profits 
from a Federal contract) for lobbying Congress or any Federal agency in 
connection with the award of a particular contract, grant, cooperative 
agreement, or loan. This includes grants/cooperative agreements that, 
in whole or in part, involve conferences for which Federal funds cannot 
be used directly or indirectly to encourage participants to lobby or to 
instruct participants on how to lobby.
    In addition, the FY 1998 Department of Labor, Health and Human 
Services, and Education, and Related Agencies Appropriations Act 
(Public Law 105-78) states in sections 503(a) and (b) that no part of 
any appropriation contained in this Act shall be used, other than for 
normal and recognized executive-legislative relations, for publicity or 
propaganda purposes, for the preparation, distribution, or use of any 
kit, pamphlet, booklet, publication, radio, television, or video 
presentation designed to support or defeat legislation pending before 
the Congress or any State legislature, except in presentation to the 
Congress or any State legislature itself. No part of any appropriation 
contained in this Act shall be used to pay the salary or expenses of 
any grant or contract recipient, or agent acting for such recipient, 
related to any activity designed to influence legislation or 
appropriations pending before the Congress or any State legislature.

Background

    In the United States (U.S.) and elsewhere, infectious diseases 
continue to threaten public health and contribute to the escalating 
costs of health care. While infectious diseases remain the leading 
cause of death in developing countries, the burden of illness and death 
due to chronic medical conditions has surpassed the role of infectious 
diseases in most industrialized countries. However, an increasing body 
of evidence now suggests that infectious agents play critical roles in 
several chronic diseases, including major problems such as cancer, 
heart disease, and diabetes mellitus. The emerging role of micro-
organisms as etiologies for chronic diseases has important implications 
for therapy, prevention, and pathogenesis, and this topic merits 
research efforts designed with the public health implications of these 
new associations kept in mind.
    Over the past decade, causative roles have been proposed or 
established for infectious agents in conditions as diverse as: duodenal 
ulcers and gastric cancer; juvenile onset diabetes mellitus; 
atherosclerosis; Kaposi's sarcoma; Guillain-Barre syndrome; Crohn's 
disease; cerebral palsy; preterm low birth weight, and infertility. The 
burden of evidence supporting some of these associations has been 
sufficient to introduce intervention trials (e.g., Chlamydia pneumoniae 
and atherosclerosis) and even consensus treatment standards (e.g., 
Helicobacter pylori and peptic ulcer disease), while other associations 
remain speculative at present. The fraction of a given chronic disease 
which can be attributed to specific infectious agents is unknown for 
the majority of conditions for which an association is now considered 
likely. Further, although several specific infections are now 
recognized causes of pre-term low birth weight, the proportion of 
infants born prematurely as a result of infectious diseases is not 
known, nor is the proportion of these occurrences which can be 
prevented through appropriate screening and treatment of infections 
prenatally.
    CDC has developed a plan for revitalizing the nation's ability to 
identify, contain, and prevent illness from emerging infectious 
diseases (Addressing Emerging Infectious Diseases Threats: A Prevention 
Strategy for the U.S). The plan includes applied research as a major 
objective, stressing the importance of integrating laboratory science 
and epidemiology to optimize public health practice in the U.S. CDC has 
developed an Extramural Applied Research Program in Emerging Infections 
(EARP) designed to fill gaps in existing support for research in 
emerging infectious disease surveillance, epidemiology, and prevention. 
This announcement specifically addresses investigations of infectious 
causes of chronic diseases and solicits applications in this area.
    For additional reading on this topic, the following article is 
recommended: Lorber B. Are All Diseases Infectious? Ann Intern Med 
1996;125:844-851.

Purpose

    The purpose of the EARP is to provide financial and technical 
assistance for applied research projects on emerging infections in the 
U.S. As a component of EARP, the purpose of this grant/cooperative 
agreement announcement is to provide assistance for one or more 
projects addressing infectious causes of chronic diseases.
    The objective is to address potential associations between one or 
more infectious agents and a chronic disease syndrome by conducting an 
investigation which either: (a) evaluates a suspected relation between 
a specific infectious agent and a chronic disease syndrome; (b) designs 
and tests an intervention strategy aimed at the infection as a means of 
reducing chronic disease sequelae; or (c) determines the health burden 
of a chronic disease attributable to the infectious agent. Note that in 
addition to the standard chronic disease syndromes such as cancer, 
heart disease, diabetes, etc., syndromes that may be addressed under 
this announcement include preterm low birth weight and infertility.

Program Requirements

    In conducting activities to achieve the purpose of this program, 
the recipient will be responsible for the activities under A. 
(Recipient Activities), and CDC will be responsible for conducting 
activities under B. (CDC Activities) under cooperative agreements:

A. Recipient Activities

    1. Develop a research protocol to conduct one or more of the 
following studies:

[[Page 36913]]

    a. Evaluate a suspected association between one or more infections 
and a chronic disease syndrome.
    b. Develop, implement, and evaluate a prevention strategy for 
reducing a chronic disease by addressing the associated infectious 
agent.
    c. Determine the health burden of a chronic disease attributable to 
an associated infectious agent.
    2. Conduct the proposed study using a pilot phase, where 
appropriate, to identify potential problems and make modifications to 
the research protocol.
    3. Publish and/or otherwise disseminate results of the project.

B. CDC Activities (Cooperative Agreements)

    1. Provide technical assistance in the design and conduct of the 
research.
    2. Perform selected laboratory tests, as appropriate and necessary.
    3. Participate in data management, the analysis of research data, 
and the interpretation and presentation of research findings.
    4. Provide biological materials (e.g., strains, reagents, etc.) as 
necessary for studies.

Technical Reporting Requirements

    Narrative progress reports are required semiannually. The first 
semiannual report is required with the second year's noncompeting 
continuation application and should cover program activities from the 
date of award for reporting in the first year of the project. The 
second semiannual report is due 90 days after the end of each budget 
period and should cover activities from the date of previous report. 
Progress reports should summarize tasks completed, problems 
encountered, and plans for continued research activities. Reports 
should also include copies of any publications resulting from the 
project.
    An original and two copies of a Financial Status Report (FSR) are 
required no later than 90 days after the end of each budget period.
    A final performance report and FSR are due no later than 90 days 
after the end of the project period. All reports are to be submitted to 
the Grants Management Branch, CDC.

Application

1. Pre-application Letter-of-Intent

    In order to enable CDC to plan and review applications submitted 
under this Program Announcement, all parties intending to submit 
applications are requested to inform CDC of their intention to do so as 
soon as possible but not later than 30 business days prior to the 
application due date. Notification should include: (1) this program 
Announcement Number 99003, (2) name and address of institution, and (3) 
name, address, and telephone number of contact person. Notification can 
be provided by facsimile, postal mail, or electronic mail (E-mail) to 
Anne Schuchat, M.D., National Center for Infectious Diseases, Centers 
for Disease Control and Prevention (CDC), 1600 Clifton Road, NE., 
Mailstop C-23, Atlanta, GA 30333, Facsimile (404) 639-3970, Internet 
[email protected].

2. Application Content

    Applicants are strongly encouraged to develop applications in 
accordance with PHS Form 398 (Revised 5/95, OMB Control Number 0925-
0001) information contained in this grant/cooperative agreement 
announcement and the instructions outlined below. In order to ensure an 
objective, impartial, and prompt review, applications must conform to 
these instructions.
    The original and five (5) complete copies of the application must 
be UNSTAPLED and UNBOUND. ALL pages must be clearly numbered, and a 
complete index to the application and its appendices must be included. 
All typewritten materials must be single-spaced, using a font no 
smaller than size 12. All supplemental pages of the application (i.e., 
in addition to the 398 forms) must be on the 8\1/2\'' by 11'' white 
paper. All pages must be printed on ONE side only, with at least 1'' 
margins, headers, and footers.
    The application narrative must not exceed 12 pages (excluding 
budget and appendices). Unless indicated otherwise, all information 
requested below must appear in the narrative. Materials or information 
that should be part of the narrative will not be accepted if placed in 
the appendices. The application narrative must contain the following 
sections in the order presented below:
a. Abstract
    Provide a brief (two pages maximum) abstract of the project. 
Clearly identify the project period proposed (not to exceed maximum of 
3 years as indicated in Availability of Funds section). Clearly 
identify the type of award that is being applied for, grant or 
cooperative agreement.
b. Background and Need
    Discuss the background and need for the proposed project. 
Demonstrate a clear understanding of the purpose and objectives of this 
program announcement. Discuss and demonstrate how the proposed project 
addresses an important gap which is of public health importance.
c. Capacity and Personnel
    Describe applicant's past experience in conducting activities 
similar to that being proposed. Describe applicant's resources, 
facilities, and professional personnel that will be involved in 
conducting the project. Include in an appendix curriculum vitae for all 
professional personnel involved with the project. Describe plans for 
administration of the project and identify administrative resources/
personnel that will be assigned to the project. Clearly identify 
specific assigned responsibilities for all key professional personnel. 
Provide in an appendix letters of support from all key participating 
non-applicant organizations, individuals, etc. (if any), which clearly 
indicate their commitment to participate as described in the 
operational plan. (Do not include letters of support from CDC 
personnel--they will not be accepted.)
d. Objectives and Technical Approach
    Present specific objectives for the proposed research which are 
measurable and time-phased and are consistent with the Purpose and 
Recipient Activities of this announcement. Present a detailed 
operational plan for initiating and conducting the research which 
clearly and appropriately addresses these objectives (if proposing a 
multi-year project, provide a detailed description of first-year 
activities and a brief overview of subsequent-year activities). Include 
a clear description of applicant's technical approach/methods which are 
directly relevant to the above objectives. Describe specific study 
protocols or plans for the development of study protocols. Describe the 
nature and extent of collaboration with CDC (if proposing a cooperative 
agreement) and/or others during various phases of the research. 
Describe in detail a plan for evaluating progress toward achieving 
process and outcome project objectives. If the project will employ a 
particular research subject population, describe characteristics of the 
patient population and how research in this subject group will yield 
generalizable information. Describe contingency plans which acknowledge 
how the research will address likely obstacles and assure that the 
proposed task(s) can still be completed. Include sample size 
calculations where appropriate to assure that measurable objectives can 
be evaluated.

[[Page 36914]]

e. Budget
    Provide a line-item budget and accompanying detailed, line-by-line 
justification for the first year of the project that demonstrates the 
request is consistent with the purpose and objectives of this program. 
If requesting a multi-year project, provide estimated total budget 
(direct plus indirect) for subsequent years. If requesting funds for 
any contracts, provide the following information for each proposed 
contract: (1) Name of proposed contractor, (2) breakdown and 
justification for estimated costs, (3) description and scope of 
activities to be performed by contractor, (4) period of performance, 
and (5) method of contractor selection (e.g., sole-source or 
competitive solicitation).
f. Human Subjects
    Whether or not exempt from DHHS regulations, if the proposed 
project involves human subjects, describe in an appendix adequate 
procedures for the protection of human subjects. Also, ensure that 
women, racial and ethnic minority populations are appropriately 
represented in applications for research involving human subjects.

Evaluation Criteria

    The applications will be reviewed and evaluated according to the 
following criteria:

1. Background and Need (15 Points)

    Extent to which applicant demonstrates a clear understanding of the 
background, purpose, and objectives of the project and the extent to 
which the proposed project addresses an area of public health 
importance not adequately addressed in ongoing programs.

2. Capacity (30 Points)

    Extent to which applicant describes adequate resources and 
facilities (both technical and administrative) for conducting the 
project. Extent to which applicant documents that professional 
personnel involved in the project are qualified and have past 
experience and achievements in research related to that proposed as 
evidenced by curriculum vitae, publications, etc. If applicable, extent 
to which applicant includes letters of support from non-applicant 
organizations, individuals, etc., and the extent to which such letters 
clearly indicate the author's commitment to participate as described in 
the operational plan. If the proposed project includes evaluation of 
health conditions in a defined population, the extent to which 
generalizations from this particular study population to broader 
populations can be made.

3. Objectives and Technical Approach (55 Points Total)

    a. Extent to which applicant describes objectives of the proposed 
research which are consistent with the purpose of this announcement and 
which are measurable and time-phased. (15 points)
    b. Extent to which applicant presents a detailed operational plan 
for initiating and conducting the research which clearly and 
appropriately addresses all Recipient Activities. Extent to which the 
plan clearly describes applicant's technical approach/methods for 
conducting the proposed research and extent to which the approach/
methods are appropriate and adequate to accomplish the objectives. 
Extent to which applicant describes specific study protocols or plans 
for the development of study protocols that are appropriate for 
achieving project objectives. Extent to which applicant describes 
adequate and appropriate collaboration with CDC (if proposing a 
cooperative agreement) and/or others during various phases of the 
project. If the proposed project involves human subjects, whether or 
not exempt from HHS regulations, the extent to which adequate 
procedures are described for the protection of human subjects, and 
extent to which protections appear adequate that women, racial and 
ethnic minority populations are appropriately represented in 
applications involving human research. (35 points)
    c. Extent to which applicant provides a detailed and adequate plan 
for evaluating progress toward achieving project process and outcome 
objectives. (5 points)

4. Budget (Not Scored)

    Extent to which the proposed budget is reasonable, clearly 
justifiable, and consistent with the intended use of grant/cooperative 
agreement funds.

Executive Order 12372 Review

    This program is not subject to 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 93.283.

Other Requirements

    Paperwork Reduction Act
    Projects that involve the collection of information from ten or 
more individuals and funded by the grant/cooperative agreement will be 
subject to review and approval by the Office of Management and Budget 
(OMB) under the Paperwork Reduction Act.

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 to demonstrate that the project 
will be subject to initial and continuing review by an appropriate 
institutional review committee. The applicant will be responsible for 
providing evidence of this assurance in accordance with the appropriate 
guidelines and form provided in the application kit.
    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 
the Native American community is involved, its Tribal government must 
also approve that portion of the project applicable to it.

Women, Racial and Ethnic Minorities

    It is the policy of the 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 or Alaska Native, Asian, 
Black or African American, Hispanic or Latino, Native Hawaiian or Other 
Pacific Islander. Applicants shall 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, and dated Friday, September 15, 1995.

[[Page 36915]]

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 by Awardee Institutions.'' An applicant organization 
proposing to use vertebrate animals in PHS-supported activities must 
file an Animal Welfare Assurance with the Office for Protection from 
Research Risks at the National Institutes of Health.

Application Submission and Deadline

    Applicants are strongly encouraged to submit the original and five 
complete copies of application PHS Form 398 (Revised 5/95, OMB Control 
Number 0925-0001) to Sharron P. 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 300, 
Mailstop E-18, Atlanta, GA 30305, on or before October 1, 1998.
    1. Deadline: Applications shall be considered as meeting the 
deadline if they are either:
    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 U.S. Postal Service. Private 
metered postmarks shall 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 and to request an 
application kit, call 1-888-GRANTS (1-888-472-6874). You will be asked 
to leave your name and address and will be instructed to identify the 
Announcement number of interest. (Please refer to Announcement Number 
99003.) 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 Oppie M. Byrd, 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) 842-6546, Facsimile (404) 842-
6513, Internet [email protected]. Programmatic technical assistance may be 
obtained from Anne Schuchat, M.D., National Center for Infectious 
Diseases, Division of Bacterial and Mycotic Diseases, Centers for 
Disease Control and Prevention (CDC), 1600 Clifton Road, NE., Mailstop 
C-23, Atlanta, GA 30333, telephone (404) 639-4720, Internet 
[email protected].
    Please refer to Announcement Number 99003 when requesting 
information regarding this program.
    You may obtain this announcement from one of two Internet sites on 
the actual publication date: CDC's Home Page at http://www.cdc.gov or 
at the Government Printing Office Home Page (including free on-line 
access to the Federal Register at http://www.access.gpo.gov).
    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, D.C. 20402-9325, telephone (202) 512-1800.

    Dated: July 1, 1998.
Joseph R. Carter,
Acting Associate Director for Management and Operations, Centers for 
Disease Control and Prevention (CDC).
[FR Doc. 98-18018 Filed 7-7-98; 8:45 am]
BILLING CODE 4163-18-P