[Federal Register Volume 61, Number 125 (Thursday, June 27, 1996)]
[Notices]
[Pages 33520-33523]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-16388]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Announcement Number 662]


Applied Research in Emerging Infections--Controlling the Spread 
of Antimicrobial Resistance in Community-Acquired Bacterial Pathogens

Introduction

    The Centers for Disease Control and Prevention (CDC) is 
implementing a program for competitive cooperative agreement and/or 
research project grant applications to support applied research on 
emerging infections. CDC announces the availability of fiscal year (FY) 
1996 funds to provide assistance for a program to conduct research on 
controlling the spread of antimicrobial resistance among community-
acquired bacterial pathogens.
    The 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) [42 
U.S.C. 241(a) and 247b(k)(2)] of the Public Health Service Act, as 
amended.

Smoke-Free Workplace

    CDC strongly encourages all grant recipients to provide a smoke-
free workplace and to promote the nonuse of all tobacco products, and 
Public Law 103-227, the Pro-Children 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 and 
for-profit organizations and governments and their agencies. Thus, 
universities, colleges, research institutions, hospitals, other public 
and private organizations, including State and local governments or 
their bona fide agents, federally recognized Indian tribal governments, 
Indian tribes or Indian tribal organizations, and small, minority- and/
or women-owned businesses are eligible to apply.

Availability of Funds

    Approximately $250,000 is available in FY 1996 to fund one or two 
awards. It is expected that the awards will begin on or about September 
30, 1996, and will be made for a 12-month budget period within a 
project period of up to two years. 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.

Purpose

    The purpose of the emerging infections extramural research program 
is to provide financial and technical assistance for applied research 
projects on emerging infections in the United States. As a component of 
this emerging infections extramural research program, this announcement 
focuses on controlling the spread of antimicrobial resistance among 
community-acquired bacterial respiratory pathogens.
    Specifically, the purpose of this announcement is to provide 
assistance for the development and implementation of a program to 
promote judicious antimicrobial use in an outpatient population, and 
the evaluation of its impact on carriage or infection with community-
acquired drug-resistant bacterial respiratory pathogens. If successful, 
such a project could serve as the scientific foundation for national 
efforts to change antibiotic use practices of physicians in order to 
decrease the spread of resistance.

Program Requirements

    In conducting activities to achieve the purpose of this program, 
the recipient shall be responsible for the activities under A., below 
and CDC shall be responsible for conducting activities under B., below. 
In Recipient Activities below, the study of drug resistant S. 
pneumoniae, H. influenzae, or M. catarrhalis in a pediatric population 
are examples of an appropriate approach and are provided for 
illustration purposes. Applicants may propose studies which focus on 
other populations and/or pathogens which are appropriate under the 
Purpose section of this announcement.

A. Recipient Activities

    1. Select study population. This may include selection of non-
overlapping control and intervention groups of patients for 
participation. One example of an appropriate approach would be to 
enroll children from two groups of day care centers, from two small 
towns, or from two communities within a large metropolitan area. These 
groups of children would constitute discrete populations and be served 
by different medical care providers. They would be similar 
demographically, have similar utilization of medical care, and 
comparable baseline rates of carriage or infection with resistant 
pathogens.
    2. Collect and analyze baseline data. For example, nasopharyngeal 
(NP) carriage rates for drug-resistant Streptococcus pneumoniae (DRSP) 
and/or -lactamase producing Haemophilus influenzae or 
Moraxella catarrhalis could be measured in the two groups of children 
by separate NP swab surveys conducted several months before and 
immediately prior to the start of the intervention phase. NP surveys 
for the intervention and control groups would be done concurrently. 
Laboratory methods would include evaluating the potential for carriage 
of multiple populations of pneumococci, which

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may have different resistance patterns, by analysis of multiple 
pneumococcal colonies per culture plate.
    3. Design and implement an intervention promoting judicious 
antimicrobial use. Again, using a pediatric age population as an 
example, develop and implement an intensive program to reduce the rate 
of antibiotic use focusing on pediatric providers and the children's 
parents from one of the study groups. The control group would allow 
comparison of outcomes. Techniques with proven effectiveness, such as 
face-to-face discussions with ``peer-counselors,'' would be an 
important component of such an intervention. Educational materials for 
physicians, including written guidelines for diagnosis and management 
of common respiratory conditions established in collaboration with 
professional organizations, and materials to educate parents on the 
potential adverse effects of unnecessary antibiotic use would be made 
available from CDC. Materials may also be developed by the recipient 
for use in the intervention. Other techniques that may be applicable in 
some settings include providing feedback to physicians comparing their 
practices with those of their colleagues and providing incentives which 
promote judicious antimicrobial use.
    4. Measure effect of the intervention. Measure the differences in 
the rate of antimicrobial resistance among isolates obtained from 
carriers or persons with infection in the intervention and control 
groups. Other appropriate measures or analyses could include: (a) 
differences between control and intervention groups in rates and types 
of antimicrobial use; (b) differences in carriage or infection with 
resistant bacterial pathogens among family members or the community in 
general; (c) differences in the rate of recurrent or refractory 
infections; and (d) changes in parent or provider knowledge and 
attitudes regarding antimicrobial use.
    5. Disseminate research findings. Disseminate research results by 
appropriate methods such as publication in journals, presentation at 
meetings, conferences, etc.

B. CDC Activities

    1. Research Project 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 
documenting that applicant has sufficient resources for clinical, 
laboratory, and data management services, and for demonstrating a level 
of scientific expertise to achieve the objectives described in the 
research proposal without substantial technical assistance from CDC.
    2. Cooperative Agreements. In a cooperative agreement, 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. In addition to the financial support provided, CDC will 
collaborate by: (1) Providing technical assistance in the design and 
conduct of the research including intervention methods and analytic 
approach; (2) performing selected laboratory tests as appropriate; and 
(3) participating in data management, the analysis of research data, 
and the interpretation and presentation of research findings.

C. 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 section of this 
announcement. 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.

Notice of Intent To Apply

    In order to assist CDC in planning for and executing the evaluation 
of applications submitted under this announcement, all parties 
intending to submit an application are requested to inform CDC of their 
intention to do so at their earliest convenience prior to the 
application due date. Notification should include: (1) Name and address 
of institution, and (2) name, address, and phone number of contact 
person. Notification should be provided by facsimile, postal mail, or 
E-mail to Greg Jones, M.P.A., National Center for Infectious Diseases, 
1600 Clifton Road, NE., Mailstop C-19, Atlanta, Georgia 30333, E-mail 
[email protected], facsimile (404) 639-4195.

Evaluation Criteria

    The applications will be reviewed and evaluated according to the 
following criteria:
    1. Background and Need (15 points). Extent to which applicant's 
discussion of the background for the proposed project demonstrates a 
clear understanding of the purpose and objectives of this grant/
cooperative agreement program. Extent to which applicant illustrates 
and justifies the need for the proposed project that is consistent with 
the purpose and objectives of this program.
    2. Capacity (35 points total):
    a. Extent to which applicant describes adequate resources and 
facilities (both technical and administrative) for conducting the 
project. (10 points)
    b. 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. (20 points)
    c. Extent to which applicant includes letters of support from non-
applicant organizations, individuals, etc. Extent to which the letters 
clearly indicate the author's commitment to participate as described in 
the operational plan. (5 points)
    3. Objectives and Technical Approach (50 points total):
    a. Extent to which applicant describes specific objectives of the 
proposed project which are consistent with the purpose and goals of 
this program and which are measurable and time-phased. (10 points)
    b. Extent to which applicant presents a detailed operational plan 
for initiating and conducting the project, which clearly and 
appropriately addresses all Recipient Activities. Extent to which 
applicant clearly identifies specific assigned responsibilities for all 
key professional personnel. Extent to which the plan clearly describes 
applicant's technical approach/methods for conducting the proposed 
studies and extent to which the plan is adequate to accomplish the 
study objectives. Extent to which applicant describes specific study 
protocols or plans for the development of study protocols that are 
appropriate for achieving project objectives. The degree to which the 
applicant has met the CDC Policy requirements regarding the inclusion 
of women, ethnic, and racial groups in the proposed research. This 
includes: (1) The proposed plan for the inclusion of both sexes and 
racial and ethnic minority populations for appropriate representation; 
(2) the proposed justification when representation is limited or 
absent; (3) a statement as to whether the design of the study is 
adequate to measure differences when warranted; and (4) a statement as 
to whether the plans for recruitment and outreach for study 
participants include the process of establishing partnerships

[[Page 33522]]

with community(ies) and recognition of mutual benefits. (20 points)
    c. Extent to which applicant describes adequate and appropriate 
collaboration with CDC and/or others during various phases of the 
project. (10 points)
    d. Extent to which applicant provides a detailed and adequate plan 
for evaluating study results and for evaluating progress toward 
achieving project objectives. If the proposed project involves 
notifiable conditions, the degree to which applicant describes an 
adequate process for providing necessary information to appropriate 
State and/or local health departments. (10 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.
    5. Human Subjects (not scored): If the proposed project involves 
human subjects, whether or not exempt from the DHHS regulations, the 
extent to which adequate procedures are described for the protection of 
human subjects. Note: Objective Review Group (ORG) recommendations on 
the adequacy of protections include: (1) Protections appear adequate 
and there are no comments to make or concerns to raise, or (2) 
protections appear adequate, but there are comments regarding the 
protocol, or (3) protections appear inadequate and the ORG has concerns 
related to human subjects, or (4) disapproval of the application is 
recommended because the research risks are sufficiently serious and 
protection against the risks are inadequate as to make the entire 
application unacceptable.

Executive Order 12372 Review

    This program is not subject to Executive Order 12372 Review, 
Intergovernmental Review of Federal Programs.

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 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.

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 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, dated Friday, September 15, 1995.

Application Submission and Deadline

    The original and two copies of each application PHS Form 5161-1 
(Revised 7/92, OMB Control Number 0937-0189) must be submitted 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 314, Mailstop E-
18, Atlanta, GA 30305, on or before August 6, 1996.
    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 in the current competition and will 
be returned to the applicant.

Where To Obtain Additional Information

    A complete program description and information on application 
procedures are contained in the application package. An application 
package and business management and technical assistance may be 
obtained from Marsha Driggans, Grants Management Specialist, Grants 
Management Branch, Procurement and Grants Office, Centers for Disease 
Control and Prevention (CDC), 255 East Paces Ferry Road, NE., Mailstop 
E-18, Room 300, Atlanta, GA 30305, telephone (404) 842-6523, E-mail 
address [email protected], facsimile (404) 842-6513.
    Programmatic technical assistance may be obtained from Dr. Benjamin 
Schwartz, Division of Bacterial and Mycotic Diseases, National Center 
for Infectious Diseases, Centers for Disease Control and Prevention 
(CDC), 1600 Clifton Road, NE., Mailstop C-09, Atlanta, GA 30333, 
telephone (404) 639-4747, E-mail address [email protected].
    Important Notice: Atlanta, GA, will be the host of the 1996 Summer 
Olympics Games, July 19 through August 4, 1996. As a result of this 
event, it is likely that the Procurement and Grants Office (PGO), CDC, 
may experience delays in the receipt of both regular and overnight mail 
deliveries. Contacting PGO employees during this time frame may also be 
hindered due to the possible telephone disruptions. To the extent 
authorized, please consider the use of voice mail, E-mail, and 
facsimile transmission to the maximum extent practicable. However, do 
not fax lengthy documents or grant applications.
    You may obtain this announcement from one of two Internet sites on 
the actual publication date: CDC's homepage at http://www.cdc.gov or at 
the Government Printing Office homepage (including free on-line access 
to the Federal Register at http://www.access.gpo.gov).

[[Page 33523]]

    Please refer to Announcement Number 662 when requesting information 
regarding this program.
    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: June 21, 1996.
Joseph R. Carter,
Acting Associate Director for Management and Operations, Centers for 
Disease Control and Prevention (CDC).
[FR Doc. 96-16388 Filed 6-26-96; 8:45 am]
BILLING CODE 4163-18-P