[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
[[Page 33521]]
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