# Research and Demonstration Programs in Surveillance, Prevention, and Control of Healthcare-Associated Infections and Antimicrobial Resistant Infections

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URL: https://www.frixlaw.com/law-library/documents/fr%3A97-17700

## Record

- **Collection:** Federal Register
- **Document type:** Notice
- **Published:** July 8, 1997
- **Citation:** 62 FR 36541

## Text

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention
[Announcement Number 789]

Research and Demonstration Programs in Surveillance, Prevention,
and Control of Healthcare-Associated Infections and Antimicrobial
Resistant Infections

Introduction

The Centers for Disease Control and Prevention (CDC) announces the
availability of fiscal year (FY) 1997 funds to provide assistance for
cooperative agreements to develop research and demonstration programs
in the surveillance, prevention, and control of healthcare-associated
infections and antimicrobial resistant infection.
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 Section(s) 301 [42 U.S.C. 241] and
317(k)(2) [42 U.S.C. 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
health care delivery systems and organizations. Thus, universities,
colleges, research institutions, hospitals, other public and private
non-profit organizations are eligible to apply.

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 shall not
be eligible for the receipt of Federal funds constituting an award,
grant (cooperative agreement), contract, loan, or any other form.

Availability of Funds

Approximately $700,000 will be available in Fiscal Year 1997 to
fund 2 to 3 cooperative agreements. The award is expected to begin on
or about September 29, 1997, for a 12-month budget period within a
project period of up to 3 years. The funding estimate is subject to
change. Continuation awards within the project period will be made on
the basis of satisfactory progress and the availability of funds. There
are no matching or cost participation requirements; however, the
applicant's anticipated contribution to the overall program costs, if
any, should be provided in the application.

Restrictions on Lobbying

Applicants should be aware of restrictions on the use of Department
of Health and Human Services (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 1997 Departments of Labor, HHS, and Education,
and Related Agencies Appropriations Act, which became effective October
1, 1996, expressly prohibits the use of 1997 appropriated funds for
indirect or ``grass roots'' lobbying efforts that are designed to
support or defeat legislation pending before State legislatures.
Section 503 of this new law, as enacted by the Omnibus Consolidated
Appropriations Act, 1997, Division A, Title I, Section 101(e), Pub. L.
No. 104-208 (September 30, 1996), provides as follows:
Sec. 503: (a) No part of any appropriation contained in this Act
shall be used, other than for normal and recognized executive-
legislative relationships, 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, . . . except
in presentation to the Congress or any State legislative body itself.
(b) 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

Nosocomial, or hospital-acquired, infections occur at a rate of 5
to 10 per hundred admissions in U.S. hospitals. An estimated 30,000
patients die each year as a direct result of nosocomial bloodstream
infection. Furthermore, many nosocomial infections are associated with
an extended length of stay, substantial morbidity, and prolonged
therapy. It has been estimated that nosocomial infections have a direct
cost of $5 billion to $10 billion annually in this country.

Purpose

The purpose of these cooperative agreements is to provide
assistance in establishing centers of excellence for research and
demonstration to improve the surveillance, prevention, and control of
healthcare-associated infections and antimicrobial resistant
infections. For purposes of this program announcement, centers of
excellence in the surveillance, prevention, and control of healthcare-
associated infections and antimicrobial resistant infections are
defined as those recipients who are successfully conducting the
activities delineated below. Thus, recipients will establish centers by
developing programs with three components: (1) program to conduct
research and demonstrate academic leadership in healthcare epidemiology
and infection control; (2) program to adapt and implement infection
control and healthcare epidemiology practice across the full range of
settings in an integrated health care delivery model; (3) program to
conduct training of healthcare epidemiologists and infection control
practitioners that utilizes quality

[[Page 36542]]

management and outcomes management methods and practices.
These programs may be developed sequentially or at the same time;
however, the research program must be developed during the first year
of the program and the program to adapt practice to integrated delivery
models must be developed no later than during the second year of multi-
year projects. It is not required that all three components be fully
operational at the end of the three-year project period; however, clear
progress toward completion of all three components should be
demonstrable by the end of year three of multi-year programs.
These centers are intended to conduct research in and demonstrate
the application of infection surveillance, prevention, and control
principles and methods in health care delivery systems encompassing the
fullest range of settings, including, but not limited to acute
inpatient care, long term and chronic care, ambulatory care, ambulatory
surgical care, and home health care, with an emphasis on adaptations
relevant to populations of patients whose health care is provided by
managed care organizations. They are also intended to conduct training
in healthcare epidemiology. Component programs should demonstrate
activities directed toward the three principal goals of infection
control and healthcare epidemiology: (1) protection of patients from
adverse health events; (2) protection of health care workers from
occupationally-acquired illness; and (3) research to identify risk
factors for infection and develop interventions to ameliorate those
risk factors and prevent infections in a cost-effective manner.
The specific objectives of this cooperative agreement program are:
1. To study the effectiveness of traditional hospital-based
infection control methods and practice in integrated health care
delivery systems.
2. To improve and enhance existing methods by developing and
studying innovative approaches to infection surveillance, prevention,
and control that will maximize effectiveness in integrated health care
delivery systems.
3. To develop and study innovative approaches to using new
management information systems for the surveillance of antimicrobial
resistance and monitoring of the use of antimicrobial agents.
4. To develop and study improved evaluation methodologies to assess
the effectiveness of prevention and control methods for healthcare-
associated infections and antimicrobial resistant infections.
5. To develop and study innovative approaches for training of
infection control practitioners and hospital epidemiologists that
include the techniques and practices of quality management and outcomes
management.
6. To foster collaborative relationships between the demonstration
program center and CDC.

Program Requirements

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

A. Recipient Activities

1. Program in research.
a. Recipient will assess the relationship between nurse-to-patient
ratios in intensive care units (ICUs) and the risk of bloodstream
infections (BSI) in ICU patients.
b. Recipient will study clinical performance indicator systems and
outcomes measures for infectious diseases and infection control
practice based on surveillance methods used in the National Nosocomial
Infections Surveillance (NNIS), and compare these to other types of
outcome indicators in use in hospitals and integrated delivery systems,
such as those based on data obtained from insurance claims and medical
records coding.
2. Program to adapt and implement infection control and
epidemiologic practice in integrated health care delivery systems.
Recipient will identify infection control issues in the major areas of
nosocomial infection control (antimicrobial resistant infections,
bloodstream infections, nosocomial pneumonias, and surgical site
infections) for which adaptation and modification of existing infection
control methods as practiced within an acute care general hospital may
improve patient outcome and effectiveness in the setting of a health
network or integrated delivery system.
3. Publish and disseminate research findings.
4. Program in training. Recipients will develop and demonstrate
innovative training programs for hospital epidemiologists and infection
control practitioners which respond to current and likely changes in
the organization of health care delivery.

B. CDC Activities

1. Provide technical assistance in the design and conduct of
research activities, in the design and implementation of innovative
approaches to hospital epidemiologic and infection control practice,
and in the design of educational and training strategies and the
dissemination of educational and training materials.
2. Provide assistance regarding development of study protocols,
data collection methods, and analyses as necessary.
3. Assist in the development of data management processes and
protocols.
4. Participate in the preparation of study findings for publication
and presentation.

Technical Reporting Requirements

Progress reports on project activities should be submitted within a
non-competing continuation application and in an annual report. An
original and two copies of a final performance report must be submitted
within 90 days after the end of the project period. These reports must
address progress toward overall objectives as represented in the
Purpose and Recipient Activities sections of this announcement.
Financial status reports must be submitted no later than 90 days
after the end of each budget period. A final financial status report is
required no later than 90 days after the end of the project period. All
reports are submitted to the Grants Management Branch, Procurement and
Grants Office, CDC.

Application Process

Letter of Intent

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 SUBMIT A LETTER OF
INTENTION TO APPLY TO CDC BEFORE THE APPLICATION DUE DATE. The letter
should include (1) name and address of institution and (2) name,
address, and telephone number of contact person. Notification should be
provided by facsimile or, postal mail 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, Georgia 30305;
facsimile: (404) 842-6513. Announcement Number 789 must be referenced.

Application Content

All applicants must develop their application in accordance with
the PHS Form 5161-1 (revised 5/96), information contained in this
cooperative agreement announcement, and the instructions outlined
below.

[[Page 36543]]

General Instructions:

1. All pages must be clearly numbered.
2. A complete index to the application and its appendixes must be
included.
3. The original and two copies of the application must be submitted
unstapled and unbound. No bound materials will be accepted.
4. All materials must be typewritten, single spaced, and in
unreduced type (no smaller than font size 12) on 8\1/2\'' by 11'' white
paper, with at least 1'' margins, headers, and footers.
5. All pages must be printed on one side only.

Specific Instructions:

The application narrative must not exceed 20 pages (excluding
budget and appendixes). 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:
1. Abstract: Provide a brief (two pages maximum) abstract of the
project. State the length of the project period (maximum is 3 years)
for which assistance is being requested (see ``Availability of Funds''
for additional information).
2. Background and Need: Discuss the background and need for the
proposed project. Demonstrate a clear understanding of the purpose and
objectives of this cooperative agreement program. Illustrate and
justify the need for the proposed project that is consistent with the
purpose and objectives of this cooperative agreement program.
3. Capacity and Personnel: Describe applicant's past experience in
conducting projects/studies 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. Provide in an appendix letters of support from all key
participating non-applicant organizations, individuals, etc., which
clearly indicate their commitment to participate as described in the
operational plan. Do not include letters of support from CDC personnel.
Letters of support from CDC will not be accepted in the application.
4. Objectives and Technical Approach: For each of the proposed
Recipient Activities (A.1.a., A.1.b., A.2., and A.3.,) described under
Program Activities, describe specific objectives which are measurable
and time-phased and are consistent with the purpose and goals of this
cooperative agreement. Present a detailed operational plan for
initiating and conducting the project which clearly and appropriately
addresses all Recipient Activities. (If proposing a multi-year project
for one or more of the Recipient Activities, provide a detailed
description of first-year activities and a brief overview of activities
in subsequent years. Clearly state the proposed length of the project
period for each of these activities.) Clearly identify specific
assigned responsibilities for all key professional personnel. Include a
clear description of applicant's technical approach/methods which are
directly relevant to the study objectives.
Describe specific study protocols or plans for the development of
study protocols. Describe the nature and extent of collaboration with
CDC and/or others during various phases of the project. Describe in
detail a plan for evaluating study results and for evaluating progress
toward achieving project objectives.
a. Within the research component of the program, as described in
Recipient Activities A.1., applicants should submit proposals for each
of the listed activities (A.1.a. and A.1.b.), although both activities
will not necessarily be funded at each site. The design and plan for
implementation of each of the projects should demonstrate the
recipients' implementation of the innovative approaches sought in this
announcement. Describe methods for inclusion of Women, Racial, and
Ethnic Minorities.
1. Within research activity A.1.a., assessing the relationship
between nurse-to-patient ratios in ICUs and the risk of bloodstream
infections (BSI) in ICU patients. Recipient, ideally as part of a
multi-hospital system so that data can be collected from ICUs at
several large hospitals, should conduct prospective surveillance for
BSIs using standardized methods. Prospective surveillance should be
conducted at different types (e.g., medical, surgical, pediatric,
neonatal) of ICUs. Definitions, denominators, and rate calculations at
all participating facilities will be done using standardized criteria
and methods such as those used in the NNIS system; e.g., use of central
venous catheter days as the denominator. Standardized methods will also
be used to control for severity of illness (on admission and at the
time of BSI in those with BSIs) and underlying disease. Recipients will
then also assess daily and monthly change in the nurse-to-patient ratio
and its effect on the BSI rate. Recipient should stratify by nurse
level of training and perform observational studies to assess nursing
practices and attempt to calculate periodic handwashing indices.
Monthly ICU-specific BSI rates should be calculated and correlated with
the nurse-to-patient ratio. Among the outcomes of interest will be to
determine if there is a threshold nurse to patient ratio level below
which ICU patient risk of BSI significantly increases or whether there
is a linear relationship between nurse staffing and infection risk.
2. Within research activity A.1.b., studying clinical performance
indicator systems and outcomes measures for infectious diseases and
infection control practice. The goal of this activity should be to
determine the relative utility of outcome indicators derived from more
traditional infection control surveillance methods and those derived
from indicator systems based on data collected from International
Classification of Diseases, 9th Revision,(ICD-9) codes; i.e., from
medical record coding and/or the uniform bill, for measuring quality of
care and for directing quality improvement activities. Recipients
should have access to multiple institutions, through collaboration with
national or regional health care systems or through agencies or
organizations already operating clinical performance indicator systems
at multiple institutions. The validity of performance indicators should
be evaluated using strict epidemiologic criteria to determine which
measures will best assess quality of care across five parameters:
a. Do the indicators measure true outcomes or do they measure
processes of care?
b. Can the indicators be related to processes of care in a way that
permits quality improvement methods to be applied to identify and
correct problems?
c. Does the methodology for data collection and analysis ensure
comparability of data between institutions?
d. Is the risk adjustment methodology adequate to ensure accurate
inter-hospital comparison?
e. How do the validity and comparability of infection control/
infections disease performance measures compare to other types of
performance measures (e.g., anaesthesia

[[Page 36544]]

mortality, cardiovascular complications, medication errors, etc.)?
In the second and third years of this activity, recipients should
assess the utility of performance indicators as a tool for improving
quality of care. Assessments may include correlation between outcome
measures and changes in health care practice or institutional policy
(e.g., ``plan-do-check-assess'' cycle) and/or the use of clinical
practice guidelines to modify practice.
b. Within the component to adapt and modify existing infection
control methods to the setting of a health network or integrated
delivery system (Recipient Activities A.2.), modified and enhanced
approaches to infection control and healthcare epidemiologic methods
should be rigorously evaluated and compared to existing practice. Among
these approaches may be the use of practice guidelines or critical
paths, implementation of disease management, care management, or
outcomes management models, quality management techniques, and/or other
techniques developed for this program. Comparisons should be based on
specific outcome measures and should include cost-effectiveness and/or
cost-benefit analysis. Modifications should demonstrate applicability
to the continuity of care modeled by a health network or integrated
delivery system, e.g., the concept of ``covered lives.'' Specific
activities which could demonstrate such modifications and adaptations
may include:
1. Implementation of outcome measures for infection control and
infectious diseases management as part of a clinical performance
indicator system, and demonstrated use of these outcome data in
assessing and, as necessary, altering and modifying clinical and
administrative practices.
2. Implementation of systems to monitor patient risk factors and
outcome through the continuum of care, i.e., prior to and after acute
care hospital admission, with the ultimate goal of continuous
monitoring of infection risks and health outcomes of both individual
patients and populations of patients enrolled in a managed care
organization or health network.
3. Development and implementation of programs to reduce the
incidence and prevent the spread of antimicrobial resistance within the
population served by a health network or integrated health care system,
with special emphasis on groups at highest risk, e.g., patients in
intensive care units, nursing home residents, patients with long-term
indwelling devices, and patients on chronic antimicrobial therapy.
4. Use of management information systems to enhance physician
practice, especially for antimicrobial prescribing, as by providing
``on-line'' access to patient-specific clinical, microbiologic, and
pharmacologic data that assist physicians in selecting appropriate
antimicrobial therapy.
5. Assessment of existing risk-adjustment methods and, as
necessary, development of more accurate risk-adjustment methods, for
comparing surveillance data between facilities and between providers,
including comparisons of individual providers practicing in multiple
facilities.
c. Within the component of the program to develop and demonstrate
innovative training programs which respond to changes in the
organization of health care delivery (Recipient Activities A.3.),
changes which may require this response include increased delivery of
care through managed care organizations, increased utilization of
outpatient and home health care, implementation of quality management
programs in tandem with infection control programs, implementation of
clinical practice guidelines and outcomes management, etc. These model
training programs should include core curricula, didactic approaches,
and experiential learning for infection control practitioners and
hospital epidemiologists. Recipients should incorporate recommendations
of applicable professional societies and certifying bodies such as the
Association for Practitioners in Infection Control, the Society for
Healthcare Epidemiology of America, the American Board of Internal
Medicine subspecialty board for Infectious Diseases, and the National
Association for Healthcare Quality.
5. Budget: Provide in an appendix a budget and accompanying
detailed justification for the first-year of the project that is
consistent with the purpose and objectives of this program. If
proposing a multi-year project, also provide estimated total budget for
each subsequent year. For the research component of Recipient
Activities (A.1.) provide separate budgets for each of the two research
activities (A.1.a. and A.1.b.) If requesting funds for 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).
6. Human Subjects: If the proposed project involves human subjects,
describe in an appendix adequate procedures to ensure that individuals
of both sexes and various racial and ethnic groups will be included in
this CDC cooperative agreement whenever feasible and appropriate.
Identify gaps in knowledge about health problems that affect women and
racial and minority populations and describe efforts for conduct
studies to address these problems.

Evaluation Criteria

Applications will be reviewed and evaluated based on the following
weighted 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 grant/
cooperative agreement program.

2. Capacity (25 Points Total)

a. The extent to which background information and other data
demonstrate that the applicant has the appropriate organizational
structure, administrative support, and ability to access appropriately
defined target populations or study objects, and that this access will
ensure an adequate sample size and representativeness so that
epidemiologic analysis of risk factors and evaluations of intervention
strategies will be appropriate and statistically valid. (10 points)
b. Extent to which applicant documents that professional personnel
involved in the project are qualified, by training and experience; have
demonstrated achievement in research related to that proposed, as
evidenced by curriculum vitae, publications, etc.; and have an
appropriate projected level of effort directed toward accomplishment of
the proposed objectives. (10 points)
c. Extent to which applicant demonstrates appropriate
collaborative and consortia arrangements needed to fulfill the
operational plan. Extent to which application includes letters of
support from non-applicant organizations, individuals, etc. and that
these letters clearly indicate the author's commitment to participate
as described in the operational plan. (5 points)

[[Page 36545]]

3. Objectives and Technical Approach (60 Points Total)

a. Extent to which applicant describes specific objectives of the
proposed project which are consistent with the purpose and goals of
this cooperative agreement program and which are measurable and time-
phased. (5 points)
b. Extent to which applicant presents a detailed operational plan
for initiating and conducting each of the specific research projects
clearly and appropriately addressing all aspects of Part 1 of 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 objectives. Extent to which applicant
describes specific study protocols or plans for the development of
study protocols that are appropriate for achieving project objectives.
(25 points)
c. Extent to which applicant presents a detailed operational plan
for developing innovative approaches to infection control and health
care epidemiology practice well adapted to integrated health care
delivery systems, clearly and appropriately addressing all aspects of
Part 2 of Recipient Activities. (25 points)
d. 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 inadequate
to measure differences when warranted.
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. (5 points)

4. Budget (Not Scored)

The extent to which the budget is reasonable, clearly justified,
and consistent with the intended use of cooperative agreement funds.

5. Human Subjects (Not Scored)

Whether or not exempt from the Department of Health and Human
Services (HHS) regulations, are procedures adequate for the protection
of human subjects? Recommendations on the adequacy of protections
include: (1) Protections appear adequate and there are no comments to
make or concerns to raise, (2) protections appear adequate, but there
are comments regarding the protocol, (3) protections appear inadequate
and the Objective Review Group (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 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 93.283.

Other Requirements

Paperwork Reduction Act

Projects that involve the collection of information from ten or
more individuals and funded by the 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 a clear and compelling
rationale exists 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 completed application Form PHS-
5161-1 (revised 5/96, OMB Number 0937-0189) and appendices 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, N.E., Mailstop
E-18, Room 314, Atlanta, Georgia 30305, on or before August 15, 1997.
Applications will be considered to meet the deadline if they are:
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, call telephone (404)
332-4561. You will be asked to leave your name, address, and telephone
number. Please refer to Announcement 789. 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

[[Page 36546]]

management technical assistance may be obtained from Albertha Carey,
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, Mail Stop E-18, Atlanta, Georgia
30305, telephone (404) 842-6591; electronic mail at [email protected].
Programmatic technical assistance may be obtained from Steven L.
Solomon, M.D., Hospital Infections Program, National Center for
Infectious Diseases, Centers for Disease Control and Prevention, 1600
Clifton Road, Mailstop A07, Atlanta, GA 30333, telephone (404) 639-
6476; electronic mail at [email protected].
You may obtain this and other CDC announcements from one of two
Internet sites. 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).
Please refer to Program Announcement 789 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: July 1, 1997.
Joseph R. Carter,
Acting Associate Director for Management and Operations, Centers for
Disease Control and Prevention (CDC).
[FR Doc. 97-17700 Filed 7-7-97; 8:45 am]
BILLING CODE 4163-18-P

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A97-17700. Public record. Not legal advice.