[Federal Register Volume 62, Number 130 (Tuesday, July 8, 1997)]
[Notices]
[Pages 36541-36546]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-17700]


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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