[Federal Register Volume 60, Number 111 (Friday, June 9, 1995)]
[Notices]
[Pages 30572-30575]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-14165]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Announcement 560]


National Institute for Occupational Safety and Health; 
Implementation of Strategies for the Prevention of Occupational 
Transmission of Blood-Borne Pathogens

Introduction

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 1995 funds for a cooperative agreement 
program for implementation and evaluation of strategies, including 
compliance with infection control recommendations, to prevent 
occupational transmission of blood-borne pathogens, including the human 
immunodeficiency virus (HIV) and related infections (e.g., 
Mycobacterium tuberculosis).
    The Public Health Service (PHS) is committed to achieving the 
health promotion and disease prevention objectives of Healthy People 
2000, a PHS-led national activity to reduce morbidity and mortality and 
improve the quality of life. This announcement is related to the 
priority area of Occupational Safety and Health. (For ordering a copy 
of Healthy People 2000 see the section Where to Obtain Additional 
Information.)

Authority

    The legislative authority for this program is contained in Sections 
20(a)(1) and 22(e)(7) of the Occupational Safety and Health Act (29 
U.S.C. Sections 669(a)(1)and 671(e)(7)).

Smoke-Free Workplace

    The PHS strongly encourages all recipients to provide a smoke-free 
workplace and promote the non-use 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, non-profit and 
for-profit organizations and governments and their agencies. Thus, 
universities, colleges, research institutions, hospitals, health-care 
institutions, other public and private organizations, State and local 
governments or their bona fide agents, federally recognized Indian 
tribes or Indian tribal organizations, and small, minority- and/or 
women-owned businesses are eligible to apply. [[Page 30573]] 

Availability of Funds

    Approximately $1,300,000 is available in FY 1995 to fund 
approximately 4 to 6 awards. It is expected that the average award will 
be $271,000, ranging from $216,000 to $325,000. It is expected that the 
awards will begin on or about September 30, 1995, and will be made for 
a 12-month budget period within a project period of up to 3 years. (At 
least one behavioral science project will be included.) Funding 
estimates may vary and are subject to change.
    Continuation awards within the project period will be made on the 
basis of satisfactory progress and the availability of funds.

Purpose

    The purpose of this cooperative agreement program is to utilize the 
special resources of the extramural community to assist in the 
implementation and evaluation of strategies for the prevention of 
occupational transmission of blood-borne and related pathogens among 
certain workers.
    The control technology component will evaluate the effectiveness of 
engineering control or personal protective equipment in preventing 
occupational exposure to blood. Evaluation parameters include efficacy 
of exposure prevention, prevention effectiveness including cost 
analysis, and impact on patient care. A discussion of methodologies for 
conducting prevention effectiveness is presented in A Framework for 
Assessing the Effectiveness of Disease and Injury Prevention (CDC, 
Morbidity and Mortality Weekly Report, March 27, 1992, Volume 41, 
Number RR-3, pages 5-11). (For ordering a copy of A Framework for 
Assessing the Effectiveness of Disease and Injury Prevention, see the 
Section Where to Obtain Additional Information.)
    The behavioral evaluation component of this cooperative agreement 
will assess the efficacy of one or more specific intervention(s) to 
affect organizational, social and/or individual health-care workers' 
behavior(s) to improve compliance with CDC recommendations and to 
generate data upon which to base recommendations for practical methods 
of increasing worker compliance.

Program Requirements

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

A. Recipient Activities

    From among the following activities, applicants should address the 
general activities and those areas that are within the interests and 
strengths of their organizations:
1. General
    a. Develop communication models for informing management and labor 
of the nature of the work hazards and for modifying attitudes and 
behavior.
    b. Publish results of research in appropriate scientific 
literature.
2. Blood-Borne Pathogen Control Technology
    a. Develop a plan to evaluate the efficacy and effectiveness of 
specific types of control technologies including devices/personal 
protective equipment for prevention of blood exposures in a health-care 
workplace. This plan should include: (1) collection and analysis of 
data on needlestick/sharps injuries; (2) identification of new 
technologies to reduce needlestick/sharps injuries; (3) analysis of the 
impact of implementation of new technologies on the incidence, 
epidemiology and cost of needlestick injuries/blood exposures; and (4) 
determination of the relationships between exposures and devices/
equipment. The plan may also include: (1) development of device/
personal protective equipment selection and evaluation criteria; (2) 
evaluation of the decision analysis process for purchasing anti-
needlestick devices and evaluation of cost-effectiveness; (3) 
collection and analysis of data regarding positive and negative aspects 
of user acceptance for devices; (4) evaluation of impact of placement/
and use of devices/equipment such as in patient rooms and emergency 
vehicles; and (5) impact of user/worker involvement (e.g., focus 
groups) in the selection and evaluation of devices. The plan should 
include a detailed evaluation methodology.
    b. Develop and maintain a data management system for the study.
3. Behavioral
    a. Develop, implement, and evaluate a plan that assesses one or 
more specific interventions to improve workers' compliance with 
specific infection control (IC) recommendations (e.g., hand washing, 
use of personal protective equipment, appropriate sharps disposal).
    b. Develop a plan to evaluate one or more specific interventions 
by: (1) implementing the intervention(s) in a health-care work place; 
(2) quantifying its impact on an appropriate measurable outcome related 
to compliance with IC recommendations; and (3) using the data to 
propose practical recommendations to increase workers' compliance with 
IC recommendations. The plan should include a detailed description of 
the evaluation methodology, including describing potential confounders/
bias that might affect the data and addressing methods to account for 
these confounders/bias.
    c. Develop and maintain a data management system for the study.

B. CDC Activities

    1. Provide consultation and technical assistance in the conduct of 
the intervention evaluation, including input in the development of 
intervention design and review of raw and summary data.
    2. Provide assistance on analysis, dissemination, presentation and 
publication of the data.
    3. Provide scientific information related to the proposed research 
topics.
    4. Meet periodically with recipient(s) to discuss progress, 
exchange information, and seek means of resolving problems which have 
arisen.
    5. Assist in predicting hazards that may be associated with new 
technologies and new occupations and characterize changes that are 
occurring in health care settings and occupational safety and health.
    6. Assist in determining the efficacy and effectiveness of 
intervention and in measuring the impact of prevention.

Evaluation Criteria

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

1. Understanding of Purpose and Objectives (15%)

    Responsiveness to the objective of the cooperative agreement 
including: (a) applicants understanding of the objective of the 
proposed cooperative agreement, (b) relevance of the proposal to the 
objective, and (c) willingness to cooperate with CDC in the design, 
implementation and analysis of the project. The extent to which the 
applicant demonstrates knowledge and understanding of health-care 
settings and interventions described in this cooperative agreement.
    In addition, applications targeting the behavioral component should 
specifically address: The extent to which the applicant demonstrates 
knowledge and understanding of health care settings and work behaviors/
practices which influence compliance with infection control 
recommendations and need to develop specific practical interventions 
that will influence [[Page 30574]] workers compliance with recommended 
infection control practices.

2. Study Design (40%)

    Steps proposed in planning, implementing, and evaluating a project. 
The quality of the plans to coordinate and conduct the project, 
including a description of techniques for data collection, management, 
and analysis and a schedule for accomplishing the program activities, 
including time frames. The quality and feasibility of the proposed 
program activities for achieving the objectives, including the 
applicant's ability to conduct control technology or behavioral 
intervention studies with sufficient numbers to draw meaningful 
conclusions in a reasonable time period. The extent to which the 
intervention is specific and practical to implement in a hospital or 
other appropriate clinical setting.
    If the outcome variable could be affected by confounding variables 
or biases, the extent to which the proposal addressed these confounding 
variables or biases to ensure that they do not call into question the 
results of the intervention assessment. Extent to which the outcome 
variable(s) chosen represents potentially important risks for large 
numbers of HCWs and/or patients in U.S. hospitals.
    In addition, applications targeting the behavioral component should 
specifically address: The extent to which the appropriate methodology 
is proposed so that the targeted compliance behavior(s) (outcome 
variable) measured is reliably quantifiable.
    The extent to which the proposed evaluation system will document 
program process, efficacy, effectiveness, impact, and outcome, and, if 
applicable, measure surveillance system sensitivity, timeliness, 
representativeness, predictive values, and ability to detect the impact 
of specific intervention on morbidity, mortality, severity, disability, 
and cost of related diseases, injuries and prevention interventions. 
The extent to which a feasible plan for reporting evaluation results 
and using evaluation information for programmatic decisions is 
included.

3. Program Personnel (25%)

    Qualifications and time allocation of the professional staff to be 
assigned to a project and applicant's ability to provide the 
knowledgeable staff required to perform the applicant's 
responsibilities in this project, and to describe the approach to be 
used in carrying out those responsibilities. How the study will be 
administered, including the size, qualifications, duties, 
responsibilities, and time allocation, of the proposed staff. A 
statement of the applicant's demonstrated capabilities and experience 
in conducting such a project.

4. Facilities and Resources (20%)

    The adequacy of the applicants facilities, equipment, and other 
resources available for performance of a project.

5. Budget and Justification (Not Scored)

    The budget will be evaluated to the extent that it is reasonable, 
clearly justified, and consistent with the intended use of the funds.
Executive Order 12372 Review

    This program is not subject to review by Executive Order 12372.

Public Health System Reporting Requirements

    This program is not subject to the Public Health System reporting 
Requirements.

Catalog of Federal Domestic Assistance

    The Catalog of Federal Domestic Assistance number is 93.262.

Other Requirements

Paperwork Reduction Act

    Projects that involve the collection of information from 10 or more 
individuals and funded by this 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 
applicants 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 assurance in accordance with the appropriate guidelines and 
forms provided in the application kit.
    In addition to other applicable committees, Indian Health Service 
(IHS) institutional review committees also must review the project if 
any component of IHS will be involved or will support the research. If 
any American Indian community is involved, its tribal government must 
also approve that portion of the project applicable to it.

Application Submission and Deadline

    The original and two copies of the application PHS form 5161-1 
(revised 7/92, OMB Number 0937-0189) must be submitted to Henry S. 
Cassell, III, 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-13, 
Atlanta, GA 30305 on or before July 17, 1995.
    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 mailings.)
    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 Information

    To receive additional written information call (404) 332-4561. You 
will be asked to leave your name, address, telephone number and will 
need to refer to Announcement 560. You will receive a complete program 
description, information on application procedures, and application 
forms.
    If you have questions after reviewing the contents of all the 
documents, business management technical assistance may be obtained 
from David Elswick, Grants Management Specialist, Grants Management 
Branch, Procurement and Grants Office, Centers for Disease Control and 
Prevention (CDC), 255 East Paces Ferry Road, NE., Room 300, Mailstop E-
13, Atlanta, GA 30305, telephone (404) 842-6521. Programmatic technical 
assistance may be obtained from Linda S. Martin, Ph.D., National 
Institute for Occupational Safety and Health, HIV Activity, Centers for 
Disease Control and Prevention (CDC), 1600 Clifton Road, Mailstop F-40, 
Atlanta, GA 30333, telephone (404) 639-2377.
    Please refer to Announcement Number 560, when requesting 
information and submitting an application.
    Copies of A Framework for Assessing the Effectiveness of Disease 
and Injury [[Page 30575]] Prevention (CDC, Morbidity and Mortality 
Weekly Report, March 27, 1992, Volume 41, Number RR-3, pages 5-11) may 
be obtained by calling (404) 488-4334.
    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 5, 1995.
Diane D. Porter,
Acting Director, National Institute for Occupational Safety and Health, 
Centers for Disease Control and Prevention (CDC).
[FR Doc. 95-14165 Filed 6-8-95; 8:45 am]
BILLING CODE 4163-19-P