[Federal Register Volume 62, Number 139 (Monday, July 21, 1997)]
[Notices]
[Pages 38996-39000]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-19060]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention
[Announcement 786]


Cooperative Agreements To Refine a National Surveillance System 
for Hospital Health Care Workers

Introduction

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 1997 funds for cooperative agreements 
to refine a surveillance system for health care workers (HCWs) in 
hospital settings that will lead to the prevention of occupational 
transmission of bloodborne infections, vaccine-

[[Page 38997]]

 preventable diseases, tuberculosis (TB), and other occupational 
hazards.
    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, 304, 306, 308(d), 
and 317(k)(2) of the Public Health Service Act, as amended [42 U.S.C. 
241, 242b, 242k, 242m(d) and 247b(k)(2)]. Applicable program 
regulations are found in 42 CFR 51b and 52, Project Grants for 
Preventive Health Services and Research Projects.

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

    Eligible applicants include only U.S. public and non-profit private 
hospitals. Applicants must have an established surveillance system or 
program for occupational exposures to HCWs which includes a written 
protocol, plan, or policy including data collection forms. Eligibility 
requirements must be clearly specified under background information in 
Application Content.
    Competition is limited to hospitals as defined above because the 
purpose of this program is to refine a surveillance system for HCWs in 
hospital settings.
    Identifiable information provided to CDC through this agreement 
will be maintained in accordance with the assurance of confidentiality 
provided to hospitals participating in the National Surveillance System 
for Hospital HCWs (NaSH) System under Section 308(d) of the Public 
Health Service Act [42 U.S.C. 242m(d)].

Availability of Funds

    Approximately $350,000 is available in FY 1997 to fund 
approximately 8 awards. It is expected that the average award will be 
$45,000, ranging from $30,000 to $60,000. It is expected that the 
awards will begin on or about September 30, 1997, and will be made for 
a 12-month budget period within a one-year project period. Funding 
estimates may vary and are subject to change.

    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.

Use of Funds

    Cooperative agreement funds will not be used for the delivery of 
clinical/therapeutic services.

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), Public 
Law 104-208 (September 30, 1996), provides as follows:

    Section 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

    In recent years, occupational hazards faced by HCWs in the United 
States have received increasing attention. Existing surveillance 
systems are often inadequate to describe the scope and magnitude of 
occupational exposures to infectious agents and other occupational 
hazards that HCWs experience, the outcomes of these exposures, and the 
impact of preventive measures. Hospital groups and experts in 
infectious disease have requested guidance and assistance from CDC to 
develop a system for hospital data management, so that hospitals may 
develop prevention strategies, identify emerging problems, and in 
general create a safe and healthy working environment for patients and 
HCWs, in accordance with Occupational Safety and Health Administration 
(OSHA) requirements and CDC Guidelines for the Prevention and 
Management of Occupational Exposures to Tuberculosis, Bloodborne 
Pathogens and Vaccine-preventable Diseases (MMWR 1994, Vol. 43 No. RR-
13; MMWR 1990, Vol 39 No. RR-1; MMWR 1991, Vol 40 No. RR-12). Many 
hospitals around the United States have requested technical assistance 
from CDC to improve current surveillance systems for a variety of 
occupationally acquired infections and other work-related hazardous 
conditions and exposures.
    CDC has developed a surveillance system that focuses on 
surveillance of exposures and infections among hospital-based HCWs. 
This system, modeled after the National Nosocomial Infections 
Surveillance (NNIS) system for patient infections, includes 
standardized methodology and software for various occupational health 
issues. The system is called the National Surveillance System for 
Hospital HCWs, or (NaSH). The Hospital Infections Program (National 
Center for Infectious Diseases (NCID)) has developed this system in 
collaboration with the Hepatitis Branch (Division of Viral and 
Rickettsial Diseases, NCID), the Division of Tuberculosis Elimination 
(National Center for HIV, STD, and TB Prevention), the National 
Immunization Program, and the National Institute for Occupational 
Safety and Health (NIOSH). Currently, the NaSH system consists of the 
following surveillance modules: HCW Baseline Assessment; Routine 
Tuberculin Skin Testing; Exposures to Blood/Body Fluids and Blood borne 
Pathogens; Exposures to and Infections with Vaccine-Preventable 
Diseases; Exposures to Infectious

[[Page 38998]]

Tuberculosis Patients/HCWs; Non-infectious Injuries; and Annual HCW 
Survey.
    The ultimate goal and primary benefit of this cooperative agreement 
program is to improve hospital surveillance methods for management of 
occupational health information and the prevention of exposures at 
participating hospitals. Hospitals will receive technical assistance in 
order to better comply with current OSHA and CDC Guidelines for 
Occupational Exposures to Tuberculosis, Bloodborne Pathogens and 
Vaccine-Preventable Diseases. Technical assistance will also be 
provided in the development of a standardized system of data management 
for the Employee Health data for their HCWs. Information provided by 
the participating hospitals about their needs will allow CDC to refine 
the NaSH system, including data collection forms and software, in order 
to make the NaSH system more suitable for each collaborating hospital.

Purpose

    The purpose of this cooperative agreement is to assist hospitals to 
improve their current methods of assessing rates and reducing 
transmission of occupationally-acquired infections and other 
occupationally-related adverse medical outcomes in their facilities. 
With a comprehensive, organized surveillance system, hospitals will be 
able to systematically monitor trends in exposures, assess the risk for 
occupational infection and injury, and evaluate preventive measures 
including engineering controls work practices, protective equipment, 
and postexposure prophylaxis to prevent occupationally-acquired 
infections.

Program Requirements

    In conducting activities to achieve the purpose of this cooperative 
agreement, the recipient will be responsible for the activities under 
A. below, and CDC will be responsible for conducting activities under 
B. below.
A. Recipient Activities
    1. Improve its surveillance system for occupational exposures and 
infections in order to have a comprehensive and integrated surveillance 
system that includes: (a) Immunizing HCWs; (b) periodic tuberculin skin 
testing; (c) reporting, follow-up, and management of occupational 
blood/body fluid and bloodborne exposures; (d) reporting, management, 
and follow-up of exposures to, and infections with, measles, mumps, 
rubella, influenza, varicella, and TB; (e) reporting, management, and 
follow-up of non-infectious occupational injuries (e.g., sprains, back 
injuries).
    2. Assess the level of needlestick reporting and distribute the 
``Health Care Worker Survey Form'' for HCWs in occupational groups with 
higher risk of needlesticks.
    3. Attend a single planning/training meeting in Atlanta.
    Optional Recipient Activity:
    4. Recipients may elect to collect and send blood specimens from 
source patients and HCWs involved in exposures to hepatitis C virus 
(HCV) to CDC for PCR testing for HCV RNA.
B. CDC Activities
    1. Modify the NaSH surveillance system as requested by the 
recipients to maximize its usefulness to collaborating hospitals.
    2. Provide technical assistance in the conduct of the surveillance 
program.
    3. Provide technical assistance in the improvement of on-site 
hospital data management systems, such as developing data fields 
customized to the institution, etc.
    4. Provide training regarding the use and adaptation of NaSH 
software to personnel involved in data management at the participating 
hospitals.
    5. Assist in the coordination of data analysis, dissemination, and 
presentation of aggregated data.
    6. CDC will perform:--For those hospitals that elect to send 
specimens to CDC for additional HCV testing and after appropriate 
informed consents are obtained--(a) supplemental testing and PCR 
testing for HCV RNA of source-patients who are anti-HCV positive and 
(b) PCR testing for HCV RNA at 3 and 6 month follow-up of HCWs exposed 
to these source patients. PCR testing for HCV is currently not 
available for commercial use in hospitals.

Technical Reporting Requirements

    An original and two copies of progress reports must be submitted to 
CDC, semiannually. Progress reports are due no later than 30 days after 
each reporting period. The semiannual progress reports should include 
annual data (e.g., inpatient days, FTEs for some occupational groups) 
to calculate rates for the events for which surveillance is conducted 
in this system. Progress reports should also address progress toward 
overall objectives as represented in the Purpose and Recipient 
Activities sections of this announcement.
    A final performance report and financial status report are due no 
later than 90 days after the end of the project period. Please send all 
reports or other correspondence 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., Mailstop E-18, Room 314, Atlanta, Georgia 30305.

Application Content

Narrative
    All applicants must develop their applications in accordance with 
the Public Health Service (PHS) Form 5161-1, information contained in 
this program announcement, and the instructions outlined below. Also, 
the narrative must be limited to 10 pages excluding appendices and 
should include the following:
    1. Background information about the facility including: Eligibility 
requirements (documentation about surveillance system or program for 
occupational exposures to HCWs which includes a written protocol, plan, 
or policy). Provide the names and job titles for all personnel in the 
Employee Health and Infection Control Departments of the medical 
center. Applicant should provide information about: (1) The patient 
population (i.e., annual number of outpatient visits, inpatient 
admissions, patients with HIV/AIDS, and patients with TB); (2) the HCW 
population (i.e., total number of HCWs, number of nurses, physicians, 
and housekeepers); and (3) the occupational exposures in previous year 
(i.e., number of exposure-events and HCWs exposed to measles, varicella 
and TB; total number of percutaneous injuries and number of 
percutaneous injuries involving source patients infected with HIV and 
with HCV.)
    2. Information about how the project is to be organized, staffed, 
and managed. This information should demonstrate an understanding of 
important events or tasks and their management. Include the names and 
proposed duties of professional personnel assigned to the project and 
resumes with information on education, background, recent experience, 
and specific scientific or technical accomplishments. The approximate 
percentage of time each individual will be available for this project 
must be stated. The proposed staff hours for each individual should be 
allocated against each project task or subtask.
    3. Information about the facilities and computer equipment to be 
used in the performance of the cooperative agreement.
    4. The objectives of the proposed project which are consistent with 
the purposes of the cooperative agreement and which are measurable and 
time-phased.

[[Page 38999]]

    5. The methods which will be used to accomplish the objectives of 
the cooperative agreement. Describe activities and methods and 
supporting resources already in place and/or planned, including 
capacity and experience to coordinate data collection and analysis.
    6. An evaluation plan to monitor progress toward the achievement of 
the proposed objectives.
    7. Letters of support to demonstrate appropriate collaboration with 
other departments, divisions, etc., in the hospital, if applicable, 
(e.g., administrative officers, employee health, infectious diseases, 
and department chair).
    8. A budget which is reasonable and consistent with the purpose and 
objectives of the cooperative agreement. All budget items should be 
itemized and items individually justified.
    The application should be presented in a manner which demonstrates 
the applicant's ability to address the proposed activities in a 
collaborative manner with CDC.
Format
    Pages must be clearly numbered, and a complete index to the 
application and its appendices must be included. Please begin each 
separate section on a new page. The original and each copy of the 
application set must be submitted unstapled and unbound. All material 
must be typewritten, single-spaced, with unreduced type on 8\1/2\'' by 
11'' paper, with at least 1'' margins, headings and footers, and 
printed on one side only.

Evaluation Criteria

    Applications will be reviewed and evaluated based on the following 
criteria: (Total 100 points)
    1. The applicant's understanding of the purpose of the proposed 
program objectives and the willingness to cooperate with CDC. (20 
points)
    2. The extent to which the applicant demonstrates understanding of 
the need for systematic and integrated surveillance, and for utilizing 
data to assist in prevention of occupational transmission of bloodborne 
infections, vaccine-preventable diseases, TB, and other occupational 
hazards. (15 points)
    3. The extent that the applicant has the organizational structure, 
administrative support, and ability to access appropriately defined 
target populations. (10 points)
    4. A statement of the applicant's demonstrated capabilities and 
experience in conducting surveillance of occupational exposures and 
infections. (15 points)
    5. The adequacy of the plans to coordinate and conduct the project 
objectives described under recipient activities and supporting evidence 
that applicant can successfully perform these activities. (25 points)
    6. The degree to which the proposed objectives are consistent with 
the defined purpose of this program, specific, measurable, and time-
phased. The degree to which the applicant has met the CDC policy 
requirements regarding the inclusion of women, ethnic, and racial 
groups in proposed research. This includes: (a) The proposed plan for 
the inclusion of both sexes and racial and ethnic minority populations 
for appropriate representation; (b) the proposed justification when 
representation is limited or absent; (c) a statement as to whether the 
design of the study is adequate to measure differences when warranted; 
and (d) documentation of plans for recruitment and outreach for study 
participants that includes the process of establishing partnerships 
with community(ies) and recognition of mutual benefits. (15 points)
    7. Human Subjects: 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. 
Recommendations on the adequacy of protections include: (a) Protections 
appear adequate and there are no comments to make or concerns to raise, 
(b) protections appear adequate, but there are comments regarding the 
protocol, (c) protections appear inadequate and the ORG has concerns 
related to human subjects, (d) 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. (not scored)
    8. The extent to which the budget is reasonable, clearly 
justifiable, and consistent with the intended use of cooperative 
agreement funds. (not scored)

Executive Order Review 12372 Review

    Applicants are subject to Intergovernmental Review of Federal 
Programs as governed by Executive Order 12372. E.O. 12372 sets up a 
system for State and local review of proposed Federal assistance 
applications. Applicants should contact their State Single Point of 
Contact (SPOC) as early as possible to alert them to the prospective 
applications and receive any necessary instructions in the State 
process. For proposed projects serving more than one State, the 
applicant is advised to contact the SPOC of each affected State. A 
current list of SPOCs is included in the application kit. If SPOCs have 
any state process recommendations on applications to CDC, they should 
forward them 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 300, 
Mailstop E-18, Atlanta, Georgia 30305, no later than 30 days after the 
application deadline date. The granting agency does not guarantee to 
``accommodate or explain'' for State process recommendations it 
receives after that date.

Public Health System Reporting Requirement

    This program is subject to the Public Health System Reporting 
Requirements. Under these requirements, all community-based 
nongovernmental applicants must prepare and submit the items identified 
below to the head of the appropriate State or local health agency(s) in 
the program area(s) that may be impacted by the proposed project no 
later than the receipt date of the Federal application. The appropriate 
State or local health agency is determined by the applicant. The 
following information must be provided:
    A. A copy of the face page of the application (SF 424).
    B. A summary of the project that should be titled ``Public Health 
System Impact Statement'' (PHSIS), not to exceed one page, and should 
include the following:
    1. A description of the population to be served.
    2. A summary of the services to be provided.
    3. A description of the coordination plans with the appropriate 
State or local health agencies.
If the State and/or local health official desires a copy of the entire 
application, it may be obtained from the State Single Point of Contact 
(SPOC) or directly from the applicant.

Catalog of Federal Domestic Assistance Number

    The Catalog of Federal Domestic Assistance number is 93.283.

Other Requirements

Paperwork Reduction Act
    Approval for data collection initiated under this cooperative 
agreement is going through the Office of Management and Budget (OMB) 
reports clearing process.

[[Page 39000]]

Human Subjects
    If the proposed project involves research on human subjects, the 
applicant must comply with the DHHS 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 the application PHS Form 5161-1 
(revised 5/96, OMB 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, 
Georgia 30305, on or before August 22, 1997.
    1. Deadline: Applications shall be considered to meet 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 independent review group. (Applicants must request a legibly 
dated U.S. Postal Service postmark or obtain a legibly dated receipt 
from a commercial carrier or the U.S. Postal Service. Private metered 
postmarks will NOT be acceptable 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 (404) 332-4561.
    You will be asked to leave your name, address, and telephone number 
and will need to refer to Announcement Number 786. You will receive a 
complete program description, information on application procedures, 
and application forms.
    If you have questions after reviewing the contents of all 
documents, business management technical assistance may be obtained 
from Locke Thompson, 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 
314, Atlanta, Georgia 30305, telephone (404) 842-6595, or through the 
Internet or CDC WONDER electronic mail at: [email protected]. Programmatic 
technical assistance may be obtained from Scott Campbell, R.N., MSPH, 
or Denise Cardo, M.D., HIV Infections Branch, Hospital Infections 
Program, National Center for Infectious Diseases, Centers for Disease 
Control and Prevention (CDC), Mailstop E-68, Atlanta, Georgia 30333, 
telephone (404) 639-6425, or through the Internet or CDC WONDER 
electronic mail at: [email protected].
    You may obtain this and other CDC announcements 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).
    Please refer to Program Announcement Number 786 when requesting 
information and submitting an application on the Request for 
Assistance.
    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 15, 1997.
Joseph R. Carter,
Acting Associate Director for Management and Operations, Centers for 
Disease Control and Prevention (CDC).
[FR Doc. 97-19060 Filed 7-18-97; 8:45 am]
BILLING CODE 4163-18-P