[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]
=======================================================================
-----------------------------------------------------------------------
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: lxt1@cdc.gov. 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: sic3@cdc.gov.
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
