Release Date:  February 28, 2000

RFA:  OH-00-004

National Institute for Occupational Safety and Health (NIOSH) 
Centers for Disease Control and Prevention

Letter of Intent Receipt Date:  March 28, 2000
Application Receipt Date:       April 27, 2000


The National Institute for Occupational Safety and Health (NIOSH), 
Centers for Disease Control and Prevention (CDC), invites 
cooperative agreement applications for studies that will 
contribute to the understanding of the risks of exposure to blood 
borne pathogens among health care workers in non-hospital 
settings.  Such information will contribute significantly to an 
understanding not only the risk for such injuries but the 
development of effective intervention strategies. Because little 
is known about the incidence of this injury in these workers, this 
RFA has an emphasis on research that examines the incidence of 
exposures to blood, risk factors associated with such exposures, 
and the availability and use of medical safety devices. 

A special feature of this RFA is encouraging applications from 
researchers and from membership organizations comprised of health 
care workers, such as unions and professional organizations, and 
collaboration among these groups.


CDC is committed to achieving the health promotion and disease 
prevention objectives of “Healthy People 2010,” a national 
activity to reduce morbidity and mortality and improve the quality 
of life.  This announcement is related to the focus area of 
occupational safety and health.  For information on the conference 
on “Healthy People 2010,” visit the internet site:


Applications may be submitted by public and private nonprofit and 
for-profit organizations and by governments and their agencies; 
that is, universities, colleges, research institutions, hospitals, 
other public and private nonprofit and for-profit organizations, 
State and local governments or their bona fide agents, including 
small, minority and/or women-owned businesses.  Applications from 
minority and women investigators are encouraged.


The administrative and funding instrument to be used for this 
program will be a cooperative agreement (U01), an "assistance" 
mechanism (rather than an "acquisition" mechanism), in which 
substantial NIOSH scientific and/or programmatic involvement with 
the awardee is anticipated during performance of the activity.  
The awardee will be responsible for the planning, direction, and 
execution of the proposed project and interrelated activities.  
The NIOSH purpose is to support and/or stimulate the recipient's 
activity by involvement in and otherwise working jointly with the 
award recipient, but it is not to assume direction, prime 
responsibility, or a dominant role in the activity.  Details of 
the responsibilities, relationships and governance of the study to 
be funded under cooperative agreement(s) are discussed later in 
this document under the section "Terms and Conditions of Award."

The total project period for an application submitted in response 
to this present RFA may not exceed 3 years.  The anticipated award 
date is September 1, 2000.  The award and level of support depends 
on receipt of applications of high scientific merit.  Although 
this program is provided for in the financial plans of NIOSH, the 
award pursuant to this RFA is contingent upon the availability of 
funds for this purpose. 


Approximately $325,000 is available in FY 2000 to fund one award. 
The maximum amount that maybe requested is $325,000 total cost 
(direct and facilities and administrative (F&A) costs) per year. 

Continuation award within an approved project period will be made 
on the basis of satisfactory progress as evidenced by required 
reports and the availability of funds.


Recipient should allocate funds for travel for two project staff 
to attend an semi-annual one to two day meeting in Cincinnati, 
Ohio for each year of the project.   


Applicants are invited by NIOSH to attend a pre-application 
technical assistance conference on Tuesday, March 14, 2000 at 1:00 
PM (Eastern time) to discuss:  programmatic issues, potential 
research partners, how to apply; and other questions regarding the 
content of the RFA.  This conference is expected to last 
approximately two hours.  The conference will be held at the NIOSH 
Alice Hamilton Laboratory located at 5555 Ridge Avenue, 
Cincinnati, Ohio, 45213.  Applicants may also participate by 
telephone.  The conference name is “NIOSH Needle Stick Injuries.” 
 The telephone bridge number is (800) 311-3437.  Participants will 
need the conference code, 408178, to be connected.



There are nearly seven million health care workers employed in the 
United States; approximately half work in non-hospital settings.  
Health care workers are at risk of infection from blood borne 
pathogens, particularly human immunodeficiency virus (HIV), 
hepatitis B virus, and hepatitis C virus.  As of June 1999, the 
CDC was aware of 55 health care workers in the U.S. who had been 
documented as having sero-converted to HIV following occupational 
exposures.  Approximately 83% of exposures to blood reported by 
hospital-based health care workers are by percutaneous injury 
(i.e., needlestick and sharps injuries).  Mucous membrane exposure 
accounts for about 13%, skin 3%, and bite 1%.  Precise national 
data are not available on the annual number of needlesticks and 
other percutaneous injuries among health care workers since it has 
been estimated that about half of these injuries go unreported. 
Virtually all of the information on the occurrence of needlestick 
and sharps injuries is based on hospital workers.  However it has 
been estimated that 600,000 to 800,000 such injuries occur 
annually.  In addition to the serious health consequences of this 
injury, the emotional impact of a needlestick injury can be severe 
and long lasting, even when a serious infection is not 

In order to address this public health problem in the context of 
occupational injuries, past studies have shown that certain 
information about blood exposures need to be considered in a 
survey design, including relevant demographic information about 
survey respondents, general information about past exposures to 
blood, and details about the circumstances of recent exposures.  
For recent exposures to blood, a least eight critical areas of 
information have been shown to be important.  These include: 1) 
route of exposure, 2) activity during and timing of exposure, 3) 
specific medical device being used, 4) relevant characteristics of 
the source patient, 5) reasons why the exposure either was or was 
not reported, 6) suggestions on how to improve reporting of 
injuries, 7) whether respondents obtained post-exposure 
prophylactic treatment, and 8) precautions that would have 
prevented the exposure.

Another critical area for inclusion in such studies is an 
assessment of past injuries experienced by employees and, in order 
to assess under-reporting, the percentage of injuries reported to 
the worker’s employer via standard procedures.  Valuable new 
information would be contributed by a study that provided a 
comparison of injury incidence density rates among health care 
workers in the same occupations (e.g., RNs versus RNs) but 
employed in either hospital or non-hospital settings by using the 
same denominator (such as person-hours worked) for both groups. 

NIOSH has set a goal to describe the occurrence of exposure to 
blood among non-hospital health care workers in order to 
subsequently identify appropriate interventions to reduce the 
future incidence of exposure to blood borne pathogens.  This RFA 
is the first step to accomplish this goal. 

Research Goals and Objectives

The objective of this RFA is to support research on the incidence 
of and risk factors for exposures to blood among health care 
workers employed outside hospitals.  Among the issues that need to 
be understood are the significant factors that affect blood 
exposures such as rate of exposure from needlestick and sharps 
injuries, other routes of exposure, and the prevalence and use of 
medical safety devices.   Research projects should address this 
occupational issue in an integrated and comprehensive manner in 
order for the risk for this injury in non-hospital workers can be 
understood.   In designing their studies, applicants may consider 
the inclusion of these data elements in the study design: the 
incidence rate of exposure to blood from needlestick and sharps 
injuries and other routes of exposure among health care workers 
who work in non-hospital settings; risk factors for these 
injuries; and the prevalence of medical safety device availability 
and usage.  Non-hospital settings include, but are not limited to, 
public and private clinics, nursing homes and other long-term care 
facilities, non-hospital-based hospices, emergency medical 
services, home care, and correctional facilities.  Because there 
is little quantitative data on these injuries in non-hospital 
workers, the applicant should address in the application the basis 
for the selection of occupations chosen for inclusion in the 
study.  In addition, the applicant should justify the survey 
sample size.   

One approach investigators may wish to consider, is to survey, 
either retrospectively or prospectively, an entire population of 
non-hospital health care workers or a random sample thereof in 
order to estimate numbers of injuries and injury/exposure 
incidence rates by occupation, setting, and medical device, as 
well as the availability and usage of medical safety devices.  An 
important element that investigators may wish to include in the 
study design is a comparison of risk factors, rates of injury, and 
availability/use of medical safety devices between non-hospital 
and hospital health care workers in the same occupations; however, 
the focus of this RFA is on non-hospital settings. 

Investigators may also wish to include in the study design 
approaches for estimating the availability and usage of medical 
safety devices in non-hospital institutions.

Another element that investigators may wish to consider is the 
rate of vaccination against hepatitis B virus and compliance with 
recommendations for post-exposure prophylaxis for hepatitis B 
virus and human immunodeficiency virus.  Because the well-known 
problem of under-reporting of needlestick injuries could bias a 
study, applicants should consider in the study design methods for 
data collection that do not rely solely upon employers’ or health 
services’ records.  However, an investigator may wish to 
supplement a survey of health care workers with a review of injury 
records kept by employers.


National Institute for Occupational Safety and Health.  National 
Occupational Research Agenda. Cincinnati, OH: U.S. Department of 
Health and Human Services, Public Health Service, Centers for 
Disease Control and Prevention, National Institute for 
Occupational Safety and Health, DHHS (NIOSH) Publication No.96-115 


Applications should include, at a minimum, descriptions of the 

o  The source of recruitment for the population studied and 
letters of agreement;
o  A detailed timetable for the proposed study.


Applicants should highlight unique expertise and/or unusual 
opportunities  related to the purpose of this RFA.

The Terms and Conditions of Award, below, will be incorporated in 
all awards issued as a result of this RFA.  It is critical that 
each applicant include specific plans for responding to these 
terms.  These special Terms of Award are in addition to and not in 
lieu of otherwise applicable OMB administrative guidelines, HHS 
Grant Administration Regulations at 45 CFR Parts 74 and 92, and 
PHS Grants Policy Statement.  The administrative and funding 
instrument used for this program is a cooperative agreement (U01), 
an "assistance" mechanism (rather than an "acquisition" mechanism) 
in which substantial NIOSH scientific and/or programmatic 
involvement with the awardee is anticipated during performance of 
the activity.

Under the cooperative agreement, the NIOSH purpose is to support 
and/or stimulate the recipient's activity by involvement in and 
otherwise working jointly with the award recipient in a partner 
role, but it is not to assume direction, prime responsibility, or 
a dominant role in the activity. Consistent with this concept, the 
dominant role and prime responsibility for the activity resides 
with the awardee for the project as a whole, although specific 
tasks and activities in carrying out the studies will be shared 
among the awardees and the NIOSH Project Scientist where 
appropriate, including the following.

1. Recipient  (Applicant) Responsibilities

The applicant will coordinate project activities, scientifically 
and administratively, at the awardee institution and at other 
sites that may be supported by sub-contractors to this award.  The 
applicant will have primary authority and responsibility to define 
objectives and approaches, and to plan, conduct, analyze, and 
publish results, interpretations, and conclusions of studies 
conducted under the terms and conditions of the cooperative 
agreement award.  Recipient will 

a.  enroll and follow-up the study participants and establish and 
maintain mechanisms to ensure that data collection and management 
procedures have necessary quality control and confidentiality of 

b.  provide study participants with individual notification 
letters when medical tests are performed, 

c.  develop and submit semiannual progress reports in a standard 
format that is agreed upon at the initial planning meeting after 
an award is made,

d.  disseminate the scientific findings,  

e.  provide program management and oversight for the project, 

f.  notify study participants of the overall study results, and 

g.  participate in semi-annual meetings to provide information on 
program status.

2. NIOSH Responsibilities

The NIOSH Project Scientist may, at the request of the recipient, 
provide substantial scientific-programmatic involvement during 
conduct of this activity, through technical assistance, advice, 
and coordination.  

a.  provide technical assistance as a scientific liaison between 
the awardee and other program staff at NIOSH who have experience 
in the occupational health issues of health care workers, 
infection control, and epidemiology;

b.  provide expert consultation in the area of occupational 

c.  provide technical advice on monitoring of field data 
collection, developing operating guidelines, quality control 
procedures, and developing policies/protocols  for dealing with 
recurrent situations;

d.  facilitate collaborative efforts to compile and disseminate 
program results through presentations and publications,

e.  assist in the development of human subjects protocols for the 
CDC Institutional Review Board (if required) and in the 
preparation of OMB clearances that may be required during the 
conduct of the study.


Projects that involve the collection of information from 10 or 
more individuals and funded by cooperative agreement will be 
subject to review and approval by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act.


If a project involves research on human subjects, assurance (in 
accordance with Department of Health and Human Services 
Regulations, 45 CFR Part 46) of the protection of human subjects 
is required.  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 with 
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.  Unless the awardee holds a Multiple 
Project Assurance, a Single Project Assurance is required, as well 
as an assurance for each subcontractor or cooperating institution 
that has immediate responsibility for human subjects.  The Office 
for Protection from Research Risks (OPRR) at the National 
Institutes of Health negotiates assurances for all activities 
involving human subjects that are supported by the Department of 
Health and Human Services.


It is the policy of the Centers for Disease Control and Prevention 
(CDC) to ensure that individuals of both sexes and the various 
racial and ethnic groups will be included in CDC-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 or Alaska Native, 
Asian, Black or African American, Hispanic or Latino, Native 
Hawaiian or Other Pacific Islander.  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, and dated Friday, September 15, 1995. 


It is the policy of NIH that children (i.e., individuals under the 
age of 21) must be included in all human subjects research, 
conducted or supported by NIH, unless there are clear and 
compelling reasons not to include them.  This policy applies to 
all initial (Type 1) applications submitted for receipt dates 
after October 1, 1998.  This policy will be followed by  NIOSH for 
this announcement. 

All investigators proposing research involving human subjects 
should read the "NIH Policy and Guidelines on the Inclusion of 
Children as Participants in Research Involving Human Subjects" 
that was published in the NIH Guide for Grants and Contracts, 
March 6, 1998, and is available at the following URL address:

Investigators may also obtain copies of the policy from the 
program staff listed under INQUIRIES.  Program staff may also 
provide additional relevant information concerning the policy.


Prospective applicants are asked to submit, by March 28, 2000, a 
letter of intent that includes a descriptive title of the proposed 
research, name, address, and telephone number of the principal 
investigator, identities of other key personnel and participating 
institutions, and number and title of the RFA in response to which 
the application may be submitted.

Although a letter of intent is not required, is not binding, and 
does not enter into the review of subsequent applications, the 
information allows NIOSH staff to estimate the potential review 
workload and to avoid conflict of interest in the review.

The letter of intent is to be sent to: 

Ann M. Cronin
National Institute for Occupational Safety and Health (NIOSH)
Centers for Disease Control and Prevention 
1600 Clifton Road, NE
Mailstop D40
Building 1, Room 3070B
Atlanta, GA 30333
Telephone: 404/639-2277

Fax: 404/639-0035


The research grant application form PHS 398 (rev. 4/98) is to be 
used in applying for this cooperative agreement.  Applications 
kits are available at most institutional offices of sponsored 
research and may be obtained from the Division of Extramural 
Outreach and Information Resources, National Institutes of Health, 
6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 
301/710-0267, E-mail:  Applications are also 
available on the web at:

The RFA label available in the PHS 398 (rev. 4/98) application 
form must be affixed to the bottom of the face page of the 
application.  Failure to use this label could result in delayed 
processing of the application such that it may not reach the 
review committee in time for review.  In addition, the RFA title 
and number must be typed on line 2 of the face page of the 
application form and the YES box must be marked.

The sample RFA label available at: has been 
modified to allow for this change.  Please note this is in pdf 
Submit a signed, original of the application, including the 
Checklist, and three signed photocopies, in one package to:

6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)

At the time of submission, two additional copies of the 
application must also be sent to:

Ann M. Cronin
National Institute for Occupational Safety and Health (NIOSH)
Centers for Disease Control and Prevention
1600 Clifton Road, NE
Mailstop D40
Building 1, Room 3070B
Atlanta, GA 30333

Applications must be received by April 27, 2000.  If an 
application is received after that date, it will be returned to 
the applicant without review.  The Center for Scientific Review 
(CSR) will not accept any application in response to this RFA that 
is essentially the same as one currently pending initial review, 
unless the applicant withdraws the pending application.  CSR will 
not accept any application that is essentially the same as one 
already reviewed.  This does not preclude the submission of a 
substantial revision of an application already reviewed, but such 
an application must follow the guidance in the PHS Form 398 
application instructions for the preparation of revised 
applications, including an introduction addressing the previous 


Upon receipt, applications will be reviewed for completeness by 
CSR and responsiveness by NIOSH.  Incomplete and/or non-responsive 
applications will be returned to the applicant without further 
consideration.  Those applications that are complete and 
responsive, will undergo further scientific merit review in 
accordance with the criteria stated below for scientific/ 
technical merit by an appropriate peer review group convened by 
NIOSH.  The second level of review will be provided by the NIOSH 
Secondary Review Panel. 

All applications will be judged on the basis of the scientific 
merit of the proposed project and the documented ability of the 
investigators to meet the RESEARCH OBJECTIVES of the RFA.  
Although the technical merit of the proposed protocol is 
important, it will not be the sole criterion for evaluation of a 
study.  Access to the study population and ability to achieve the 
initiative’s goals will also be part of the evaluation criteria.  

As part of the initial merit review, all applications will receive 
a written critique and undergo a process in which only those 
applications deemed to have the highest scientific merit, 
generally the top half of the applications under review, will be 
discussed, assigned a priority score, and receive a second level 
review by the NIOSH Secondary Review Panel. 


Applicants are encouraged to submit and describe their own ideas 
about how best to meet the goals of the RFA, and are expected to 
address issues identified under "SPECIAL REQUIREMENTS FOR THE 
RFA."  The peer review group will assess the merit of the 
applications and related factors as follows:  

Significance:  Does the proposed research project satisfy an 
important public health, occupational health, or infection control 

Approach:  Are the conceptual framework, design, methods, and 
analyses adequately developed, well integrated, and appropriate to 
the aims of the project?  Does the applicant acknowledge potential 
problem areas and consider alternative approaches?  Will the 
research project be able to provide reliable estimates of the 
incidence rate of exposure to blood, particularly needlestick and 
sharps injuries?  Will the research project be able to identify 
risk factors for exposures to blood?  Will the research project be 
able to estimate the availability and use of medical safety 
devices among the facilities employing the respondents?   Does the 
applicant include health care workers in occupations with 
potentially the highest incidence rates of needlestick injury?  
Does the applicant demonstrate access to health care workers who 
are at high risk of occupational exposure to blood, including 
letters of support from organizations facilitating access to these 
workers?  Does the applicant justify the proposed sample size and 
statistical power calculations?

Innovation:  Does the project employ novel concepts, approaches, 
or methods?  Is the project original and innovative?  Does the 
project develop new methodologies? 

Investigators:  Are the principal investigator and her/his 
collaborators appropriately trained and well suited to carry out 
this work?  Do they have adequate experience in the areas of 
occupational health, infection control, epidemiology, and project 
management to carry out this work?  Is the work proposed 
appropriate to the experience level of the principal investigator 
and her/his collaborators?

Environment:  Are the applicant’s facilities, equipment, and other 
resources adequate for the performance of this project?  Is there 
evidence of institutional support?  Are the methods for assuring 
privacy and maintaining confidentiality of participant records, 
including specific protections for Internet-based data systems 

In addition to the above criteria, all applications will also be 
reviewed with respect to the following:

The reasonableness of the proposed budget and duration in relation 
to the proposed research.

The adequacy of plans to include both genders, minorities and 
their subgroups, and children as appropriate for the scientific 
goals of the research.  Plans for the recruitment and retention of 
subjects will also be evaluated.

The adequacy of the proposed protection for humans, animals, or 
the environment, to the extent they may be adversely affected by 
the project proposed in the application.


Applications recommended by the NIOSH Secondary Review Panel will 
be considered for award based upon (a) scientific and technical 
merit, (b) availability of funds and (c) prevalence of these 
injuries in the study population.


Letter of Intent Receipt Date: March 28, 2000 
Application Receipt Date:      April 27, 2000 
Anticipated Award Date:        September 1, 2000  


Written and telephone inquiries concerning this RFA are 
encouraged.  The opportunity to clarify any issues or questions 
from potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

Michael J. Galvin, Jr. Ph.D.
Research Grants Program
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention
1600 Clifton Road, N.E.
Building 1, Room 3053, MS D-30
Atlanta, GA  30333
Telephone: 404/639-3343
FAX: 404/639-4616

Direct inquiries regarding fiscal matters to:

Sheryl L. Heard, Grants Management Specialist
Grants Management Branch, Procurement and Grants Office

CDC Announcement Number 00038
Centers for Disease Control and Prevention
2920 Brandywine Road, Mail Stop E-13
Atlanta, Georgia 30341
Telephone: 770-488-2723
Email address:


Applicants should be aware of restrictions on the use of HHS funds 
for lobbying of Federal or State legislative bodies. Under the 
provisions of 31 U.S.C. Section 1352, recipients (and their sub-
tier 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 no part of CDC appropriated funds, 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 or any 
State or local legislature, except in presentation to the Congress 
or any State or local legislature itself. No part of the 
appropriated funds 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 or local legislature.


This program is described in the Catalog of Federal Domestic 
Assistance No.93.262.  Awards are made under authorization of the 
Public Health Service Act, Title IV, Part A (Public Law 78-410, as 
amended by Public Law 99-158, 42 USC 241 and 285) and administered 
under CDC grants policies and Federal Regulations 42 CFR Parts 52 
and 45 CFR Part 74 [and Part 92 when applicable for State and 
Local governments].


The CDC strongly encourages all grant and contract recipients to 
provide a smoke-free workplace and promote the non-use of all 
tobacco products.  In addition, Public Law 103-227, the 
Pro-Children Act of 1994, prohibits smoking in certain facilities 
(or in some cases, any portion of a facility) in which regular or 
routine education, library, day care, health care, or early 
childhood development services are provided to children.  This is 
consistent with the PHS mission to protect and advance the 
physical and mental health of the American people.

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