Release Date:  October 04, 2001

RFA:  RFA-CC-02-012

National Institute for Occupational Safety and Health

Letter of Intent Receipt Date:  November 8, 2001
Application Receipt Date:       December 19, 2001


NOTE:  If you are a current FACE awardee, a progress report should be included 
with your application. Please follow the instructions in the application kit 
for competing renewal applications (PHS 398, page 16, item C. Preliminary 
Studies/Progress Report).



The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 2002 funds for State cooperative agreements 
to build State capability for conducting traumatic occupational fatality 
surveillance, investigation, and intervention activities, using the fatality 
assessment and control evaluation (FACE) program within the National Institute 
for Occupational Safety and Health (NIOSH).  The purpose of this FACE program 
is to identify and study work-related fatalities, reducing the national burden 
of these fatalities through the development of effective prevention measures 
at the State and national level. The objectives of this State-based program 
are to 1)identify work environments that place workers at a high risk for 
fatal injury, 2)identify risk factors for these fatal injuries, and 3)develop 
and disseminate prevention strategies.  Applications are sought that 
demonstrate a high potential for achieving these objectives.

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.  To obtain a copy of Healthy People 
2010, visit the internet site:


Applications may be submitted by State health and labor departments or by 
other State or territorial health agencies that have occupational safety and 
health responsibilities.  This eligibility includes health departments or 
other official organizational authority (agency or instrumentality) of the 
District of Columbia, the Commonwealth of Puerto Rico, any territory or 
possession of the United States, and federally recognized Indian tribal 
governments, territories, Indian tribes, or Indian tribal organizations.  
Applicants other than health or labor departments must apply in collaboration 
with and through their State and territorial health department.  Awards will 
be limited to those organizations that can exercise public health authority 
for intervention into occupational safety and health problems. Program 
activities, however, may not be carried out by departmental divisions that are 
responsible for enforcement of occupational safety and health standards.  Only 
one application per State will be funded under this announcement.


The administrative and funding instrument to be used for this program will be 
a cooperative agreement (U01), an assistance mechanism in which substantial 
NIOSH scientific and/or programmatic involvement with the awardee is 
anticipated during performance of the activity.  Under the cooperative 
agreement, NIOSH acts in a partnership role to support and/or stimulate the 
proposed study by involvement in and otherwise working jointly with the award 
recipient. Details of the responsibilities, relationships, and governance of 
the study to be funded under cooperative agreement(s)are discussed under 
Section II, Terms and Conditions of Award in this document.

The total project period for an application submitted in response to the 
current research funding announcement (RFA) may not exceed four (4) years.  
The anticipated award date is July 1, 2002.  The award and level of support 
depends on the 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 $750,000 is available in FY 2002 to make four to six awards 
under this RFA.  For each award, the range of total costs (direct plus 
facilities and administration) per year is anticipated to be between $75,000 
and $150,000 (maximum).

Awards will be made for a 12-month budget period within a total project period 
up to 4 years.  Continuation awards within the total project period will be 
made yearly on the basis of satisfactory progress and availability of funds in 
future years.

Use of Funds

Applicants should allocate funds for travel to attend meetings as indicated in 
the section FACE Consortium and Coordination Committee (CC) Meetings.


Applicants are invited by NIOSH to participate in a pre-application technical 
assistance telephone conference call on Wednesday October 17, 2001 at 1:00 PM 
(Eastern standard time) to discuss:  programmatic issues regarding this 
program, how to apply, and questions regarding the content of the RFA.  The 
conference name is ASSESSMENT FATALITY.  The telephone bridge number is 800-
713-1971.  Interested parties will need the conference code (663076) to 


Prospective applicants are asked to submit by November 8, 2001, a letter of 
intent.  This letter should include 1) a descriptive title of the proposed 
project, 2)name, address, and telephone number of the Principal Investigator, 
3)identities of other key personnel and participating institutions, and 
4)number and title of the RFA to which the application is being submitted.

While 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 plan the review.

The letter of intent is to be sent to:

Gwendolyn Cattledge, M.S., Ph.D.
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention (CDC)
1600 Clifton Road, N.E.
Building 1, Room 3056, MS D-28
Atlanta, GA  30333
Telephone 404-639-2378
Fax 404-639-4175


The PHS 398 research grant application instructions and forms (rev. 5/2001) 
available at are to be 
used in applying for these grants. This version of the PHS 398 is available in 
an interactive, searchable PDF format. Although applicants are strongly 
encouraged to begin using the 5/2001 revision of the PHS 398 as soon as 
possible, the NIH will continue to accept applications prepared using the 
4/1998 revision until January 9, 2002. Beginning January 10, 2002, however, 
the NIH will return applications that are not submitted on the 5/2001 version. 
For further assistance contact GrantsInfo, Telephone 301/710-0267, Email:

Submit a signed original of the application, including the Checklist, and five 
signed photocopies, in one package to:

Procurement and Grants Office
Grants Management Branch
Attention: Sheryl L. Heard, Grants Management Specialist
Centers for Disease Control and Prevention (CDC)
2920 Brandywine Road, Suite 3000
Atlanta, Georgia 30341
Telephone: (770) 488-2723
Email address:

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

Gwendolyn Cattledge, M.S., Ph.D.
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention (CDC)
1600 Clifton Road, N.E.
Building 1, Room 3056, MS D-28
Atlanta, GA  30333
Telephone 404-639-2378
Fax 404-639-4175

Applications must be received by December 19, 2001.  If an application is 
received after that date, it will be returned to the applicant without review. 
CDC will not accept any application to this RFA that is essentially the same 
as one currently pending initial review, unless the applicant withdraws the 
pending application.  CDC 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 critique.


Letter of Intent Receipt Date:  November 8, 2001
Application Receipt Date:       December 19, 2001
Anticipated Award Date:         July 1, 2002


Inquiries concerning this RFA are encouraged.  The opportunity to clarify any 
issues or questions from potential applicants is welcome.  This RFA and other 
CDC Announcements can be found on the CDC HomePage ( under the 
Funding section (see Grants and Cooperative Agreements scroll down to 
Occupational Safety and Health).  This RFA can also be found on the NIOSH 
HomePage ( under Extramural Programs, Current Funding 

Direct inquiries regarding programmatic issues to:

Michael J. Galvin, Ph.D. 
Office of Extramural Programs
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: 404/639-1533
FAX: 404/639-4616

Direct inquiries regarding grants management to:

Sheryl L. Heard, Grants Management Specialist
Grants Management Branch, Procurement and Grants Office
Centers for Disease Control and Prevention (CDC)
2920 Brandywine Road, Suite 3000
Atlanta, Georgia 30341
Telephone: (770) 488-2723
Email address:




Traumatic occupational fatalities represent a public health problem of 
significant proportion.  From 1980 to 1997, data from the National Traumatic 
Occupational Fatalities (NTOF) surveillance system identified nearly 104,000 
occupational injury deaths in the United States. [CDC, 2001].  Recent data 
from the Bureau of Labor Statistics documented 5,915 work-related injury 
deaths in 2000 [BLS, 2000].  Surveillance data such as NTOF and those from the 
Bureau of Labor Statistics are useful for setting research and prevention 
priorities as they identify common causes of death and worker groups 
experiencing large numbers and/or rates of occupational injury death.  
However, more in-depth information is frequently required to understand the 
circumstances and contributors to fatal injuries in order to develop effective 
preventive measures.  

In 1983, the FACE program was developed within NIOSH to provide in-depth 
causal information on targeted types of work injury deaths.  FACE was expanded 
in 1989 to multiple States to provide more timely and in-depth information 
than was available from existing surveillance systems with the goal of taking 
advantage of the individual State data to make national recommendations.  
State-based FACE programs permit the States to develop a network of 
organizations which voluntarily report occupational fatalities and link these 
surveillance activities to appropriate field investigations and to the 
development and dissemination of prevention strategies to those who could 
intervene in the workplaces within the State.  In-depth, on-site 
investigations have been conducted on fatalities resulting from targeted 
causes of death that have included confined spaces, electrocutions, machine-
related, falls from elevation and logging.  Numerous articles, monographs, 
hazard identifications and alerts have been written that detail findings on 
these targeted causes of death [Higgins et al. 2001].  In 1999, the in-depth 
on-site investigation targets were reassessed and revised to include deaths 
associated with machinery, deaths of youths under 18 years of age, and 
street/highway construction work zone fatalities. 

The FACE program builds upon past experience in state-based fatality 
surveillance and intervention efforts by increasing the base of knowledge to 
prevent work-related injury deaths nationwide in the current priority areas 
and other occupations that may be identified as a result of data analysis or 
case investigations.  This is achieved by capacity building of State partners 
through competitive cooperative agreements and by an in depth analysis of 
interactions of the worker, the work environment, and work processes, whereby 
prevention/intervention strategies aimed at reducing fatal injuries in the 
workplace can be developed.

An integral part of this initiative is the establishment of a Fatality 
Assessment and Control Evaluation (FACE) Consortium.  The FACE Consortium will 
facilitate common data collection and investigation methods, sharing of 
findings across states, and identification of collaborative activities that 
can extend prevention efforts beyond individual states to groups of states or 
the Nation.  The FACE Consortium will establish a Coordination Committee (CC), 
comprised of one voting representative from each member of the consortium, to 
serve as the main governing board for the conduct of this program.  The CC 
will serve as an advisory body for the common or shared protocols to be used 
in the studies.  NIOSH staff will serve as non-voting members of the CC.

A Data Center may be established for this program through a competitive, peer-
reviewed process. If established, each recipient will be responsible for 
providing data to the Data Center in a uniform fashion that is determined by 
the CC. This center will serve as the data resource for the analysis by the 
consortium investigators of the pooled data from all work sites in 
collaboration with the FACE Consortium.  This Data Center will serve as a 
common repository for data, and these combined data will be available for all 
members of the FACE Consortium.   

Through the FACE Consortium, it is anticipated that critical risk factors for 
fatal traumatic occupational injuries will be better defined at both the State 
and national level, so that prevention and intervention strategies can be 
developed.  It is anticipated that practitioners in occupational safety and 
health will be able to use the results from this project to more quickly and 
reliably discriminate job tasks that elevate risks for fatal traumatic 
injuries.  With such knowledge, effective job design changes or interventions 
can be developed that reduce occupational traumatic fatalities.  The FACE 
Consortium will combine the expertise and resources of NIOSH research staff 
with those of external collaborators.  Individual investigators are encouraged 
to analyze and publish data and investigation findings for their states as 
soon as feasible.


The objectives of the FACE project is to reduce traumatic occupational 
fatalities within the States and throughout the nation.  NIOSH seeks project 
applications that assist in building State capacity for conducting 
occupational fatality surveillance, on-site investigations, and for developing 
and disseminating hazard prevention strategies.  The objectives of the State-
based FACE project are to (1) identify work environments that place workers at 
a high risk for fatal injury, (2) identify risk factors for these fatal 
injuries, and (3) develop and disseminate and evaluate prevention strategies. 
Applications are sought that demonstrate a high potential for implementing a 
balanced program that includes occupational fatality surveillance, field 
investigation of priority category fatalities, and development and 
dissemination of preventive strategies. 

Thus, applications which are responsive to the objectives of this RFA should 
include detailed project plans for the following three areas.  

o  A surveillance system to be used at the State level.  This surveillance 
system should enable the State to identify all traumatic occupational 
fatalities occurring within the State in a timely fashion to allow 
investigation of targeted fatalities.  The investigator should include plans 
for data management and quality control.  

o  A plan for the conduct of on-site investigations on specific traumatic 
occupational fatalities.  Investigators should include the rationale and 
criteria to be used for the selection of on-site investigations.  
Investigators are encouraged to consider the NIOSH FACE investigative model 
cited in the useful references section for guidance on the development of a 
traumatic occupational fatality protocol.

o  Development and dissemination of prevention strategies for reducing the 
incidence of traumatic occupational injuries and fatalities at the State 

Special Instructions

Special instructions for defining proposed project plans are included in the 
public health service grant guidelines (PHS 398, page 15) and should address 
the following questions 1) What do you intend to do, 2)Why is the work 
important, 3)What has already been done, and 4)How are you going to do the 
work. Items a-d should be organized to address these questions in detail. 

a. Specific Aims. Identify the broad, long-term objectives of the proposed 
project and expected accomplishments.

b. Background and Significance.  Briefly provide relevant background 
information related to this project, include a critique of existing knowledge 
on the subject and identify information gaps that the proposed project will 
address.  Described the scope and nature of occupational fatalities in the 
applicant's State.  Specifically address how this project is important and 
relevant to public health by relating the specific aims to the broad, long-
term objectives.

c. Preliminary Studies/Progress Report. For new applications, pertinent 
preliminary studies/activities conducted by the principal investigator/program 
director should be included to establish past experience and competence in the 
project area.  Include a list of references to appropriate publications and 
manuscripts.  For competing continuation applications, include a progress 
report providing a summary of the projects specific aims and the importance of 
the findings since the last project review. Provide a statement of published 
and unpublished results and achievements, include a list of titles and 
references for all publications and manuscripts.

d. Project Design and Methods. Describe in detail the project design and 
methods that will be used to achieve the specific aims of the project. 
Specifically describe how the project design and methodology will conduct 
timely surveillance of occupational injury fatalities, identify cases for in-
depth investigation, and pursue prevention activities at the state level, 
include new methodologies and expected advantages. Discuss potential 
limitations and anticipated difficulties of the proposed project, provide 
alternative approaches to be used to achieve the defined aims. Include a 
tentative timetable for the project.  Guidelines for the inclusion of special 
populations (gender, minority, and children) in project involving human 
subjects are available for review (PHS 398, pp 16-18). 


Applicants should include in their budget support for the PI and one other 
person from their institution integrally involved in the project to attend an 
annual program meeting of the FACE Consortium.  The meeting will be of two or 
three days duration and will be held at a site mutually acceptable to study 
collaborators.  The initial meeting will be in Morgantown, WV.

The applicant should also budget for attendance by the PI at two CC meetings 
during the first year and two in each subsequent year.  For budget preparation 
and project planning purposes, it should be assumed that these meetings will 
be held in Morgantown, WV.  However, the CC will determine later where and 
when recurring CC meetings will be held.  The CC chair will coordinate the 
meetings to review and assess overall progress and provide the opportunity for 
investigators to exchange information and discuss project issues.


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.

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(s) for the project as a whole, although 
specific tasks and activities in carrying out the studies may be shared among 
the awardees and the NIOSH collaborators where appropriate, including the 

1. Recipient Responsibilities

The recipient will coordinate project activities, scientifically and 
administratively, at the awardee institution and at the 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; to 
plan, conduct, and analyze data; and to publish results, interpretations, and 
conclusions of studies conducted under the terms and conditions of the 
cooperative agreement award.  In addition, the applicant is responsible for 
coordination of the individual study with the CC.  Recipient will:

a.  Identify occupational fatalities and conduct in depth investigations of 
targeted cases;

b.  Use mechanisms to ensure that data collection and management procedures 
have necessary quality control and assure confidentiality of data;

c.  Serve as a permanent member of the CC;

d.  Submit semi-annual progress reports;

e.  Collaborate in the scientific reporting of findings; 

f.  Provide program management oversight for the project; and

g.  At the time of award, Investigators in states with existing statutes 
covering guidance for the protection of human subjects in research, should 
submit a letter providing the states authority or may coordinate human subject 
clearances through an external institutional review board (IRB). If exempt, a 
justification for the exemption with sufficient information regarding the 
involvement of human subjects should be provided. The proposed project plan 
describing the involvement of human subjects and protections should be 
included in the Human Subjects Research Section of PHS 398.

h.  Investigators may also request a human subjects review from CDC IRB on a 
particular project.  Information and an application can be obtained at the CDC 
Office of Human Research Protections (OHRP) website at 

2.  NIOSH Responsibilities

NIOSH anticipates having substantial scientific programmatic involvement 
during conduct of this activity, through technical assistance, advice, and 
coordination.  NIOSH will:

a.  Serve as a scientific liaison between the awardee and other program staff 
at NIOSH with expertise in occupational injury surveillance, investigation 
methods, risk factor identification, and prevention strategies and evaluation;

b.  Provide advice on formats for data reporting and coding, computer 
software, and electronic storage of FACE surveillance and investigative data;

c.  Provide expert consultation in the area of occupational fatality 
surveillance, epidemiology, on-site fatality investigation procedures, hazard 
identification, prevention strategies, and dissemination methods, if 

d.  Facilitate collaborative efforts to compile and disseminate program 
results through presentations and publications; and

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

3.  Collaborative Responsibilities

The CC will serve as the main governing board for the cooperative agreements 
making up the FACE Consortium.  The principal investigator at the recipient 
organizations will have membership on the CC.  NIOSH will have non-voting 
representation on the CC.

Critical roles of the CC include ensuring that the study designs and data 
collection protocols are uniform and compatible across the FACE Consortium and 
developing broad-based measures and products to prevent fatal work injury.

The CC may, when it deems necessary, invite additional, non-voting scientific 
advisors to the meetings at which project priorities and opportunities are 

It is anticipated that there will be two CC meetings during the first year and 
two in each subsequent year, but the actual number and locations of the 
meetings will be determined by the CC itself.  The initial planning meeting 
will be organized by NIOSH and held in Morgantown, WV soon after the award, 
but subsequent meetings will be organized by the CC.  The committee chair will 
schedule the meetings and will be responsible for developing the meeting 
agenda, chairing the meetings, and producing CC reports.

At the Planning Meeting, the CC may:
o discuss approaches for identifying fatal work injuries in a timely manner;
o identify technical assistance needs and potential avenues to address those 
o identify potential end-users of investigation data and identify future 
products to be developed; and
o  establish data sharing mechanisms.

At the second and subsequent meetings, the CC may: 
o make recommendations on the project plans and data collection approaches; o 
discuss the targeted events that have been or will be investigated;
o identify and recommend solutions to unexpected study problems; and
o discuss ways to efficiently coordinate and combine investigation data.


Upon receipt, applications will be reviewed for completeness by CDC and 
appropriateness to the RFA program area (FACE) defined by NIOSH.  Applications 
determined to be incomplete or do not meet the program objectives defined in 
this RFA will be returned to the applicant without further consideration. 
Those applications which are complete and meet the program objectives, will 
undergo further scientific merit review in accordance with the criteria stated 
below for scientific/technical merit by a selected peer review group convened 

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  

Following the scientific review, competitive applications will be reviewed for 
programmatic importance by a NIOSH Secondary Review Committee.

Scientific Review Criteria

The peer review group will assess the scientific merit of the project design 
and significance to the FACE public health program as follows:


o  Did the applicant communicate the scope and nature of traumatic 
occupational fatalities in the State? 

o  Is the application relevant to the objectives outlined in the RFA?  Have 
the broad, long-term objectives of the project and expected accomplishments 
been defined? 


o  Does the applicant propose innovative concepts, approaches, or methods for 
intervention, prevention, and/or dissemination.

o  Does the applicant propose innovative concepts, approaches, or methods for 
dealing with state priorities? 


o  Does the applicant communicate a comprehensive approach to occupational 
fatality investigations and follow-up?

o  Does the application provide a detailed plan (project design and methods) 
and a proposed schedule for accomplishing each of the activities to be carried 
out in this project including the implementation of surveillance, on-site 
field investigations, dissemination and prevention components, and a method 
for evaluating the accomplishments?  

o  Does the application provide a summary report of past studies and 
accomplishments or results of preliminary studies, including a list of titles 
and references for all publications, manuscripts, and a synopsis of past 
related activities?

o  Does the plan include a description of the methods the State will use to 
gain access to work sites for onsite investigations to secure or review 
pertinent information?

o  Does the plan include a description of the methods the State will use to 
facilitate collaboration with other State agencies involved in the 

o  Does the applicant identify potential problem areas, limitations, and 
consider alternative approaches?

o  Are the proposed personnel adequate for accomplishing the proposed 

o  Is the time-line proposed for the project suitable?

o  Is there a method for evaluating the accomplishments for each component of 
the program (surveillance activities, on-site field investigation, formulation 
and dissemination of prevention strategies?

o  Is there a plan for internal review of investigative reports and any other 
documents produced as a result of the program?  

o  Is there a plan to produce and disseminate fatality narrative reports, 
injury prevention strategies, data, and other information that promotes the 
goals of increasing prevention activities?

o  Is there an evaluation plan to assess the impact of the project on reducing 
the types of fatalities defined in the objectives? 

o  Is the principal investigator and her/his collaborators appropriately 
trained and well suited to carry out the proposed project?  

o  Do they have adequate experience and competence in surveillance activities?

o  Do they have experience in conducting occupational traumatic injury 
investigations?  If not, does the applicant demonstrate the potential to 
acquire such knowledge and experience?

o  Has the applicant demonstrated the ability to formulate, communicate, and 
disseminate injury prevention recommendations and strategies to employers and 
workers in high-risk groups and to trade organizations, union, and other 
safety and health professionals?


o  Are the applicant's facilities, equipment, and other resources adequate for 
the performance of this project?  

o  Is there evidence of institutional support generally, or specific agency 
commitment to the development of occupational fatality surveillance, 
investigation, and dissemination activities?  

o  Are there letters of support or other documentation that demonstrates the 
applicant's ability to work with diverse groups, establish linkages, and 
facilitate worker safety awareness information?  

o  Is there a commitment to share surveillance data with other States in the 
program so as to contribute to the goal of reducing fatalities across the 

o  Is there evidence of or a potential demonstrated for the establishment of 
multiple-source network for the identification and reporting of occupational 

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

o  The adequacy of plans to include both genders, minorities and their 
subgroups, for the scientific goals of the project.

o  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.

Programmatic Review Criteria:

o  Magnitude of the problem in terms of numbers of workers affected.

o  Likelihood of developing technical knowledge for the prevention of 
occupational safety hazards on a national, regional, or State basis.


Applications will be considered for award based upon (a) scientific merit, (b) 
program importance, (c) program balance, and (d) availability of funds.



Higgins, DN, VJ Casini, P Bost, W Johnson, R Rautiainen. The fatality 
assessment and control evaluation program's role in the prevention of 
occupational fatalities. Injury Prevention 2001:7.

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 ( 

Morbidity and Mortality Weekly Report (MMWR). A Framework for Assessing the 
Effectiveness of Disease and Injury prevention. March 27, 1992/Vol.41/Jn.  The 
MMWR can be accessed through the world-wide Web at:

NIOSH FACE Program: National Institute for Occupational Safety and Health 
website at:

NIOSH Worker Health Chartbook, 2001. 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.2000-127, updated 07/21/2001


It is the policy of the CDC to ensure that individuals of both sexes and the 
various racial and ethnic groups will be included in CDC-supported 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 project 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 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.


If the proposed project involves research on human subjects, the applicant 
must comply with the Department of Health and Human Services (DHHS) 
Regulations (Title 45 Code of Federal Regulations Part 46) regarding the 
protection of human research subjects.  All awardees of CDC grants and 
cooperative agreements and their performances sites engaged in human subjects 
research must file an assurance of compliance with the regulations and have 
continuing reviews of the research protocol by appropriate institutional 
review boards.

In order to obtain a federal-wide Assurance (FWA) of Protection for Human 
Subjects, the applicant must complete an on-line application at the Office for 
Human Research Protections (OHRP) website or write to the OHRP for an 
application.  OHRP will verify that the signatory official and the Human 
Subjects Protections Administrator have completed the OHRP Assurance 
Training/Education Module before approving the FWA.  Existing Multiple Project 
Assurances (MPAs), Cooperative Project Assurances (CPAs), and Single Project 
Assurances (SPAs) remain in full effect until they expire or until December 
31, 2003, whichever comes first.

To obtain a FWA contact the OHRP at: 
or write to:
Office for Human Research Protections (OHRP)
Department of Health and Human Services
6100 Executive Boulevard, Suite 3B01, MSC 7501
Rockville, Maryland 20892-7507
(Note: For Express or Hand Delivered Mail, Use Zip Code 20852)

Note: In addition to other applicable committees, Indian Health Service (IHS) 
institutional review committees must also 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 the 
applicable portion of that project.


NIH policy requires education on the protection of human subject participants 
for all investigators submitting NIH proposals for research involving human 
subjects.  This policy announcement is found in the NIH Guide for Grants and 
Contracts Announcement dated June 5, 2000, at the following website:


All applications must be self-contained within specified page limitations.  
Unless otherwise specified, internet addresses (URLs) should not be used to 
provide information necessary to the review because reviewers are under no 
obligation to view the Internet sites.  Reviewers are cautioned that their 
anonymity may be comprised when they directly access an Internet site.


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


The Catalog of Federal Domestic Assistance number is: 93.262 for the National 
Institute for Occupational Safety and Health (NIOSH).  This program is 
authorized under the Public Health Service Act, as amended, Section 301(a) [42 
U.S.C. 241(a)], and the Occupational Safety and Health Act of 1970, Section 
20(a) [29 U.S.C. 669(a)].  The applicable program regulation is 42 CFR Part 
52.  This program is subject to the intergovernmental review requirements of 
Executive Order 12372.


Applicants should be aware of restrictions on the use of Health and Human 
Services (DHHS) funds for lobbying of Federal or State legislative bodies.  
Under the provisions of 31 U.S.C. Section 1352, 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, no part of the Center for Disease Control and Prevention (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.

Any activity designed to influence action in regard to a particular piece of 
pending legislation would be considered lobbying.  That is lobbying for or 
against pending legislation, as well as indirect or grass roots: lobbying 
efforts by award recipients that are directed at inducing members of the 
public to contact their elected representatives at the Federal or State levels 
to urge support of, or opposition to, pending legislative proposals is 
prohibited.  As a matter of policy, CDC extends the prohibitions to lobbying 
with respect to local legislation and local legislative bodies.

The provisions are not intended to prohibit all interaction with the 
legislative branch, or to prohibit educational efforts pertaining to public 
health.  Clearly there are circumstances when it is advisable and permissible 
to provide information to the legislative branch in order to foster 
implementation of prevention strategies to promote public health.  However, it 
would not be permissible to influence, directly or indirectly, a specific 
piece of pending legislation.

It remains permissible to use CDC funds to engage in activity to enhance 
prevention; collect and analyze data; publish and disseminate results of 
research and surveillance data; implement prevention strategies; conduct 
community outreach services; provide leadership and training; and foster safe 
and healthful environments.

Recipients of CDC grants and cooperative agreements need to be careful to 
prevent CDC funds from being used to influence or promote pending legislation. 
With respect to conferences, public events, publication, and grassroots: 
activities that relate to specific legislation, recipients of CDC funds should 
give attention to isolating and separating the appropriate use of CDC funds 
from non-CDC funds.  CDC also cautions recipients of CDC funds to be careful 
not to give the appearance that CDC funds are being used to carry out 
activities in a manner that is prohibited under Federal law.


CDC strongly encourages all grant 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.


It is a national policy to place a fair share of purchases with small, 
minority and women-owned business firms. The Department of Health and Human 
Services is strongly committed to the objective of this policy and encourages 
all recipients of its grants and cooperative agreements to take affirmative 
steps to ensure such fairness. In particular, recipients should:

1. Place small, minority, women-owned business firms on bidders mailing lists.

2. Solicit these firms whenever they are potential sources of supplies, 
equipment, construction, or services.

3. Where feasible, divide total requirements into smaller needs, and set 
delivery schedules that will encourage participation by these firms.

4. Use the assistance of the Minority Business Development Agency of the 
Department of Commerce, the Office of Small and Disadvantaged Business 
Utilization, DHHS, and similar state and local offices.


The signature of the institution official on the face page of the application 
submitted under this Program Announcement is certifying compliance with the 
Department of Health and Human Services (DHHS) regulations in Title 42 Part 
50, Subpart A, entitled Responsibility of PHS Awardee and Applicant 
Institutions for Dealing with and Reporting Possible Misconduct in Science.
The regulation places several requirements on institutions receiving or 
applying for funds under the PHS Act that are monitored by the DHHS Office of 
Research Integrity's (ORI) Assurance Program. 
For examples:
Section 50.103(a) of the regulation states: Each institution that applies for 
or receives assistance under the Act for any project or program which involves 
the conduct of biomedical or behavioral research must have an assurance 
satisfactory to the Secretary (DHHS) that the applicant: (1) Has established 
an administrative process, that meets the requirements of this subpart, for 
reviewing, investigating, and reporting allegations of misconduct in science 
in connection with PHS-sponsored biomedical and behavioral research conducted 
at the applicant institution or sponsored by the applicant; and (2) Will 
comply with its own administrative process and the requirements of this 
Section 50.103(b) of the regulation states that: an applicant or recipient 
institution shall make an annual submission to the [ORI] as follows: (1) The 
institution's assurance shall be submitted to the [ORI], on a form prescribed 
by the Secretary,...and updated annually thereafter...(2) An institution shall 
submit, along with its annual assurance, such aggregate information on 
allegations, inquiries, and investigations as the Secretary may prescribe.

Return to Volume Index

Return to NIH Guide Main Index

Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS) - Government Made Easy

Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.