Expired RFA-CC-02-012: STATE FATALITY SURVEILLANCE AND FIELD INVESTIGATIONS OF OCCUPATIONAL INJURIES: FATALITY ASSESSMENT AND CONTROL EVALUATION (FACE)

Department of Health
and Human Services (HHS)

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EXPIRED

STATE FATALITY SURVEILLANCE AND FIELD INVESTIGATIONS OF OCCUPATIONAL INJURIES:
FATALITY ASSESSMENT AND CONTROL EVALUATION (FACE)

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

THIS RFA USES THE DETAILED BUDGET FORMAT, RATHER THAN THE MODULAR GRANT
BUDGET FORMAT.

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).

SECTION I. GENERAL APPLICATION INFORMATION AND PROCEDURES

PURPOSE

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.

HEALTHY PEOPLE 2010

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: http://www.health.gov/healthypeople/.

ELIGIBILITY REQUIREMENTS

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.

MECHANISM OF SUPPORT

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.

AVAILABILITY OF FUNDS

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.

PRE-APPLICATION CONFERENCE CALL

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
participate.

LETTER OF INTENT

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
Email: gcattledge@cdc.gov

APPLICATION PROCEDURES

The PHS 398 research grant application instructions and forms (rev. 5/2001)
available at http://grants.nih.gov/grants/funding/phs398/phs398.html 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:
GrantsInfo@nih.gov.

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: sheard@cdc.gov

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

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.

SCHEDULE

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

INQUIRIES

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 (www.cdc.gov) 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 (www.cdc.gov/niosh) under Extramural Programs, Current Funding
Opportunities.

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
Email: mgalvin@cdc.gov

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: sheard@cdc.gov

SECTION II. SPECIFIC OBJECTIVES, REQUIREMENTS, AND RESPONSIBILITIES

RESEARCH OBJECTIVES

Background

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.

Objectives

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
level.

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).

FACE CONSORTIUM AND COORDINATION COMMITTEE (CC) MEETINGS

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.

TERMS AND CONDITIONS OF AWARD

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
following.

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
http://www.hhs.gov/ohrp/assurances/assurances_index.html.

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
requested,

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
discussed.

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
needs,
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.

REVIEW CONSIDERATIONS

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
by NIOSH.

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
OBJECTIVES of the RFA.

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:

Significance:

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?

Innovation:

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?

Approach:

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
investigation?

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

o Are the proposed personnel adequate for accomplishing the proposed
activities?

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?

Investigators:

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?

Environment:

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
nation?

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

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.

AWARD CONSIDERATIONS

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

SECTION III. REFERENCES, OTHER GENERAL REQUIREMENTS, AND REGULATIONS

USEFUL REFERENCES

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 (http://www.cdc.gov/niosh/nora.html).

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:
http://www.cdc.gov/mmwr/preview/mmwrhtml/00016403.htm

NIOSH FACE Program: National Institute for Occupational Safety and Health
website at: http://www.cdc.gov/niosh/face/faceweb.html

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 http://www.cdc.gov/niosh/publistd.html

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

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.

HUMAN SUBJECTS REQUIREMENTS

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: http://www.hhs.gov/ohrp/assurances/assurances_index.html
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.

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS

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:
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

URLS IN NIOSH GRANT APPLICATIONS OR APPENDICES

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.

PAPERWORK REDUCTION ACT

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.

AUTHORITY AND REGULATIONS

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.

LOBBYING RESTRICTIONS

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.

SMOKE-FREE WORKPLACE

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.

SMALL, MINORITY, AND WOMEN-OWNED BUSINESS

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.

RESEARCH INTEGRITY

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
Subpart.
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.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices