COLLABORATIVE PROGRAM FOR THE IDENTIFICATION AND PREVENTION OF WORK-RELATED
MUSCULOSKELETAL DISORDERS
RELEASE DATE: April 7, 2003
RFA: OH-03-006
Department of Health and Human Services,
Centers for Disease Control and Prevention (CDC),
National Institute for Occupational Safety and Health (NIOSH)
(http://www.cdc.gov/niosh/homepage.html)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.262
LETTER OF INTENT RECEIPT DATE: May 20, 2003
APPLICATION RECEIPT DATE: June 12, 2003
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Purpose of the RFA
o Research Objectives
o Mechanism(s)of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS RFA
The National Institute for Occupational Safety and Health (NIOSH) invites
applications for a Cooperative Agreement (U01) from single institutions or
consortia of institutions which are capable of, and interested in,
participating in a Musculoskeletal Disorders Consortium (MSDC). The goal of
the MSDC is to coordinate a prospective cohort study to quantify the risk of
upper limb and low back musculoskeletal disorders at varying levels of
exposure to physical job stressors (repetitive motion, forceful exertions,
awkward postures, manual handling, etc.). This research will involve multiple
work sites from the service and manufacturing industries with job tasks that
represent a range of exposures to physical job stressors that can result in
musculoskeletal disorders. Under this RFA, one new extramural partner that
demonstrates expertise in the evaluation of exposure response between low back
disorders and the physical demands of lifting and manual handling tasks will
be awarded a cooperative agreement and will participate in the MSDC.
RESEARCH OBJECTIVES
Background
Work-related Musculoskeletal Disorders (MSDs) remain a large and costly
disease to our society even though there have been many advances in
understanding the ergonomics of work. For 1996, the Bureau of Labor
Statistics (BLS) reported that a total of 600,390 work-related musculoskeletal
injury cases resulting in work absence or restriction were caused by
overexertion and repetitive motion. Because the BLS annual survey does not
cover approximately one-third of workers, this figure significantly
underestimates the overall incidence of MSDs in the American workforce. Of
all MSD cases, sixty-nine percent were low back or distal upper limb
disorders. The magnitude of the problem in today's workforce is confirmed by
workers' compensation data. For instance, in Washington State between 1990
and 1997, 27 percent of all workers' compensation claims and 46 percent of the
cost of all claims resulted from non-traumatic musculoskeletal disorders of
the neck, upper extremity or back. The results from this research program
will provide practitioners in occupational health critical data that will
facilitate their identification of job tasks that represent low, moderate and
high risk for MSDs and that will provide a knowledge base for effective job
design changes or interventions. Because of the limitations of cross-
sectional and retrospective studies, it is widely agreed that a prospective
cohort study design is the best approach for this problem.
This RFA builds on an initial effort in 2000 to begin a Collaborative Program
for the Identification and Prevention of Work-related Musculoskeletal
Disorders (see https://grants.nih.gov/grants/guide/rfa-files/rfa-OH-00-
003.html). As a result of the initial RFA, awards were made to evaluate
exposure response relationships between physical stressors and upper extremity
and low back musculoskeletal disorders. A second RFA in 2002 expanded this
program by awarding an additional cooperative agreement to evaluate upper
extremity disorders (see https://grants.nih.gov/grants/guide/rfa-files/RFA-OH
-02-010.html). The current RFA is focused on providing an additional award
to expand the research effort on low back disorders in relation to varying
levels of physical demand due to lifting and manual material handling. An
integral part of this initiative is participation in a Musculoskeletal Disorders
Consortium (MSDC). In order to achieve the goals of this program, it is
important to have shared data elements among awardees that are managed in a
uniform and compatible format. In addition, because much of the shared data
elements are centered on job tasks and workers, a critical role of the MSDC is
to assure that job tasks are studied using uniform exposure assessment methods
and health assessment methods to identify MSDs. In order to accomplish that
goal, the initial awardees established a Coordination Committee (CC), to serve
as the main governing board for the conduct of this research program. The CC
is comprised of one voting representative from each member of the consortium.
The new awardee under this current RFA will also be a voting member on the CC.
The CC will continue to serve as an advisory body for the common or shared
protocols to be used in the studies. NIOSH staff serves as non-voting members
of the CC.
Goals
An important goal of this research program is to better define exposure-
response relationships between job physical stressors and musculoskeletal
disorders across manufacturing and service industries. Information regarding
the utility of practical methods that could be readily employed by
occupational safety and health practitioners, such as the NIOSH Lifting
Equation and the American Conference of Governmental Industrial Hygienists
Threshold Limit Value for Hand Activity, is another anticipated outcome. In
addition, it is anticipated that practitioners in occupational health will be
able to use the results from this study to more quickly and reliably
discriminate job tasks that represent low, moderate and high risk for
musculoskeletal disorders. With such knowledge effective job design changes
or interventions can be developed that reduce the burden of work-related
musculoskeletal disorders.
In summary, the intent of the initial RFA (RFA: OH-00-003) was to assemble a
cross-disciplinary, multi-institutional consortium to define exposure response
relationships among physical job stressors and upper limb and low back MSDs.
Three Cooperative agreements were awarded, one focused on upper extremity
disorders, one focused on low back disorders and the third focused on hand-arm
vibration. As a result of a second RFA (RFA: OH-02-010), one cooperative
agreement was awarded that focused on upper extremity disorders. The intent
of the current RFA is to support additional research that is focused on low
back disorders in relation to multiple levels of physical demands related to
lifting and manual handling tasks in the manufacturing or service industry.
USEFUL REFERENCES
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).
MECHANISM OF SUPPORT
This RFA will use NIH U01 award mechanism(s). As an applicant you will be
solely responsible for planning, directing, and executing the proposed
project. This RFA is a one-time solicitation. Future unsolicited, competing-
continuation applications based on this project will compete with all
investigator-initiated applications and will be reviewed according to the
customary peer review procedures. The anticipated award date is September 30,
2003. Applications that are not funded in the competition described in this
RFA may be resubmitted as NEW investigator-initiated applications using the
standard receipt dates for NEW applications described in the instructions to
the PHS 398 application.
This RFA uses just-in-time concepts. It also uses the modular as well as the
non-modular budgeting formats (see
https://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if
you are submitting an application with direct costs in each year of $250,000
or less, use the modular format. Otherwise follow the instructions for non-
modular research grant applications. This program does not require cost
sharing as defined in the current NIH Grants Policy Statement at
https://grants.nih.gov/archive/grants/policy/nihgps_2001/part_i_1.htm.
The NIH (U01) is a cooperative agreement award mechanism in which the
Principal Investigator retains the primary responsibility and dominant role
for planning, directing, and executing the proposed project, with NIH staff
being substantially involved as a partner with the Principal Investigator, as
described under the section "Cooperative Agreement Terms and Conditions of
Award".
FUNDS AVAILABLE
NIOSH intends to commit approximately $500,000 in FY 2003 to fund one new
cooperative agreement award in response to this RFA. If additional monies
become available, an additional award may be made. An applicant may request a
project period of up to three years and a budget for total costs (direct and
indirect) up to $500,000 per year. Because the nature and scope of the
proposed research will vary from application to application, it is anticipated
that the size and duration of each award will also vary. Although the
financial plans of NIOSH provide support for this program, awards pursuant to
this RFA are contingent upon the availability of funds and the receipt of a
sufficient number of meritorious applications.
Applicants should allocate funds for travel for two project staff to attend
two CC meetings held during each project year.
ELIGIBLE INSTITUTIONS
You may submit (an) application (s) if your institution has any of the
following characteristics:
o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges, hospitals,
and laboratories.
o Units of State and local governments
o Eligible agencies of the Federal government
o Domestic or foreign
o Faith-based or community-based organizations
Note: Title 2 United States Code section 1611 states that an organization
described in section 501(c)(4) of the Internal Revenue Code that engages in
lobbying activities is not eligible to receive Federal funds constituting an
award, grant, or loan.
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Any individual with the skills, knowledge, and resources necessary to carry
out the proposed program is invited to work with their institution to develop
an application for support. Individuals from underrepresented racial and
ethnic groups as well as individuals with disabilities are always encouraged
to apply for NIOSH/CDC programs.
SPECIAL REQUIREMENTS
Applicants with established resources and facilities to recruit study sites
and to enroll workers willing to participate in the study in a cost effective
manner are encouraged.
The following should be addressed in a clear and organized manner (see also
peer review criteria section):
o Timeline: a detailed timeline for the proposed study must be included in the
application.
o In a separate section labeled ,"Participant Notification of Study Results",
the applicant should describe plans for notifying participants about their
individual results and the overall results of the study.
o Plan for sharing data with other members of the MSDC and using uniform
exposure assessment methods and health assessment methods to identify MSDs.
Applicants should highlight unique expertise and/or unusual opportunities as
related to the purpose of this RFA. Examples include, but are not limited to:
o Expertise in specialized areas with potential applications to the
issues/questions considered in this RFA, conducting epidemiologic field
studies of working populations, experience in exposure assessment using
practical field methods such as the NIOSH lifting equation; and collection of
health outcome data at the workplace;
o Access to specific work sites and working populations that are willing to
participate in studies of work-related low back disorders;
o Expertise in assessing work situations and individual job tasks in relation
to the development of work-related low back disorders; and/or
o Expertise in negotiating with work site management in field settings.
Coordination Committee and Annual MSDC Meetings
Applicants should include in their budget support for themselves and for at
least one other person from their institutions integrally involved in the
project to attend two Coordination Committee (CC) meetings of the MSDC each
year. For budget preparation and project planning purposes, it should be
assumed that these meetings will be of one or two days duration and will be
held in Cincinnati, Ohio. 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 research issues.
Cooperative Agreement Terms and Conditions of Award
The Terms and Conditions of Award, below, will be incorporated in the award
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 and HHS Grant Administration Regulations at 45 CFR Parts 74 and 92.
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(s) 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 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. It is anticipated that
recipients will utilize common approaches as agreed upon by the CC so that
data can be combined. Recipient will:
a. Enroll and follow the study participants and establish and maintain
mechanisms to ensure that data collection and management procedures have
necessary quality control and assure confidentiality of data.
b. Serve as a permanent member of the CC.
c. Develop and submit semiannual progress reports in a standard format that is
agreed upon after an award is made.
d. Provide program management oversight for the project.
e. Notify study participants of the overall study results.
2. NIOSH Staff Responsibilities
NIOSH will have substantial scientific programmatic involvement during conduct
of this activity, through technical assistance, advice, and coordination.
a. Serve as a scientific liaison between the awardee and other program staff
at NIOSH with experience in the occupational health issues of MSDs and
epidemiology.
b. Provide expert consultation in the area of occupational epidemiology.
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 (and
other) clearances that may be required during the conduct of the study.
3. Collaborative Responsibilities
The Coordination Committee will serve as the main governing board for the
cooperative agreements making up the MSDC. NIOSH scientists and one external
scientist from each award will have membership on the Coordination Committee.
One critical role of the CC is to ensure that the study designs and data
collection protocols are uniform and compatible across the MSDC.
The Coordination Committee may invite, when it deems it to be necessary,
additional, non-voting scientific advisors to the meetings at which research
priorities and opportunities are discussed.
It is anticipated that there will be two Coordination Committee meetings each
year. Locations of the meetings will be determined by the CC. The committee
chair (NIOSH representatives will not serve in this position) will schedule
the meetings and will be responsible for developing the meeting agenda,
chairing the meetings, and producing CC reports.
At the Coordination Committee meetings, the Coordination Committee will: 1)
make recommendations on the study protocols and data collection approaches, 2)
discuss the study populations that have been/will be recruited, 3) identify
and recommend solutions to unexpected study problems and 4) discuss ways to
efficiently coordinate and combine common study activities. These
recommendations will be of direct benefit to the awardees by improving the
scientific quality and comparability of their research.
WHERE TO SEND INQUIRIES
We encourage inquiries concerning this RFA and welcome the opportunity to
answer questions from potential applicants. Inquiries may fall into two
areas: scientific/research, peer review and financial or grants management
issues. This RFA and other CDC Announcements can be found on the CDC HomePage
(http://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 (http://www.cdc.gov/niosh) under
"Extramural Programs", "Current Funding Opportunities".
Direct inquiries regarding programmatic issues to:
Lee M. Sanderson, Ph.D.
Scientific Program Administrator
Office of Extramural Programs
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention
1600 Clifton Road, N.E.
Executive Park Building 24, Room 1429, MS E-74
Atlanta, GA 30333
Telephone: (404) 498-2546
FAX: (404) 498-2571
Email: lsanderson@cdc.gov
Direct your questions about peer review issues to:
Pervis C. Major, Ph.D.
Scientific Review Administrator
Office of Extramural Programs
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention
1095 Willowdale Road
Morgantown, WV 26505
Telephone: 304-285-5979
Fax: 304-285-6147
Email: pmajor@cdc.gov
Direct inquiries regarding grants management business matters to:
Larry Guess
Acting Chief
Acquisition and Assistance Field Branch
Centers for Disease Control and Prevention
626 Cochrans Mill Road
Pittsburgh, Pennsylvania 15236-0070
Announcement Number OH-03-006
Telephone: (412) 386-6826
Email: lguess@cdc.gov
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that includes
the following information:
o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
o Participating institutions
o Number and title of this RFA
Although a letter of intent is not required, is not binding, and does not
enter into the review of an application, the information that it contains is
used to estimate the potential review workload and plan the review.
The letter of intent should be sent to by the date listed at the beginning of
the document. The letter of intent should be sent to:
Pervis C. Major, Ph.D.
Scientific Review Administrator
Office of Extramural Programs
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention
1095 Willowdale Road
Morgantown, WV 26505
Telephone 304-285-5979
Fax 304-285-6147
Email: pmajor@cdc.gov
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant application
instructions and forms (rev. 5/2001). The PHS 398 is available at
https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive
format. For further assistance contact GrantsInfo, Telephone (301) 710-0267,
Email: GrantsInfo@nih.gov. Information to prepare a detailed budget is
provided in the instructions. If the proposed project involves organizations
or persons other than those affiliated with the applicant organization,
letters of support and/or cooperation must be included.
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting
up to $250,000 per year in direct costs must be submitted in a modular grant
format. The modular grant format simplifies the preparation of the budget in
these applications by limiting the level of budgetary detail. Applicants
request direct costs in $25,000 modules. Section C of the research grant
application instructions for the PHS 398 (rev. 5/2001) at
https://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step
guidance for preparing modular grants. Additional information on modular
grants is available at
https://grants.nih.gov/grants/funding/modular/modular.htm.
USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001)
application form must be affixed to the bottom of the face page of the
application. Type the RFA number on the label. 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 RFA label is also available at:
https://grants.nih.gov/grants/funding/phs398/labels.pdf
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of
the application, including the Checklist, and three signed photocopies, in one
package to:
Center for Scientific Review (CSR)
National Institutes of Health
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:
Pervis C. Major, Ph.D.
Scientific Review Administrator
Office of Extramural Programs
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention
1095 Willowdale Road
Morgantown, WV 26505
Telephone 304-285-5979
Fax 304-285-6147
Email: pmajor@cdc.gov
APPLICATION PROCESSING: Applications must be received on or before the
application receipt date listed in the heading of this RFA. If an application
is received after that date, it will be returned to the applicant without
review.
Although there is no immediate acknowledgement of the receipt of an
application, applicants are generally notified of the review and funding
assignment within 8 weeks.
The Center for Scientific Review (CSR) and NIOSH 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. However, when a previously unfunded application, originally
submitted as an investigator-initiated application, is to be submitted in
response to an RFA, it is to be prepared as a NEW application. That is the
application for the RFA must not include an Introduction describing the
changes and improvements made, and the text must not be marked to indicate the
changes. While the investigator may still benefit from the previous review,
the RFA application is not to state explicitly how.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by CSR and
responsiveness by NIOSH. Incomplete applications will be returned to the
applicant without further consideration.
Incomplete applications will be returned to the applicant without further
consideration.
Applications that are complete and responsive to the RFA will be evaluated for
scientific and technical merit by a scientific review group convened by NIOSH
in accordance with the review criteria stated below. As part of the initial
merit review, all applications will:
o Receive a written critique
o Undergo a process in which only those applicants deemed to have the highest
scientific or technical merit, generally the top half of the applications
under review, will be discussed and assigned a priority score
o Receive a second level of review by the NIOSH Secondary Review Committee.
REVIEW CRITERIA
The criteria that NIOSH will use to review applications for scientific merit
and for meeting program objectives are provided below. In the written
comments, reviewers will be asked to discuss the following aspects of your
application in order to judge the likelihood that the proposed research will
have a substantial impact on the pursuit of these goals:
o Significance
o Approach
o Innovation
o Investigator
o Environment
The scientific review group will address and consider each of these criteria
in assigning your application=s overall score, weighting them as appropriate
for each application. Your application does not need to be strong in all
categories to be judged likely to have major scientific impact and thus
deserve a high priority score. For example you may propose to carry out
important work that by its nature is not innovative but essential to move a
field forward.
SIGNIFICANCE: Does this study address an important problem in the area of
work-related musculoskeletal disorders? If the aims of the applications are
achieved, how will scientific knowledge be advanced? What will be the effect
of these studies on the concepts or methods that drive this field? Will the
proposed research contribute to the overall aim of better defining the
exposure-response relationships between varying levels of job physical
stressors and low back disorders?
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
alternatives? Does the recruitment plan address the need to enroll workers
with a range of exposure to the physical demands of lifting and manual
material handling (high, medium and low) to have sufficient exposure contrast
to assess exposure response? Is the plan for assembling work sites and
participants suitable for this study? Will these worksites provide
participants who will be representative of the US workforce? Does the project
employ standardized, comparable approaches for exposure assessment such as the
NIOSH Lifting Equation? Is the time line for the studies appropriate and well
described? Are the methods for assuring privacy and maintaining
confidentiality of participant records, including specific protections for
computerized data systems adequate? Is there adequate consideration of follow
up of study participants to assess changes in exposure and health outcomes?
Does the proposed project provide an appropriate approach for maintaining
participation over the study time period? Is there adequate consideration of
data design and analysis issues related to prospective studies of
musculoskeletal disorders, such as sample size, drop outs, multiple
comparisons, and recurrent and episodic health outcomes?
INNOVATION: Does the project employ novel concepts, approaches, or methods?
Are the aims original and innovative? Does the project challenge existing
paradigms or develop new methodologies or technologies? Are the investigators
open to coordinating methods of data collection and analysis with other MSDC
consortium members?
INVESTIGATORS: Are the Principal Investigator, Co-Principal Investigators and
their teams appropriately trained and have adequate experience to conduct both
exposure and health assessments in order to evaluate exposure response? Does
the team have a multidisciplinary background to design and conduct a
prospective epidemiologic field study? Is the work proposed appropriate to the
experience level of the principal investigator and his/her collaborators?
ENVIRONMENT: Does the scientific environment in which the work will be done
significantly contribute to the probability of success? Do the proposed
experiments take advantage of unique features of the scientific environment or
employ useful collaborative arrangements? Is there evidence of institutional
support to facilitate and maintain a high response rate? Does the proposed
project utilize an existing resource or constitute a new one?
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following
items will be considered in the determination of scientific merit and the
priority score:
PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human
subjects and protections from research risk relating to their participation in
the proposed research will be assessed. (See criteria included in the section
on Federal Citations, below).
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans
to include subjects from both genders, all racial and ethnic groups (and
subgroups), and children as appropriate for the scientific goals of the
research. Plans for the recruitment and retention of subjects will also be
evaluated. (See Inclusion Criteria in the sections on Federal Citations,
below).
CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to
be used in the project, the five items described under Section f of the PHS
398 research grant application instructions (rev. 5/2001) will be assessed.
ADDITIONAL CONSIDERATIONS
DATA SHARING: The adequacy of the proposed plan to share data.
BUDGET: The reasonableness of the proposed budget and the requested period of
support in relation to the proposed research.
PROGRAMMATIC REVIEW CRITERIA
(1) Magnitude and severity of the condition (problem) in the worker
population.
(2) Likelihood of developing applied technical knowledge for the prevention
of occupational safety and health hazards on a national or regional basis.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: May 20, 2003
Application Receipt Date: June 12, 2003
Earliest Anticipated Award Date: September 30, 2003
AWARD CRITERIA
Award criteria that will be used to make award decisions include:
o Scientific and technical merit
o Availability of funds
o Programmatic priorities
REQUIRED FEDERAL CITATIONS
OFFICE OF MANAGEMENT AND BUDGET CLEARANCE: Projects that involve the
collection of information from ten or more individuals and are funded by this
cooperative agreement will be subject to review by the Office of Management
and Budget (OMB) under the Paperwork Reduction Act.
HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that
applications and proposals involving human subjects must be evaluated with
reference to the risks to the subjects, the adequacy of protection against
these risks, the potential benefits of the research to the subjects and
others, and the importance of the knowledge gained or to be gained.
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.
MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components
involving Phase I and II clinical trials must include provisions for
assessment of patient eligibility and status, rigorous data management,
quality assurance, and auditing procedures. In addition, it is NIH policy
that all clinical trials require data and safety monitoring, with the method
and degree of monitoring being commensurate with the risks (NIH Policy for
Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998:
https://grants.nih.gov/grants/guide/notice-files/not98-084.html).
INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of
the NIH that women and members of minority groups and their sub-populations
must be included in all NIH-supported clinical research projects unless a
clear and compelling justification is provided indicating that inclusion is
inappropriate with respect to the health of the subjects or the purpose of the
research. This policy results from the NIH Revitalization Act of 1993 (Section
492B of Public Law 103-43).
All investigators proposing clinical research should read the "NIH Guidelines
for Inclusion of Women and Minorities as Subjects in Clinical Research -
Amended, October, 2001," published in the NIH Guide for Grants and Contracts
on October 9, 2001 (https://grants.nih.gov/grants/guide/notice-files/
NOT-OD-02-001.html); a complete copy of the updated Guidelines are available
at: https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_
2001.htm. The amended policy incorporates: the use of an NIH definition of
clinical research; updated racial and ethnic categories in compliance with the
new OMB standards; clarification of language governing NIH-defined Phase III
clinical trials consistent with the new PHS Form 398; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a)
all applications or proposals and/or protocols must provide a description of
plans to conduct analyses, as appropriate, to address differences by
sex/gender and/or racial/ethnic groups, including subgroups if applicable;
and b) investigators must report annual accrual and progress in conducting
analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS:
The NIH maintains a policy that children (i.e., individuals under the age of
21) must be included in all human subjects research, conducted or supported by
the NIH, unless there are scientific and ethical reasons not to include them.
This policy applies to all initial (Type 1) applications submitted for receipt
dates after October 1, 1998.
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 is available at
https://grants.nih.gov/grants/funding/children/children.htm
REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: tc
"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. You will find this policy announcement in the NIH Guide for Grants
and Contracts Announcement, dated June 5, 2000, at
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The
Office of Management and Budget (OMB) Circular A-110 has been revised to
provide public access to research data through the Freedom of Information Act
(FOIA) under some circumstances. Data that are (1) first produced in a
project that is supported in whole or in part with Federal funds and (2) cited
publicly and officially by a Federal agency in support of an action that has
the force and effect of law (i.e., a regulation) may be accessed through FOIA.
It is important for applicants to understand the basic scope of this
amendment. NIH has provided guidance at
https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this PA in a public archive,
which can provide protections for the data and manage the distribution for an
indefinite period of time. If so, the application should include a
description of the archiving plan in the study design and include information
about this in the budget justification section of the application. In
addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award.
STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The
Department of Health and Human Services (DHHS) issued final modification to
the "Standards for Privacy of Individually Identifiable Health Information",
the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal
regulation under the Health Insurance Portability and Accountability Act
(HIPAA) of 1996 that governs the protection of individually identifiable
health information, and is administered and enforced by the DHHS Office for
Civil Rights (OCR). Those who must comply with the Privacy Rule (classified
under the Rule as "covered entities") must do so by April 14, 2003 (with the
exception of small health plans which have an extra year to comply).
Decisions about applicability and implementation of the Privacy Rule reside
with the researcher and his/her institution. The OCR website
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including
a complete Regulation Text and a set of decision tools on "Am I a covered
entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes
involving the review, funding, and progress monitoring of grants, cooperative
agreements, and research contracts can be found at
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals
for NIH funding must be self-contained within specified page limitations.
Unless otherwise specified in an NIH solicitation, 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. Furthermore,
we caution reviewers that their anonymity may be compromised when they
directly access an Internet site.
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, NIOSH/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 NIOSH/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 NIOSH/CDC grants and cooperative agreements need to be careful
to prevent NIOSH/CDC funds from being used to influence or promote pending
legislation. With respect to conferences, public events, publication, and
"grass roots" activities that relate to specific legislation, recipients of
NIOSH/CDC funds should give attention to isolating and separating the
appropriate use of NIOSH/CDC funds from non-NIOSH/CDC funds. NIOSH/CDC also
cautions recipients of NISOH/CDC funds to be careful not to give the
appearance that NIOSH/CDC funds are being used to carry out activities in a
manner that is prohibited under Federal law.
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."
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. This RFA is
related to one or more focus areas. Potential applicants may obtain a copy of
"Healthy People 2010" at http://www.healthypeople.gov/
AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal
Domestic Assistance under 93.262: Occupational Safety and Health Research
Grants at http://www.cfda.gov/ and is not subject to the intergovernmental
review requirements of Executive Order 12372 or Health Systems Agency review.
This program is authorized under the Public Health Service Act, as amended,
Section 301(a)[42 U.S.C. 2419a)], 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. The NIH Grants Policy Statement can be found at
https://grants.nih.gov/grants/policy/policy.htm
SMOKE-FREE WORKPLACE: The PHS/CDC/NIOSH strongly encourages all grant
recipients to provide a smoke-free workplace and discourage the 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.