Collaborative Program for the Identification and Prevention of
Work-related Musculoskeletal Disorders
RELEASE DATE: May 2, 2002
RFA: OH-02-010
PARTICIPATING INSTITUTES AND CENTERS (ICs):
National Institute for Occupational Safety and Health (NIOSH)
Centers for Disease Control and Prevention (CDC)
(http://www.cdc.gov/niosh/homepage.html)
LETTER OF INTENT RECEIPT DATE: June 11, 2002
APPLICATION RECEIPT DATE: July 11, 2002
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Purpose of the RFA
o Research Objectives
o Mechanism(s)of Support
o Funds Available
o Use of Funds
o Eligibility Considerations and Requirements
o Special Requirements
o Terms and Conditions of Award
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 invites
applications for Cooperative Agreements (U01s) from single
institutions or consortia of institutions who are capable of, and
interested in, conducting research to quantify the risk for upper
limb and low back musculoskeletal disorders at varying levels of
exposure to physical job stressors (repetitive motion, forceful
exertion, awkward postures, manual handling, etc.).
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. In 1996, a
total of 600,390 work-related musculoskeletal injury cases
resulting in work absence or restriction were reported to be
caused by overexertion and repetitive motion by the Bureau of
Labor Statistics (BLS). 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% of
all workers= compensation claims and 46% 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. Past studies primarily have been cross sectional
or retrospective, the limitations of these approaches for
determining exposure response relationships have been widely
discussed in the scientific literature.
This RFA builds on an initial effort (see
https://grants.nih.gov/grants/guide/rfa-files/RFA-OH-00-003.html)
in 2000 to begin a Collaborative Program for the Identification
and Prevention of Work-related Musculoskeletal Disorders. The
current RFA expands this program by making available additional
funds to meet the objective of collecting sufficient data to
better understand exposure response relationships between physical
stressors and MSDs. An integral part of this initiative is
participation in a Work-related Musculoskeletal Disorders
Consortium (MSDC). In order to achieve the goals of this program,
it is important to have common data elements shared 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
that workers undergo standard health tests to identify MSDs.
Etiology is a critical element in meeting the RFA objective of
studying MSD. 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 MSDC. New awardees under this current RFA will also have
one 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. The NIOSH liaison serves as a non-voting member of the
CC.
Research Goals
An anticipated outcome of this research program will be better
defined exposure-response relationships between job physical
stressors and musculoskeletal disorders across industries.
Information regarding the utility of practical methods that could
be readily employed by occupational safety and health
practitioners, such as the American Conference of Governmental
Industrial Hygienists Threshold Limit Value for Hand Activity and
the NIOSH Lifting Equation, is another anticipated outcome. With
such knowledge, effective job design changes or interventions can
be developed that reduce the burden of work-related MSDs.
The MSDC will combine the expertise and resources of NIOSH
research staff with those of external collaborators. It is
anticipated that up to four new extramural partners that
demonstrate expertise in 1) upper limb MSDs (CTS, hand-wrist
tendinitis, epicondylitis) at varying levels of hand activity,
exertion, and other physical stressors in job tasks, and/or 2) low
back pain in relation to physical demands of lifting and manual
handling tasks will be awarded cooperative agreements and will
participate in the MSDC. Individual investigators will be free to
analyze and publish data from the work sites they study. In
addition, each investigator will be responsible for providing data
to a data coordinating center in a uniform fashion.
The intent of this initiative is to assemble a cross-disciplinary,
multi-institutional consortium to define exposure response
relationships among physical job stressors and upper limb and low
back MSDs. To accomplish this objective, it is envisioned that
the following research areas be examined: 1) upper limb MSDs at
varying levels of hand activity, exertion, and other physical
stressors in job tasks, and 2) low back pain in relation to
physical demands of lifting and manual handling tasks.
USEFUL REFERENCE
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
The administrative and funding instrument to be used for this
program will be a cooperative agreement (U01). Details of the
responsibilities, relationships and governance of the study to be
funded under cooperative agreement(s) are discussed later in this
document under the section Terms and Conditions of Award.
The total project period for an application submitted in response
to this present RFA may not exceed four (4) years. The
anticipated award date is September 30, 2002. The award and level
of support depends on receipt of applications of high scientific
merit. The award pursuant to this RFA is contingent upon the
availability of funds.
An applicant may only submit applications that are limited in
scope to one of the two research areas defined in this RFA. On
the face page of the application, line two, the applicant must
indicate the proposed research, either 1) upper limb MSDs (CTS,
hand-wrist tendinitis, epicondylitis) at varying levels of hand
activity, exertion, and other physical stressors in job tasks, or
2) low back pain in relation to varying levels of physical demand
due to lifting and manual handling tasks. If an applicant wishes
to apply for more than one research area, you must submit a
separate and independent application. Applications which address
more than one of the RFA topics will be returned as non-
responsive.
This RFA is a one time announcement. If by the end of the fourth
year of the award NIOSH has not determined whether or how this
program will be continued, awardees should contact NIOSH program
staff and consider submitting investigator-initiated (R01)
application which will compete with all investigator-initiated
applications and be reviewed according to the customary peer
review procedures.
FUNDS AVAILABLE
Approximately $1,000,000 is available in FY 2002 to fund two to
four awards. The maximum amount that may be requested is $500,000
total cost (direct and indirect) per year.
Awards will be made for a 12-month budget period within a project
period up to four(4) years.
Continuation awards within an approved project period will be made
on the basis of satisfactory progress as evidenced by required
reports and the availability of funds.
USE OF FUNDS
Recipient should allocate funds for travel for two project staff
to attend two MSDC meetings held during each project year.
ELIGIBILITY REQUIREMENTS
Applications may be submitted by public and private nonprofit and
for-profit organizations and by governments and their agencies,
that is, universities, colleges, research institutions, hospitals,
other public and private nonprofit and for-profit organizations,
State and local governments or their bona fide agents, including
small, minority and/or women-owned businesses. Applications from
minority and women investigators are encouraged.
SPECIAL CONSIDERATIONS AND 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 Time line: a detailed time line 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.
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, such as health
effects assessment for the upper extremities, field studies of
working populations experiencing work-related MSDs and experience
utilizing the NIOSH lifting equation,
o Access to specific work sites and working populations that are
willing to participate in studies of work-related MSDs,
o Expertise in assessing work situations and individual job tasks
in relation to the development of work-related MSDs, and/or
o Expertise in interviewing workers and 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.
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 in 45 CFR Parts 74 and 92, and
PHS Grants Policy Statement. The administrative and funding
instrument used for this program is a cooperative agreement (U01),
an assistance mechanism (rather than an acquisition mechanism) in
which substantial NIOSH scientific and/or programmatic involvement
with the awardee is anticipated during performance of the
activity.
Under the cooperative agreement, the NIOSH purpose is to support
and/or stimulate the recipient"s activity by involvement in and
otherwise working jointly with the award recipient in a partner
role, but it is not to assume direction, prime responsibility, or
a dominant role in the activity. Consistent with this concept,
the dominant role and prime responsibility for the activity
resides with the awardee(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. develop an appropriate data collection instrument,
b. 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,
c. provide study participants with individual notification
letters when medical tests are performed,
d. serve as a permanent member of the CC,
e. develop and submit semiannual progress reports in a standard
format that is agreed upon after an award is made,
f. collaborate in the scientific reporting of findings,
g. provide program management oversight for the project, and
h. 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. NIOSH staff will:
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. One external
scientist from each award will have membership on the Coordination
Committee, the NIOSH liaison will be a non-voting member.
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 CC may, when necessary, invite additional, non-voting
scientific advisors to the meetings at which research priorities
and opportunities are discussed.
It is anticipated that there will be two CC 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.
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 and
financial or grants management issues. 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 Funding
Opportunities.
Direct inquiries regarding programmatic issues to:
Lee M. Sanderson, Ph.D.
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 inquiries regarding grants management business matters to:
Mildred Garner or Robert Williams
Announcement Number OH-02-010
Grants Management Branch, Procurement and Grants Office
Centers for Disease Control and Prevention (CDC)
2920 Brandywine Road, Suite 3000
Atlanta, Georgia 30341
Telephone: 770-488-2745 or 770-488-2656
Email: mgarner@cdc.gov or rww8@cdc.gov
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent by
June 11, 2002, 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:
Price Connor, Ph.D.
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 1423, MS E-74
Atlanta, GA 30333
Telephone 404-498-2511
Fax 404-498-2569
Email: pconnor@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.
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:
Price Connor, Ph.D.
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 1423, MS E-74
Atlanta, GA 30333
Telephone 404-498-2511
Fax 404-498-2569
Email: pconnor@cdc.gov
APPLICATION PROCESSING: Applications must be received by July 11,
2002. If an application is received after that date, it will be
returned to the applicant without review.
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. CSR and NIOSH 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 include an introduction addressing the previous
critique.
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.
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.
(1) 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 job physical stressors and
musculoskeletal disorders?
(2) 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? Are the plans for the
recruitment and retention of subjects adequate? Is there adequate
consideration of follow up of study participants? For example, is
the plan for follow up of participants adequate? Is the plan for
tracking drop outs adequate? Is the plan for assembling work
sites and participants suitable for this study? 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? Does the project employ
standardized, comparable approaches for exposure assessment such
as the American Conference of Governmental Industrial Hygienists
Threshold Limit Value for Hand Activity and the NIOSH Lifting
Equation.
(3) 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?
(4) INVESTIGATORS: Are the Principal Investigator, Co-Principal
Investigators and their teams appropriately trained and have
adequate experience to carry out this work? Is the work proposed
appropriate to the experience level of the principal investigator
and his/her collaborators?
(5) 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? Does the proposed project utilize an existing resource
or constitute a new one?
(6) OTHER: In addition to the above criteria, all applications
will also be reviewed with respect to the following. The
reasonableness of the proposed budget and duration in relation to
the proposed research. The adequacy of plans to include both
genders, minorities and their subgroups, for the scientific goals
of the research. 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
(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: June 11, 2002
Application Receipt Date: July 11, 2002
Anticipated Award Date: September 30, 2002
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
o Program balance for the two study areas (priority for funding at
least one for each area, low back and upper limb) provided
applications are of sufficient scientific merit.
REQUIRED FEDERAL CITATIONS
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 research projects involving human
subjects, whenever feasible and appropriate. Racial and ethnic
groups are those defined in OMB Directive No. 15 and include
American Indian or Alaska Native, Asian, Black or African
American, Hispanic or Latino, Native Hawaiian or other Pacific
Islander. Applicants shall ensure that women, racial and ethnic
minority populations are appropriately represented in applications
for research involving human subjects. Where clear and compelling
rationale exist that inclusion is inappropriate or not feasible,
this situation must be explained as part of the application. This
policy does not apply to research studies when the investigator
cannot control the race, ethnicity, and/or sex of subjects.
Further guidance to this policy is contained in the Federal
Register, Vol. 60, No. 179, pages 47947-47951, and dated Friday,
September 15, 1995.
All investigators proposing research involving human subjects
should read the NIH Guidelines For Inclusion of Women and
Minorities as Subjects in Clinical Research-Amended, October 9,
2001, published in the NIH Guide for Grants and Contracts on
October 9, 2001,
https://grants.nih.gov/grants/funding/women_min/women_min.htm.,a
complete copy of the updated Guidelines are available at
https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN
SUBJECTS: It is the policy of NIH that children (i.e., individuals
under the age of 21) must be included in all human subjects
research, conducted or supported by 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. This policy will be followed by
NIOSH for this announcement. All investigators proposing research
involving human subjects should read the NIH Policy and
Guidelines, on the inclusion of children as participants in
research involving human subjects that is available at
https://grants.nih.gov/grants/funding/children/children.htm
Investigators also may obtain copies of these policies from the
program staff listed under INQUIRIES. Program staff may also
provide additional relevant information concerning the policy.
REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT
PARTICIPANTS: 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 performance 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.
Note: Investigators in states with existing statutes covering
guidance for the protection of humans, will be asked to submit
documentation detailing fully the state authority. If a state
does not have statutory authority for all the human subjects
activities proposed in the application, the awardee must obtain
human subject clearances as described above. The project plan in
the application must fully describe the involvement of human
subjects and protections. This information should be included in
the Human Subjects Research Section of PHS 398.
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-(45 CFR 74.36) 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. Guidance is
provided at:
https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm
Applicants may wish to place data collected under this RFA 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.
URLS IN NIOSH GRANT APPLICATIONS OR APPENDICES: All applications
and proposals 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
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, 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.
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. For a copy of Healthy People 2010,
visit the internet site:
http://www.health.gov/healthypeople/default.htm
AUTHORITY AND REGULATIONS: This program is described in the
Catalog of Federal Domestic Assistance Number 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 not subject to the intergovernmental review requirements of
Executive Order 12372 or Health Systems Agency Review.