and Human Services (HHS)
EXPIRED
OCCUPATIONAL HEALTH AND SAFETY RESEARCH (R01)
RELEASE DATE: December 12, 2003
PA NUMBER: PA-04-038 (This PA has been replaced with PA-07-318)
(See amendment in NOT-CA-07-002)
EXPIRATION DATE: November 23, 2006
(This Program Announcement (PA) replaces PA-99-143)
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATIONS:
Centers for Disease Control and Prevention (CDC)
National Institute for Occupational Safety and Health (NIOSH)
(http://www.cdc.gov/niosh)
National Institutes of Health (NIH)
(http://www.nih.gov)
COMPONENTS OF PARTICIPATING ORGANIZATIONS:
National Cancer Institute (NCI)
(http://www.nci.nih.gov/)
National Heart, Lung, and Blood Institute (NHLBI)
(http://www.nhlbi.nih.gov/)
National Institute on Aging (NIA)
(http://www.nia.nih.gov/)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
(http://www.niaaa.nih.gov/)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
(http://www.niams.nih.gov/)
National Institute on Deafness and Other Communication Disorders (NIDCD)
(http://www.nidcd.nih.gov/)
National Institute of Environmental Health Sciences (NIEHS)
(http://www.niehs.nih.gov/)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): This program is described
in the Catalog of Federal Domestic Assistance Nos. 93.262 NIOSH; 93.393 NCI;
93.837, 93.838, and 93.839 NHLBI; 93.866 NIA; 93.273 NIAAA; 93.855, 93.856
NIAID; 93.846 NIAMS; 93.173 NIDCD; and 93.113 and 93.115 NIEHS.
THIS PA CONTAINS THE FOLLOWING INFORMATION
o Purpose of the PA
o Research Objectives
o Mechanism(s) of Support
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS PA
The National Institute for Occupational Safety and Health (NIOSH), Centers
for Disease Control and Prevention (CDC) and participating Institutes and
Centers, National Institutes of Health (NIH) invite grant applications for
research related to occupational safety and health. NIOSH research programs
support priority areas identified in the National Occupational Research
Agenda (NORA) and other significant programs related to occupational safety
and health. Visit the NIOSH homepage for a full description of occupational
safety and health program areas http://www.cdc.gov/niosh/homepage.html.
Research areas described in the RESEARCH OBJECTIVES section provide an
example of NORA and other occupational safety and health research program
areas.
The overall purpose of this grants program is to develop knowledge that can
be used in preventing occupational diseases and injuries and to understand
better their underlying pathophysiology. This purpose is shared by several
components of the Public Health Service (PHS) within the CDC and the NIH.
Within CDC, NIOSH is the lead Federal Institute responsible for conducting
research and making recommendations for the prevention of work-related
illnesses and injuries. However, there are other Federal components that
contribute significantly to the research base for understanding the causes of
occupational illnesses and injuries. Interest statements from the sponsors
of this program announcement are given below, and more information about
their individual interests may be found on their respective Internet sites.
Applications will be assigned to an institute on the basis of established PHS
referral guidelines.
NIOSH supports research to identify and investigate the relationships between
hazardous working conditions and associated occupational diseases and
injuries; to develop more sensitive means of evaluating hazards at work
sites, as well as methods for measuring early markers of adverse health
effects and injuries; to develop new protective equipment, engineering
control technology, and work practices to reduce the risks of occupational
hazards; and to evaluate the technical feasibility or application of a new or
improved occupational safety and health procedure, method, technique, or
system.
The National Cancer Institute (NCI) supports training and research related to
the causes, detection, prevention, diagnosis, prognosis, and treatment of
cancer. Of special interest is basic, applied, methodological, and
statistical research that can advance cancer control activities, including
surveillance, dissemination of public health information, and elucidation of
susceptibility factors associated with cancer risk in individuals and
population subgroups. NCI-relevant NORA priority areas include applicable
research approaches and methods (for example: exposure and risk assessment,
bio-monitoring and surveillance techniques, analysis of cancer risk factors,
and characterization of possible carcinogens in mixed exposures).
The National Heart, Lung and Blood Institute (NHLBI) supports an integrated
and coordinated program of basic research, clinical investigations and
trials, observational studies, and demonstration and education projects.
Research is related to the causes, prevention, diagnosis, and treatment of
heart, blood vessel, lung, and blood diseases; and sleep disorders. The
NHLBI plans and directs research in the development and evaluation of
interventions and devices related to prevention, treatment, and
rehabilitation of patients suffering from such diseases and disorders. It
also supports research on clinical use of blood and all aspects of the
management of blood resources.
The National Institute on Aging (NIA) supports training and research on basic
mechanisms involved in aging processes and the onset of age-related disease;
social and behavioral research on aging processes and the place of older
people in society; the structure and function of the aging nervous system and
the behavioral manifestations of the aging brain; and topics related to the
causes, prevention, and treatment of health problems in older persons. The
NIA supports a variety of data collections related to work and retirement
including the Panel Study of Income Dynamics, the Health and Retirement
Study, and the English Longitudinal Study on Aging. Specific to this PA, NIA
is interested in expanding research on the health needs of older workers, and
occupations such as physicians, researchers, air traffic controllers,
computer programmers, accountants, and others working in an environment of
high cognitive complexity. The development of tools to define functional
work abilities similar to the concept of ADLs and IADLs used to assess
function in general settings is also encouraged. A helpful tool in this
regard is a prepublication report of the Workshop on Technology for Adaptive
Aging from the National Research Council of the National Academy of Sciences
located at http://books.nap.edu/catalog/10857.html. NIA also looks forward
to the imminent publication of the NAS Panel report on The Health and Safety
of Older Workers. This report, among other items, will call for: the
development of longitudinal data sets that focus on job demands and health
and safety risks; the addition of modules to existing longitudinal surveys
(HRS, PSID) to investigate workplace health and safety risks; examination of
the effect of environmental exposures on normal aging and/or comorbidities;
cost/benefit analyses of job design interventions for the older worker. NIA
is also interested in studies that better quantify the impact of lifetime
exposures on health outcomes. Such exposures include work-related stress,
negative affect related to work, and low job control and autonomy.
Conversely, the NIA is also interested in studies of any positive effects
that work may have on the health and functioning of older workers. Studies
are also encouraged on health and other workplace determinants on the timing
of retirement, and the net of public and private pensions. The examination
of gender effects in any of these areas is encouraged.
The National Institute on Alcohol Abuse and Alcoholism (NIAAA) supports basic
and applied research on the causes, consequences, treatment and prevention of
alcohol-related problems including research into the effects of alcohol on
the human mind and body, prevention and treatment of alcohol abuse and
alcoholism among general and specific populations, the epidemiology of
alcoholism and alcohol-related problems, and health services research.
The National Institute of Arthritis and Musculoskeletal and Skin Diseases
(NIAMS) supports basic, clinical, and epidemiologic research and research
training and disseminates information on many forms of arthritis and diseases
of the musculoskeletal system and the skin, including (1) the normal
structure and function of joints, muscles, bones, and skin and (2) clinical
research in the fields of rheumatology, orthopedics, dermatology, metabolic
bone diseases, heritable disorders of bone and cartilage, inherited and
inflammatory muscle diseases, and sports and rehabilitation medicine.
The National Institute on Deafness and Other Communication Disorders (NIDCD)
supports biomedical and behavioral research and research training in the
normal and disordered processes of hearing, balance, smell, taste, voice,
speech and language; disease prevention and health promotion; special
biomedical and behavioral problems associated with people who have
communication impairments or disorders; and creation of devices which
substitute for lost and impaired sensory and communication function.
The National Institute of Environmental Health Sciences (NIEHS) supports
research to reduce the burden of human illness and dysfunction from exposure
to physical and chemical agents in the environment by understanding the
interactions between environmental exposures, individual susceptibility and
time.
RESEARCH OBJECTIVES
In today's society, Americans are working more hours than ever before. The
workplace environment profoundly affects health; simply by going to work each
day, we may face hazards that threaten our health and safety. Risking one's
life or health should never be considered merely part of the job. In 1970,
Congress passed the Occupational Safety and Health Act to ensure Americans
the right to "safe and healthful working conditions," yet workplace hazards
continue to inflict a tremendous toll in both human and economic costs. In
2000, private industry employers reported 5.3 million work injuries and
363,000 cases of occupational illness. An average of 16 American workers die
each day from injuries on the job (in 2000, there were 5915 fatal work
injuries). Moreover, even the most conservative estimates find that about
137 additional workers die each day from workplace diseases. Additionally,
in 1999, occupational injuries and deaths have cost approximately $123
billion in wages and lost productivity, administrative expenses, health care
and other costs. This does not include the cost of occupational disease.
These occupational injuries and diseases create needless human suffering, a
tremendous burden upon health care resources, and an enormous drain on U.S.
productivity.
NIOSH is the lead Federal institute responsible for conducting research and
making recommendations for the prevention of work-related illnesses and
injuries. NIOSH’s mandate includes the support of research in numerous
occupational safety and health areas in addition to the topics identified in
the NORA, described below. Investigators are encouraged to discuss their
research topics with NIOSH to determine the relevance to occupational health
and safety.
Because of the diverse nature of occupational safety and health issues, many
research topics are supported by NIOSH in addition to the NORA topics
described below. Thus, NIOSH supports research in other areas related to
occupational disease and injury including: violence, biomarkers, emergency
response, mining, bio-terrorism, agricultural related illnesses and injuries,
and other occupational safety and health issues. Visit the NIOSH homepage
for more information on NIOSH’s research program areas
http://www.cdc.gov/niosh/homepage.html.
In 1996, NIOSH and its partners in the public and private sectors developed
the NORA to provide a framework to guide occupational safety and health
research into the next decade. Approximately 500 organizations and
individuals outside NIOSH provided input into the development of NORA. The
agenda identifies 21 research priorities and reflects an attempt to consider
both current and emerging needs. The priority areas are not ranked; each is
considered to be of equal importance. The NORA priority research areas are
grouped into three categories: Disease and Injury, Work Environment and
Workforce, and Research Tools and Approaches.
NORA Priority Research Areas are:
Disease and Injury
1. Allergic and Irritant Dermatitis
2. Asthma and Chronic Obstructive Pulmonary Disease
3. Fertility and Pregnancy Abnormalities
4. Hearing Loss
5. Infectious Diseases
6. Low Back Disorders
7. Musculoskeletal Disorders of the Upper Extremities
8. Traumatic Injuries
Work Environment and Workforce
9. Emerging Technologies
10. Indoor Environment
11. Mixed Exposures
12. Organization of Work
13. Special Populations at Risk
Research Tools and Approaches
14. Cancer Research Methods
15. Control Technology and Personal Protective Equipment
16. Exposure Assessment Methods
17. Health Services Research
18. Intervention Effectiveness Research
19. Risk Assessment Methods
20. Social and Economic Consequences of Workplace Illness and Injury
21. Surveillance Research Methods
Potential applicants may obtain a copy of the "National Occupational Research
Agenda" (HHS, CDC, NIOSH Publication No.96-115) from the National Institute
for Occupational Safety and Health, telephone (800) 356-4674 or on the
internet at http://www.cdc.gov/niosh/nora.html.
Applicants should provide a statement about which NIOSH/NIH research area is
being addressed and a rationale for how the proposal will contribute to the
specified priority area (this information should be placed in the "Background
and Significance" section of the "Research Plan" of the application).
Assignment of applications to sponsoring Institutes will be made on the basis
of matching the research topics with the appropriate programmatic interests.
Applicants are encouraged to contact individuals listed under INQUIRIES if
they wish to discuss the relevance of their research ideas.
MECHANISM(S) OF SUPPORT
This PA will use the NIH R01 award mechanism. As an applicant, you will be
solely responsible for planning, directing, and executing the proposed
project. The total requested project period for an application submitted in
response to this PA may be up to five (5) years.
This PA uses just-in-time concepts. It also uses the modular budgeting
format as well as the non-modular budgeting formats (see
http://grants.nih.gov/grants/funding/modular/modular.htm, for more
information). Specifically, if you are submitting an application with direct
costs in each year of $250,000 or less, use the modular budget format.
Otherwise follow the instructions for non-modular budget research grant
applications. This program does not require cost sharing as defined in the
current NIH Grants Policy Statement at
http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm.
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 institutions/organizations
o Faith-based organizations
o Indian Tribes, Tribal Government, College and/or Organizations
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Any individual with the skills, knowledge, and resources necessary to carry
out the proposed research is invited to work with their institution to
develop an application for support. Individuals from under-represented
racial and ethnic groups as well as individuals with disabilities are always
encouraged to apply for CDC/NIOSH and NIH programs.
WHERE TO SEND INQUIRIES
We encourage your inquiries concerning this PA and welcome the opportunity to
answer questions from potential applicants. Inquiries may fall into two
areas: scientific/research and financial or grants management issues.
o Direct your questions about NIOSH scientific/research issues to:
For exposure assessment method, control technology, emerging technology,
surveillance, and mixed exposure studies contact:
Susan B. Board, M.S.
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 1415, MS E-74
Atlanta, GA 30333
Telephone: (404) 498-2512
FAX: (404) 498-2517
Email:[email protected]
For dermatitis, cancer research methods, fertility and pregnancy
abnormalities, hearing loss, health services research, infectious diseases,
indoor environment, organization of work, and special populations contact:
Adele Childress, Ph.D., M.S.P.H.
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) 498-2509
FAX: (404) 498-2571
Email:[email protected]
For asthma and COPD, social and economic consequences, intervention
effectiveness, musculoskeletal disorders, risk assessment methods, traumatic
injuries and all other occupational safety and health issues contact:
Michael J. Galvin, Jr., 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 1536, MS E-74
Atlanta, GA 30333
Telephone: (404) 498-2524
FAX: (404) 498-2571
Email:[email protected]
o Direct your questions about NIH scientific/research issues to:
Kumiko Iwamoto, M.D., Dr.P.H.
Epidemiology and Genetics Research Program
National Cancer Institute, NIH
6130 Executive Boulevard, ROOM 5115
Bethesda, MD 20892-7324
Telephone: (301) 435-4911
FAX: (301) 402-4279
Email: mailto:[email protected]
Hector Ortega, M.D., Sc.D.
Division of Lung Diseases
National Heart, Lung, and Blood Institute, NIH
6701 Rockledge Drive, Suite 10018, MSC 7952
Bethesda, MD 20892
Telephone: (301) 435-0202
FAX: (301) 480-3557
Email: mailto:[email protected]
Jeffrey Elias, PhD
Behavioral and Social Research Program
National Institute on Aging
Gateway Building, Suite 533
Bethesda, MD 20892-9205
Telephone: (301) 402-4156
Email: [email protected]
Kathy Salaita, Sc.D.
Prevention Research Branch
National Institute on Alcohol Abuse and Alcoholism, NIH
Willco Bldg., Suite 505
6000 Executive Blvd.
Rockville, MD 20892-7003 (Fed-Ex Zipcode: 20852)
Telephone: (301) 443-0633
FAX: (301) 443-8774
Email: mailto:[email protected]
Alan Moshell, M.D.
Skin Diseases Branch
National Institute of Arthritis and Musculoskeletal and Skin Diseases, NIH
One Democracy Plaza
6701 Democracy Boulevard, Suite 800
MSC 4872
Bethesda, MD 20892-4872
Telephone: (301) 594-5017
FAX: (301) 480-4543
Email: mailto:[email protected]
James S. Panagis, M.D., M.P.H.
Musculoskeletal Diseases Branch
National Institute of Arthritis and Musculoskeletal and Skin Diseases, NIH
One Democracy Plaza
6701 Democracy Boulevard, Suite 800
MSC 4872
Bethesda, MD 20892-4872
Telephone: (301) 594-5055
FAX: (301) 480-4543
Email: mailto:[email protected]
Amy Donahue, Ph.D.
Chief, Hearing and Balance/Vestibular Section
National Institute on Deafness and Other Communication Disorders, NIH
6120 Executive Boulevard, EPS Room 400 MSC-7180
Bethesda, MD 20892-7180
Telephone: (301) 402-3458
FAX: (301) 402-6251
Email: mailto:[email protected]
J.Patrick Mastin, Ph.D.
Division of Extramural Research and Training
National Institute of Environmental Health Sciences, NIH
P.O. Box 12233, MD EC-21
Research Triangle Park, NC 27709
Telephone: (919) 541-3289
FAX: (919) 541-4937
Email: mailto:[email protected]
o Direct your questions about financial or grants management matters to:
(Contact information has been updated - 2/15/06)
Peter E. Grandillo Jr.
Contract Specialist
Centers for Disease Control & Prevention (CDC)
Procurement & Grants Office (PGO)
Acquisition & Assistance Field Branch
626 Cochrans Mill Road
P.O. Box 18070 - MS P05
Pittsburgh, PA 15236
Telephone: (412) 386-6834
Fax: (412) 386-6429
Email: [email protected]
Crystal Wolfrey
Grants Administration Branch
National Cancer Institute, NIH
6120 Executive Boulevard, Room 243
Bethesda, MD 20892-7150
Telephone: (301) 496-8634
FAX: (301) 496-8601
Email: mailto:[email protected]
Suzanne White
Division of Extramural Affairs
National Heart, Lung, and Blood Institute, NIH
6701 Rockledge Drive, Suite 7128
Bethesda, MD 20892-7128
Telephone: (301) 435-0182
FAX: (301) 480-3310
Email: mailto:[email protected]
Carol Lander
Grants and Contracts Management Office
National Institute on Aging, NIH
7201 Wisconsin Avenue, Suite 2N212, MSC 9205
Bethesda, MD 20892-9205
Telephone: (301) 496-1472
FAX: (301) 402-3672
Email: mailto:[email protected]
Judy Fox Simons
Grants Management Officer
National Institute on Alcohol Abuse and Alcoholism, NIH
6000 Executive Boulevard MSC 7003
Bethesda, Maryland 20892-7003
Telephone: (301) 443-4704
FAX: (301) 443-3891
Email: mailto:[email protected]
Melinda B. Nelson
Chief Grants Management Officer
National Institute of Arthritis and Musculoskeletal and Skin Diseases, NIH
One Democracy Plaza
6701 Democracy Boulevard, Suite 800
MSC 4872
Bethesda, MD 20892-4872
Phone: (301) 594-3535
Fax: (301) 480-5450
E-mail: mailto:[email protected]
Sara Stone
Chief, Grants Management Branch
National Institute on Deafness and Other Communication Disorders, NIH
6120 Executive Boulevard, EPS Room 400-B, MSC 7180
Bethesda, MD 20892-7180
Telephone: (301) 402-0909
Fax: (301) 402-1758
Email: mailto:[email protected]
Dorothy Williams
Chief, Grants Management Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences, NIH
P.O. Box 12233, MD E1-03
Research Triangle Park, NC 27709-2233
Telephone: (919) 541-3827
Email: mailto:[email protected]
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant application
instructions and forms (rev. 5/2001). Applications must have a Dun and
Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the
Universal Identifier when applying for Federal grants or cooperative
agreements. The DUNS number can be obtained by calling (866) 705-5711 or
through the web site at http://www.dunandbradstreet.com/. The DUNS number
should be entered on line 11 of the face page of the PHS 398 form. The PHS
398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html
in an interactive format. For further assistance contact GrantsInfo,
Telephone (301) 710-0267, Email: [email protected].
The title and number of this program announcement must be typed on line 2 of
the application form and the YES box must be checked.
APPLICATION RECEIPT DATES: Applications submitted in response to this program
announcement will be accepted at the standard application deadlines, which
are available at http://grants.nih.gov/grants/dates.htm. Application
deadlines are also indicated in the PHS 398 application kit.
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
http://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
http://grants.nih.gov/grants/funding/modular/modular.htm.
SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR:
Applications requesting $500,000 or more in direct costs for any year must
include a cover letter identifying the NIOSH or NIH staff member (as
appropriate) within NIOSH or one of NIH institutes or centers who has agreed
to accept assignment of the application. Applicants requesting more than
$500,000 must carry out the following steps:
(1) Contact the IC program staff at least six weeks before submitting the
application, i.e., while you are developing plans for the study;
(2) Obtain agreement from the IC staff that the IC will accept your
application for consideration for award; and,
(3) Identify, in a cover letter sent with the application, the staff member
and IC who agreed to accept assignment of the application.
This policy applies to all investigator-initiated new (type 1), competing
continuation (type 2), competing supplement, or any amended or revised
version of these grant application types. Additional information on this
policy is available in the NIH Guide for Grants and Contracts, October 19,
2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.
SENDING AN APPLICATION TO THE NIH: Applications may not be submitted
electronically. Submit a signed, typewritten original of the application,
including the checklist, and five 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)
APPLICATION PROCESSING: Applications must be received by or mailed on or
before the receipt dates described at http://grants.nih.gov/grants/dates.htm
The CSR will not accept any application in response to this PA that is
essentially the same as one currently pending initial review unless the
applicant withdraws the pending application. The CSR will not accept any
application that is essentially the same as one already reviewed. This does
not preclude the submission of a substantial revision of an application
already reviewed, but such application must include an Introduction
addressing the previous critique.
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.
PEER REVIEW PROCESS
Applications submitted for this PA will be assigned on the basis of
established PHS referral guidelines. An appropriate scientific review group
convened in accordance with the standard NIH peer review procedures
http://www.csr.nih.gov/refrev.htm will evaluate applications for scientific
and technical merit.
As part of the initial merit review, all applications will:
o Undergo a selection process in which only those applications deemed to have
the highest scientific merit, generally the top half of applications under
review, will be discussed and assigned a priority score
o Receive a written critique
o Receive a second level review by the appropriate national advisory council
or board
REVIEW CRITERIA
The goals of NIOSH and NIH-supported research are to advance our
understanding of biological systems, improve the control of disease, and
enhance health. 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. The scientific review group will address and consider each of
the following criteria in assigning the application’s overall score,
weighting them as appropriate for each application.
o Significance
o Approach
o Innovation
o Investigator
o Environment
The 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, an investigator may propose to carry out important work
that by its nature is not innovative but is essential to move a field
forward.
SIGNIFICANCE: Does your study address an important problem? If the aims of
your application are achieved, how do they advance scientific knowledge?
What will be the effect of these studies on the concepts or methods that
drive this field?
APPROACH: Are the conceptual framework, design, methods, and analyses
adequately developed, well integrated, and appropriate to the aims of the
project? Do you acknowledge potential problem areas and consider alternative
tactics?
INNOVATION: Does your project employ novel concepts, approaches or methods?
Are the aims original and innovative? Does your project challenge existing
paradigms or develop new methodologies or technologies?
INVESTIGATOR: Are you appropriately trained and well suited to carry out
this work? Is the work proposed appropriate to your experience level as the
principal investigator and to that of other researchers (if any)?
ENVIRONMENT: Does the scientific environment in which your work will be done
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?
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your
application will also be reviewed with respect to the following. New
wording: 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 will be assessed. 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 REVIEW CONSIDERATIONS
Sharing Research Data
Applicants requesting more than $500,000 in direct costs in any year of the
proposed research are expected to include a data sharing plan in their
application. The reasonableness of the data sharing plan or the rationale
for not sharing research data will be assessed by the reviewers. However,
reviewers will not factor the proposed data sharing plan into the
determination of scientific merit or priority score.
BUDGET: The reasonableness of the proposed budget and the requested period
of support in relation to the proposed research.
AWARD CRITERIA
Applications submitted in response to a PA will compete for available funds
with all other recommended applications. The following will be considered in
making funding decisions:
o Scientific merit of the proposed project as determined by peer review
o Availability of funds
o Relevance to program priorities
REQUIRED FEDERAL CITATIONS
HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that
applications and proposals involving human subjects must be evaluated with
reference to the risks of 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.
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for
all types of clinical trials, including physiologic, toxicity, and dose-
finding studies (phase I), efficacy studies (phase II), efficacy,
effectiveness and comparative trials (phase III). The establishment of data
and safety monitoring boards (DSMBs) is required for multi-site clinical
trials involving interventions that entail potential risk to the
participants. NIH Policy for Data Safety and Monitoring, NIH Guide for Grants
and Contracts, June 12, 1998:
http://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
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines are available at
http://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. NIOSH has adopted this policy 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
http://grants.nih.gov/grants/funding/children/children.htm.
REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIOSH
policy requires education on the protection of human subject participants for
al 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
http://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
http://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
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs IN NIOSH GRANT APPLICATIONS OR APPENDICES: All applications and
proposals for NIOSH 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 HHS 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 PHS 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.
HEALTHY PEOPLE 2010: CDC is committed to achieving the health promotion and
disease prevention objectives of "Healthy People 2010," a national activity
for reducing morbidity and mortality, and to 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" http://www.healthypeople.gov.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of
Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review. Awards are made under the authorization of Sections
301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284
and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. And under
the Occupational Safety and Health Act of 1970, Section 20(a) (29 USC
669(a)).
All awards are subject to the terms and conditions, cost principles, and
other considerations described in the NIH Grants Policy Statement. The NIH
Grants Policy Statement can be found at
http://grants.nih.gov/grants/policy/policy.htm
The PHS 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.
References
USDOL, 2001. Workplace injuries and illnesses in 2000. News Release 12/18/01;
Bureau of Labor Statistics
USDOL, 2001. National census of fatal occupational injuries in 2000. News
Release 8/14/01; Bureau of Labor Statistics
National Safety Council, 2000. Injury Facts, 2000 Edition.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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