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:sboard@cdc.gov

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:achildress@cdc.gov

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:mgalvin@cdc.gov

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:ki6n@nih.gov

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:ho28y@nih.gov

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:  eliasj@nia.nih.gov

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:ksalaita@mail.nih.gov

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:am40j@nih.gov

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:jp149d@nih.gov

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:amy_donahue@nih.gov

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:jm436j@nih.gov

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: PGrandillo@cdc.gov 

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:wolfreyc@mail.nih.gov

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:sw52h@nih.gov

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:LanderC@mail.nih.gov

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:js182a@nih.gov
 
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:mn23z@nih.gov

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:stones@nidcd.nih.gov

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:dw47y@nih.gov

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) 435-0714, Email: GrantsInfo@nih.gov.

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

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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