Part I Overview Information


Department of Health and Human Services

Participating Organizations
Centers for Disease Control and Prevention (CDC), (http://www.cdc.gov/)

Components of Participating Organizations
National Institute for Occupational Safety and Health (NIOSH), (http://www.cdc.gov/niosh/homepage.html)

Title:   Commercial Truck Driver Health and Safety- Preventing Injury and Illness
 
Note: The policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH.

Announcement Type
New

Request For Applications (RFA) Number: RFA-OH-07-001

Catalog of Federal Domestic Assistance Number(s)
93.262

Key Dates
Release Date: May 4, 2006
Letters of Intent Receipt Date(s): June 21, 2006
Application Receipt Date(s): July 21, 2006
Peer Review Date(s): October 2006
Council Review Date(s): January 2007
Earliest Anticipated Start Date: April 1, 2007
Expiration Date: July 22, 2006

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

The National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC), invites applications to conduct research projects that address specified work-related safety and health issues affecting large truck operators (gross vehicle weight rating of more than 10,000 lb) safety and health.  The intent of this RFA is to stimulate and fund research that will address work-related health issues associated with commercial truck driving.  The desired outcomes are to characterize health risks, and ultimately to develop, implement, and evaluate interventions to reduce specific work-related health risks and thus enhance driver health.

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
    A. Eligible Institutions
    B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
    A. Receipt and Review and Anticipated Start Dates
       ;1. Letter of Intent
    B. Sending an Application to the NIH
    C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Sharing Research Data
    D. Sharing Research Resources
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

The National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC), announces the availability of fiscal year (FY) 2007 funds for research project grant (R01) applications from single institutions or consortia of institutions to support research to assess the effects of operating a large truck on the safety and health of drivers.  Applications to conduct research projects that address large truck operator driver safety and health in the areas of non-fatal injuries, musculoskeletal disorders, and chronic illnesses associated with the operation of large commercial truck (gross vehicle weight rating of more than 10,000 lb) are solicited under this RFA.  Intervention projects that implement and evaluate interventions to reduce the risk or consequences of non-fatal injuries, MSD, or major chronic illnesses are particularly encouraged and such projects should include a well described evaluation plan.

Background

The mission of NIOSH is to help assure safe and healthful working conditions for working men and women by providing research, information, education, and training in the field of occupational safety and health.  NIOSH provides national and world leadership to prevent work-related illness, injury, disability, and death by gathering information, conducting scientific research, and translating the knowledge gained into products and services.  NIOSH’s mission is critical to the health and safety of every American worker. 

This initiative addresses occupational health and safety risks of workers who operate large and heavy trucks with a gross vehicle weight rating of more than 10,000 lb.  Promotion of commercial driver health is an important public health goal.  Results of research based on this RFA may help motor carrier employers to implement interventions to enhance driver health.  An estimated 1,767,000 U.S. workers were employed as heavy and tractor-trailer truck drivers in 2002, with salaried drivers accounting for 87% [BLS 2005a].  Truck drivers consistently sustain more nonfatal occupational injuries and illnesses than any other occupation, with an estimated 112,232 cases in 2002 resulting in lost work time.  Lost-time injuries to truck drivers in 2002 most often resulted from overexertion (28.5%), contact with objects and equipment (17.5%), transportation incidents (13.5%), and falls on the same level (11.5%) [BLS 2004].   

Because of life style factors related to their occupation, drivers may be at increased risk of pre-morbid and morbid conditions including elevated blood pressure, overweight, obesity, musculoskeletal disorders, cardiovascular disease, and possibly some cancers,   Such factors may include poor diet, lack of fitness, and sleep disorders resulting in stress.  The relationships are complex, and age probably acts as a confounding factor.  

Driver health can directly or indirectly affect driver performance.  Recent evidence suggests that driver health, including sleepiness, fatigue, and inattention affect performance, as measured by the risk of being in a fatal crash. [Bunn,2005]   In addition such health problems as sleep disorders, depression, tiredness, non-medicated diabetes, and history of heart disease, may be linked to driving performance. [Sagberg 2006].  

National Occupational Research Agenda (NORA) areas related to this RFA include: Traumatic Injuries; Intervention Effectiveness Research; Organization of Work; Risk Assessment Methods; and Musculoskeletal Disorders.  In addition, this initiative will yield results of interest with relation to the Transportation Sector emphasis identified for the second decade of NORA.

Focus and Outcomes

This RFA will focus on driver health and the risk factors underlying driver health with the purpose of developing and evaluating intervention for work related serious or chronic illness, MSD, and non-fatal injuries. Fatalities are not a focus of this RFA

Serious or chronic illness, MSD, and non-fatal injuries effects differ in their nature and occurrence, and they presumably have different causes and may require distinctly different interventions.  Applications may focus on one effect or the other, or both.  However within the time and funds available it may be strategic to concentrate on one in order to fully determine the outcomes of the project.  NIOSH intends to fund both types to achieve programmatic balance.

The overall desired outcome of research is a reduction in the frequency or occurrence of either type of health effect, or mitigation of the consequences and lessening of the impact on those affected.  Other typical outcomes might include lessened impacts on high-risk subgroups, or changes in the temporal or spatial occurrence of non-fatal injury or illness.

Applicants interested in fatal injuries or other aspects of driver health should submit applications through another of the NIOSH mechanisms of funding such as the Program Announcements that are listed on the NIOSH Web page at: http://www.cdc.gov/niosh/oep/funding.html  

The Federal Motor Carrier Safety Administration (FMCSA) is partnering with NIOSH on this RFA.  In 2005, FMCSA published new rules on the hours-of-service (HOS).  The rule changes were challenged by a Federal Court, in part due to the lack of adequate data on driver health.   Subsequently the FMCSA conducted and published an extensive literature review directed to driver health and lifestyle issues including nutrition, and exercise.  The Rules became effective October 1, 2005.  The FMCSA is expected to evaluate the long term impact of the rules, as well as to sponsor research on fatigue.  Hence these issues are not emphasized in this RFA.

Applications should include the nature of the prevention or intervention effort, the expected impact or outcome variables to be examined in reducing health effects or their consequences, and a detailed discussion of the planned evaluation.  Applications should include both process and outcome measures.  Process measures should be detailed enough to allow for replication of the intervention.  Outcome measures of interest include, but are not limited to: incidence, distribution, and magnitude of  work related illness and injury among various worker populations and the costs workers, employers, and society.  Research applications need to indicate that the study design and size is sufficient to produce generalizable results, to detect intervention effects, and to distinguish changes in outcomes of interest attributable to the the intervention from effects of  confounding variables, such as age, natural changes, extraneous events, etc. 

Applications that focus on evaluation of existing interventions will be considered to be of higher programmatic importance.  Interventions that are translatable into other occupations or workplaces are encouraged, as such applications are important for the NIOSH research to practice (r2p) initiative as described on the NIOSH Web page at: . http://www.cdc.gov/niosh/r2p/.

The research objectives may address understanding of risk factors and or prevention of health and safety  work-related issues known or suspected to be problematic in the commercial trucking industry (involving gross vehicle weight rating of more than 10,000 lb).  Some of the research topics that may be addressed are summarized below.  Investigators may propose other topics focused on the goals of this RFA.

Driver health

Truck drivers are at increased risk for numerous preventable diseases, such as myocardial infarction, hypertension, ulcers, and cancers of the lung, prostate, bladder, and gastric cardia. [NIOSH 2005].  

Research on factors to prevent or reduce the risk of these and other health conditions such as obesity, pre-diabetic states, or diabetes will be of interest.   These factors might include life style factors related to occupation, including nutrition or diet, exercise patterns, lack of suitable rest areas, and limited access to health care.   Economic factors that may affect health are of interest .   Many factors may interact with each other, and interactions are of interest, for example interactions between stress, age, obesity, and musculoskeletal disease. 

While substance use, alcohol abuse and illegal drug use are probably limited among drivers due to licensing regulations and scrutiny by authorities, the use of and effects of prescription or over the counter drugs have not been characterized in commercial drivers.  To the extent applications address the impact on driver health, they will be considered.

Musculo-skeletal disorders

Back injuries and other musculoskeletal disorders among truckers have been associated with materials handling tasks [Jensen et al. 1996].   Studies of interventions to reduce musculo-skeletal disorders among truck drivers are welcomed.  MSD are known to be a major cause of workers compensation costs

Non-fatal Occupational injuries

The development and evaluation of effective intervention strategies to prevent non-fatal injuries among truckers is encouraged.  Of particular interest are evaluations of health and safety interventions such as driver training programs, fatigue management initiatives, novel safety management practices, or engineering or environmental controls.  Possible focus areas include risks of assaults, motor vehicle crashes, injuries from overexertion, and slips, trips, and falls, and mishaps while entering or exiting vehicles.

Partnerships

Partnerships with trucking industry stakeholders are encouraged and applications with partnerships may be given high program priority.

References

BLS [2004], Occupational injuries and illnesses: counts, rates, and characteristics, 2002 (Bulletin 2566).  Washington, DC: U.S. Department of Labor, Bureau of Labor Statistics.

BLS [2005a], 2002-12 national employment matrix, detailed occupation by industry. Available: http://www.bls.gov/emp/empoils.htm.  Last accessed February 22, 2005.

BLS [2005b], Census of Fatal Occupational Injuries, 1992-2002, public data query (event or exposure=highway transportation incident, occupation=truck driver).  Available: http://data.bls.gov/PDQ/outside.jsp?survey=cf.  Last accessed February 22, 2005.

Bunn, T.L., S. Slavova, Struttman, T.W., and S.R. Browning (2005) Sleepiness/fatigue and distraction/inattention as factors for fatal versus nonfatal commercial motor vehicle driver injuries. Accident Analysis and Prevention 37 862-869.

Dawson D, Lamond N, Donkin K, Reid KJ [1998].  Quantitative similarity between the cognitive psychomotor performance decrement associated with sustained wakefulness and alcohol intoxication.  In Hartley L, ed., Managing fatigue in transportation: selected papers from the 3rd Fatigue in Transportation conference, Fremantle, Western Australia, 1998.  New York: Elsevier.

70 Fed. Reg. 3339 [2005].  Federal Motor Carrier Safety Administration, 49 CFR Parts 385, 390, and 395; hours of service of drivers.

70 Fed Reg. August 25, 2005 (Volume 70, Number 164) Rules and Regulations Page 49977-50073Hours of Service Final Rule.

Jensen MV, Tuchsen F, Orhede E [1996].  Prolapsed cervical intervertebral disc in male professional drivers in Denmark, 1981-1990: a longitudinal study of hospitalizations.  Spine 21:2352-2355.

NHTSA [2004].  Traffic safety facts 2002 (Publication DOT HS 809 620).  Washington, DC: U.S. Department of Transportation, National Highway Traffic Safety Administration. Available: http://www-nrd.nhtsa.dot.gov/pdf/nrd-30/NCSA/TSFAnn/TSF2002Final.pdf.  Last accessed February 23, 2005.

NIOSH [2003].  Work-related roadway crashes: challenges and opportunities for prevention (NIOSH Hazard Review).  Cincinnati, OH: Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health.  DHHS (NIOSH) Pub. No. 2003-119.

NIOSH [2005].  Unpublished literature review . Source personal communications from S. Pratt,  Alterman, T,, and J. Birdsey  : Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health. 

Projects are encouraged to have relevant partnerships with government, academia, industry, or other organizations.  Investigators should describe how these partnerships will be established and how each partner will be able to contribute to the research plan.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information


1. Mechanism(s) of Support

This funding opportunity will use the R01 Investigator Initiated Research grant award mechanism(s).

As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This funding opportunity uses just-in-time concepts (see Section I. G. at: http://grants.nih.gov/grants/funding/phs398/PolAssurDef.doc).

It also uses the modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm

2. Funds Available

NIOSH intends to commit approximately $1,000,000 annually for three years for this program.  In addition, the Federal Motor Carriers Safety Administration intends to commit approximately $100,000 per year. NIOSH intends to fund three to four new grants in response to this RFA.  The maximum award per year for project direct costs is $200,000.  The anticipated start date is April 1, 2007, with a three year period of performance.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization has any of the following characteristics:

Applications from foreign institutions are not eligible.

1.B. Eligible Individuals

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 underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIOSH programs.   

2. Cost Sharing or Matching

Cost sharing is not required and will not result in a competitive advantage.

The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing

3. Other-Special Eligibility Criteria

Applicants may submit more than one application under this announcement provided they are scientifically distinct. 

Section IV. Application and Submission Information


1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

3. Submission Dates and Times

Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date(s): June 21, 2006
Application Receipt Date(s): July 21, 2006
Peer Review Date(s): October 2006
Council Review Date(s): January 2007
Earliest Anticipated Start Date: April 1, 2007
 
3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed at the beginning of this document.

The letter of intent should be sent to:
 
Charles N. Rafferty, Ph.D.
Assistant Director for Review and Policy
Office of Extramural Programs/NIOSH
Centers for Disease Control and Prevention
1600 Clifton Road, N.E., MS E-74
Atlanta, GA 30333
Telephone: (404) 498-2582
FAX: (404) 498-2571
Email:
cor9@cdc.gov
 
3.B. Sending an Application to the NIOSH
 
Applications must be prepared using the research grant applications found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:


Charles N. Rafferty, Ph.D.
Assistant Director for Review and Policy
Office of Extramural Programs/NIOSH
Centers for Disease Control and Prevention
1600 Clifton Road, N.E., MS E-74
Atlanta, GA 30333
Telephone: (404) 498-2582
FAX: (404) 498-2571
Email: cor9@cdc.gov

Using the RFA Label: The RFA label available in the PHS 398 application instructions 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: http://grants.nih.gov/grants/funding/phs398/labels.pdf.

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by NIOSH. Incomplete and non-responsive applications will not be reviewed.

If the application is not responsive to the RFA, NIOSH staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next appropriate NIH review cycle.

The NIOSH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

4. Intergovernmental Review
 
This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIOSH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
 
Pre-Award Costs are allowable. A grantee may, at its own risk and without NIOSH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or competing continuation award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIOSH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIOSH approval before incurring the cost. NIOSH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or competing continuation award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIOSH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

6. Other Submission Requirements

Plan for Sharing Research Data

All applicants must include a plan for sharing research data in their application. The data sharing policy is available at:http://grants.nih.gov/grants/policy/data sharing.

All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the 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 the priority score.
 
Sharing Research Resources

NIOSH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.

Section V. Application Review Information


1. Criteria

The following will be considered in making funding decisions:

2. Review and Selection Process

Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIOSH in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

Receive a second level of review by the NIOSH Secondary Review Committee.

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an 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 this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?  If successful, will the results of the study have a measurable impact on driver safety and health?  Has the applicant provided a method for assessing the impact of the study on drivers?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?  Are appropriate collaborations with commercial trucking identified?   Is the method for evaluating impact on driver safety and health sufficiently detailed and adequate?  Does the program design adequately address the distinct characteristics, specific populations, and safety and health of commercial heavy truck operators?   Are partnerships with trucking industry stakeholders proposed and adequately developed.

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to 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 the Research Plan, Section E on Human Subjects in the PHS Form 398).

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 the Research Plan, Section E on Human Subjects in the PHS Form 398).
 
Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

2.C. Sharing Research Data

Data Sharing Plan: 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 the priority score. The presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy.

Section VI. Award Administration Information


1. Award Notices

After the peer review of the application is completed, the Principal Investigator will also receive a written critique called a Summary Statement.

If the application is under consideration for funding, NIOSH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the Notice of Award will be generated via email notification from the awarding component to the grantee business official (designated in item 14 on the Application Face Page). If a grantee is not email enabled, a hard copy of the Notice of Award will be mailed to the business official.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

All NIOSH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the Notice of Award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

3. Reporting
 
Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.  NIOSH follows this policy.  A final report and final financial status report are also required within 90 days of the end of the project.
 
Section VII. Agency Contacts


We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

E. Lee Husting, Ph.D., MPH
Office of Extramural Programs/NIOSH
Centers for Disease Control and Prevention
1600 Clifton Road, N.E., MS E-74
Atlanta, GA 30333
Telephone: (404) 498-2506
FAX: (404) 498-2571
Email: eih8@cdc.gov

 
2. Peer Review Contacts:

Charles N. Rafferty, Ph.D.
Assistant Director for Review and Policy
Office of Extramural Programs/NIOSH
Centers for Disease Control and Prevention
1600 Clifton Road, N.E., MS E-74
Atlanta, GA 30333
Telephone: (404) 498-2582
FAX: (404) 498-2571
Email: cor9@cdc.gov


3. Financial or Grants Management Contacts:

Cynthia Mitchell
Acquisition and Assistance Field Branch
Centers for Disease Control and Prevention
626 Cochrans Mill Road
Pittsburgh, PA 15236-0070
Telephone: (412) 386-6434
FAX: (412) 386- 6429
Email: cmitchell@cdc.gov

Section VIII. Other Information


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 to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (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). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing/).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

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 funding opportunity 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.
 
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 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is 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 Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

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 (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_Manual.htm).

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).

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 NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to focus area 20: Occupational Safety and Health. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

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 Section 20 of the Occupational Safety and Health Act of 1970 (29 USC 669) and Section 301 of the Public Health Service Act as amended (42 USC 241), and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. 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.

Smoke Free Workplace:
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.

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 healthy 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.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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