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: Workplace Violence Prevention Research (R01)

Note: The policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH.

Announcement Type
 This is a modification of RFA-OH-02-011 that was previously released May 2, 2002.

Update: The following update relating to this announcement has been issued:

Request For Applications (RFA) Number: RFA-OH-06-004

Catalog of Federal Domestic Assistance Number(s)
 93.262

Key Dates
Release Date: December 13, 2005
Letters of Intent Receipt Date(s): January 3, 2006
Application Receipt Dates(s): April 18, 2006
Peer Review Date(s): May-June, 2006
Council Review Date(s): June 2006
Earliest Anticipated Start Date: July 2006
Additional Information To Be Available Date (Url Activation Date): NA
Expiration Date: April 19, 2006

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary  

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 

Purpose

The National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC) announces the availability of funds for fiscal year 2006 to support research grant (R01) applications to develop, implement and validate intervention strategies designed to reduce the risks of violence in the workplace.  It is estimated that 1.7 million workers are assaulted annually at work and an additional 800 are fatally injured.  The purpose of this announcement is to enhance existing knowledge and improve safety and health of workers by supporting research on workplace violence which addresses development of new interventions and evaluation of existing interventions.   Important outcomes will include full evaluations of the effectiveness of interventions in reducing workplace violence, and of the likelihood that interventions can be translated into a variety of workplace settings.

Background

In the 13-year period 1992 through 2004, there were an average of 808 workplace homicides in the U.S. each year, ranging from a high of 1,080 in 1994 to a low of 551 in 2004.   The most common scenario of workplace homicide was a retail worker killed during the course of a robbery or other crime.  Taxicab drivers have the very highest rates of workplace homicide.  Other circumstances or perpetrators of workplace homicides include co-workers or former co-workers, customers, clients, or patients, and current or former domestic partners.  From 1993 through 1999, there was an average of 1.7 million non-fatal violent victimizations in the U.S. each year, accounting for 18% of all violent crime during the 7-year period.  Of the occupations for which data were available, police officers had the highest rate of workplace violent crime at 261 per 1,000 persons, followed by corrections officers (156 per 1,000) and taxicab drivers (128 per 1,000).  The majority (75%) of the violent victimizations were simple assaults.

Although the risks for fatal workplace violence have been more completely described and recognized over the last decade, there remain a number of questions regarding the nature, magnitude and impact of workplace violence, especially with regard to nonfatal events.  As well, with increasing recognition of the problem, employers, workers, labor unions, and others have developed and implemented a range of strategies to address the risk factors for workplace violence.  Unfortunately, however, there has been little rigorous evaluation of the effectiveness of the range of efforts undertaken to date. Therefore, regulators, employers, workers, and safety and health professionals do not know the most effective components of a violence prevention program, either generally or for specific high-risk settings.

In April 2000, the University of Iowa sponsored a Workplace Violence Intervention Research Workshop in Washington, DC.  One of the fundamental organizing principles from the workshop is that research and prevention efforts may be more clearly understood when workplace violence is divided into four categories: Criminal Intent (Type I) when the perpetrator has no legitimate relationship to the business and is usually committing a crime in conjunction with the violence; Customer/Client (Type II) when the perpetrator has a legitimate relationship with the business and becomes violent while being served by the business; Worker-on-Worker (Type III) when the perpetrator is an employee or past employee of the business who attacks or threatens another employee; and Personal Relationship (Type IV) when the perpetrator does not have a relationship with the workplace, but has a personal relationship with the intended victim.  "Workplace Violence: A Report to the Nation" identifies important research questions in each of these four categories.

Despite efforts on the part of researchers and others in government, industry, labor, and academia, our knowledge regarding the incidence and distribution of workplace violence, especially non-fatal workplace violence, is still incomplete.  As well, there has been little rigorous scientific research on the development of new interventions and the effectiveness of existing strategies for the reduction of workplace violence. 

On January 11, 2002, Senate Appropriations Language S-107-84 stated ”The Committee recognizes that workplace violence is a major national occupational priority and that it is the second leading cause of workplace deaths among women workers.   The Committee further recognizes that several hundred workers die each year as victims of workplace violence, that at least 2 million workers suffer from injuries that result from workplace violence, and that the healthcare costs, lost productivity and countermeasure costs run into the billions of dollars.  The Committee has included increased funding for NIOSH to develop an intramural and extramural prevention research program that will target all aspects of workplace violence and to coordinate its effort with the Departments of Justice and Labor.”   This RFA is an integral part of this charge to NIOSH.

Focus/Outcome

This RFA will focus on the development and/or evaluation of interventions for workplace violence of Type I, Criminal Intent, and Type III, Worker on Worker.   Type I is known to be the most frequent for both fatal and non-fatal outcomes in the workplace.  Type III is important because it involves risk within the workplace rather than from an external source.  These two types of violence differ in their characteristics and occurrence, and presumably have different causes and may require distinctly different interventions.  Applications may focus on one typology 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 is a reduction in the frequency or occurrence of either type of violence, or mitigation of the consequences and lessening of the impact on victims.  Other typical outcomes might include lessened impacts on high-risk subgroups, or changes in the temporal or spatial occurrence of violence, facilitating deterrence or rapid intervention by law enforcement or security.

Applicants interested in Type II or Type IV violence should submit applications through one of the other 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

Applications should include the nature of the prevention or intervention effort, the expected impact or outcome variables to be examined in reducing violence or violent 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 workplace violence among various worker populations and the costs of workplace violence to victims (i.e. 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 from the intervention with confounding variables, such as 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 numerous 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/.

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

Useful references: In April 2000, with funding from the National Institute for Occupational Safety and Health and the National Center for Injury Prevention and Control, the University of Iowa sponsored a Workplace Violence Intervention Research Workshop in Washington, DC.  Thirty-seven invited participants representing industry, organized labor, municipal, state, and federal governments, and academia gathered to review the state of knowledge regarding workplace violence and to make recommendations for research.  Theme papers from the workshop addressing the roles of surveillance and evaluation research, legislation, and regulation as well as business and labor perspectives on workplace violence were published in the February 2001 issue of the American Journal of Preventive Medicine.  The discussions and recommendations from the workshop were summarized in "Workplace Violence: A Report to the Nation" published in February 2001. The full report is available at: http://www.public-health.uiowa.edu/iprc.                                                                         

Section II. Award Information


1. Mechanism(s) of Support

This funding opportunity will use the R01research grant award mechanism(s).

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

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

2. Funds Available  

NIOSH intends to commit approximately $1 million in FY 2006 to fund 3-6 new or competing continuation research grant awards in response to this RFA.  Applicants may request a budget for direct costs up to $250,000 per year.  Applicants may request a project period of up to three years for new intervention research and up to five years for intervention evaluation research.   Applicants should include in their budgets funds for one trip per year for an annual meeting of grantees to provide an opportunity for the exchange of program and scientific information, to be held in Pittsburgh, PA, or Atlanta, GA.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of NIOSH  provide support for this program, awards pursuant to this 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:

Note: Title 2 of the United States Code section 1611 states that an organization described in section 501 (c) (4) of the Internal revenue Code that engages in lobbying activities is not eligible to receive Federal funds constituting an award, grant, or loan.   

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 NIH programs.

2. Cost Sharing or Matching

Cost sharing or matching are not required to be eligible to obtain funding under this RFA.  

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

To be considered, applications must be responsive to the objectives of the RFA.

Applicants may only submit one application in response to this announcement.  Foreign entities are not eligible.  

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

Letter of Intent Receipt Date: April 4, 2006
Application Receipt Date(s): April 18, 2006
Peer Review Date: May-June 2006
Council Review Date:
June 2006
Earliest Anticipated Start Date:
July 2006

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 NIOSH 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.
Office of Extramural Programs/NIOSH/CDC
1600 Clifton Rd., NE, MS E-74
Atlanta GA 30333
Telephone: (404) 498-2582
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 Rd., NE, 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.

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 NIH 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.

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

NIH 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:

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:  What are the Research to Practice impacts and outcomes of the project with regard to the public health importance of occupational violence? Have the broad, long-term objectives of the proposed intervention project and expected outcomes been defined? Does this research address an important problem related to prevention or reduction of Type I or Type III workplace violence?  Does the application detail the importance of the proposed research and the role it will play in reducing the occupational safety burden of violence in the workplace? If the aims of the application are achieved, how will knowledge of violence prevention be advanced?  What will be the effect on the concepts or methods currently used in violence prevention?  What are the expected outcomes in affecting Type I or III violence?  Does the intervention have plausible likelihood of being implemented and successful?

Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated and appropriate to the aims of the project?  Has the applicant selected an appropriate workplace setting or population for the project ?  Is the environment or population studied recognized as high risk for violence?  Is the population suitable for intervention evaluation?  Does the applicant acknowledge potential difficulties in measuring or observing violence and consider alternative tactics? Is the time line proposed for the project suitable and realistic to demonstrate a reduction in violence?  

Innovation: Does the project employ novel concepts, approaches or methods for prevention of Type I or Type III violence?  Are the aims original and innovative?  Does the project challenge existing paradigms or develop new methodologies or technologies?


Investigators: Are the principal investigator and collaborators appropriately trained and experienced in the field of workplace violence prevention?  Are they recognized as knowledgeable in regard to prevention of Type I or Type III violence? 

Environment: Does the environment in which the work will be done contribute to the probability of success?  Do the proposed interventions and evaluations take advantage of unique features of the environment or employ useful collaborative arrangements?    Is there documentation of cooperation from industry, unions, communities, or other participants in the project, where applicable?  Is there evidence of institutional support and availability of resources necessary to perform the project?

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).

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 Form 398 research grant application instructions will be assessed.

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     NIOSH intends to fund projects focused on Type I and Type III violence to achieve programmatic balance.

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.

2.D. 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 (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

Program staff will be responsible for the administrative review of the plan for sharing research resources.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.

3. Anticipated Announcement and Award Dates
Not applicable

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, NIH 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 NoA 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 NoA 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).

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.

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:

Lee Husting, Ph.D., M.P.H.
Scientific Program Administrator
Office of Extramural Programs/NIOSH/CDC
24 Executive Park Drive, Room 1420, MS E-74
Atlanta, GA 30329
Phone: (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:

Peter Grandillo
Acquisition and Assistance Field Branch
Centers for Disease Control and Prevention
626 Cochrans Mill Road
Pittsburgh, PA 15236-0070
Telephone: (412) 386-6834
FAX: (412) 386- 6429
Email: pgrandillojr@cdc.gov

Section VIII. Other Information


Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

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 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://www.nih.gov/about/publicaccess/ and view the Policy or other Resources and Tools including the Authors' Manual (http://www.nih.gov/about/publicaccess/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 Healthy People 2010 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 Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284), Section 20(a) of the Occupational Safety and Health Act of 1970 (29 USC 669(a)), 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.

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.


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