Part I Overview Information


Department of Health and Human Services

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

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

Title: Childhood Agricultural Safety And Health Research

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

Authority: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and of 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

Announcement Type: This is a modification of RFA-OH-03-003 that was previously released March 20, 2003.

Looking Ahead:  As part of the Department of Health and Human Services' implementation of e-Government, during FY 2006 the NIH will gradually transition each grant mechanism to electronic submission through Grants.gov and the use of the SF 424 Research and Related (R&R) forms. Therefore, once the transition is made for a specific grant mechanism, investigators and institutions will be required to submit applications electronically using Grants.gov.. For more information and an initial timeline, see http://era.nih.gov/ElectronicReceipt/. NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/index.html). Specific funding opportunity announcements will also clearly indicate if Grants.gov submission and the use of the SF424 (R&R) is required. Investigators should consult the NIH Forms and Applications Web site (http://grants.nih.gov/grants/forms.htm) for the most current information when preparing a grant application.

Request For Applications (RFA) Number: RFA-OH-07-002

Catalog of Federal Domestic Assistance Number(s):
93.262 Occupational Safety and Health Program  

Key Dates
Release Date: May 4, 2006
Letter of Intent Receipt Date:  NA  
Application Receipt Date(s): August 16, 2006
Peer Review Date(s): October-November, 2006
Council Review Date(s): January 2007
Earliest Anticipated Start Date(s): April 1, 2007
Additional Information To Be Available Date (URL Activation Date): NA
Expiration Date: August 17, 2006

Due Date for E.O. 12372
Executive Order 12372 does not apply to this program.

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
     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  
    A. Cooperative Agreement Terms and Conditions of Award
       1. Principal Investigator Rights and Responsibilities
       2. CDC Responsibilities
       3. Collaborative Responsibilities
3. Reporting

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

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

The CDC and NIOSH are committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010" and to measuring program performance as stipulated by the Government Performance and Review Act (GPRA).  This RFA addresses “Healthy People 2010” priority area(s) to promote the health and safety of people at work through prevention and early intervention and is in alignment with NIOSH performance goal(s) to conduct research to prevent occupational safety and health injuries and illnesses. For more information, see www.health.gov/healthypeople and www.whitehouse.gov/omb/mgmt-gpra/.

Purpose

The Centers for Disease Control and Prevention (CDC), National Institute for Occupational Safety and Health (NIOSH) announces the availability of fiscal year (FY) 2007 funds for grant applications for research on childhood agricultural safety and health.

Projects are sought which will conduct research to: (1) develop and evaluate new or existing enhanced control technologies to reduce injury to youth exposed to farm hazards, (2) identify and implement strategies which encourage adults to adopt injury control methods to protect youth, (3) identify the economic and social consequences of youth working on farms.  Findings from these projects are intended to advance the scientific base of knowledge needed to maximize the safety and health of children exposed to agricultural production hazards.  Important outcomes will include full evaluations of the effectiveness of interventions and of the likelihood that interventions can be translated into a variety of agricultural workplace settings.

This announcement identifies program needs consistent with the National Occupational Research Agenda (NORA) developed by NIOSH and partners in the public and private sectors to provide a framework to guide occupational safety and health research in the new millennium towards topics which are most pressing and most likely to yield gains to the worker and the nation.  The agenda identifies 21 research priorities.  NORA priorities with specific relevance to this announcement are: traumatic injuries, special populations at risk, intervention effectiveness research, and social and economic consequences of workplace illness and injury.  Information about NORA is available through the NIOSH Home Page; http://www.cdc.gov/niosh/nora/.

Background

Agricultural production, which commonly encompasses farming, consistently ranks among the industries with the highest rates of work-related injuries and deaths in the United States and is unique with respect to children and adolescents. This is the only industry in which the workplace is often also a home. Youth, children and adolescents, who commonly work on farms are exposed to agricultural production hazards.  However, exposures to agricultural hazards are not only experienced by working youths, non-working children who live on or visit farms may also be exposed to farm hazards. Research is needed to expand the knowledge base for the development and implementation of effective and appropriate intervention strategies.

Surveillance efforts by NIOSH indicate an estimated 22,648 agriculture-related injuries occurred nationally to children or adolescents under the age of 20 who lived on, worked on, or visited a farm in 2001 (1). Males accounted for the majority (62%) of the injuries with 37% or more than 8,000 of those injured on farms being work-related injuries.  Youth who live on farms accounted for 74% of all the injuries with 34% of their injuries being work-related.  Fatality surveillance for the period 1990-1996 indicated that more than 100 deaths occurred to youth 19 years of age and younger on farms annually (2).  About 33% of the farm deaths occurred to youth 15-19 years of age and males accounted for 85% of all farm deaths.  Nearly 40% of the deaths among males occur between the ages of 15 and 19, while about 40% of the deaths were to females before the age of five.  Two regions of the United States, the South and the Midwest, account for 79% of all fatal farm injuries.  Farm tractors, farm machinery, stored grain, power lines, manure pits, ponds, and livestock are among the many hazards youth are exposed to in the agricultural workplaces. Children and adolescents may be exposed to agricultural production hazards not only through work activities, but by virtue of living on a farm, accompanying their parents to work, or visiting farms.

Focus/Outcome

The goals of childhood agricultural safety and health research grants are to maximize the safety and health of children and adolescents exposed to agricultural hazards through the prioritization, development, or implementation of intervention efforts. 

Projects are sought in one of three research areas which are included as priority areas in the documents:

National Committee for Childhood Agricultural Injury Prevention.  Children and Agriculture: Opportunities for Safety and Health: A National Action Plan http://research.marshfieldclinic.org/children/action/title.htm

Childhood Agricultural Injury Prevention: Progress Report and Updated National Action Plan for the 2001 Summit http://www.marshfieldclinic.org/research/children/childrensReport/

1) Develop and Evaluate New or Existing Enhanced Control Technologies. 

Control technologies, in the broadest sense, include any strategy which will  control the exposure of children to agricultural hazards. Exposures to  agricultural hazards may be reduced through engineering controls and/or administrative controls. Examples of research efforts which are appropriate under this priority area include, but are not limited to: (a) engineering controls: these could encompass the development and evaluation of new, or the application and evaluation of existing, equipment or devices which could prevent childhood agricultural injuries, such as ensuring that agricultural structures have proper barriers and warnings, developing and evaluating play area designs to reduce child exposures to hazards, and developing and evaluating, or evaluating existing, sensor technology to notify operators or automatically shut down machines when children are in harms way and/or (b) administrative controls: these could encompass the evaluation of the impact of changes in work practices, such as limiting the type of work a youth does [e.g., not allowing youth under 16 to drive tractors or evaluation of the impact of the North American Guidelines for Children's Agricultural Tasks (NAGCATs)], modification of work periods, (such as limiting the amount of time a youth works), limiting the exposure of the youth (ensuring equipment in the work environment is properly shielded or limiting loads lifted or carried), and the type and amount of training and supervision given to the young worker.

2) Identify and implement strategies which encourage adults to adopt injury control methods to protect youth.

Adults are the primary agent for determining the safety of youth on farms. Understanding and identifying the factors which cause adults to adopt protective activities for youth on their farms or cease activities which increase risk for youth are important to prevention efforts.  Identifying barriers and developing methods for overcoming these barriers are essential to successful intervention efforts.  Additionally, the involvement of organizations or industries which support these intervention efforts and to which farmers pay attention are important to the overall prevention effort and should help to operationalize the intervention. 

Examples of research efforts which are appropriate under this priority area include, but are not limited to: (a) developing methods to overcome barriers by adults to reduce or eliminate the risk of injury from agricultural production, such as implementing affordable and accessible childcare which is readily available to farm families and/or overcoming barriers to decreasing exposures by youth to farm hazards, (b) methods required to establish safe play and recreation areas for youth on farms by adults, or c) for farms that are using young workers, incentives which are successful in getting adults to use model programs for training and supervising young agricultural workers to reduce the risk of injury.

3) Identify the Economic and/or Social Consequences of Youth Working on Farms.

Data on positive as well as negative outcomes of youth's involvement in agriculture are needed to develop a balanced response to protecting children.  Examples of research efforts which are appropriate under this priority area include, but are not limited to: (a) studies to estimate the societal and economic costs and consequences associated with childhood agricultural injury; (b) assessments of short- and long-term disability from injuries; (c) assessment of short- and long-term psychosocial outcomes (positive and/or negative) related to children's and adolescents' participation in different types of agricultural work; (d) actual costs to protect youth from hazards on the farm; (e) physical assessments of children and adolescents who have been exposed to agricultural hazards such as agricultural chemicals, organic dusts, toxic gases, nitrates, volatile organic compounds, oils and solvents; and, (f) studies of the impact of noise, vibration, cumulative trauma, and other work or environment-induced health hazards on children and adolescents working on farms.

Useful References

1.  2001 Childhood Agricultural-Related Injuries.  January 8, 2004.  USDA/NASS. (http://usda.mannlib.cornell.edu/reports/nassr/other/injury/injr0104.pdf )

2. Fatal Unintentional Farm Injuries Among Persons Less Than 20 years of Age in the United States:  Geographic Profiles, DHHS (NIOSH) Publication No. 2001-131, July 2001. (http://www.cdc.gov/niosh/childag/docs/2001131.html

(3) National Committee for Childhood Agricultural Injury Prevention. Children and Agriculture: Opportunities for Safety and Health. Marshfield, WI: Marshfield Clinic. 1996, (http://research.marshfieldclinic.org/children/action/title.htm.)

(4) Childhood Agricultural Injury Prevention: Progress Report and Updated National Action Plan for the 2001 Summit. Marshfield, WI: Marshfield Clinic.  Lee, B. Gallagher, S. ,Marlenga, B. and Hard, D. (Eds.). 2002.  (http://www.marshfieldclinic.org/research/children/childrensReport/.)

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

Section II. Award Information


1. Mechanism(s) of Support

This RFA will use the NIOSH individual research project grant (R01) award mechanism.  As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation.  Applications that are not funded in the competition described in this RFA may be submitted as NEW investigator-initiated applications using the standard receipt dates for NEW applications described in the instructions on the PHS 398 application.

This funding opportunity uses just-in-time concepts. It also uses the modular budget format described in the PHS 398 application instructions (see ).

2. Funds Available

NIOSH intends to commit approximately one million ($1,000,000) in fiscal year (FY) 2007 to fund approximately three to six new and/or competitive continuation grants in response to this RFA. An applicant may request a project period of up to three (3) years and a budget for direct costs of up to $250,000 dollars per year.  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 RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

All estimated funding amounts are subject to availability of funds.

Use of Funds

Applicants should include in their budget travel funds for one trip per year for an annual meeting with NIOSH scientists to be held in Atlanta Georgia.  The purpose of this meeting is to provide an opportunity for the exchange and dissemination of scientific information.

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:

A Bona Fide Agent is an agency/organization identified by the state as eligible to submit an application under the state eligibility in lieu of a state application.  If you are applying as a bona fide agent of a state or local government, you must provide a letter from the state or local government as documentation of your status.  Place this documentation behind the first page of your application form.

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 CDC programs.

2. Cost Sharing or Matching

Cost sharing or matching are not required to be eligible for funding under this RFA.   Cost-sharing will not assist in obtaining a better score.

The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/gps/

3. Other-Special Eligibility Criteria

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

If your application is incomplete or non-responsive to the special requirements listed in this section, it will not be entered into the review process.

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.

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.

CDC Telecommunications for the hearing impaired: TTY 770-488-2783.

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 Dun & Bradstreet (D&B) Data Universal Numbering System 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 in Section IV.3.A. Submission times are not applicable.

3.A. Receipt, Review and Anticipated Start Dates
Letter of Intent Receipt Date: NA
Application Receipt Date(s): August 16, 2006
Peer Review Date(s):  October-November 2006
Council Review Date(s): January 2007
Earliest Anticipated Start Date(s): April 1, 2007

3.A.1. Letter of Intent

Not Applicable

3.B. Sending an Application To The NIOSH

Applications follow the PHS 398 application instructions for content and formatting of your applications.  If the instructions in this announcement differ in any way from the PHS 398 instructions, follow the instructions in this announcement.

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)

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.

Personal deliveries to CSR 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

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.

CDC 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

Executive Order 12372 does not apply to this program.

5. Funding Restrictions

All CDC awards are subject to the terms and conditions, cost principles, and other considerations described in the PHS Grants Policy Statement.

Additional guidance can be found at NIH Grants Policy Statement.

Restrictions, which must be taken into account while writing your budget, are as follows:

6. Other Submission Requirements

Plan for Sharing Research Data

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 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). References to data sharing may also be appropriate in other sections of the application.

All applicants must include a plan for sharing research data in their application. The data sharing policy is available at http://www.cdc.gov/od/pgo/funding/ARs.htm under Additional Requirements 25 Release and Sharing of Data. 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 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

PHS policy requires that grant award recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (PHS Grants Policy Statement).   http://grants.nih.gov/grants/policy/gps/8postnew.htm#phs. 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://www.cdc.gov/od/pgo/forminfo.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 childhood health and safety? 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 childhood health and safety in agriculture? Does the application detail the importance of the proposed research and the role it will play in reducing the occupational safety burden in the agricultural workplace? If the aims of the application are achieved, how will knowledge of childhood health and safety be advanced?  What will be the effect on the concepts or methods currently used?  What are the expected outcomes? Does the intervention have plausible likelihood of being implemented and successful?

Approach: 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? Is the population suitable for intervention evaluation?  Does the applicant acknowledge potential difficulties and consider alternative tactics? Is the time line proposed for the project suitable and realistic? 

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?

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 documentation of cooperation from Agricultural stakeholders and 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). http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm. Additional CDC Requirements under AR-1 Human Subjects Requirements can be found on http://www.cdc.gov/od/pgo/funding/ARs.htm.

Inclusion of Children as Participants in Clinical Research:  The NIOSH 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 NIOSH, 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).

Inclusion of Women and Minorities in Research:

Does the application adequately address the CDC Policy requirements regarding the inclusion of women, ethnic, and racial groups in the proposed research?  This includes: (1) The proposed plan for the inclusion of both sexes and racial and ethnic minority populations for appropriate representation; (2) The proposed justification when representation is limited or absent; (3) A statement as to whether the design of the study is adequate to measure differences when warranted; and (4) A statement as to whether the plans for recruitment and outreach for study participants include the process of establishing partnerships with community(ies) and recognition of mutual benefits.

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. Additional CDC Requirements under AR-3 Animal Subjects Requirements can be found on http://www.cdc.gov/od/pgo/funding/ARs.htm.

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.

2.D. Sharing Research Resources

PHS policy requires that grant award recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication. http://grants.nih.gov/grants/policy/gps/8postnew.htm#phs. 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 http://www.cdc.gov/od/pgo/forminfo.htm). 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/archive/grants/policy/nihgps_2003/index.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/archive/grants/policy/nihgps_2003/index.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/archive/grants/policy/nihgps_2003/index.htm).

The Code of Federal Regulations 45 CFR Part 74 and Part 92 have details about policy requirements.  For more information on the Code of Federal Regulations, see the National Archives and Records Administration at the following Internet address: http://www.access.gpo.gov/nara/cfr/cfr-table-search.html

Additional requirements can be found in Section VIII. Other Information of this document or on the CDC website at the following Internet address: http://www.cdc.gov/od/pgo/funding/ARs.htm

These will be incorporated into the NoA by reference.

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 Section VII. Agency Contacts.

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

Inclusion of Children as Participants in Clinical Research:  The NIOSH 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 NIOSH, 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).

Human Subjects Protection
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated and if funded must comply 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).   Additional CDC Requirements under AR-1 Human Subjects Requirements can be found on http://www.cdc.gov/od/pgo/funding/ARs.htm.

Use of Animals in Research
Recipients of PHS support for activated 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.  Additional CDC Requirements under AR-3 Animal Subjects Requirements can be found on http://www.cdc.gov/od/pgo/funding/ARs.htm

Requirements for Inclusion of Women and Racial and Ethnic Minorities in Research
It is the policy of the Centers for Disease Control and Prevention (CDC) and the Agency for Toxic Substances and Disease Registry (ATSDR) to ensure that individuals of both sexes and the various racial and ethnic groups will be included in CDC/ATSDR-supported research projects involving human subjects, whenever feasible and appropriate. Racial and ethnic groups are those defined in OMB Directive No. 15 and include American Indian or Alaska Native, Asian, Black or African American, Hispanic or Latino, Native Hawaiian or Other Pacific Islander. Applicants shall ensure that women, racial and ethnic minority populations are appropriately represented in applications for research involving human subjects. Where clear and compelling rationale exist that inclusion is inappropriate or not feasible, this situation must be explained as part of the application. This policy does not apply to research studies when the investigator cannot control the race, ethnicity, and/or sex of subjects. Further guidance to this policy is contained in the Federal Register, Vol. 60, No. 179, pages 47947-47951, and dated Friday, September 15, 1995.

Paperwork Reduction Act Requirements
Under the Paperwork Reduction Act, projects that involve the collection of information from 10 or more individuals and funded by a grant or a cooperative agreement will be subject to review and approval by the Office of Management and Budget (OMB).

Smoke-Free Workplace Requirements
CDC strongly encourages all recipients to provide a smoke-free workplace and to promote abstinence from all tobacco products. Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities that receive Federal funds in which education, library, day care, health care, or early childhood development services are provided to children.

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 one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Lobbying Restrictions
Applicants should be aware of restrictions on the use of HHS funds for lobbying of Federal or State legislative bodies. Under the provisions of 31 U.S.C. Section 1352, recipients (and their sub-tier 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 CDC appropriated funds, shall be used, other than for normal and recognized executive-legislative relationships, for publicity or propaganda purposes, for the preparation, distribution, or use of any kit, pamphlet, booklet, publication, radio, television, or video presentation designed to support or defeat legislation pending before the Congress or any State or local legislature, except in presentation to the Congress or any State or local legislature itself. No part of the appropriated funds shall be used to pay the salary or expenses of any grant or contract recipient, or agent acting for such recipient, related to any activity designed to influence legislation or appropriations pending before the Congress or any State or local legislature.

Any activity designed to influence action in regard to a particular piece of pending legislation would be considered "lobbying." That is lobbying for or against pending legislation, as well as indirect or "grass roots" lobbying efforts by award recipients that are directed at inducing members of the public to contact their elected representatives at the Federal or State levels to urge support of, or opposition to, pending legislative proposals is prohibited. As a matter of policy, CDC extends the prohibitions to lobbying with respect to local legislation and local legislative bodies.

The provisions are not intended to prohibit all interaction with the legislative branch, or to prohibit educational efforts pertaining to public health. Clearly there are circumstances when it is advisable and permissible to provide information to the legislative branch in order to foster implementation of prevention strategies to promote public health. However, it would not be permissible to influence, directly or indirectly, a specific piece of pending legislation

It remains permissible to use CDC funds to engage in activity to enhance prevention; collect and analyze data; publish and disseminate results of research and surveillance data; implement prevention strategies; conduct community outreach services; provide leadership and training, and foster safe and healthful environments.

Recipients of CDC grants and cooperative agreements need to be careful to prevent CDC funds from being used to influence or promote pending legislation. With respect to conferences, public events, publications, and "grassroots" activities that relate to specific legislation, recipients of CDC funds should give close 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.

Prohibition on Use of CDC Funds for Certain Gun Control Activities
The Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act specifies that: "None of the funds made available for injury prevention and control at the Centers for Disease Control and Prevention may be used to advocate or promote gun control."

Anti-Lobbying Act requirements prohibit lobbying Congress with appropriated Federal monies. Specifically, this Act prohibits the use of Federal funds for direct or indirect communications intended or designed to influence a member of Congress with regard to specific Federal legislation. This prohibition includes the funding and assistance of public grassroots campaigns intended or designed to influence members of Congress with regard to specific legislation or appropriation by Congress.

In addition to the restrictions in the Anti-Lobbying Act, CDC interprets the language in the CDC's Appropriations Act to mean that CDC's funds may not be spent on political action or other activities designed to affect the passage of specific Federal, State, or local legislation intended to restrict or control the purchase or use of firearms.

Accounting System Requirements
The services of a certified public accountant licensed by the State Board of Accountancy or the equivalent must be retained throughout the project as a part of the recipient's staff or as a consultant to the recipient's accounting personnel. These services may include the design, implementation, and maintenance of an accounting system that will record receipts and expenditures of Federal funds in accordance with accounting principles, Federal regulations, and terms of the cooperative agreement or grant.

Capability Assessment
It may be necessary to conduct an on-site evaluation of some applicant organization's financial management capabilities prior to or immediately following the award of the grant or cooperative agreement. Independent audit statements from a Certified Public Accountant (CPA) for the preceding two fiscal years may also be required.

Security Clearance Requirement
All individuals who will be performing work under a grant or cooperative agreement in a CDC-owned or leased facility (on-site facility) must receive a favorable security clearance, and meet all security requirements. This means that all awardee employees, fellows, visiting researchers, interns, etc., no matter the duration of their stay at CDC must undergo a security clearance process.

Small, Minority, And Women-owned Business
It is a national policy to place a fair share of purchases with small, minority and women-owned business firms. The Department of Health and Human Services is strongly committed to the objective of this policy and encourages all recipients of its grants and cooperative agreements to take affirmative steps to ensure such fairness. In particular, recipients should:

  1. Place small, minority, women-owned business firms on bidders mailing lists.
  2. Solicit these firms whenever they are potential sources of supplies, equipment, construction, or services.
  3. Where feasible, divide total requirements into smaller needs, and set delivery schedules that will encourage participation by these firms.
  4. Use the assistance of the Minority Business Development Agency of the Department of Commerce, the Office of Small and Disadvantaged Business Utilization, DHHS, and similar state and local offices.

Research Integrity
The signature of the institution official on the face page of the application submitted under this Program Announcement is certifying compliance with the Department of Health and Human Services (DHHS) regulations in Title 42 Part 50, Subpart A, entitled "Responsibility of PHS Awardee and Applicant Institutions for Dealing with and Reporting Possible Misconduct in Science."

The regulation places several requirements on institutions receiving or applying for funds under the PHS Act that are monitored by the DHHS Office of Research Integrity's (ORI) Assurance Program.

For examples:

Required Education on the Protection of Human Subject Participants:
NIOSH policy requires education on the protection of human subject participants for all investigators submitting NIOSH 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.

Section 50.103(a) of the regulation states: "Each institution that applies for or receives assistance under the Act for any project or program which involves the conduct of biomedical or behavioral research must have an assurance satisfactory to the Secretary (DHHS) that the applicant: (1) Has established an administrative process, that meets the requirements of this subpart, for reviewing, investigating, and reporting allegations of misconduct in science in connection with PHS-sponsored biomedical and behavioral research conducted at the applicant institution or sponsored by the applicant; and (2) Will comply with its own administrative process and the requirements of this Subpart."

Section 50.103(b) of the regulation states that: "an applicant or recipient institution shall make an annual submission to the [ORI] as follows: (1) The institution's assurance shall be submitted to the [ORI], on a form prescribed by the Secretary,...and updated annually thereafter...(2) An institution shall submit, along with its annual assurance, such aggregate information on allegations, inquiries, and investigations as the Secretary may prescribe."

An additional policy is added in the year 2000 that "requires research institutions to provide training in the responsible conduct of research to all staff engaged in research or research training with PHS funds.

Compliance with Executive Order 13279
Faith-based organization are eligible to receive federal financial assistance, and their applications are evaluated in the same manner and using the same criteria as those for non-faith-based organizations in accordance with Executive Order 13279, Equal Protection of the Laws for Faith-Based and Community Organizations.  All applicants should, however, be aware of restrictions on the use of direct financial assistance from the Department of Health and Human Services (DHHS) for inherently religious activities. Under the provisions of Title 45, Parts 74, 87, 92 and 96, organizations that receive direct financial assistance from DHHS under any DHHS program may not engage in inherently religious activities, such as worship, religious instruction, or proselytization as a part of the programs or services funded with direct financial assistance from DHHS.  If an organization engages in such activities, it must offer them separately, in time or location, from the programs or services funded with direct DHHS assistance, and participation must be voluntary for the beneficiaries of the programs or services funded with such assistance.  A religious organization that participates in the DHHS funded programs or services will retain its independence from Federal, State, and local governments, and may continue to carry out its mission, including the definition, practice, and expression of its religious beliefs, provided that it does not use direct financial assistance from DHHS to support inherently religious activities such as those activities described above.  A faith-based organization may, however, use space in its facilities to provide programs or services funded with financial assistance from DHHS without removing religious art, icons, scriptures, or other religious symbols.  In addition, a religious organization that receives financial assistance from DHHS retains its authority over its internal governance, and it may retain religious terms in its organization=s name, select its board members on a religious basis, and include religious references in its organization=s mission statements and other governing documents in accordance with all program requirements, statutes, and other applicable requirements governing the conduct of DHHS funded activities.  For further guidance on the use of DHHS direct financial assistance see Title 45, Code of Federal Regulations, Part 87, Equal Treatment for Faith-Based Organizations, and visit the internet site:http://www.whitehouse.gov/government/fbci/

Health Insurance Portability and Accountability Act Requirements
Recipients of this grant award should note that pursuant to the Standards for Privacy of Individually Identifiable Health Information promulgated under the Health Insurance Portability and Accountability Act (HIPAA) (45 CFR Parts 160 and 164) covered entities may disclose protected health information to public health authorities authorized by law to collect or receive such information for the purpose of preventing or controlling disease, injury, or disability, including, but not limited to, the reporting of disease, injury, vital events such as birth or death, and the conduct of public health surveillance, public health investigations, and public health interventions.  The definition of a public health authority includes a person or entity acting under a grant of authority from or contract with such public agency.  CDC considers this project a public health activity consistent with the Standards for Privacy of Individually Identifiable Health Information and CDC will provide successful recipients a specific grant of public health authority for the purposes of this project.

Release and Sharing of Data
The Data Release Plan is the Grantee's assurance that the dissemination of any and all data collected under the CDC data sharing agreement will be released as follows:

a.      In a timely manner.

b.      Completely, and as accurately as possible.

c.       To facilitate the broader community.

d.      Developed in accordance with CDC policy on Releasing and Sharing Data.

April 16, 2003, http://www.cdc.gov/od/foia/policies/sharing.htm, and in full compliance with the 1996 Health Insurance Portability and Accountability Act (HIPPA), (where applicable), The Office of Management and Budget Circular A110, (2000) revised 2003, www.whitehouse.gov/omb/query.html?col=omb&qt=Releasing+and+Sharing+of+Data and Freedom of Information Act (FOIA) http://www.4.law.cornell.edu/uscode/5/5/552/html.

Applications must include a copy of the applicant's Data Release Plan.  Applicants should provide CDC with appropriate documentation on the reliability of the data.  Applications submitted without the required Plan may be ineligible for award.  Award will be made when reviewing officials have approved an acceptable Plan.  The successful applicant and the Program Manager will determine the documentation format.  CDC recommends data is released in the form closest to micro data and one that will preserve confidentiality.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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