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/oep)

Components of Participating Organizations
Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health (CDC/NIOSH), (http://www.cdc.gov/niosh/oep)

Title: NIOSH Small Research Grant Program (R03)

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

Announcement Type
This is a reissue of PA-04-021

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

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide. APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission and should be started at least four weeks in advance of the planned submission (See Section IV).

The application must be successfully submitted to Grants.gov by 5:00 p.m. local time (of the applicant institution/organization) on the submission date (see “Key Dates” below).

No registration in the NIH eRA Commons by either institutions/organizations or Project Directors/Principal Investigators (PD/PIs) is needed to respond to the FOA, and the procedures associated with NIH eRA Commons will not be followed for this FOA.

Program Announcement (PA) Number: PAR-06-364

Catalog of Federal Domestic Assistance Number(s).
93.262

Key Dates
Release/Posted Date: May 3, 2006
Opening Date: May 3, 2006 (earliest date an application may be submitted to Grants.gov.
Letter of Intent Receipt Date(s): Not applicable
NOTE: On time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 local time (of the applicant Institution/Organization.)
Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm for details.
Expiration Date: September 19, 2006

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

The National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC) invite grant applications for research related to occupational safety and health. The NIOSH research program goal is to support research that is relevant, of high quality, and demonstrates impact in reducing occupational disease and injury. Emphasis is placed on research projects that address needs in the National Occupational Research Agenda (NORA), for which information may be found at: http://www.cdc.gov/niosh/nora/. To extend NORA beyond the first ten years, NIOSH has created a Program Portfolio that is organized into eight (8) NORA Sector Programs that represent industrial sectors, and fifteen (15) cross-sector programs organized around adverse health outcomes, statutory programs and global efforts. In addition to these program areas, NIOSH has identified seven (7) Coordinated Emphasis Areas that support the Sector and Cross-Sector Programs. http://www.cdc.gov/niosh/programs/

Below is a concise description of the funding opportunity under this announcement.

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 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. Request Application Information

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


Section V. Application Review Information
1. Criteria
2. Review and Selection Process

A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates

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

Section VII. Agency Contact(s)

1. Scientific/Research Contact(s)
2. Peer Review Contact(s)

3. Financial/Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

The 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 FOA addresses “Healthy People 2010” priority area(s) of reducing injuries and disease in occupational settings and to promote a healthy work environment and is in alignment with NIOSH’s performance goal(s) to support research that is relevant, of high quality, and demonstrates impact in reducing occupational disease and injury. For more information, see www.health.gov/healthypeople and www.whitehouse.gov/omb/mgmt-gpra/.

In today's society, Americans are working more hours than ever before. The workplace environment profoundly affects health; simply by going to work each day, we may face hazards that threaten our health and safety. Risking one's life or health should never be considered merely part of the job. In 1970, Congress passed the Occupational Safety and Health Act to ensure Americans the right to "safe and healthful working conditions," yet workplace hazards continue to inflict a tremendous toll in both human and economic costs. In 2000, private industry employers reported 5.3 million work injuries and 363,000 cases of occupational illness. An average of 16 American workers die each day from injuries on the job (in 2000, there were 5915 fatal work injuries). Moreover, even the most conservative estimates find that about 137 additional workers die each day from workplace diseases. Additionally, in 1999, occupational injuries and deaths cost approximately $123 billion in wages and lost productivity, administrative expenses, health care and other costs. This figure does not include the cost of occupational disease. These occupational injuries and diseases create needless human suffering, a tremendous burden upon health care resources, and an enormous drain on U.S. productivity.

Within CDC, NIOSH is the lead Federal Institute responsible for conducting research and making recommendations for the prevention of work-related illnesses and injuries. However, there are other Federal components that contribute significantly to the research base for understanding the causes of occupational illnesses and injuries, so NIOSH coordinates with those other organizations in co-sponsoring programs and funding applications.

Research Objectives

In 1996, NIOSH and its partners in the public and private sectors developed the NORA to provide a framework to guide occupational safety and health research into the next decade. Approximately 500 organizations and individuals outside NIOSH provided input into the development of NORA. The agenda identifies 21 research priorities and reflects an attempt to consider both current and emerging needs. The priority areas were not ranked; each is considered to be of equal importance. Potential applicants may obtain a copy of the "National Occupational Research Agenda" (HHS, CDC, NIOSH Publication No.96-115) from the National Institute for Occupational Safety and Health, telephone (800) 356-4674 or on the internet at http://www.cdc.gov/niosh/nora/ (click on “About NORA” and “first agenda”)

Objectives of research supported by NIOSH include, but are not limited to: (1) identify and investigate the relationships between hazardous working conditions and associated occupational diseases and injuries; (2) develop more sensitive means of evaluating hazards at work sites, as well as methods for measuring early markers of adverse health effects and injuries; (3) develop new protective equipment, engineering control technology, and work practices to reduce the risks of occupational hazards; (4) evaluate the technical feasibility or application of a new or improved occupational safety and health procedure, method, technique, or system.

The goal of the NIOSH research program is to support research that is relevant, of high quality, and demonstrates impact in reducing occupational disease and injury. Emphasis is placed on research projects that address needs in NORA. In 2006, NIOSH is extending NORA for another ten years with a shift in organization of the research portfolio to reflect the industries in which workers are employed. In that context, NIOSH created a Program Portfolio to broadly guide activities by categorizing programs into eight (8) NORA Sector Programs that represent groups of industrial sectors, and fifteen (15) cross-sector programs organized around adverse health outcomes, statutory programs and global efforts. In addition to these program areas, NIOSH has identified seven (7) Coordinated Emphasis Areas that support the Sector and Cross-Sector Programs. http://www.cdc.gov/niosh/programs/

The NIOSH Program Portfolio is outlined below:

NORA Sector Programs

NIOSH Cross-Sector Programs

NIOSH Coordinated Emphasis Areas

Applicants should provide a statement about which industry sector, cross-sector, and emphasis area (if applicable) are being addressed and a rationale for how the proposal will contribute to the specified priority area (this information should be placed in the "Background and Significance" section of the "Research Plan" of the application).

In addition to NORA, NIOSH has initiated a Research to Practice (r2P) initiative to reduce or eliminate occupational disease and injury by increasing the use and translation of effective NIOSH-funded research findings in the workplace and through stakeholder involvement in the research process. Therefore, applications should include an explanation of how their proposed research will contribute to this initiative. Information is available at: http://www.cdc.gov/niosh/r2p/

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

Section II. Award Information


1. Mechanism(s) of Support
This Funding Opportunity Announcement (FOA) uses the small research projects (R03) mechanism which pertains to studies that can be carried out in a short period of time with limited resources. The applicant will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses just-in-time concepts. It also uses the modular budget formats (see the “Modular Applications and Awards” section of the NIH Grants Policy Statement. All applications submitted in response to this FOA must use the modular budget format. Specifically, use the PHS398 Modular Budget component provided in the SF424 (R&R) Application Package and SF424 (R&R) Application Guide (see specifically Section 5.4, “Modular Budget Component,” of the Application Guide).

A project period of up to two years and a budget for direct costs of up to two $25,000 modules, or $50,000 per year, may be requested (i.e., a maximum of $100,000 over two years in four modules of $25,000 each). Commensurate Facilities and Administrative (F&A) costs are allowed.

F&A costs requested by consortium participants are not included in the direct cost limitation, See NOT-OD-05-004, November 2, 2004.

Competing renewal (formerly “competing continuation”) applications will not be accepted for the R03 grant mechanism. Small grant support may not be used for thesis or dissertation research. Up to two resubmissions (formerly “revisions/amendments") of a previously reviewed small grant application may be submitted as defined in NIH Policy. See NOT-OD-05-046 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-046.html

2. Funds Available

Although the financial plans of the CDC/NIOSH provides support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of relevant, meritorious applications.

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:

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with his/her 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/NIOSH programs. Individuals who are junior investigators (no higher than assistant professor) have a higher priority for funding. Individuals in a training program are not eligible for this program (masters, doctoral, or postdoctoral).

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current NIH Grants Policy Statement.

3. Other-Special Eligibility Criteria

Applicants may submit more than one application, provided each application is scientifically distinct. Small grant support may not be used for thesis or dissertation research.

Section IV. Application and Submission Information


To download an Application Package and Application Guide for completing the SF424 (R&R) forms for this FOA, link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

A one-time registration is required for institutions/organizations at:

Grants.gov (http://www.grants.gov/GetStarted))

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the “Attachment” files may be useable for more than one FOA.

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

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide (MS Word or PDF).

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to CDC/NIOSH. Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see “Tips and Tools for Navigating Electronic Submission” on the front page of “Electronic Submission of Grant Applications.”

The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
PHS398 Modular Budget Component

Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Form

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Submission, Review, and Anticipated Start Dates
Letter of Intent Receipt Date: None
Application Submission Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
Peer Review Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
Council Review Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
Earliest Anticipated Start Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm

3.A.1. Letter of Intent

Not Required.

3.B. Electronic Transmission of an Application to the NIH

Applications in response to this FOA may only be submitted to Grants.gov through Grants.gov/Apply.
PAPER APPLICATIONS WILL NOT BE ACCEPTED.

3.C. Application Processing

Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application submission/receipt date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the receipt date(s) and time, the application may be delayed in the review process or not reviewed.

Upon receipt, applications will be evaluated for completeness by NIOSH Incomplete applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov.

The CDC will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The CDC will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of an application already reviewed with substantial changes, but such application must include an “Introduction” addressing the previous critique. Note that such an application is considered a "resubmission" for the SF424 (R&R).

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

Pre-Award Costs are allowable. A grantee may, at its own risk and without NIOSH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or competing renewal award if such costs: are necessary to conduct the project and would be allowable under the grant, if awarded, without NIOSH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIOSH approval before incurring the cost. NIOSH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or competing renewal award.

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

6. Other Submission Requirements

For additional information, see “Tips and Tools for Navigating Electronic Submission” on the front page of “Electronic Submission of Grant Applications.”

Application Characteristics

R03 applications will use the modular budget format and “Just-in-Time” concepts, with direct costs of up to two $25,000 modules, or $50,000 per year, may be requested for up to two years (i.e., a maximum of $100,000 over two years in four modules of $25,000 each).

Research Plan:

The Specific Aims, Background and Significance, Preliminary Studies, and Research Design and Methods components of the Research Plan must not exceed 10 pages. All tables, graphs, figures, diagrams, and charts must be included with the 10-page limit. Be succinct and remember that there is no requirement to use all 10 pages allotted to the Research Plan. Please note that a Progress Report is not needed.

For a resubmission application, an Introduction (not to exceed one page) in addition to the Research Plan is required. This Introduction, which is not included in the ten-page limit, must include responses to the criticisms and issues raised in the summary statement. The changes in the Research Plan must be clearly marked by appropriate bracketing, indenting or changing of typography, unless the changes include most of the text. Changes should be summarized in the Introduction.

Note: While each section of the Research Plan needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.

Appendix: (New and Resubmission Applications)

Note: Follow the guidance above about PDF files.

Plan for Sharing Research Data

Not applicable

Sharing Research Resources

Data sharing is not required.

Section V. Application Review Information


1. Criteria

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Applications submitted for this NIOSH funding opportunity will be reviewed by an appropriate scientific review group convened by NIOSH in accordance with the standard NIH peer review standards (http://www.csr.nih.gov/refrev.htm).

The peer review of all applications consists of the following:

Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:

Initial Review Criteria:

The NIOSH R03 small grant is a mechanism for supporting discrete, well-defined projects that realistically can be completed in two years and that require limited levels of funding. Because the research plan is restricted to 10 pages, a small grant application will not have the same level of detail or extensive discussion found in an R01 application. Accordingly, reviewers should evaluate the conceptual framework and general approach to the problem, placing less emphasis on methodological details and certain indicators traditionally used in evaluating the scientific merit of R01 applications, including supportive preliminary data. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or from investigator-generated data. Preliminary data are not required, particularly in applications proposing pilot or feasibility studies.

In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance: Does this study address an important occupational safety and health problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Approach: Are the conceptual or clinical framework, design, methods, and analyses of occupational safety and health adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

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 occupational safety and health work? Is the work proposed appropriate to the experience level of the PD/PI and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

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

Second Level Review Criteria:

Relevance to occupational safety and health by contributing to achievement of the research objectives in this FOA.

Potential contribution to applied technical knowledge in the identification, evaluation, and/or control of occupational safety and health hazards

Magnitude of the problem in terms of numbers of workers affected

Severity of the disease or injury in the worker population

Program balance

Policy and budgetary considerations

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. See item 6 of the Research Plan component of the SF424 (R&R)).

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 item 7 of the Research Plan component of the SF424 (R&R)).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under item 11 of the Research Plan component of the SF424 (R&R) 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 and Period of Support: The reasonableness of the proposed budget and the appropriateness of the requested period of support in relation to the proposed research may be assessed by the reviewers. Is the effort listed for the PD/PI appropriate for the work proposed? Is each budget category realistic and justified in terms of the aims and methods?

2.C. Sharing Research Data

Not applicable.

2.D. Sharing Research Resources

CDC/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/archive/grants/policy/nihgps_2003/index.htm#_Toc54600131). 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.

Section VI. Award Administration Information


1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the NIH eRA Commons.

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

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.

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 Section IV.5., “Funding Restrictions.”

2. Administrative and National Policy Requirements

All CDC/NIOSH and NIH grant awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities.

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

3. Reporting

Awardees are required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm).

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:

For specific information, such as relevance of a research topic, please consult the appropriate Scientific Program Administrators in the NIOSH Office of Extramural Programs at http://www.cdc.gov/niosh/oep/about.html#portfolio.

For general information, please contact:

Susan B. Board, M.S.
Office of Extramural Programs
National Institute for Occupational Safety and Health

regular mail: 1600 Clifton Rd. S.W.
overnight mail: 24 Executive Park Drive, Rm. 1415
Atlanta, Georgia 30333
Phone: 404-498-2530
Fax: 404-929-2775
Email address: SBoard@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: CRafferty1@cdc.gov

3. Financial/Grants Management Contacts:

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

Section VIII. Other Information


Required Federal Citations

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).

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. NIOSH supports this policy.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIOSH that women and members of minority groups and their sub-populations must be included in all NIOSH-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). NIOSH supports this policy. 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 SF424 (R&R) application; 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 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).

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.

NIOSH Public Access Policy:
NIOSH-funded investigators are requested to submit to the NIOSH 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 NIOSH. 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.

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

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

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

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.

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. NIOSH derives its authority from Occupational Safety and Health Act of 1970, Sections 20(a) and 21(a), 29 U.S. Code 669(a) and 670(a); Federal Mine Safety and Health Act, Section 501(a), 30 U.S. Code 951(a); Public Health Service Act, Section 301(a) and 405; 42 U.S. Code 241 and 284 and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

Smoke-Free Workplace:
The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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