Mining Occupational Safety and Health Research

RFA Number: RFA-OH-05-005

Part I Overview Information

Department of Health and Human Services

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

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

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

Announcement Type
New

Catalog of Federal Domestic Assistance Number(s)
93.262

Key Dates

Release Date: November 15, 2004
Letters Of Intent Receipt Date(s): February 15, 2005
Application Receipt Dates(s): March 15, 2005
Peer Review Date(s): April-May , 2005
Council Review Date(s) : May, 2005
Earliest Anticipated Start Date: June 1, 2005
Expiration Date: March 16, 2005

Due Dates for E.O. 12372
Not Applicable

Executive Summary

Applications are sought that investigate the broad issues of mining safety and health through population-based or laboratory research projects that are focused on mining safety related to: (1) powered-haulage equipment injuries (2) assessment of safety interventions (3) reduction of injuries from materials handling (4) hearing loss prevention (5) diesel exhaust exposure and (6) other mine safety and health topics. NIOSH i ntends to commit approximately $1 million in FY 2005 to fund 4 -7 new grants in response to this RFA. An applicant may request a project period of up to three years and a budget for direct costs up to $150,000 per year. This funding opportunity will use the NIOSH research grant (R01) award mechanism. You may submit an application if your organization has any of the following characteristics:

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. NIOSH encourages individuals from all racial and ethnic groups as well as individuals with disabilities to apply for this program. An applicant may submit only one application 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(s) of Support
    2. Funds Available

  Section III. Eligibility Information
    1. Eligible Applicants
      A. Eligible Institutions
      B. Eligible Individuals
    2.Cost Sharing
    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
      A. Receipt and Review and Anticipated Start Dates
        1. Letter of Intent
      B. Sending an Application to the NIH
      C. Application Processing
    4. Intergovernmental Review
    5. Funding Restrictions
    6. Other Submission Requirements

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

  Section VI. Award Administration Information
    1. Award Notices
    2. Administrative Requirements
     A. Cooperative Agreement Terms and Conditions of Award
        1. Principal Investigator Rights and Responsibilities
        2. NIH Responsibilities
        3. Collaborative Responsibilities
        4. Arbitration Process
    3. Award Criteria
    4. 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

This request for applications (RFA) announcement builds on the initiative of two prior mining research RFA announcements.

1. Research Objectives

Background

Despite many technological and work environment advances, mining remains one of the most dangerous occupations in the United States. The fatality rate in mining is six times higher than the national average for other industries. Additionally, the severity of injuries for mining exceeds all other industries with the highest percentage of lost work days per incident. Over the past 20 years, black lung disease has contributed to the deaths of over 20,000 U.S. coal miners. In addition, almost 70 percent of miners experience occupational hearing loss by the time they retire. With the increased demand for coal to meet the nation's energy needs, many of the health and safety problems associated with mining will be increased such as noise levels, methane gas levels, respirable dust levels etc. As a result, mining research interests span a wide range of disciplines. Therefore, this announcement solicits research in a number of priority mining areas including reduction of injuries and fatalities from powered-haulage equipment, assessment of programs aimed at reducing worker injuries, reduction of injuries from materials handling, hearing loss prevention, diesel particulate matter exposures and other topics related to mine safety and health. All projects must have a focus on reducing the risks of injuries and illnesses caused explicitly by employment in the mining environment.

Research Objectives

Types of research applications that are appropriate for this topic include but are not limited to the following areas:

1. Reduction of injuries and fatalities from powered-haulage equipment. In the underground workplace, the operation of large equipment is responsible for about 30% of the fatalities and about 24% of the lost-time injuries. Fatalities and lost-time injuries at surface mining operations resulting from equipment use and powered-haulage are 59% and 21%, respectively. The limited visibility around the large machinery and the confined nature of the underground workplace contribute to the hazards of safely operating the equipment. Areas of interest include:

2. Assessment of intervention effectiveness. Health and safety programs in the industrial sectors are aimed at preventing injuries and health hazards and the mining community has been a leader in developing and implementing a wide variety of health and safety programs. While the mining community has made significant strides in reducing workplace hazards, assessing the validity of the programs for achieving the desired outcomes of a healthier and safer work environment is not always clearly understood. Approaches and methodologies that focus on assessing the value of health and safety interventions for reaching the desired outcomes are of interest.

3. Reduction of injuries from materials handling. The handling of materials at surface and underground mining operations is a significant contributor to injuries accounting for 33% of the lost-time injuries in underground mines and 30% of the lost-time injuries at surface mining operations. These types of injuries are often times severe with the median numbers of days lost being 20 for underground mining operations and 12 for surface mining operations. Areas of interest include technologies, strategies or methodologies that reduce the number or severity of injuries from material handling at surface or underground mining operations.

4. Hearing loss prevention in miners. Noise-induced hearing loss is more prevalent in the mining industry than other industries with 65 percent of the mining workforce experiencing hearing damage by the time they retire. The confined nature of the environment coupled with the size and power of the mechanized mining equipment are thought to be significant noise factors that contribute to the serious loss of hearing experienced by career miners. Areas of interest include:

5. Exposure of mine workers to diesel exhaust. Diesel particulate matter (DPM) has been declared a probable carcinogen by a number of State, Federal and private health-watch organizations. Recently one non-governmental body responsible for recommending occupational exposure guidelines recommended a DPM concentration limit of 50 micrograms/cubic meter. DPM levels in U.S. mines expose about 30,000 workers to concentrations that approach 20 times this limit. Additionally, the use of diesel-powered equipment in underground mines is increasing as eastern coal mines are beginning to replace battery-powered equipment with diesel-powered. Areas of interest include:

6. Other health and safety topics. All health and safety topics for the mining industry are of interest and additional topics include, controlling coal dust and silica dust, ergonomic studies, health and safety during construction and maintenance operations and control of chemical hazards and toxic substances. Due to the nature of mining operations with a dynamic environment, large and powerful equipment, confined space and often low levels of visibility the mine workers deal with a variety of health and safety concerns and all of these topics are of interest. The research studies may address methodologies for controlling or eliminating the hazards by improved engineering designs or where appropriate could include surveillance and monitoring studies.

Useful References

National Institute for Occupational Safety and Health. National Occupational Research Agenda. Cincinnati, OH: U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No.96 115 (http://www.cdc.gov/niosh/nora.html).

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the NIOSH research grant (R01) award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions. Specifically, a detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

2. Funds Available

NIOSH intends to commit approximately $1 million in FY 2005 to fund 4 -7 new grants in response to this RFA. An applicant may request a project period of up to three years and a budget for direct costs up to $150,000 per year. The amount of total funding per award, on average, experienced in previous years is $200,000. The anticipated start date is June 1, 2005. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the 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.

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 their institution to develop an application for support. NIOSH encourages individuals from all racial and ethnic groups as well as individuals with disabilities to apply for this program.

2. Cost Sharing

This program does not require cost sharing as defined in the current PHS Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/index.htm. Additional guidance may be found at: http://grants.nih.gov/grants/policy/policy.htm.

3. Other-Special Eligibility Criteria

Applicants with established resources and facilities to recruit study sites and to enroll workers willing to participate in the study in a cost effective manner are encouraged. An applicant may submit only one application under this announcement.

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. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

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

2. Content and Form of Application Submission

Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the website at http://www.dnb.com The D&B number should be entered on line 11 of the face page of the PHS 398 form.

See Section VI.2. Administrative Requirements for additional information.

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

3.A. Receipt, Review and Anticipated Start Dates

Letters Of Intent Receipt Date(s): February 15, 2005
Application Receipt Dates(s): March 15, 2005
Peer Review Date(s): April-May , 2005
Council Review Date(s) : May, 2005
Earliest Anticipated Start Date: June 1, 2005

3.A.1. Letter of Intent

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

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

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

The letter of intent should be sent to:

Price Connor, Ph.D.
Office of Extramural Programs
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention
1600 Clifton Road, N.E.
Executive Park Building 24, Room 1618, MS E-74
Atlanta, GA 30333
Telephone: (404) 498-2511
FAX: (404) 498-2571
Email: pconnor@cdc.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the PHS 398 research grant application instructions and forms as described above. 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)

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

Price Connor, Ph.D.
Office of Extramural Programs
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention
1600 Clifton Road, N.E.
Executive Park Building 24, Room 1618, MS E-74
Atlanta, GA 30333
Telephone: (404) 498-2511
FAX: (404) 498-2571
Email: pconnor@cdc.gov

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.

3.C. Application Processing

Applications must be received on or before the application receipt date listed in the heading of this funding opportunity. If an application is received after that date, it will be returned to the applicant without review.

Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by NIOSH . Incomplete applications will not be reviewed.

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

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

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All awards are subject to the terms and conditions, cost principles, and other considerations described in the PHS Grants Policy Statement http://grants1.nih.gov/grants/policy/policy/nihgps_2003/index.html. Additional guidance may be found at http://grants.nih.gov/grants/policy/policy.htm (See also Section VI.3. Award Criteria).

6. Other Submission Requirements

The following should be addressed in a clear and organized manner (see also peer review criteria section):

Timeline: a detailed timeline for the proposed study must be included in the application. Tasks should be identified for each specific aim, showing how the study will be managed over the project period.

If applicable, in a separate section labeled, “Participant Notification of Study Results”, the applicant should describe plans for notifying participants about their individual results and the overall results of the study.

Applicants should include in their budget support for themselves to attend an annual one day grantee meeting in Pittsburgh, PA. These meetings are to review and assess overall progress and provide the opportunity for investigators to exchange information and discuss research issues.

Plan for Sharing Research Data

Applicants for this program are not required to include a plan for sharing research data in their application. However, if data sharing is planned, the funding organization will be responsible for monitoring the data sharing policy (http://grants.nih.gov/grants/policy/data_sharing).

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

The reasonableness of the data sharing plan may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Sharing Research Resources

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

The adequacy of the data sharing plan and the resources sharing plan 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). See Section VI.3. Award Criteria.

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

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

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:

3. Merit Review Criteria

NIOSH objectives include the support of research to reduce work-related illnesses and injuries. In the written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these objectives. The scientific review group will address and consider each of these criteria in assigning the application's overall score, weighting them as appropriate for each application.

The application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance : Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? Will the proposed research contribute to the overall aim of reducing mining illnesses or injuries?

Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Is sufficient detail provided to explain clearly how the study will be conducted? Are statistical considerations appropriately addressed to ensure usefulness of the study results?

Innovation: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies?

Investigator: Is the investigator 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 (if any)? Do the study investigators have experience in working with the mining industry or supply evidence that such expertise is adequately provided by consultants or collaborators? If appropriate, does the team have a multidisciplinary background to conduct the proposed study?

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

3.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 also Section VIII - Other Information.

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 also Section VIII-Other Information.

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed.

3.B. Additional Review Considerations

Budget: While the priority score will not be affected by evaluation of the budget, the scientific review group will examine the reasonableness of the proposed budget and the requested period of support in relation to the proposed research.

3.C. Sharing Research Data

Data sharing is not required in this program. However, if data sharing is planned, t he reasonableness of the data sharing plan may be assessed by the reviewers, but they will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

3.D. Sharing Research Resources

NIOSH requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (see Section IV. 6. above).

Section VI. Award Administration Information

1. Award Notices

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

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

A formal notification in the form of a Notice of award will be provided to the applicant organization. The notice of award signed by the grants management officer is the authorizing document.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NGA (Notice of Grant Award) are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

The Notice of Award will be transmitted by mail and/or e-mail to the business official .

2. Administrative Requirements

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

3. Award Criteria

The following will be considered in making funding decisions:

4. 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 PHS Grants Policy Statement.

Requirements for final reports are found at: http://www.cdc.gov/niosh/oep/pdfs/Award_Closeout_Guidance_12-24-04.pdf.

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 Contact:

Susan B. Board, M.S.
Scientific Program Administrator
Office of Extramural Programs
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention
1600 Clifton Road, N.E.
Executive Park Building 24, Room 1415, MS E-74
Atlanta, GA 30333
Telephone: (404) 498-2512
FAX: (404) 498-2571
Email: sboard@cdc.gov

2. Peer Review Contact:

Price Connor, Ph.D.
Office of Extramural Programs
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention
1600 Clifton Road, N.E.
Executive Park Building 24, Room 1618, MS E-74
Atlanta, GA 30333
Telephone: (404) 498-2511
FAX: (404) 498-2571
Email: pconnor@cdc.gov

3. Financial or Grants Management Contact:

Peter Grandillo
Acquisition and Assistance Field Branch
Centers for Disease Control and Prevention
626 Cochrans Mill Road
Pittsburgh, Pennsylvania 15236-0070
Announcement Number OH-05-005
Telephone: (412) 386-6834
Email: pgrandillo@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.

Sharing Research Data:

Investigators should seek guidance from their institutions, on issues related to institutional policies, local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan into the determination of the scientific merit or the priority score.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated. NIOSH concurs and supports this effort.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH and NIOSH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH and 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 NIH and 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 that is available at http://grants.nih.gov/grants/funding/children/children.htm.

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

Public Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. NIOSH concurs and supports this effort.

Lobbying Restrictions:

Applicants should be aware of restrictions on the use of Health and Human Services (DHHS) funds for lobbying of Federal or State legislative bodies. Under the provisions of 31 U.S.C. Section 1352, recipients (and their subtier contractors) are prohibited from using appropriated Federal funds (other than profits from a Federal contract) for lobbying congress or any Federal agency in connection with the award of a particular contract, grant, cooperative agreement, or loan. This includes grants/cooperative agreements that, in whole or in part, involve conferences for which Federal funds cannot be used directly or indirectly to encourage participants to lobby or to instruct participants on how to lobby.

In addition, no part of the Center for Disease Control and Prevention (CDC) appropriated funds shall be used, other than for normal and recognized executive-legislative relationships, for publicity or propaganda purposes, for the preparation, distribution, or use of any kit, pamphlet, booklet, publication, radio, television, or video presentation designed to support or defeat legislation pending before the Congress or any State or local legislature, except in presentation to the Congress or any State or local legislature itself. No part of the appropriated funds shall be used to pay the salary or expenses of any grant or contract recipient, or agent acting for such recipient, related to any activity designed to influence legislation or appropriations pending before the Congress or any State or local legislature.

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

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

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

Recipients of NIOSH/CDC grants and cooperative agreements need to be careful to prevent NIOSH/CDC funds from being used to influence or promote pending legislation. With respect to conferences, public events, publication, and “grass roots” activities that relate to specific legislation, recipients of NIOSH/CDC funds should give attention to isolating and separating the appropriate use of NIOSH/CDC funds from non-NIOSH/CDC funds. NIOSH/CDC also cautions recipients of NIOSH/CDC funds to be careful not to give the appearance that NIOSH/CDC funds are being used to carry out activities in a manner that is prohibited under Federal law.

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.htm.

NIOSH concurs and supports this effort.

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 NIOSH 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:
CDC is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a national activity for setting focus areas. This RFA is related to one or more of the focus 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 under 93.262: Occupational Safety and Health Research Grants 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), )], the Occupational Safety and Health Act of 1970, Section 20(a) {29 U.S.C. 669(a)}, the Mine Safety and Health Act of 1977(30 USC 801 et seq, Section 951), 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 HHS Grants Policy Statement. The HHS Grants Policy Statement can be found at http://grants1.nih.gov/grants/policy/policy/nihgps_2003/index.html.

Smoke-Free Workplace:

The CDC 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.


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