Part I Overview Information

Department of Health and Human Services

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

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

Title: Occupational Safety and Health Training Project Grants

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

Announcement Type
New

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

Program Announcement (PA) Number: PAR-05-126

Catalog of Federal Domestic Assistance Number(s)
93.262

Key Dates
Release Date: June 22, 2005
Letters of Intent Receipt Date(s): N/A
Application Receipt Date: August 24, 2005; August 24, 2006; August 24, 2007
Peer Review Date(s): December each year
Council Review Date(s): May each year
Earliest Anticipated Start Date: July 1 each year
Additional Information To Be Available Date (Url Activation Date): N/A
Expiration Date: August 25, 2007

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

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

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

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt, 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 purpose of this program is to continue existing, and/or establish new Training Project Grants (TPG) that are focused on occupational safety and health. NIOSH is mandated to provide an adequate supply of qualified personnel to carry out the purposes of the Occupational Safety and Health Act, and the TPGs are one of the means for meeting this mandate. TPGs are academic institutions that provide graduate training in the core disciplines of Industrial Hygiene (IH), Occupational Health Nursing (OHN), Occupational Medicine Residency (OMR), Occupational Safety (OS), and other fields closely related to occupational safety and health (OSH). Special technical and other programs for long-term training of occupational safety and health technicians or specialists may also be supported. Applicants proposing training programs in related OSH areas or long-term training should contact the program administrator identified in this announcement to ensure the area is of interest to NIOSH.

Training Programs

This program will support Masters and Doctoral training. NIOSH intends to publish a separate announcement for undergraduate occupational safety and health training project grants. Applicants proposing to apply for support of undergraduate OS&H programs should contact the program administrator identified in this announcement to ensure the area is of interest to NIOSH.

Certain training areas are considered “core disciplines”. The core disciplines are: OMR, OHN, IH, and OS. In addition to these core disciplines, in order to take full advantage of the unique strengths and capabilities of institutions, consideration will be given to the development of new and innovative academic component programs in allied disciplines that are relevant to the occupational safety and health field, e.g., ergonomics, industrial toxicology, occupational injury prevention, occupational epidemiology, occupational health psychology, occupational health services, and agricultural safety and health. There must be a minimum of five (5) full time trainees in each program, with the exception of OMR, where there must be at least four (4) full time trainees.

TPGs must document that the core or allied disciplines will fill a critical gap in the selected occupational safety and health disciplines that meets a specific regional workforce need. In addition, TPGs are encouraged to have an advisory committee of three or more individuals who can provide advice on the program focus and curriculum. The committee may include representatives of labor, industry, government agencies, academic institutions and professional associations.

Each core area program curriculum should include courses that fully prepare trainees to move into and/or advance in the OSH work community. Appropriate clinical rotations and field experiences with occupational safety and health agencies or other appropriate groups and with labor-management health and safety groups are encouraged.

Core programs can offer masters and doctoral degrees. Pre-doctoral training must lead to the Masters degree and/or the Ph.D. degree or a comparable research doctoral degree. Pre-doctoral training should emphasize fundamental training in areas of occupational safety and health sciences.

A TPG is encouraged to provide Doctoral and Master trainees instruction in the following areas:

1. Responsible conduct of research (required for all Research Masters and Doctoral trainees)

2. How to write research grant proposals (optional)

3. How to manage research laboratories (optional)

A TPG may provide training in as many core or allied program OSH areas as resources allow.

In addition, a TPG must have a Diversity Recruitment Plan. TPGs are encouraged to recruit and train students from appropriate groups to help address the under-representation among the occupational safety and health professional workforce. A detailed plan to address the under-representation of minorities among occupational safety and health professionals and for the recruitment of underrepresented minorities must be a part of the application. The initial review group will review this plan as part of the overall rating of the application.

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

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the NIOSH T01, T02, and T15 award mechanism(s).

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

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

2. Funds Available

The total amount of funds awarded under this program is approximately $3 million dollars per year for new competing applications, competing renewal applications, and continuing awards. The number of awards for this program is between 20 and 30 depending on the quality of the applications and funds available. Each year the number of new competing and competing renewal awards will vary between one and ten depending on the number of five year awards that have ended. The anticipated start date for these awards is July 1 of the year following application submission and the maximum performance period that may be requested is five years.

Although the financial plans of NIOSH provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

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

Note: Foreign institutions are not eligible to apply.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIOSH programs.

2. Cost Sharing or Matching

Cost sharing is not required.

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

3. Other-Special Eligibility Criteria

An applicant institution may only submit one application under this announcement. If an institution would like to submit more than one application, they must contact the program administrator listed in this announcement.

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.

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

2. Content and Form of Application Submission

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

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

The application for this program uses the substitute form page 4 (“NRSA Substitute Detailed Budget for Initial Budget Period Direct Costs”) and substitute form page 5 of the 398 application. Applicants that do not submit the budget in the required format will have their applications returned as non-responsive. Limits on funding levels for each component are listed below in Section IV.6. “Other Submission Requirements." Supplementary instructions to assist the investigator with the preparation of the application is provided on the NIOSH web site at the following address: http://www.cdc.gov/niosh/oep/training.html.

Supplemental Instructions

All training activities should be consistent with the goals of the TPG and should be based on well documented occupational safety and health needs. In order to assist applicants in the preparation of an application that can be reviewed, a number of supplemental instructions are provided. The applicant should follow the special instructions for institutional training grants contained within the PHS 398 instructions. In addition, supplemental instructions for preparing a training program application are provided at http://www.cdc.gov/niosh/oep/training.html. The applicant should follow the page limits specified in the outline below, and ensure that each training activity is clearly described and identified. The application should be organized as indicated below:

Table of Contents for a Training Project Grant Application

In order to facilitate the preparation and review of the TPG application, the following Table of Contents should be used. It is a minor modification of the PHS 398 Substitute Form Page 3 Table of Contents.

Note: Type density and size throughout the entire application must conform to the limits provided on page 14 in the PHS 398 instructions.

3. Submission Dates and Times
See Section IV.3.C for details.

3.A. Receipt, Review and Anticipated Start Dates

Letter of Intent Receipt Date: NA
Application Receipt Date(s): August 24, 2005; August 24, 2006; August 24, 2007
Peer Review Date: December each year
Council Review Date: May each year
Earliest Anticipated Start Date: July 1 each year

3.A.1. Letter of Intent
A letter of intent is not required for the funding opportunity.

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant application forms 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)

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
National Institute for Occupational Safety and Health, 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

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

3.C. Application Processing

Applications must be received on or before the application receipt/submission 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 CSR. Incomplete applications will not be reviewed.

NIOSH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. NIOSH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique.

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 CDC NIOSH 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: http://grants.nih.gov/grants/policy/policy.htm.

Indirect costs are limited to 8%. Indirect costs are not paid on equipment or tuition and fees.

6. Other Submission Requirements

Applications for this announcement will use the NRSA substitute form page 4 and 5 to display the budgets. The facilities and administrative costs for this program are limited to 8% of the total direct costs (excluding equipment and tuition and fees). The NIOSH web site provides special instructions to assist an applicant in the preparation of an application. The web address is http://www.cdc.gov/niosh/oep/training.html.

Stipends, tuition, and fees may only be paid for two years for full time masters trainees, four years for doctoral trainees, and two years for post doctoral trainees from this award. Stipends are not allowed for part-time trainees. Under extenuating circumstances exceptions to this policy may be granted by the NIOSH program director.

Funding may be requested up to the levels described below. Unless an applicant receives written permission from the NIOSH program official named below, any requests for funding above these levels will cause the application to be determined non-responsive, and the application will not be reviewed.

Trainee Stipends

Stipends are provided as a subsistence allowance to help trainees defray living expenses during the training experience. It is not provided as a condition of employment with either the Federal Government or the awardee institution. Stipends may be paid to eligible trainees. Stipend budgets must be based on the levels established for the current fiscal year of the grant. For appointments of less than a full year, the stipend will be based on a monthly or daily pro-ration. The monthly stipend amount is calculated by dividing the current annual stipend by 12. The daily stipend is calculated by dividing the current annual stipend by 365.

Tuition and Fees

The institution may request tuition and fees (including appropriate health insurance) only to the extent that the same resident or nonresident tuition and fees are charged to regular non-Federally supported students. Tuition at the postdoctoral level is limited to that required for specified courses.

Other Trainee Costs

Trainee travel, including attendance at scientific meetings that the institution determines to be necessary to the individual's training, is an allowable trainee expense.

Additional support for travel to a training experience away from the institution may be permitted. training experiences away from the parent institution must be justified considering the type of opportunities for training available, the manner in which these opportunities differ from and compliment those offered at the parent institution, and the relationship of the proposed experience to the trainee's career stage and goals. This type of training requires prior approval from the NIOSH. Letters requesting such training may be submitted to NIOSH at any time during the award period.

Trainee Related Expenses

Funds may be requested to defray the cost of other training related expenses such as staff salaries, consultant costs, equipment, supplies, and travel expense for the training faculty. Because there are core costs that are fixed, the following scale should be used to determined the training related expenses. For the core academic programs (IH,OS, OMR, OHN), training related expenses are $12,000 per full time trainee for the first five (5) trainees, and $1,000 per each additional full time/full time equivalent trainee. For the allied OSH programs, training related expenses are $12,000 per full time trainee for the first three (3) trainees, and $1,000 per each additional full time/full time equivalent trainee. However, training related expenses cannot exceed 40% of the program budget (direct costs). The training programs use substitute form page 4, and in the training related expense section, the name of the students and academic status (full time (ft), half time(1/2) , one third time (1/3) are listed. If needed, use a continuation page to list the names of the students. For programs that have vacant positions, enter TBN for each position requested.

Diversity Recruitment Plan (REQUIRED)

Up to $2,000 in direct costs may be requested per year. Include in the overall budget page under “Trainee Related Expenses”, and label it Diversity A detailed budget for this activity is not required, however in the budget justification; the principal investigator should describe the use of these funds.

Plan for Sharing Research Data
Not applicable

Sharing Research Resources
Not applicable

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

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

The following will be considered in making funding decisions:

The NIOSH objectives include the support of education programs that train personnel to address occupational safety and health issues. 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 training and 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.

Site Visits

A site visit to the applicant institutions may be made (but such site visits are not assured) to evaluate the overall merit of the application. The site visit team includes members of the Special Emphasis Panel who have expertise in major academic training, continuing education, facilities, outreach, and other activities of the proposed Center, the NIOSH Scientific Review Administrator, and NIOSH staff observer(s).

A site visit is not a prerequisite and is not assured for consideration of an application by NIOSH. Therefore, the application is considered a complete document for review purposes. Furthermore, the applicant should not use the site visit as an occasion for adding core units, research projects, or investigators, for making major changes, or for delivering another exposition of the application. Rather, it should be used by the principal investigator and associates to elaborate on the program and core units, cost effectiveness and quality control features of the core units, and on other Center activities for which funding is requested, as well as to answer reviewers' questions. The site visit team will not consider any area that is presented for evaluation at the site visit which has not been included in the application. Budgetary changes also will not be considered at the time of a site visit. The findings of the site visit team are reported and discussed by the members of the SEP, which makes the final peer review recommendations and assigns the priority score.

Review Criteria Training Programs

Core and other OSH Academic Training Programs

Competing continuation applications must include a detailed account of experiences in recruiting individuals from underrepresented groups during the previous funding period. Information must be included on successful and unsuccessful recruitment strategies. The report should provide information on the racial/ethnic distribution of:

The success of efforts to recruit and retain minority trainees is a factor in the assessment of the quality of the trainee pool and thus will be included within the priority score. In addition, peer reviewers will separately evaluate the minority recruitment plan and report (for competing renewals) after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment of minorities and whether the experience in recruitment during the previous award period has been incorporated into the formulation of the plan for the next award period. The review panel's evaluation will be included in an administrative note in the summary statement. If the plan or the record of minority recruitment and retention is judged to be unacceptable, funding will be withheld until a revised plan (and report) that addresses the deficiencies is received. Staff within the NIOSH, with guidance from the NIOSH Secondary Review Committee, will determine whether amended plans and reports submitted after the initial review are acceptable.

Training in the Responsible Conduct of Research:

Every pre-doctoral and Masters trainee supported by an institutional training grant must receive instruction in the responsible conduct of research. (NIOSH follows the NIH policies for this requirement, see the NIH Guide for Grants and Contracts, Volume 21, Number 43, November 27, 1992, see http://grants.nih.gov/grants/guide/notice-files/not92-236.html.)

Applications must include a description of a program to provide formal or informal instruction in scientific integrity or the responsible conduct of research. Applications without plans for instruction in the responsible conduct of research will be considered incomplete and will be returned to the applicant without review.

Although the NIH and NIOSH do not establish specific curricula or formal requirements, all programs are encouraged to consider instruction in the following areas: conflict of interest, responsible authorship, policies for handling misconduct, data management, data sharing, and policies regarding the use of human and animal subjects. Within the context of training in scientific integrity, it is also beneficial to discuss the relationship and the specific responsibilities of the institution and the graduate students appointed to the program.

Plans must address the subject matter of the instruction, the format of the instruction, the degree of faculty participation, trainee attendance, and the frequency of instruction. The rationale for the proposed plan of instruction must be provided.

Program reports on the type of instruction provided, topics covered, and other relevant information, such as attendance by trainees and faculty participation, must be included in future competing continuation and non-competing applications. The NIOSH encourages institutions to provide instruction in the responsible conduct of research to all graduate students, and research staff regardless of their source of support.

NIOSH initial review group will assess the applicant's plans on the basis of the appropriateness of topics, format, amount and nature of faculty participation, and the frequency and duration of instruction. The plan will be discussed after the overall determination of merit, so that the review panel's evaluation of the plan will not be a factor in the determination of the priority score. Plans will be judged as acceptable or unacceptable. The acceptability of the plan will be described in an administrative note on the summary statement. Regardless of the priority score, applications with unacceptable plans will not be funded until the applicant provides a revised, acceptable plan. NIOSH Staff will judge the acceptability of the revised plan.

Following initial review, the NIOSH Secondary Review Committee will consider the assessment of the scientific and educational merit of the research training grant application as well as the initial review group's comments on the recruitment of individuals from underrepresented groups and the plan for instruction in the responsible conduct of research.

2.A. Additional Review Criteria:

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

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

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

2.C. Sharing Research Data
Not applicable

2.D. Sharing Research Resources
Not applicable

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 Notice of Award will be generated via email notification from the awarding component to the grantee business official (designated in item 14 on the Application Face Page). If a grantee is not email enabled, a hard copy of the Notice of Award will be mailed to the business official.

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

2. Administrative and National Policy Requirements

All NIH 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).

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.

Section VII. Agency Contacts

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

1. Scientific/Research Contacts:

John Talty
Office of Extramural Programs
National Institute for Occupational Safety and Health
4676 Columbia Parkway, Mail stop C- 7
Cincinnati, OH 45226-1998
Telephone: (513) 533-8241
FAX: (513) 533-8564
Email: jtt2@cdc.gov

2. Peer Review Contacts:

Charles N. Rafferty, Ph.D.
Assistant Director for Review and Policy
Office of Extramural Programs
National Institute for Occupational Safety and Health/CDC
1600 Clifton Road, N.E.
Building 24, Room 1536, 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
Grants Management Branch, Procurement and Grants Office
Centers for Disease Control and Prevention
626 Cochrans Mill Road
Pittsburgh, Pennsylvania 15236-0070
Telephone: (412) 386-6834
FAX: (412) 386-6459
Email: png2@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 public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

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

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

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

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review.

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

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

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

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

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

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

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Section Section 670 (a) of the Occupational Safety and Health Act [29 U.S.C. 670(a)] and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

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

Lobbying Restrictions:
Applicants should be aware of restrictions on the use of Health and Human Services (DHHS) funds for lobbying of Federal or State legislative bodies. Under the provisions of 31 U.S.C. Section 1352, recipients (and their subtier contractors) are prohibited from using appropriated Federal funds (other than profits from a Federal contract) for lobbying congress or any Federal agency in connection with the award of a particular contract, grant, cooperative agreement, or loan. This includes grants/cooperative agreements that, in whole or in part, involve conferences for which Federal funds cannot be used directly or indirectly to encourage participants to lobby or to instruct participants on how to lobby. In addition, no part of the Center for Disease Control and Prevention (CDC) appropriated funds shall be used, other than for normal and recognized executive-legislative relationships, for publicity or propaganda purposes, for the preparation, distribution, or use of any kit, pamphlet, booklet, publication, radio, television, or video presentation designed to support or defeat legislation pending before the Congress or any State or local legislature, except in presentation to the Congress or any State or local legislature itself. No part of the appropriated funds shall be used to pay the salary or expenses of any grant or contract recipient, or agent acting for such recipient, related to any activity designed to influence legislation or appropriations pending before the Congress or any State or local legislature. Any activity designed to influence action in regard to a particular piece of pending legislation would be considered “lobbying.” That is lobbying for or against pending legislation, as well as indirect or “grass roots: lobbying efforts by award recipients that are directed at inducing members of the public to contact their elected representatives at the Federal or State levels to urge support of, or opposition to, pending legislative proposals is prohibited. As a matter of policy, CDC extends the prohibitions to lobbying with respect to local legislation and local legislative bodies. The provisions are not intended to prohibit all interaction with the legislative branch, or to prohibit educational efforts pertaining to public health. Clearly there are circumstances when it is advisable and permissible to provide information to the legislative branch in order to foster implementation of prevention strategies to promote public health. However, it would not be permissible to influence, directly or indirectly, a specific piece of pending legislation. It remains permissible to use CDC funds to engage in activity to enhance prevention; collect and analyze data; publish and disseminate results of research and surveillance data; implement prevention strategies; conduct community outreach services; provide leadership and training; and foster safe and healthy environments.

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


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.