Part I Overview Information


United States Department of Health and Human Services (HHS)

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

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

Title: Miner Safety and Health Training Program - Western United States (U60)

The policies, guidelines, terms, and conditions of the HHS Centers for Disease Control and Prevention (CDC) stated in this announcement might differ from those used by the HHS National Institutes of Health (NIH).  If written guidance for completing this application is not available on the CDC website, then CDC will direct applicants elsewhere for that information. 

Authority:  This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency Review. Awards are made under the authorization of the Occupational Safety and Health Act of 1970, Section 20(a) and 21(a) (29 USC 669(a) and 29 USC 670); Federal Mine Safety and Health Act, Section 501(a), 30 USC 1 (Note), and 30 USC 951(a); Section 301 of the Public Health Service Act as amended (42 USC 241) and under Federal Regulations 42 CFR Part 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.

Announcement Type:

New

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

Funding Opportunity Announcement (FOA) Number: RFA-OH-10-001

Catalog of Federal Domestic Assistance Number(s):  
93.262

Key Dates
Release/Posted Date: February 18, 2010
Letter of Intent Receipt Date: March 30, 2010
Application Due Date: April 30, 2010
Peer Review Date(s): May-June 2010
Council Review Date(s): August 2010
Earliest Anticipated Start Date: September 1, 2010
Additional Information to Be Available Date: Not Applicable
Expiration Date: May 1, 2010

Due Date for E.O. 12372

Executive Order 12372 does not apply to this program.

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
    1. Research Objectives

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

Section III. Eligibility Information
    1. Eligible Applicants
        A. Eligible Institutions   
    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. Submitting an Application
        C. Application Processing
    4. Intergovernmental Review
    5. Funding Restrictions
    6. Other Submission Requirements

Section V. Application Review Information
    1. Criteria
    2. Review and Selection Process
    3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
    1. Award Notices
    2. Administrative and National Policy Requirements  
        A. Cooperative Agreement
            1. Recipient Rights and Responsibilities
            2. HHS/CDC Responsibilities
            3. Collaborative Responsibilities
            4. Dispute Resolution Process
    3. Reporting

Section VII. Agency Contacts
    1. Scientific/Research Contact
    2. Peer Review Contact
    3. Grants Management Contact
    4. General Questions Contact

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

Purpose

The purpose of this FOA is to enhance the quality and availability of health and safety training for mineworkers in the Western United States. As a result, the National Institute for Occupational Safety and Health (NIOSH) invites applications for cooperative agreements to support the development of training and education programs. To maximize impact, a major focus is expected to be directed toward train-the-trainer programs for workers engaged in mining operations in the Western United States.

A major objective of this solicitation is to establish a training program that 1) addresses the training needs of miners in the Western United States, 2) develops and delivers training to trainers of miners in the Western United States, 3) provides qualified instructors and faculty to conduct the training, 4) evaluates the effectiveness and impact of the training program on reducing injuries and illnesses to miners, and 5) coordinates with existing training programs, such as those offered by the Mine Safety and Health Administration (MSHA). NIOSH intends that the training provided by this program will be consistent with recommendations and guidelines of the Occupational Safety and Health Administration (OSHA) and MSHA and that the training provided does not overlap with existing MSHA or OSHA training programs.

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. In 2006 and 2007, there were 73 and 67 occupational mining fatalities, respectively.  The overall fatality rate was 21.9 per 100,000 Full Time Equivalent (FTE) workers. The fatality rate at underground work locations was 47.2 per 100,000 FTE workers, compared with the lower rate at surface locations of 16.1. Additionally, the severity of injuries for mining exceeds all other industries with the highest percentage of lost work days per incident. There were 7,742 nonfatal lost-time injuries reported to the Mining Safety and Health Administration (MSHA) in 2007. These injuries occurred at an overall rate of 2.5 per 100 FTE workers and resulted in a total of 426,219 days lost from work. The underground nonfatal lost-time injury rate was greater than the surface injury rate (4.6 vs. 2.0 per 100 FTE workers). Respiratory disease and hearing loss are two critical concerns. In the last decade, death certificates list coal workers' pneumoconiosis, commonly called black lung disease, as a cause in more than 10,000 deaths. In addition, more than 65 percent of miners experience occupational hearing loss by the time they retire (www.cdc.gov/niosh/mining/statistics). With the increased demand for coal and other mined commodities, many of the health and safety problems associated with mining will increase as a result of high levels of noise, methane gas, respirable dust, etc. As a result, the focus areas for mining training must encompass a wide range of hazards and risks.

In 1969, the Coal Mine Safety and Health Act provided funding for state health and safety training through grants by MSHA. The mining community in the Eastern United States is served by the MSHA Training Academy in Beckley, West Virginia (http://www.msha.gov/Programs/MineAcademy/Academy.asp). MSHA, under the Department of Labor, provides training to federal mine inspectors and mining professionals from other governmental agencies, the mining industries, and labor. MSHA also provides Part 46 Training Assistance for new employees, refresher training, new task training, and training on Site-specific Hazards. States use MSHA grant funds to provide federally mandated training to miners working at coal, metal, and nonmetal mines, both on the surface and underground. In 2009, 47 states and the Navajo Nation were funded by this MSHA grant program.

Since 1999, NIOSH has supported the safety and health training of miners in the Western United States, when the authorities of the Bureau of Mines were transferred to NIOSH. NIOSH support for miner training has been provided through various projects, contracts, and grants, including the Western Mining Training Centers which have included the Colorado School of Mines, and the Missouri University of Science and Technology (formerly the University of Missouri at Rolla).

General Training Goals and Objectives

This training program is intended to improve the availability and quality of mineworker training in the western U.S., where MSHA’s programs at the Mine Safety Academy in Beckley, WV, may not be as accessible to some western miners. Moreover it provides an opportunity to address gaps that exist in current training materials, particularly those related to western mining operations.

An immediate goal of safety and health training for miners is to provide workers with relevant knowledge regarding hazards encountered in the mining environment, and with practical tools for reducing risks for injuries and illness.  Another goal of the training program is to assist workers in becoming active participants in determining and improving the health and safety conditions under which they work, and in establishing collaborative employer-employee relationships for creating safe workplaces. The goals and objectives of the miner training program focus on outcomes. Since primary prevention of illness and injury among miners depends in large part on the appropriate use and maintenance of engineering controls, training that includes these is appropriate.

Some of the training attendees will have significant amounts of experience with mine safety and hazard recognition, and they should be utilized interactively as a resource for training classes. Since successful adult education frequently emphasizes peer-sharing activities, such as problem-solving and simulation exercises that tap the experience of the trainee, these experienced miners are an invaluable asset.  Regardless of the training model used, the program’s expectation is that attending trainers should be able to convey what they have learned during training in the classroom or work-site back to their jobs and to their coworkers.

An applicant may join with one or more external organizations or institutions in a single application and propose to share resources that would maximize coverage and availability of training, enhance the effectiveness of training, and bring together the appropriate expertise for an effective training program.  Where appropriate, such collaborations are strongly encouraged. In such cases the application must have specific plans to implement the cooperative arrangements necessary for program integration and to insure effectiveness.  The application should define the specific expertise, facilities, or services that will be provided by each participating member. The budget requirements for each participant must also be identified.

Awards under this announcement will be made for miner training including the training of miners through train-the-trainer programs, technical support of training, and training program evaluation in regard to quality and effectiveness.  Many curricula and training materials exist for miner training that can be adapted with minimal effort.  Programs targeted to multiple states to reach wider worker populations will be given preference in funding.  Applications should include plans for reaching underserved workers in the proposed target populations especially those disadvantaged in education, language skills or limited in literacy. 

The overarching goal of this cooperative agreement is to reduce the occurrence of adverse health effects and the number of injuries to workers who are involved in mining operations through a coordinated training program. This cooperative agreement is intended to support training of miners working in the Western United States. The program shall:

  1. Address the training needs of mining personnel,
  2. Increase the number of qualified mine safety and health trainers in the western U.S. by developing and offering train-the-trainer courses,
  3. Develop and deliver miner training to mineworkers working in the mining industry of the Western United States,
  4. Provide qualified instructors and faculty to achieve the goals of this project,
  5. Evaluate the effectiveness and impact of the training program on reducing injuries to mining personnel, and
  6. Coordinate with existing training programs (such as MSHA and OSHA).

The training and education needs specific to miners in the Western United States are to be defined in the application along with supporting data from industry, unions, and miners. These data are to be used to justify the proposed training and education of miners. In addition to identifying training needs, the application must provide information regarding the location of the training. Ideally, training will be provided at convenient, centralized facilities. Training may also occur at mining worksites. The application should provide justification for the choice of location in terms of impact, accessibility, feasibility, and cost.

The training program may include a combination of trainee targets including miners, with a major emphasis placed on train-the-trainer programs. The application should identify and provide credentials for the instructors and faculty who will provide the training. The training program must include an evaluation that will be performed by those trained in this program. An evaluation plan that addresses the impact of the training on the safety and health of miners must be included in the application.

Funding from a NIOSH cooperative agreement award made under this announcement is not intended to overlap training currently available to Western miners. To maximize the impact of miner training and to avoid overlap with existing training programs provided by MSHA and OSHA (both those based out of their academy locations and through grants to states), all existing programs should be identified and considered when the training program is developed. Further, the training provided by any NIOSH-funded training program for miners should be consistent with current recommendations and guidelines of both OSHA and MSHA. Information on MSHA training is provided http://www.msha.gov/Education&Training.HTM, and for OSHA at http://www.osha.gov/dcsp/ote/index.html.

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

Section II. Award Information


1. Mechanism of Support

This funding opportunity will use the U60 activity code. The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.  

This FOA uses “Just-in-Time” information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). 

The HHS/CDC U60 is a cooperative agreement assistance instrument. Under the U60 assistance instrument, the Recipient Organization retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, and with HHS/CDC staff is substantially involved as a partner with the Recipient Organization, as described in Section VI.2.A., "Cooperative Agreement”.

2. Funds Available

NIOSH intends to commit a total of approximately $1 million in FY2010 to fund 1-3 cooperative agreements in response to this FOA for a period of up to 3 years. The anticipated start date for new awards is September 2010.

This U60 funding opportunity announcement is for training. Facilities and Administrative (F&A) costs are limited to 8 per cent of total direct costs.

If an applicant requests a funding amount greater than the ceiling of the award range, HHS/CDC will consider the application non-responsive, and it will not enter into the review process. HHS/CDC will notify the applicant that the application did not meet the submission requirements.

Because the nature and scope of the proposed training will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of NIOSH provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Facilities and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004.  

HHS grants policies as described in the HHS Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

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

A Bona Fide Agent is an agency/organization identified by the state as eligible to submit an application under the state eligibility in lieu of a state application.  If you are applying as a bona fide agent of a state or local government, you must provide a letter from the state or local government as documentation of your status.  Attach this documentation behind the first page of your application form or for electronic applications, use a PDF file and attach as “Other Documents” and label as appropriate.

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

Number of Applications. Applicants may not submit more than one application. 

Resubmissions. Resubmission applications are not permitted in response to this FOA. 

Renewals.  Renewal applications are not permitted in response to this FOA.  

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

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

Section IV. Application and Submission Information


1. Request Application Information

The current 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 PGO TIMS: Telephone 770-488-2700, Email:  PGOTIM@cdc.gov

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

2. Content and Form of Application Submission

Prepare all applications using the PHS 398 application forms and in accordance with the PHS 398 Application Guide (http://grants.nih.gov/grants/funding/phs398/phs398.html).

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 in item (box) 2 only of the face page of the application form and the YES box must be checked.

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: March 30, 2010
Application Due Date: April 30, 2010
Peer Review Date(s): May-June 2010
Council Review Date: August 2010
Earliest Anticipated Start Date: September 1, 2010
Additional Information to Be Available Date: Not Applicable
Expiration Date: May 1, 2010

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 CDC Program staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed in Section IV.3.A.

The letter of intent should be sent to:

Price Connor, Ph.D.
Scientific Review Officer
Office of Extramural Programs
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention
1600 Clifton Road, N.E., Mailstop E74
Atlanta, GA 30333
Telephone: (404) 498-2511
FAX: (404) 498-2571
Email: PConnor@cdc.gov

3.B. Submitting an Application

Applications must be prepared using the 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)

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

At the time of submission, two additional copies of the application and all 5 CDs of the appendix material must be sent to:

Price Connor, Ph.D.
Scientific Review Officer
Office of Extramural Programs
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention
1600 Clifton Road, N.E., Mailstop E74
Atlanta, GA 30333
Telephone: (404) 498-2511
FAX: (404) 498-2571
Email: PConnor@cdc.gov

This announcement is the definitive guide on Letter Of Intent (LOI) and application content, submission procedures, and deadline.  It supersedes information provided in the application instructions.  If your application does not meet the deadline described in Section IV.3.A, it will not be eligible for review. You will receive notification that you did not meet the submission requirements.

3.C. Application Processing

Applications must be received on or before the application receipt date described above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed.  Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by the reviewing Institute. Incomplete and/or non-responsive applications will not be reviewed.

Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on their application status in the Commons.

The HHS/CDC will not accept any application in response to this FOA 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.

4. Intergovernmental Review

Executive Order 12372 does not apply to this program.

5. Funding Restrictions

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

Restrictions, which applicants must take into account while writing their budgets, are as follows:

6. Other Submission Requirements

PHS398 Research Plan Component Sections

All application instructions outlined in the PHS 398 Application Guide are to be followed, with the following additional requirements:

Budget Component

This FOA uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). 

Appendix Materials

All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDs in the same package with the two application copies sent to the NIOSH Scientific Review Officer listed in Section IV.3.B.

Up to 10 publications, manuscripts (accepted for publication), abstracts, patents, or other printed materials directly relevant to the proposed project. Do not include manuscripts submitted for publication. Applicants should refer to instruction guides and specific Funding Opportunity Announcements (FOAs) to determine the appropriate limit on the number of publications that may be submitted for a particular program. Note that not all grant activity codes allow the inclusion of publications.

The following materials may be included in the Appendix:

Please note the following restriction on appendix attachments: The Research Plan appendix attachments are limited to 10 attachments. Appendices are uploaded as attachments in the PHS 398 Research Plan form, in field #18, within the electronic application package. An applicant will receive an error message if the number of appendix attachments exceeds 10, which will result in an unsuccessful submission of the application. You may include more than one publication, or other allowable appendix material, within one attachment; however, do not let your attachments exceed 10.

Do not to use the Appendix to circumvent the page limitations.  An application that does not observe the relevant policies and procedures may not be considered in the review process. Applicants are reminded to review specific FOAs for any additional program-specific guidance on Appendix material and other application requirements.

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

Review Process

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIOSH and in accordance with HHS peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

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

The mission of HHS/CDC is to promote health and quality of life by preventing and controlling disease, injury, and disability.  As part of this mission, applications submitted to the HHS/CDC for grants or cooperative agreements to support public health research and training are evaluated for scientific and technical merit through the HHS/CDC peer review system. 

Overall Impact

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five scored review criteria, and additional review criteria (as applicable for the project proposed). 

Scored Review Criteria

Reviewers will consider each of the five review criteria below in the determination of educational merit and effectiveness, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major training or educational impacts. For example, a project that by its nature is not innovative may meet an essential training gap or educational need.

Significance.  Does the proposed work address the appropriate gaps in specific mining sectors, e.g. coal, metal, and/or nonmetal?  Does it identify key opportunities and training topics? Does the proposed project present a compelling plan to improve the availability and quality of miner training in the western U.S.? If the aims of the project are achieved, to what extent will the number of trained miners be increased, and how will miner training be improved?  How will successful completion of the aims change the concepts, methods, technologies, and services associated with miner training?

Investigator(s).  Are the PD/PIs, collaborators, and other researchers well suited to the project?  If Early Stage Investigators or New Investigators, do they have appropriate experience and training?  If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)?  If the project is collaborative, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Is evidence of experienced and technically qualified key personnel included and are these personnel appropriate for this type of miner safety and health training?

Does the Principal Investigator strongly demonstrate the capacity for providing leadership and assuring productivity of appropriate miner safety and health training and education programs and for overall management of the training programs including quality assurance and program evaluation?

Is there sufficient evidence of an applicant’s organizational structure or consortium, if applicable, that provides adequate knowledge and oversight of resources and administrative management of the program? 

Is there evidence of lines of responsibility and accountability and is it clearly delineated when two or more organizations are collaborating on an activity? 

Innovation.  Does the application offer an innovative approach to accomplish the project goals? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or training interventions proposed?

Approach.  Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project?  Are potential problems, alternative strategies, and benchmarks for success presented?   If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

How adequate are the organization's or consortia's performance and effectiveness in planning, implementing and operating appropriate miner safety and health training and education programs?

Does the applicant demonstrate past experience in development and implementation of miner safety and health training and education programs and application of appropriate adult education techniques?

Are the methods and techniques to be used for identifying, describing, and accessing target specific worker populations for miner safety and health training and anticipated impact of the proposed program sufficient? 

Is the detailed program plan adequate for miner safety and health training in adapting existing curricula, training of instructors, distributing course materials, directing worker training, and conducting program evaluations? 

Is there evidence of appropriate combinations of classroom or worksite instruction and hands on demonstration and instruction that simulates site activities and conditions?

Does the applicant have the ability to immediately initiate direct miner safety and health training, program evaluation, and related support activities?

Are their procedures for assuring the long-term viability of the program convincing?

Is the training plan adequate for reaching underserved miner populations especially those disadvantaged in education, culture, or language or limited in literacy and access to training?

Environment.  Will the training environment in which the work will be done contribute to the probability of success?  Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed?  Will the project benefit from unique features of the training environment, subject populations, or collaborative arrangements? 

Are there appropriate facilities and equipment to support the described miner safety and health training and education activities including hands-on instruction? Is there evidence that the operation of training facilities assures the protection of prospective trainees during program delivery? Are there appropriate policies and procedures for assuring fitness for training and medical clearance?

Additional Review Criteria

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.

Protections for Human Subjects: For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.

Additional HHS/CDC Requirements under AR-1 Human Subjects Requirements are available on the Internet at the following address: http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar1.

Inclusion of Women, Minorities, and Children When the proposed project involves human subjects research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.

Please see http://www.cdc.gov/OD/foia/policies/inclusio.htm for more information.

Does the application adequately address the HHS/CDC Policy requirements regarding the inclusion of women, ethnic, and racial groups in the proposed research?  This includes: (1) The proposed plan for the inclusion of both sexes and racial and ethnic minority populations for appropriate representation; (2) The proposed justification when representation is limited or absent; (3) A statement as to whether the design of the study is adequate to measure differences when warranted; and (4) A statement as to whether the plans for recruitment and outreach for study participants include the process of establishing partnerships with community(ies) and recognition of mutual benefits (see Section 2, item 7 Inclusion or Women and Minorities of the Research Plan component of the PHS398.

Vertebrate Animals.  The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.

Biohazards.  Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Additional Review Considerations

As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact/priority score.

Applications from Foreign Organizations.  Not Applicable.

Select Agents Research. Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans.  Not applicable.

Budget and Period Support.  Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Selection Process

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

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 applicant organization will receive a written critique called a “Summary Statement.”  The applicant organization and the PD/PI will be able to access the Summary Statement via the eRA Commons.

HHS/CDC will contact those applicants under consideration for funding for additional information.

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 (GMO) is the authorizing document.  HHS/CDC will mail and/or e-mail this document to the recipient fiscal officer identified in the application. 

Selection of the application for award is not an authorization to begin performance.  Any cost incurred before receipt of the NoA is 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

The Code of Federal Regulations 45 CFR Part 74 and Part 92 have details about requirements.  For more information on the Code of Federal Regulations, see the National Archives and Records Administration at the following Internet address: http://www.access.gpo.gov/nara/cfr/cfr-table-search.html. Additional requirements are available Section VIII. Other Information of this document or on the HHS/CDC website at the following Internet address: http://www.cdc.gov/od/pgo/funding/ARs.htm. These will be incorporated into the NoA by reference.

The following terms and conditions will be incorporated into the NoA and will be provided to the appropriate institutional official and a courtesy copy to the PD/PI at the time of award.

2.A. Cooperative Agreement

The following terms of award are in addition to, and not in lieu of, otherwise applicable Office of Management and Budget (OMB) administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS/CDC grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" instrument (rather than an "acquisition" instrument), in which substantial HHS/CDC programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the HHS/CDC purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the HHS/CDC may share specific tasks and activities, as defined below.

2.A.1. Recipient Rights and Responsibilities

The Recipient will have the primary responsibility for the following:

Recipient Organization will retain custody of and have primary rights to the information, data and software developed under this award, subject to U.S. Government rights of access consistent with current HHS/CDC policies.

2.A.2. HHS/CDC Responsibilities

A NIOSH Program Coordinator will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

Additionally, a NIOSH Program Official will be responsible for the normal programmatic stewardship of the award and will be named in the award notice. The NIOSH Program Official may also serve as the NIOSH Program Coordinator.

2.A.3. Collaborative Responsibilities

Conflict of Interest Management: The NIOSH Program Official will be responsible for the normal scientific and programmatic stewardship of the cooperative agreement award including evaluation of non-competing applications, supplemental requests, etc. and will be named in the award notice. When the Program Official also serves as the Program Coordinator, the Program Official will not publish with awardees on activities specifically associated with the cooperative agreement unless it is an introduction or editorial regarding the basic information on the NIOSH role in managing the technical and administrative aspects of the program.

2. A.4. Dispute Resolution

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and NIOSH may be brought to arbitration. A Dispute Resolution Panel composed of three members will be convened. It will have three members: the Principal Investigator, the NIOSH Program Official and a third designee with expertise in the relevant area that is chosen by the other two. This special dispute resolution procedure does not alter the awardees’ right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

Recipient Organization must provide HHS/CDC with an original, plus two hard copies of the following reports:

  1. Non-Competing Grant Progress Report, (use form PHS 2590, posted on the HHS/CDC website, http://www.cdc.gov/od/pgo/funding/forms.htm and at http://grants.nih.gov/grants/funding/2590/2590.htm, no less than 120 days prior to the end of the current budget period. The progress report will serve as the non-competing continuation application.
  2. Financial status report, no more than 90 days after the end of the budget period.
  3. Final financial and performance reports, no more than 90 days after the end of the project period.

Recipient Organization must forward these reports by the U.S. Postal Service or express delivery to the Grants Management Specialist listed in the “Agency Contacts” section of this FOA.

Each awardee is required to submit an Annual Report to the NIOSH Program Official/Coordinator, which describes the number, location and nature of all training activities and the characteristics of the trainees reached during a particular budget period. Results and findings from training program evaluations will be summarized by each awardee and submitted to the NIOSH Program Official/Coordinator on an annual basis.  Program evaluation reports shall quantitatively describe the current status of instructor effectiveness, trainee retention of knowledge and skills, and positive impacts of training activities on work practices, workplace safety and health conditions, and overall worker protection from on the job hazards. The report must be submitted electronically. The report will include:

1.     An "Introduction and Summary" of the program.

2.     Principal Investigator’s report on major accomplishments (highlights).

3.     Detailed progress reports on each training component. This should include a table by component for all trainees in the past budget period.

4.     A report on the evaluation of each training component including the assessments by trainees.

5.     An administrative report, discussing relevant personnel and other matters.

This report will be made available on the NIOSH web page and will be used to provide information on mining training activities to the Congress, the public, and others.

Although the financial plans of the NIOSH provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports) and the determination that continued funding is in the best interest of the Federal government.

Section VII. Agency Contacts


HHS/CDC encourages your inquiries concerning this FOA and welcomes the opportunity to answer questions from potential applicants. Inquiries can fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contact:

Viji Potula, Ph.D.
Scientific Program Official
Office of Extramural Programs
National Institute for Occupational Safety and Health
U.S. Department of Health and Human Services
1600 Clifton Road N.E. (E74)
Atlanta, GA 30333
Phone: 404-498-2530
Fax: 404-498-2571             
e-mail: VPotula@cdc.gov

2. Peer Review Contact:

Price Connor, Ph.D.
Scientific Review Officer
Office of Extramural Programs
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention
1600 Clifton Road, N.E., Mailstop E74
Atlanta, GA 30333
Telephone: (404) 498-2511
FAX: (404) 498-2571
Email: PConnor@cdc.gov 

Overnight Mail Address:

2400 Century Parkway NE (4th Floor)
Atlanta GA 30345-3114

3. Grants Management Contact:

Maryann P. Monroe
Centers for Disease Control and Prevention
Procurement and Grants Office, Field Branch V
626 Cochrans Mill Road
P.O. Box 18070
Pittsburgh, PA 15236-0070
(412) 386-5075
Fax: (412) 386-6429
Email: MPMonroe@cdc.gov

4. General Questions Contact:

Technical Information Management Section
CDC Procurement and Grants Office
U.S. Department of Health and Human Services
2920 Brandywine Road
Atlanta, GA  30341
Telephone:  770-488-2700
Email: PGOTIM@cdc.gov

Section VIII. Other Information


Required Federal Citations

Human Subjects Protection

Federal regulations (45 CFR Part 46) 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).   Additional HHS/CDC Requirements under AR-1 Human Subjects Requirements can be found on the Internet at the following address:  http://www.cdc.gov/od/pgo/funding/ARs.htm.

Use of Animals in Research

Recipients of PHS support for activities involving live, vertebrate animals must comply with the PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.  Additional HHS/CDC Requirements under AR-3 Animal Subjects Requirements can be found at http://www.cdc.gov/od/pgo/funding/ARs.htm

Requirements for Inclusion of Women and Racial and Ethnic Minorities in Research

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

Inclusion Of Persons Under The Age Of 21 In Research

The policy of CDC is that persons under the age of 21 must be included in all human subjects research that is conducted or supported by CDC, unless there are scientific and ethical reasons not to include them. This policy applies to all CDC-conducted or CDC-supported research involving human subjects, including research that is otherwise exempt in accordance with Sections 101(b) and 401(b) of 45 C.F.R. Part 46, HHS Policy for the Protection of Human Subjects. Therefore, proposals for research involving human subjects must include a description of plans for including persons under the age of 21. If persons under the age of 21 will be excluded from the research, the application or proposal must present an acceptable justification for the exclusion.

In an extramural research plan, the investigator should create a section titled "Participation of persons under the age of 21." This section should provide either a description of the plans to include persons under the age of 21 and a rationale for selecting or excluding a specific age range, or an explanation of the reason(s) for excluding persons under the age of 21 as participants in the research. When persons under the age of 21 are included, the plan must also include a description of the expertise of the investigative team for dealing with individuals at the ages included, the appropriateness of the available facilities to accommodate the included age groups, and the inclusion of a sufficient number of persons under the age of 21 to contribute to a meaningful analysis relative to the purpose of the study. Scientific review groups at CDC will assess each application as being acceptable or unacceptable in regard to the age-appropriate inclusion or exclusion of persons under the age of 21 in the research project, in addition to evaluating the plans for conducting the research in accordance with these provisions.

The inclusion of children (as defined by the applicable law of the jurisdiction in which the research will be conducted) as subjects in research must be in compliance with all applicable subparts of 45 C.F.R. Part 46, as well as with other pertinent federal laws and regulations.

The policy of inclusion of persons under the age of 21 in CDC-conducted or CDC-supported research activities in foreign countries (including collaborative activities) is the same as that for research conducted in the United States.

HIV/AIDS Confidentiality Provisions

Recipients must have confidentiality and security provisions to protect data collected through HIV/AIDS surveillance, including copies of local data release policies; employee training in confidentiality provisions; State laws, rules, or regulations pertaining to the protection or release of surveillance information; and physical security of hard copies and electronic files containing confidential surveillance information.

Describe laws, rules, regulations, or health department policies that require or permit the release of patient-identifying information collected under the HIV/AIDS surveillance system to entities outside the public health department; describe also the measures the health department has taken to ensure that persons reported to the surveillance system are protected from further or unlawful disclosure.

Some projects may require Institutional Review Board (IRB) approval or a certificate of confidentiality.

HIV Program Review Panel Requirements

Compliance with Content of AIDS-Related Written Materials, Pictorials, Audiovisuals, Questionnaires, Survey Instruments, and Educational Sessions (June 1992) is required.

To meet the requirements for a program review panel, you are encouraged to use an existing program review panel, such as the one created by the State health department's HIV/AIDS prevention program. If you form your own program review panel, at least one member must be an employee (or a designated representative) of a State or local health department. List the names of the review panel members on the Assurance of Compliance form, CDC 0.1113. Submit the program review panel's report that all materials have been approved.

If the proposed project involves hosting a conference, submit the program review panel's report stating that all materials, including the proposed conference agenda, have been approved. Submit a copy of the proposed agenda with the application.

Before funds are used to develop educational materials, determine whether suitable materials already exist in the CDC National Prevention Information Network (NPIN).  The website can be found at; http://www.nchstp.cdc.gov/od/infocenter/npin.htm.

Patient Care

Ensure that all STD or HIV infected patients enrolled in the proposed project will be linked to an appropriate local care system that can address their specific needs, such as medical care, counseling, social services, and therapy.

Public Health System Reporting Requirements

This program is subject to the Public Health System Reporting Requirements. Under these requirements, all community-based non-governmental organizations submitting health services applications must prepare and submit the items identified below to the head of the appropriate State and/or local health agency(s) in the program area(s) that may be impacted by the proposed project no later than the application deadline date of the Federal application. The appropriate State and/or local health agency is determined by the applicant. The following information must be provided:

A. A copy of the face page of the application (PHS398).

B. A summary of the project that should be titled "Public Health System Impact Statement" (PHSIS), not exceed one page, and include the following:

1.        A description of the population to be served.

2.        A summary of the services to be provided.

3.        A description of the coordination plans with the appropriate state and/or local health agencies.

If the State and/or local health official should desire a copy of the entire application, it may be obtained from the State Single Point of Contact (SPOC) or directly from the applicant.

Paperwork Reduction Act Requirements

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

Smoke-Free Workplace Requirements

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

Healthy People 2010

The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at www.healthypeople.gov

Lobbying Restrictions

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

In addition no part of HHS/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, HHS/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 HHS/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 HHS/CDC grants and cooperative agreements need to be careful to prevent CDC funds from being used to influence or promote pending legislation. With respect to conferences, public events, publications, and "grassroots" activities that relate to specific legislation, recipients of HHS/CDC funds should give close attention to isolating and separating the appropriate use of HHS/CDC funds from non-CDC funds. HHS/CDC also cautions recipients of HHS/CDC funds to be careful not to give the appearance that HHS/CDC funds are being used to carry out activities in a manner that is prohibited under Federal law.

Prohibition on Use of HHS/CDC Funds for Certain Gun Control Activities

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

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

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

Accounting System Requirements

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

Capability Assessment

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

Proof of Non-profit Status

Proof of nonprofit status must be submitted by private nonprofit organizations with the application. Any of the following is acceptable evidence of nonprofit status: (a) a reference to the applicant organization's listing in the Internal Revenue Service's (IRS) most recent list of tax-exempt organizations described in section 501(c)(3) of the IRS Code; (b) a copy of a currently valid IRS tax exemption certificate; (c) a statement from a State taxing body, State Attorney General, or other appropriate State Official certifying that the applicant organization has a nonprofit status and that none of the net earnings accrue to any private shareholders or individuals; (d) a certified copy of the organization's certificate of incorporation or similar document that clearly establishes nonprofit status; (e) any of the above proof for a State or national parent organization and a statement signed by the parent organization that the applicant organization is a local nonprofit affiliate.

Security Clearance Requirement

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

Peer and Technical Reviews of Final Reports of Health Studies – HHS/ATSDR

Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA), as amended by Superfund Amendments and Reauthorization Act of 1986 (SARA), Section 104 (I)(13), and [42 U.S.C. 9604 (I)] requires all studies and results of research (other than public health assessments) that ATSDR carries out or funds in whole or in part will be peer reviewed by ATSDR. The ATSDR peer review process for final reports requires that:

1. Studies must be reported or adopted only after appropriate peer review.

2. Studies shall be peer reviewed within a period of 60 days to the maximum extent practical.

3. Studies shall be reviewed by no fewer than three or more than seven reviewers who:

a.              Are selected by the Assistant Administrator, ATSDR;

b.              Are disinterested scientific experts;

c.              Have a reputation for scientific objectivity; and

d.              Who lack institutional ties with any person involved in the conduct of the study or research under review.

HHS/ATSDR encourages rapid reporting and interpretation of laboratory results and reference ranges back to individual participants. However, if summary tables or distribution of laboratory results are prepared using the study data, this is considered a preliminary finding and will require ATSDR technical and peer review prior to release.

When, in the opinion of the investigator(s), a public health concern exists requiring the release of summary study statistics prior to the completion of the study, the investigator must obtain concurrence from HHS/ATSDR prior to releasing the summary statistics. A request for HHS/ATSDR concurrence for the release of information must be documented in a letter to HHS/ATSDR and should outline the public health concern, the investigator's interpretation of the concern and recommended response, and the draft document proposed for release by the investigator. HHS/ATSDR will provide a technical review and peer review within ten working days to the maximum extent possible. At sites where HHS/ATSDR must coordinate with another Federal agency, this requires additional time. Summary statistics may be released only after peer review. The release of summary statistics does not preclude the requirement for a final report.

By statute, the reporting of preliminary studies and preliminary research results to the public is not acceptable without prior review by HHS/ATSDR. This includes manuscripts prepared for publication, presentations at scientific meetings and reporting of preliminary findings to the community or the media.

Final Report

1. The final report for every study should include a detailed description of the problem, hypothesis, methods, results, conclusions, and recommendations that constitute a complete performance record of the study. A copy of the suggested format for the final report will be supplied by HHS/ATSDR to the investigator.

2. HHS/ATSDR is responsible for the technical and peer review of the draft final reports of any study that it funds prior to the submission of the final report. This will allow the recipient to incorporate technical and peer review comments into the final report. Responses to all HHS/ATSDR required technical and peer review comments should be summarized in a letter to HHS/ATSDR. This letter should also include the investigator's response to each comment and a rationale for those responses. Based upon the comments of the technical and peer reviewers, modifications in the study report may result. The modified study report should accompany the letter to HHS/ATSDR.

3. Following the steps outlined above, a final report of all studies and results of research carried out or supported by HHS/ATSDR must be submitted to the Procurement and Grants Office with a copy furnished to HHS/ATSDR.

All requirements, including peer review, technical review, and cost recovery, are applicable to award recipients and any subcontractors employed by the award recipient. Failure to comply with these requirements could adversely affect future funding.

Cost Recovery – HHS/ATSDR

CERCLA, as amended by SARA, provides for the recovery of costs incurred for response actions at each Superfund site from potentially responsible parties. The recipient would agree to maintain an accounting system that will keep an accurate, complete, and current accounting of all financial transactions on a site-specific basis, i.e., individual time, travel, and associated cost including indirect cost, as appropriate for the site. The recipient would also maintain documentation that describes the site-specific response actions taken with respect to the site, e.g., contracts, work assignments, progress reports, and other documents that describe the work performed at a site. The recipient will provide the site-specific costs and description of response actions taken with the supporting documentation upon request by HHS/ATSDR. The recipient will retain the documents and records to support these financial transactions and documentation of work performed, for possible use in a cost recovery case, for a minimum of ten years after submission of a final financial status report, unless there is litigation, claim, negotiation, audit or other action involving the specific site, then the records will be maintained until resolution of all issues on the specific site.

Third Party Agreements – HHS/ATSDR

Applicant must justify the need to use a contractor. If contractors are proposed, the following must be provided: (1) name of contractor, (2) method of selection, (3) period of performance, (4) detailed budget, (5) justification for use of contractor, and (6) assurance of non-conflict of interest.

Project activities which are approved for contracting pursuant to the prior approval provisions shall be formalized in a written agreement that clearly establishes the relationship between the recipient and the third party.

The written agreement shall, at a minimum:

1. State or incorporate by reference all applicable requirements imposed on the contractors under the terms of the grant and/or cooperative agreement, including requirements concerning technical review (ATSDR selected reviewers), ownership of data, and the arrangement for copyright when publications, data, or other copyrightable works are developed under or in the course of work under a PHS grant-supported project or activity.

2. State that any copyrighted or copyrightable works shall be subject to a royalty-free, nonexclusive, and irrevocable license to the government to reproduce, publish, or otherwise use them, and to authorize others to do so for Federal government purposes.

3. State that whenever any work subject to this copyright policy may be developed in the course of a grant by a contractor under a grant, the written agreement (contract) must require the contractor to comply with these requirements and can in no way diminish the government's right in that work.

4. State the activities to be performed, the time schedule for those activities, the policies and procedures to be followed in carrying out the agreement, and the maximum amount of money for which the grantee may become liable to the third party under the agreement.

5. State non-conflict of interest concerning activities conducted for HHS/ATSDR and site-remediation activities for other parties.

The written agreement required shall not relieve the recipient of any part of its responsibility or accountability to PHS under the cooperative agreement. The agreement shall, therefore, retain sufficient rights and control to the recipient to enable it to fulfill this responsibility and accountability.

Small, Minority, And Women-owned Business

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

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

Research Integrity

The signature of the institution official on the face page of the application submitted under this Funding Opportunity Announcement is certifying compliance with the Department of Health and Human Services (DHHS) regulations in Title 42 Part 93, Subparts A-E, entitled PUBLIC HEALTH SERVICE POLICIES ON RESEARCH MISCONDUCT.

The regulation places requirements on institutions receiving or applying for funds under the PHS Act that are monitored by the DHHS Office of Research Integrity (ORI) (http://ori.hhs.gov./policies/statutes.shtml).

For example:

Section 93.301 Institutional assurances. (a) General policy. An institution with PHS supported biomedical or behavioral research, research training or activities related to that research or research training must provide PHS with an assurance of compliance with this part, satisfactory to the Secretary. PHS funding components may authorize [[Page 28389]] funds for biomedical and behavioral research, research training, or activities related to that research or research training only to institutions that have approved assurances and required renewals on file with ORI. (b) Institutional Assurance. The responsible institutional official must assure on behalf of the institution that the institution-- (1) Has written policies and procedures in compliance with this part for inquiring into and investigating allegations of research misconduct; and (2) Complies with its own policies and procedures and the requirements of this part.

Compliance with Executive Order 13279

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

Health Insurance Portability and Accountability Act Requirements

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

Release and Sharing of Data

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

  1. In a timely manner.
  2. Completely, and as accurately as possible.
  3. To facilitate the broader community.
  4. Developed in accordance with CDC policy on Releasing and Sharing Data.

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

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

National Historic Preservation Act of 1966

(Public Law 89-665, 80 Stat. 915)

The grantee’s signature on the grant application attests to their: (1) knowledge of the National Historic Preservation Act of 1966 (Public Law 89-665, 80 Stat. 915); and (2) intent to ensure all grant related activities are in compliance with referenced public law, as stated:

a.     Section 106 of the National Historic Preservation Act (NHPA) states:

The head of any Federal agency, having direct or indirect jurisdiction over a proposed Federal or Federally assisted undertaking in any State and the head of any Federal department or independent state agency having authority to license any undertaking,  shall, prior to the approval of the expenditure of any Federal funds on the undertaking or prior to the issuance of any license, as the case may be, take into account the effect of the undertaking on any district, site, building, structure, or object that is included in or is eligible for inclusion in the National Register.  The head of any such Federal agency shall afford the Advisory Council on Historic Preservation established under Title II of this ACT a reasonable opportunity to comment with regard to such undertaking.

b.     Additionally, the NHPA also contains the following excerpt that forbids “anticipatory demolition:”

Each Federal agency shall ensure that the agency will not grant a loan, loan guarantee, permit, license, or other assistance to an applicant who, with intent to avoid the requirements of Section 106 of this Act, has intentionally, significantly, adversely affected a historic property to which the grant would relate or, having legal power to prevent it, allowed such significant adverse effect to occur, unless the agency, after consultation with the Council, determines that circumstances justify granting such assistance despite the adverse effect created or permitted by the applicant.

Conference Disclaimer and Use of Logos

{Mandatory for all grants and cooperative agreements.}

Disclaimer: Where a conference is funded by a grant or cooperative agreement, a sub grant or a contract the recipient must include the following statement on conference materials, including promotional materials, agenda, and internet sites:

“Funding for this conference was made possible [in part] by [insert grant or cooperative agreement award number] from the Centers for Disease Control and Prevention(CDC) or the Agency for Toxic Substances and Disease Registry (ATSDR) .  The views expressed in written conference materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does mention of trade names, commercial practices, or organizations imply endorsement by the U.S. Government.”

Logos: Neither the HHS nor the CDC (“CDC” includes ATSDR) logo may be displayed if such display would cause confusion as to the source of the conference or give the false appearance of Government endorsement. A non-federal entity’s unauthorized use of the HHS name or logo is governed by U.S.C. § 1320b-10, which prohibits the misuse of the HHS name and emblem in written communication. The appropriate use of the HHS logo is subject to the review and approval of the Office of the Assistant Secretary for Public Affairs (OASPA). Moreover, the Office of the Inspector General has authority to impose civil monetary penalties for violations (42 C.F.R. Part 1003).  Neither the HHS nor the CDC logo can be used on conference materials under a grant, cooperative agreement, contract, or co-sponsorship agreement without the expressed, written consent of either the Project Officer or the Grants Management Officer.  It is the responsibility of the grantee (or recipient of funds under a cooperative agreement) to request consent for the use of the logo in sufficient detail to assure a complete depiction and disclosure of all uses of the Government logos, and to assure that in all cases of the use of Government logos, the written consent of either the Project Officer or the Grants Management Officer has been received.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices



NIH Office of Extramural Research Logo
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy
NIH... Turning Discovery Into Health®



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