and Human Services (HHS)
EXPIRED
United States Department of Health and Human Services (HHS)
Participating OrganizationsComponents
of Participating Organizations
Centers for
Disease Control and Prevention, National Institute for Occupational Safety and
Health (NIOSH), (http://www.cdc.gov/niosh/homepage.html)
Title: State-Based Occupational Health and Safety Surveillance (U60)
The policies, guidelines, terms, and conditions of the HHS Centers for Disease Control and Prevention (CDC) stated in this funding opportunity announcement (FOA) 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 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 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:
Reissue of
PAR-04-106
Update: The following update relating to this announcement has been issued:
NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted using the most recently approved PHS 398 forms and the PHS 398 Application Guide.
Program Announcement Number: PAR-09-184Catalog of Federal Domestic Assistance
Number(s):
93.262
Key Dates
Release/Posted
Date: July 6, 2009
Letter of Intent Receipt Date: Not applicable
Application Receipt Date(s): September 2, 2009; September 2, 2010; (Applications not accepted for September 2, 2010 date per NOT-OH-10-007); September 2,
2011
Peer Review Date(s): November/December 2009, 2010, 2011
Council Review Date(s): January/February 2010, 2011, 2012
Earliest Anticipated Start Date(s): July 2010, 2011, 2012
Expiration Date: September 3, 2011
Additional Overview Content
Executive Summary
The National Institute for Occupational Safety and Health (NIOSH) within the Centers for Disease Control and Prevention (CDC) invites applications for state-based, occupational health and safety surveillance programs.
Table of Contents
Part I Overview Information
Part II Full Text of
Announcement
Section I. Funding
Opportunity Description
1. Background
2. Research Objectives and Activities
Section II. Award
Information
1. Mechanism of Support
2. Funds Available
Section III. Eligibility
Information
1. Eligible Applicants
A. Eligible
Institutions
B.
Eligible Individuals
2.Cost Sharing or Matching
3.Other - Special
Eligibility Criteria
Section IV. Application and
Submission Information
1. Request Application Information
2. Detailed Content and
Form of Application Submission
3. Submission Dates and
Times
A. Receipt, Review and
Anticipated Start Dates
1. Letter of Intent
B. Submitting
an Application to CDC
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. Resource
Sharing Plan(s)
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. Reporting
Section VII. Agency
Contact(s)
1. Scientific/Research
Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants
Management Contact(s)
4. General Questions
Contact(s)
Section VIII. Other
Information - Required Federal Citations
Part II - Full Text of Announcement
Section I. Funding Opportunity Description
1. Background
Every year, millions of U.S. workers suffer occupational injuries or illness resulting in substantial human and economic costs. As part of its mission to prevent injuries, illness, and deaths caused by hazards in the workplace, the National Institute for Occupational Safety and Health (NIOSH) has established surveillance programs intended to assess the extent and severity of workplace injury and illness, to identify workers at greatest risk, to develop research and prevention priorities, and to measure the effectiveness of prevention activities. States can play a central role in public health surveillance because they are uniquely positioned to utilize state-specific data sources for surveillance and to link surveillance with intervention and prevention activities. Under the NIOSH Program Portfolio, the Surveillance Strategic Plan recognizes that States have a vital role to play in the surveillance of occupational injuries, illnesses, and hazards. Under the Surveillance Strategic Plan, State-based surveillance systems and activities will provide a vital foundation for several Federal surveillance systems and will augment other Federal surveillance systems. In the long-range vision of an improved, comprehensive, nationwide occupational health surveillance program, all States will have the core capacity to conduct surveillance of occupational injuries, diseases, and hazards that will contribute to State and local prevention efforts, as well as to national data concerning magnitude, trend, and distribution. In addition, States will also have the capacity to conduct focused in-depth surveillance, follow-up investigations, and intervention for selected, targeted conditions (diseases, injuries, or hazards). Given inevitable resource constraints, it is not realistic to expect all States to conduct in-depth surveillance for all occupational conditions at the present time [http://www.cdc.gov/niosh/programs/surv/goals.html]
For over 20 years NIOSH has provided technical and financial assistance to states to develop and/or enhance their occupational safety and health (OSH) surveillance activities. The concept of a state-based OSH surveillance program was developed from dialogue between NIOSH and its state partners, and was based on the mutual interest of integrating occupational health into mainstream public health practice. The program was developed to increase state OSH capacities. NIOSH has supported both basic OSH surveillance in the states (e.g., Fundamental programs) as well as in-depth (e.g., Expanded) programs focused on specific diseases, injuries, hazards, or special populations. Thus, in collaboration with its partners, NIOSH has established surveillance programs that help describe the extent of occupational hazards, diseases, injuries and deaths in the U.S. These surveillance activities have aided in documenting the Nation’s progress in reducing the burden of work-related illnesses and injuries. They also have identified many old and new problems requiring additional research and prevention efforts. Such efforts include translation of successful intervention approaches into the workplace. States are in a unique position to generate data on worker populations not gathered by the Bureau of Labor Statistics (BLS), e.g., immigrant and self-employed workers. They are also able to obtain data on occupational diseases such as asthma which typically are not captured by Bureau of Labor Statistics (BLS) and other existing data sources.
Prior funding opportunity announcements related to the NIOSH state-based OSH surveillance program include the following: State-Based Occupational Safety and Health Surveillance (PAR 04-106); Program for the Initiation and Development of State-Based Surveillance Capacity in Occupational Safety and Health (OH-02-007); State Fatality Surveillance and Field Investigations of Occupational Injuries: Fatality Assessment and Control Evaluation (FACE) (RFA-CC-02-012); Development of Core State-Based Surveillance Model Programs (OH-00-007); and Cooperative Agreement for State: Based Surveillance Activities-Sentinel Event Notification Systems for Occupational Risk (SENSOR) (PA 708). The current funding opportunity announcement builds upon experiences with these previous funding announcements. It seeks to accomplish two complementary objectives of the NIOSH Surveillance Strategic Plan: 1) to develop capacity among states to conduct surveillance of occupational injuries, diseases and hazards that will contribute to State and local prevention efforts; and 2) to expand the role of states in conducting in-depth surveillance, follow-up investigations, and interventions that will contribute to state and local prevention efforts and simultaneously fill gaps in surveillance data at the national level. In this funding announcement, these objectives are addressed respectively by two different types of awards: Fundamental and Expanded.
Fundamental Program: The Fundamental Program provides states the resources to establish an OSH program and to carry out basic population-based surveillance using existing data sets, e.g., the 19 occupational health indicators (see also http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5601a1.htm). The Program encourages states to develop partnerships with other state-based public health programs and agencies as well as academic institutions, unions and industry groups. By sharing findings with partners and stakeholders states are able to raise awareness of occupational health, leverage resources, spark new initiatives, integrate the topic into existing public health datasets, and to foster the use of surveillance data to set prevention priorities. For example, as part of their Fundamental Program, one state funded in the mid-2000s was able to create a web-based system for tracking Occupational Safety and Health Administration (OSHA) recordable injuries and illnesses among public service employees. This state group produced the first detailed report on serious work-related injuries and illnesses among state employees based on workers compensation claims for lost wages helping to focus prevention efforts. In another example, a state reported how they were able to use their data on young worker injuries to inform educators throughout the state of the extent of the problem and to gather support for using NIOSH’s Youth@Work: Talking Safety curriculum. Another state reported that when several emergency responders experienced symptoms of pesticide poisoning after entering a house recently treated with pesticides, relevant safety and health information was distributed to thousands of police officers and firefighters throughout the state and is now being used to train future public safety officers. In addition to developing and disseminating educational and other materials within their states, states may collaborate with NIOSH surveillance experts on peer-reviewed publications, reports, NIOSH Alerts, and NIOSH Workplace Solutions.
Expanded Program: The existing Expanded Program provides states the resources to undertake not only basic activities such as collection of the Occupational Health Indicators (OHIs) but to be able to focus surveillance activities on one or more priority health conditions, injuries, or hazards, or worker populations of special interest (Priority Focus Areas). These focused efforts involve more in-depth data acquisition, analysis, and dissemination, using existing or new data and/or new case finding and case follow-up. They should address major and compelling worker health and safety problems, and opportunities amenable to guiding intervention efforts to improve and monitor the progress of worker health and safety and health. In addition to developing and disseminating educational and other materials within their states, states may collaborate with NIOSH surveillance experts on peer-reviewed publications, reports, NIOSH Alerts, and NIOSH Workplace Solutions. The following excerpt, from the NIOSH Respiratory Diseases Research Program website, is but one of many examples of the value of a Priority Focus Area in the Expanded program wherein a state-based surveillance program identified a well-known health problem, Work-Related Asthma (WRA), in a new work setting One death in Michigan from status asthmaticus and eight confirmed cases of WRA in the state of Washington were identified as due to isocyanate-induced asthma caused by isocyanate exposure during spray-on truck-bed liner application. This finding resulted in the NIOSH Alert Preventing Asthma and Death from MDI [Methylene diphenyl diisocyanate] Exposure During Spray-on Truck-bed Liner and Related Applications (A4-12, A4-13, A4-14). By providing funding to states and technical support, e.g., from NIOSH scientists, this Program enables and strengthens the capacity of state agencies to conduct WRA surveillance. It promotes the national coordination of state-level surveillance and facilitates preventive intervention activities related to WRA, as well as fostering the integration of WRA into mainstream public health surveillance for asthma.
Another example of a priority focus area within the current Expanded Program is the Sentinel Event Notification Systems for Occupational Risks-Pesticides (SENSOR-Pesticides) Program which began in 1987 and which, in 2008, operated in 12 states. Six of these states have cooperative agreement funding from NIOSH to carry out this work. Besides identifying, classifying, and tabulating pesticide poisoning cases, the states periodically perform in-depth investigations of pesticide-related events, and develop interventions aimed at particular industries or pesticide hazards. Also, data submitted annually by each SENSOR-Pesticides state program are aggregated to produce a national database consisting of acute pesticide-related illness and injury cases.
A second example of a Priority Focus Area within the Expanded Program is the Fatality Assessment and Control Evaluation (FACE) Program which began in 1989. Currently, nine State health or labor departments are funded by NIOSH to conduct surveillance, targeted investigations, and prevention activities at the State level using the FACE model. The FACE program is designed to identify and study fatal occupational injuries. The goal of the program is to prevent occupational fatalities across the nation by identifying and investigating work situations at high risk for injury and illness and then formulating and disseminating prevention strategies to those who can intervene in the workplace.
2. Research Objectives and Activities
NIOSH invites applications for cooperative agreements from state agencies or their bona fide agents to establish, maintain, or expand state occupational safety and health (OSH) surveillance capacity. As described earlier, the purpose of this surveillance is to collect, compile, analyze, disseminate and use data and information resources to promote prevention of occupational injuries, illnesses, fatalities, and exposures within the states and throughout the nation. NIOSH has supported occupational surveillance programs since 1980. Although significant accomplishments have been made in OSH surveillance in the U.S., gaps still exist and many states have yet to develop the critical infrastructure needed to support basic programs. This program announcement provides support for state-based Fundamental and Expanded surveillance programs. The announcement supports the following goals developed by the NIOSH surveillance community, in particular, Goal 2.
Goal 1: Enhance the use of surveillance information at the Federal level for the prevention of occupational injuries, illnesses, and hazards.
Goal 2: Enhance the use of State-level public health surveillance information at both the State and national levels for prevention of occupational illnesses, injuries, and hazards.
Goal 3: Develop and strengthen the use of surveillance data to identify priorities, trends, and emerging issues within the eight NORA industry sectors.
Goal 4: Promote occupational safety and health surveillance conducted by employers, unions, and other non-governmental organizations.
Goal 5: Increase research to improve occupational surveillance.
The purpose of this announcement is two-fold. The first is to provide states an opportunity to establish basic OSH surveillance activities (Fundamental Programs) including the: 1) collection, analysis, interpretation, use, and dissemination of findings on the incidence of occupational injuries, illnesses, deaths and exposures using existing state-level data; 2) identification of trends, emerging issues, high-risk occupations, industries, and worker populations; and 3) development of recommendations for workplace interventions.
The second purpose of the announcement is to provide states with an established OSH program or with experience in OSH surveillance, the opportunity to expand their capacity by conducting in-depth surveillance of specific conditions, injuries, hazards, and populations (Expanded Programs). In addition to fostering prevention activities at the state level, the Priority Focus Areas that comprise the Expanded Programs are expected to fill gaps in existing national surveillance systems.
Guidelines for the planning and development of surveillance activities and associated policy, intervention, and infrastructure activities are described in Guidelines: Minimum and Comprehensive State-based Activities in Occupational Safety and Health (DHHS[NIOSH] Publication No. 2008-148). Potential applicants should consult these guidelines when creating their program. Additionally, attention should be paid to the Council of State and Territorial Epidemiologists (CSTE) and NIOSH set of 19 occupational health indicators, along with a companion guide on how to access data for each indicator (see also: http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5601a1.htm). The role of state-based OSH surveillance in worker safety and health, and the identification of priority OSH conditions are further described in The Role of States in a Nationwide Comprehensive Surveillance System for Work-related Diseases, Injuries and Hazards. In addition to the NIOSH Surveillance goals, recipients should relate and report their activities and findings by NIOSH Industry Sector.
Fundamental Program
The Fundamental Program is intended to provide state agencies the resources to initiate or continue activities for a basic state-based surveillance program for occupational injuries, diseases, exposures, and worker populations of special interest. This Program is most closely aligned with NIOSH’s Intermediate Surveillance Goal 2.1: Enhance and expand the development of State-based public health surveillance systems through State-based surveillance for the prevention of occupational illnesses, injuries, and hazards. Fundamental Programs will contribute to state and local prevention efforts as well as to national data concerning magnitude, trend, and distribution of occupational health conditions. State agencies interested in conducting a basic level of OSH safety surveillance must at a minimum demonstrate that they are able to conduct population-based surveillance using existing data systems.
An important component of the Fundamental Program is the generation of Occupational Health Indicators (OHIs) for selected occupational health conditions. These indicators were developed by the Council of State and Territorial Epidemiologists (CSTE) and NIOSH as a standard set of measures that allow states and territories to uniformly define, collect and report occupational illness, injury, and risk data. The indicators were selected based on their public health importance, the availability of easily obtainable statewide data in most states and their potential for prevention/intervention activities. The list of 19 OHIs along with a how-to guide can be found on the CSTE website. Generation and dissemination of as many of the first 13 indicators as are available in their states is expected of grant recipients; the generation and dissemination of all 19 indicators is encouraged. The key elements of a state-based Fundamental Program are described in the CSTE/NIOSH 2008 document Guidelines for Minimum and Comprehensive State-Based Public Health Activities in Occupational Safety and Health and should be consulted.
Activities for the Fundamental Program include, but are not limited to, the following:
Expanded Program:
Expanded awards are intended for states with experience in conducting OSH surveillance, e.g., experience collecting OHIs, or those with an established OSH program. The Expanded Program is closely aligned with NIOSH’s Intermediate Surveillance Goal 2.3 to Expand State-based surveillance programs of selected occupational conditions or hazards, and population at high risk including special populations. The ultimate goal for in-depth surveillance activities is to reduce priority occupational fatalities, injuries, disease, and exposures within the states and throughout the nation. It is expected that expanded programs will collect data that is not currently available from national occupational safety and health surveillance systems. The specific objectives are to (1) identify work environments that place workers at high risk for occupational disease or injury, (2) identify potential risk factors, (3) formulate and disseminate prevention strategies to those who can intervene in the workplace and (4) fill gaps in national occupational safety and health surveillance systems. Expanded applications must demonstrate a high potential for implementing a balanced program that includes occupational surveillance, field observation of the state priority conditions, and the development and dissemination of prevention strategies.
An Expanded Program will include the activities of the Fundamental Program listed above, particularly generation of the OHIs, and will build upon that Program to include targeted surveillance efforts on selected Priority Focus Areas. Such focused information is required to understand the circumstances and contributors for an occupational health condition, exposure, or working populations of special interest so as to formulate and develop effective preventive measures. The Priority Focus Areas involve more intense in-depth analysis of information using existing data sets, new datasets, and/or new case finding and case follow-up. Priority Focus Areas should address significant and compelling worker health and safety problems, and consider opportunities amenable to guide intervention efforts to improve and monitor the progress of worker health and safety. Such OSH conditions, exposures, or populations may be identified through a collaborative process involving data analysis and input from the advisory committee, key stakeholders, NIOSH, and other partners. An important feature of the Expanded Program is the identification of opportunities for intervention and prevention activities, evaluation of these efforts, and the translation of effective efforts to the local, state and national workplace. The effectiveness of an Expanded Program in meeting these goals may be facilitated, for example, through collaboration with other states and with NIOSH and through regional surveillance efforts with neighboring states
All Expanded Program applications must provide evidence of having experience with and active participation in a basic occupational surveillance program and the ability to produce the OHIs as described above under the Fundamental Program. Priority Focus Areas may include those historically supported by NIOSH (e.g., fatalities through state-based FACE programs, pesticides, asthma, silicosis), or outcomes, exposures or worker populations that are inadequately addressed by existing national occupational safety and health surveillance systems (i.e., dermatitis, musculoskeletal disorders, migrant workers, public employees, contingent or contract workers). Applicants must demonstrate commitment by assigning sufficient FTEs dedicated to work on the program(s). In addition to a plan for collecting the OHIs, applications for the Expanded Program should contain detailed surveillance activity plans in the application for each Priority Focus Area proposed for the expanded program.
In addition to the activities listed under Activities for the Fundamental Program above, components of Expanded Programs will include the following:
Applicants may apply for either a Fundamental or an Expanded Program.
Meetings: An objective of this initiative is to increase the dissemination and use of State-based surveillance (SBS) information for decision-making regarding research and intervention activities (see Intermediate goal 2.2 at http://www.cdc.gov/niosh/programs/surv/goals.html). Ultimately the goal is to have an integrated and interoperable state-based surveillance (SBS) Program that builds on the results of previous projects which were independent SBS programs. As such, recipients of this cooperative agreement are expected to set aside funds to attend and actively participate in relevant CDC/NIOSH-convened meetings.
Within three months of issuance of all awards, NIOSH will convene a one-day kick-off meeting of the Principal Investigators (PIs) to (1) review State and NIOSH program goals, (2) introduce NIOSH staff, (3) outline administrative procedures and expectations, and (4) discuss the format of and agenda for semiannual grantee meetings. Recipients of the Fundamental and Expanded programs are expected to attend, and include funds in their budgets for, the PI or designee to attend the kick-off meeting in Atlanta. Thereafter, recipients are expected to attend, and include funds in their budgets for two representatives from each funded state, including the PI or designee, to attend two grantee meetings per year to meet with other state surveillance award recipients and NIOSH staff. One of these meetings possibly will coincide with the annual CSTE conference during which grantees attend the OSH portion of the CSTE conference. The other meeting typically will be held in the fall or winter, usually in conjunction with the CSTE Workgroup meeting (2-3 days total). Meetings will be organized and convened by NIOSH OEP officials with input from awardees and from NIOSH staff. For budget preparation and project planning purposes, it should be assumed that these semiannual meetings will be held in Washington D.C.
In addition to the meetings described above, applicants for the FACE program must budget for two personnel to attend a 2-3 day annual meeting on this Priority Focus Area. Applicants for the pesticide program must budget for one person to attend a 1-2 day meeting held semiannually. Applicants for the work-related asthma and/or silicosis programs are expected to attend an annual meeting for up to two people.
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
1. Mechanism of Support
This FOA will use the HHS/CDC U60 award mechanism which is a cooperative agreement assistance instrument. Under this assistance instrument, the Recipient Organization retains the primary responsibility and dominant role for planning, directing, and executing the proposed project with HHS/CDC staff 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 approximately $5.5 million in new money for up to five (5) years for up to 6 Fundamental Programs and up to 30 Priority Focus Areas within the Expanded Program.
FUNDAMENTAL PROGRAM
An applicant may request a project period of up to 5 years with up to $120,000 in Total Costs per 12-month budget period.
EXPANDED PROGRAM
The maximum amount of Total Costs per state is $670,000 per 12-month budget period for up to 5 years. Expanded Program applications must include a plan for providing basic OSH surveillance activities including OHIs for which they may request up to $70,000 to cover these basic activities. The $70,000 is to be included in the cap for Total Costs ($670,000). Applicants wishing to request more than the maximum total cost per application must contact the Scientific Program Official to obtain express permission.
There is no limit on the number of Priority Focus Areas for which a state may apply with the caveat that a maximum of $670,000 Total Costs will be allowed per application/year. No maximum dollar amount for a specific Priority Focus Area is specified; however, the budget for the entire Expanded Program application is limited to $670,000 Total Costs. Applicants must propose how much it will cost to carry out a particular program/project and justify the budget in their applications. An Expanded Program application with a meritorious OHI component may be considered for funding as a Fundamental Program if none of the proposed Priority Focus Area components are acceptable. The latter will be allowed to submit a revised scope of work and budget as a Fundamental Program. Such programmatic decisions will depend on the number of meritorious applications, availability of funds, and program priorities and needs.
Although the financial plans of NIOSH provide support for these programs, awards issued under this FOA are contingent upon the availability of funds, programmatic considerations, and the receipt of meritorious application(s) as judged by peer review evaluations of the individual components within the application and the application as a whole.
Continuation awards within an approved project period will be made based on satisfactory progress as evidenced by required reports and the availability of funds.
Section III. Eligibility Information
1.
Eligible Applicants
1.A. Eligible Institutions
State Health and/or Labor Departments or their Bona Fide Agents. 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 government, you must provide a letter from the state as documentation of your status. Attach this documentation behind the first page of your application form.
Foreign organizations are not eligible.
1.B. Eligible Individuals
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Principal Investigator (PI) is invited to work with his/her organization 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 support.
2. Cost Sharing or Matching
Cost Sharing or Matching is not required as
defined in the current HHS Grants Policy Statement http://www.hhs.gov/grantsnet/adminis/gpd/.
3. Other-Special Eligibility Criteria
Fundamental awards generally are intended for states without an established OSH surveillance program or those lacking experience in OSH surveillance. We anticipate funding up to 6 states for fundamental programs. The number of awards will be based on the availability of funds and receipt of meritorious applications. Priority will be given to funding at least one new applicant state in HHS Region 3, one in HHS Region 4, and one in HHS Region 8. Information on the HHS Regions is available at http://www.hhs.gov/about/regionmap.html.
Expanded awards are intended for states with experience in conducting OSH surveillance, for example, those experienced in collecting OHIs or those with an established OSH program. We anticipate funding up to 30 Priority Focus Areas within the Expanded Program according to the following plan:
Exposures:
Pesticides: up to 7 states*
Outcomes:
FACE: up to 10 states
Asthma: up to 5 states
Silicosis: up to 4 states
MSD: up to 2 states
Self Initiated: up to 2 states
* For pesticide programs, priority will be given to funding at least 1 state in HHS/OSHA Region 4 and 1 state in HHS/OSHA Region 8.
To be eligible for an Expanded Program award, an applicant must provide evidence that he/she has actively participated in a basic occupational surveillance program and has generated or is able to generate the OHIs as described above under the Fundamental Program. In addition to providing a plan for collecting and disseminating the OHIs, applicants must identify and provide a plan for targeting one or more occupational health and safety topics; either the Priority Focus Areas listed above, or other self-initiated areas such as migrant workers, truck drivers, public employees, contingent or contract workers, for focused surveillance efforts. Applicants must demonstrate commitment by assigning sufficient FTEs dedicated to work on the program(s).
If an 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 PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. HHS/CDC Telecommunications for the hearing impaired: TTY 770-488-2783.
2. Detailed 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.
TABLE OF CONTENTS FOR AN APPLICATION TO THIS FUNDING OPPORTUNITY ANNOUNCEMENT (FOA)
Note: The research plan for each of the Fundamental Programs (or the OHI Component of the expanded program) and for each Priority Focus Area under the Expanded Program should use the following outline. Each research plan should not exceed 25 pages.
Note: Type density and size of the entire application must conform to the limits provided in the PHS 398 instructions on Page I-17.
Note: The CDC U60 (activity code) uses ONLY the detailed Research & Related Budget. (Do not use the PHS 398 Modular Budget.)
3. Submission Dates and Times
See Section IV.3.A. for details.
3.A. Receipt, Review and Anticipated Start Dates
Release/Posted Date: July 6, 2009
Letter of Intent Receipt Date: Not applicable
Application Receipt Date(s): September 2, 2009; September 2, 2010; September 2,
2011
Peer Review Date(s): November/December 2009, 2010, 2011
Council Review Date(s): January/February 2010, 2011, 2012
Earliest Anticipated Start Date(s): July 2010, 2011, 2012
Expiration Date: September 3, 2011
3.A.1.
Letter of Intent
A letter of intent does not apply to this FOA.
3.B. Submitting an Application to NIH
Applications to this NIOSH FOA will be
received at the Center for Scientific Review, National Institutes of Health.
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, plus 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 paper copies of the application and all copies of the appendix materials (if any) on five identical CD ROMs must be sent to:
Price Connor, Ph.D.
Office of Extramural Programs
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention
1600 Clifton Road
Mailstop E-74
Atlanta, GA 30329-4018
404-498-2511
Fax 404-498-2571
Overnight mail address:
2400 Century Parkway NE (4th floor)
Atlanta, GA 30345
Email: spc3@cdc.gov
3.C.
Application Processing
Applications must be received on or before the
application submission receipt date 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 NIOSH.
Incomplete applications will not be reviewed.
NIOSH will not accept any application
submitted 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.
Information on the status of an application should be checked by the Principal
Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.
4. Intergovernmental Review
Executive Order 12372 does not apply to this program
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
Awardees upon acceptance of Notice of Award (NoA), must agree to the
"Cooperative Agreement Terms and Conditions of Award" in Section VI. "Award Administration
Information.
If you are requesting indirect costs in your budget, you must include a copy of your indirect cost rate agreement. If your indirect cost rate is a provisional rate, the agreement should be less than 12 months of age. If submitting electronically, use a PDF version of the agreement, attach it in Grants.gov under Other Attachments , and title it appropriately.
Applicants research plan(s) should address activities they will conduct over the entire project period.
The HHS/CDC requires the PI to fill in his/her eRA Commons User ID in the PROFILE Project Director/Principal Investigator section, Credential log-in field of the Research & Related Senior/Key Person Profile component. The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Registration FAQs Important Tips -- Electronic Submission of Grant Applications.
Research Plan Component Sections
The research plan must not exceed limits set in Section IV.2. If the research plan exceeds the page limitation, the application may be considered unresponsive and ineligible for review.
CDC/NIOSH considers surveillance conducted under this FOA to be human subjects research. Therefore, a complete human subjects section (Section E) of the research plan is required.
Appendix Materials
All paper PHS 398 applications submitted for May 25, 2008 and subsequent due dates must provide appendix material on CD only, and include five identical CDs in the same package with the application. Paper applications submitted for due dates prior to May 25, 2008 may voluntarily provide the appendix on five identical CDs; if submitting CDs, it is not necessary to include a paper appendix (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.)
NIOSH (with AHRQ and NIH) has published new limitations on grant application appendix materials to encourage applications to be as concise as possible while containing the information needed for expert scientific review.
Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.
Resource Sharing Plan(s)
All applicants must include a plan for sharing research data in their application. The HHS/CDC data sharing policy is available at http://www.cdc.gov/od/pgo/funding/ARs.htm under Additional Requirements 25 Release and Sharing of Data. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.
The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants should describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation they will provide, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not the awardee will place any conditions on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). References to data sharing may also be appropriate in other sections of the application.
The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.
HHS policy
requires that grant award recipients make unique research resources readily
available for research purposes to qualified individuals within the scientific
community after publication (see the HHS Grants Policy Statement http://www.hhs.gov/grantsnet/docs/HHSGPS_107.doc.)
Investigators responding to this funding opportunity should include a plan for
sharing research resources addressing how unique research resources will be
shared or explain why sharing is not possible.
The adequacy of the resources sharing plan and any related data sharing plans
will be considered by the HHS/CDC Program staff of the funding organization
when making recommendations about funding applications. The effectiveness of
the resource sharing will be evaluated as part of the administrative review of
each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm).
See Section VI.3. Reporting.
Section V. Application Review Information
1. Criteria
Only the review criteria described below will be considered in the review process
2. Review and Selection Process
Applications submitted for this FOA will be assigned to NIOSH. 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 in accordance with the
review criteria stated below.
As part of the
initial merit review, all applications will:
Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:
The goal of the NIOSH research program is to develop an understanding of the risks and conditions that are associated with occupational diseases and injuries, to explore methods for reducing risks and for preventing or minimizing exposure to hazardous conditions in the workplace, and to translate significant scientific findings into prevention practices and products that will effectively reduce work-related illnesses and injuries. Specific research priorities are derived from the National Occupational Research Agenda (NORA) which is used by NIOSH for determining how best to carry out its mission of providing national and world leadership in preventing work-related illnesses and injuries. Detailed information about NORA can be found at http://www.cdc.gov/niosh/nora/. In the written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. 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.
Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.
Criteria for Fundamental Programs (or OHI Component of the Expanded Program)
Significance: Does this application address available data within the state? Are important occupational problem(s) addressed? Does the application include measures to ensure stakeholder involvement? If the applicant achieves the aims of the application, how will it advance worker safety and health in the state? Is the application relevant to the objectives outlined in this announcement? Have the broad, long-term objectives of the program and expected accomplishments been defined? Are the needs and approaches to link surveillance and prevention activities well-described? Does the application describe the public health importance of the proposed surveillance and associated activities in evaluating and reducing occupational injuries, illnesses or hazards? If the aims of the application are achieved, how will state-based OSH capacity be advanced?
Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Are the purpose and operation of the state-based surveillance program adequately described? Does the application provide a detailed plan (project design and methods) and a realistic schedule for accomplishing each of the activities to be carried out in this program? Are the conceptual framework and methods adequately developed and appropriate to the aims of the project? Are the resources used to conduct surveillance and recommend interventions identified? Are coordination and collaboration with relevant local and state agencies described adequately? Is the time line proposed for the project suitable and realistic?
Innovation: Does the project employ novel concepts, approaches, or
objectives for surveillance, dissemination and other associated activities that
lead to enhanced efficiencies or cost-effectiveness?
Investigators: Are the investigators appropriately trained and well suited
to carry out this work? Is the work proposed appropriate to the experience
level of the principal investigator and co- investigators? Does the
investigative team bring complementary and integrated expertise to the project
(if applicable)? Is the work proposed appropriate to the experience
level of the PI and that of other investigators? Does applicant provide
evidence of capacity to conduct fundamental surveillance?
Environment: Does the environment in which the work will be done contribute to the probability of success? Are the applicant’s facilities, equipment, and other resources adequate for the performance of this project? Is there evidence of agency/institutional support generally, or specific agency commitment to support occupational surveillance and associated activities? Is there documentation of cooperation from relevant local agencies, state agencies, or other participants in the project, where applicable?
Criteria for Expanded Programs
Significance: Does the application describe the public health importance of the proposed surveillance and associated activities in evaluating and reducing occupational injuries, illness or exposures/hazards? If the applicant achieves the aims of the application, how will this advance scientific knowledge or practice? Is the application relevant to the objectives outlined in this announcement? Have the broad, long-term objectives of the program and expected accomplishments been defined? Are the needs and approaches to link surveillance and prevention activities well-described? If the aims of the application are achieved, how will worker safety and health be advanced?
Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant demonstrate the ability to maintain the Fundamental OSH surveillance? Does the applicant build on past efforts? Has the applicant established a state-based surveillance program that is comprehensive, including intervention activities linked to surveillance activities? Are the purpose and operation of the state-based surveillance program adequately described? Does the application provide a detailed plan (project design and methods) and a realistic schedule for accomplishing each of the activities to be carried out in this program? Does intervention work have an evaluative component? Does the applicant acknowledge potential problem areas and consider alternative tactics? Are the resources used to conduct surveillance and encourage interventions identified? Are coordination and collaboration with relevant local and state agencies described adequately? Is the time line proposed for the project suitable and realistic?
Innovation: Does the project
employ novel concepts, approaches, or objectives for surveillance, recognition
of risk factors and communication of the need for interventions, dissemination
of findings and other associated activities that promote efficiency or
cost-effectiveness? Does the project improve or develop methodologies? Does
the project employ state-of-the-art concepts, approaches, or objectives for
surveillance, intervention, dissemination and other associated activities that
may lead to enhanced efficiencies or cost-effectiveness? Does the project
propose any relevant new activities or methodologies to enhance the developed
state-based surveillance program?
Investigators: Is
the work proposed appropriate to the experience level of the principal
investigator and to that of co-investigators/program managers? Are the
investigators appropriately trained and well suited to carry out this work? Is
the work proposed appropriate to the experience level of the principal
investigator and other investigators? Does the investigative team bring
complementary and integrated expertise to the project (if applicable)?
Environment: Does the scientific
environment in which the applicant will do the work contribute to the
probability of success? Do the proposed studies benefit from unique features of
the scientific environment, or subject populations, or employ useful
collaborative arrangements? Is there evidence of institutional support?
2.A. Additional Review Criteria
In addition to the above criteria, the following items will be
considered in the determination of scientific merit and the priority score.
Renewal Applications: Do the new specific aims and goals constitute logical extensions of previous projects and is there clear evidence that the continuation of the program will continue to provide important information or lead to new findings? Does past or related performance demonstrate the applicant’s ability for success with work proposed? Have applicants published or submitted for publication manuscripts or educational materials? Have they developed interventions to effect change?
Resubmission Applications: Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate?
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 Human Subjects Sections of the PHS398 Research Plan.
Inclusion of Women, Minorities and Children in Research: 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 the Human Subjects Sections of the PHS398 Research Plan component).
Care and Use of Vertebrate Animals in Research: If applicants plan to use vertebrate animals
in the project, HHS/CDC will assess the five items described in the Vertebrate
Animals of the Research Plan component. Additional HHS/CDC
Requirements under AR-3 Animal Subjects Requirements are available on the
Internet at the following address: http://www.cdc.gov/od/pgo/funding/ARs.htm.
Biohazards: If applicants propose the applicant has proposed materials
or procedures that are potentially hazardous to research personnel and/or the
environment, determine if the proposed protection is adequate.
2.B. Additional Review Considerations
Budget and Period of Support: For Expanded Programs, a budget must be provided for each Priority
Focus Area. The reasonableness of the proposed budget and the appropriateness
of the requested period of support in relation to the proposed research may be
assessed by the reviewers. Is the number of person months listed for the
effort of the PD/PI appropriate for the work proposed? Is each budget category
realistic and justified in terms of the aims and methods? The evaluation of the
budget should not affect the priority score.
2.C. Resource Sharing Plan(s)
The reasonableness of the data sharing plan may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The funding organization will be responsible for monitoring the data sharing policy.
HHS policy requires that recipients of grant awards make unique
research resources readily available for research purposes to qualified
individuals within the scientific community after publication. Please see http://grants.nih.gov/grants/policy/gps/8postnew.htm#phs.
Investigators responding to this funding opportunity should include a plan addressing how unique
research resources will be shared or explain why sharing is not possible.
The adequacy of the resources sharing plan and any related data sharing plans will be considered by the HHS/CDC Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.
Program staff of the funding organization will be responsible for the administrative review of the plan for sharing research resources.
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 PI will be able to access the Summary Statement via the eRA
Commons. If the application is under consideration for funding, NIOSH will
request "Just-In-Time" (JIT) information from the applicant. For
details, applicants may refer to Just-In-Time on the NIOSH/OEP website or to the NIH Grants
Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A:
General.
Selection of the application for award is not an authorization to begin performance. Pre-award costs are not allowed. See also Section IV.5 Funding Restrictions.
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.
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 U60 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 above.
2. A.1. Recipient Rights and Responsibilities
The recipient will have the primary responsibility of all management, administrative and scientific aspects of the Program. The grantee is strongly encouraged to review the HHS grant policy statement, for aid with post award administration, at http://www.hhs.gov/grantsnet/adminis/gpd/index.htm.
Recipient Organizations 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.
The recipient will coordinate project activities technically, scientifically, and administratively at the awarded institution and at other sites that may be supported by sub-contracts to this award. The applicant will have primary authority and responsibility to define objectives and approaches; collect and analyze data; and to publish results, interpretations, and conclusions of studies conducted under the terms and conditions of the program award.
Recipients of Fundamental and Expanded Awards will have responsibility for the activities listed in Section I. Research Objectives and Activities under each Program.
2.A.2. HHS/CDC Responsibilities
NIOSH/OEP Scientific Program Official
NIOSH/CDC recognizes the potential need for assistance, when appropriate, in state-based surveillance programs. An HHS/CDC/NIOSH agency Scientific Program Official (SPO) will be designated for this cooperative agreement. This person will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the Notice of Award (NoA). Responsibilities of the SPO include the following:
NIOSH Project Scientists
NIOSH anticipates having substantial scientific and programmatic involvement during conduct of this activity in the form of technical assistance, collaboration, guidance and coordination. Responsibilities of the NIOSH project scientists include the following:
NIOSH project scientists will be named in the Notice of Award and will work closely with the recipient and the Scientific Program Official.
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. Annual report suitable for public distribution submitted in electronic format to NIOSH/OEP Scientific Program Official.
3. Financial status report, no more than 90 days after the end of the budget period.
4. Final financial and performance reports, no more than 90 days after the end of the project period.
5. Final Invention Statement and Certification Form
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 and must provide electronic copies of these reports.
Although the financial plans of the HHS/CDC 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.
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:
Linda Frederick, Ph.D.,
Office of Extramural Programs
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention
1600 Clifton Road NE, MS-E-74
Atlanta, GA 30329-4018 USA
404/498-2557
404/498-2571 (fax)
Email: ljf3@cdc.gov and copy OEPCorrespond@cdc.gov
Overnight Mail Address:
2400 Century Parkway NE (4th Floor)
Atlanta GA 30345-3114
2. Peer Review Contact:
Price Connor, Ph.D.
CDC/NIOSH/OEP
Clifton Road NE, MS-E-74
Atlanta, GA 30329-4018
404/498-2511
404/498-2571 (fax)
Overnight mail address:
2400 Century Parkway NE (4th Floor)
Atlanta GA 30345-3114
3. Financial or Grants Management Contact:
Peter Grandillo, Jr.
Acquisition and Assistance Field Branch
Centers for Disease Control and Prevention
626 Cochrans Mill Road
Pittsburgh, PA 15236-0070
Telephone: 412-386-6834
FAX: 412-386-6429
Email: pgrandillo@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).
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.
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 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:
a. In a timely manner.
b. Completely, and as accurately as possible.
c. To facilitate the broader community.
d. Developed in accordance with CDC policy on Releasing and Sharing Data.
April 16, 2003, http://www.cdc.gov/od/foia/policies/sharing.htm, and in full compliance with the 1996 Health Insurance Portability and Accountability Act (HIPPA), (where applicable), The Office of Management and Budget Circular A110, (2000) revised 2003 OMB Circular A110 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
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
|
| ||||||
|
|
|
Department of Health and Human Services (HHS) |
|
|||
|
NIH... Turning Discovery Into Health® |
||||||