TITLE 77: PUBLIC HEALTH
SUBPART A: GENERAL PROVISIONS
SUBPART B: PENNY SEVERNS BREAST, CERVICAL, AND OVARIAN CANCER RESEARCH FUND
SUBPART C: TICKET FOR THE CURE |
AUTHORITY: Implementing and authorized by Sections 2310-347 and 2310-350 of the Department of Public Health Powers and Duties Law of the Civil Administrative Code of Illinois [20 ILCS 2310/2310-347 and 2310-350].
SOURCE: Emergency rules adopted at 18 Ill. Reg. 9549, effective June 10, 1994, for a maximum of 150 days; emergency expired on November 7, 1994; adopted at 18 Ill. Reg. 17919, effective December 5, 1994; amended at 24 Ill. Reg. 7543, effective May 15, 2000; amended at 30 Ill. Reg. 17924, effective October 27, 2006.
SUBPART A: GENERAL PROVISIONS
Section 970.10 Definitions
"Act" means Sections 2310-347 and 2310-350 of the Department of Public Health Powers and Duties Law of the Civil Administrative Code of Illinois [20 ILCS 2310/2310-347 and 2310-350].
"Applicant" means any eligible physician, hospital, laboratory, education institution, other organization or person in Illinois whose intent is to conduct breast, cervical, and ovarian cancer research; public or private entities in Illinois whose intent is to conduct research concerning breast cancer or to fund services for breast cancer victims; or any of the above whose intent is to support a fellowship in the area of breast, cervical, and ovarian cancer. (Section 21.5 of the Illinois Lottery Law)
"Breast, Cervical, and Ovarian Cancer Advisory Committee" means a committee chaired by the Director or his/her designee and composed of at least six additional members appointed by the Director, of which four must be representatives of the State Board of Health, Y-Me, Susan G. Komen Foundation, and American Cancer Society-Illinois Chapter and the remaining individuals must be knowledgeable of either breast, cervical, or ovarian cancer or representative of an at-risk population. With the exception of the Chair, no appointee shall be an employee of the Department.
"Breast Cancer" means malignant tumor of the breast characterized by uncontrolled, abnormally rapid division of cells that originate in the breast and surrounding tissue and may spread to other organs.
"Cervical Cancer" means malignant tumor of the narrow lower end or neck of the uterus (cervix) characterized by uncontrolled, abnormally rapid division of cells that originate in the cervix and surrounding tissue and may spread to other organs.
"Clinical Diagnosis" means the process of identifying a disease by its characteristic signs, symptoms and laboratory findings.
"Clinical Trial" means the testing of diagnostic, treatment, and prevention techniques by comparing results in patients randomly assigned to receive one of two or more techniques being tested.
"Cure" means the eradication of disease through removal of the risk of death invoked by the disease that was treated.
"Department" means the Illinois Department of Public Health.
"Detection" means the discovery of breast, cervical, or ovarian cancer in a woman previously thought to be free of such cancer.
"Diagnostic Evaluation" means use of various techniques including physical exams, mammography, and evaluation by a pathologist of breast, cervical, or ovarian cells removed from the body to determine the presence and type of cancer.
"Director" means the Director of the Illinois Department of Public Health.
"Early Detection" means discovery of breast, cervical, or ovarian cancer at the first possible time when spread to other organs is least likely to occur.
"Fellowship" means supervised practical experience for an individual in a health care or scientific specialty beyond that required to earn a doctorate or, in the case of medicine, beyond that provided to hospital resident physicians to broaden expertise in breast, cervical, and ovarian cancer.
"Funding Period" means the time (usually twelve months coinciding with the Department's Fiscal Year) during which money is to be spent in support of a particular research project or training course.
"General Award" means presentation of funds by the Department to an applicant to conduct research on breast, cervical, and/or ovarian cancer and for funding services to breast cancer victims.
"Governmental Unit Code" means the Illinois Comptroller's preassigned vendor identification number for governmental agencies and municipalities.
"Grant Agreement Period" (see Funding Period).
"Not-for-Profit" means a corporation as described in the General Not-for-Profit Corporation Act of 1986 [805 ILCS 105].
"Ovarian Cancer" means malignant tumor of the ovaries characterized by uncontrolled, abnormally rapid division of cells, which originates in the ovaries and may spread to other organs.
"Peer Review Panel" means a group appointed by the Director, whose members demonstrate and are acknowledged to have expertise in areas dealing with breast, cervical, and ovarian cancer research.
"Prevention" means using various techniques including drugs, diet, and/or lifestyle changes to stop cancer from developing in healthy women.
"Principal Investigator" means the person with prime responsibility for conducting a research project.
"Project Period" means a minimum of one year and a maximum of three years (possibility of two continuation grants).
"Referral" means the process of linking persons who may be or who have been diagnosed with breast, cervical, and ovarian cancer with services in response to those needs.
"Research" means a scientific investigation into possible causes, location, progression, treatment, care and cure for breast, cervical, and ovarian cancer. Research includes, but is not limited to, expenditures to develop and advance the understanding, techniques, and modalities effective in early detection, prevention, cure, screening, and treatment of breast, cervical, and ovarian cancer and may include clinical trials. (Section 2310-350 of the Act)
"Research Fund" means the Penny Severns Breast, Cervical, and Ovarian Cancer Research Fund, which is a special fund in the State Treasury as described in Section 2310-350 of the Civil Administrative Code of Illinois.
"Research Fund Checkoff" means a voluntary process by which an Illinois taxpayer may use a provision on the standard individual income tax form to contribute to the Penny Severns Breast, Cervical, and Ovarian Cancer Research Fund.
"Research Grant" means funding provided to qualified principal investigators to investigate specific questions related to breast, cervical, and ovarian cancer research.
"Services for Breast Cancer Victims" means any type of assistance to aid in the lives of victims of breast cancer.
"Services for Breast Cancer Victims Grants" means funding to non-research grantees that provide services to breast cancer victims.
"Screening" means examining and testing for cancer in women who have no overt symptoms of cancer.
"Ticket for the Cure Board" means an advisory board within the Department created by Section 2310-347 of the Act.
"Ticket for the Cure Fund" means a special fund created by Section 21.5 of the Illinois Lottery Law [20 ILCS 1605].
"TIN" means the nine digit federal Taxpayer Identification Number that includes the Federal Employer Identification Number (FEIN), Social Security Number, or Governmental Unit Code.
"Training and Continuing Education" means extending or updating the knowledge of research scientists, health care professionals and other allied persons.
"Treatment" means the management and care of a woman for the purpose of combating breast, cervical, or ovarian cancer.
(Source: Amended at 30 Ill. Reg. 17924, effective October 27, 2006)
Section 970.15 Referenced Materials
The following State and federal laws and State administrative rules are referenced in this Part:
a) State of Illinois Laws:
1) The Department of Public Health Powers and Duties Law of the Civil Administrative Code of Illinois [20 ILCS 2310/2310-347 and 2310-350]
2) General Not-for-Profit Corporation Act of 1986 [805 ILCS 105]
3) Illinois Lottery Law [20 ILCS 1605]
4) Illinois Human Rights Act [775 ILCS 5]
5) Illinois Procurement Code [30 ILCS 500]
b) State of Illinois Administrative Rules:
Local Health Protection Grant Rules (77 Ill. Adm. Code 200)
c) Federal Laws:
1) The Civil Rights Act of 1964 (42 USC 1981)
2) The Drug-Free Workplace Act of 1988 (41 USC 701-707)
3) The Davis-Bacon Act of 1931 (40 USC 3141-3144, 3146, 3147)
(Source: Added at 30 Ill. Reg. 17924, effective October 27, 2006)
Section 970.20 Eligibility (Repealed)
(Source: Repealed at 30 Ill. Reg. 17924, effective October 27, 2006)
Section 970.30 Application Procedures (Repealed)
(Source: Repealed at 30 Ill. Reg. 17924, effective October 27, 2006)
Section 970.40 Application Review Criteria
A non-technical and technical review shall be conducted for each application received by the Department:
a) Criteria for the non-technical review shall include:
1) The inclusion of all required forms specified in Sections 970.230, 970.330 and 970.340; and
2) The inclusion of a response to each required item as specified in Sections 970.230, 970.330 and 970.340.
b) Criteria for the technical review shall be as follows:
1) The activities identified by the applicant will lead to achievement of the objectives;
2) The project objectives are achievable in the stated time frame;
3) The evaluation methods will measure progress toward the identified objectives;
4) The budget provides sufficient resources and justifies the need for funds to carry out the project; and
5) Continuation applicants have documented the status of each activity in support of the current year's objectives and have provided an estimate of the extent to which each current year objective will be met.
(Source: Amended at 30 Ill. Reg. 17924, effective October 27, 2006)
Section 970.60 Award and Use of Grant Funds (Repealed)
(Source: Repealed at 30 Ill. Reg. 17924, effective October 27, 2006)
Section 970.80 Contract Expiration
All projects shall end on the date specified in the grant agreement and shall not be extended or renewed. A continuation application, as provided for in Sections 970.230(c) and 970.330(c), may result in a new grant agreement with a new expiration date.
(Source: Amended at 30 Ill. Reg. 17924, effective October 27, 2006)
SUBPART B: PENNY SEVERNS BREAST, CERVICAL, AND OVARIAN CANCER RESEARCH FUND
Section 970.200 Purpose
The purpose of the Penny Severns Breast, Cervical, and Ovarian Cancer Research Fund is to support research, which includes, but is not limited to, expenditures to develop and advance the understanding, techniques, and modalities effective in early detection, prevention, cure, screening, and treatment of breast, cervical, and ovarian cancer and may include clinical trials. [20 ILCS 2310/2310-350]
(Source: Added at 30 Ill. Reg. 17924, effective October 27, 2006)
Section 970.210 Penny Severns Breast, Cervical, and Ovarian Cancer Research Fund
From funds appropriated from the Penny Severns Breast, Cervical, and Ovarian Cancer Research Fund, the Department shall award grants to eligible physicians, hospitals, laboratories, education institutions, and other organizations and persons to enable organizations and persons to conduct research. Disbursements from the Penny Severns Breast, Cervical, and Ovarian Cancer Research Fund for the purpose of ovarian cancer research shall be subject to appropriations. [20 ILCS 2310/2310-350]
(Source: Added at 30 Ill. Reg. 17924, effective October 27, 2006)
Section 970.220 Eligibility
Eligible applicants include:
a) Physicians licensed in Illinois to practice medicine in all of its branches, licensed hospitals in Illinois, certified laboratories in Illinois, certified mammography professionals and facilities, post-secondary higher education institutions in Illinois, and other medically affiliated organizations in Illinois and persons who are Illinois residents or sponsored by an Illinois facility guaranteeing benefits to Illinois residents.
b) All certified local health departments that provide public health programs as
defined in Section 615.200 of the Local Health Protection Grant Rules (77 Ill. Adm. Code 615.200).
(Source: Added at 30 Ill. Reg. 17924, effective October 27, 2006)
Section 970.230 Application Procedures
The Department will provide written application instructions and forms to potential applicants.
a) All applications shall include the following:
1) The principal investigator's name, address, and telephone and FAX and teletypewriter (TTY) numbers, if available;
2) The name, address, and telephone and FAX and TTY numbers, if available, of the entity (such as a university) through which the application is being submitted, if different from the information provided in subsection (a)(1) of this Section;
3) The curriculum vitae of the principal investigator;
4) A one-page non-technical abstract that describes the significance of the applicant's project for breast and/or cervical and/or ovarian cancer research;
5) The TIN;
6) The signature of principal investigator or agency official authorized to certify the application;
7) An approximate timetable for project completion;
8) A detailed budget for the funding period, documenting sufficient resources to carry out the project. The budget shall be by line item category and shall provide sufficient detail to justify the use of grant funds to support project activities. The applicant shall indicate the total cost of conducting the projects, the anticipated funding request for years two and three of the project (if applicable), the source of other funds supporting the projects, and the amount of support requested from the Department;
9) A signed Statement of Assurances indicating compliance with applicable State and federal requirements, such as the Fiscal Control and Internal Auditing Act, Office of Management and Budget (OMB) Circular A-128 (local governments), OMB Circular A-133 (not-for-profit organizations), bribery certification, contract debarment, unlawful discrimination, Illinois Human Rights Act, The Civil Rights Act of 1964, The Drug-Free Workplace Act of 1988, The Davis-Bacon Act of 1931, conflict of interest as specified in the Illinois Procurement Code [30 ILCS 500], and protection of the confidentiality of services;
10) A statement of whether funds are being requested for a fellowship or a general award;
11) A statement of the research question or hypothesis, or a description of interventions or model programs on which the research will be based;
12) A prioritized listing of measurable objectives for the funding period;
13) For each objective proposed for the first year of the project, a sequential listing of activities to achieve the objective, the time line for completing each activity, and identification of the individual responsible for coordinating the implementation of each objective; and
14) The evaluation methods to be used to measure progress in achieving
objectives and a plan for monitoring the overall project.
b) If the funds are being requested to support a fellowship, the following information shall be provided, in addition to the information required in subsection (a) of this Section:
1) The name of the individual to be supported through the fellowship;
2) The curriculum vitae of the individual; and
3) At least one letter of recommendation from the principal investigator or agency official authorized to certify the application.
c) All continuation applications shall contain the information required in subsection (a), as well as the following:
1) A progress report that contains a description of the status of each activity of the project to date, using the evaluation methods and monitoring plan specified in subsection (a)(14) of this Section;
2) Documentation of progress in meeting each project objective;
3) The project objectives for the new grant year, along with activities and timelines for completion of each activity; and
4) Any revisions in the evaluation methods or the monitoring plan, along with the rationale for such revisions.
(Source: Added at 30 Ill. Reg. 17924, effective October 27, 2006)
Section 970.240 Award and Use of Grant Funds
a) Project funds shall be used only for the direct cost of administering, operating and maintaining a project. The following direct costs are examples of those that may be incurred when specified in the grant agreement:
1) Personal services costs, including gross salaries and employer-paid fringe benefits for full-time and part-time employees of the project;
2) Contractual services costs, including, but not limited to, fees for consultants and specialists, exclusive of consultant services for patient care; conference registration fees; repair and maintenance of furniture and equipment; postage and postal services; subscriptions; training and education costs; software; and telecommunications costs;
3) Travel of personnel in carrying out authorized activities. Travel costs are the expenses for transportation, lodging and subsistence for personnel who are on travel status on official business for the applicant. Out-of-State travel requires prior written approval of the Department;
4) Supplies/commodities as required in the operation of the project that are directly related to its operation. Supplies include, but are not limited to, office, medical and educational supplies; equipment items costing less than $100 each; printing; and paper; and
5) Equipment directly related to the operation of the project. (Equipment is defined as items costing over $100 each, with a useful life of more than one year. Equipment costs shall include all freight and installation costs. Purchase of equipment items, other than those included in the approved budget, requires prior written approval from the Department.)
b) Payments to the grantee shall be made on a reimbursement basis.
1) The grantee shall use the Department's Reimbursement Certification Form or a reasonable facsimile to request reimbursement.
2) The grantee shall document actual expenditures incurred for the purchase of goods and services necessary for conducting program activities.
A) Expenditures shall be itemized on the Reimbursement Certification Form in such a manner as to establish an audit trail for future verification of appropriate use of grant funds.
B) Each item claimed on the Reimbursement Certification Form must be based on an expenditure traceable through the grantee's internal accounting system and shall include:
i) The check number or internal ledger transfer code;
ii) Date of payment;
iii) Dates goods or services were received for the period covered;
iv) A description of the goods or services and gross amount of
the check or transfer; and
v) The amount claimed for reimbursement from the Department.
3) The grantee shall submit requests for reimbursement periodically (monthly or quarterly) throughout the period of the grant. The final request for reimbursement shall be submitted within 45 calendar days after the end of the grant agreement period.
c) Requests for budget adjustments shall be submitted to the Department in writing and shall be received by the Department no later than 45 calendar days before the end of the grant agreement period.
(Source: Added at 30 Ill. Reg. 17924, effective October 27, 2006)
SUBPART C: TICKET FOR THE CURE
Section 970.310 Ticket for the Cure Fund
From funds appropriated from the Ticket for the Cure Fund, the Department shall award grants to public or private entities in Illinois for the purpose of funding research concerning breast cancer and for funding services for breast cancer victims. For purposes of this Section, the term "research" includes, without limitation, expenditures to develop and advance the understanding, techniques, and modalities effective in the detection, prevention, screening, and treatment of breast cancer and may include clinical trials. The grant funds may not be used for institutional, organizational, or community-based overhead costs, indirect costs, or levies (i.e., fees, fines or assessments such as tax levies, tax penalties, or association dues). [20 ILCS 1605/21.5]
(Source: Added at 30 Ill. Reg. 17924, effective October 27, 2006)
Section 970.320 Eligibility
a) Eligible applicants for the purpose of funding research concerning breast cancer include physicians licensed in Illinois to practice medicine in all of its branches; hospitals licensed in Illinois; certified laboratories in Illinois that hold a Clinical Laboratory Improvement Act (CLIA) certificate issued by the Centers for Medicare and Medicaid Services/Department of Health and Human Services; certified mammography professionals and facilities in Illinois that are certified by the Illinois Emergency Management Agency; post-secondary higher educational institutions in Illinois and other medically affiliated organizations in Illinois and persons who are Illinois residents or sponsored by an Illinois facility guaranteeing benefits to Illinois residents.
b) Eligible applicants for the purpose of funding services for breast cancer victims include local health departments; not-for-profit organizations; governmental entities; all Illinois licensed hospitals; and community health centers.
c) Eligible applicants for the purpose of funding services for breast cancer victims include all certified local health departments that provide public health programs as defined in Section 615.200 of the Local Health Protection Grant Rules (77 Ill. Adm. Code 615.200).
(Source: Added at 30 Ill. Reg. 17924, effective October 27, 2006)
Section 970.330 Application Procedures for Research Concerning Breast Cancer
The Department will provide written application instructions and forms to potential applicants upon request. Information concerning the grant will be available on the Department's website, http://www.idph.state.il.us/fundop.htm.
a) All applications shall include the following:
1) The principal investigator's name, address, and telephone and FAX and teletypewriter (TTY) numbers, if available;
2) The name, address, and telephone and FAX and TTY numbers, if available, of the entity (such as a university) through which the application is being submitted, if different from the information provided in subsection (a)(1) of this Section;
3) The curriculum vitae of the principal investigator;
4) A one-page non-technical abstract, which describes the significance of the applicant's project for breast cancer research;
5) The TIN;
6) The signature of the principal investigator or agency official authorized to certify the application;
7) An approximate timetable for project completion;
8) A detailed budget for the funding period, documenting sufficient resources to carry out the project. The budget shall be by line item category and shall provide sufficient detail to justify the use of grant funds to support project activities. The applicant shall indicate the total cost of conducting the projects, the anticipated funding request for years two and three of the project (if applicable), the source of other funds supporting the projects, and the amount of support requested from the Department;
9) A signed Statement of Assurances indicating compliance with applicable State and federal requirements, such as the Fiscal Control and Internal Auditing Act, Office of Management and Budget (OMB) Circular A-128 (local governments), OMB Circular A-133 (not-for-profit organizations), bribery certification, contract debarment, unlawful discrimination, Illinois Human Rights Act, The Civil Rights Act of 1964, The Drug-Free Workplace Act of 1988, The Davis-Bacon Act of 1931, conflict of interest as specified in the Illinois Procurement Code [30 ILCS 500], and protection of the confidentiality of services;
10) A statement of whether funds are being requested for a fellowship or a general award;
11) A statement of the research question or hypothesis, or a description of interventions or model programs on which the research will be based;
12) A prioritized listing of measurable objectives for the funding period;
13) For each objective proposed for the first year of the project, a sequential listing of activities to achieve the objective, the time line for completing each activity, identification of the individual responsible for coordinating the implementation of each objective; and
14) The evaluation methods to be used to measure progress in achieving objectives and a plan for monitoring the overall project.
b) If the funds are being requested to support a fellowship, the following information shall be provided, in addition to the information required in subsection (a) of this Section:
1) The name of the individual to be supported through the fellowship;
2) The curriculum vitae of the individual; and
3) At least one letter of recommendation from the principal investigator or agency official authorized to certify the application.
c) All continuation applications shall contain the information required in subsection (a) and, in addition, shall include the following:
1) A progress report that contains a description of the status of each activity of the project to date, utilizing the evaluation methods and monitoring plan specified in subsection (a)(14) of this Section;
2) Documentation of progress in meeting each project objective;
3) The project objectives for the new grant year, along with activities and timelines for completion of each activity; and
4) Any revisions in the evaluation methods or the monitoring plan, along with the rationale for such revisions.
(Source: Added at 30 Ill. Reg. 17924, effective October 27, 2006)
Section 970.340 Application Procedures for Services for Breast Cancer Victims
The Department will provide written application instructions and forms to potential applicants upon request. Information concerning the grant will be available on the Department's website, http://www.idph.state.il.us/fundop.htm.
a) All applications shall include the following:
1) The applicant's name, address, and telephone and FAX and teletypewriter (TTY) numbers, if available;
2) The name, address, and telephone and FAX and TTY numbers, if available, of the entity (such as a local health department, not-for-profit organization, governmental entity, licensed hospital, or community health center) through which the application is being submitted;
3) A one-page abstract, which describes the significance of the applicant's method to provide services for breast cancer victims;
4) A summary statement of the applicant's proposed plan of action to address the need for this service described in the Department's request for proposals;
5) A description of the geographic area or special population group to be served by the applicant's service, a statement of the special needs of the area or groups, and a thorough explanation of the manner in which the proposed services would meet those needs;
6) A statement of the measurable and relevant objectives the applicant proposes to achieve in the grant year;
7) An evaluation plan that will allow documentation of the applicant's progress in meeting the particular needs of the area or group and a plan for monitoring the overall project;
8) The TIN;
9) The signature of agency official authorized to certify the application;
10) A detailed budget for the funding period, documenting sufficient resources to carry out the project. The budget shall be by line item category and shall provide sufficient detail to justify the use of grant funds to support project activities. The applicant shall indicate the total cost of conducting the projects, the anticipated funding request for years two and three of the project (if applicable), the source of other funds supporting the projects, and the amount of support requested from the Department;
11) A signed Statement of Assurances indicating compliance with applicable State and federal requirements, such as the Fiscal Control and Internal Auditing Act, Office of Management and Budget (OMB) Circular A-128 (local governments), OMB Circular A-133 (not-for-profit organizations), bribery certification, contract debarment, unlawful discrimination, Illinois Human Rights Act, The Civil Rights Act of 1964, The Drug-Free Workplace Act of 1988, The Davis-Bacon Act of 1931, conflict of interest as specified in the Illinois Procurement Code [30 ILCS 500], and protection of the confidentiality of services.
(Source: Added at 30 Ill. Reg. 17924, effective October 27, 2006)
Section 970.350 Award and Use of Grant Funds
a) Funds shall be used only for the direct cost of administering, operating and maintaining a project or service. The following direct costs are examples of those that may be incurred when specified in the grant agreement:
1) Personal services costs, including gross salaries and employer paid fringe benefits for full-time and part-time employees of the project or service;
2) Contractual services costs, including, but not limited to, fees for consultants and specialists, exclusive of consultant services for patient care;
3) Supplies/commodities as required in the operation of the project or service that are directly related to its operation, which may include medical supplies and equipment supplies costing less than $100; and
4) Equipment directly related to the operation of the project. (Equipment
is defined as items costing over $100 each, with a useful life of more than one year. Equipment costs shall include all freight and installation costs. Purchase of equipment items, other than those included in the approved budget, require prior written approval from the Department.)
5) The grant funds may not be used for institutional, organizational, or
community-based overhead costs, indirect costs, or levies.
b) Payments to the grantee shall be made on a reimbursement basis.
1) The grantee shall use the Department's Reimbursement Certification Form or a reasonable facsimile to request reimbursement.
2) The grantee shall document actual expenditures incurred for the purchase of goods and services necessary for conducting program activities or services.
A) Expenditures shall be itemized on the Reimbursement Certification Form in such a manner as to establish an audit trail for future verification of appropriate use of grant funds.
B) Each item claimed on the Reimbursement Certification Form must be based on an expenditure traceable through the grantee's internal accounting system and shall include:
i) The check number or internal ledger transfer code;
ii) Date of payment;
iii) Dates goods or services were received for the period covered;
iv) A description of the goods or services and gross amount of the check or transfer; and
v) The amount claimed for reimbursement from the Department.
3) The grantee shall submit requests for reimbursement periodically (monthly or quarterly) throughout the period of the grant. The final request for reimbursement shall be submitted within 45 calendar days after the end of the grant agreement period.
c) Line-item budget adjustments to reallocate awarded funds shall be submitted to the Department on Department-provided forms no later than 45 calendar days before the end of the grant agreement period.
(Source: Added at 30 Ill. Reg. 17924, effective October 27, 2006)