AUTHORITY: Implementing and authorized by Sections 2310-397 and 2310-398 of the Department of Public Health Powers and Duties Law of the Civil Administrative Code of Illinois [20 ILCS 2310/2310-397 and 2310-398] and by the Illinois Grant Funds Recovery Act [30 ILCS 705].

SOURCE: Adopted at 25 Ill. Reg. 15422, effective November 16, 2001.

SUBPART A: GENERAL PROVISIONS

 

Section 950.10  Definitions

 

"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 Department of Public Health.

 

"Director" means the Director of Public Health.

 

"Early Detection" means the discovery of prostate or testicular cancer in a man previously thought to be free of these cancers and 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 prostate cancer.

 

"Funding Period" means the time (usually 12 months coinciding with the State's Fiscal Year) during which money is to be spent in support of a particular research project, program, or training course.

 

"General Award" means presentation of funds by the Department to an applicant to conduct research on prostate cancer.

 

"Governmental Unit Code" means the State Comptroller's preassigned vendor identification number for governmental agencies and municipalities.

 

"Indirect Costs" benefitting more than one cost objective yet not readily assignable to any of the cost objectives specifically benefitted, without effort disproportionate to the results achieved.

 

"Non-profit Organization" includes, but is not limited to, a corporation as described in the General Not-for-Profit Corporation Act of 1986 [805 ILCS 105].

 

"Prevention" means using various techniques, including drugs, diet, or lifestyle changes to stop cancer from developing.

 

"Principal Investigator" means the person with prime responsibility for conducting the research project.

 

"Project Period" means a minimum of one year and a maximum of three years (possibility of two continuation grants).

 

"Prostate Cancer" means malignant tumor of the prostate characterized by uncontrolled, abnormally rapid division of cells that originate in the prostate and surrounding tissue and may spread to other organs.

 

"Referral" means the process of linking persons who may be or who have been diagnosed with cancer with services in response to those needs.

 

"Research" means a scientific investigation into possible causes, location, progression, treatment, care and cure for prostate cancer.  Research includes, but is not limited to, expenditures to develop and advance the understanding, techniques, and modalities effective in prevention, cure, and treatment of prostate cancer and may include clinical trials.

 

"Research Fund" means the Prostate Cancer Research Fund, which is a special fund in the State Treasury as described in Section 2310-398 of the Department of Public Health Powers and Duties Law of the Civil Administrative Code of Illinois.

 

"Research Grant" means funding provided to qualified principal investigators to investigate specific questions related to prostate cancer research.

 

"Screening" means examining and testing for cancer in men who have no overt symptoms of cancer.  Screening includes, but is not limited to, laboratory tests, physical examination and medical history.

 

"Taxpayer Identification Number" means the nine digit federal Taxpayer Identification Number also known as the Federal Employer Identification Number (FEIN), Social Security Number, or Governmental Unit Code.

 

"Testicular Cancer" means malignant tumor of the testicle characterized by uncontrolled, abnormally rapid division of cells that originate in the testicle and surrounding tissue and may spread to other organs.

 

"Treatment" means the management and care for the purpose of combating prostate or testicular cancer.

 

Section 950.20  Reports

 

a)         To the extent not prohibited by law, all reports issued by the Department that are aggregated to make it impossible to identify any individual or reporting facility shall be made available to the public under the Department's Freedom of Information Code (2 Ill. Adm. Code 1126) and the Freedom of Information Act [5 ILCS 140].

 

b)         All requests from researchers for access to data must be submitted in writing to the Department.

 

c)         Disclosure of information may only be made if not otherwise prohibited by State or federal law or regulation.

 

Section 950.30  Grant Notification

 

a)         The Department shall award funds based upon the application process.  The exact amount and number of grants will depend upon the amount of funds available to the Department and the number of applications received and approved.

 

b)         The Department may award an amount less than the amount requested in an application.

 

c)         The Department shall prepare grant agreements and award transmittal letters.  Receipt of the transmittal letter and grant agreement for signature by the applicant shall constitute notification of a grant award.

 

d)         Applicants who are not awarded grant funds shall be notified in writing by the Department.

 

e)         The grant agreement shall not be sold, assigned, or transferred in any manner.  An actual or attempted sale, assignment, or transfer of the grant agreement shall result in immediate termination and automatically render the grant agreement null, void, and of no further effect.

 

f)         If the grantee ceases operation, then the grant agreement shall be terminated.  The grantee must notify the Department in writing by certified mail within 10 days if the project or program operations have ceased.

 

g)         The general provisions of this Subpart apply to the entire Part.

 

Section 950.40  Expiration

 

Projects or programs shall end on the date specified in the grant agreement and shall not be extended or renewed, except if approved through a continuation application.  A continuation application  may result in a new grant agreement with a new expiration date.

 

Section 950.50  Termination

 

a)         Except as otherwise provided in this Section, the grant agreement may be terminated by either party upon 30 calendar days written notice to the other party as specified in the grant agreement.

 

b)         The grant agreement may be terminated immediately without penalty of further payment being required if the General Assembly fails to appropriate or otherwise make available sufficient funds for the award or if sufficient funds are not available in the Prostate Cancer Research Fund, a special fund in the State Treasury.

 

c)         The Department may immediately suspend funding or terminate the contract of a grantee who has substantially failed or continually failed to comply with statute, this Part, another regulation, or the grant agreement.

 

Section 950.60  Denial, Suspension, or Revocation

 

a)         The Director may deny the application for grant funds or may suspend or revoke the grant agreement of a grantee when finding substantial or continued failure to comply with statute, this Part, another regulation, or the grant agreement. Except as provided in subsection (b), the Director must provide notice and an opportunity for a hearing to the party before executing the denial, suspension, or revocation.

 

b)         If the Director finds that the public interest, health, safety, or welfare requires emergency action, then the Director may immediately order summary suspension of a grant agreement pending proceedings for revocation.  The Director's order must be written and include the reasons for the public emergency.  These proceedings shall be promptly instituted and promptly determined.

 

c)         The notice of the denial, suspension, or revocation shall be made by certified mail or by personal service, state the particular reasons for the proposed action, and provide the opportunity to request a hearing.  If a written hearing request is not received within 10 days after receipt of the notice, then the right to a hearing is deemed to be waived.

 

Section 950.70  Hearings

 

The Department's Rules of Practice and Procedure in Administrative Hearings (77 Ill. Adm. Code 100) apply to proceedings conducted under this Part.  Where the terms "license" and "licensing" are used in Part 100, the definitions of those terms shall be expanded to include a grant applicant, a grantee awarded funds, and a grant agreement executed under this Part.

 

Section 950.80  Grant Funds Recovery

 

Grants made under this Part are also subject to the provisions of the Illinois Grant Funds Recovery Act [30 ILCS 705].  If a provision of this Part conflicts with a provision of the Illinois Grant Funds Recovery Act, then the provision of the Illinois Grant Funds Recovery Act controls.

SUBPART B: PROSTATE CANCER RESEARCH FUND

 

Section 950.200  Purpose

 

The purpose of grants under the Prostate Cancer Research Fund is to support research applicable to prostate cancer patients by public or private entities in Illinois.  The grant purposes include, but are not limited to, the use of clinical trials and treatment and prevention of prostate cancer.

 

Section 950.210  Prostate Cancer Research Grants

 

From the Prostate Cancer Research Fund, the Department of Public Health shall make grants based upon the application process for funding research applicable to prostate cancer patients.  The grant funds may not be used for institutional overhead costs, indirect costs, other organizational levies, or costs of community-based support services (Section 2310-398 of the Department of Public Health Powers and Duties Law of the Civil Administrative Code [20 ILCS 2310/2310-398]).

 

Section 950.220  Eligibility

 

The following persons are applicants eligible for grants under this Subpart:

 

a)         Physicians licensed in Illinois to practice medicine in all of its branches.

 

b)         State-licensed hospitals in Illinois.

 

c)         State-certified laboratories in Illinois.

 

d)         Post-secondary higher educational institutions in Illinois.

 

e)         Healthcare affiliated organizations in Illinois.

 

f)         Persons who are Illinois residents or sponsored by an Illinois facility guaranteeing benefits to Illinois residents.

 

Section 950.230  Application

 

a)         The Department shall provide a written application, instructions, and forms to potential or requesting applicants.  In addition to other items required in this Part, the Department shall request at least the following items in the application:

 

1)         The name, address, and telephone, facsimile, and teletypewriter numbers of the applicant and principal investigator.

 

2)         The name, address, and telephone, facsimile, and teletypewriter numbers of the entity through which the application is being submitted.

 

3)         The curriculum vitae of the principal investigator.

 

4)         The Social Security Number, Taxpayer Identification Number, or the Governmental Unit Code assigned by the State Comptroller.

 

5)         The signature of principal investigator or agency official authorized to certify the application.

 

6)         A statement of whether funds are being requested for a fellowship or a general award.

 

7)         A statement of the research question, hypothesis, intervention, or model program on which the research will be based.

 

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 project, the anticipated funding request, if applicable, for years 2 and 3 of the project, the source of other funds supporting the project, and the amount of support requested from the Department.

 

9)         A one-page non-technical abstract that describes the significance of the applicant's project concerning prostate cancer.

 

10)         For each objective proposed for the first year of the project, a sequential listing of activities to achieve the objective, the timeline for completing each activity, and the identification of the individual responsible for coordinating the implementation of each objective.

 

11)         An approximate timetable for completion of the entire project.

 

12)         A prioritized listing of measurable objectives for the funding period.

 

13)         The evaluation methods to be used to measure progress in achieving objectives and a plan for monitoring the overall project.

 

14)         A signed statement of assurances indicating compliance with applicable State and federal statute and regulations.

 

15)         A statement of approval by an institutional review board for research involving human subjects.

 

b)         If the funds are being requested to support a fellowship, then the following information shall be provided in addition to the information required in subsection (a):

 

1)         The name of the individual to be supported through the fellowship.

 

2)         The curriculum vitae of the individual.

 

3)         At least one letter of recommendation from the principal investigator or agency official authorized to certify the application.

 

c)         Continuation applications shall contain the information required under subsection (a) and shall include at least the following additional items:

 

1)         A progress report of the status of each project activity to date, under the evaluation methods and monitoring plan specified in Sections 950.240 and 950.260.

 

2)         The project objectives for the new grant year, along with activities and timelines for completion of each activity.

 

3)         The revisions in the evaluation methods or the monitoring plan, with the reasons for the revisions.

 

4)         A budget and expense listing for the previous grant.

 

Section 950.240  Application Review

 

a)         The Department shall conduct a non-technical and technical review of each application.

 

b)         The non-technical review shall evaluate at least each of the following items:

 

1)         If the application contains each of the forms required under this Subpart.

 

2)         If the application contains a response to each required item as specified in this Subpart.

 

c)         The technical review shall evaluate at least each of the following items:

 

1)         If the activities identified by the applicant will lead to achievement of the objectives.

 

2)         If the project objectives are achievable in the stated timeframe.

 

3)         If the project's evaluation methods will measure progress toward the identified objectives.

 

4)         If the budget provides sufficient resources and justifies the need for funds to carry out the project.

 

5)         If continuation applicants have documented the status of each activity supporting the current year's objectives and have provided an estimate of the extent to which each current year objective will be met.

 

Section 950.250  Grant Use

 

a)         Except as otherwise provided in this Part, project funds shall only be used for the direct cost of administering, operating, and maintaining a project.  Project grant funds cannot be used for institutional overhead costs, indirect costs, other organizational levies, or costs of community-based support services.  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; lab and other directly related test costs; conference registration fees; repair and maintenance of equipment; postage and postal services; training and education costs; software; and telecommunications costs.

 

3)         Travel of personnel in carrying out authorized activities.   Proper travel costs include the expenses for transportation, lodging, and subsistence for personnel who are on travel status on official business for the applicant.  Out-of-State travel expenses require prior written approval of the Department.

 

4)         Supplies and 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.

 

5)         Equipment directly related to the operation of the project. Equipment includes only those items costing over $100 with a useful life of more than one year. Equipment costs include all freight and installation expenses.  Purchase of equipment items, other than those included in the approved budget, require 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 to request payment.

 

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 at least the following items:

 

i)          Check number or internal ledger transfer code.

 

ii)         Date of payment.

 

iii)        Dates goods or services were received for the reimbursement period.

 

iv)        Description of the goods or services and gross amount of the check or transfer.

 

v)         Amount claimed for reimbursement from the Department.

 

c)         The grantee shall submit requests for reimbursement periodically as determined by the Department 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.

 

d)         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 funding period.

 

Section 950.260  Progress Reporting

 

a)         Applicants will be required to submit written reports of progress toward achieving objectives at each of the following times:

 

1)         Each 6-month interval after the start of the funding period.

 

2)         The submission of a continuation application.

 

3)         The conclusion of the funding period.

 

b)         The reports must include at least each of the following items:

 

1)         Information reflecting the status of the project under the proposed timeframes reflected in the application.

 

2)         Information on each objective addressing the methods implemented to achieve the status.

 

3)         A projection of methods and timeframes involved to accomplish the objectives within the timeframe remaining, except for the submission of the project summary report.

 

4)         A project summary at the close of the project period documenting the achievements and ultimate conclusions derived as result of the project.

 

5)         A specification of the budget and use of funds.

 

c)         The Department reserves the right to request an oral presentation concerning a status or an end-of-project report for the benefit of the Department or other formally recognized audiences.

SUBPART C: PROSTATE AND TESTICULAR CANCER PROGRAM

 

Section 950.300  Purpose

 

The purpose of the Prostate and Testicular Cancer Program is to support awareness, early detection, and screening applicable to prostate and testicular cancer patients by public or private entities in Illinois.

 

Section 950.310  Prostate and Testicular Cancer Program

 

a)         The Department of Public Health, subject to appropriation or other available funding, shall conduct a program to promote awareness and early detection of prostate and testicular cancer. The program may include, but need not be limited to:

 

1)         dissemination of information regarding the incidence of prostate and testicular cancer, the risk factors associated with prostate and testicular cancer, and the benefits of early detection and treatment;

 

2)         promotion of information and counseling about treatment options;

 

3)         establishment and promotion of referral services and screening programs; and

 

4)         making grants for these purposes (Section 2310-397 of the Department of Public Health Powers and Duties Law of the Civil Administrative Code [20 ILCS 2310/2310-397]).

 

b)         The applicants eligible for grants under this Section include, but are not limited to, the following entities:

 

1)         Certified local health departments that provide public health programs as defined in the Local Health Protection Grant Rules (77 Ill. Adm. Code 615).

 

2)         State-licensed hospitals in Illinois.

 

3)         Post-secondary higher educational institutions in Illinois.

 

4)         Healthcare affiliated organizations in Illinois.

 

Section 950.320  Prostate Cancer Screening Program

 

a)         Subject to appropriation or other available funding, the Department shall establish a Prostate Cancer Screening Program for the following persons:

 

1)         Uninsured and underinsured men 50 years of age and older.

 

2)         Uninsured and underinsured men between 40 and 50 years of age who are at high risk for prostate cancer, upon the advice of a physician or upon the request of the patient.

 

b)         Any entity, as described in subsection (d), funded by the Department shall coordinate with other local providers of prostate cancer screening, diagnostic, follow-up, education, and advocacy services to avoid duplication of effort. Any entity funded by the Department shall comply with any applicable State and federal standards regarding prostate cancer screening.

 

c)         Any entity funded by the Department shall collect data and maintain records that are determined by the Department to be necessary to facilitate the Department's ability to monitor and evaluate the effectiveness of the entities and the program.  [20 ILCS 2310/2310-397]

 

d)         The applicants eligible for grants (Section 2310-397 of the Department of Public Health Powers and Duties Law of the Civil Administrative Code [20 ILCS 2310/2310-397]) must be non-profit organizations and include, but are not limited to, the following entities:

 

1)         Certified local health departments that provide public health programs as defined in the Local Health Protection Grant Rules (77 Ill. Adm. Code 615).

 

2)         Non-profit State-licensed hospitals in Illinois.

 

3)         Non-profit post-secondary higher educational institutions in Illinois.

 

4)         Non-profit healthcare affiliated organizations in Illinois.

 

Section 950.330  Application

 

The Department shall provide a written application, instructions, and forms to potential or requesting applicants.  In addition to other items required in this Part, the Department shall request at least the following items in the application:

 

a)         The name, address, and telephone, facsimile, and teletypewriter numbers of the applicant.

 

b)         The name, address, and telephone, facsimile, and teletypewriter numbers of the entity through which the application is being submitted.

 

c)         A two-page non-technical abstract that describes the significance of the applicant's program concerning prostate or testicular cancer.

 

d)         The Social Security Number, Taxpayer Identification Number, or the Governmental Unit Code assigned by the State Comptroller.

 

e)         The signature of the agency official authorized to certify the application.

 

f)         A detailed budget for the funding period, documenting sufficient resources to carry out the program.  The budget shall be by line item category and shall provide sufficient detail to justify the use of grant funds to support program activities.

 

g)         An approximate timetable for completion of the entire program.

 

h)         A signed statement of assurances indicating compliance with applicable State and federal statute and regulations.

 

Section 950.340  Application Review

 

The Department shall review each application, and at a minimum, evaluate the following items:

 

a)         If the application contains the items required under this Subpart.

 

b)         If the budget provides sufficient resources and justifies the need for funds to carry out the program.

 

c)         If continuation applicants have documented the status of the program.

 

Section 950.350  Grant Use

 

a)         Except as otherwise provided in this Part, program funds shall only be used for the direct cost of administering, operating, and maintaining a program.  Grant funds may not be used for indirect costs of more than 12% of the funding amount.  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 program.

 

2)         Contractual services costs, including, but not limited to, fees for consultants and specialists, exclusive of consultant services for patient care; lab and other directly related test costs; conference registration fees; repair and maintenance of equipment; postage and postal services; training and education costs; software; and telecommunications costs.

 

3)         Travel of personnel in carrying out authorized activities.  Proper travel costs include the expenses for transportation, lodging, and subsistence for personnel who are on travel status on official business for the applicant.  Out-of-State travel expenses require prior written approval of the Department.

 

4)         Supplies and commodities, as required in the operation of the program, 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.

 

5)         Equipment directly related to the operation of the program. Equipment includes only those items costing over $100 with a useful life of more than one year. Equipment costs include all freight and installation expenses.  Purchase of equipment items, other than those included in the approved budget, require 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 to request payment.

 

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 at least the following items:

 

i)          Check number or internal ledger transfer code.

 

ii)         Date of payment.

 

iii)        Dates goods or services were received for the reimbursement period.

 

iv)        Description of the goods or services and gross amount of the check or transfer.

 

v)         Amount claimed for reimbursement from the Department.

 

c)         The grantee shall submit requests for reimbursement periodically as determined by the Department 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.

 

d)         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 funding period.

 

Section 950.360  Progress Reporting

 

a)         Applicants will be required to submit written reports of progress toward achieving objectives at each of the following times:

 

1)         Each 6-month interval after the start of the funding period.

 

2)         The conclusion of the funding period.

 

b)         The reports must include at least each of the following items:

 

1)         The number of people served by the program.

 

2)         The ethnic, geographic, and age breakdowns of the people served by the program.

 

3)         The stages of presentation of any prostate or testicular cancer diagnosed in the people served by the program.

 

4)         The diagnostic and treatment status of the people served by the program.

 

5)         A specification of the budget and use of funds.

 

c)         The Department reserves the right to request an oral presentation concerning a status or an end-of-program report for the benefit of the Department or other formally recognized audiences.