TITLE 25. HEALTH SERVICES

PART 1. DEPARTMENT OF STATE HEALTH SERVICES

CHAPTER 1. MISCELLANEOUS PROVISIONS

SUBCHAPTER D. DESIGNATING INCURABLE NEURODEGENERATIVE DISEASES

25 TAC §1.61

The Executive Commissioner of the Texas Health and Human Services Commission (HHSC), on behalf of the Department of State Health Services (DSHS), proposes new §1.61, concerning designating incurable neurodegenerative diseases.

BACKGROUND AND PURPOSE

The proposal is necessary to comply with House Bill (H.B.) 3703, 86th Legislature, Regular Session, 2019, which amended Texas Occupations Code, Chapter 169, and requires the Executive Commissioner of HHSC to adopt a rule designating incurable neurodegenerative diseases. The new rule designates incurable neurodegenerative diseases eligible for prescription of low-THC cannabis pursuant to Texas Occupations Code, Chapter 169. The Executive Commissioner charged rule development for the designation of incurable neurodegenerative diseases to DSHS.

SECTION-BY-SECTION SUMMARY

The new rule includes a definition for an incurable neurodegenerative disease.

The new rule includes a list of incurable neurodegenerative diseases eligible for prescription of low-THC cannabis pursuant to Texas Occupations Code, Chapter 169.

The new rule provides a method to expand the list to include other incurable neurodegenerative diseases.

FISCAL NOTE

Donna Sheppard, DSHS Chief Financial Officer, has determined that for each year of the first five years that the rule will be in effect, enforcing or administering the rule does not have foreseeable implications relating to costs or revenues of state or local governments.

GOVERNMENT GROWTH IMPACT STATEMENT

DSHS has determined that during the first five years that the rule will be in effect:

(1) the proposed rule will not create or eliminate a government program;

(2) implementation of the proposed rule will not affect the number of DSHS employee positions;

(3) implementation of the proposed rule will result in no assumed change in future legislative appropriations;

(4) the proposed rule will not affect fees paid to DSHS;

(5) the proposed rule will create a new rule;

(6) the proposed rule will not expand, limit, or repeal an existing rule; and

(7) the proposed rule will not change the number of individuals subject to the rule.

DSHS has insufficient information to determine the proposed rule's effect on the state's economy.

SMALL BUSINESS, MICRO-BUSINESS, AND RURAL COMMUNITY IMPACT ANALYSIS

Donna Sheppard has also determined that there will be no adverse economic effect on small businesses, micro-businesses, or rural communities, as the rule does not apply to small or micro-businesses, or rural communities. The rule does not impose any additional costs to small businesses, microbusinesses, or rural communities.

LOCAL EMPLOYMENT IMPACT

The proposed rule will not affect a local economy.

COSTS TO REGULATED PERSONS

Texas Government Code, §2001.0045 does not apply to this rule because the rule is necessary to implement H.B. 3703 that does not state that §2001.0045 applies to the rule.

PUBLIC BENEFIT AND COSTS

Dr. Manda Hall, Associate Commissioner of DSHS Community Health Improvement Division, has determined that for each year of the first five years the rule is in effect, the public benefit anticipated through this rule is the implementation of H.B. 3703, which designates incurable neurodegenerative diseases eligible for prescription of low-THC cannabis pursuant to Texas Occupations Code, Chapter 169.

Donna Sheppard has also determined that for the first five years the rule is in effect, there are no anticipated economic costs to persons who are required to comply with the proposed rule because the rule does not require any additional conduct for compliance.

TAKINGS IMPACT ASSESSMENT

DSHS has determined that the proposal does not restrict or limit an owner's right to his or her property that would otherwise exist in the absence of government action and, therefore, does not constitute a taking under Texas Government Code, §2007.043.

PUBLIC COMMENT

Questions about the content of this proposal may be directed to Raiza Ruiz at (512) 776-3829 or at HPCDPS@dshs.texas.gov in the DSHS Heath Promotion and Chronic Disease Prevention Section.

Written comments on the proposal may be submitted to Rules Coordination Office, P.O. Box 13247, Mail Code 4102, Austin, Texas 78711-3247, or street address 4900 North Lamar Boulevard, Austin, Texas 78751; or emailed to HHSRulesCoordinationOffice@hhsc.state.tx.us.

To be considered, comments must be submitted no later than 31 days after the date of this issue of the Texas Register. Comments must be: (1) postmarked or shipped before the last day of the comment period; (2) hand-delivered before 5:00 p.m. on the last working day of the comment period; or (3) emailed before midnight on the last day of the comment period. When emailing comments, please indicate "Comments on Proposed Rule 19R060" in the subject line.

STATUTORY AUTHORITY

The new section is authorized by Texas Government Code, §531.0055, which provides that the Executive Commissioner of HHSC shall adopt rules for the operation and provision of services by the health and human services agencies; and H.B. 3703, which requires the Executive Commissioner of HHSC, in consultation with the National Institutes of Health, to adopt a rule designating incurable neurodegenerative diseases eligible for prescription of low-THC cannabis pursuant to Texas Occupations Code, Chapter 169.

The new section implements Texas Occupations Code, Chapter 169.

§1.61.Incurable Neurodegenerative Diseases.

(a) An incurable neurodegenerative disease is a condition, injury, or illness:

(1) that occurs when nerve cells in the brain or peripheral nervous system lose function over time; and

(2) for which there is no known cure.

(b) A qualifying physician under Texas Occupations Code, Chapter 169, may prescribe low-THC cannabis to a patient with a documented diagnosis of one or more of the following incurable neurodegenerative diseases:

(1) Incurable Neurodegenerative Diseases with Adult Onset:

(A) Motor Neuron Disease:

(i) Amyotrophic lateral sclerosis;

(ii) Spinal-bulbar muscular atrophy; and

(iii) Spinal Muscular Atrophy.

(B) Muscular Dystrophies:

(i) Duchenne Muscular Dystrophy;

(ii) Central Core; and

(iii) Facioscapulohumeral Muscular Dystrophy.

(C) Freidrich's Ataxia.

(D) Vascular dementia.

(E) Charcot Marie Tooth and related hereditary neuropathies.

(F) Spinocerebellar ataxia.

(G) Familial Spastic Paraplegia.

(H) Progressive dystonias DYT genes 1 through 20.

(I) Progressive Choreas: Huntington's Disease.

(J) Amyloidoses:

(i) Alzheimer's Disease;

(ii) Prion Diseases:

(I) Creutzfeldt-Jakob Disease;

(II) Gerstmann-Strausller-Scheinker Disease;

(III) Familial or Sporadic Fatal Insomnia; and

(IV) Kuru.

(K) Tauopathies.

(i) Chronic Traumatic Encephalopathy:

(ii) Pick Disease;

(iii) Globular Glial Tauopathy;

(iv) Corticobasal Degeneration;

(v) Progressive Supranuclear Palsy;

(vi) Argyrophilic Grain Disease;

(vii) Neurofibrillary Tangle dementia, also known as Primary Age-related Tauopathy; and

(viii) Frontotemporal dementia and parkinsonism linked to chromosome 17 caused by mutations in MAPT gene.

(L) Synucleinopathies:

(i) Lewy Body Disorders:

(I) Dementia with Lewy Bodies; and

(II) Parkinson's Disease; and

(ii) Multiple System Atrophy.

(M) Transactive response DNA-binding protein-43 (TDP-43) Proteinopathies:

(i) Frontotemporal Lobar Degeneration;

(ii) Primary Lateral Sclerosis; and

(iii) Progressive Muscular Atrophy.

(2) Incurable Neurodegenerative Diseases with Pediatric Onset:

(A) Mitochondrial Conditions:

(i) Kearn Sayers Syndrome;

(ii) Mitochondrial Encephalopathy Ragged Red Fiber;

(iii) Mitochondrial Encephalopathy Lactic Acidosis Stroke;

(iv) Neuropathy, Ataxia, and Retinitis Pigmentosa;

(v) Mitochondrial neurogastrointestinal encephalopathy;

(vi) Polymerase G Related Disorders:

(I) Alpers-Huttenlodcher syndrome;

(II) Childhood Myocerebrohepatopathy spectrum;

(III) Myoclonic epilepsy myopathy sensory ataxia; and

(IV) Ataxia neuropathy spectrum;

(vii) Subacute necrotizing encephalopathy, also known as Leigh syndrome;

(viii) Respiratory chain disorders complex 1 through 4 defects: Co Q biosynthesis defects;

(ix) Thymidine Kinase;

(x) Mitochondrial Depletion syndromes types 1 through 14:

(I) Deoxyguanisine kinase deficiency;

(II) SUCLG1-related mitochondrial DNA depletion syndrome, encephalmyopathic form with methylmalonic aciduria; and

(III) RRM2B-related mitochondrial disease.

(B) Creatine Disorders:

(i) Guanidinoacetate methytransferase deficiency;

(ii) L-Arginine/glycine amidinotransferase deficiency; and

(iii) Creatine Transporter Defect, also known as SLC 6A8.

(C) Neurotransmitter defects:

(i) Segawa Diease, also known as Dopamine Responsive Dystonia;

(ii) Guanosine triphosphate cyclohydrolase deficiency;

(iii) Aromatic L-amino acid decarboxylase deficiency;

(iv) Monoamine oxidase deficiency;

(v) Biopterin Defects:

(I) Pyruvoyl-tetahydropterin synthase;

(I) Sepiapterin reductase;

(III) Dihydropteridine reductase; and

(IV) Pterin-4-carbinolamine dehydratase.

(D) Congenital Disorders of Glycosylation.

(E) Lysosomal Storage Diseases:

(i) Mucopolysaccaridosis:

(I) Mucopolysaccharidosis Type I, also known as Hurler Syndrome or Scheie Syndrome;

(II) Mucopolysaccharidosis Type II, also known as Hunter Syndrome;

(III) Mucopolysaccharidosis Type III, also known as Sanfilippo A and B; and

(IV) Mucopolysaccharidosis Type IV, also known as Maroteaux-Lamy; and

(V) Mucopolysaccharidosis Type VII, also known as Sly.

(ii) Oligosaccharidoses:

(I) Mannosidosis;

(II) Alpha-fucosidosis;

(III) Galactosialidosis;

(IV) Asparylglucosaminuria;

(V) Schindler; and

(VI) Sialidosis;

(iii) Mucolipidoses:

(I) Mucolipidoses Type II, also known as Inclusion Cell disease; and

(II) Mucolipidoses Type III, also known as pseudo-Hurler polydystrophy;

(iv) Sphingolipidoses:

(I) Gaucher Type 2 and Type 3;

(II) Neimann Pick Type A and B;

(III) Neimann Pick Type C;

(IV) Krabbe;

(V) GM1 gangliosidosis;

(VI) GM2 gangliosidosis also known as Tay-sachs and Sandhoff Disease;

(VII) Metachromatic leukodystrophy;

(VIII) Neuronal ceroid lipofuscinosis types 1-10 including Batten Disease;

(IX) Farber Disease; and

(v) Glycogen Storage-Lysosomal: Pompe Disease.

(F) Peroxisomal Disorders:

(i) X-linked adrenoleukodystrophy;

(ii) Peroxisomal biosynthesis defects:

(I) Zellweger syndrome:

(II) Neonatal Adrenoleukodystrophy; and

(iii) D Bidirectional enzyme deficiency.

(G) Leukodystrophy:

(i) Canavan disease;

(ii) Pelizaeus-Merzbacher disease;

(iii) Alexander disease;

(iv) Multiple Sulfatase deficiency;

(v) Polyol disorders;

(vi) Glycine encephalopathy, also known as non-ketotic hyperglycinemia;

(vii) Maple Syrup Urine Disease;

(viii) Homocysteine re-methylation defects;

(ix) Methylenetetrahydrofolate reductase deficiency severe variant;

(x) L-2-hydroxyglutaric aciduria;

(xi) Glutaric acidemia type 1;

(xii) 3-hydroxy-3-methylglutaryl-CoA lyase deficiency;

(xiii) Galactosemia;

(xiv) Manosidosis alpha and beta;

(xv) Salidosis;

(xvi) Peripheral neuropathy types 1 through 4;

(xvii) Pyruvate Dehydrogenase Deficiency;

(xviii) Pyruvate Carboxylase Deficiency;

(xix) Refsum Disease; and

(xx) Cerebral Autosomal Dominant Arteriopathy with Sub-cortical Infarcts and Leukoencephalopathy.

(H) Fatty Acid Oxidation:

(i) Trifunctional protein deficiency; and

(ii) Long-chain L-3 hydroxyacyl-CoA dehydrogenase deficiency.

(I) Metal Metabolism:

(i) Wilson Disease;

(ii) Pantothenate Kinase Associated Neurodegeneration; and

(iii) Neurodegeneration with brain iron accumulation.

(J) Purine and Pyrimidine Defects:

(i) Adenylosuccinate synthase Deficiency;

(ii) 5-aminoimidazole-4-carboxamide ribonucleotide transformylase deficiency;

(iii) Hypoxanthine-guanine phosophoribosyltransferase Deficiency also known as Lesch-Nyhan disease;

(iv) Dihydropyrimidine dehydrogenase Deficiency; and

(v) Dihydropirimidinase Deficiency.

(c) A treating physician of a patient suffering from an incurable neurodegenerative disease not listed in subsection (b) of this section may submit a request to the department to have a disease added.

(d) A request under subsection (c) of this section shall be submitted to the department on a form prescribed by the department, which can be found on the department's website at https://www.dshs.texas.gov/chronic/default.shtm.

(e) After review of the submitted documentation, the department may request additional information or make a determination.

The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.

Filed with the Office of the Secretary of State on September 13, 2019.

TRD-201903252

Barbara L. Klein

General Counsel

Department of State Health Services

Earliest possible date of adoption: October 27, 2019

For further information, please call: (512) 776-3829


PART 11. CANCER PREVENTION AND RESEARCH INSTITUTE OF TEXAS

CHAPTER 703. GRANTS FOR CANCER PREVENTION AND RESEARCH

25 TAC §703.14, §703.24

The Cancer Prevention and Research Institute of Texas ("CPRIT" or "the Institute") proposes amendments to 25 Texas Administrative Code §703.14(c) and §703.24(a) relating to the Institute's consideration and approval of a grant recipient's request to extend its grant contract and the process for a grant recipient to report and receive reimbursement for expenses the grant recipient paid prior to the current financial status reporting period.

Background and Justification

The proposed change to §703.14(c) provides a process for the Institute to review and approve a grant recipient's request to extend the grant recipient's grant contract termination date even if the grant recipient has fiscal or programmatic reports pending approval by the Institute. Currently, Texas Administrative Code §703.14 requires a grant recipient to be in "good fiscal and programmatic standing" before the Institute may approve a request to extend the contract term. (Since the approval provides only additional time to complete the grant project and does not provide any additional funds, CPRIT refers to these requests as "no cost extensions.") Grant recipients must submit regular fiscal and programmatic reports to the Institute at specified times during their grant contract. Report due dates are set in Texas Administrative Code Chapters 701-703. In some instances, the Institute may not have approved one or more fiscal or programmatic reports at the time that the grant recipient requests an extension of the grant contract. The proposed change allows the Institute to consider and approve a no cost extension request while other reports are pending approval. Approval of a no cost extension remains at the discretion of the Institute. The Institute will retain documentation of the request and approval as part of the grant record.

The proposed change to §703.24(a) clarifies the process for the Institute to consider and approve a grant recipient's reimbursement request for an otherwise allowable cost paid by the grant recipient prior to the current reporting period. The proposed change clarifies that the Institute may consider and approve reimbursement after the grant recipient provides a written explanation for failing to timely seek reimbursement during the fiscal quarter it paid the expense. The Institute will retain documentation of the request and approval as part of the grant record.

Fiscal Note

Kristen Pauling Doyle, Deputy Executive Officer and General Counsel for the Cancer Prevention and Research Institute of Texas, has determined that for the first five-year period the rule changes are in effect, there will be no foreseeable implications relating to costs or revenues for state or local government due to enforcing or administering the rules.

Public Benefit and Costs

Ms. Doyle has determined that for each year of the first five years the rule changes are in effect the public benefit anticipated due to enforcing the rule will be clarifying processes regarding extending the grant contract termination deadline and submitting requests for reimbursement of costs incurred and paid by the grant recipient.

Small Business, Micro-Business, and Rural Communities Impact Analysis

Ms. Doyle has determined that the rule changes will not affect small businesses, micro businesses, or rural communities.

Government Growth Impact Statement

The Institute, in accordance with 34 Texas Administrative Code §11.1, has determined that during the first five years that the proposed rule changes will be in effect:

(1) the proposed rule changes will not create or eliminate a government program;

(2) implementation of the proposed rule changes will not affect the number of employee positions;

(3) implementation of the proposed rule changes will not require an increase or decrease in future legislative appropriations;

(4) the proposed rule changes will not affect fees paid to the agency;

(5) the proposed rule changes will not create new rules;

(6) the proposed rule changes will not expand existing rules;

(7) the proposed rule changes will not change the number of individuals subject to the rules; and

(8) The rule changes are unlikely to have a significant impact on the state's economy. Although these changes are likely to have neutral impact on the state's economy, the Institute lacks enough data to predict the impact with certainty.

Submit written comments on the proposed rule changes to Ms. Kristen Pauling Doyle, General Counsel, Cancer Prevention and Research Institute of Texas, P.O. Box 12097, Austin, Texas 78711, no later than October 28, 2019. The Institute asks parties filing comments to indicate whether they support the rule revisions proposed by the Institute and, if a change is requested, to provide specific text proposed to be included in the rule. Comments may be submitted electronically to kdoyle@cprit.texas.gov. Comments may be submitted by facsimile transmission to (512) 475-2563.

Statutory Authority

The Institute proposes the rule changes under the authority of the Texas Health and Safety Code Annotated, §102.108, which provides the Institute with broad rule-making authority to administer the chapter. Ms. Doyle has reviewed the proposed amendments and certifies the proposal to be within the Institute's authority to adopt.

There is no other statute, article, or code affected by these rules.

§703.14.Termination, Extension, Close Out of Grant Contracts, and De-Obligation of Grant Award Funds.

(a) The termination date of a Grant Contract shall be the date stated in the Grant Contract, except:

(1) The Chief Executive Officer may elect to terminate the Grant Contract earlier because the Grant Recipient has failed to fulfill contractual obligations, including timely submission of required reports or certifications;

(2) The Institute terminates the Grant Contract because funds allocated to the Grant Award are reduced, depleted, or unavailable during the award period, and the Institute is unable to obtain additional funds for such purposes; or

(3) The Institute and the Grant Recipient mutually agree to terminate the Grant Contract earlier.

(b) If the Institute elects to terminate the Grant Contract pursuant to subsection (a)(1) or (2) of this section, then the Chief Executive Officer shall notify the Grant Recipient in writing of the intent to terminate funding at least thirty (30) days before the intended termination date. The notice shall state the reasons for termination, and the procedure and time period for seeking reconsideration of the decision to terminate. Nothing herein restricts the Institute's ability to terminate the Grant Contract immediately or to seek additional remedies if justified by the circumstances of the event leading to early termination.

(c) The Institute may approve the Grant Recipient's written request to extend the termination date of the Grant Contract to permit the Grant Recipient additional time to complete the work of the project.

(1) A no cost extension may be granted if the Grant Recipient is in good fiscal and programmatic standing. [The Institute's decision to approve or deny a no cost extension request is final.]

(A) If a Grant Recipient is not in good fiscal and programmatic standing, the Grant Recipient may petition the Chief Executive Officer in writing to consider the no cost extension. The Grant Recipient's petition must show good cause for failing to be in good fiscal and programmatic standing.

(B) Upon a finding of good cause, the Chief Executive Officer may consider the request. If a no cost extension is approved under this subsection, the Chief Executive Officer must notify the Oversight Committee in writing and provide justification for the approval.

(2) The Grant Recipient may request a no cost extension no earlier than 180 days and no later than thirty (30) days prior to the termination date of the Grant Contract.

(A) If a Grant Recipient fails to request a no cost extension within the required timeframe, the Grant Recipient may petition the Chief Executive Officer in writing to consider the no cost extension. The Grant Recipient's petition must show good cause for failing to submit the request within the timeframe specified in subsection (c) of this section.

(B) Upon a finding of good cause, the Chief Executive Officer may consider the request. If a no cost extension request is approved under this subsection, the Chief Executive Officer must notify the Oversight Committee in writing and provide justification for the approval.

(3) The Institute may approve one or more no cost extensions. The duration of each no cost extension may be no longer than six months from the termination date of the Grant Contract, unless the Institute finds that special circumstances justify authorizing additional time to complete the work of the project. If a grant recipient requests a second no cost extension or requests a no cost extension greater than six months, the grantee must provide good cause for approving the request.

(4) If the Institute approves the request to extend the termination date of the Grant Contract, then the termination date shall be amended to reflect the change.

(5) Nothing herein prohibits the Institute and the Grant Recipient from taking action more than 180 days prior to the termination date of the Grant contract to extend the termination date of the Grant Contract. Approval of an extension must be supported by a finding of good cause and the Grant Contract shall be amended to reflect the change.

(6) The Institute's decision to approve or deny a no cost extension request is final.

(d) The Grant Recipient must submit a final Financial Status Report and final Grant Progress Report as well as any other required reports as specified in the Grant Contract. For purposes of this rule, the final Grant Progress Report and other required reports shall be collectively referred to as "close out documents."

(1) The final Financial Status Report shall be submitted to the Institute within ninety (90) days of the end of the state fiscal quarter that includes the termination date of the Grant Contract. The Grant Recipient's failure to submit the Financial Status report within thirty (30) days following the due date specified in this subsection will waive reimbursement of project costs incurred during the reporting period. The Institute may approve additional time to submit the final Financial Status Report if the Grant Recipient can show good cause for failing to timely submit the final Financial Status Report.

(2) Close out documents must be submitted within ninety (90) days of the termination date of the Grant Contract. The final reimbursement payment shall not be made until all close out documents have been submitted and approved by the Institute. Failure to submit one or more close out documents within 180 days of the Grant Contract termination date shall result in the Grant Recipient being ineligible to receive new Grant Awards or continuation Grant Awards until such time that the close out documents are submitted unless the Institute waives the final submission of close out documents by the Grant Recipient.

(A) Approval of the Grant Recipient's request to waive the submission of close out documents is at the discretion of the Institute. Such approval must be granted by the Chief Executive Officer.

(B) The Oversight Committee shall be notified in writing of the Grant Recipient's waiver request and the Chief Executive Officer's decision to approve or reject the waiver request.

(C) Unless the Oversight Committee votes by a simple majority of members present and able to vote to overturn the Chief Executive Officer's decision regarding the waiver, the Chief Executive Officer's decision shall be considered final.

(e) The Institute may make upward or downward adjustments to the Allowable Costs requested by the Grant Recipient within ninety (90) days following the approval of the close out reports or the final Financial Status Report, whichever is later.

(f) Nothing herein shall affect the Institute's right to disallow costs and recover Grant Award funds on the basis of a later audit or other review or the Grant Recipient's obligation to return Grant Award funds owed as a result of a later refund, correction, or other transaction.

(g) Any Grant Award funds paid to the Grant Recipient in excess of the amount to which the Grant Recipient is finally determined to be entitled under the terms of the Grant Contract constitute a debt to the state. If not paid within a reasonable period after demand, the Institute may reduce the debt owed by:

(1) Making an administrative offset against other requests for reimbursements;

(2) Withholding advance payments otherwise due to the Grant Recipient; or

(3) Other action permitted by law.

(h) Grant Award funds approved by the Oversight Committee and specified in the Grant Contract but not spent by the Grant Recipient at the time that the Grant Contract is terminated are considered de-obligated for the purposes of calculating the maximum amount of annual Grant Awards and the total amount authorized by Section 67, Article III, Texas Constitution. Such de-obligated funds are available for all purposes authorized by the statute.

(i) If a deadline set by this rule falls on a Saturday, Sunday, or federal holiday as designated by the U.S. Office of Personnel Management, the required filing may be submitted on the next business day. The Institute will not consider a required filing delinquent if the Grant Recipient complies with this subsection.

§703.24.Financial Status Reports.

(a) The Grant Recipient [Recipients ] shall report expenditures to be reimbursed with Grant Award funds on the quarterly Financial Status Report form. The Grant Recipient must report all expenses for which it seeks reimbursement that the Grant Recipient paid during the fiscal quarter indicated on the quarterly Financial Status Report form.

(1) Expenditures shall be reported by budget category consistent with the Grant Recipient's Approved Budget.

(2) If the Grant Recipient seeks reimbursement for an expense it paid prior to the period covered by the current quarterly Financial Status Report but did not previously report to the Institute, the Grant Recipient must provide a written explanation for failing to claim the prior payment in the appropriate period.

(A) The Grant Recipient must submit the written explanation with any supporting documentation at the time that the Grant Recipient files its current Financial Status Report.

(B) The Institute shall consider the explanation and may approve reimbursement for the otherwise eligible expense. The Institute's decision whether to reimburse the expense is final.

(3) [(2)] All expenditures must be supported with appropriate documentation showing that the costs were incurred and paid. A Grant Recipient that is a public or private institution of higher education as defined by §61.003, Texas Education Code is not required to submit supporting documentation for an individual expense totaling less than $750 in the "supplies" or "other" budget categories.

(4) [(3)] The Financial Status Report and supporting documentation must be submitted via the Grant Management System, unless the Grant Recipient is specifically directed in writing by the Institute to submit or provide it in another manner.

(5) [(4)] The Institute may request in writing that a Grant Recipient provide more information or correct a deficiency in the supporting documentation for a Financial Status Report. If a Grant Recipient does not submit the requested information within 21 days after the request is submitted, the Financial Status Report will be disapproved by the Institute.

(A) Nothing herein restricts the Institute from disapproving the FSR without asking for additional information or prior to the submission of additional information.

(B) Nothing herein extends the FSR due date.

(6) [(5)] The requirement to report and timely submit quarterly Financial Status Reports applies to all Grant Recipients, regardless of whether Grant Award funds are disbursed by reimbursement or in advance of incurring costs.

(b) Quarterly Financial Status Reports shall be submitted to the Institute within ninety (90) days of the end of the state fiscal quarter (based upon a September 1 - August 31 fiscal year). The Institute shall review expenditures and supporting documents to determine whether expenses charged to the Grant Award are:

(1) Allowable, allocable, reasonable, necessary, and consistently applied regardless of the source of funds; and

(2) Adequately supported with documentation such as cost reports, receipts, third party invoices for expenses, or payroll information.

(c) A Grant Award with a Grant Contract effective date within the last quarter of a state fiscal year (June 1 - August 31) will have an initial financial reporting period beginning September 1 of the following state fiscal year.

(1) A Grant Recipient that incurs Authorized Expenses after the Grant Contract effective date but before the beginning of the next state fiscal year may request reimbursement for those Authorized Expenses.

(2) The Authorized Expenses described in paragraph (1) of this subsection must be reported in the Financial Status Report reflecting Authorized Expenses for the initial financial reporting period beginning September 1.

(d) Except as provided herein, the Grant Recipient waives the right to reimbursement of project costs incurred during the reporting period if the Financial Status Report for that quarter is not submitted to the Institute within thirty (30) days of the Financial Status Report due date. Waiver of reimbursement of project costs incurred during the reporting period also applies to Grant Recipients that have received advancement of Grant Award funds.

(1) For purposes of this rule, the "Financial Status Report due date" is ninety (90) days following the end of the state fiscal quarter.

(2) The Chief Executive Officer may approve a Grant Recipient's request to defer submission of the reimbursement request for the current fiscal quarter until the next fiscal quarter if, on or before the original Financial Status Report due date, the Grant Recipient submits a written explanation for the Grant Recipient's inability to complete a timely submission of the Financial Status Report.

(3) A Grant Recipient may appeal the waiver of its right to reimbursement of project costs.

(A) The appeal shall be in writing, provide good cause for failing to submit the Financial Status Report within thirty (30) days of the Financial Status Report due date, and be submitted via the Grant Management System.

(B) The Chief Executive Officer may approve the appeal for good cause. The decision by the Chief Executive Officer to approve or deny the grant recipient's appeal shall be in writing and available to the Grant Recipient via the Grant Management System.

(C) The Chief Executive Officer's decision to approve or deny the Grant Recipient's appeal is final, unless the Grant Recipient timely seeks reconsideration of the Chief Executive Officer's decision by the Oversight Committee.

(D) The Grant Recipient may request that the Oversight Committee reconsider the Chief Executive Officer's decision regarding the Grant Recipient's appeal. The request for reconsideration shall be in writing and submitted to the Chief Executive Officer within 10 days of the date that the Chief Executive Officer notifies the Grant Recipient of the decision regarding the appeal as noted in subparagraph (C) of this paragraph.

(E) The Chief Executive Officer shall notify the Oversight Committee in writing of the decision to approve or deny the Grant Recipient's appeal. The notice should provide justification for the Chief Executive Officer's decision. In the event that the Grant Recipient timely seeks reconsideration of the Chief Executive Officer's decision, the Chief Executive Officer shall provide the Grant Recipient's written request to the Oversight Committee at the same time.

(F) The Grant Recipient's request for reconsideration is deemed denied unless three or more Oversight Committee members request that the Chief Executive Officer add the Grant Recipient's request for reconsideration to the agenda for action at the next regular Oversight Committee meeting. The decision made by the Oversight Committee is final.

(G) If the Grant Recipient's appeal is approved by the Chief Executive Officer or the Oversight Committee, the Grant Recipient shall report the project costs and provide supporting documentation for the costs incurred during the reporting period covered by the appeal on the next available financial status report to be filed by the Grant Recipient.

(H) Approval of the waiver appeal does not connote approval of the expenditures; the expenditures and supporting documentation shall be reviewed according to subsection (b) of this section.

(I) This subsection applies to any waivers of the Grant Recipient's reimbursement decided by the Institute on or after September 1, 2015.

(4) Notwithstanding subsection (c) of this section, in the event that the Grant Recipient and Institute execute the Grant Contract after the effective date of the Grant Contract, the Chief Program Officer may approve additional time for the Grant Recipient to prepare and submit the outstanding Financial Status Report(s). The approval shall be in writing and maintained in the Grants Management System. The Chief Program Officer's approval may cover more than one Financial Status Report and more than one fiscal quarter.

(5) In order to receive disbursement of grant funds, the most recently due Financial Status Report must be approved by the Institute.

(e) If a deadline set by this rule falls on a Saturday, Sunday, or federal holiday as designated by the U.S. Office of Personnel Management, the required filing may be submitted on the next business day. The Institute will not consider a required filing delinquent if the Grant Recipient complies with this subsection.

The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.

Filed with the Office of the Secretary of State on September 12, 2019.

TRD-201903224

Heidi McConnell

Chief Operating Officer

Cancer Prevention and Research Institute of Texas

Earliest possible date of adoption: October 27, 2019

For further information, please call: (512) 305-8487