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Home My WebLink About20122741.tiff RESOLUTION RE: APPROVE TASK ORDER CONTRACT FOR FAMILY SMOKING PREVENTION AND TOBACCO CONTROL ACT AND AUTHORIZE CHAIR TO SIGN WHEREAS, the Board of County Commissioners of Weld County, Colorado, pursuant to Colorado statute and the Weld County Home Rule Charter, is vested with the authority of administering the affairs of Weld County, Colorado, and WHEREAS, the Board has been presented with a Task Order Contract for the Family Smoking Prevention and Tobacco Control Act between the County of Weld, State of Colorado, by and through the Board of County Commissioners of Weld County, on behalf of the Department of Public Health and Environment, and the Colorado Department of Public Health and Environment, commencing September 30, 2012, and ending September 29, 2013, with further terms and conditions being as stated in said Task Order Contract, and WHEREAS, after review, the Board deems it advisable to approve said Task Order Contract, a copy of which is attached hereto and incorporated herein by reference. NOW, THEREFORE, BE IT RESOLVED by the Board of County Commissioners of Weld County, Colorado, that the Task Order Contract for the Family Smoking Prevention and Tobacco Control Act between the County of Weld, State of Colorado, by and through the Board of County Commissioners of Weld County, on behalf of the Department of Public Health and Environment, and the Colorado Department of Public Health and Environment, be and hereby is, approved. BE IT FURTHER RESOLVED by the Board that the Chair be, and hereby is, authorized to sign said Task Order Contract. The above and foregoing Resolution was, on motion duly made and seconded, adopted by the following vote on the 1st day of October, A.D., 2012. BOARD OF COUNTY COMMISSIONERS WELD COUNTY, COLORADO ATTEST: j .��°r�� O Sean P. o Chair Weld County Clerk to the Board dllam F. Garcia, Pro-Tem Deputy Cler o the Bo 1-arbara Kirkmeyer APP VEDAS 17 EXCUSED David E. Long twi4' w ounty ttorney ,c U11ce K ugla ademach Date of signature: /�� i2 1-/Z- 2012-2741 /b " -/0? HL0039 Memorandum 6(ft\ ,(4f-- TO: Sean Conway, Chair Board of County Commissioners FROM: Mark E. Wallace, MD, MPH, Director O Department of Public Health and Environment COLORADO• DATE: August 20, 2012 SUBJECT: Tobacco FDA— 13 FLA 48015 — Task Order Contract - Waiver#154 Enclosed for Board review and approval is the Tobacco FDA Task Order Contract— Waiver #154 between the Colorado Department of Public Health and Environment and the Weld County Board of Commissioners for the use and benefit of the Department of Public Health and Environment(WCDPHE) to continue the FDA Enforcement of Family Smoking Prevention and Tobacco Control project. The task order contract is for continuation funding in the amount of $98,389 for the twelve-month period September 30, 2012 through September 29, 2013. This budget reflects an annualized flat budget from our previous grant cycle. This funding will cover two Community Inspector positions (1 FTE total), contracting with minor youth in the region to assist with youth access compliance checks, and related expenses (e.g., mileage and meals for field travel, supplies, etc.). The scope of work for this contract is to actively enforce provisions of the Family Smoking Prevention and Tobacco Control Act in the northeast region for compliance with the sale to minor provisions of FSPTC Act and for advertising and labeling restrictions. Inspectors will conduct a minimum of 300 inspections in identified region(s) on the FDA Tobacco Retailer Inspection Map or as directed by CDPHE for compliance with the law. All data will be secured and sent through mobile devices provided by the FDA. I recommend your approval of this contract. Enclosure 2012-2741 DEPARTMENT OF PURI.IC I ILAI:FH AND ENV1RONNtEN'I' ROUTING NO.13 FLA 48015 APPROVED TASK ORDER CONTRACT-WAIVER#154 This Task Order Contract is issued pursuant to Master Contract made on 01/17/2012,with routing number 13 FAA 00051 UONIRAC!OR: State of Colorado for the use&benefit of the Board of County Commissioners of Weld Department of Public I lealth and County (a political subdivision of the state of Environment Colorado) PSD—FDA-STEPP 915 10th Street 4300 Cherry Creek Drive South Greeley,Colorado 80632-0758 Denver, Colorado 80246 for the use and benefit of the Weld County Department of Public Health and Environment 1555 17th Avenue Greeley,Colorado 80631 TASK ORDER MADE D:AI : CONTRACTOR[NTH Y TYPE: August 15,2012 Colorado Political Subdivision PO/SC ENCUMBRANCE NUNI0ER PO FLA PPG1348015 TERM: BILLING STATEMENTS RECEIVED_ This"Task Order shall be effective upon Monthly approval by the State Controller,or designee, or on 09/30/2012,whichever is later. The STATUTORY AIIHORIFY- 'Cask Order shall end on 09/29/2013. Not Applicable PRICE SIRLCI USE CON I RACI PRICE NOT IOEXCEED, Cost Reimbursement $98,389.00 PROCI:REMENT Mlnvoll FIIDII2VUPENDING DOLT ARS: $98,389.00 Exempt STATE f It NDING DOI I.ARS: $0 BID/REI'/I.ISI PRICE AUREEMI:N I NLMtIER: MAXIMEM AMOUNT AVAILABLE PER FISCAL YEAR: Not Applicable FY 13: $73,792.00 FY 14: $24,597.00 IAW SPECIFIM VENDOR STA fC T lip. Not Applicable STATE RE PRI.SINTAII VEL CON IRA(:FOR REPRISE NFA FIVE: Celeste Schoenthaler Mark Wallace Department of Public Health and Weld County Depatttnent of Public Health Environment and Environment PSD—FDA—STEPP—A-5 1555 17th Avenue 4300 Cherry Creek Drive South Greeley, Colorado 80631 Denver,CO 80246 SCOPE O1-AI ORK: Perform work for the project Enforcement of Family Smoking Prevention and Tobacco Control Act. PXI MILTS Page 1 of 6 Rev 6/25/09 The following exhibits are hereby incorporated: Exhibit A- Additional Provisions (and its attachments if any—e.g.,A-1,A-2,etc.) Exhibit B- Statement of Work(and its attachments if any—e.g.,B-1, B-2,etc.) Exhibit C- Budget (and its attachments if any—e.g., C-1,C-2,etc.) GENERAL PROVISIONS The following clauses apply to this Task Order Contract. These general clauses may have been expanded upon or made more specific in some instances in exhibits to this Task Order Contract. To the extent that other provisions of this task Order Contract provide more specificity than these general clauses,the more specific provision shall control. I. This Task Order Contract is being entered into pursuant to the terms and conditions of the Master Contract including,but not limited to, Exhibit One thereto. The total term of this Task Order Contract, including any renewals or extensions, may not exceed five(5)years. The parties intend and agree that all work shall be performed according to the standards,terms and conditions set forth in the Master Contract. 2. In accordance with section 24-30-202(I),C.R.S.,as amended,this Task Order Contract is not valid until it has been approved by the State Controller,or an authorized delegee thereof. The Contractor is not authorized to,and shall not;commence performance under this Task Order Contract until this Task Order Contract has been approved by the State Controller or delegee. The State shall have no financial obligation to the Contractor whatsoever for any work or services or,any costs or expenses, incurred by the Contractor prior to the effective date of this Task Order Contract. If the State Controller approves this Task Order Contract on or before its proposed effective date,then the Contractor shall commence performance under this Task Order Contract on the proposed effective date. If the State Controller approves this Task Order Contract after its proposed effective date, then the Contractor shall only commence performance under this Task Order Contract on that later date. The initial term of this Task Order Contract shall continue through and including the date specified on page one of this Task Order Contract, unless sooner terminated by the parties pursuant to the terms and conditions of this Task Order Contract and/or the Master Contract. Contractor's commencement of performance under this Task Order Contract shall be deemed acceptance of the terms and conditions of this Task Order Contract. 3. The Master Contract and its exhibits and/or attachments are incorporated herein by this reference and made a part hereof as if fully set forth herein. Unless otherwise stated,all exhibits and/or attachments to this Task Order Contract are incorporated herein and made a part of this Task Order Contract. Unless otherwise stated, the terms of this Task Order Contract shall control over any conflicting terms in any of its exhibits. In the event of conflicts or inconsistencies between the Master Contract and this Task Order Contract(including its exhibits and/or attachments),or between this Task Order Contract and its exhibits and/or attachments,such conflicts or inconsistencies shall be resolved by reference to the documents in the following order of priority: 1)the Page 2 of 6 Rev 6/25/09 Special Provisions of the Master Contract;2)the Master Contract(other than the Special Provisions)and its exhibits and attachments in the order specified in the Master Contract;3)this Task Order Contract;4)the Additional Provisions-Exhibit A,and its attachments if included,to this Task Order Contract;5) the Scope/Statement of Work-Exhibit B,and its attachments if included,to this Task Order Contract;6)other exhibits/attachments to this Task Order Contract in their order of appearance. 4. The Contractor, in accordance with the terms and conditions of the Master Contract and this Task Order Contract,shall perform and complete, in a timely and satisfactory manner,all work items described in the Statement of Work and Budget,which are incorporated herein by this reference,made a part hereof and attached hereto as"Exhibit B"and"Exhibit C". 5. The State,with the concurrence of the Contractor,may,among other things,prospectively renew or extend the term of this Task Order Contract, subject to the limitations set forth in the Master Contract, increase or decrease the amount payable under this Task Order Contract,or add to,delete from,and/or modify this Task Order Contract's Statement of Work through a contract amendment. To be effective,the amendment must be signed by the State and the Contractor,and be approved by the State Controller or an authorized delegate thereof. This contract is subject to such modifications as may be required by changes in Federal or State law,or their implementing regulations. Any such required modification shall automatically be incorporated into and be part of this Task Order Contract on the effective date of such change as if fully set forth herein. 6. The conditions, provisions,and terms of any RFP attached hereto, if applicable,establish the minimum standards of performance that the Contractor must meet under this Task Order Contract. If the Contractor's Proposal,if attached hereto,or any attachments or exhibits thereto,or the Scope/Statement of Work- Exhibit B,establishes or creates standards of performance greater than those set forth in the RFP,then the Contractor shall also meet those standards of performance under this Task Order Contract. 7. STATEWIDE CONTRACT MANAGEMENT SYSTEM/This section shall apply when the Effective Date is on or after July 1. 2009 and the maximum amount payable to Contractor hereunder is$100,000 or higher/ By entering into this Task Order Contract,Contractor agrees to be governed,and to abide,by the provisions of CRS §24-102-205, §24-102-206, §24-103-601, §24-103.5-10I and §24-105-102 concerning the monitoring of vendor performance on state contracts and inclusion of contract performance information in a statewide contract management system. Contractor's performance shall be evaluated in accordance with the terms and conditions of this Task Order Contract, State law,including CRS §24-103.5-I0I,and State Fiscal Rules, Policies and Guidance. Evaluation of Contractor's performance shall be part of the normal contract administration process and Contractor's performance will be systematically recorded in the statewide Contract Management System. Areas of review shall include,but shall not be limited to quality,cost and timeliness.Collection of information relevant to the performance of Contractor's obligations under this Task Order Contract shall be determined by the specific requirements of such obligations and shall include factors tailored to match the requirements of the Statement of Project of this Task Order Contract. Such performance information shall be entered into the statewide Contract Management System at intervals established in the Statement of Project and a final review and rating shall be rendered within 30 days of the end of the Task Order Contract term.Contractor shall be notified following each performance and shall address or correct any identified problem in a timely manner and maintain work progress. Should the final performance evaluation determine that Contractor demonstrated a gross failure to meet the performance measures established under the Statement of Project,the Executive Director of the Colorado Department of Personnel and Administration(Executive Director), upon request by the Colorado Department of Public Health and Environment and showing of good cause, may debar Contractor and Page 3 of 6 Rev 6/25/09 prohibit Contractor from bidding on future contracts.Contractor may contest the final evaluation and result by:(i)filing rebuttal statements,which may result in either removal or correction of the evaluation(CRS §24-105-102(6)),or(ii) under CRS §24-105-102(6),exercising the debarment protest and appeal rights provided in CRS §§24-109-106, 107,201 or 202,which may result in the reversal of the debarment and reinstatement of Contractor,by the Executive Director,upon showing of good cause. 8. If this Contract involves federal funds or compliance is otherwise federally mandated,the Contractor and its agent(s)shall at all times during the term of this contract strictly adhere to all applicable federal laws, state laws, Executive Orders and implementing regulations as they currently exist and may hereafter be amended. Without limitation,these federal laws and regulations include the Federal Funding Accountability and Transparency Act of 2006(Public Law 109-282),as amended by §6062 of Public Law 110-252,including without limitation all data reporting requirements required there under. This Act is also referred to as FFATA. Page 4 of 6 Rev 6/25/09 THE PARTIES HERETO HAVE EXECUTED THIS CONTRACT * Persons signing for Contractor hereby swear and affirm that they are authorized to act on Contractor's behalf and acknowledge that the State is relying on their representations to that effect. CONTRACTOR: STATE OF COLORADO: BOARD OF COUNTY COMMISSIONERS John W. Hickenlooper, GOVERNOR OF WELD COUNTY (a political subdivision of the state of Colorado) for the use and benefit of the WELD COUNTY DEPARTMENT OF PUBLIC HEALTH AND ENVIRONMENT , lli X0/ Fur Executive Director Department of Public llealth and Environment Signature of Authorized Officer OCT 0 Sean P. Conway _ Print Name of Authorized Officer Depart ent Program Approval: Chair Br Print Title of Authorized Officer ALL CONTRACTS MUST BE APPROVED BY THE STATE CONTROLLER CRS§24-30-202 requires the State Controller to approve all State Contracts.This Contract is not valid until signed and dated below by the State Controller or delegate.Contractor is not authorized to begin performance until such time. If Contractor begins performing prior thereto,the State of Colorado is not obligated to pay Contractor for such performance or for any goods and/or services provided hereunder. STATE CONTROLLER: David J.McDermott,CPA BYE\ C 3/ Date /D ye-/z- Page 5 of 6 Rev 6/25/09 This page left intentionally blank. Page 6 of 6 Rev 6/25/09 EXHIBIT A ADDITIONAL PROVISIONS To Task Order Contract Dated 08/15/2012-Contract Routing Number 13 FLA 48015 These provisions are to be read and interpreted in conjunction with the provisions of the Task Order Contract specified above. The list of acronyms attached hereto as Attachment A-I may be referenced to in Exhibit A, Exhibit B, and all and any attachments thereof in this Task Order Contract. 2. This Task Order Contract contains federal funds. 3. The United State Department of Health&Human Services(`USHHS"),through the Food and Drug Administration("FDA")has awarded federal funds under Contract HHSE22320111009C to perform the following—Inspection of Tobacco Retailers. 4. Notwithstanding the terms contained in General Provisions of the Master Contract,Section 27,Annual Audit,for the purpose of this Task Order,the Contractor is a Vendor as defined by Office of Management and Budget(OMB)Circular A-133 (Audits of States, Local Governments,and Non-Profit Organizations). 5. Notwithstanding the terms contained in General Provisions of the Master Contract,Section 25, Conformance with Law,Contractor shall comply with all applicable requirements of the following for Contractor's respective entity type: a. 2 Code of Federal Regulations(CFR) Part 215, Uniform Administration Requirements for Grants and Agreements with Institutions of Higher Education. Hospitals, and Other Non-Profit Organizations, formerly known as OMB Circular A-I 10; b. OMB Circular A-I02,Grants and Cooperative Agreements with State and Local Governments; c. 2 C.F.R. 230, Cost Principles for Nonprofit Organizations,formerly known as OMB Circular A- 122; d. 2 C.F.R. 225,Cost Principles for State, Local, and Indian Tribal Governments,formerly known as OMB Circular A-87; e. 2 C.F.R.220,Cost PrinciplesJor Educational Institutions, formerly known as OMB Circular A- 21; f. OMB Circular A-I 33,Audits of States. Local Governments, and Non-profit Organizations 6. To receive compensation under this Task Order Contract,the Contractor shall submit a signed monthly Invoice/Cost Reimbursement Statement in a format acceptable to the State. An Invoice/Cost Reimbursement Statement must be submitted within sixty(60)calendar days of the end of the billing period for which services were rendered. Expenditures shall be in accordance with Federal Clauses of Contract HHSF223201/1009C,attached hereto as Attachment A-2, Statement of Work attached hereto as Exhibit B and incorporated herein and in accordance with the work requirements outlined. These items may include,but are not limited to,the Contractor's salaries, fringe benefits,supplies,travel,operating, indirect costs which are allowable,and other allocable expenses related to its performance under this Task Order Contract. Invoice/Cost Reimbursement Statements shall: I)reference this Task Order Contract by its contract routing number,which number is located on page one of this Task Order Contract;2) state the applicable performance dates; 3)state the names of payees;4) include a brief description of the services performed To be attached to CDPHE Page I of 4 Revised: 12/19/06 Task Order v1.0(3/12)contract template EXHIBIT A during the relevant performance dates; 5)describe the incurred expenditures if reimbursement is allowed and requested;and,6)show the total requested payment. Payment during the initial,and any renewal or extension,term of this Task Order Contract shall be conditioned upon affirmation by the State that all services were rendered by the Contractor in accordance with the terms of this Task Order Contract. Invoice/Cost Reimbursement Statements shall be sent to: Colorado Department of Public Health and Environment Accounting/Grants Unit PSD-STEPP-FDA-A5 4300 Cherry Creek Drive South Denver, CO 80246 To be considered for payment, billings for payments pursuant to this Task Order Contract must be received within a reasonable time after the period for which payment is requested,but in no event no later than sixty (60)calendar days after the relevant performance period has passed. Final billings under this Task Order Contract must be received by the State within a reasonable time after the expiration or termination of this Task Order Contract;but in no event no later than sixty(60)calendar days from the effective expiration or termination date of this Task Order Contract. Unless otherwise provided for in this Task Order Contract,"Local Match", if any,shall be included on all billing statements as required by the funding source. The Contractor shall not use federal funds to satisfy federal cost sharing and matching requirements unless approved in writing by the appropriate federal agency. 7. Time Limit For Acceptance Of Deliverables. a. Evaluation Period. The State shall have thirty(30)calendar days from the date a deliverable is delivered to the State by the Contractor to evaluate that deliverable,except for those deliverables that have a different time negotiated by the State and the Contractor. b. Notice of Defect. If the State believes in good faith that a deliverable fails to meet the design specifications for that particular deliverable,or is otherwise deficient,then the State shall notify the Contractor of the failure or deficiencies, in writing, within thirty(30)calendar days of: 1)the date the deliverable is delivered to the State by the Contractor if the State is aware of the failure or deficiency at the time of delivery;or 2)the date the State becomes aware of the failure or deficiency. The above time frame shall apply to all deliverables except for those deliverables that have a different time negotiated by the State and the Contractor in writing pursuant to the State's fiscal rules. c. Time to Correct Defect. Upon receipt of timely written notice of an objection to a completed deliverable,the Contractor shall have a reasonable period of time,not to exceed ten(10)calendar days,to correct the noted deficiencies. If the Contractor fails to correct such deficiencies within ten(10)calendar days,the Contractor shall be in default of its obligations under this Task Order Contract and the State,at its option,may elect to terminate this Task Order Contract or the Master Contract and all Task Order Contracts entered into pursuant to the Master Contract. 8. Health Insurance Portability and Accountability Act(HIPAA) Business Associate Determination. The State has determined that this Task Order Contract does not constitute a Business Associate relationship under HIPAA. 9. Contractor must notify the State within thirty(30)days of a change of the Project Director or Principal Investigator responsible for the performance of services provided under this Task Order Contract. To be attached to CDPHE Page 2 of 4 Revised: 12/19/06 Task Order v 1.0(3/12)contract template EXHIBIT A 10. Contractor shall request prior approval in writing from the State for all modifications to the Statement of Work/Work Plan or for any modification to the Budget in excess of ten percent(10%)of the total budget. Any request for modifications to the Budget in excess of thirty percent(30%)of the total budget or $1,000,000.00,whichever is less, shall be submitted to the State by February 28,2013 and may require an amendment in accordance with Section 5 of this Task Order Contract. Requests for modifications to the Statement of Work/Work Plan may require an amendment regardless of dollar amount. 11. Notwithstanding the terms contained in General Provisions of the Master Contract, Section 9, Rights in Data, Documents and Computer Software or Other Intellectual Property, unless otherwise provided for, all data collected or produced or derived exclusively from the Contractor's or subcontractor's work under this Task Order Contract shall remain the sole property of the State,whether in individual,aggregate, identified or de-identified form or any other form required by the State. To facilitate follow-up,research,surveillance and evaluation,any such data collected, used or acquired shall be made available in any form required by the State,to the State and any other entity designated by the State. Any such data collected, used or acquired shall be used solely for the purposes of this Task Order Contract. The Contractor and its subcontractors agree not to release,divulge,publish,transfer,sell,or otherwise make known any such data to unauthorized persons without the express prior written consent of the State or as otherwise required by law.This includes a prior written request by the Contractor to the State for submission of abstracts or reports to conferences,which utilize data collected under this Task Order Contract. Notwithstanding the foregoing,the Contractor shall be entitled to retain a set of any such data collected or work papers necessary to perform its duties under this Task Order Contract and in accordance with professional standards. I2. Notwithstanding the terms contained in General Provisions of the Master Contract,Section 9,Rights in Data, Documents and Computer Software or Other Intellectual Property,or Section 23.i,General Provisions, Media or Public Announcements,the State of Colorado,specifically the Department of Public Health and Environment,shall be the owner of all printed materials,graphic representations,educational materials,audio-visual products,or any other media, in whatever form,created under this Task Order Contract.This requirement applies,but is not limited to,any brochure, flyer,presentation,billboard,radio spot,website,banner advertisement. The State reserves the right to require logos,or other wording on any material,representation,product or other media form created under this Task Order Contract. Any material, representation,product or other media form that will use the State's or logo or information must be approved by the State prior to production and distribution. A minimum of ten(10) business days is required for the review and approval process. 13. Funds provided under this Task Order Contract may not be used to: supplant funding for any existing programs/models;develop new cessation programs/models; develop curricula for youth or adults not reviewed and approved by the State pay for individual cessation aids or nicotine replacement therapy;fund capital improvements;or fund costs of enforcement of state or local laws and ordinances. 14. Notwithstanding the terms contained in the General Provisions of the Master Contract, Section 25, Conformance with Law,the Contractor shall comply with the provisions of Section 601 of Title VI of the Civil Rights Act of 1964,as amended,which states that"no person in the United States shall on the grounds of race,color or national origin,be excluded from participation in,be denied the benefits of,or be To be attached to CDPHE Page 3 of 4 Revised: 12/19/06 Task Order vl.0(3/12)contract template EXHIBIT A subjected to discrimination under any program actively receiving Federal financial assistance." The Office for Civil Rights has established that it is the responsibility of any program that is a recipient of federal funds to ensure that any Limited English Proficient(LEP)person or beneficiary have meaningful access to programs,services and information. The Contractor and contract personnel shall adopt and implement policies and procedures in which reasonable steps are taken to provide language assistance in order to ensure equal access to LEP persons or beneficiaries. The Contractor and contract personnel shall advise LEP individuals that language assistance will be provided at no cost to the LEP person or beneficiary. 15. The Contractor affirms that it maintains no affiliations or contractual relationships,direct or indirect, with tobacco companies,owners,affiliate,subsidiaries,holding companies or companies involved in any way in the production,processing,distribution,promotion, sales,or use of tobacco. 16. Notwithstanding anything in this Task Order to the contrary,the parties understand and agree that all terms and conditions of this Task Order which may require continued performance,compliance,or effect beyond the termination date of this Task Order and shall survive such termination date and shall be enforceable by the State as provided herein in the event of failure to perform or comply by the Contractor. 17. Contractor shall comply with Enforcement Guidelines and Federal Clauses of Contract HHSF22320/1/009C incorporated herein by this reference,made a part hereof,and attached hereto as Attachment A-2. I8. Travel and per diem costs shall be reimbursed according to the State of Colorado Fiscal Rules and Federal Contract HI-SF22320/1/009G. 19. Any supplies purchased by CDPHE for use by Contractor,such as but not limited to,notebook computers and portable printers shall be returned to CDPHE within 30 days of the end of this Task Order Contract. To be attached to CDPHE Page 4 of 4 Revised: 12/19/06 Task Order vl.0(3/12)contract template Attachment A-I Commonly Used Acronyms and Abbreviations That May Be Referenced In the Scope of Work: ACS American Cancer Society ACNS Alamosa County Nursing Service ACF Administration for Children and Families ADA Americans with Disabilities Act ADAD Alcohol and Drug Abuse Division AIIA American Heart Association AIDS Acquired Immune Deficiency Syndrome ALA American Lung Association ALA(C) American Lung Association(of Colorado) AMCHP Association of Maternal Child Health Programs ANR Americans fur Non-Smokers' Rights ARC Addiction Recovery Centers ARRA American Recovery and Reinvestment Act ASC Adams State College ASSIST American Stop Smoking Intervention Study ASTHO Association of State and Territorial Health Office B&G Boys&Girls BACCHUS BACCIlUS Peer Education Network BAG Build a Generation BBLIIC Boulder Broomfield Latino Health Coalition BC Boulder County BCCP Breast and Cervical Cancer Program BCHD Bent County I lealth Dept BCPH Boulder County Public Health BCPHA Baca County Public Health Agency BCDSS Baca County Dept Social Services BCTEPP Bent County Tobacco Education Prevention Partnership BGC Boys&Girls Club BGCMD Boys&Girls of Metro Denver BHS Broomfield High School BMTF Baby&Me Tobacco Free BOCES Board of Cooperative Educational Services BOB Board of Health BRFSS Behavioral Risk Factor Surveillance System BVBAG Buena Vista Build a Generation BVSD Boulder Valley School District Bx Biopsy C Choice CAD Coronary Artery Disease CASB Colorado Association of School Board CB Community-based System CBE Clinical Breast Exam CBO Community-based Organization CC Clear Creek CC Custer County CC Community Coordination/Coordinator CCAP Latimer County Child Care Assistance Program CCC Colorado Cancer Coalition CCCHE Colorado Community Coalition for health Equity CCGC Colorado Clinical Guidelines Collaborative CCIAA Colorado Clean Indoor Air Act CCMC Colorado Clinical Managed Care Network CCMC Commission for Case Manager Certification CCPD Cancer.Cardiovascular,and Pulmonary Disease Page 1 of 6 Attachment A-I CCTCI Colorado Chew Tobacco Collaborative Initiative CCTEPP Custer County Tobacco Education Prevention Partnership CDC Centers for Disease Control and Prevention CDE Colorado Department of Education CDPHE Colorado Department of Public Health and Environment CDU Chronic Disease Unit CEC Career Education Center CEO Chief Executive Officer CFDA Catalog of Federal Domestic Assistance CFFC Colorado Foundation for Families and Children CFPI Colorado Family Planning Initiative CHIN Community Health Information Network CICP Colorado Indigent Care Program CID Colorado Judicial Department CM Case Management CMC Colorado Mountain College CMS Contract Management System CMS Creative Media Solutions CNCC Colorado Northwestern Community College CNS County Nursing Service CO Colorado COD Colorado Donated Dental Services Program COPAN Colorado Physical Activity and Nutrition Program COV Colorado Van Program CPCF Colorado Parent and Child Foundation CPI IA Colorado Public Health Association CPT Current Procedural Technology CRCCP Colorectal Cancer Screening Program CRUE Culturally Responsive Urban Education CSAP Colorado Student Assessment Program CSH Coordinated School Health CSU Colorado State University CSU-P Colorado State University-Pueblo's CTC Connect to Care CTEPA Colorado Tobacco Education and Prevention Alliance CTFK Campaign for Tobacco-Free Kids CTRP Colorado Tobacco Research Program CTP Crossroads Turning Point CU tniversity of Colorado,Boulder CWCCI Colorado Women's Cancer Control Initiative CY Contract Year DAISI Denver At-home Intervention Service Initiative DASH Division of Adolescent&School I lealth (CDC) DCMI I Delta County Memorial Hospital DH Denver Health DHHA Denver Health and Hospital Authority DHS Department of Human Services DHHS Unites States Department of Health and Human Services DOR Department of Revenue DOS Delta Opportunity School DSS Department of Social Services E&l Education and Information LAP Employee Assistance Program EBHV Evidence-Based Home Visiting to Prevent Child Maltreatment Grant Program ECC Early childhood council ECC Electrocardiogram ECCLC Early Childhood Council of Latimer County ECI.C Early Childhood Leadership Council/Commission Page 2 of6 Attachment A-1 E.D. Executive Director EHS Early Head Start EMR Electronic Medical Record EMT Emergency Medical Technicians EPA Environmental Protection Agency EPE Epidemiology Planning and Evaluation ESL English as a Second Language ETS Environmental Tobacco Smoke(a.k.a.secondhand smoke) FIRC Family and Intercultural Resource Center FICA The Federal Insurance Contribution Act FDA Food and Drug Administration PNA Final Needle Aspiration FPP Family Planning Program FPL Federal Poverty Level FRCC Front Range Community College FTE Full Time Equivalent LIP File Transfer Protocol FY Fiscal Year FYI Family Youth Initiatives GASO Great American Smoke-out GED General Education Development GASP CO Group to Alleviate Smoking Pollution of Colorado Get R!EAL(GR) Resist!Expose Advertising Lies(Youth Empowerment Program) GI HT Gay.Lesbian,Bisexual,and Transgender GYN Gynecological HCP Health Care Program Fur Children with Special Needs HCYS Huerfano County Youth Services HHS Health and I finnan Services HIPPA Health Insurance Portability and Accountability Act of 1996 HIPPY Home Instruction for Parents of Preschool Youngster HIT Health Improvement Team HIV Human Immunodeficiency Virus HPV Human Papillomamavirus HR Human Resources hr hour I IRSA Health Resources and Services Administration HSL High School Leadership ID Identification IIK Invest in Kids ISHT Interagency School Ilealth Team IT Information Technology JAC Juvenile Assessment Center KIS Keeping in STEPP KMH Keefe Memorial Hospital KPC Kevin Patrick Caleum LAHCDHD Las Animas Huerfano Counties District Health Department LBW Low Birth Weight LC Learning Community I.GBT Lesbian.Gay.Bisexual,Transgender LEM I,atinas en Movimiento LHA Local Health Agency LIID Local Health Department LLC Limited Liability Company LRCC Latino Regional Community Coalition LRPC Latino a Research and Policy Center LST Life Skills Training LSTPEN Latino Statewide Tobacco Prevention and Education Netw I,WB Live Well Broomfield Page 3 of 6 Attachment A-1 MCHA Montezuma Housing Authority MCHD Montezuma County Health Department MCIIS Montezuma-Cortez High School MCPN Metro Community Provider Network MCRC Media Campaign Resource Center—CDC MD Medical Doctor MHCBBC Mental Health Center Serving Boulder and Broomfield Counties MIECHV Maternal,Infant and Early Childhood Home Visiting Program MO Month MOB Medical Office Building MOIJ Memorandum of Understanding MPA Master of Public Administration in Health and I luman Services MPH Master of Public Health MRI Magnetic Resonance Imaging Scan MS Master of Science MSA Master Settlement Agreement MUFF Multi-user Housing MYAT Multi-Disciplinary Youth Assessment Team N/A Not Applicable NACCHO National Association of County and City Health Officials NACR Native American Cancer Research NAQC North American Quitline Consortium NASHE National Association of State Hoard of Education NCHD Northeast Colorado Health Department NCI National Cancer Institute NE North East NFP Nurse-Family Partnership NFPNSO Nurse-Family Partnership National Service Office NIIVP Nurse Home Visitor Program NIDA National Institute on Drug Abuse NII I National Institute of Health NJH National Jewish Medical and Research Center N-O-f Not-on-Tobacco,(ALA's Youth Smoking Cessation Program) NP Nurse Practitioner NPP Nurturing Parenting Program NR Nicotine Replacement Therapy NSBA National School Boards Association OSH Office on Smoking or I Iealth (CDC) OTC Over the Counter PA Physician's Assistant PAC Prevention Awareness Crew PAC Partners Assessing Chew Tobacco PAT Parents as Teachers PCCI ID Pueblo City-County Health Department PPC Personal Care Providers PE Presumptive Eligibility PEN Parent Engagement Network PVCFIC Peak Vista Community Health Center PHN Public Health Nurse PIO Public Information Officer PM Peer Mentor PMC Parkview Medical Center PMR Planning Management Region PN Patient Navigator PO Purchase Order PPC Policy Partner Committee PPFC Pikes Peak Family Connections PPN Prevention Policy Network Page 4 of 6 Attachment A-I PRA Policy Resource Alliance PRAMS Pregnancy Risk Assessment and Monitoring Survey PRIDE Pure Respect Initiative Direct Education PSA Public Service Announcement PSD Prevention Service Division PTEPP Pueblo Tobacco Education and Prevention Partnership PVC Prairie View Clinic QI Quarter One Q2 Quarter Two Q3 Quarter Three Q4 Quarter Four QI Quality Improvement QOt. Quality oft-ife RDAC Regional Disparities Advisory Council RFA Request for Applications RFP Request For Proposals RIE Reach,Implementation and Effectiveness RIHEL Regional Institute for Health and Environment RMC Rocky Mountain Center for I lealth Promotion&Education RMRII Rocky Mountain Rural Health RMYC Rocky Mountain Youth Corps RN Registered Nurse Rs Prescription RY Reconnecting Youth SafeCare SAMHSA Substance Abuse Mental Health Services Administration SB School-based System SHAG Salida Build A Generation SBIIC School-Based Health Centers SCYC Schoot Community Youth Coalition SCRHC Southern Colorado Regional Health Collaborative SD Service Delivery SECH Southeast Colorado Hospital SEMI IS Southeast Mental Health Services SES Socio-Economic Status SEW School Employee Wellness SGR Surgeon General's Report SHAC Smoke-free Housing Action Committee SHI School Health Index SIIS Secondhand Smoke SIDS Sudden Infant Death Syndrome SI.V San I.uis Valley SMART Staying Motivated at Reducing Temptations SMART OUTCOME OBJECTIVE Specific.Measurable,Achievable,Realistic.Time-Bound SMSU Self Management Service Unit SRO School Resource Officer STD Sexually Transmitted Disease STEPP State Tobacco Education and Prevention Partnership SEW Straight-to-Work SVVSD St.Vrain Valley School District SWOT Strengths.Weaknesses,Opportunities.Threats SYNAR Synar Regulation TA Technical Assistance TABS Tobacco Attitudes and Behavior Survey TAG Technical Advisory Group(for evaluation&TPEG) TANF Temporary Aid to Needy Families TARP Tobacco Advocacy and Resource Partnership TBD To Be Determine Page5 of6 Attachment A-I TCP Tobacco Control Partners ILIAC Tobacco Disparities Advisory Council TDG Tobacco Disparities Grant TDS Tobacco Disparities Subcommittee TEACH Teaching Equity to Advance Community Health TEFAP The Emergency Food Assistance Program TEPCGP Tobacco Education Prevention and Cessation Grant Program I EPP Tobacco Education Prevention Partnership TFCCI Tobacco-Free Colorado Communities Initiative TFLC Tobacco Free Larimer County TES Tobacco-Free Schools TES Law Tobacco-Free Schools Law TG YS Tony Grampsas Youth Services Title V Title V of the Social Security Act TND Project Toward No Drug Abuse TPEG Tobacco Program Evaluation Group TPI Tobacco Prevention Initiative TRC Tobacco Education and Prevention and Cessation Program Review Committee TRI Tobacco Rapid Improvement Activity TRIA Tobacco Rapid Improvement Assessment TII Tony Grampsas Tobacco Initiative UCD University of Colorado—Denver UCDHSC Health Sciences Center at UCD(sometimes abr. UCHSC) UCDHSC University of Colorado at Denver and Health Sciences Center US United States of America USSTC US Smokeless Tobacco Company VP Vice President Well COA Wellness Councils of America WI IL! Women's Health Unit WIC Women,Infants,Children WWC Women's Wellness Connection Y@C Youth at Crossroads YE Youth Empowerment YPH Youth Partnership for Health Yr Year YRBS Youth Risk Behavior Survey YSAP Youth Substance Abuse Prevention Coalition YTS Youth Tobacco Survey YVMC Yampa Valley Medical Center 5 A's Ask,Advise,Assess,Assist,Arrange 2A's R Ask,Advise,Refer Page 6 of 6 Attachment A-2 Enforcement Guidelines and Federal Clauses of Contract HHSF22320111009C These federal requirements are mandated by Contract HHSF22320111009C between USHHA FDA and CDPHE. I. PROVISIONS APPLICABLE TO DIRECT COSTS Notwithstanding Clause 52.216-7 "Allowable Cost and Payment" and Clause 52.244-2 "Subcontracts", of the Federal Acquisition Regulation (FAR), unless otherwise expressly provided elsewhere in the contract or in any modification thereto, the cost of the following items or activities shall be unallowable as direct costs: A. Acquisition by purchase or lease, of any interest in real property; B. Special rearrangement or alteration of facilities; C. Purchase or lease or rental of any item of general purpose; office furniture or office equipment(including data tapes); D. Travel to foreign countries; and E. Food and beverage costs unless part of per diem expenses paid in accordance with the Federal Travel Regulations. H. TRAVEL AND OTHER COSTS A. Travel claims shall be submitted and included with the monthly invoices for approval. Listed below is a description of receipts required as attachments to the invoice to support travel claims: B. Copy of common carrier ticket reflecting class of travel, dates of travel and amount of fare; 1. Lodging receipt; 2. Parking/tolls receipt; 3. Rental car receipt including receipts for gasoline; 4. Receipts for taxi travel. C. Any equipment having a unit acquisition cost in excess of$3,000, the cost of which the Contractor is to be reimbursed as a direct item of cost, shall not be acquired by the Contractor without the specific advance written approval of the CDPHE. Page 1 of 20 Attachment A-2 HI. BACKGROUND The provisions of the Federal Food, Drug and Cosmetic Act (FDCA), as amended by the Tobacco Control Act, to be enforced under the resultant contract are as follows: • Section 907 (a)(I)(A) states, in relevant part, that "a cigarette or any of its component parts (including the tobacco, filter, or paper) shall not contain, as a constituent(including a smoke constituent)or additive, an artificial or natural flavor(other than tobacco or menthol) or an herb or spice, including strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, or coffee, that is a characterizing flavor of the tobacco product or tobacco smoke." • Section 911 (a) states that"(n) no person may introduce or deliver for introduction into interstate commerce any modified risk tobacco product unless an order issued pursuant to subsection (g) is effective with respect to such product." The provisions of the Comprehensive Smokeless Tobacco Health Education Act of 1986 (CSTHEA)to be enforced under the resultant contract are referenced in Section 204 of the Tobacco Control Act which provide that advertising and packages of smokeless tobacco products must bear one of four specified warning label statements (warnings), and the warning area must occupy at least a specified percentage of the packaging(30%) and advertising(20%). Additionally, the warnings must be in either black text on a white background or white text on a black background. The burden is generally on retailers to ensure that a warning appears on smokeless tobacco packages and advertisements on display in their outlets. The Tobacco Control Act also required FDA to reissue the 1996 final rule, "Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents." The FDA has accordingly reissued the rule, which is at 21 Code of Federal Regulations (CFR) Part 1140, et seq. The Contractor shall conduct tobacco inspections for compliance with certain provisions of these regulations with respect to retail outlets on behalf of FDA and CDPHE. For illustration purposes, some, not all, of the provisions in 21 CFR Part 1 140 that are subject to inspection by the Contractor under this contract include: A. Age and Photo Identification Restrictions— Retailers: 1. May not sell cigarettes or smokeless tobacco to anyone younger than 18 years of age; 2. Must verify that any person purchasing cigarettes or smokeless tobacco is at least 18 years old or older by means of photo identification containing the bearer's date of birth; B. Advertising and Labeling Restrictions - Retailers: 1. May only sell cigarettes or smokeless tobacco in direct, face-to-face transactions; 2. May not have impersonal modes of sales at their facility(e.g., vending machines or self-service displays that enable direct access by consumers to cigarettes or smokeless Page 2 of 20 Attachment A-2 3. tobacco) unless they ensure that persons younger than 18 years of age are not present or permitted to enter the facility at any time; 4. May not offer or cause to be offered coupons that may be redeemed by mail for cigarettes or smokeless tobacco; 5. May not break or otherwise open packages of cigarettes to sell or distribute single cigarettes or any package with less than 20 cigarettes; 6. May not break or otherwise open packages of smokeless tobacco product to sell or distribute any quantity of cigarette tobacco product or smokeless tobacco that is smaller than the smallest package distributed by the manufacturer for individual use; 7. May not distribute or cause to be distributed free samples of cigarettes or smokeless tobacco products, except for samples of smokeless tobacco products in limited circumstances, as defined by the regulations; 8. May not offer or cause to be offered any non-tobacco gift or item to any person in consideration for the purchase of cigarettes or smokeless tobacco including redemption of credits, proofs-of-purchase, or coupons towards the purchase of a non- tobacco item whether or not such redemption is for all or part value of the non- tobacco item; 9. May not sponsor or cause to be sponsored any athletic, musical, artistic, or other social or cultural event, or any entry or team in any event, in the brand name, logo, symbol, motto, selling message, recognizable color or pattern of colors, or any other indicia of product identification similar to, or identifiable with, those used for any brand of cigarettes or smokeless tobacco. The Synar Regulation, which is administered by the Substance Abuse and Mental Health Services Administration's Center for Substance Abuse Prevention (SAMHSA/CSAP), requires the 50 states, the District of Columbia and 8 U.S. territories (American Samoa, Guam, Palau, Federated States of Micronesia, U.S. Virgin Islands, Puerto Rico, Marshall Islands and Commonwealth of the Northern Mariana Islands) to: • I lave in effect a law prohibiting any manufacturer, retailer, or distributor of tobacco products from selling or distributing such products to any individual younger than age 18; • Enforce this law; • Conduct annual, unannounced inspections (referred to as the Synar survey) in a way that provides a valid probability sample of tobacco sales outlets accessible to minors; • Negotiate interim targets and a date to achieve a noncompliance rate(or retailer violation rate)of no more than 20 percent(SAMHSA required that each state reduce its retailer violation rate (RVR) to 20 percent or less by FY 2003); and • Submit an annual report detailing state activities to enforce its law. Page 3 of 20 Attachment A-2 The funds used for FDA's tobacco inspection program are restricted, by statute, for use only for FDA tobacco inspection efforts. IV. SCOPE OF WORK Independently and not as an agent of the Federal government, the Contractor shall furnish the necessary personnel, materials, services, equipment, facilities, and otherwise do all things necessary for the performance of the work described below. The Contractor shall provide support in accordance with the timelines stated in the implementation plan. Attachment A-2-A contains a list of materials necessary for conducting FDA tobacco compliance check inspections. A. Inspectors The Contractor shall conduct compliance check inspections using law enforcement, health, food, or drug officers or employees of the state, local, or tribal government. These individuals must be United States citizens and be able to be commissioned as officers of the United States Department of Health and Human Services (HHS), Food and Drug Administration, under the authority of the FDCA. All persons to be commissioned must have enforcement authority from the state or local Government to be able to conduct inspections under this contract. B. Background Investigations/Commissioning Process Prior to carrying out compliance check inspection activities inspectors, and other employees working under this contract and/or with FDA inspection data or evidence (e.g., administrative personnel, supervisors) must be commissioned by FDA. In addition, should the program include chaperones (staff dedicated to overseeing the safety of the minors), they also require background investigations. Chaperones will not be commissioned by FDA. In general, the commissioning process begins with a background investigation, including a fingerprint check, credit check, and childcare check facilitated by FDA. Several parties within HHS may be involved in the process, with oversight by the Center for Tobacco Products (CTP). Any of these parties may contact the Contractor for additional information to facilitate the process. Upon clearance of the fingerprint check, a person may be commissioned while the background investigation continues, if applicable. The Contractor must submit contact information for the person(s) or entity most familiar with their agency's background investigation procedure. If applicable, the Contractor must also provide security contact information for individuals that the Contractor intends to subcontract. Upon award of the contract, CDPHE will work with the Contractor's security contact(s) to assess whether the Contractor's existing background investigation is Page 4 of 20 Attachment A-2 equivalent to FDA's, which is a federal Level 5 minimum background investigation (MBI) public trust background investigation. Upon award, the Contractor shall provide information for the available employees to be commissioned/receive background investigations, and subsequently, immediately upon identifying new staff it wishes to have commissioned (see F.2 reporting requirements). More specifically, the Contractor shall provide CDPHE with each such person's name, work address, work number or cell number, and email address. The Contractor shall provide CDPHE with information related to all minors and chaperones as determined by CDPHE. The Contractor shall notify CDPHE if any of this information changes. Receiving a commission signifies that the employee has accepted a position of public trust and must comply with all applicable federal laws and ethical standards. Each FDA commission is issued for a period of five years. Each employee is responsible for immediately notifying his/her Program Coordinator of any event or occurrence that could affect or change his/her status. The status of a background investigation may be continuously monitored by the Contractor, the Program Coordinator, and FDA. The issuance of a commission is discretionary, and FDA may revoke a commission at any time. Reasons for revocation may include: • The abuse or misuse of the commission; • The transmittal of confidential information from a commissioned official to individuals who are not employees or commissioned officials of FIFES. • A conflict of interest; • Change in criminal or credit history; • Substance abuse; and • Behavior that may discredit FDA. Upon separation of a commissioned employee, the Contractor shall ensure the commissioning credentials and all equipment are returned to CDPHE. C. Information Regarding Minors The Contractor shall keep one photo on file of the minors involved in the Program. The Contractor may determine that minors should be photographed with frequent regularity and/or prior to conducting any undercover buy assignments in order to document their appearance. FDA protocol does not require minors to carry photo identification for the undercover buy assignments. However, the Contractor may determine that minors should carry valid photo identification and present identification if requested. Such decisions are left to the discretion of CDPHE. Page 5 of 20 Attachment A-2 D. Contractor Responsibilities Regarding Minors The Contractor(or designated person or entity), rather than FDA, has the oversight responsibility for minors involved in the Program. The Contractor shall ensure that the minor is within the required age range (See Section C.3.E, "Compliance Check Inspections") by obtaining a copy of his/her birth certificate and minor's identification (if available) and an original parental/legal guardian consent form and submitting these to CDPHF. The Contractor must obtain permission from the minor's parents/legal guardian and school if the minor is going to conduct undercover buy assignments during school hours. The Contractor shall secure a grant of immunity from the proper authorities prior to using minors in any jurisdiction where it would be illegal to use minors to conduct undercover buy assignments. The Contractor shall maintain the confidentiality of the minor, although, in the event of a possible enforcement or judicial action, the minor's identity may be revealed and the minor may need to provide a narrative report, declaration, and/or give oral testimony in a hearing. This information must be contained in the parental consent form. All minors selected shall be insured against accidents or other injuries. If the minors are not covered under the Contractor's policy, the Contractor shall purchase the insurance. Proof of insurance shall be maintained by the Contractor and must be submitted to CDPHE. E. Conflicts of Interest The individuals conducting compliance check inspections or responsible for compliance information or evidence ("covered persons") shall not have significant financial interests in the following ("covered companies"): (I) any company that the covered person inspects; (2) any company whose compliance information and/or evidence the covered person is responsible for gathering, maintaining, or reporting; or(3) any manufacturer, distributor, or importer of cigarettes or smokeless tobacco products. Examples of significant financial interests include: • the covered person or a close family member owns stock in a covered company, other than through ownership of shares of a mutual fund that invests in a covered company; • the covered person or a close family member serves as an employee, trustee, officer, or director of a covered company. Page 6 of 20 Attachment A-2 In addition, a covered person shall not participate personally or substantially in any matter under the contract that may significantly affect that person's own financial interests or the financial interests of: • His or her spouse or minor child; • His or her general partner; • An organization in which he or she serves as an officer, director, trustee, general partner or employee; and • A person with whom he or she is negotiating for or has an arrangement concerning prospective employment. These requirements are contractual, and do not alter, modify, or replace obligations imposed on program coordinators or commissioned officers by any applicable federal law or ethical standard. V. RETAIL INSPECTION PROGRAM TRAINING A. Initial Training for contracted staff who have not previously held a FDA Retail Inspection Contract CDPHE officials will provide the initial FDA Tobacco Compliance Check Inspection training materials and conduct the initial training of the Program inspectors. Inspectors must be commissioned by FDA before reviewing the training materials. The CDPHE Program Coordinator shall ensure that all inspectors are trained and begin conducting compliance check inspections within two (2) weeks of successfully completing their initial training. B. Training for Minors The Contractor must ensure that minors are appropriately trained. Minors shall be trained by the Contractor. The training program may include mock undercover buy assignments so newly recruited minors may observe experienced minors conduct undercover buy assignments before conducting them on their own. C. Training Records and Annual Refresher Training The Contractor shall ensure that each inspector, chaperone and minor shall have their initial training documented and, at a minimum, receive annual refresher training. CDPHE will consider requests for additional training by the Contractor and may require additional training as needed and determined by CDPHE and FDA. Page 7 of 20 Attachment A-2 VI. FDA'S TOBACCO INSPECTION MANAGEMENT SYSTEM (TIMS) FDA's Tobacco Inspection Management System (TIMS) is designed to receive and store data and information, but currently has limitations on data analysis and reporting. The TIMS Application can work in conjunction with a specific handheld mobile device that will be provided by FDA and allows for the electronic transmission of information. The TIMS Application provides FDA and Contractors with a front-end web interface for accessing and managing FDA tobacco inspection assignment information and related processes. Inspectors not using the handheld device for data submission shall submit paper forms or enter data using a computer. The mobile device currently provided to some inspectors by FDA is the iPhone, serviced by AT&T. FDA will also provide the service plans for these devices. Not all inspectors/contractors will be issued mobile devices by FDA. Therefore, all inspectors will be trained to use paper forms whether given a government furnished mobile device or not. The Contractor must notify CDPHE immediately of any hardware and software problems so that CDPHE can work to resolve them. VII. COMPLIANCE CHECK INSPECTIONS A. Overview of General Inspection Procedures CDPHE will assign tobacco compliance check inspections of entities that sell or advertise cigarettes and/or smokeless tobacco products for the inspector to determine whether those entities are complying with the Tobacco Control Act and the implementing regulations (See Section C.1). Generally,* the Contractor shall carry out two types of tobacco compliance check inspection assignments: (I) undercover buy, to determine a retailer's compliance with age and photo identification requirements; and (2) advertising and labeling to cover other provisions of the Tobacco Control Act. FDA prefers an equal mix of each type of tobacco compliance check assignments be conducted. In some instances, FDA may request that both types of assignments be conducted within a short timeframe (specified during training) of each other at a particular retail outlet. *Note: some retail outlets that never permit anyone under the age of 18 to enter may be inspected using only the advertising and labeling assignment form. Each inspector shall conduct and document each assignment according to FDA protocol (provided in the training). Documentation of the assignment requires the inspector to: (I) record the findings on a compliance check inspection form, which will be provided by FDA via the handheld device, a computer, or hardcopy form; (2) prepare a narrative report revealing potential violations (according to the FDA template); (3) collect evidence, such as tangible items of potentially violative tobacco products or photographs of conditions observed via the handheld device or a digital camera; and (4) record any additional observations as instructed by CDPHE and FDA. Page 8 of 20 Attachment A-2 If the retail outlet is found to be out of compliance, CDPHE may request assistance from the Contractor in researching the ownership information of a particular retail outlet or entity. The Contractor is responsible for the collection, handling, sealing, documentation, storage, and submission of evidence pursuant to CDPHE protocol to ensure that evidence is maintained in a manner that shall allow the FDA to use the evidence to support an enforcement action. The Contractor shall ensure procedures and standards for data and evidence security. This should include but is not limited to ensuring anonymity of compliance check inspection participants, confidentiality of data and evidence collection, transmission, and storage of property and evidence. Further details shall be provided in FDA's State Compliance Inspection Check Program Training. B. Undercover Buy Assignments The Contractor shall ensure that compliance check assignments to determine retailer compliance with the age and photo identification provisions of the regulations follow FDA and CDPHE protocol. Generally, undercover buy assignments shall be conducted by teams comprised of an inspector and a minor. The minor must be supervised at all times. The inspector shall position him/herself so that they can observe and hear the minor during the entire undercover buy assignment to ensure that they can later complete a narrative report attesting that they have witnessed the violation. In certain circumstances, minors may be required to complete narrative reports regarding inspections they conducted. A representative mix of 15, 16 and 17 year old minors who look their age should be used. The minor group should also reflect a representative mix of male and female minors and should reflect the racial/ethnic composition of the population where the undercover buy is conducted. The Contractor shall ensure that Minors used in the undercover buy assignments are not related to the inspectors. The Contractor shall ensure that undercover buy assignments using minors shall be conducted during the hours deemed. . If it is required under state law to issue a citation after a violation, the Contractor shall not issue the state citation until all compliance check assignments for that day are completed and the minor is returned to his/her proper end location. C. Advertising and Labeling Assignments The Contractor shall conduct compliance check assignments to determine compliance with the provisions of the Tobacco Control Act and the implementing regulations, other than age and photo identification requirements. The Contractor may either conduct Page 9 of 20 Attachment A-2 advertising and labeling check assignments at the same time as the undercover buy compliance check assignments, or at a separate time, using one or more inspectors. Generally, a minor should not accompany an inspector during an advertising and labeling assignment to ensure that the minor's identity remains anonymous. Minors must be supervised at all times. In some circumstances, the inspector may be required to provide his/her FDA credentials during this type of compliance check assignment. D. Timing of Routine Compliance Check Inspections When instructed by CDPHE, the Contractor shall, to the extent practicable, conduct both undercover buy and advertising and labeling assignments within a short timeframe of each other at a specified retail outlet to expeditiously initiate and support a potential enforcement action. The timing of the assignments is discussed further in the FDA training program. E. Compliance Follow-up Inspections CDPHE shall assign follow-up compliance check inspections for retail outlets found to be out of compliance with the Tobacco Control Act and/or the implementing regulations. Follow-up compliance check inspections are to be completed by the Contractor within ninety(90)days of receipt of the follow-up inspection request from CDPHE. CDPHE shall provide specific instructions regarding the conduct of follow-up inspections during the initial training session. F. Complaint Follow-Up Inspections CDPHE may issue complaint follow-up inspections after the FDA receives a complaint or report that may pose a public health risk or other regulatory concern. Specific compliance check inspections and investigations assigned by CDPHE shall be scheduled and completed no later than ninety (90) days after assigned by CDPHE. CDPHE shall provide specific instructions regarding the conduct of follow-up inspections during the initial training session and when assignments are issued. G. Data Transmission FDA and CDPHE will supply the Contractor with handheld devices (if applicable) and/or hardcopy forms and access to the TIMS application for recording information related to each compliance check inspection. Inspectors shall record compliance check inspection data and manage compliance check inspection work. Page 10 of 20 Attachment A-2 The inspectors shall submit the results of each compliance check assignment, including the narrative report and evidence if applicable; within 72 hours after the compliance check assignment was initiated. The Contractor shall follow protocol provided by CDPHE. H. Compliance Check Inspection Follow-up—FDA Inquiries If the inspection data and evidence submitted by the Contractor requires clarification or is not sufficient, CDPHE may request that the Contractor provide clarification and/or collect additional evidence. Within 48 hours of receiving a request from CDPHE, the Contractor shall provide CDPHE with information about a compliance check inspection and investigation unless citing extenuating circumstances. I. FDA Enforcement Actions FDA intends to review the results of every compliance check inspection recommendation and the accompanying evidence submitted by the Contractor. If FDA determines that enforcement action shall be taken against a retailer, FDA has several enforcement tools that it may use, including: (I) issuance of a Warning Letter, (2) imposing an administrative civil money penalty (CMP) and/or a no-tobacco sale order, (3) initiating judicial actions, such as a seizure or injunction, or(4) initiating criminal prosecution. If FDA takes enforcement action, the Contractor shall assist CDPHE and FDA with any needed follow-up related to the compliance check inspections. For example, the Contractor shall be responsible for securing prompt and continuing cooperation from witnesses. In addition, if requested, the inspector and minor must remain available to testify as a witness and provide oral testimony following any compliance check inspection in support of an FDA enforcement action. Apart from FDA enforcement actions for violations of the Tobacco Control Act and its implementing regulations, the Contractor may pursue separate enforcement actions against retail outlets that are found to have also violated state or local laws. These efforts must be coordinated with FDA and not compromise FDA's compliance check inspection procedures, data, or evidence. VIII. REPORTING REQUIREMENTS/DELIVERABLE AND ACTIVITY SCHEDULE All deliverables required by this contract shall be delivered to CDPHE except where indicated that the Contracting Officer(CO) and the COTR receive copies. The description of each deliverable is identified below. All deliverables shall be subject to the inspection and acceptance of CDPHE. All Page 11 of 20 Attachment A-2 deliverables shall be submitted electronically to the State Program Coordinator, whose contact information shall be supplied by CDPHE. A. DESCRIPTION OF DELIVERABLES/ACTIVITIES: 1. Notification of Changes- The Contractor shall inform the contract monitor/program coordinator when there are any changes to the inspector's . or Minors information. (e.g., phone number, e-mail address, change of personnel, etc.). 2. Completion of Initial Training- The Contractor shall ensure that all inspectors are trained and begin conducting compliance check inspections within two (2) weeks of successfully completing their initial training. 3. Follow-up Inspections for Non-Compliance. Follow-up inspections for establishments found to be out of compliance with the Tobacco Control Act shall be completed by the Contractor within ninety(90) days of receipt of the follow-up inspection request from CDPHE. 4. Complaint Follow-Up Inspections. CDPHE may issue complaint follow-up inspections after the FDA receives a complaint or report that may pose a public health risk or other regulatory concern. Specific compliance check inspections and investigations assigned by CDpHE shall be scheduled and completed no later than ninety(90)days after assigned by FDA. 5. Inspection Follow-up Information - If the inspection data and evidence submitted by the Contractor requires clarification or is not sufficient, CDPHE may request clarification and/or collect additional evidence. The Contractor shall provide CDPHE with additional information about a compliance check inspection and investigation within 48 hours. 6. Quarterly Reports - A quarterly report is a quantitative description of overall progress and applicable supporting data in sufficient detail to comprehensively explain progress to date. Appropriate topics include, for example: a) Total number of retail outlets inspected. b) Total number of undercover buy compliance check assignments conducted. c) Total number advertising and labeling compliance check assignments conducted. d) Percent of retail outlets checked compared to total number of retail outlets on state list. e) Violation rates among retail outlets checked. A breakdown of rates in minority vs. non-minority populations. Page 12 of 20 Attachment A-2 f) Total number of follow up inspection assignments conducted. (Breakout to specify Undercover Buy and Advertising and Labeling assignments) g) Total number of complete inspections conducted in response to complaint follow- up assignments. (Breakout to specify Undercover Buy and Advertising and Labeling assignments) h) Number of follow-up questions answered concerning compliance check inspections; number pending and reasons why. i) Media coverage, contact, and/or inquiries, if any. j) Dates on which inspectors received training and updates. k) Feedback regarding the use of handheld devices and other hardware, TIMS, and the online compliance check inspection process. I) Feedback regarding the FDA program in general. The Contractor shall abide by Program changes needed to maintain efficiency of Program operations and accuracy of compliance check inspection data and evidence. Such changes may include, but are not limited to compliance check inspection procedures, evidence collection, training, report submissions, and IT system improvements. 7. FDA 1350 Access To Non-Public Information— All Contractor and Subcontractor employees are required to sign the Contractor's Commitment to Protect Non-Public Information Agreement form provided as an attachment to this contract(see Attachment A-2-B). If a person who has signed this agreement resigns, is dismissed, or is otherwise no longer working on this contract, the contractor shall notify CDPHE. Any new Contractor and subcontractor employees assigned to this contract shall sign the form. The signed form shall be submitted to CDPHE within ten (10) days prior to commencement of any work under this contract. IX. GOVERNMENT FURNISHED PROPERTY (GFP) Equipment Return - Upon the departure or reassignment of an inspector, or upon expiration of the contract ALL FDA and CDPHE provided IT equipment shall be returned to CDPHE immediately. X. SPECIAL CONTRACT REQUIREMENTS A. FDA 1350 ACCESS TO NON-PUBLIC INFORMATION All Contractor employees assigned to this contract are required to sign the Contractor's Commitment to Protect Non-Public Information Agreement form (see Attachment A-2- B). If a person who has signed this agreement resigns, is dismissed, or is otherwise no Page l3 of 20 Attachment A-2 longer working on this contract, the contractor shall notify CDPHE. Any new Contractor employees assigned to this contract shall sign the form and shall submit to CDPHE within ten (10)days prior to commencement of any work under this contract. The prime contractor, subcontractors, and consultants shall not be provided nor possess non-public information in any form unless written approval and a facility clearance have been granted by FDA's Contracting Officer. B. FDA 1354 PHYSICAL SECURITY REQUIREMENTS FOR RELEASING NON- PUBLIC INFORMATION Under the provisions of Title 21, United States Code, Section 331(j), the Contractor shall establish and maintain comprehensive security measures for controlling access to non- public information released under a contract involving the processing of such information. This clause applies to the contractor, any subcontractors, and any consultants. Non- public information shall be released to only those persons who will be using the contractor's approved facility unless the off-site facility has been reviewed by the FDA Physical Security Staff and approved in writing by the FDA Physical Security Office. For transmittal of documents the Contractor shall adhere to the following: 1. Documents to be transmitted internally shall be transmitted on a person-to-person basis between approved employees only. 2. Documents to be transmitted outside the contractor's facility shall be double- wrapped with the inner wrapping marked "CDPHE/FDA Privileged Information - Access Controlled". The names and addresses of the sender and addressee shall be typed on both the inner and outer wrappings. 3. Documents to be transmitted back to CDPHE or to another address designated by the FDA shall be transmitted by an approved employee or by U. S. Registered mail (return receipt requested). It shall be double-wrapped or wrapped by such a method as specifically approved in writing by the FDA Physical Security Office. 4. A receipt log shall be maintained for all external transmittals. 5. The Contractor shall follow up all transmittals in order to obtain signed receipt within five (5) working days of transmittal. Failure of recipient to furnish such receipt shall be reported to the FDA Physical Security Office within ten (10) working days of transmittal. Page 14 of 20 Attachment A-2 Non-public information shall not be released to the Contractor unless all required security precautions have been met as demonstrated during an inspection by the Food and Drug Administration (FDA) Physical Security Staff, and written procedures for enforcing them have been provided by the contractor and approved in writing by the Physical Security Staff. The FDA Physical Security Office shall notify the Contractor of the approval. When the Contractor facilities have a current certification from the Defense Contract Administration Services/Defense Logistics Agency(DCAS/DLA) as a "Secret" or higher classification, such rating will satisfy the FDA security requirements for the contractor's facility. Loss of such certification during the period of the contract will be cause for a possible issuance of a Stop Work Order pending review by the FDA's Physical Security Staff of the contractor's facility. The contractor shall notify the FDA Physical Security Office in the event their DCAS/DLA rating is expected to be terminated. Pending the outcome of any subsequently required investigation, additional requirements on the contractor shall include, but not be limited to, the following: restrictions on access to data by contractor employees, subcontractor employees, and consultants; special storage requirements; restrictions on transmission and disclosure of information; changes in periods of retention and in methods of destruction of source documents or related material; and disclosure statements for all contractor employees, subcontractor employees, and consultants. The FDA Physical Security Staff may review the contractor's facility and assess the contractor's compliance. Recommendations for bringing noncompliant areas into compliance shall be provided to the contractor by the FDA Physical Security Office. The Contractor shall make any changes necessary within thirty (30) days after written notice from the FDA Physical Security Office in order to comply with FDA security requirements. When appropriate changes have been made the Contractor shall contact the FDA Physical Security Office to request further review by the FDA. The FDA Physical Security Office will notify the Contractor in writing of the outcome of the second inspection. Failure of the contractor to satisfy FDA security requirements within thirty(30) days after the first written notification from the Contracting Officer may be cause for termination of the contract. In addition to the above, if this is an automated data processing/telecommunications (ADP/TC) contract, special requirements are necessary. Contractor and subcontractor employees and consultants participating in the design, operation, maintenance or use of FDA automated information systems or ADP/TC resources shall comply with the DHHS Automated Information Systems Security Program Handbook. Chapter VII, entitled, "Personnel Security/Suitability and Training," which establishes criteria for assigning positions to the three(3) computer/ADP position risk levels: Level 6, high risk public trust position; Level 5, moderate risk public trust position; and Level I, low risk position. Chapter VIII, entitled, "AIS Facilities," requires contractors to meet or exceed the security requirements described therein. Page 15 of 20 Attachment A-2 C. COMMISSIONG OF INSPECTORS The Government requires that certain Contractor personnel be commissioned by the Government to enable the Contractor to conduct activities under this contract including, but not limited to, undertaking examinations, inspections, and investigations, and related activities to protect the public health in accordance with federal law, such as the provisions of"Public Health Security and Bioterrorism Preparedness and Response Act of 2002" (Public Law 107-188). The Government has an established procedure to commission the Contractor's employee to perform certain functions pursuant to the Federal Food, Drug, and Cosmetic Act, such as conducting FDA examinations, inspections, and investigations, collecting and obtaining samples, copying and verifying records, and receiving and reviewing official FDA documents. D. FEDERALLY FUNDED RESEARCH AND DEVELOPMENT CENTERS AND SUPPORT CONTRACTORS The Government may contract with federally funded research and development centers (FFRDC) and support contractors for services to support in technical and management oversight of the Contractor's efforts and products under this contract. Employees of these FFRDCs and support contractors may attend meetings between the Contractor and the Government and may observe and participate with Government personnel in function and performance tests, may review any and all documentation and underlying data supporting work performed under this contract, and may have access to the Contractor's facilities as related to any effort under this contract. No employee of an FFRDC or support contractor has the authority to issue directions to the Contractor or effect changes to the contract. The Contracting Officer will identify to the Contractor the FFRDCs and support contractors who will be supporting this contract. The Contractor shall be provided the names of the FFRDC and support contractor personnel who will sign appropriate non- disclosure and conflict of interest statements. The Contractor agrees to cooperate with the FFRDCs and support contractors by engaging in technical discussions with their personnel, and permitting access to information and data relating to technical, cost, and schedule matters concerning this contract to the same degree such access is accorded to Government personnel. E. HHSAR 352.270-10 - ANTI-LOBBYING (JANUARY 2006) Pursuant to the current HITS annual appropriations act, except for normal and recognized executive-legislative relationships, the Contractor shall not use any HITS contract funds for(i) publicity or propaganda purposes; (ii)the preparation, distribution, or use of any kit, pamphlet, booklet, publication, radio, television or video presentation designed to support or defeat legislation pending before the Congress or any State legislature, except in presentation to the Congress or any State legislature itself; or(iii) payment of salary or Page 16 of 20 Attachment A-2 expenses of the Contractor, or any agent acting for the Contractor, related to any activity designed to influence legislation or appropriations pending before the Congress or any State legislature (see Attachment A-2-C). Page 17 of 20 Attachment A-2 XL CONTRACT CLAUSES A. FAR 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998) This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es): FAR—http://www.acquisition.gov/far and HHSAR-http://www.hhs.gov/oamp/pol icies/hssar.doc._ 1. FAR Clause No. Title and Date 52.246-5 Inspection of Services - Cost Reimbursement(APR 1984) 52.242.15 Stop Work Order(AUG 1989) 2. Federal Acquisition Regulation (FAR) (48 CFR Chapter 1)Clauses ≥' 3 'yam w t: " t''t'x\ .:✓S' X§ FAR 52.202-I Jul-04 Definitions FAR 52.203-3 Apr-84 Gratuities FAR 52.203-5 Apr-84 Covenant Against Contingent Fees FAR 52.203-6 Sep-06 Restrictions on Subcontractor Sales to the Government FAR 52.203-7 OCT 2010 Anti-Kickback Procedures Cancellation, Rescission, and FAR 52.203-8 Jan-97 Recovery of Funds for Illegal or Improper Activity FAR 52.203-10 Jan-97 Price or Fee Adjustment for Illegal or Improper Activity FAR 52.203-12 Oct-10 Limitation on Payments to Influence Certain Federal Transactions FAR 52.203-13 Apr-10 Contractor Code of Business Ethics and Conduct FAR 52.203-14 Dec-07 Display Hotline Poster(s) FAR 52.204-4 Aug-00 Printed or Copied Double-Sided on Recycled Paper FAR 52.204-7 Apr-08 Central Contractor Registration Protecting the Government's Interests FAR 52.209-6 Sep-06 When Subcontracting With Contractors Debarred, Suspended, or Proposed for Debarment FAR 52.215-2 Oct-10 Audit and Records— Negotiation Page 18 of 20 Attachment A-2 FAR 52.215-8 Oct-97 Order of Precedence- Uniform Contract Format FAR 52.215-10 Oct-10 Price Reduction for Defective Cost or Pricing Data(Over$650,000) FAR 52.215-15 Oct-10 Pension Adjustments and Asset Reversions Reversion or Adjustment of Plans for FAR 52.215-18 Jul-05 Post-Retirement Benefits(PRB)other than Pensions FAR 52.215-19 Oct-97 Notification of Ownership Changes Requirements for Cost or Pricing Data FAR 52.215-20 Oct-10 or Information Other Than Cost or Pricing Data Requirements for Cost or Pricing Data FAR 52.215-21 Oct-10 or Information Other Than Cost or Pricing Data-Modifications FAR 52.216-5 Oct-97 Price Redetermination- Prospective Allowable Cost and Payment modify FAR 52.216-7 Dec-02 paragraph (a)The words 31.2 and substitute 31.6 FAR 52.216-11 Apr-84 Cost Contract-No Fee FAR 52.219-8 May-04 Utilization of Small Business Concerns FAR 52.222-3 Jun-03 Convict Labor FAR 52.222-26 Mar-07 Equal Opportunity Equal Opportunity for Special FAR 52.222-35 Sep-10 Disabled Veterans, Veterans of the Vietnam Era,and Other Eligible Veterans FAR 52.222-36 Oct-10 Affirmative Action for Workers with Disabilities Employment Reports on Special FAR 52.222-37 Sep-10 Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans FAR 52.222-50 Feb-09 Combating Trafficking in Persons FAR 52.222-54 Jan-09 Employment Eligibility Verification FAR 52.223-6 May-01 Drug-Free Workplace FAR 52.223-14 Aug-03 Toxic Chemical Release Reporting FAR 52.225-1 Feb-09 Buy American Act- Supplies Restrictions on Certain Foreign FAR 52.225-13 Jun-08 Purchases FAR 52.227-I Dec-07 Authorization and Consent FAR 52.227-2 Dec-07 Notice and Assistance Regarding Patent and Copyright Infringement FAR 52.229-3 Apr-03 Federal, State and Local Taxes FAR 52.232-I Apr-84 Payments FAR 52.232-8 Feb-02 Discounts for Prompt Payment FAR 52.232-9 Apr-84 Limitation on Withholding of Payments Page 19 of 20 Attachment A-2 FAR 52.232-I1 Apr-84 Extras FAR 52.232-17 Oct-10 Interest FAR 52.232-20 Apr-84 Limitation of Cost FAR 52.232-23 Jan-86 Assignment of Claims FAR 52.232-25 Oct-08 Prompt Payment Payment by Electronic Funds FAR 52.232-33 Oct-03 Transfer--Central Contractor Registration FAR 52.233-1 Jul-02 Disputes FAR 52.233-3 Aug-96 Protest After Award FAR 52.233-4 Oct-04 Applicable Law for Breach of Contract Claim FAR 52.242-1 Apr-84 Notice of intent to Disallow Costs FAR 52.243-2 Aug-87 Changes—Cost Reimbursement Alternate II(Apr 1984) FAR 52.245-1 Jun-07 Government Property FAR 52.246-25 Feb-97 Limitation of Liability-Services FAR 52.249-4 Apr-84 Termination for Convenience of the Government(Services)(Short Form) FAR 52.253-1 Jan-91 Computer Generated Forms 3. Department of Health and Human Services Acquisition Regulation (HHSAR)(48 CFR Chapter 3)Contract Clauses HHSAR 352.201-70 Jan-06 Paperwork Reduction Act HHSAR 352.202-I Jan-06 Definitions HHSAR 352.203-70 Jan-06 Anti-Lobbying HHSAR 352.216-70 Jan-06 Additional Cost Principles Contractor HHSAR 352.222.70 Jan-10 Cooperation in Equal Employment HHSAR 352.233-71 Jan-06 Litigation and Claims Security Requirements HHSAR 352.239-72 Jan-10 for Federal Information and Technology Accessibility HHSAR 352.242-73 Jan-06 Withholding of Contract Payments Final Decisions on HHSAR 352.242-74 Apr-84 Audit Findings Page 20 of 20 Attachment A-2-A Material List (Revised 12/9/10) L','� +b';':� - � inn -e",i• sr . � _ . r, as� '4 , w9v+T Equipment/Supplies: Forms/Tools: Equipment/Supplies: • iPhones(built-in camera) • Undercover buy • Digital cameras(including memory cards o 2 levels of passwords compliance check and batteries for cameras) o Battery pack inspection form • Computers(including keyboard and o Wall charger • Advertising and labeling mouse if applicable) o Car charger compliance check • Printers/fax/scanner (including ink o Stylus(upon request) inspection form cartridges) o iPhone case • TIMS Web Application • Regulatory notebooks(bound) • Commissioning Credentials Quick Guide • Ballpoint pens for inspectors and Program • TIMS Mobile(iPhone) • Permanent marker pens Coordinators(sent by Application Quick Guide • Resealable plastic bags FDA/DFSR to Program • CD-Rs for the official CD copy(for Coordinator to hold until manual,digital camera process) appropriate time to • CD-RWs or CD-Rs for working CD copy disseminate) (for manual,digital camera process) • Commissioning Certificates • Envelopes for CDs for"other"personnel(sent by FDA/DFSR to Program • Boxes and/or large envelopes for Coordinator to hold until inspection packages appropriate time to • Secure storage for records and inspection disseminate) packages • Clear packing tape Forms/Tools: • Form FDA-415A(FDA Forms/Tools*: Official Seal) • Proof of insurance for minors against • Form FDA-482(Notice of accidents or other injuries Inspection)carbon copies • Parental consent forms for minors • Permission slips from the school for the • Contractor Programs High- Level Workflow minors(if applicable) • iPhone return form • Grant of immunity from proper • Narrative Report Templates authorities for minors, if applicable • Sample Quarterly Report • Employee records for all employees, Form including identification verification records • FDA State Contract Invoice • Training record/log for all employees form(Recommended form to submit invoice info) • Training completion certificate for • Invoice Request Instructions "other"personnel, minors,and, if for FDA Cost Reimbursement applicable,adult supervisors/chaperones Type Contracts (document • Time and attendance records for all employees providing guidance for • Inspection log or other activity tracking invoices) p tool Training Materials: • Time tracking tool for minors and, if • Training manual and other applicable,adult supervisors/chaperones resource materials during inspections for reimbursement • Exam purposes • Overnight mail service that includes tracking • Evidence/Chain-of-Custody Log while in Page 1 of 2 Attachment A-2-A Proirideitby FDA to the State previded td$ed 4y coonktior gi►tk bl L F J J� OtkittketOr Vonii A � M Istorage with the Contractor The non-exclusive list of the prohibited items is as follows: • Recording equipment(e.g.,electronic surveillance or wiretapping) • Guns or ammunition • Purchase of vehicles. Contractors may lease vehicles or personnel may be reimbursed for mileage used on POVs. . * All documents are to be maintained by Contractor and made available to FDA upon request. Page 2 of 2 Attachment A-2-B DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service FOOO AND DRUG ADMINISTRATION CONTRACTOR'S COMMITMENT TO PROTECT NON-PUBLIC INFORMATION (NPI)AGREEMENT Whereas access to non-public information (NPI)from the files of the Food and Drug Administration (FDA) is required in the performance of my official duties, under Contract Number and between FDA and my employer, , hereby agree that I shall not further release,publish or disclose such information and I shall protect such information entrusted to me in accordance with the provisions of 21 U.S.C. §3310),21 U.S.C. §3600), 18 U.S.C,§ 1905, as well as other applicable statutory and regulatory provisions. Further, I agree to: 1. Store NPI in the secured offices of the FDA or in FDA approved contractor facility containers if work is performed off an FDA site. 2. Grant access to NPI only to known employees of the FDA or to other persons designated in writing by the FDA. 3. Return all NPI and any pertinent notes to the FDA Project Officer I am assigned to upon completion of the contract, or at any time upon the FDA's request. 4. Report in writing to the FDA Project Officer I am assigned to, all incidents in which unauthorized persons may have gained access to any NPI entrusted to me. I understand the provisions of 21 U.S,C. §331(j), 21 U.S.C. § 3600), 18 U.S.C. § 1905 and that I am subject to criminal penalties prescribed by law for any violation thereof. Signature: Date: Type or Print Name: Witnessed by: Date: Type or Print Name: Page 1 of 1 Attachment A-2-C Disclosure of Lobbying Activities DISCLOSURE OF LOBBYING ACTIVITIES Approved by OMB Complete this form to disclose lobbying activities pursuant to 31 U.S.C. 1352 0348-0046(See reverse for public burden disclosure.) 1. Type of Federal Action: 2. Status of Federal Action: 3. Report Type: a. contract a. bid/offer/application a. initial filing b. grant b. initial award b. material change c. cooperative agreement c. post-award For Material Change Only: d. loan year quarter e. loan guarantee date of last report f. loan insurance 4. Name and Address of Reporting Entity: 5. If Reporting Entity in No.4 is a Subawardee, Enter Name and Address of Prime: Tier , if known: Congressional District, if known: Congressional District, if known: 6. Federal Department/Agency: 7. Federal Program Name/Description: CFDA Number, if applicable: 8. Federal Action Number, if known: 9. Award Amount, if known: $ 10. a. Name and Address of Lobbying Registrant b. Individuals Performing Services (including address if(if individual, last name, first name, MI): different from No. 10a) (last name,first name, MI): 11. Signature: Print Name: Title:Telephone No.: Authorized for Local Reproduction Standard Form LLL(Rev.7-97)Information requested through this form is authorized by title 31 U.S.C.section 1352 This disclosure of lobbying activities is a matenal representation of fact upon which reliance was placed by the tier above when this transaction was made or entered into This disclosure is required pursuant to 31 U.S C.1352 This information will be available for public Inspection required disclosure shall be subject to a not more than 510O 000 for each such failure.Prime Subawardee Federal Use Only: Date: who fails to file the Any person$10,000 and than avil penalty of not less Page 1 of 2 Attachment A-2-C INSTRUCTIONS FOR COMPLETION OF SF-LLL, DISCLOSURE OF LOBBYING ACTIVITIES This disclosure form shall be completed by the reporting entity,whether subawardee or prime Federal recipient, at the initiation or receipt of a covered Federal action,or a material change to a previous filing, pursuant to title 31 U.S.C.section 1352.The filing of a form is required for each payment or agreementto make paymenttoanylobbyingentityforinfluencingorattemptingtoinfluenceanoffceroremployeeofanyagency,aMemberof Congress,anofficer oremployeeof Congress,oranemployeeofa MemberofCongressi nconnectionwithacovered Federalaction.Compleleallitemsthatapplyforboththei nitialfili ng andmaterial change report.Refer to the implementing guidance published by the Office of Management and Budget for additional information. 1. Identify the type of covered Federal action for which lobbying activity is and/or has been secured to influence the outcome of a covered Federal action. 2. Identify the status of the covered Federal action. Identify the appropriateclassification of this report.If this is a followup report caused by a material change to the information previously reported,enter the year and quarter in which the change occurred.Enter the date of the last previously submitted report by this reporting entity for this covered Federal action. 4. Enterthefullname,address,city,Statea ndzi pcodeofthereportingentity.l ncludeC ongress ionalDistdct,i&nown.C hecktheappropri ateclassif ication ofthereportingentitythatdesignatesif itis,orexpectstobe,aprimeorsubawardrecipient.ldentifythetierof thesubawardee,e.g.,thefirst subawardee of the prime is the 1st tier.Subawards include but are not limited to subcontracts, subgrants and contract awards under grants. 5. If the organization filing the report in item 4 checks"Subawardee,"then enter the full name,address,city,State and zip code of the prime Federal recipient.Include Congressional District,if known. 6. Enter the name of the Federal agency making the award or loan commitment. Include at least one organizationallevel below agency name,if known. For example, Department of Transportation,United States Coast Guard. 7.Enter the Federal program name or description for the covered Federal action(item 1). If known,enter the full Catalog of Federal Domestic Assistance(CFDA)number for grants,cooperative agreements,loans,and loan commitments. 9_Enter the most appropriate Federal identifying number available for the Federal action identified in item 1 (e.g.,Request for Proposal(RFP)number;Invitation for Bid(IFB)number;grant announcement number;the contract,grant,or loan award number; the application/proposal control number assigned by the Federal agency).Include prefixes,e.g.,"RFP-DE-90-001." 9. For a covered Federal action where there has been an award or loan commitment by the Federal agency,enter the Federal amount of the award/loan commitment for the prime entity identified in item 4 or 5. 10. (a)Enter the full name,address,city,State and zip code of the lobbying registrant under the Lobbying Disclosure Act of 1995 engaged by the reporting entity identified in item 4 to influence the covered Federal action. (b) Enter the full names of the individual(s) performing services, and include full address if different from 10(a). Enter Last Name, First Name,and Middle Initial(MI). 11. The certifying official shall sign and date the form,print his/her name,title,and telephone number. According to the Paperwork Reduction Act,as amended,no persons are required to respond to a collection of information unless it displays a valid OMB Control Number.The valid OMB control number for this information collection is OMB No.0348-0046.Public reporting burden for this collection of information is estimated to average 10 minutes per response,including time for reviewing instructions,searching existing data sources,gathering and maintaining the data needed,and completing and reviewing the collection of information.Send comments regarding the burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden,to the Office of Management and Budget,Paperwork Reduction Project(0348-0046), Washington,DC 20503. Page 2 of 2 era 7,± ) O cas k ( al [ [ ( }\ §iln O et ) / 06 6 # / E HI 61 3 . 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O O. e E c C IS O O O C 4- d t w AL Cl V 0 o S 7 y O a c 7 I- - u 4o — i q +L+' o - i d © OUd d e O' Ud d d m3. C .- o C v N h L' •.E v c L .. iv li o w ° .c c° "v E et R F .m uuc R w _ a o .. v o .c c Cl }L, Y ,� Cl O . u •O A i > LO O g:1 R G �, c-) c ° d o 0 'c1 L — N c N 3 O L c E V C c .0 0 0 .o o ' O O Q. v O O O 4= U `� b0 E p I- v o a 6 L L v v w cn v tC 5O ,� •� N U L °°-oo O Cl L v s7u c L a Cl v o ac •° N o a o > E A a oL. a .E p ft o ° o o °' •'c o on E. O 47 0 '?� A 0 F LE CC ° i x F Q -o H S o F < v o Cl 'V 0 z t' a � ,≥ c ≥ v ao a`a R v en v v q o ooa o aoa a a 04 C.4 "O O 04 b VI R O MD 0 N c v .C Cl v v c E �; '' a cu -o E c CO 3 c E v C ou ° °0V = R u .� c-. v a L cCt E T O -O .Ny _ - O a p u an c" 3 c C v "v r v 4�_. L 0 p L a N c3 0 L > O � '�..� 0 'O m U 40 ,L °'� d 4- O vi 0 .-L• 0n Q'a -O 5a COc O E a"i r e a o > a c v O L O az 5 E C > ._ 0 0 .r �+NI 73 Cr E «�+ o o .v O 0 W 11 L y N O N b.0 o o 0 c CO 0 cr a.3 4a- - J 0 .c L c O v, •R A ae .E v v c O 5 E .. M ..• 0 Cs. •v L U � U E o v c b a E ° m C d v •o OO 0 > " o as o v c c a._ at c C O v to U b F t ≥ cl c E F y o 5 r aL' s aEi a . ti '_ ta 69 v Y .6 h •E o c n i4 c° 00 a vv, c 3 O y ee E 6 r avi v 0 � 5 .01. ° .E E C v o • c Lt. z E A c t cC o t.. e E = E 4 s a c U cc li > '- t m N v "('i >, L O — 'FS C N cC "L O E = N en 'O ctl en ris 0. Oq :@ CA M act r' E Ott uu co, v 3 Lmv vQ Kt E i I > m F- m Z x -a Lt 0 aJ v C C a) a C 0 C a a) C O O -0 '.,p O O O O O ...-s .O L •- La Ci - `-' •g' E 0 E 0 0 0020E0 E O E O E v E I.) E 0 o o a Lv EIC Et. 0 • I- ° E E Eye Ew Ea"-. E ° E �= vo Uo � 4011 pa 0000 u0 aauo 0 E ° a ° o • v. 0 w d o n. I E v v v q o o.v a a ; aUa a a 0' a aUa 90 U o u o N 0 0 ,D o L. a C '-' Cr to, lay GJ a a i N L C L . 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C 'R Y s i, C O R O .��.. v .E c c0 c m w° L a v 3 e w ,�cj v o el a v c•, 6=. o s c a, .�T m o a a o iii y ri D Q E nS.. .E o a n y M o i- o c °' .> a > Q s 0 a.> 0 •E °3 ' o o Q ' a• c wal a C C .E o C U 7 Y U u N C) .C 0 °L' = 0 c o T- _ N O -e T3 ' T :a E ? o v oo L O .i sv op. E 0 s o 3 s a c s In r C — o 3 " o y c �? �o r c -a .n •O O .O = m a~+ 0 C -a 0 C °• " o " *� I-. 0 v O v ;9 F F7 ca c a c s'. LS -o Ey g' a S E :D E a o .5 — v t.� m W E c o °n 0 0u ° ° E a — ? ° a C Q s ch a ¢ n v a a�iF ° S o ' Eo •E O° aai F mU wmc Ern 0a. 0 o aCG acL2yTA CA o co a 0 v o N ct '^ o >a °L' •C ›, o — O r„, a ,c- fl o .1. „9 _O>-..-a..›.. `C 0• •C >, a — v _ 2 v 0 O 4 o s ca 0. W Z v; U .n L . c ' t - .ca ° v, L Q Qa cn 3 q' 0] Ov — m ° " 3 CZ �'3 u• 3 0 S u C O c `� k � ' v .o t'' c�'i o v 5 .Eo. s G7 O c0 k v ' Y G O I... C •y v y O L- 'O OU U o c0 c c a O U -p O L cc0 c) t 171`—' Q c `� ,._, •N v v o v .o .., -.,, N N = o H u a = 0 s p c V 4. aU+ -o b0 U L v E 0 0 V B 'C E• w t o E r c v D > i U O • ` y V m a c 'E o y c L '5 V O 7 -�-. C u a U ^ U 4a En v -p v O O c y v T C y y Y 0 0 rn R 7 c c0 7 u a v O V ..• c0 C N O •= V = V U 0. U 'O v a. U • V Y d - O R U y �� a v y a 0 V t0 V o V E ` n 'o co y .? t i CI-. C L . C.) a� c o a> c" C c,.; v •O • E rt - �+ L E c0 o c > 3 v Cl. = o N c •7 v > V O o N O 'U bq.E 6 y U U 7 c L 'O 'Q E C V O o c C v tc0 .t+ cL0 .E i0 E yv gct 7 c 0 e0 r"il Rs '«. v T uU ,� . u o E y E i c .a co .E m y ca a E c .o CD u '- T C �0 _ y on c a U c n. .ca E E 7 M y '° — a Q E 7 O O A y U E c0 u V a cn c C cn O ya " ct V v u V 7 = E V v '-c 7 c c. o v EDGE)° s v Y 7 .O o 7 y A s p m o •o v • c C E- 0 -o s L U C U '6 v E a7, - 3 3 �° L -C ° cr O 0 L -- L o on ° c o s o u O v O V v E 7 E O v c = .71 4.. 00 c C y 7 O E .> U C N _ 4. E c V V C w O 3 o v v -o ay v U 'O y y t C 2 y . w .. .E v -0 :r, c cci p ' c0 •= u -o L c — E M E '3 V a � 'O V C v c0 '4 c6 v ti V rn .N OD.`" v „' _ .e'L_ " = cc0 E a.� N •' Y > a o v L., c N E o C7 .� a., cl O cr U v V O jc Er U C E .o O r... .N c cU -o V , - =0 0 3 y ffi o y c0 c _a v C O o ao — c 030 '0. uau00 7 0 �, - z L y .b cc: r, c . C 'E E- r 3 ca w, o �, E Y ,Ef •o '�, u C bf1 E Y a v 7 R 'p O c O v u N o C c v, i G v �' ,� L v v U .n 3 . > al 0 o ❑ i E U I. CL.1 y E ' O .9 T u = N C "6 c0 — = •p v y c U C Lc. O •' cn O v v a C a .O oyn,moo ou o v v a v y E E O J o V• v Oy v v Gl R v v c > v v v N act a. a ..- D ., I-4 n Ugp a cc: > ShhibrtC Cone!Routing limber 13 FIA 45015 Weld County Na1M Oep10nnl FDA Tobacco Retell Inspection-Mutlnm Proposal 0.m On The I nwwebe0 sore repmYK to concluding aµmvre0y w roed core rayed..he mmbnce won Poasers Ste Feerob Smoking Prevention and Tobacco Control ht(rmlutg I.Y.w.up and aVen vnpanll s),reaweroet eeva Nwpnwllt raining,and vpmelm of erco mianrc carbon and SW"lurlmclor Wceareob00e.reprsrg,and Idiwnp al FDA and COPNE 050 Sa.75717 II {}MSdI P.hm's and procedures ingaKKs or Weld Cwrey will be 600 n a41.Sabres are abvbled h xmunl fora tlq mmll mem as coo as coal of Irmg alWreno olyProshlnery 3%This ryes e!d a6c be the mariner he the program and aM a the mm conbct ro Ile stale The Inspector wY be rend Me Or onoetng o.Poerlaty 300 retileh ie dombrcorpbanelrhporseesoflhe F mip Smemg Reese*.and Tao control Acl(irrchrre Ptlfna lolbw.Wenacn¢encenpaningeM¢),revurtrrenl CHirWComrvrnM oamiy,ahnrs ro.lrnemam5nce oActon and OA 53.246 05 12 11947$ spolYiWmpdor Waco°ban'ccete.and!diming all FDA and COPNE eoeRdaeMPoseees.inspections ce NW CosrynXh KO In total.Steles OI,e brnob onva9gnml incr2%aa x!aell n nml d Inmg a}mAnenb of agrronaYy Total Direct Salary Ftl%g 'Die agency bemM.ar s 3e.53%arid a he ratu4 W rat to Smelts cover Unerplynenl:rgomx,Wales Cmp Health JP 93% 518,,694 Inaaarainclutireason and hnn.FICA toes andM sae. Total Sanehlled Poalen 166113 Was wl adA the rq^x0r Wong unbewa buy aryeckns no Oetrmlre rebind currkrxe oath the age and atronoM ponions of tie reµi4na by aMgingha Wrdaa bbanu as metaled persons.Its enmryted that as ad be needed Pr S0%00 300 toll ngaTm¢needed no.he reacn elq,mm.ty r lour Per inmeecmn Aa res y Minors(under lfi yam 60%of he bunesII occur out&dot agency Mnemunly, olagel b¢vNhreh rnhas tom Weld Cavity requested at an 51200 600 17.920 a6Jbnar 360 van Rlnlrsa bps Tape=Wk..) 300.SOP 650 and abe nrttes taring The hourly rate hies n b ere account tereed b rises he moos The rerots at n amed on the amount olbne,and high the of renonadiy o llM1s peibon Then rats ollpellert oath other youth-Darted positions lh¢ge:gyhe sea Tad Peretl 114.453 aPmrenlxPm.s Evbns ecm include materials set as Disco 0.rale begs. bona..Iekrg Die.and postage for WMway of evdeee(0 teiMrce Naedllg COpIE{1O Pe month h supplies and 525 per Anm pt $2 ly Il 61!02 620 Fed Ex sem.a 06020 eToy ICO arohb.Fa year=E=Sn 2620) Tobacco 12 no-6120•(100 sots.a$25lgnpmenli= 1620) Tobacco Purchase or Mlnvs wll aesopl 0 ardlese tote®ding mmoNTe.TAM Non•Coenlince item¢calculated at E6 per peck of ryaehs pee inspection and W M.W iffi Inspections a actor ate otl0%(300 iwe;hon x31%Intl Office stpllen vcrpe perm.papa.pine oetdle5..makes 011e supplies etc AlxnWdeseec0P5 Units got2owaedr°Reesman.. 12 $10OW 61310 ae estnaled at 1100 per rtmh per FIE ell monlls=$1]W Mel oparainno p5fi3 Pape 1 oft Chose C ravel In Rogers 2.(lane.Weld.BroanM],Adam.Mogen_ Legal 5eegwiG,Phay,Yux,Welriybn comas),in. sah travel wet encennrms Eon a Yqe wet and AEen vm 0110100 whit d spinal,and denmly gquhld wit hgh and low 02000 10.60 56.604 totem°retail dnvty Pemuumwnlu®Iahtd al be Stale o f Cohae mileage ras of$60 par mile Pent cached-gas may be remb sed In lea of mileage P erden,is allowed tor mspecWrrs cob}of Weld'minty and abased on nonce be steer dlemeeled nghl almyrg a f000iem be Peed ring an average µedun rek of 6.50 0Redly.based on me It 2orrtadalrml paaam rale Avenge pa hmraad so 55060 $2,525 determined by aunty Lerner fY.Wed N0,Brartd 561.Adorns 556.Morgm$40 Login 546.5n¢uek 546 Fillips 45.Ame$46 and Washington 546 Lairs is bassi.trawl over lW miles ton goal Malt agency in Wed County aMedudgd1M br25 rights usng a Ladgfrg do,Field Travel mg-range of cost an baggy'swam min"?Lams amt. 20 45®g $2,00 Weld 147 6m0000d 5104,Nyns:5141.Morgan III Ulan.511.5erdggwck Al.Phillips 577.Yuma.177 and Washington all IOW Trani 110,7 Total aired Costs SE9,W 1magenryiMsedrarool1777%n calculated to Include sourly%ppeR Iron palest"amounting.nvnan resources. Irrareneoaalae halls dept 6dseless office compact.services.am 0000 Isl...phone a compul unites Its nladti based some see% 56,01 AttachmentJ total dyed mss.I o,..,because ate tat fumy,tee difference beMren this ral acrd me charged rale of 0 BB%wgl ▪xmeed by the see Teti Page 2 or STATE OF COLORADO John W.Hickenlooper,Governor Christopher E. Urbina,MD,MPH "by cot \ Executive Director and Chief Medical Officer Dedicated to protecting and improving the health and environment of the people of Colorado o P 9 P P + �.- 4300 Cherry Creek Dr.S. Laboratory Services Division . 6 Denver,Colorado 80246-1530 8100 Lowry Blvd. ta� Phone(303)692-2000 Denver,Colorado 80230-6928 Colorado Department Located in Glendale,Colorado (303)692-3090 of Public Health http://www.cdphe.state.co.us and Environment October 12, 2012 Mark Wallace WELD COUNTY DEPARTMENT OF PUBLIC HEALTH AND ENVIRONMENT 1555 17th Avenue Greeley, CO 80631 HI, Mark: Enclosed is your copy of the fully executed Colorado Department of Public Health and Environment Task Order Contract listed below. You may begin work on October 10,2012. Contractor Name: Weld County Dept of Public Health and Environment Task Order Contract Number: 13 FLA 48015 Original Contract Number: N/A Division: Prevention Services Division/PSD Program Name: STEPP/FDA Project Name: Perform work for Enforcement of Family Smoking Prevention and Tobacco Control Act Reason for Contract: New Please contact Chandra Hardwick at(303) 692-2505 or by email at Chandra.Hardwick@state.co.us if you have questions or concerns. Sincerely, KATHY JACOBSEN,MS Contracts Administrator Prevention Services Division (303)-692-2479 kathylacobsen@state.co.us Hello